Kornimate/medical-research-clean huggingface dataset:
the effect of melatonin supplementation on fatigue symptoms during chemotherapy treatment of breast cancer patients

Conditions: Breast Cancer

Summary: the aim of the present 3-month randomized, placebo-controlled trial was to evaluate whether adherence to mediterranean diet (md) together with melatonin oral treatment or plaebo, would ameliorate cancer related fatigue in breast cancer patients receiving chemotherapy treatment.

cancer related fatigue (crf) is a common distressing complaint in breast cancer (bc) patients treated with chemotherapy. nutrition quality plays a pivotal role in crf, while an increased interest towards new pharmacological agents has been observed. melatonin, an endogenous hormone that regulates the human sleep-wake cycle, could alleviate crf. in the present randomized, placebo-controlled 3-month trial, we investigated the effects of melatonin intake (i.e., 1 mg/day) vs. placebo on crf of bc patients. melatonin and placebo tablets were of similar physical and sensory properties. in both arms, mediterranean diet (md) was implemented. medical history, anthropometry and blood withdrawal were performed. crf was evaluated by the functional assessment of chronic illness therapy - fatigue questionnaire and md adherence by the meddiet score.

Eligibility criteria:
inclusion criteria: 1. adult women (≥ 18 years of age) with bc diagnosis who underwent chemotherapy at the time of invitation, 2. women receiving pharmacological treatment that did not interact with melatonin, 3. women receiving standard pharmacological treatment for at least last two months prior to study initiation, 4. patients with good performance status, as indicated by scoring "0 or 1" of the eastern cooperative oncology performance status (ecog ps) questionnaire \[26\], 5. patients not needing a transfusion, as indicated by hemoglobin ≥ 9 g/dl, 6. patients having the ability to understand and give a written statement of consent. patients were excluded from the study when: 7. fatigue was attributed to conditions other than cancer e.g., uncontrolled hypothyroidism, hypercalcemia, congestive heart failure, chronic obstructive pulmonary disease, 8. using pharmacological agents for crf or sleeping disorders prior to the study, 9. pharmacological treatment that was modified during the study or that could interact with melatonin, 10. diagnosed with gastrointestinal diseases that could affect absorption of nutrients such as inflammatory bowel diseases infections. 11. diagnosed with psychiatric disorders such as depression, psychosis, bipolar disorder, and receiving equivalent medication. 12. excessive alcohol consumption. 13. a lifestyle that can affect sleep patterns (e.g., night shifts). 14. patients with a poor clinical state as indicated by laboratory markers: creatinine clearance \ 3 x upper limit of normal (uln); alanine aminotransferase (alt) \> 3 x uln; bilirubin \> 1 x uln.
sino-nasal inhalation of colistin in patients with cystic fibrosis and pseudomonas aeruginosa colonization

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Summary: the purpose of this study is to determine whether the nasal inhalation of colistin is effective to decrease the pseudomonas aeruginosa bacterial count in the nasal lavage fluid.


Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of cystic fibrosis * detection of p. aeruginosa in nasal lavage (culture) with chronic p.a. colonization of the lung (from day -28) * informed consent of the patients or parents * subject \>= 6 years * subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol * women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol exclusion criteria: * subject has a critical condition defined as: forced expiratory volume at one second \< 30% and / or arterial oxygen saturation \< 93% without o2-substitution; need of o2-substitution * subject had an ear, nose, and throat surgery within 3 months prior to study * subject shows signs of nasal bleeding * subject has an ear drum perforation * subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aeruginosa * subject is unlikely to comply with the procedures scheduled in the protocol * subject has a known allergic reaction to the medication * subject is pregnant or breastfeeding * subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study. * systemic (oral or intravenous) antibiotic treatment against p.a. 14 days prior to the inclusion and during the study
aim covid for covid 19 tracking and prediction

Conditions: COVID 19

Summary: university of warwick (coventry, uk) and ntuu "igor sikorsky" kyiv polytechnic institute (kyiv, ukraine), together with clickmedix llc, have developed an app and a chatbot "aim covid" for efficient monitoring and mitigation of covid-19. these products are available for free download on computers and mobile phones. these can be used by a wide range of users from various sectors - patients and people living with them, doctors, nurses, specialists, community health workers, hospitals, clinics, hospital it staff, mhfa, and insurance companies.


