Kornimate/medical-research-clean huggingface dataset:
voxelotor sickle cell exercise study

Conditions: Sickle Cell Anemia

Summary: this study is a pilot, open-label, single-arm study to evaluate the effect of the sickle cell medication voxelotor on exercise capacity, as measured by cardiopulmonary exercise testing (cpet) in patients 12 years of age and older with sickle cell anemia (sca).

this study will assess exercise capacity by cardiopulmonary exercise testing (cpet) before and after 8 weeks of voxelotor therapy. patients with genetically severe forms of sickle cell disease, including hgb ss, hgb s beta 0 thalassemia, hgb sc harlem, etc., age 12 or older, with stable hgb and hgb f will be recruited. enrolled subjects will have study labs drawn, undergo baseline cpet in the exercise lab, then take voxelotor 1500mg daily for 2 months, followed by repeat study labs and a second cpet. each subject's cpet results before and after voxelotor will be compared, and the study labs before and after voxelotor will be compared. each subject will be compared to him/herself.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, age \> 12 years 4. in good general health as evidenced by medical history and diagnosed with a genetically severe form of sickle cell anemia (hgb ss, hgb s beta 0 thalassemia, hgb scharlem, and others) 5. patients who are on hydroxyurea need to be on a stable dose for at least 3 months without anticipated change in dosing until the study is completed. 6. ability to take oral medication and willingness to adhere to daily voxelotor and 2 cpets at scheduled intervals. 7. for females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 30 days after the end of study. 8. for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner exclusion criteria: 1. patients on chronic transfusions or who received a transfusion within last 8 weeks 2. patients who had hospitalization for vaso-occlusive crisis or acute chest syndrome within 30 days prior to informed consent/assent. 3. patients who have screening alanine aminotransferase (alt) \> 4x upper limit of normal 4. patients who suffer from physical inactivity attributable to clinically significant musculoskeletal, cardiovascular, or respiratory comorbidities 5. patients already taking commercially available voxelotor 6. prior hypersensitivity to voxelotor or excipients. 7. pregnant patients
mechanical thrombectomy for acute large vessel occlusion stroke with mild symptoms

Conditions: Ischemic Stroke; Acute Stroke

Summary: mechanical thrombectomy(mt) has been recommended in patients with acute large vessel occlusion stroke(lvo) , especially for those with national institutes of health stroke scale (nihss) score ≥6. however, it is still unclear if patients with minor strokes and lvo also benefit from mt.the aim of this study was to evaluate the safety and efficacy of mt for acute lvo and mild symptoms.

this is a prospective cohort study of patients with with mild ischemic stroke (nihss score \<6) and lvo. patients were divided into 2 groups: mt or medical management.baseline data and clinical outcomes were compared. a independent clinical outcome was defined as a modified rankin scale score of 0 to 2 at 90 days. a excellent clinical outcome was defined as a modified rankin scale score of 0 to 1 at 90 days. symptomatic intracranial hemorrhage(sich) was the safety outcome.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke within 24 hours of symptom onset presenting cortical symptoms (such as aphasia, somnolence,slow-minded,etc.) or vertigo with bilateral pathological signs; 2. age≥18 years old; 3. the nihss score before evaluation of thrombectomy\<6; 4. large artery occlusion including middle cerebral artery m1, proximal m2 segment, intracranial internal carotid artery and infarct core volume≤50ml and mismatch ratio\>1.8 or basilar artery and posterior cerebral artery p1 occlusion exclusion criteria: 1. patients without prior functional independence (mrs score of \>2) 2. patients in intervention group with occlusive artery spontaneous recanalization in digital subtraction angiography 3. patients in control group with neurological worsening and received rescue thrombectomy

Keywords: acute ischemic stroke acute large vessel occlusion thrombectomy mild stroke; prognosis
effect of colony stimulating factor on implantation and pregnancy rates following ivf (in vitro fertilization)

Conditions: Infertility, Female

Summary: this a trial designed to test whether granulocyte colony stimulating factor (g-csf, neupogen) can increase the rate of embryo implantation following ivf and embryo transfer. preliminary data at the center for human reproduction(chr) and elsewhere suggest that intrauterine infusion of g-csf can improve endometrial development and can increase implantation rates of embryos.

objective: to investigate the effect of treatment with csf on pregnancy rates in routine in vitro fertilization (ivf). design: double blinded crossover randomized controlled clinical trial setting: academically affiliated private infertility centers subjects: normal female ivf patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment. interventions: subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with g-csf (neupogen), 300ug (in 1 ml); controls receive saline. patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm. main outcome measures: implantation rate(ir) and pregnancy rates. second outcome measures: live birth rates and miscarriage rates. statistical and power considerations: analysis will be by regression with ir as dependent and treatment as independent. results will be adjusted by age and indices of ovarian reserve, such as antimulerian hormone (amh). presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm, will have to be recruited for 80% power and alpha of 0.05.

Eligibility criteria:
inclusion criteria: * women already enrolled in an ivf cycle at one of the participating institutions exclusion criteria: * sickle cell disease * renal insufficiency * upper respiratory infection or pneumonia * chronic neutropenia * known past or present malignancy

Keywords: fertility agents, female in vitro fertilization
depth of anaesthesia and postoperative cognitive decline in patients undergoing heart surgery

Conditions: Cardiac Bypass Surgery in Adult Patients 65 Years and Older; Postoperative Cognitive Dysfunction; Postoperative Delirium

Summary: post-operative cognitive decline (pocd) is common after cardiac surgery and associated with increased morbidity and mortality. the pathophysiology of pocd is only poorly understood. causes include hypoperfusion, microemboli and the systemic inflammatory response, which result in a reduction of cerebral oxygen delivery. cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen saturation (rso2). the bispectral index (bis) of the electroencephalogram is widely known to measure depth of anaesthesia, and there is a high correlation between bis, a dimensionless calculated number between 0 and 100, and clinical criteria of sedation. with bis below 60 recall is extremely low. the investigators demonstrated recently that inappropriately high levels of anaesthesia may be associated with poorer long-term outcomes in cognition after non-cardiac surgery (ballard et al. 2012). whether optimisation of the depth of anaesthesia and cerebral oxygenation has an effect on postoperative cognitive function in patients undergoing cardiac surgery is unknown. the investigators hypothesize that the incidence of pocd in elderly patients (\> 65 years old) at 6 weeks is less with mildly deep anaesthesia (bis 50 +- 10) and optimised rso2 (interventions when rso2 drops below 15% of baseline reading) when compared with current practice (bis blinded anaesthesia, reflecting moderately to highly deep anaesthesia and blinded rso2 measurements).


Eligibility criteria:
inclusion criteria: * patients undergoing elective coronary artery bypass graft surgery * patients at 65 years of age and older exclusion criteria: * diseases of the central nervous system including dementia * inadequate knowledge of english * a current or past psychiatric illness * current use of tranquilizers or antidepressants * severe visual, auditory, or motor handicap

Keywords: postoperative cognitive dysfunction coronary artery bypass graft surgery postoperative cognitive improvement postoperative delirium
effect of exercise on post-covid symptoms

Conditions: COVID-19

Summary: the study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. control group patients did not perform any program. all participants were assessed with mcgill pain scale short form (sfmpq), short-form 36 (sf-36), pittsburgh sleep quality index (psqi) before and after the study.

after covid-19, musculoskeletal pain, anxiety, and sleep problems can continue. the study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. the study was performed at gaziosmanpaşa education and research hospital with 76 post-covid patients that were randomized into experimental and control groups. experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. control group patients did not perform any program. all participants were assessed with mcgill pain scale short form (sfmpq), short-form 36 (sf-36), and pittsburgh sleep quality index (psqi) before and after the study.

Eligibility criteria:
inclusion criteria: * to be between the ages of 18-65 * to be diagnosed with covid-19 in the last 3 months * to have a negative pcr test, or to have completed the 14-day isolation period exclusion criteria: * have undergone surgery in the last 6 months * have severe mental retardation that would prevent communication
l reuteri for the prevention of nosocomial diarrhea

Conditions: Nosocomial Infection; Diarrhea; Gastroenteritis

Summary: nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. in children, it is commonly caused by enteric pathogens, especially rotavirus. the reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. nosocomial diarrhea may prolong the hospital stay and increase medical costs. one of the potential strategies for the prevention of nosocomial infections is the use of probiotics. the number of studies have shown the efficacy of lactobacillus reuteri (dsm 17938) in the treatment of acute diarrhea. however, there are no data on the efficacy of l. reuteri in the prevention of nosocomial diarrhea. the investigators, therefore, plan to perform the study with the aim of evaluating the role of lactobacillus reuteri dsm 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.

infants will be randomly assigned at admission to receive l. reuteri in dose of 10(8) cfu in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay. patients will be evaluated daily for stool number and consistency. in case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.

Eligibility criteria:
inclusion criteria: * age 1-48 mo * cause of hospitalization must be other than acute gastroenteritis or diarrhea exclusion criteria: * acute gastroenteritis within 3 days before admission * other symptoms which suggest gastroenteritis * usage of probiotics and/or prebiotics within 7 days before admission * visible blood in the stool * patient in bad condition * lack of approval from patients parents * breastfeeding * no compliance

Keywords: nosocomial infection diarrhea lactobacillus reuteri gastroenteritis rotavirus
fecal microbiota transplantation for primary clostridium difficile diarrhea

Conditions: Clostridium Difficile

Summary: clostridium difficile associated diarrhea (cdad) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. conventional treatment uses antibiotics to kill clostridium difficile. a novel treatment uses replacement of gut flora by fecal microbiota transplant (fmt). randomized trials have established safety and efficacy of fmt in recurrent cdad, but no trial has used fmt for primary cdad. this study will randomize patients to oral encapsulated fmt or oral vancomycin.

patients with primary cdad will be approached for consent and randomized equally to two arms: oral fmt with oral vancomycin placebo, or oral fmt placebo with oral vancomycin. fmt will be prepared from anonymous donors screened according to health canada guidelines and stored frozen.

Eligibility criteria:
inclusion criteria: * life expectancy \> 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization exclusion criteria: * pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received \>4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-cdad concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to vancomycin, anaphylactic reaction to any food, current induction chemotherapy, hiv infection with cluster of differentiation 4 (cd4) count \<200, or any medical or non-medical condition considered by the investigator to preclude participation.
bread study: comparison of the tolerance of spelt and wheat bread

Conditions: Non-celiac Gluten Sensitivity; Wheat Intolerance

Summary: this project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. in addition, the influence of different manufacturing processes will be considered.

wheat cereals are known to be capable of triggering wheat allergy and celiac disease. the prevalence of both diseases is about 1%. recently, another clinical entity was described, the non-celiac wheat sensitivity (ncws). the origin and mechanisms of ncws are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. three different grain components have been proposed as triggers of ncws, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (fodmaps). it is reported that individuals with self-diagnosed ncws quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. so far, human study addressing such questions are lacking. this project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. in addition, the influence of different manufacturing processes on wheat sensitivity will be revealed. for this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. aim of this part is to objective bread wheat and spelt intolerance in a defined population. to find out whether fodmaps or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added fodmaps.

Eligibility criteria:
inclusion criteria: * age ≥18 ≤70 years * signed declaration of consent * willingness to adhere to the prescribed diet for the duration of the study * subjective bread wheat intolerance * no known spelled intolerance * no acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy) * no participation in another clinical trial (current or within the past 30 days) * gluten-containing diet at least 6 weeks before the start of the study exclusion criteria: * taking intestinal therapeutics, antibiotics, immunosuppressants or similar * pregnancy / lactation * relevant violations of the nutritional protocol * occurrence of relevant diseases (possibly individual decision) * revocation of consent * accommodation in a clinic or similar facility based on an official or judicial order

Keywords: human nutrition ncws spelt wheat bread
urolift pre-sbrt for reduced urinary toxicity in patients with bph and prostate cancer.

