Kornimate/medical-research-clean huggingface dataset:
non-invasive point-of-care hemoglobin testing in an obstetric population

Conditions: Pregnancy Anemia

Summary: anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. this screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment. masimotm has developed a non-invasive device that can detect anemia without a blood draw. this device has not been extensively studied in pregnant patients. the aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.

this is a prospective observational study of a non-invasive hemoglobin measurement device in a pregnant patient population. the device is fda approved for use in adults, children, and neonates. the current standard of care for anemia screening during pregnancy involves performing invasive venipuncture at two separate visits throughout the course of the pregnancy. the purpose of this research study is to compare the device performance with the gold standard hemoglobin measurement (venipuncture) when patients receive routine hemoglobin measurement during the course of their prenatal care. the research team will approach pregnant patients who are presenting for prenatal care at beth israel deaconess medical center, including the labor and delivery triage unit. the research team also will approach patients during an antepartum or postpartum admission. the research team will use the masimo rad-67 handheld co-oximeter which has a reusable finger-tip sensor that enables spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin measurement. study personnel will receive training on proper device use and cleaning by the local masimo support team. at the time of a blood draw, the research team will place the pulse oximeter on the participant's finger. the devices requires 1-3 minutes for an accurate measurement. after the measurement is complete, the participant will be asked 2 questions on their satisfaction and comfortability with the device and 1 question regarding their skin tone using a validated skin tone scale.

Eligibility criteria:
inclusion criteria: * pregnant or postpartum; * age ≥18 years old; * undergoing phlebotomy for clinical purpose exclusion criteria: - none
study of intravitreal aflibercept injection (iai; eylea®; bay86-5321) in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the purpose of this study is to determine the efficacy of intravitreal aflibercept injection (iai; eylea®; bay86-5321) on the best corrected visual acuity (bcva) assessed by the early treatment diabetic retinopathy study (etdrs) chart in patients with diabetic macular edema (dme) with central involvement.


Eligibility criteria:
inclusion criteria: the following is an abbreviated list of inclusion criteria: * adults ≥ 18 years with type 1 or 2 diabetes mellitus * decrease in vision determined to be primarily the result of dme in the study eye * bcva etdrs letter score of 73 to 24 (20/40 to 20/320) in the study eye exclusion criteria: the following is an abbreviated list of exclusion criteria: * laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1 * previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1 * previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1 * active proliferative diabetic retinopathy (pdr) in the study eye * uncontrolled diabetes mellitus * only 1 functional eye even if that eye is otherwise eligible for the study

Keywords: diabetic macular edema diabetic retinopathy
safety and efficacy study of dose-escalated hypofractionated radiotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.


Eligibility criteria:
inclusion criteria: * men \>18 years * histologically confirmed prostate adenocarcinoma * low or low-intermediate risk prostate cancer, defined as clinical stage t1-2b, gleason score \<=6, and psa \<15 ng/ml, or clinical stage t1-2b, gleason score 7, and psa \<=10 ng/ml exclusion criteria: * prior pelvic radiotherapy * anticoagulation medication (if unsafe to discontinue for gold seed insertion) * diagnosis of bleeding diathesis * presence of a hip prosthesis * pelvic girth \>40cm - large prostate (\>90cm3) on imaging * severe lower urinary tract symptoms (international prostate symptom score \>19 or nocturia \>3)

Keywords: prostatic neoplasms radiotherapy hypofractionation low and intermediate risk prostate cancer
guiding evidence based therapy using biomarker intensified treatment

Conditions: Heart Failure

Summary: the primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.

heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. common symptoms of heart failure include shortness of breath, swelling, and fatigue. standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ace-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. we are testing whether the use of a blood test called nt-probnp (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

Eligibility criteria:
inclusion criteria: * age 18 years or older * most recent lvef to be ≤ 40% by any method within 12 months of randomization. * high risk heart failure as defined by the following criteria: a heart failure event in the prior 12 months, defined as any one of the following: * hf hospitalization * treatment in the emergency department (or equivalent) for heart failure * outpatient treatment for heart failure with intravenous diuretics and * nt-probnp greater than 2000 pg/ml or bnp greater than 400 pg/ml at any time during the 30 days prior to randomization * willing to provide informed consent exclusion criteria: * acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days * cardiac resynchronization therapy (crt) within prior 3 months or current plan to implant crt device * active myocarditis, hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy * severe stenotic valvular disease * anticipated heart transplantation or ventricular assist device within 12 months * chronic inotropic therapy * complex congenital heart disease * end stage renal disease with renal replacement therapy * non cardiac terminal illness with expected survival less than 12 months * women who are pregnant or planning to become pregnant * inability to comply with planned study procedures * enrollment or planned enrollment in another clinical trial

