Kornimate/medical-research-clean huggingface dataset:
comparative study of anterior vs. posterior surgical treatment for lumbar isthmic spondylolisthesis

Conditions: Isthmic Spondylolisthesis

Summary: the aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar isthmic spondylolisthesis. the primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by oswestry disability index (odi) v2.1a and to compare safety outcomes measured by treatment-related adverse events. secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. finally, a cost-effectiveness analysis will be performed. this analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.


Eligibility criteria:
inclusion criteria: * aged 18 to 80 years, inclusive * grade i, ii or iii (less than 75% slip of the cephalad vertebra compared to the caudal vertebra) isthmic spondylolisthesis at single level between l4 and s1 * unresponsive to a minimum of 3 months of non-surgical treatment * no previous surgical treatment for isthmic spondylolisthesis * patients who are medically suitable for surgical management * patients who have consented for surgical treatment * willing and able to comply with the investigational protocol (ip) * informed consent form (icf) signed by patient exclusion criteria: * any previous lumbar spine surgery * patient has significant scoliosis (cobb angle is greater than 25 degrees) * subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction * subject is pregnant or of child-bearing potential and not currently on adequate birth control method * active infection at the surgical site * recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator * pre-existent neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. alzheimer's disease, parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia * participation in another clinical trial of drug or device within the past 30 days that could influence the outcomes of this study * is a prisoner * acquired immune deficiency syndrome (aids) or aids-related complex * active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated; patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study
protein blends (soy, whey and casein) for muscle synthesis

Conditions: Muscle Synthesis

Summary: soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs. soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow). this intermediate rate may allow soy protein to have an extended window of muscle protein synthesis that has not been monitored in previous studies. while most of the sports nutrition "recovery" products are dairy-based protein blends (high in branched-chain amino acids), soy protein offers additional benefits that can make an important contribution to these types of sports nutrition products. soy protein contains approximately 300% more arginine and 30% more glutamine compared to whey protein and these two amino acids may bring additional benefits (immunity and hydration, respectively) to athletes. a "blend" of high-quality proteins (soy and dairy) may be the optimal sports nutrition product for athletes to consume following training.


Eligibility criteria:
inclusion: 1. age 18-35 yrs 2. stable body weight for at least 1 year exclusion criteria will be: 1. exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise) 2. significant heart, liver, kidney, blood, or respiratory disease 3. peripheral vascular disease 4. diabetes mellitus or other untreated endocrine disease 5. active cancer (all groups) and history of cancer (groups potentially randomizable to rapamycin) 6. acute infectious disease or history of chronic infections (e.g. tb, hepatitis, hiv, herpes) 7. recent (within 6 months) treatment with anabolic steroids, or corticosteroids. 8. alcohol or drug abuse 9. tobacco use (smoking or chewing) 10. malnutrition (bmi \< 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia) 11. obesity (bmi \> 30 kg/m2) 12. low hemoglobin levels (below normal values) 13. food allergies 14. taking dietary supplements such as green tea, etc. 15. currently on a high-soy diet (consuming \>2 servings of soy per day)

Keywords: muscle synthesis mtor antioxidant inflammatory markers soy protein whey casein
a twelve week study of virtually supervised mouth rinse and flossing

Conditions: Healthy

Summary: the purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and gingivitis.


Eligibility criteria:
inclusion criteria: * able to read and understand (participants capable of reading the documents) * adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect) * negative pregnancy urine tests (females of childbearing potential only) * females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to visit 1 and agree to continue using this method during their participation in the study * a minimum of 20 natural teeth with scorable facial and lingual surfaces. teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count * a minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (bi) * participants will have evidence of some gingivitis; there will be no minimum or maximum mean mgi score for gingivitis or tpi score for plaque; mild to severe gingivitis and mild to moderate periodontitis * no more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth exclusion criteria: * history of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products) * dental prophylaxis within four weeks prior to screening/baseline visit * history of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures * use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the baseline exam. intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator * suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates
brain sleep deprivation mri effects (bedtime)

Conditions: Alzheimer's Disease

Summary: the primary purpose of this study is to explore the underlying mechanisms that link sleep to alzheimer's disease (ad), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. subjects will wear an actigraph for 1 week to determine regular daytime activity and sleep patterns. subjects will then undergo partial sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (npsg). participants will be be asked to stay awake and active all day after the partial sleep deprivation with a new actigraphy secured by a hospital band to assure participants remain awake. they will seep inside an mri machine for 90 minutes on the following night during their usual bedtime (established by 1 week actigraphy study.) morphologic imaging, flow imaging and diffusion kurtosis imaging (dki) will be performed on a 3t siemens scanner.