Conditions: Benign Prostatic Hyperplasia

Summary: many patients may face long-term urinary side effects following stereotactic body radiation therapy (sbrt), including increased urinary frequency, dysuria, and nocturia. the investigator hypothesizes that urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (sbrt).

urolift is a standard of care treatment for bph. it involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. it pulls and maintains the opening of a continuous channel through the prostatic urethra. a previous study examined the effect of urolift on urinary symptoms and urinary medications at six months post-procedure.urolift was associated with significant urinary improvements measured by ipss and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.

Eligibility criteria:
inclusion criteria: * subject is 50 - 99 years of age * subject has provided informed consent * subject has diagnosis of prostate cancer requiring sbrt * subject is able to complete self-administered questionnaires * subject is a surgical candidate for urolift * subject has a diagnosis of bph * medical record documentation of prostate volume from 30-80 ml by trus * absence of a middle lobe exclusion criteria: * life expectancy \&lt; 2 years * currently enrolled in or plans to enroll in any concurrent drug or device study * concurrent androgen deprivation therapy * has an active infection (e.g., urinary tract infection or prostatitis) * diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis) * subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days * subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years * diagnosis of lichen sclerosis * neurogenic bladder or other neurologic disorder that affects bladder function * diagnosis of polyneuropathy (e.g., diabetic) * history of lower urinary tract surgery * subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use * subject has been catheterized or has a pvr \&gt; 400 ml in the 14 days prior to the surgical procedure * current diagnosis of bladder stones

Keywords: stereotactic body radiation therapy urolift prostatic urethral lift dysuria nocturia minimally invasive therapy
somatoform disorder in british south asians

Conditions: Somatic Syndrome Disorder

Summary: the study uses in depth interviews to understand their experience of somatoform disorder, possible explanations and their experience of somatoform disorder, possible explanations and their understanding of treatments, especially their ideas about psychosocial treatments.

"somatoform" or "functional" syndromes are those that present with physical symptoms, not explained by well-recognized medical illness. such symptoms are common in all settings and studies have reported that they accounted for one-fifth of all new presentations in primary care. literature suggests that they are associated with significant levels of psychological distress, disability, impairments in quality of life and high levels of healthcare utilization. research also suggests that medically unexplained symptoms cause similar (or higher) levels of disability than medically explained symptoms in primary care settings. there have been a number of studies that have looked at the cognitive and behavioural basis of somatisation, and treatment strategies have been trialed based upon a cognitive behavior therapy (cbt)-led approach for these patients. in british south asian patients the difficulties in managing this condition are further compounded as culture can have an important role in shaping the experience, interpretation \& clinical presentation of emotional distress. patel reported that gps found it very challenging to manage south asian patients with chronic pain due to the way they present with pain, and a greater likelihood of psychosomatic presentations. language differences as well as cultural differences contributed to the challenges, especially among first- generation south asians. further, they felt that self-management strategies were difficult to address. the author concludes by saying 'cultural influences play an important role in the consultation process where patients' behaviour is often bound in their cultural view of health care. (south asian) patients' presentation of their condition makes diagnosis difficult but can also lead to miscommunication'.

Eligibility criteria:
inclusion criteria: * men and women of self-ascribed british south asian origin. * over the age of 18 years. * able to understand spoken and written english and/or urdu, gujarati. * able to provide written informed consent. * registered with the gp practice. * criteria for somatoform disorder (determined by phq15). exclusion criteria: * individuals with diagnosed physical or learning disability * any form of psychosis.

Keywords: mus british south asians somatic symptoms qualitative interviews