Kornimate/medical-research-clean huggingface dataset:
serial phlebotomy in voluntary blood donors

Conditions: Atherosclerosis

Summary: blood donation has been proposed to be associated with reduced risk of cardiovascular disease, but the effects of phlebotomy on vascular function in human subjects have not been well characterized. a prospective randomized double-blind study was undertaken to determine the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular endothelial function in the brachial artery.

84 fe-replete, non-anemic subjects were randomly assigned to one of three experimental serial phlebotomy procedures designed to induce fe loss or rbc loss. brachial artery reactivity (bar, %) in response to transient oxidative stress induced by oral methionine was measured with high-resolution duplex ultrasound imaging before and after study phlebotomy procedures.

Eligibility criteria:
inclusion criteria: * hemoglobin levels \>13.5 g/dl for men, or \>12.5 g/dl for women * serum ferritin 50-400 ng/ml exclusion criteria: * known intolerance of phlebotomy procedures * major trauma or surgical procedures in the last 2 years * menstrual or other uterine bleeding in the last 2 years * chronic oral anticoagulation or dual antiplatelet therapy * chronic non-steroidal anti-inflammatory drug use * known history of hemochromatosis or other disorder of hematopoiesis or fe metabolism * chronic oral fe supplementation other than fe-containing multivitamins * history of active cancer in the past 2 years * known history of chronic inflammatory disease * uncontrolled hypertension * electrocardiographic evidence of prior myocardial infarction * diabetes mellitus * fasting glucose \>100 mg/dl * body mass index \>40 kg/m2 * any tobacco use in the past 6 months

Keywords: endothelial function iron stores red blood cell blood donation
retrieval of sperm from men with azoospermia using ultrasound-guided rete testis aspiration

Conditions: Azoospermia, Nonobstructive; Infertility, Male

Summary: the objective of this study is to use ultrasound-guided rete testis flushing and aspiration technique to retrieve sperm, non-surgically, from the testes of azoospermic men. if sperm are retrieved by this method, it will provide a direct benefit to the infertile men. this protocol will also establish the safety and feasibility of the ultrasound-guided rete testis injection approach in consenting men before the approach is translated to teenage boys.

the aim of this study is to demonstrate that ultrasound-guided rete testis aspiration is a safe and effective method to flush and aspirate rare sperm from the testes of men with azoospermia (no sperm in the ejaculate). current methods to recover sperm from men with azoospermia range from invasive and time consuming micro testicular sperm extraction (microtese) to fine needle aspiration (fna), which is less invasive and less time consuming, but also less effective because it is a blind approach. this approach is less invasive; it involves the percutaneous insertion of a hypodermic needle into the rete testis space. this approach is also not blind because the needle is accurately positioned under ultrasound guidance into the rete testis space that is contiguous with all seminiferous tubules (where sperm are made). the investigators will first perform the experimental ultrasound-guided rete testis flushing and aspiration on both testis. if sperm is found, no standard of care procedure (tese, microtese etc) will be performed. if sperm is not found, the participant can choose whether or not to proceed with a standard of care procedure. in cases were participants have previously tried a standard of care procedure, they may not want to do that again if the experimental procedure does not work. for the ultrasound-guided rete testis flushing and aspiration, the investigators will flush and aspirate the tubules with 500ul of physiological saline and optison ultrasound contrast agent in sterile 0.9% saline (routinely used in clinics). presence of sperm in the aspirate will be determined. the investigators hypothesize that sperm recovery using the ultrasound-guided rete testis injection/aspiration approach will at least as effective as the standard of care approach employed in the magee male fertility clinic and it will be less invasive.

