Kornimate/medical-research-clean huggingface dataset:
monitoring key activity and physiology of neonates in intensive care

Conditions: Neonatal Seizure

Summary: to optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (nicu)

to optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (nicu)

Eligibility criteria:
inclusion criteria: * written informed parental consent exclusion criteria: -
traction manipulation of upper cervical spine on cervicogenic dizziness

Conditions: Dizziness; Neck Pain

Summary: manual therapy reduces symptoms in patients with cervicogenic dizziness. the mobilization and manipulation of upper cervical spine are the most popular treatment in this patients. the international federation of orthopaedic manipulative physical therapists suggest different recommendations for the safety application of manual therapy techniques in the upper cervical spine, traction manipulation techniques complies with this conditions. however, there isn´t investigation about the effect of traction manipulation in patients with cervicogenic dizziness. the aim of this study is to investigate the effects of traction manipulation in dizziness intensity, range of motion of cervical spine and quality of life on patients with cervicogenic dizziness.


Eligibility criteria:
inclusion criteria: * dizziness associated with neck stiffness and/or neck pain. * hypomobility of upper cervical spine. * sing the informed consent form. exclusion criteria: * contraindications for traction manipulation. * pending litigation or legal claim. * poor language and communication skills making difficult to understand the informed consent.

Keywords: manual therapy physiotherapy manipulation
ayurveda for flu like illness during covid-19 outbreak

Conditions: Flu Like Illness

Summary: this study aimed to evaluate the efficacy and safety of ayurveda in reducing symptoms of flu like illness during the covid 19 outbreak.


Eligibility criteria:
inclusion criteria: * patients with fu like symptoms within 48 hours of onset during march2020 * mild to moderate symptoms who were advised to self isolate at home for 7-14 days * flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration * willing to consent and follow up exclusion criteria: * pregnant/lactating * participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress * clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - known hypersensitivity to any ayurveda herbal substances * severe symptoms of respiratory distress patients deemed to require intensive care immediately
comparison of the efficacy and tolerability of femal versus placebo

Conditions: Breast Cancer; Menopause

Summary: femal, a food supplement based on pollen extracts introduced in europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms. patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by gnrh analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included. patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry. patients on ssri or snri antidepressant therapy are excluded. eligible patients will be randomly assigned to either femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).


Eligibility criteria:
inclusion criteria: - patients with a history of breast cancer, in spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by gnrh analogue and experiencing severe vasomotor symptoms (at least 20 hot flushes per week). patients who are on tamoxifen or aromatase anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry exclusion criteria: * patients on ssri or snri antidepressant therapy are excluded
everbeat ring ecg clinical concordance study

Conditions: Cardiovascular Diseases

Summary: this study is a cross-sectional observational study conducted in patients referred for routine ecg, to compare output from the everbeat finger-worn ecg device to standard of care (soc) 12-lead electrocardiography. no intervention is involved in this study. patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.


Eligibility criteria:
inclusion criteria: * males or females aged 18 to 90 years. * under the care of a board-certified physician and referred for a routine electrocardiogram (ecg) * resting heart rate between 50 to 120 beats per minute (bpm). exclusion criteria: * inability to wear the everbeat ring. * prior history of movement disorders including parkinson's or benign tremors. * prior history of allergic skin reactions to metal including stainless steel.

Keywords: ecg wearables electrocardiography
dolutegravir-based dual therapies in hiv-infected patients with virological suppression

Conditions: HIV Infection

Summary: the objective of this study was to evaluate the efficacy and safety, and evolution of causes leading to change, of dual therapies based in dolutegravir in patients requiring a change of virologically effective antiretroviral therapy.

despite the high rate of virological suppression and low risk of toxicity, hiv-infected patients continue to need new antiretroviral strategies, such as dual therapies, because of different end-organ involvement (kidney, bone, cardiovascular..), intolerance or toxicity. to date, only a protease inhibitor (pi)-based regimen was able to permit the use of dual therapies (two antiretrovirals), especially in case of patients with history of virological failure to other regimens. however, the recent license of dolutegravir, a integrase inhibitor with high genetic barrier, could help to clinicians to manage patients with intolerance or toxicity to nucleoside analogues without putting in risk virological suppression.