Keywords: heart failure
effect of at home pain management products on acute low back pain, disability, and range of motion

Conditions: Low Back Pain; Acute Pain

Summary: the purpose of this study is to compare the effect of a combination of separate therapies of biofreeze® and theraband kinesiology tape to advice on acute pain, disability and fear avoidance among low back patients over a 1-week period of time.

a convenience sample of 120 acute low back pain patients will be recruited from sport and spine rehab at their initial appointment. exclusionary criteria will include pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. additionally, anyone who has a history of low back surgery will be excluded. patients will be recruited following their initial examination if they meet the inclusion criteria of reporting low back pain for less than 2 weeks and be \>18 years of age. patients will complete the informed consent, demographics information questionnaire, numeric pain rating scale (nprs), roland-morris low back pain and disability questionnaire (rmdq), fear avoidance beliefs questionnaire (fabq). following paper documents their lumbar range of motion and posture will be analyzed using the dorsavi vimove device \[http://us.dorsavi.com/vimove/\] (t1). after completing t1, patients will then be randomized into 1 of 4 at-home pain management groups (n=30 per group), to be followed for one week. group 1 (biofreeze® + tape), group 2 (tape only), group 3 (biofreeze only), and group 4 (advice alone). treatment at the first office visit will be standardized to include manipulation only; no in-office therapy will be provided to either group at the first visit. upon returning for their 2nd (t2), and 3rd (t3) office visits, all patients will rate their pain (nprs). at one week (t4) patients will complete the paper and pencil instruments from the first visit, which assess the subjects' pain on the numeric pain rating scale (nprs), low back disability on the roland-morris low back pain and disability questionnaire (rmdq), and fear on the fear avoidance beliefs questionnaire (fabq). lumbar range of motion and posture will also be reassessed. in addition,, at home pain management compliance and pain medication will be documented on a daily basis for the entire week.

Eligibility criteria:
inclusion criteria: * low back pain for less than 2 weeks and 18 years of age or older exclusion criteria: * pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery

Keywords: pain management topical analgesic acute low back pain kinesiology tape
flexor tenotomy and ulcer recurrence

Conditions: Hammer Toe Syndrome; Foot Ulcer, Diabetic

Summary: the main purpose of this study is to assess the efficacy of flexor tenotomy on the prevention of recurrence of toe ulcers in people with diabetes and a history of toe ulceration. additionally, the investigators aim to assess interphalangeal joints (ipj) and metatarsophalangeal joint (mtpj) angles in a weight-bearing and non-weight-bearing position, bare-foot plantar pressure during walking and quality of life before and after the intervention and compare between study groups.

foot ulcers are a frequent problem in patients with diabetes mellitus and can lead to amputations. prevention of these ulcers is therefore of paramount importance. claw/hammer toe deformity is commonly seen in patients with diabetes. these deformities increase the risk of ulcer development specifically at the (apex of) the toe. tenotomy of the tendon of the flexor muscles of the toes (tendon tenotomy) can be used to treat the consequences of claw/hammer toe deformity with the goal to prevent ulcer recurrence. for indication and assessment of outcomes of flexor tenotomy, weight-bearing ct and dynamic barefoot plantar pressure measurement can be used. this mono-center investigator blinded randomized controlled trial will compare the flexor tenotomy with usual care (including orthoses and shoe offloading). the effect on ulcer recurrence, toe joint angles, barefoot plantar pressure and quality of life will be assessed and compared between the intervention and control group.

Eligibility criteria:
inclusion criteria: * a minimum age of 18 years * sufficient understanding of dutch/english language * capable of filling out informed consent * peripheral polyneuropathy * diabetes mellitus type 1 or 2 * a minimum of one claw/hammer toe * a documented history of diabetic ulcers underneath the toe apex in the past 5 years exclusion criteria: * no written informed consent * not meeting the inclusion criteria * open ulcers on the toes * previous participation in the study * pregnant women * concomitant participation in a study in which the patient is exposed to x-rays
lugol's solution in addition to acetic acid during colposcopy

Conditions: Uterine Cervical Dysplasia

Summary: to assess the benefits of using lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.


