Kornimate/medical-research-clean huggingface dataset:
investigate effects of a2 milk on breastmilk composition and subsequent infant gut health, crying and sleep patterns in healthy, full-term infants

Conditions: Digestive System Disease; Sleepiness; Crying

Summary: the goal of this interventional study is to investigate effects of a2 full cream milk on breastmilk composition and subsequent infant gut health, crying frequency and sleep patterns in healthy full-term infants. 50 mothers and thier infants will be enrolled into 2 study sites, mother and her child as one subject will be randomized to 2 groups for assigned interventions, a2 full cream milk and conventional milk (weidendorf). the study will continue for 14 days, and 3 site visits will be made duing the study period. all data specified in the protocol will be captured and recorded into ctms for analysis. researchers will compare the two groups of participants to see if a2 full cream milk has significantly better breastmilk composition and improve infant's gut health, crying frequency and sleep patterns.


Eligibility criteria:
inclusion criteria: * mothers who are 25 to 45 years old; * mothers who are exclusively breastfeeding with healthy and full-term infants; * infants of these mothers who have been exclusively breastfed since birth, and their parent(s) decides to continue exclusively breastfeeding until at least 120 days of age, birth weight between 2500g and 4500g; * willing to sign icf before the study launched. exclusion criteria: * mothers with infection or have recently taken the flu / covid vaccine in the last 4 weeks; * infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases that could interfere with the survey; * evidence of feeding difficulties or intolerance/allergy to cow's milk (mixed-fed group only); * conditions requiring infant feedings other than those specified in the protocol; * significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other); or parental refusal to participate; * infants with an acute infection or gastroenteritis at time of enrollment; * participation in another clinical trial; * investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.

Keywords: a2 full cream milk breastmilk composition gut health
a study of jnj-63733657 in participants with early alzheimer's disease

Conditions: Alzheimer Disease; Cognitive Dysfunction; Dementia

Summary: the primary purpose of this study is to evaluate the effect of jnj-63733657 versus placebo on clinical decline as measured by the integrated alzheimer's disease rating scale (iadrs), a composite of cognition and function.


Eligibility criteria:
inclusion criteria: * early alzheimer's disease (ad): gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and clinical dementia rating-global score (cdr-gs) of 0.5 and memory box score greater than or equal to (\>=) 0.5 at screening * participants must have positive tau pet results * able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening * have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant * male participants must agree not to donate sperm for the purpose of reproduction during the study and up to 16 weeks after receiving the last dose of study intervention exclusion criteria: * participants with cdr gs \>=2 at predose baseline clinical dementia rating (cdr) administration * participants who fulfill diagnostic criteria for mild cognitive impairment (mci) or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than ad (example, parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, (et cetera\[etc\]) * geriatric depression scale (gds) 30 score greater than (\>) 12 * hachinski ischemic scale (his) \>4 * has received medications that affect the central nervous system (cns), except treatments for ad, for less than 2 months; that is, doses of chronic medications that effect the cns should be stable for at least 2 months before the start of screening. if a participant has recently stopped a chronic medication that effects the cns, he or she must have discontinued treatment at least 2 months before the start of screening. chronic use of benzodiazepines is not permitted
therapeutic epidural patch versus pain block in the midface for headache

Conditions: Postdural Puncture Headache

Summary: the purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

the sphenopalatine nerve block has been used to treat headaches. patients have headaches after epidural access from post dural puncture. we need to know if sphenopalatine nerve block will help the patient with the headache.

Eligibility criteria:
inclusion criteria: * males and females ages 13-92 * subjects have medical diagnosis of pdph and require treatment * subjects who signed consent/assent exclusion criteria: * \<13 years of age * pregnancy * subjects with heart failure * subjects already being treated with lidocaine patch or other vehicle for chronic pain * non-english speaking subjects * subjects with platelets \<100,000 * subjects that are septic * subjects with an allergy to lidocaine * subjects with known nasal polyps * subjects with recent neurological event * subjects on anticoagulant therapy * subjects that received prior therapy with spg block or ebp
a study to evaluate the efficacy of oral akst4290 in participants with moderately severe to severe diabetic retinopathy (capri)

Conditions: Diabetic Retinopathy

Summary: a double-masked, placebo-controlled study to evaluate the efficacy of oral akst4290 in participants with moderately severe to severe diabetic retinopathy (capri).

this study is designed to evaluate the efficacy of akst4290 administered at a total daily dose (tdd) of 800 mg daily (400 mg twice daily \[b.i.d.\]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (npdr) to severe npdr. participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (akst4290: placebo). participants will receive treatment for a total of 24 weeks with either akst4290 800 mg daily (400 mg b.i.d.) in arm 1 or placebo (matching tablets) in arm 2

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. type 1 or type 2 dm. 3. bcva etdrs visual acuity letter score≥ 69 letters at screening. 4. moderately severe npdr (drss level 47) to severe npdr (drss level 53). exclusion criteria: 1. evidence of neovascularization (nv) (including active iris or angle nv) requiring treatment, per investigator discretion. 2. prp or grid laser within 1000 microns of the foveal center. 3. center-involvedi-diabetic macular edema (ci-dme) on clinical examination (ci is defined as dme within 1,000 microns of the foveal center). 4. prior intraocular of periocular steroid injection 5. systemic anti-vegf or pro-vegf treatment within 4 months prior to enrollment and assignment to a randomized treatment. 6. history of vitreoretinal surgery. 7. history of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. 8. history of dme or dr treatment with laser or intraocular injections of medication. 9. medical history or condition that, in the opinion of the investigator would preclude participation in the study. 10. clinically relevant abnormal laboratory value at screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the screening phase). 11. malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed). 12. concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to screening.

Keywords: ccr3 inhibition diabetic retinopathy oral treatment
mechanisms of diabetes control after weight loss surgery

Conditions: Gastric Bypass Surgery; Obesity

Summary: obesity and type 2 diabetes (t2dm) are increasing in the us. one third of patients seeking bariatric surgery have t2dm. although all surgeries result in significant weight loss and often 'cure' the t2dm, the rapid onset and the magnitude of the benefits of gastric bypass (gbp) on t2dm has thus far baffled clinical scientists. limited data suggest that the improvement in t2dm after gbp occurs very rapidly, and may not be wholly accounted for by weight loss. secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in t2dm and improves after gbp, possibly due to the specific anatomical changes after this surgery. while some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after gbp might be specific to this surgery. the aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after gbp than after an equivalent diet-induced weight loss. we will compare, in obese patients with diabetes, randomized to very low calorie diet or to gbp, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (iv) glucose loads). as more obese diabetic patients undergo gbp, understanding the mechanisms that produce improvement in their diabetes is increasingly important.


Eligibility criteria:
inclusion criteria: * morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet. exclusion criteria: * any condition that would be contra-indicated for bariatric surgery (ex:unstable angina) * diabetes treated by insulin, thiazolidinediones (tzd), exenatide, dpp-iv inhibitors * hba1c \> 8%

Keywords: gastric bypass diabetes obesity diet-induced weight loss incretin levels (glp-1,gip) incretin effect
analgesic effect of escitalopram in total knee arthroplasty (tka)

Conditions: Postoperative Pain

Summary: pain is a major problem after tka, especially in patients with high pain catastrophizing. newer mr-scan studies indicate that escitalopram may have an immediate cognitive and emotional effect. the investigators therefore investigate the effect of escitalopram as a perioperative analgesic.

pain is a major problem after tka, especially in patients with high pain catastrophizing. newer mr-scan studies indicate that escitalopram may have an immediate cognitive and emotional effect. patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of escitalopram. we therefore investigate the effect of escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.

Eligibility criteria:
inclusion criteria: * primary, unilateral total knee arthroplasty (tka) * age \> 18 \> 81 * ethnic danes * score \> 20 on pain catastrophising scale exclusion criteria: * medication that causes risk in combination with ssri (6 month) * treatment for anxiety or depression * history of depression or mania * treatment with systemic glucocorticoids (6 month) * treatment with opioids (4 weeks) * alcohol or drug abuse * history of malignancy * fertile woman * history of epilepsia * treatment with anticoagulants * bmi \> 40 * disease affecting central or peripheral nerve function * dementia * history of gastrointestinal bleeding * history of hepato- or renal insufficiency * allergy to escitalopram
the effect of music played and acupressure application on pain and anxiety in women undergoing gynecological examination

Conditions: Pain, Acute; Anxiety Acute

Summary: this study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.


Eligibility criteria:
inclusion criteria: * - not to be pregnant, * no hearing problems * being between the ages of 19 and 65, not having any psychiatric illness, * no gynecological cancer, not to have any deformity in her extremities exclusion criteria: -

Keywords: acupressure, nursing music gynecological examination
low-level laser therapy in genitourinary symptoms of menopause

Conditions: Menopause Related Conditions

Summary: the study will employ a prospective single-arm design involving menopausal women who present with genitourinary symptoms of menopause (gsm). due to the preliminary nature of this study and the absence of a control group, the primary objective is to evaluate the feasibility and potential efficacy of low-level laser therapy in alleviating gsm in this population.

a convenience sample of menopausal women aged more or equal to 45 years will be recruited from the gynecology clinic in our hospital and its branches. participants will undergo an initial screening to confirm the presence of genitourinary symptoms associated with menopause. inclusion criteria will encompass women experiencing symptoms such as urinary incontinence, vaginal dryness, dyspareunia, and decreased sexual satisfaction. the exclusion criteria will be diagnosed with advanced pelvic organ prolapse (more or equal to stage 2 prolapse by pelvic organ prolapse quantification system). all participants will receive low-level laser therapy (lllt) as the intervention. lllt sessions will be conducted once a week for eight weeks. the laser therapy will be administered by a trained healthcare professional using a standard protocol, targeting the genitourinary area. the laser device will emit low-energy laser light, which is hypothesized to stimulate tissue regeneration, improve blood circulation, and alleviate symptoms in the genitourinary region. baseline assessments will be conducted prior to the initiation of lllt, including demographic data collection and validated outcome measures to evaluate gsm and quality of life. these measures may include the international consultation on incontinence questionnaire - short form (iciq-sf), female sexual function index (fsfi), vaginal health index (vhi), incontinence impact questionnaire-7 (iiq-7), overactive bladder symptom score (oabss), urogenital distress inventory-6 (udi-6), urgency severity scale (uss), king's health questionnaire (khq), and a urodynamic study with a 20-minute pad test. follow-up assessments will be conducted immediately after the fourth- and eighth-week treatment period and at a three-month post-treatment follow-up. during these assessments, participants will complete the same validated outcome measures as the baseline assessment to evaluate changes in genitourinary symptoms and quality of life following lllt.

Eligibility criteria:
inclusion criteria: * menopause women * with genitourinary symptoms of menopause exclusion criteria: * acute or chronic infection of the genitourinary tract * advanced pelvic organ prolapse (\>= stage 2 on pelvic organ prolapse quantification system) * history of pelvic malignancy * unstable blood pressure * fever * abnormal sensory nerve * abnormal coagulation

Keywords: genitourinary symptom vulvovaginal atrophy menopause
prevention of recurrence of venous thromboembolism in patients with a history of venous thromboembolism

Conditions: Venous Thromboembolism

Summary: the study objective is to evaluate the efficacy and safety of oral ym150 for 52 weeks in patients with a history of venous thromboembolism.


Eligibility criteria:
inclusion criteria: * subject has symptomatic vte and/or asymptomatic deep vein thrombosis * written informed consent obtained before screening exclusion criteria: * subject has history of deep vein thrombosis and/or pulmonary embolism * subject has a hemorrhagic disorder and/or coagulation disorder * subject has had clinically important bleeding occurred within 90 days prior to the screening visit * subject has an acute bacterial endocarditis * subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke * subject is receiving anticoagulants/antiplatelet agents * subject has a body weight less than 40 kg

Keywords: ym150 bleeding vte fxa inhibitor venous thromboembolism
a study to evaluate ocrelizumab compared with placebo in patients with rheumatoid arthritis who have an inadequate response to methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on days 1 and 15, 2) infusions of ocrelizumab 400mg iv on day 1 and placebo iv on day 15, or 3) infusions of placebo iv on days 1 and 15. at the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. all patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. the anticipated time on study treatment is 1-2 years. target number of patients to be enrolled in this trial is 300.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age * active rheumatoid arthritis * inadequate treatment with any dmard other than methotrexate exclusion criteria: * rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis * concurrent treatment with any dmard other than methotrexate * previous treatment with any cell-depleting therapies * any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline

Keywords: ra
time of treatment with lmwh in cancer patients with thromboembolic disease

Conditions: Venous Thromboembolism; Pulmonary Thromboembolisms; Cancer

Summary: cancer is the most important acquired risk factor of thromboembolisms. more than 20% of all episodes of venous thromboembolism (vt) or pulmonary thromboembolisms (pt) are cancer related. cancer patients with vt or pt are treated with low molecular weight heparins (lmwh) during at least 3 months, but nowadays the duration of treatment is not accurately determined. the d-dimer determination has been used like recurrence predictors after lmwh treatment suspension, but in cancer patients the useful is limited. phospholipid-dependent microparticles could been used like recurrence predictors in cancer patients and tailored the duration of lmwh treatment for each patient.

we are carrying out a study in cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. a set of exclusion criteria is being used to determine in which patients lmwh will be withdrawn. patients are being followed after lmwh withdrawal until 6 months. blood samples are being taken at baseline (lmwh withdrawal), 3 weeks and 3 months after. we will look for association between several biomarkers and venous thromboembolism recurrences.

Eligibility criteria:
inclusion criteria: * patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (pt) or venous thromboembolism (vt) , in treatment with low molecular weight heparin (lmwh). * patients treated with lmwh since cancer diagnostic. * signed informed consent sheet exclusion criteria: * patients with life expectancy lower than 6 months * pregnancy woman * patients with cerebral metastasis

Keywords: low molecular weight heparins procoagulants phospholipid-dependent microparticles
efficacy of acupuncture in patients post-covid brain fog

Conditions: Brain Fog

Summary: after being infected with covid-19, many people developed to brain fog. the treatment strategy now is based on the presumed pathological phenomenon and the physician's clinical experience. acupuncture has been used to improve cognitive dysfunction caused by central nervous system diseases for many years. a randomized rater-blinded controlled study is proposed to see the efficacy of acupuncture for brain fog.

after being infected with covid-19, many people develop cognitive dysfunction, including deficits in attention, executive ability, language, processing speed, and memory. these symptoms are collectively known as brain fog or covid fog. the pathological mechanism of the cognitive deficit is inconclusive. therefore, the treatment strategy is based on the presumed pathological phenomenon and the physician's clinical experience. acupuncture has been used to improve cognitive dysfunction caused by central nervous system diseases for many years. this study aims to evaluate the medium and long-term clinical efficacy of acupuncture in patients with post-covid related mild cognitive impairment (mci). a randomized rater-blinded controlled study is proposed. eligible patients were over 18 years old and \<65 years old. these patients were diagnosed with covid-19 more than 12 weeks earlier and developed mild cognitive impairment (mci) after the diagnosis of covid-19. divided into the acupuncture group and the sham acupuncture group for an 8-week course of treatment, the mini-mental state examination (mmse), the quality of life assessment scale the 5-level eq(euroqol group)- five dimensions version(eq-5d-5l) and the stroop color and word test evaluates the degree of cognitive impairment and the impact of cognitive impairment on quality of life and attention.

Eligibility criteria:
inclusion criteria: 1. have been tested positive for severe acute respiratory syndrome coronavirus 2(sars-cov-2) or had serum antibody positivity more than 12 weeks before. 2. present cognitive impairment after been diagnosed as covid-19 3. clinical dementia rating (cdr) score of 1 4. normal activities of daily living score (adl) 5. (mini-mental state examination) mmse score of 24-28 6. age of 18-65 years 7. signed informed consent exclusion criteria: 1. diagnosed with any type of dementia. 2. a history of acute or chronic cerebrovascular disease, encephalitis, parkinson's disease, leukoencephalopathy, and other central nervous system diseases 3. a history of hypothyroidism, vitamin b12 deficiency, depression, syphilis, and other diseases that may affect cognitive decline. 4. severe hearing and visual impairment, inability to complete neuropsychological tests 5. impaired liver and kidney function and hematopoietic system disorders

Keywords: brain fog