Eligibility criteria:
inclusion criteria: * older than 18 years * receiving a virologically effective antiretroviral regimen * switching to a dual therapy based in dolutegravir because of intolerance or toxicity to nucleoside analogues exclusion criteria: * pregnant women * receiving other investigational drugs * recent diagnosis of opportunistic infection (\< 1 month)

Keywords: hiv dolutegravir intolerance dual therapies
upper airway inflammation and olfaction: mechanisms of loss and recovery

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Summary: the goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (od) in chronic rhinosinusitis (crs). the main questions it aims to answer are: * is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to od? * does a treatment interfering with one of the major t2 inflammatory cytokines, have an impact on the mechanisms of od in crs? participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.


Eligibility criteria:
inclusion criteria: * at least two of the following symptoms: nasal obstruction, rhinorrhoea, smell loss, facial pain for 12 weeks. * endoscopic visualisation of bilateral sinonasal polyps * ssi (tdi) \< 30.75 and decreased sense of smell subjectively * eosinophilia \> 300/μl of blood ku/l * on a stable nasal steroid treatment for at least 4 weeks exclusion criteria: * active smoking * primary and secondary immune deficiencies * ciliary diseases (cystic fibrosis, primary ciliary diskinesia) * history of or current nasal malignancies * \ 70 years * patients unable to express consent * use of systemic corticosteroids for \< 4 weeks before visit 1 • use of systemic or local antibiotics for \< 4 weeks before visit 1
24-week open-label extension study evaluating pxt00864 effect in mild ad patients further to pleodial-i completion

Conditions: Alzheimer Disease

Summary: pleodial-ii study is an extension of the previous pilot pleodial-i study (cln-pxt00864-03 protocol) and is designed for the descriptive analysis of patients with mild ad who are exposed to pxt00864 over an additional 24-week period.

patients having completed the previous 12-week pleodial-i study were eligible to receive pxt00864 in this 24-week open-label extension pleodial-ii study in order to collect some additional long-term data regarding the safety and the potential effect of pxt00864 on cognitive and behavioural impairments.

Eligibility criteria:
main inclusion criteria: * mild alzheimer's disease patient who was included in pleodial-i study * mini mental state examination (mmse) score greater or equal to 20 main exclusion criteria: * patient who was not compliant with the previous pleodial-i study protocol * patient who experienced significant adverse events which necessitated treatment discontinuation during the pleodial-i study

Keywords: pxt00864 mild ad phase 2a
effect of dutasteride on androgen-response gene expression in patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

we have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. we have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. in this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the u19 tumor suppressor androgen response gene during the regrowth phase of treatment. in the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. prostate-specific antigen (psa) levels will also be measured to determine the psa doubling time during the off-phase to determine the effect of dutasteride on psa kinetics.

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer * patients are hormone-naive * patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (lhrh) agonist or already receiving therapy with lhrh agonist * advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis * must have an intact prostate (no previous surgery or xrt) * eastern cooperative oncology group (ecog) performance status 0-2 * recovery from any major infection or surgical procedure * signed informed consent exclusion criteria: * known intolerance or allergy to dutasteride * concomitant chemotherapy, biologic therapy, or xrt to prostate * bilateral orchiectomy * prior malignancy within 5 years of registration
the biomarkers of risk of colorectal cancer (boricc) follow-up (bfu) study

Conditions: Colorectal Cancer

Summary: worldwide, colorectal cancer is the 3rd most common cancer; risk increases with age and is modified by lifestyle factors notably diet, physical activity and obesity. the boricc follow-up (bfu) study is a 12+ year follow-up of participants recruited to the biomarkers of risk of colon cancer (boricc) study. this longitudinal study will investigate associations between ageing and lifestyle factors and a panel of molecular biomarkers linked with colorectal cancer risk.

the boricc follow-up (bfu) study builds on the findings from the boricc study where the investigators observed associations between age and nutritional factors, including selenium and folate, and biomarkers of colorectal health. the bfu study will investigate the relationships between ageing (12+ years) and such biomarkers longitudinally. it is anticipated that the project will produce novel data on (i) changes in biomarkers of colorectal cancer risk with age and (ii) the effects of obesity and lifestyle factors on biomarkers of colorectal cancer risk. these biomarkers include differentially expressed proteins, dna methylation markers and inflammation markers.