Eligibility criteria:
inclusion criteria: * age range 21-30 * capable of giving informed consent exclusion criteria: * diagnosis of any brain disease or brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorders (e.g. parkinson's disease or other movement disorders). persons with silent cortical infarcts will be excluded. white matter lesions will not be exclusions. * history of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression) * conditions that alter normal sleep patterns: irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy), moderate to severe periodic limb movement while you sleep (plms) or obstructive sleep apnea (osa). * history of claustrophobia. * bmi≥30 * significant history of alcoholism or drug abuse. * inability to avoid the use of alcohol or caffeine during the 48h before the mri. * current pregnancy or intent to become pregnant during the period of study. * any electronic or ferromagnetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for mri imaging. * any medications adversely affecting cognition, blood pressure, glucose metabolism, or sleep will result in exclusion.

Keywords: cerebrospinal fluid (csf) sleep obstructive sleep apnea (osa) sleep disordered breathing (sdb) period limb movement during sleep (plms)
decreasing leak rate in colorectal surgery using near infra-red (nir) imaging

Conditions: Anastomotic Leak

Summary: anastomotic leak is a devastating complication of colorectal surgery. there is no widespread means of assessing the viability of a laparoscopic anastomosis. the investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (nir). the aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.

multicentric prospective study of 260 consecutive patients undergoing colonic resection and being assessed during the course of surgery for microvascularisation. after vessel division and after colorectal anastomosis, indocyanine green (2.5mg/ml) is injected intravenously and anastomotic microvascularisation assessed with the pinpoint nir system (novadaq, vancouver, canada). study primary endpoint is the anastomotic leak rate secondary endpoint are peroperative and post-operative complications according to the clavien dindo scale, time of the procedure and time to record a signal as well as any change of the procedure. this study will be performed on 3 different sites geneva, oxford and dublin university hospitals

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * participant willing and able to comply with the study procedures. * diagnosed with required colon or rectal neoplasia requiring surgical excision by either laparoscopic or open surgery. * a negative pregnancy test for women of childbearing potential prior to surgery * able (in the investigators opinion) and willing to comply with all study requirements exclusion criteria: * female participant who is pregnant, lactating or planning pregnancy during the course of the study. * allergy to indocyanine green. * participant who is undergoing purely palliative surgery or who is terminally ill * subject has other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Keywords: colorectal surgery near infrared indocyanine green anastomotic leak prevention of leak
capable transplant

Conditions: Quality of Life; Depression; End Stage Renal Disease; Disability Physical

Summary: the purpose of this mixed methods study is to adapt capable as capable transplant to accomplish two things: 1) to resolve barriers to being classified as active on the kidney transplant (kt) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail kt waitlist population. it consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for capable transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.

capable is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research. the purpose of this study is to adapt capable, an existing evidence-based program for functionally and socio-economically vulnerable older adults, as a prehabilitation intervention for people with frailty awaiting kt. as in capable, the delivery characteristics of capable kidney transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (ot) (\~6 home visits for ≤ 1hour), a registered nurse (rn) (\~4 home visits for ≤ 1hour) and a handy worker (hw). in earlier phases, research team members conducted preliminary activities to design the capable kidney transplant intervention using human-centered design techniques. this study will seek to accomplish two aims: 1. to iteratively refine the capable -transplant prototype for those currently kt inactive or those who are active and low-income on the waitlist. 2. to pilot test the capable-transplant intervention the investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial.

Eligibility criteria:
inclusion criteria: * deceased donor waitlist * ≥18 years old * community dwelling * current inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing or active on the waitlist and low-income exclusion criteria: * living donor waitlist * severe cognitive impairment * inactivity expected to last \> 3 months (eg cancer treatment) * \>4 hospitalizations in the last 12 months * current home nursing, physical or occupational therapy

Keywords: activities of daily living instrumental activities of daily living physical function executive function home intervention kidney transplant end stage renal disease
evaluation of oxidative stress and effect of levothyroxine treatment on oxidative stress in hashimoto disease

Conditions: Hashimoto Disease

Summary: oxidative stress leads to or accompanies with numerous disease. oxidative balance in subclinical hypothyroid or euthyroid state in hashimoto disease are not known. effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.

oxidative stress markers will be measured initially(tas,tos,osi,paraoxonase,arylesterasa,pon1 phenotypi̇ng,li̇pi̇dperoxi̇d).after 3 months therapy with levothyroxine measurements will be repeated except pon1 phenotyping.