Eligibility criteria:
inclusion criteria: * participants 18 and above * living in uk * reported with or without symptoms from february 28 to march 28 with community support groups exclusion criteria: * below 18 years old
neurodevelopmental effects of antiseizure medications (neam) - ug3 phase

Conditions: Epilepsy

Summary: to compare in-person to remote video assessments in children to determine the reliability of remote evaluations for future neuropsychological assessments and set a precedent for future investigations.


Eligibility criteria:
inclusion criteria: 1. parents able to provide informed consent for themselves and their child 2. access to computer and reliable internet connection for remote testing 3. child of women with epilepsy who was taking antiseizure medications during the pregnancy of the child being enrolled into the current study 4. child between the ages of 24 months and 30 months of age 5. primary language is english exclusion criteria: 1. child unable to complete the cognitive assessment (e.g., expected iq\<70) 2. child with a major medical condition (e.g., epilepsy, diabetes, heart disease, active cancer) 3. child who use centrally active medications

Keywords: epilepsy
botulinum toxin a & weekly serial casting in abi inpatients with lower extremity spasticity

Conditions: Spastic Foot

Summary: effects of chemodenervation (botulinum toxin a) and serial casting vs botulinum toxin a and without serial casting in lower limb spasticity following abi.

the investigators will be studying the effects of chemodenervation (botulinum toxin a) and serial casting vs botulinum toxin a and without serial casting in lower limb spasticity following abi. patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy the primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.

Eligibility criteria:
inclusion criteria * patients with acquired brain injury (abi) including but not limited to stroke, traumatic and anoxic brain injury in abi unit of rrc * dorsiflexion limitation of \< 10 degrees from neutral and modified ashworth score (mas) of 2 or 3 * patients that are on oral medication for spasticity tx are still allowed to participate (ie. baclofen) * patients both with bilateral or unilateral lower limb spasticity are included * there will be no sex or age restrictions exclusion criteria * patients cannot have had botulinum toxin a injections in their lower extremities within the past 6 months * patients cannot have had any sort of custom bracing or serial casting previously * patients with mas of 4 * patients with generalized spasticity that require other alternative treatment such as intra-thecal baclofen or surgical intervention * patients need to be medically stable (all co-morbidities under control via medical/pharmacological therapy), patients with ongoing co-morbid medical condition that are unmanaged will be excluded. * patients whom have skin breakdown in their lower extremities prior to the study will be excluded * patients who develop skin breakdown (grade 2 or higher) during the course of the study will be removed automatically
the turbine-based insufflator safety and feasibility study

Conditions: Laparoscopy; Pneumoperitoneum

Summary: the turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. this first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device.

the turbine-based insufflator for minimal access surgery provides a new technological basis for insufflation. until now, insufflation uses a static pressurized gas volume that is strongly affected by external pressure and vice versa pressures onto the surrounding structures. turbine technology permits highly accurate pressure control, and an intra-abdominal volume that is dynamically adapted to ventilation. in this safety and feasibility trial, the pressure stability of a turbine-based insufflator is investigated in patients undergoing laparoscopic surgery. in addition, small amplitude oscillation are superimposed to the intra-abdominal pressure at the start of insufflation. those oscillometric measurements will be used to estimate the abdominal compliance through the forced oscillation technique. study population: adults who are scheduled for an elective intraperitoneal laparoscopic surgical procedure at erasmus mc. main study parameters: safety and feasibility of turbine-based insufflation in terms of (serious) adverse device effects.