Eligibility criteria:
inclusion criteria: * took part in the boricc study at baseline (recruited 2005/6) exclusion criteria: * unable to travel to the hospital to attend study visit * unable to provide informed written consent

Keywords: colorectal cancer biomarkers cancer risk cancer prevention ageing diet obesity physical activity colorectal adenoma
gravitas-119: itacitinib in combination with calcineurin inhibitor-based interventions for the prophylaxis of graft-versus host disease

Conditions: Hematologic Malignancies

Summary: the purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (cni)-based interventions for the prophylaxis of graft-versus-host-disease (gvhd).


Eligibility criteria:
inclusion criteria: * subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and \< 5% blasts in the bone marrow. * subjects with non-hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large b cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. subjects with hodgkin lymphoma with chemosensitive disease at the time of transplant. * must be candidates for reduced-intensity conditioning regimens. * must be candidates for peripheral blood stem cell transplants. * karnofsky performance status score ≥ 70% or eastern cooperative oncology group performance status score of 0 to 2. * serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 40 ml/min measured or calculated by cockcroft-gault equation. * be willing to avoid pregnancy or fathering children. exclusion criteria: * has previously received an allogenic hematopoietic stem cell transplant. * presence of an active uncontrolled infection. * known hiv infection. * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection that requires treatment or at risk for hbv reactivation. * prior malignancies. * severe organ dysfunction. * prior treatment with a jak inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment. * currently breastfeeding. * known allergies, hypersensitivity, or intolerance to any of the study medications. * receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study. * history of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to \> 28 days after transplant. * post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.

Keywords: acute leukemia chronic myelogenous leukemia myelodysplasia chronic lymphocytic leukemia/small lymphocytic lymphoma follicular marginal zone diffuse large b-cell hodgkin's lymphoma mantle cell lymphoma janus kinase inhibitor graft-versus-host disease
evaluation of ocular biometry in pacd with two swept source optical coherence tomography devices

Conditions: Primary Angle Closure Glaucoma

Summary: purpose: to investigate agreement between 2 swept source oct biometers, iol m.aster700 and anterion, in various ocular biometry and intraocular lens (iol) calculations of primary angle-closure disease (pacd). methods: this was a prospective study conducted in a tertiary eye care centre involving biometric measurements obtained with 2 devices in phakic eye with diagnosis of pacd. mean difference and intraclass correlation coefficient (icc) with confidence limits were assessed, and calculations of estimated residual refraction of the iol were analysed using barrett's formula.

primary angle-closure disease (pacd) is the leading cause of blindness worldwide. pacd is an anatomic disorder, typically of relatively small eye with shallow anterior chamber depth (acd), thick lens, shorter axial length (al), small corneal curvature, and relatively anterior lens position. pupillary block, plateau iris and phacomorphic mechanisms play major roles in the pathophysiology of the disease, and pupillary block is thought to be the most common causal mechanism. for decades, phacoemulsification and intraocular lens implantation (pei) has been proposed for initial management of pacd.4 pei relieves pupillary block, deepening acd and widening irido-corneal angle. biometry is essential in evaluating ocular dimensions and calculating iol power in pacd, and ocular biometers have been evolving in recent years. optical coherence tomography (oct) includes partial coherence interferometry (pci), and swept source oct (ss-oct) is in general use in clinical practice. the agreement of the calculations of these devices has been studied by many investigators; however, research into their agreement in pacd patients has been sparse so far. a newer ss-oct, anterion, is now available and its performance needs to be evaluated.

Eligibility criteria:
inclusion criteria: * inclusion criteria were age \> 40 years old * phakic eye * diagnosis of pacd, including primary angle-closure suspect (pacs), primary angle-closure (pac) and primary angle-closure glaucoma (pacg) as classified by foster et al exclusion criteria: * patients who had opaque optical media * dense cataract * anterior and/or posterior segment diseases such as advanced pterygium, diabetic retinopathy, or maculopathy * participants who had previous history of ocular trauma, ocular surgery

Keywords: ocular biometry swept source oct agreement
sirolimus versus anti-vascular endothelial growth factor (antivegf) for wet amd

Conditions: Age-Related Macular Degeneration

Summary: phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of sirolimus in subjects with wet age-related macular degeneration (wet amd) with persistent intraretinal or subretinal edema due to neovascular amd despite previous antivegf treatment.

forty subjects will be randomized to receive intravitreal sirolimus or standard of care treatment in a 1:1 ratio. over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. treatment with sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. for subjects in the extension sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. subjects in the standard of care group will receive anti-vegf injections or sham monthly. retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (cnv)

Eligibility criteria:
inclusion criteria: * best corrected visual acuity of 5-65, inclusive, in study eye * presence of choroid neovascularization secondary to amd * persistent edema despite at least 3 previous intravitreal anti-vegf injections in the past 5 months exclusion criteria: * greater than 100 micron decrease in central subfield thickness on optical coherence topography (oct) since last standard of care visit * history of major ophthalmic surgery in the study eye in the past 3 months * history of significant ocular disease or condition other than exudative amd that may confound results
dresden glaucoma and treatment study (dgts)

Conditions: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Glaucoma, Low Tension

Summary: to assure the quality of follow-up and treatment, data of glaucoma patients are stored and evaluated after anonymisation.

the aim of the study is to evaluate the quality of follow-up and treatment by means of consecutive data collection and anonymised analysis of all glaucoma patients of a tertiary university hospital glaucoma service. parameters being analyzed are: age, sex, refraction, family history, known duration of glaucoma, highest intraocular pressure before treatment, systemic and topical medication, previous ocular surgery. 24h goldmann-applanation tonometry, biomicroscopy, gonioscopy, heidelberg retinal tomograph (hrt), glaucoma diagnosis with scanning-laser-polarimetry (gdx), optical coherence tomography (oct), pentacam, ocular response analyzer (ora), corvis st (corneal visualization with the scheimpflug technology), perimetry

Eligibility criteria:
inclusion criteria: * manifest glaucoma, ocular hypertension, glaucoma suspect exclusion criteria: * under 18 years of age, corneal diseases

Keywords: follow-up intervals treatment efficiency laser therapy glaucoma surgery minimal invasive glaucoma surgery (migs)
urinary markers for unilateral kidney obstruction

Conditions: Renal Colic; Acute Renal Failure

Summary: renal colic is usually caused from an obstructing stone along the ureter. some of the patients present with a high level of creatinin in the blood, even though there is a normal functioning contralateral kidney. furthermore creatinin is not an ideal marker for renal function during acute changes. several works have shown that modern urinary markers such as ngal (neutrophil gelatinase-associated lipocalin), kim-1 (kidney injury molecule-1) and others rise earlier and are much more sensitive for kidney insult. there is a lack of research on their role in acute kidney obstruction

the study population will include 100 men and women that will be recruited during the upcoming year, with a follow up of up to 3 months. the study population will be divided into 2 groups: 1. the stone group: about 80 patients, aged 18-65, with normal creatinine for the past year that presented in our er because of renal colic, and their imaging shows a ureteral stone. 2. the non-stone group: about 20 patients that present in our department for elective surgery not related to stones or bladder outlet obstruction. the stone group: ---------------- in the er the patients will be examined, undergo blood and urine workup and imaging as usual. if they are applicable according to our inclusion and exclusion criteria and admitted and they will be included in our stone group. after signing an informed consent, either as patients with a ureteral stone and normal creatinine or as patients with a ureteral stone and an abnormal creatinine, their urine sample will be sent for the urinary markers: ngal, kim-1, endothelin and cystatin c. at this point it will be decided to admit or discharge them according to their clinical imaging and laboratory findings, as acceptable. the admitted patients will be followed for 48 with additional blood and urine tests. the admitted patients that will undergo renal drainage will be a specific subgroup in which a selective urine test will be taken from the drained kidney the non stone group: -------------------- these are our control group from which we will take a single blood and urine test before their elective surgery.

Eligibility criteria:
inclusion criteria for stone group: * no known kidney disease * turned to the er due to renal colic * imaging demonstrates a partially or totally obstructing ureteral stone inclusion criteria for non stone group: * turned to the urology department for ambulatory surgery: hydrocelectomy, varicocelectomy, stress incontinence repair,circumcision,cystoscopy exclusion criteria: * patients with stones in the contralateral ureter * patients who underwent renal surgery * patients who took nsaid's (nonsteroidal antiinflammatory drugs) in the past week before presentation * patients woth anatomical defects in the kidneys

Keywords: renal colic acute renal failure neutrophil gelatinase associated lipocalin