Eligibility criteria:
inclusion criteria: * age more than 18 years exclusion criteria: * inability to give a written consent * other conditions and drug usage affect oxidative stress
psycho-social intervention with paro robotic seal focused on patients with dementia

Conditions: Alzheimer Disease; Older Adults

Summary: the overall objective of the study is to evaluate the improvement in patient-perceived quality of life following the use of the paro robot integrated with traditional intervention in the elderly with dementia.

the primary aim of this study is to evaluate the patient-perceived improvement in terms of quality of life through quality of life - alzheimer's disease (qol-ad), following the use of the paro robot, integrated with traditional intervention carried out within the irccs inrca alzheimer's day center. the secondary aims are the evaluation of the improvement in cognitive status of the elderly person with dementia, in terms of orientation, attentional-executive, mnestic and visuospatial functions, detected through the addenbrooke's cognitive examination (ace-r); the assessment of mood improvement in terms of reduction of anxiety and depression, detected through the rating anxiety in dementia (raid) scale and the cornell scale for depression in dementia (csdd); the assessment of the elderly person's acceptance of the technology through quebec user evaluation of satisfaction (quest 2.0), semi-structured interview and analysis of physiological activation during interaction, with the noldus face reader system and direct observation by the operator; the analysis of behavioral symptomatology through neuropsychiatric inventory (npi); the assessment of practitioner's acceptance of technology through technology acceptance model (tam) and the assessment of job quality through semi-structured interview.

Eligibility criteria:
inclusion criteria: * diagnosis of mild-moderate dementia according to the diagnostic and statistical manual of mental disorders (dsm v). * mmse between 10 and 24 * attending the alzheimer's day center since at least 3 months * presence of a caregiver exclusion criteria: * severe sensory disabilities (visual and auditory) * comprehension difficulties * history of syncopal episodes, epilepsy, and dizziness not controlled pharmacologically * severe autonomic system dysfunction * severe behavioral syndromes not compensated by medication

Keywords: technology-based intervention alzheimer disease dementia older adults
conditional cash transfers to increase uptake of and retention of pmtct services

Conditions: HIV

Summary: the goals of the proposed study are to: 1) test whether small, increasing cash payments to hiv-infected pregnant women, on the condition that they attend scheduled clinic visits and receive proposed services, will increase the proportion of women who receive the most effective antiretroviral regimen they are eligible for by the time of delivery, and 2) elucidate factors that facilitate or inhibit the uptake and adherence to the pmtct cascade, and to what extent the conditional cash payment program addresses these factors. this intervention will be implemented and evaluated within our well-established pmtct program in kinshasa, democratic republic of congo (drc),


Eligibility criteria:
inclusion criteria: * newly diagnosed as hiv-positive * pregnant between 28 and 32 weeks of gestation (\>27 and \<32 completed weeks of pregnancy) * intend to stay in kinshasa through delivery and six weeks postpartum * able and willing to participate (provide informed consent) exclusion criteria: * women will be excluded from the study if they are severely ill and require extended hospitalization or need to be cared for at a referral hospital out of the pmtct network

Keywords: contingency management conditional cash transfer pmtct retention hiv
effects exercise training in patients with pituitary adenoma

Conditions: Pituitary Adenoma

Summary: this study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. the hypotheses are; h1: aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma. h2: aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma. h3: aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma. h4: yoga is effective on biochemical factors in people with pituitary adenoma. h5: yoga is effective on physical performance in people with pituitary adenoma. h6: yoga is effective on quality of life in people with pituitary adenoma. h7: aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.


Eligibility criteria:
inclusion criteria: * volunteers * macroadenomas * at least 1 hormonal axis affected * karnofsky perfomance scale between 70-100 * 18-65 years * approved by cardiologists exclusion criteria: * regular exercise habit * acute pain in many part of the body * additional neurologic condititons * any rheumatological and immunologic conditions
a study of icp-022 in patients with r/r dlbcl

Conditions: Diffuse Large B Cell Lymphoma

Summary: it is a phase ii, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel btk inhibitor, icp-022, in approximately 85 subjects with r/r dlbcl. there will be no control group in this study. each subject will receive treatment orally every day in 28-day cycles. each cycle starts immediately after the previously completed cycle without a break between cycles.


Eligibility criteria:
key inclusion criteria： 1. men and women between 18 and 75 years old, 2. histologically confirmed diffuse large b-cell lymphoma（dlbcl）with myd88 l265p and cd79b positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced ct/mri, 3. ecog performance status of 0-2, 4. voluntary written informed consent prior to trail screening. key exclusion criteria: 1. history of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry 2. history of richter's syndrome 3. current or history of lymphoma involved central nervous system 4. prior corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer tcm within 4 weeks of the start of study drug. 5. the investigator considers other conditions unsuitable for this study. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: relapsed/refractory