Kornimate/medical-research-clean huggingface dataset:
effects of meditation on multiple sclerosis and peripheral neuropathy

Conditions: Multiple Sclerosis; Peripheral Neuropathy

Summary: this study will evaluate the effects of mindfulness and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis or peripheral neuropathy.

we propose a prospective, randomized controlled study evaluating the effects of mindfulness meditation and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis ms or a generalized polyneuropathy (pn). a secondary endpoint for the ms arm will include spasticity and for the pn arm will be the physical examination findings of sensory changes and weakness. meditation classes of 90 minutes duration will be led by a buddhist monk with over 20 years experience in meditation. sessions will be held once weekly over a 3-month period. there will be an initial introduction session that will last approximately 180 minutes for the adminsitration of formal instructions and a training session on how to do the meditation. outcome assessments will be answered electronically on a secure system or in written form that will be able to be completed at home or at the site of the meditation class. the data will be directly downloaded into a queriable database. outcome assessments will be based on the short form (sf)-36 health survey and visual analog scale (vas) for pain at baseline and at 3 months. additionally, the neuropathy impairment score (nis) will be used for the pn pts. the pdds spasticity questionnaire and the fatigue portion of the msqli for fatigue will be used for the ms patients. we plan to recruit adult patients with either ms or pn through the current patient population in the mellen center and neuromuscular center and flyers placed throughout the cleveland clinic. patients will be excluded if they have performed meditation within the last 6 months, are cognitively impaired, or have an underlying illness that would preclude comprehension of the instructions. other exclusion criteria include a history of symptomatic cardiopulmonary disease, uncontrolled htn, current alcohol or drug abuse, and kidney or renal failure. patients must be ambulatory and able to toilet themselves.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis or peripheral neuropathy exclusion criteria: * unable to walk without the assistance of others * unable to toilet independently * currently abusing drugs or alcohol * have performed meditation within the last 6 months * cognitive impairment or an underlying illness which would prevent the comprehension of instructions * history of symptomatic/unstable heart or lung disease * uncontrolled high blood pressure * kidney or renal failure

Keywords: meditation multiple sclerosis peripheral neuropathy
high intensity interval training vs moderate intensity and continuous training in chronic heart failure

Conditions: Chronic Heart Failure

Summary: purpose: exaggerated sympathetic nervous system (sns) activity associated with low heart rate variability (hrv) is considered as a trigger of cardiac arrhythmias and sudden death. regular exercise training is efficient to improve autonomic balance. in 2013, the investigators published that a single session of an optimized short-high intensity interval exercise with passive recovery (hiit) protocol was efficient in chronic heart failure (chf) patients for enhancing vagal tone and to decrease arrhythmias in the 24-h post exercise period when compared to a single session of moderate intensity continuous exercise (mict). nevertheless the effects of hiit training performed on several weeks have never yet been studied on the parameters described by coumel's triangle (the arrhythmogenic substrate, the trigger factor as premature ventricular contraction and the modulation factors of which the most common is the autonomic nervous system). the aim of this study was to verify the superiority of hiit to enhance parasympathetic activity, cardiorespiratory fitness and cardiac function when compared to mict in a short and intense cardiac rehabilitation program.

before and after the rehabilitation program (rp), all patients underwent a 24-hour ecg recording, an echocardiography, a cardiopulmonary exercise test. the rp consisted of 2 types of exercise training according to the randomization: 1. a short-high intensity interval exercise with passive recovery 2. a classical moderate and continuous exercise training at 60% of peak power output the rp lasted 4 weeks.

Eligibility criteria:
inclusion criteria: * stable chronic heart failure with nyha functional class from i to iii * stable left ventricular ejection fraction (lvef) \< 45% over at least 6 months * stable optimal medical therapy including a beta-blocker and an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers for at least 6 weeks * ability to perform a maximal cardiopulmonary exercise test * admitted to the rehabilitation centre for a comprehensive cardiovascular rehabilitation program exclusion criteria: * any relative or absolute contraindications to exercise training according to current recommendations * fixed-rate pacemaker with heart rate limits set lower than exercise training target * major cardiovascular event or procedure within the 3 months preceding enrolment * chronic atrial fibrillation * heart failure secondary to significant uncorrected primary valve disease (except for mitral regurgitation secondary to left ventricular dysfunction) * heart failure secondary to congenital heart disease or obstructive cardiomyopathy.

Keywords: exercise training chronic heart failure parasympathetic autonomic nervous system cardiorespiratory fitness cardiac rehabilitation
risk factors and treatment outcome of oncology children hospitalized in the intensive care unit due to sepsis

Conditions: Oncologic Complications and Emergencies; ICU; Sepsis; Childhood Cancer

Summary: children treated with intensive chemotherapy are at increased risk for life-threatening infections (sepsis). as the survival of oncology patients increased with the use of aggressive treatment protocols, there was also an increase in the need for hospitalization in intensive care units (icu) due to sepsis.several prognostic factors are known to affect the survival of these patients, including the number and type of damaged systems, the type of oncology disease and the duration of neutropenia. with the development of the treatment of icu, the survival of the oncology patients hospitalized for sepsis has also increased. we will collect demographic details, details of their oncology and infections, laboratory tests and imaging. the goal is to identify prognostic factors in oncologic children hospitalized in icu due to sepsis, as well as clinical and laboratory parameters that characterize this group of patients.


Eligibility criteria:
inclusion criteria: * treatment in the hemato-oncology for cancer * admission to the icu in scmci between 2008-2018 because of sepsis during chemotherapy exclusion criteria: * admission to the icu more than 3 month after last chemotherapy or 1 year after sct
a trial on different dosages of vitamin d in preterm infants with late-onset sepsis

Conditions: Prematurity; Late-onset Sepsis

Summary: this is a randomized controlled trial (rct) to evaluate the influence of different doses of vitamin d3 (800 iu/d versus 400 iu/d), on serum levels of interleukin (il)-6, tnf-alpha and c- reactive (crp) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

vitamin d has an important role in the regulation of both the innate and adaptive immune systems. there are very few studies of such roles in the neonatal population. it is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. there is no consensus regarding to the dose of vitamin d supplementation required for preterm infants given the paucity of evidence. aap and espghan have recommended different dosages of vitamin d ranging from 400 iu to 1000 iu per day. the influence of different doses of vitamin d on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. this rct will evaluate the influence of different doses of vitamin d3 (800 iu/d versus 400 iu/d), on serum levels of interleukin (il)-6, tnf-alpha and c- reactive (crp) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants

Eligibility criteria:
inclusion criteria: * preterm infants (28-37 wk gestational age) * late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs: 1. temperature instability (hypothermia, hyperthermia); 2. respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis); 3. neurologic (hypotonia, lethargy, seizures); 4. gastrointestinal (feeding intolerance, abdominal distension). exclusion criteria: * major congenital anomalies. * chromosomal anomalies. * known inborn error(s) of metabolism

Keywords: preterm late-onset sepsis vitamin d dose interleukin-6 tumor necrosis factor-alpha
effect of prebiotic and pufa on the gut microbiota and metabolic risk markers

Conditions: Overweight

Summary: the main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-pufa diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers. intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. the investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.


Eligibility criteria:
inclusion criteria: * bmi: 25-40 kg/m2 * non-smoking * indices of the metabolic syndrome defined by the international diabetes federation (idf 2006): central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/l), reduced hdl cholesterol (men: \<1.03 mmol/l, women: \<1.29 mmol/l), raised bp (systolic ≥130 mm hg or diastolic ≥85 mm hg) or raised fasting plasma glucose (≥5.6 mmol/l). exclusion criteria: * use of antibiotics * weight change \>3 kg 2 months prior to study start * intensive physical training/ elite athlete * medication for dyslipidemia, type 2 diabetes or elevated blood pressure * dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement * lactation, pregnancy or planning of pregnancy during the study * gastro intestinal and liver disorders * chronic inflammatory disorders * diagnosed psychiatric disorder including treatment required depression * surgical treatment of obesity and abdominal surgery
non invasive external monitoring in dialysis patients

Conditions: Kidney Failure

Summary: this is a single center, non randomized study to gather data to correlate physiological signals with the patient's fluid status during fluid removal in hemodialysis.

patients undergoing hemodialysis will be monitored with the study device . the collected information will be correlated with fluid loss.

Eligibility criteria:
inclusion criteria: * is female or male, 18 years of age or older * undergoing hemodialysis for fluid removal exclusion criteria: * is participating in another clinical study that may confound the results of this study
acoustic reflection method and work of breathing

Conditions: Airway Obstruction

Summary: upper airway obstruction (uao) is very common in children. presently, the importance of the uao is evaluated by the physician during an endoscopic evaluation under general anaesthesia. the aim of the study is to evaluate two new techniques to quantify the importance of the uao in children; the acoustic reflection method and the measurement of the work of breathing. 80 children will be included in this monocentric, prospective, open labelled study.

the following evaluations will be performed the day prior to the endoscopic evaluation :1) calculation of a clinical score based on the diurnal and nocturnal respiratory and nutritional tolerance of the uao, 2) evaluation of the importance and the localisation of the uao assessed by the acoustic reflection method, 3) measurement of the work of breathing, 4) recording of nocturnal gas exchange during at least 6 hours by s single monitor (sentec™) which measures pulse oximetry (sao2) and transcutaneous carbon dioxide (ptcco2), and evaluation of sleep quality by actigraphy (recording of patient's movements by an actiwatch™). all the patients will be re-assessed after 3 months. if no treatment is required, a second clinical evaluation with an acoustic reflection examination will be performed. if a surgical treatment or a noninvasive positive pressure ventilation will be necessary, a second complete evaluation will be performed with an endoscopic examination, the calculation of the clinical score, an acoustic reflection examination, the measurement of the work of breathing, and the recording of the nocturnal gas exchange and sleep quality. this second endoscopic examination will be performed only for medical purpose and not for research only. the study will last 24 months, comprising 21 months for the inclusion of the patients and 3 months for the analysis of the data.

Eligibility criteria:
inclusion criteria: * children aged 0 to 15 years old, * in a stable state, * presenting an uao which requires an endoscopic evaluation under general anaesthesia * signed informed consent * affiliation to french health benefits exclusion criteria: * uao due solely to a hypertrophy of the adenoids and/or the tonsils, * patients with a tracheostomy or a non operated cleft palate

Keywords: upper airway obstruction child acoustic reflection method endoscopy work of breathing sleep study ct scan
shockwave treatment of diabetic foot ulcer: step i

Conditions: Chronic Diabetic Foot Ulcers

Summary: extracorporeal shock wave treatment is a well established treatment in orthopedics. considerable success has been reported after treatment of various soft tissue pathologies (tendinitis, heel spur etc). in recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. it has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. yet, randomized, controlled, prospective trials are missing. in this study, the effect of shock-waves on diabetic foot ulcer shall be assessed. the study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). one group serves as an untreated control group. all groups get standardized wound treatment and wound dressing. that shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * age 18 and older * diabetes type i or ii * chronic ulcer on the foot * ulcer present for at least 6 weeks * wagner grade 1 or 2 exclusion criteria: * chronic rest pain * critical ischemia * gangrene * ankle-arm-index \< 0,5 * critical ischemia treated within 6 weeks before possible enrollment * ulcer of grade 3 or worse according to the wagner classification * osteomyelitis * affection of toes * necessity of surgical intervention * malalignment of the foot sustaining the ulcer * treatment of ulcer with prostaglandins or vasodilatators within the last 2 weeks * current therapy with corticoids * infection with hiv; hepatitis * suppression of immune system (due to illness or medication) * medication with vitamin-k-antagonists * known hemophilia * sever hypalbuminemia \< 2 g/dl * severe anemia * ulcer other than of diabetic origin * pregnant or breast-feeding women * known coagulopathies * implants such as artificial heart valves, joint replacement, bone replacement, osteosynthesis material * patients participating on other studies * chemotherapy within the last 60 days * mentally disabled patients

Keywords: foot ulcers extracorporeal shockwave chronic wound
fmt in gut agvhd treated

Conditions: Acute-graft-versus-host Disease

Summary: with the stem cell transplanting increasing, patients which effected with gut gvhd were also increased. to evaluation the safety and efficacy of fmt for gut gvhd,patients with gut gvhd were recruited.


Eligibility criteria:
inclusion criteria: * gut gvhd exclusion criteria: * age\>60; or age\<10
a study of ly3361237 in participants with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the main purpose of this study is to learn more about the safety of ly3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (sle). ly3361237 will be administered by injections just under the skin. the study will last up to 26 weeks and may include up to 17 visits to the study center.


Eligibility criteria:
inclusion criteria: * participants must have received a diagnosis of sle at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised american college of rheumatology \[acr\] classification) * if a participant is taking oral prednisone (or prednisone equivalent) for sle, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks * if a participant is taking any of the following medications for sle, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks: * azathioprine ≤200 mg/day * antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine) * mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 grams per day (g/day) * oral, sc, or intramuscular methotrexate ≤15 milligrams per week (mg/week) exclusion criteria: * participants must not have a history of, or current, inflammatory joint or skin disease other than sle * participants must not have a current active bacterial, viral, or fungal infection * participants must not have evidence of significant liver or kidney dysfunction * participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months. * participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months * participants must not have received blood products (e.g., blood transfusion, platelets, etc.) within the last 12 months
randomized placebo controlled clinical study of an oral product in subjects with menopausal symptoms

Conditions: Menopausal Symptoms

Summary: the objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.


Eligibility criteria:
inclusion criteria: * healthy females aged 40 to 65 years, * self-reporting menopausal symptoms (\> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit. * reporting a variable cycle length of \> 7 days different from normal * bmi 20-40 kg/m2 * able to read, understand, and complete the study questionnaire and records. * able to understand the study procedures. * able to comply with all study requirements. * written informed consent to participate in the study. * willingness to actively participate in the study and to come to the scheduled visits. exclusion criteria: * pregnancy or breastfeeding. * immune insufficiency * women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal. * history of hysterectomy * women on hormone replacement therapy * use of systemic corticosteroids or immunosuppressant drugs. * other diseases or medications that might directly interfere in the study or put the subject's health under risk. * employees of the institute * cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol, * alcohol or drug abuse, * use of hormonal contraceptives within the last 3 months * bp ≥160/110 mmhg * oophorectomy or amenorrhea \> two years
ai4hope dementia care planning pilot study 2 ( ai4hope2)

Conditions: Dementia

Summary: this pilot study will test a digital care planning decision support system for patients with dementia.

he clinical study is part of an eu-funded project on the use of artificial intelligence for patients with dementia. this study will test a digital toolkit for advance care planning and decision making for patients with dementia and pilot-test this digital support system for feasibility and acceptability. other workpackages of the ai4hope project will design a digital technology platform to provide relevant, timely and appropriate information for people with dementia and their carers, and to facilitate them to document their goals, wishes, and preferences for future care. patients with mild to moderate dementia will be recruited for the pilot study in the six participating countries. the study population includes all types of dementia without stratification, as the aim of the study is to develop a digital technology platform to facilitate acp for clinical practice in any patient with cognitive impairment from any type of dementia. even though the digital platform could be adapted to be useful for patients with advanced dementia and more severe cognitive impairment, or for use just by their families, the pilot study will recruit only patients with mild or moderate dementia, who will still be able to provide informed consent, and who will be able to self-assess for patient-related outcome or patient-related experience measures to inform the assessment of the digital technology platform. patients with dementia treated in the participating study centers will be screened for inclusion criteria and, if suitable will be invited to participate. the study will be performed for up to 90 days, with optional extension to 180 days according to patients' preferences. patients with baseline data and at least one interaction with the digital platform and data completed before and after that interaction will be included in the evaluation.

Eligibility criteria:
inclusion criteria: * mild or moderate dementia of any type * able to provide informed consent, or consent from surrogate decision maker * able to self-assess patient-related outcome (prom) or experience (prem) measures exclusion criteria: * ongoing delir * severe cognitive impairment (mmse \< 10 \[22\]) * unable to provide informed consent * life expectancy estimated less than 3 month
effect of education on treatment decision making for patients with prostate cancer on chronic hormone treatments

Conditions: Prostate Cancer

Summary: the purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic prostatic adenocarcinoma * receiving luteinizing hormone-releasing hormone (lhrh) agonist or lhrh antagonist therapy continuously for at least 1 year with anticipated lifelong therapy * able to complete written surveys in english exclusion criteria: * more than 2 prior systemic treatment regimens utilized in addition to castration.