Eligibility criteria:
inclusion criteria: * be a male over the age of 18 * be diagnosed with azoospermia * have 2 testicles * sign an approved consent and authorization permitting the release of personal health information. the patient must acknowledge in writing that consent for sperm collection has been obtained, in accordance with institutional policies approved by the u.s. department of health and human services. exclusion criteria: * diagnosed with psychological, psychiatric, or order conditions which prevent giving fully informed consent * diagnosed with underlying medical condition that significantly increases their risk of complications from this procedure

Keywords: testicular sperm extraction
steroid delivery to the frontal sinus opening with a bioabsorbable implant vs. a bioabsorbable nasal dressing

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: the purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.

this is a single center, randomized \& controlled trial comparing the efficacy of the propel mini stent or propel contour stent vs. nasopore impregnated with triamcinolone acetonide at reducing frontal sinus opening stenosis and polypoid edema after endoscopic sinus surgery in patients with chronic rhinosinusitis with polyposis. eligible subjects who undergo standard of care bilateral frontal sinusotomy will have each frontal sinus randomly assigned to either a propel mini or contour steroid eluding stent or a nasopore nasal dressing impregnated with 2.5 ml of triamcinolone acetonide 40 mg/ml. specific propel stent will be chosen based on the shape of frontal sinus opening and best fit as decided by the operating surgeon. patients will be reassessed on approximately post-operative day 7, 14, 30, 90 days, 6 months, and 12 months at their standard of care follow-up visits. on the day 14 visit, the frontal sinus propel stent and nasopore will be completely removed per standard of care. video will be taken of the frontal sinus opening, and assessed for scarring/adhesions, presence of polypoid edema, frontal sinus patency, need for oral steroids or other interventions. additionally, endoscopic scoring of frontal sinus by the above measures will be evaluated by 2 independent sinus surgeon reviewers. the reviewers will also be asked to rank the two frontal sinus openings as better, same or worse, compared to the opposite side

Eligibility criteria:
inclusion criteria: * adults aged 18 and older * diagnosis of chronic rhinosinusitis with nasal polyps based on the american academy of otolaryngology-head and neck surgery guidelines * patient scheduled for bilateral endoscopic sinus surgery with evidence of bilateral frontal sinus disease based on computed tomography (lund-mackay score greater than or equal to 1) * at the time of surgery bilateral frontal sinusotomy of type draf 2a or 2b was performed using the same technique on both sides * bilateral endoscopic sinus surgery performed successfully without complication * frontal sinus opening diameter greater than 4.0 mm achieved (4 mm olive tipped suction easily passed into frontal sinus) exclusion criteria: * any patient who had frontal sinus surgery for tumor * allergy to mometesone and/or triamcinolone * frontal sinusotomy type draf 1 or draf 3 performed * one or both frontal sinus openings not amenable to implant placement * patients with chronic oral steroid dependent conditions * invasive fungal sinusitis * immune deficiency
voice analysis using the lpc (linear predictive coding)method for the prediction of aspiration

Conditions: Deglutition Disorder

Summary: it was well known that aspiration is the primary cause of an aspiration pneumonia among the dysphagia patients. in order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are invasive and allowed only in a limited condition. in this study, as a precedent study for the non-linear analysis, voice analysis using lpc method will be evaluated. the superiority of lpc method will be compared with a spectral analysis using jitter and simmer as a positive control. this clinical study will be performed prospective, positive-controlled, single-blind (i.e. assessor-blind),and single cohort clinical trial for efficacy


Eligibility criteria:
inclusion criteria: * patients who were referred for vfss exclusion criteria: * patients cannot phonate d/t tracheostomy * preexisting oro-laryngo-pharyngeal disease * patients cannot follow 1 step command * patients cannot maintain a phonation for 3 seconds * refusal of participation * patients who were not classified for the candidate by physicians * patients who coughs following drinking of 5ml normal saline

Keywords: voice analysis aspiration prediction
relaxation and meditation techniques on pain, fatigue and quality of life

Conditions: Neuropathy, Diabetic

Summary: patients with painful diabethic peripheral neuropathy will be entered.. participants will be randomized to one of three study arms: arm 1: relaxatio; arm 2:meditation arm 3: attention matched control hypothesis: progressive muscle relaxation and mindfullness meditation will decrease severity of neuropathc pain and fatigue and improve quality of life.