Eligibility criteria:
inclusion criteria: * adult * elective laparoscopic surgery * intraperitoneal procedure * planned use of a main 11 mm trocar * informed consent exclusion criteria: * pregnancy * inability to contain the insufflation gas to the intraperitoneal cavity

Keywords: pneumoperitoneum device development insufflator laparoscopy
hypothyroidism in patients with type 2 diabetes with early diabetic nephropathy

Conditions: Hypothyroidism in Diabetes

Summary: diabetes mellitus is the most common disorder seen. the impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (usa) on diabetes . so, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . the association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. with insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other.

diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis . sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy. severe hypothyroidism (biochemically) may be completely asymptomatic. though our patient had throid stimulating hormone level more than 100 miu/l, he did not have any symptoms of hypothyroidism.so diagnosis of hypothyroidism depends on laboratory parameters rather than clinical findings recognition and treatment of hypothyroidism in diabetic patients will benefit glycemic control and improve general well-being ). diabetic nephropathy, a major micro-vascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. it results from interactions between hemodynamic and metabolic factors .

Eligibility criteria:
inclusion criteria: * all patients with type 2 diabetes mellitus and with diabetic nephropathy. * all diabetics irrespective of glucose control. * all diabetics irrespective of treatment (oral hypoglycemic drugs/insulin) exclusion criteria: * 1) type 1 diabetes mellitus 2) patients with: * gestational diabetes mellitus. * pancreatitis. * steroid induced diabetes. * hepatobiliary disease * on systemic drug therapy such glucocorticoids and oral contraceptives.
brief telehealth cognitive rehabilitation following mild tbi

Conditions: Mild Traumatic Brain Injury; Cognitive Impairment

Summary: in the united states, more than a million people sustain a mild traumatic brain injury (mtbi) every year. although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. among veterans, a nationwide survey found that more than 75% of 55,000 veterans with a history of mtbi reported persistent moderate to severe levels of forgetfulness and poor concentration. reduced cognitive functioning following mtbi contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the covid-19 pandemic. the proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mtbi and that will be administered over video-based telehealth technology. the development of this intervention was supported by a grant from the department of defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mtbi, and also the clinical expertise of the team.


Eligibility criteria:
inclusion criteria: * age 18+; * read, speak, understand english; * history of at least one mtbi; * endorses moderate to severe cognitive difficulties in one or more of neurobehavioral symptom inventory items m-p; * ability and willingness to participate in audio recorded sessions over video telehealth platform in a private setting, including equipment and internet access; * lives within 2 hours of va puget sound or affiliated clinics/university of washington; * will be in washington state when engaging in treatment sessions exclusion criteria: * significant cognitive impairment that would limit ability to engage on treatment; * neurologic injury or illness that affects cognitive functioning, including history of moderate or severe tbi; * history of tbi in the past 3 months, from the date of screening; * history of serious mental illness involving psychotic symptoms; * current psychotic or manic symptoms; * current or active flag, or documentation in medical record, for behavior or suicide risk; * current (within the past 3 months) substance use disorder (not including caffeine or nicotine disorder)
virtual reality music in geriatric inpatients

Conditions: Older Adult; Hospitalization

Summary: older adults, especially those in acute care require accessible non-pharmacological interventions, such as music to improve their mental health. immersive 360 virtual reality (vr), is an innovative technology that has been found to be feasible, safe, and enjoyable by older adults. however, vr based music intervention to improve older adults' mental health has not been studied in acute in-patient settings.


Eligibility criteria:
inclusion criteria: * age of 60 years or older; * medical stability to participate in the trial as determined by treating physician (defined as stable vital signs, absence of new medical events and deteriorating signs), * admitted to the gau (5 north) at st. mary's hospital. exclusion criteria: * medical instability which limits ability to participate in the study (unstable vital signs, delirium, new medical events, deteriorating signs), * unablility to communicate in english or french, * behavioural issues/delirium that limit participation in the study, * those who have very severe dementia (using the reisberg stage 7 which is defined by very limited communication ability, and dependence for all self-care * those without sufficient auditory acuity to undergo assessment and participate in the intervention, which affects their ability to communicate their consent for this study and to listen to music * ophthalmological conditions which affects their ability to participate in the immersive vr (recent eye surgery, severe macular degeneration, severe glaucoma, epilepsy and seizures, etc.).
effectiveness of dry needling and ischemic compression in sternocleidomastoid, on cervical motor control in patients with cervical pain.

Conditions: Cervical Pain

Summary: this study will compare the effect of dry needling on the active trigger point on sternocleidomastoid versus the effect of dry needling at 1.5 centimeters of active trigger point on sternocleidomastoid, both combined with ischemic compression, on cervical pain and cervical motor control short and medium term.


Eligibility criteria:
inclusion criteria: * be between 18 and 65 years old * have pain in the cervical region, which extends from the occipital to the 7th cervical vertebra. * have an active trigger point on the sternocleidomastoid. exclusion criteria: * present history of trauma in the neck. * present cervical radiculopathy * present a vestibular pathology * previous surgery on the neck or shoulder area * having a primary headache diagnosis * have received dry needling in the neck in the previous 6 months * present cognitive deficit. * be pregnant * taking anticoagulants. * have phobia to the needles (belonephobia).

Keywords: cervical pain motor control sternocleidomastoid dry needling
acetylcysteine in the prevention of renal failure after bypass surgery

Conditions: Kidney Failure

Summary: the purpose of this study is to determine if acetylcysteine is effective in preventing renal failure associated with cardiac surgery

postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. the mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. for example, among those patients with preoperative creatinine \>2.5 mg/dl, almost 50% require hemodialysis. comparison: n-acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery

Eligibility criteria:
inclusion criteria: * pts with baseline chronic kidney disease (egfr\<60 ml/min/1.73m2)undergoing cardiac surgery exclusion criteria: * patients on hemodialysis preoperatively * iv contrast within 4 days prior to surgery * urgent/emergent surgery * history of renal transplantation

Keywords: kidney failure thoracic surgery acetylcysteine
yukon choice versus taxus liberté in diabetes mellitus

Conditions: Coronary Arteriosclerosis

Summary: revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals. there is only limited data available on the efficacy and safety of the novel yukon choice drug-eluting stent system specifically in patients with diabetes mellitus. the trial will determine the efficacy and safety of the novel yukon choice stent system compared to the well established taxus liberté stent system. the primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.


Eligibility criteria:
inclusion criteria: * age \> 18 years * diabetes mellitus * symptoms (stable or unstable angina pectoris) or objective evidence of myocardial ischemia * one or more de novo lesions in 1, 2 or 3 native coronary arteries * clinically significant diameter of stenosis (50-99 % according to visual assessment of operator) * lesion must be covered by stent length of no more than 24 mm and stent diameter of no more than 3,5 mm * vessel diameter of no more than 4 mm in vessel area adjacent to stenosis * informed consent exclusion criteria: * unprotected left main disease * complete occlusion of target vessel * in-stent-restenosis * stenoses of bypass grafts * indication for bypass surgery * bifurcation lesions (side branch \> 2,0 mm) * thrombus in target lesion as visualized by angiography * allergy or contraindication to concomitant medication (clopidogrel, aspirin, heparin, contrast media) * acute myocardial infarction within preceding 48h * participation in another trial * pregnancy * severe disorder of coagulation or platelet function
the role of platelet rich plasma for erectile dysfunction

Conditions: Erectile Dysfunction

Summary: purpose of study: this randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.

eligibility: men with erectile dysfunction. ages 50-80. international index of erectile function score of mild (17-21/25) or moderate (8-16/25). intervention and evaluation:men who consent to join the trial will be randomized to receive either a single injection prp or saline to the penis. all patients will have blood drawn in clinic the day of injection. those randomized to prp arm will have their own blood prepared and separated into the prp. this solution of their own blood will be injected back into the penis. follow up: men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the iief by phone or by electronic means

Eligibility criteria:
inclusion criteria: * history of mild to moderate erectile dysfunction measured by iief exclusion criteria: * history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)