Kornimate/medical-research-clean huggingface dataset:
south asian women & yoga education study

Conditions: Cardiovascular Disease

Summary: the purpose of this randomized, control pilot study is to measure the effects of a gentle, 12 week hatha yoga program on post-menopausal, obese, sedentary south asian women at risk for cardiovascular disease. hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. the yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.


Eligibility criteria:
inclusion criteria: * 40- 65 years old * postmenopausal (amenorrhea for ≥ 12 months) * overweight as evidenced by a body mass index (bmi) ≥ 25 kg/m2), or waist circumference ≥ 80 cm, or have a first degree relative with diabetes or essential hypertension * sedentary, do not do a regular exercise program (exercising for 20 minutes at sufficient intensity to produce sweating less than 2x/week) * self-identify as a south asian (sometimes referred to as east indian in canada and may be defined "as any person who reports an ethnicity associated with the southern part of asia or who self-identifies as part of the south asian visible minority group. this definition encompasses people from a great diversity of ethnic backgrounds, including those with bangladeshi, bengali, east indian, goan, gujarati, hindu, ismaili, kashmiri, nepali, pakistani, punjabi, sikh, sinhalese, south asian, sri lankan and tamil ancestry. south asians may have been born in canada, on the indian sub-continent, in the caribbean, in africa, in great britain or elsewhere * given consent to research protocol and willingness to be randomized to either the treatment (yoga) or control (no yoga) group. exclusion criteria: * have had a period within the last year * are not between the ages of 40 and 65 * have experience with yoga within the last 12 months * have any serious disease or condition such as diabetes, serious high blood pressure or heart problems, kidney disease, severe asthma, cancer (except for skin cancer that is not melanoma) * have a major brain or nervous system diagnosis, such as parkinson's disease or stroke * have a severe infectious or other medical illness right now such as pneumonia * use medications to lower blood sugar levels * have serious back, hip, or neck problems or pain in joints or bones that would prevent the safe completion of a gentle 12 week hatha yoga program * regularly use an assistive device (e.g., cane, walker) to walk

Keywords: yoga postmenopausal, sedentary south asian women
use of prophylactic lubricating drops after cataract surgery

Conditions: Dry Eye; Cataract Surgery; Patient Related Outcome Measures; Patient Satisfaction

Summary: this is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.

on entry into the study patients will be randomized to receive either lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% sodium hyaluronate with vitamins a and e (aeontm repair) to be administered four times a day for 6 weeks following surgery (in addition to the usual post-operative topical medications of chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (maxidex) four times a day for 4 weeks) or no additional lubricant drops in addition to the usual medications described above

Eligibility criteria:
inclusion criteria: * bilateral or unilateral cataracts requiring surgical intervention * age over 18 years * able to understand informed consent and the objectives of the trial * not pregnant, not breast feeding * no previous eye surgery exclusion criteria: * age-related macula degeneration * glaucoma * previous retinal vascular disorders * previous retinal detachment or tear * any neuro-ophthalmological condition * any inherited retinal disorder or pathology * previous strabismus surgery or record of amblyopia * previous tia, cva or other vaso-occlusive disease * already enrolled in another study
alloimmune response to citrullinated shared epitope sequence in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an autoimmune and sistemic disease,characterized by joint sinovitis and the production of autoantibodies (ab). the ab against citrullinated peptides (acpa) are the most specific (92-98%), and high sensitivity (75-81%) and they are of prognostic value. acpa are already in the beginning of the disease in most cases, having been found years before its onset. recent studies have suggested that acpa may have a role in perpetuating inflammation, in the generation of bone erosions and in pain in ra. citrullination is a post-translational modification mediated by the pad, which transforms an arginine into a citrulline. in vivo, this enzyme acts in proinflammatory environments. despite being widely studied, none of the natural citrullinated substrates have been shown to be the triggering and/or perpetuating factor in the response of b cells in ra, understanding this response as the production of acpa. in fact, the most specific and sensitive commercial test for the detection of acpa uses synthetic peptides protected by a patent. in the other hand, the genetic factor that most increases susceptibility to develop ra is a shared sequence of aminoacids (qkraa, qrraa i rrraa), in the hla-drb1 gene, known as the shared epitope (se). also, se, confers prognostic value, and is associated with the presence of acpa. these se sequences contain arginines (r), which are susceptible to be citrullinated by the pad enzyme. we propose the hypothesis that citrullinated se act as an antigen capable of activating the inflammatory response mediated by b and t cells in ra. the recognition of an hla as a foreign one, would originate an answer of alloimmune type, not valued to date. the objective of the study is to test the immune response mediated by b cells and t cells, in cases and control samples, through an in vitro model that confronts them with peptides containing the citrullinated-se sequence. in addition, we will evaluate the association between these results with the clinical features of cases (ra included in the study). their role as a biomarker, as well as their potential to improve the tests currently available to detect acpa will be explored.


Eligibility criteria:
inclusion criteria: * patients with ra who meet 1987 acr criteria patients with arthritis no ra exclusion criteria: * having an intellectual disability that allows understanding the informed consent to participate in the study

Keywords: shared epitope hla-drb1 citrullinated peptides autoantibodies
the effect of supplementation of flaxseed, hesperidin, flaxseed and hesperidin together in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: to study the effects of hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. at the first and the end of the intervention, metabolic factors will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 70 years * having 3 of 5 of high blood sugar, hypertension, high tg, high waist circumference, low hd exclusion criteria: * pregnancy or lactation * history of cardiovascular disease, pulmonary disease, renal disease \& celiac disease; cirrhosis * following a program to lose weight in recent 3 mo
letrozole for frozen embryo transfer (fet) in patients with polycystic ovary syndrome (pcos)

Conditions: Infertility, Female; Polycystic Ovary Syndrome; IVF; Ovulation Disorder

Summary: to offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. the use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. the purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in pcos patients. the primary outcome is early pregnancy loss.


Eligibility criteria:
inclusion criteria: * age more than or equal to 18 and less than or equal to 40 * bmi more than or equal to 18 and less than or equal to 35 * diagnosis of pcos according to rotterdam criteria * normal gynaecological ultrasound \< 6 months before inclusion * signed informed consent form * day 5 or 6 frozen-thawed embryo transfer, blastocyst stage exclusion criteria: * recurrent implantation failure * recurrent miscarriage * presence of adenomyosis * untreated intrauterine pathology * rafs (revised american fertility society) grade iii or iv endometriosis * hydrosalpinx * in vitro maturation (ivm) * untreated autoimmune disorders * (history of) malignancy * allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past * pre-implantation genetic testing (pgt)

Keywords: frozen embryo transfer
toll-like receptor 9 agonist treatment in chronic hiv-1 infection

Conditions: HIV

Summary: combination antiretroviral treatment (cart) effectively suppresses virus replication and partially restores immune functions. however, cart cannot cure hiv infection. this study aim to investigate whether the antiviral immune response can be enhanced and/or viral transcription reactivated with mgn1703. mgn1703 is an agonist to toll-like receptor (tlr) 9. activation of tlr9 has been shown to augment innate and adaptive immune effector functions, most notably enhanced nk cell and t cell functions. furthermore, tlr9 agonists have been shown in vitro to reactivate viral transcription in latently infected cells, potentially leading to enhanced recognition of infected cells by the immune effector cells.

in part a, participants will receive 4 weeks mgn1703 therapy (60 mg s.c. twice weekly). during the 4 weeks, participants will be closely monitored for safety and therapeutic effects of the drug. targeted enrolment in part a is 14-16 study subjects. in part b, participants will receive 24 weeks of mgn1703 therapy (60 mg s.c. twice weekly). during the 24 weeks, participants will be frequently monitored for safety and therapeutic effects of the drug. targeted enrolment in part b is 10-12 study subjects, preferentially recruited from part a.

Eligibility criteria:
inclusion criteria: * documented hiv-1 infection * age \>18 years * cd4+ t-cell count \>350/µl at screening * on cart (for a minimum of 12 months) * able to give informed consent. exclusion criteria: * pregnancy as determined by a positive urine beta-hcg (if female) * males or females who are unwilling or unable to use barrier contraception during sexual intercourse for the entire study period. * currently breast-feeding (if female) * viral load (hiv rna) \> 50 copies/ml * contraindication to receive mgn1703 as per current investigator brochure * presence of acute bacterial infection or undiagnosed febrile condition * concurrent chronic systemic immune therapy or immunosuppressant medication, including continuous systemic steroid treatment within the last 2 weeks prior to randomization * use of antibiotic therapy within the last 2 weeks prior to randomization * known hbv or hcv infection * any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the principal investigator (pi), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia) * unable to follow protocol regimen
comparison of amoxicillin and amoxicillin + clavulanic acid in treating acute otitis media in children

Conditions: Acute Otitis Media

Summary: this study aims to compare the effectiveness of two treatments for children with acute otitis media (middle ear infection). the two treatments being compared are amoxicillin alone and a combination of amoxicillin plus clavulanic acid. the study will help determine which treatment works better in helping children recover faster and reduce the risk of treatment failure or recurrence. by providing clearer evidence, the research aims to guide better treatment choices for children suffering from this common infection.

this study will evaluate the effectiveness of two antibiotic treatments in children diagnosed with acute otitis media, a common ear infection. the two treatments being compared are amoxicillin alone and a combination of amoxicillin and clavulanic acid. acute otitis media is a significant health concern in children, causing pain, fever, and possible hearing loss. the study will be conducted as a randomized controlled trial at the department of pediatric medicine, nishtar hospital, multan. a total of 162 children, aged 1 to 5 years, will be enrolled in the study. they will be randomly assigned to one of two treatment groups: one group will receive amoxicillin, and the other group will receive amoxicillin plus clavulanic acid. the children will be monitored throughout their treatment to assess how quickly their symptoms resolve, whether they experience treatment failure or recurrence, and if they develop any side effects. the study aims to provide clearer evidence on the efficacy of the combination treatment (amoxicillin + clavulanic acid) compared to amoxicillin alone. by analyzing treatment outcomes such as symptom resolution time, side effects, and recurrence, the study will help inform clinical decisions and improve treatment protocols for acute otitis media in pediatric patients. the data will be analyzed using statistical software to determine whether the combination therapy leads to faster recovery and fewer complications. the findings from this study will contribute to better management of upper respiratory infections in children.

Eligibility criteria:
inclusion criteria: * children aged 1 to 5 years * diagnosed with acute otitis media (as per operational definition) * both male and female participants * parental consent obtained exclusion criteria: * children with allergies or contraindications to the trial drugs (amoxicillin or amoxicillin + clavulanic acid) * children with asthma or chronic obstructive pulmonary disease (copd) (as per medical record) * children who have received treatment with the trial drugs within the past month * children already enrolled in other research programs or who have received trial treatment * children with any comorbid conditions that may interfere with the study
study to evaluate outcomes of patients receiving treatment for wound care, pain management or surface skin scar therapy

Conditions: Chronic Pain; Fungal Infection

Summary: this observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. the patients will complete the patient reported outcome (pro) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy.

this observational study is designed to evaluate the reported outcomes for patients receiving topical therapy for the treatment of pain, fungal infections or skin scars. the patients will complete the patient reported outcome (pro) survey monthly and provide valuable data on the patients perception of their health status and well being while receiving therapy. patients are enrolled for 18 months. the investigator will complete a global patient assessment monthly of the patient's condition.

Eligibility criteria:
inclusion criteria: 1. an 18 to 85 years old (inclusive) female or male patient 2. prescribed compound for the treatment of pain, wound healing or surface skin scar by their principal investigator 3. any systemic disease (cardiac, renal, or hepatic) must be well controlled. 4. has no skin lesions at the site of application of study medication except for wound under treatment 5. able to provide informed consent exclusion criteria: 1. pregnant or lactating females or women at the child bearing potential not using effective contraception. 2. use of other topical or transdermal medication. patients may be withdrawn for a period of 2 weeks from all topical or transdermal medications prior to study initiation. 3. hypersensitivity to local anesthetic or other ingredients of the compounded creams to be used in a study. 4. prior reconstruction skin surgery or skin grafts in the area of cream application preventing absorption of cream except for the treatment of surface skin scar 5. chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer, or gouty arthritis.

Keywords: pain wound care fungal infections scars chronic pain outcomes pro
the use of galantamine hbr (reminyl) in electroconvulsive therapy: impact on mood and cognitive functioning

Conditions: Major Depression; Bipolar Depression; Schizoaffective Disorder

Summary: the purpose of the study is to see if galantamine hbr (razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ect).


Eligibility criteria:
inclusion criteria: * criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a dsm-iv diagnosis of major depressive disorder, major depressive disorder with psychotic features, bipolar disorder, depressed type, or schizoaffective disorder, depressed type (19). exclusion criteria: * dsm-iv diagnoses of dementia and its subtypes * substance use disorder (active use within the last 6 months) * organic mental disorders; seizure disorder * unstable physical disorder or physical disorder judged to significantly affect the central nervous system function * a heart rate of \<60 * a systolic blood pressure \< 90 * heart block * pre-existing sick-sinus * chronic treatment with beta blockers * any cardiac arrythmia * hypotension * coronary artery disease * liver and renal function impairment * urge incontinence, colitis crohn's disease, gi motility disorders, asthma and copd * treatment with anti-cholinergic and cholinomimetic medications; and * female patients who are pregnant. * additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. norplanttm, depoproveratm ), or transdermally delivered contraceptives (ortho evratm) before entry and throughout the study; and have a negative serum b-hcg pregnancy test at screening. note: abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
population pharmacokinetics of amikacin in neonates

Conditions: Neonatal Sepsis, Late-Onset

Summary: aminoglycosides such as amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli. despite the frequency of this indication, it has not yet been possible to establish definitive dosage schedules that ensure effectiveness and low risk of toxicity, due to the high pharmacokinetic variability observed in this population. in addition to anthropometric variables, evidence from retrospective studies suggests that sepsis could be capable of significantly modifying the pharmacokinetics of aminoglycosides in neonates, but the investigators suggest conducting prospective studies of higher methodological quality to verify this hypothesis. due to the lack of pharmacokinetic and pharmacodynamic (pk / pd) studies of amikacin in this group of patients, the investigators have raised the need to develop a prospective observational study; describing a pk / pd model of amikacin in newborns with suspected sepsis.

three blood samples will be taken from each of the 138 participants. as a standard of care, a sample will always be taken at 0.5h (cmax) after the first dose and a sample before the second dose, which can be at 24h, 36h, or 48h as per physician indication. the third sample will be collected according to what has been assigned by a block randomization method, in one of the following moments: 1, 2, 4, 8, 12 or 18 hours after the administration of the first dose of amikacin. the methods used to analyze the samples will be: particle enhanced turbidimetric immunoassay (petia), architect c8000; and homogeneous microparticle immunoassay in solution (kims), roche systems. the determination of the susceptibility and minimum inhibitory concentration (mic) will be carried out by the laboratories of each hospital by agar dilution method. pk/pd profile of amikacin will be evaluated with nonmem (non-linear mixed effects modelling) software for the analysis.

Eligibility criteria:
inclusion criteria: * receive at least one dose of amikacin * be at least three days old (72 hours) exclusion criteria: * receive the first dose of amikacin in a healthcare center other than those included in the research * patient on renal replacement therapy

Keywords: neonatal sepsis amikacin population pharmacokinetic neonate
5-element music therapy on patients with breast cancer

Conditions: Breast Cancer Female; Quality of Life; Depression, Anxiety

Summary: in this study, we observed the clinical effect of using music therapy of tcm to improve the status of liver depression in patients with postoperative breast cancer patients, second we want to explore the efficacy and advantages of traditional chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.

the study is a prospective controlled trial. sixty-four patients were divided randomly into two groups. patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. the treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. instead, the control group was given every 3 weeks of health education preach. it will take 12 weeks for treatment and observation. the efficacy was evaluated by observing the beginning and end of the trial of the self-rating anxiety scale score, the self-rating depression scale score, and the breast cancer patients' quality of life scale. at the end of the treatment, we take software packages spss 20.0 for management and statistical analysis.

Eligibility criteria:
inclusion criteria: * the diagnosis of breast cancer in clinical stage (ⅰ, ⅱ, ⅲ) and postoperative breast cancer during one month; * all participants had to have clinical depression and stagnation of liver qi; * age 27-66; * participants are conscious and willing to be followed up during the treatment. exclusion criteria: * metastasis of breast cancer or serious complications; * patients with major depressive disorder; * the past medical history of mental disorders; * the primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases; * participating in another clinical study or undergoing another intervention; * patients with hearing loss.

Keywords: breast cancer music therapy quality of life depression, anxiety