previous reports have revealed that progressive muscle relaxation and meditation are promising for glycemic control in type 2 diabetes patients. on the other hand, research examining effects of these approaches on painful diabetic peripheral neuropathy, fatigue and quality of life is limited. the present study investigates the effects of progressive muscle relaxation and mindfullness meditation in a single-site, 3-arm, assessor blinded randomized, controlled study of 77 type 2 diabetes patients with painful diabetic peripheral neuropathy. arm 1: relaxation; arm 2: mindfulness meditation; arm 3: attention matched control. the investigators hypothesize that progressive muscle relaxation and mindfulness meditation will decrease severity of neuropathic pain and fatigue and improve quality of life.

Eligibility criteria:
inclusion criteria: * being diagnosed with painful diabethic peripheral neuropathy , * being at least primary school graduates, * not using any other complementary or integrative therapy during the study period exclusion criteria: * neuropathy history due to any other causes such as megaloblastic anemia, fibromyalgia, autoimmune diseases, hypothyroidism, and lumbar disc hernia * having end-stage of renal failure, chronic obstructive pulmonary disease, advanced cardiac failure, musculoskeletal disorders or depression * having a diabetic foot ulcer or amputation.

Keywords: fatigue, meditation, diabetic neuropathy, relaxation, quality of life.
impact of extended cpap on bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia; Prematurity

Summary: the purpose of this pilot study is to compare if keeping infants on cpap (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to hfnc (high flow nasal cannula).

there are two ways to help premature babies breathe. both hfnc and cpap are commonly used in our nicu. cpap, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. hfnc provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. our goals are to reduce long term complications such as lung disease of prematurity, also called bronchopulmonary dysplasia (bpd). bpd causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. in recent years, hfnc has become a common choice for care. there is no clear agreement in previous research which way may be best to reduce bpd.

Eligibility criteria:
inclusion criteria: * babies born at \<30 weeks' gestation * babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age exclusion criteria: * babies born at \<30 weeks' gestation * requiring less than 2l nc at birth or * those who are extubated after 32.0 weeks' postmenstrual age * congenital anomalies * skeletal disorders * neuromuscular disorders * genetic syndromes

Keywords: bronchopulmonary dysplasia prematurity high flow nasal cannula continuous positive airway pressure nicu
a study of adalimumab for the induction of clinical remission in japanese subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in japanese subjects with crohn's disease.


Eligibility criteria:
inclusion criteria: * crohn's disease activity index (cdai) score of \>= 220 and \<= 450 * if subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy exclusion criteria: * ulcerative colitis or indeterminate colitis * history of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (tb), or human immunodeficiency virus (hiv) * body weight is below 30 kg * surgical bowel resections within the past 6 months * females who are pregnant or breast-feeding or considering becoming pregnant during the study
tolerability/safety and efficacy of inhaled azd4818 in patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to see if treatment with azd4818 for four weeks is tolerable, safe and effective in treating copd and, if so, how it compares with placebo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd, with symptoms for more than 1 year * current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year) * lung function (fev1) 40 to 80% of the predicted normal value after using a short acting bronchodilator exclusion criteria: * clinical suspicion of active tuberculosis * any current clinically significant respiratory tract disorder other than copd * history of current clinically relevant arrhythmia, heart block, ecg abnormalities, or unstable angina

Keywords: copd tolerability inhalation
induction of labor in intrahepatic cholestasis of pregnancy

Conditions: Intrahepatic Cholestasis

Summary: induction of labour in intrahepatic cholestasis of pregnancy (icp) has become a common procedure in management of icp to avoid fetal complications. surprisingly, this empirical approach has not been evaluated as to delivery complications and fetal outcome as yet. the investigators now examine weather icp affects (i) delivery procedures chosen, in particular the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and (iii)possible impact of bile acids and udca treatment in a retrospective cohort study based on approximately 5000 induced deliveries at danderyd hospital, karolinska institutet, stockholm. the investigators analyze data on on previous deliveries, bmi, medical history and medical book data. primary endpoint is the risk of caesarian section.