Eligibility criteria:
inclusion criteria: * women referred for colposcopy due to cervical abnormalities * written informed consent exclusion criteria: * pregnant women * presence of a language barrier * history of conization or other treatments on the cervix uteri * iodine allergy

Keywords: cervical dysplasia colposcopy lugol's solution acetic acid
dermatological assessment of primary dermal irritability accumulated, sensitization, photoallergy and photosensitization of a scar gel

Conditions: Sensitivity, Contact; Photosensitivity; Phototoxicity

Summary: evaluate the potential of primary dermal irritability, accumulated dermal irritability, dermal sensitization, photoallergy and photosensitization, of health products through the application of patch test, proving the safety of the product for topical use. the study will be conducted with a brazilian sample in which 55 research participants will be included. depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.


Eligibility criteria:
inclusion criteria: * participants of both sexes aged 18 to 70 years; * phototypes: i, ii, iii, and iv (for the phototest trial, only phototypes ii and iii will be considered); * intact skin in the application area; * willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings; * understanding, consent, and signing of the informed consent form (icf). exclusion criteria: * pregnancy or risk of pregnancy/lactation; * use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection; * immunosuppression due to drugs or active diseases; * uncompensated endocrinopathies; * personal history of atopy; * intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period; * plans to bathe in the sea, pool, or sauna during the study; * practice of water sports during the study; * dermographism; * use of oral or topical treatments with vitamin a acid and/or its derivatives up to one month before the start of the study; * aesthetic and/or dermatological treatments on the body within three weeks prior to selection; * scheduled vaccination during the study period or within three weeks prior to selection; * history of sensitization, irritation, or photosensitization to topical products; * active skin conditions (local and/or widespread) that could interfere with study results; * skin reactivity; * use of new medications during the study; * previous participation in studies with the same product; * congenital or acquired immunodeficiency; * clinically significant or current evidence of alcohol or drug abuse; * known or suspected history of intolerance to any ingredient in the study product; * history of non-adherence or unwillingness to adhere to the study protocol; * employees of medcin or the sponsoring company involved in the study, or close family members of an employee involved in the study; * other conditions deemed reasonable by the researcher for disqualification from study participation. if applicable, this must be noted in the clinical record. exclusion criteria for the phototest: * previous history of conditions exacerbated or triggered by ultraviolet radiation; * use of photosensitizing drugs; * history or presence of photodermatoses; * personal or family history of skin cancer.
linguistic and clinical validation of the arabic version of acute cystitis symptom score (accs)

Conditions: Cystitis Acute

Summary: the goal of this prospective observational study is to provide an arabic translation of the acute cystitis symptom score (acss) and to test the linguistic validity and clinical reliability of the translated arabic version of accs (arabic-accs) in arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis. the main questions it aims to answer are: * do the questions of the arabic-acss have sufficient clarity? * can the arabic-accs serve its purpose in identifying the presence of uncomplicated cystitis in arabic-speaking women? the participant will be asked to fill out the arabic-accs questionnaire at the time of diagnosis. the participants will be asked to fill out the second part of the arabic-accs questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician. researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract.


Eligibility criteria:
inclusion criteria: * women. * presented to the urology or gynecology and obstetrics outpatient clinics. * having the diagnosis of uncomplicated cystitis. exclusion criteria: * pregnancy. * urethral catheterization. * anatomical abnormality of the urinary tract. * neurologic abnormality that affects bladder function. * urinary tract stones. * recent antibiotic usage (within 1 month). * immunosuppression.

Keywords: uncomplicated cystitis linguistic validation acute cystitis symptom score acss
digitally-enabled weight management program on t2dm

Conditions: Weight Change, Body; Type 2 Diabetes

Summary: the study (known as clinical audit in uk) will observe and report on a digitally-enabled structured weight management program including use of a meal replacement on clinical and economic outcomes for community-dwelling adults living with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of t2dm within the last 6 years 2. aged 20 - 70 years 3. have a bmi ≥ 27 kg/m2 4. hba1c ≥ 48 mmol/mol (≥ 42mmol/mol if prescribed glucose-lowering agents) 5. have access to the internet and a computer, smartphone or tablet 6. ability to read and understand english 7. willing to provide individual consent exclusion criteria: 1. current insulin use 2. more than two anti-hyperglycemic agents prescribed 3. recent routine hba1c ≥ 90 mmol/mol 4. diagnosed with moderate or severe frailty 5. diagnosed eating disorder or purging 6. unable or unwilling to tolerate soy/milk-based meal replacements 7. myocardial infarction within last 6 months 8. recent egfr \<30 ml/min/1.73 m2 9. prescribed sglt2 inhibitor for diabetic kidney disease (dkd) or left ventricular hypertrophy (lvh) 10. severe heart failure defined as equivalent to the new york heart association grade 3 (nyha) 11. current treatment with anti-obesity drugs 12. learning difficulties that would prevent engagement with the program 13. having required hospitalization for depression or being prescribed antipsychotic drugs 14. known cancer 15. active substance misuse 16. contraindications to exercise 17. contraindications to lose weight 18. mental or physical incapacity that makes self-management inappropriate 19. pregnant, planning a pregnancy or lactating 20. currently undergoing palliative care 21. previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list) 22. unable to commit to long term lifestyle change 23. known proliferative retinopathy that has not been treated
pet imaging of high-grade glioma using 18f-fluoromethylcholine: a tool for the early detection of tumour recurrence after combined radiochemotherapy?

Conditions: High-grade Glioma of the Brain

Summary: the aim of the study is to define preferential sites of tumour recurrence by observing tracer uptake in the tumour in sequential pet images with 18f-fluoromethylcholine (and perfusion mr, see also below). changes in the intensity of the tracer uptake in the tumour during and after the course of radiotherapy will be correlated with the site of tumour recurrence as will be assessed by conventional mri. in due time, these results must enable clinicians to change their therapeutic approach of high-grade glioma.


Eligibility criteria:
inclusion criteria: * 18 years or older * patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery exclusion criteria: * low global performance state * pregnancy * lactation period * presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips
study of dolutegravir (dtg) on pk of cenicriviroc (cvc), and cvc on pk of dtg & on a single dose of midazolam

Conditions: HIV-infection/AIDS

Summary: to evaluate the pk, safety and tolerability of cenicriviroc (cvc) administered with and without dolutegravir (dtg) and cvc with and without a single dose of midazolam in healthy subjects.

primary objectives * to evaluate the steady-state pk of cvc administered with and without dtg . * to evaluate the steady-state pk of dtg administered with and without cvc . * to evaluate the pk of a single dose of midazolam administered with and without steady state cvc when both are administered orally. secondary objectives * to evaluate the safety and tolerability of cvc administered with and without dtg. * to evaluate the safety and tolerability of cvc administered with and without midazolam.

Eligibility criteria:
inclusion criteria: 1. provide written informed voluntary consent 2. adult male and female healthy volunteers 3. body mass index (bmi) ≥ 18.0 and ≤ 30.0 kg/m2. 4. be in good general health with no clinically relevant abnormalities 5. agree to comply with study procedures and restrictions exclusion criteria: 1. any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator 2. history of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed 3. clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication 4. known or suspected hypersensitivity or allergic reaction to any of the components of cvc or dtg tablets, or midazolam syrup 5. serum alt, ast, or bilirubin values greater than or equal to division of acquired immunodeficiency syndrome (daids) grade 1 at screening

Keywords: hiv/aids cenicriviroc (cvc) dolutegravir (dtg) midazolam healthy subjects
investigate the responsiveness of the erectile quality scale to vardenafil flexible dose vs placebo in males with erectile dysfunction (ed)

Conditions: Erectile Dysfunction

Summary: this study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil hcl on the quality of their erections. many men experience occasional erectile problems during their lives. the causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. this study is designed to study the responsiveness of the erection quality scale (eqs) to vardenafil hcl. in this study, vardenafil hcl will be compared to placebo. placebo is a pill which looks like the real drug but it is not. it contains no active ingredients.


Eligibility criteria:
inclusion criteria:- males who have had ed for at least six months- heterosexual relationship.- males 18 and older. exclusion criteria:- primary hypoactive sexual desire.- history of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- stable heterosexual relationship for \> 6 month- other exclusion criteria apply according to the us product information

Keywords: erectile dysfunction vardenafil