Eligibility criteria:
inclusion criteria: * icp during pregnancy and induction of labor icp and spontaneous delivery no icp but induction of labor exclusion criteria: * no icp spontaneous delivery * elective caesarian section

Keywords: intrahepatic cholestasis of pregnancy induction of labor pregnancy caesarian section pruritus iufd
segmental trunk stability training on sitting and upper limbs functions in children with spastic cerebral palsy

Conditions: Cerebral Palsy

Summary: the study aims to: 1. investigate the effect of segmental trunk stability training on sitting in children with spastic cp. 2. investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic cp.

postural dysfunction is one of the most limiting factors in children with cp. it restricts reaching skills and in turn reduces participation in activities of daily living. the trunk plays a key role in maintaining the postural control mechanism and also in the organization of balance reactions in this developmental process. the trunk control is also required for a stable base of support which is necessary to execute functional activities for limb movements. the optimal level of trunk support for a child with spastic cp still remains unknown. thus, providing intermediate levels of trunk stabilization would be a better solution than providing full support in children with cp. innovation is necessary to improve outcomes for children with moderate to- severe cp who are at level iv and v on gmfcs. however, these children are often excluded from posture research . very little research has examined postural constraints in children with moderate-to-severe cp. as there is a lack of tools used in precise trunk stabilization during training, a further researches are needed. recently, a special attention has been given to the segmental trunk control and its effects on improvement of gross and fine motor skills. most of previous studies have been applied during segmental fixation of the trunk at multiple levels from static position either sitting or standing. in the present study, the effect of external segmental stabilization of the trunk at selected parts will be monitored during the active training and participation of the child.

Eligibility criteria:
inclusion criteria: 1. children with spastic cp, their chronological age will be ranged from 2 years to 4 years. 2. their level of motor function will be 4 or 5 according to gross motor function classification system - expanded and revised 3. the degree of spasticity for these children will ranged from grade 1 to 2 according to modified ashworth scale 4. all children's level of segmental trunk control will be level 3 according to segmental assessment of trunk control 5. they will be able to follow instructions during evaluation and treatment. exclusion criteria: * any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. surgical interference in upper limbs and/or spine that may restrain the child performance during activities.2. orthopedic problems or fixed deformities in the vertebral column and/or upper extremities. 3. uncontrolled seizures. 4. visual or hearing impairment.
rct of automated conversational agent vs. treatment as usual for the management of perinatal mood

Conditions: Cognitive Therapy; Depression, Postpartum; Mental Health; Depression; Depressive Disorder; Anxiety; Telemedicine

Summary: the purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from labor and delivery at stanford children's health - lucile packard children's hospital. using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.

the intervention is a cognitive behavioral therapy (cbt) based automated conversational agent available as a mobile device smartphone application. when a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. the app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of cbt-based tools and other general psychoeducation. this smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. the app's artificial intelligence becomes more specific to a user over time, based on conversations. the app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).

Eligibility criteria:
inclusion criteria: * postpartum day 0-7 after delivery * medically stable and cleared for discharge * owns smartphone * english-speaking (because all intervention materials are in english) exclusion criteria: * neonatal demise this admission * intrauterine fetal demise this admission

Keywords: automated conversational agent
clinical assessment of a daily wear monthly replacement silicone hydrogel toric contact lens

Conditions: Refractive Errors; Astigmatism

Summary: the purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

subjects will be randomized to 1 of 2 crossover wear sequences. subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

Eligibility criteria:
key inclusion criteria: * successful wearers of weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months; * best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 snellen in each eye. * able to wear contact lenses within the range of available sphere \& cylinder power and axes. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * daily disposable contact lens wearers. * monovision and multifocal contact lens wearers. * habitual biofinity toric/biofinity toric xr contact lens wearers in the past 3 months prior to consent. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses