Kornimate/medical-research-clean huggingface dataset:
emotion formative study

Conditions: Physical Inactivity; Overweight or Obesity; Cancer

Summary: the emotion study is a two-part orbit model phase 1 trial. the first part, called the formative study, will assess acceptability and feasibility of a novel physical activity intervention in adults at increased risk for cancer due to overweight or obesity.

the emotion study is a two-part orbit model phase 1 trial. the first part of the emotion study, the formative study, will iteratively test and refine the implementation of a novel treatment to manipulate affective mechanisms during physical activity among individuals at higher risk for cancer due to overweight or obesity. acceptability and feasibility of content, delivery, device usage, engagement, and achieving clinically meaningful changes in affective mechanisms will be addressed. treatment components targeting intensity-based goals and affect-based goals will be tested separately in four groups.

Eligibility criteria:
inclusion criteria: * adults aged ≥18 years * residing in the united states * self-reported bmi ≥ 25 * currently engaging in \< 60 minutes per week of structured physical activity * owning a personal smartphone device * residing in an area with internet or wi-fi connectivity during the study period * able to speak and read in english * interested and willing to start a physical activity program * willing to wear a fitbit versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any fitbits or smartwatches they previously wore, for the duration of the study period * able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen exclusion criteria: * unable to provide informed consent due to cognitive disability * unable to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist for any reason * currently pregnant

Keywords: affective response psychological needs physical activity
a study of rapastinel as adjunctive therapy in major depressive disorder (rap-md-02)

Conditions: Depressive Disorder, Major

Summary: this study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (adt) in patients with major depressive disorder (mdd) who have a partial response to adt.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at visit 1 * have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test. exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before visit 1 * lifetime history of meeting dsm-5 criteria for: 1. schizophrenia spectrum or other psychotic disorder 2. bipolar or related disorder 3. major neurocognitive disorder 4. neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study 5. dissociative disorder 6. posttraumatic stress disorder 7. mdd with psychotic features * significant suicide risk, as judged by the investigator.
effects of robotic-assisted gait training in patients with stroke (eoragtipws)

Conditions: Stroke, Robotic Rehabilitation

Summary: this study was conducted to examine effects of gait training with exoskeleton exoathlet and lokomat free-d on functional independence, functional capacity and quality of life in stroke patients.

the study included 32 patients who had stroke. participants were randomized into two groups. functional independence of patients was evaluated with functional independence measure (fim), physical function with 30-second chair stand test (30-cst), functional capacity with 6-minute walk test (6mwt), and their quality of life with short form 36 (sf36). conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. then, one group received walking exercise training with exoskeleton exoathlet (exoatlet 1 model/2019, russia), other group with lokomat free-d (hocoma, lokomat pro free-d model/2015, switzerland). participants were assessed at baseline and post-intervention.

Eligibility criteria:
inclusion criteria: * age between18-65 years old * patients who had a stroke at least three months ago * can independently ambulated exclusion criteria: * heart failure and rhythm disorder, * visual and cognitive problems, * neglect phenomenon (neglect syndrome), * cerebellar pathology, * any lower extremity surgery * an additional neurological pathology that could prevent receiving a training program

Keywords: stroke robotic rehabilitation functional independence functional capacity quality of life
prevention of preterm birth using cervical pessary in pregnant women with short cervix

Conditions: Preterm Birth

Summary: placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

this trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * minimal age of 18 years exclusion criteria: * major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * srom at the time of randomization * cervical cerclage in situ * active vaginal bleeding * previous cone biopsy or cerclage * major uterine structural anomalies * placenta previa

Keywords: short cervix preterm birth arabin pessary
evaluation of dual therapy with dabigatran vs. triple therapy with warfarin in patients with af that undergo a pci with stenting (redual-pci)

Conditions: Atrial Fibrillation; Percutaneous Coronary Intervention

Summary: the main objective of this study is to compare a dual antithrombotic therapy (dat) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (de) dat) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg de-dat) with a triple antithrombotic therapy (tat) combination of warfarin plus clopidogrel or ticagrelor plus aspirin (asa) \<= 100mg once daily (warfarin-tat) in patients with atrial fibrillation that undergo a pci with stenting (elective or due to an acute coronary syndrome). the study aims to show non-inferiority of each dose of de-dat when compared to warfarin-tat in terms of safety. safety will be determined by comparing the rates of bleeding events, assessed using the modified international society of thrombosis and haemostasis classification of major bleeding and clinically relevant non major bleeding events.


Eligibility criteria:
inclusion criteria: * male or female patients aged \>=18 years * patients with non valvular atrial fibrillation * patient presenting with: an acute coronary syndrome (acs) (st elevation myocardial infarction (stemi), nonstemi \[nstemi\] or unstable angina \[ua\]) that was successfully treated by pci and stenting (either bare metal stent (bms) or drug eluting stent) or stable coronary artery disease with at least one lesion eligible for pci that was successfully treated by elective pci and stenting (either bms or des) * the patient must be able to give informed consent in accordance with international conference on harmonisation good clinical practice guidelines and local legislation and/or regulations. exclusion criteria: * patients with a mechanical or biological heart valve prosthesis * cardiogenic shock during current hospitalisation * stroke within 1 month prior to screening visit * patients who have had major surgery within the month prior to screening * gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated * major bleeding episode including life-threatening bleeding episode in one month prior to screening visit * anaemia (haemoglobin \<10g/dl) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count \<100 x 109/l) at screening * severe renal impairment (estimated creatinine clearance (crcl) calculated by cockcroft-gault equation) \<30ml/min at screening * active liver disease
fecal microbiota therapy versus standard therapy in nash related cirrhosis.

Conditions: Non Alcoholic Steatohepatitis

Summary: patients of nash (non alcoholic steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the department of hepatology at institute of liver and biliary sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.


Eligibility criteria:
inclusion criteria: 1. age more then 18 years. 2. all patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis. 3. histologic evidence of definite or probable nash based upon a liver biopsy prior to enrollment and a nafld activity score (nas) ≥5 with ≥1 in each component of the nas score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3). 4. no past history of upper gi bleeding, ascites, hepatic encephalopathy exclusion criteria: 1. diagnosis of liver disease other than nash cirrhosis 2. history of gastrointestinal bleeding, ascites, hepatic encephalopathy 3. ongoing bacterial infection requiring antibiotic treatment. 4. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening 5. treatment with antibiotics or probiotics in the preceding 3 months. 6. inability to safely obtain a liver biopsy or perform an upper gi endoscopy 7. psychiatric disorder 8. hiv 9. pregnant women 10. patients on sbp (spontaneous bacterial peritonitis) prophylaxis
the utility of levofloxacin-rifampin in the therapy of prosthetic joint infection

Conditions: Staphylococcal Infection; Staphylococcus Aureus Prosthetic Joint Infection

Summary: prosthetic joint infection is a devastating complication of total joint arthroplasty ultimately leading to the failure of the total joint arthroplasty function and possibly death. optimal treatment requires the resection of the infected total joint arthroplasty followed by prolonged parenteral antimicrobial therapy. this procedure is followed by reimplantation of a new total joint arthroplasty at a later date. surgical debridement and retention of the infected total joint arthroplasty offers a more conservative surgical approach and has been proven to be cost-effective in selected groups of patients. traditional medical therapy for staphylococcal infection would require an initial parenteral antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression regimen for the life of the total joint arthroplasty. with this strategy the success rate is close to 30%. recently, several prospective studies of patients with tha, tka and fracture fixation device infections conducted in europe showed that the success rate with a 3-6 month course of a quinolone-rifampin combination is effective in 70% to 100% of cases. the proposed study will be a prospective open label observational cohort that will evaluate the outcome of patients with s. aureus pji treated with a medical regimen that includes oral levofloxacin- rifampin and debridement and retention of components. this medical regimen was approved for use by the orthopedic infectious diseases focus group, mayo clinic, rochester. 15 patients will be enrolled over a one-year period and followed up to minimum of 1 additional year. the outcome of this group will be compared to a historical group that is treated with traditional therapy.


Eligibility criteria:
a maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at mayo clinic rochester.
ultrasound elastography assessment of spleen and liver stiffness before and after transjugular intrahepatic portosystemic shunt (tips) procedure

Conditions: Portal Hypertension

Summary: the primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after tips placement results in reduced morbidity and mortality from shunt failure.

portal hypertension is a condition that is caused by various disorders of the liver, including cirrhosis, hepatitis, portal vein thrombosis, or budd-chiari disease. portal hypertension can lead to the accumulation of fluid in the abdomen, called ascites, or put patients at risk for bleeding of the esophagus, stomach, and bowel. in certain patients, portal hypertension is treated by placement of a transjugular intrahepatic portosystemic shunt (tips). elastography is a newer exam which measures the consistency, or softness/stiffness, of various organs in the body. it is performed with ultrasound by sliding a transducer across the abdomen. elastography is most commonly used to evaluate the liver, as disorders that cause damage to the liver result in stiffer liver tissue. the spleen has also been shown to get stiffer in the setting of portal hypertension.

Eligibility criteria:
inclusion criteria: * all patients who undergo tips placement at the university of kansas medical center (kumc) are eligible for participation in this study exclusion criteria: * patients under 18 years of age * patients with prior splenectomy

Keywords: transjugular intrahepatic portosystemic shunt tips cirrhosis hepatitis portal vein thrombosis budd-chiari disease elastography
nicotinamide riboside and metabolic health

Conditions: Obesity; Insulin Resistance

Summary: this study will investigate the effects of 6 week nicotinamide riboside supplementation (1000 mg/day) on metabolic health in healthy (pre)obese humans. the primary objective will be hepatic and whole body insulin sensitivity. secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.


Eligibility criteria:
inclusion criteria: * signed informed consent * caucasian * males and postmenopausal females * aged 45-65 years at start of the study * body mass index (bmi) 27 - 35 kg/m2 * stable dietary habits (no weight loss or gain \>5kg in the past 3 months) * sedentary lifestyle (not more than 2 hours of sports per week) exclusion criteria: * type 2 diabetes * active diseases (cardiovascular, diabetes, liver, kidney, cancer or other) * contra-indication for mri * participation in earlier research or medical examination that included pet/ct scanning * alcohol consumption of \>2 servings per day * smoking in the past 6 months

Keywords: nicotinamide riboside obesity metabolic health insulin resistance mitochondrial function brown adipose tissue energy expenditure ectopic lipid accumulation cardiovascular risk acetylcarnitine
impact of a program of non-pharmacological intervention in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.

this study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months . in one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. meanwhile , the control group that will be followed in the consultations as usual. we will make a determination of hba1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus with poor control of their disease. * no changes have been made in pharmacological previous 3 months. exclusion criteria: * changes in their drug treatment in the past 3 months.
tapestry for people with cardiovascular and metabolic disease: a pilot study

Conditions: Diabetes Mellitus; Hypertension

Summary: tapestry-cm pilot study is a 12-week pilot test of the tapestry-cm using a web application (app) to help patient manage their diabetes and hypertension and other chronic conditions by assisting them in setting goals and connecting them to their healthcare team.

this pilot study is a program evaluation that will employ developmental evaluation techniques to collect qualitative and quantitative data that will be handled, using a sequential explanatory mixed methods approach.developmental evaluation is particularly useful for pre-formative development of potential scalable interventions. developmental evaluation tracks and attempts to make sense of what emerges under conditions of complexity, documenting and interpreting the dynamics, interactions, and interdependencies that occur as innovations unfold. it will be helpful to explicitly understand: 1) what important decisions occur during the tapestry-cm intervention development process and; 2) what data have validated those decisions about how the intervention will be structured and delivered. this understanding will provide a basis for describing key decisions and their rationale to our community and to other communities so that they make more informed adaptations to their local context. tapestry-cm has applied the principles of participatory design by engaging community stakeholders to co-create and refine tapestry-cm interventions in the early phases of the project. the use of mixed methods was purposefully chosen for this developmental evaluation. answering a set of related research questions which included the collecting, analyzing and interpreting of qualitative and quantitative data increases the depth of understanding of results, provides stronger evidence for patterns or themes if data converge, can neutralize or cancel out some of the disadvantages of each method alone, and explicitly recognizes that social phenomena are complex such that varied methods are helpful to best understand these complexities.

Eligibility criteria:
inclusion criteria: * patients over the age of 55 at the start of the study * patients with both diabetes and hypertension * patients with access to a computer and the internet exclusion criteria: * patient is palliative or receiving end-of-life care * patient is deceased * has explicitly stated that they do not want to be part of a research project * patient resides in long-term care * patient has indicated that they do not want to receive a home visit from trained community volunteers. * patient or family member does not speak english * patient will be out of the country for more than 50% of trial duration * patients without access to a computer with the internet

Keywords: chronic conditions, self-management, phr
xl999 administered intravenously to a subject with advanced malignancies

Conditions: Advanced Malignancy

Summary: cancer is a worldwide clinical and economic problem. conventional approaches to treating cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as combined therapies. recently, targeted therapies including antibodies and small molecule inhibitors have also demonstrated clinical benefit. it is now possible to study different genetic lesions involved in cancer types due to advances in genomic methodologies. the investigational drug in this study, xl999 inhibits multiple receptor tyrosine kinases, including vegf receptor (vegfr2/kdr), platelet derived growth factor receptors (pdgfrβ), fms-like tyrosine kinase receptor 3 (flt3), fibroblast growth factor receptors (fgfr1, fgfr3), ret, and kit, and thus, interferes with multiple cellular processes simultaneously and will likely have effects on the integrity of tumor neovasculature and angiogenesis. together with the ability to induce a novel cell cycle arrest, the spectrum of activities that xl999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic. the rationale and purpose of this maintenance study is to allow a subject receiving clinical benefit from xl999 to continue treatment.


Eligibility criteria:
inclusion criteria: * the subject is eligible to continue to receive xl999 in the absence of progressive disease and unacceptable xl999-related toxicity. exclusion criteria: * progressive disease.

Keywords: xl999 advanced malignancy
fatigue and sleep quality in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: this study was planned to examine the effect of reiki application on fatigue and sleep quality in patients with multiple sclerosis.

fatigue and sleep quality in multiple sclerosis patients: does reiki application affect?

Eligibility criteria:
inclusion criteria: * being over 18 years old * volunteering to participate in the research * having the ability to use technological tools * not using reiki and similar integrative treatment methods * not having a verbal communication disability (hearing and speaking) * not having a diagnosed psychiatric disorder * patients who have been treated for ms for more than three months * having a scale score of \>5 on the piper fatigue scale * a score of \>5 on the pittsburgh sleep quality scale exclusion criteria: * none

Keywords: reiki fatigue sleep quality nursing
effect of vitamin d-biofortified eggs on wintertime serum 25-hydroxyvitamin d in adults: randomized controlled trial

Conditions: Vitamin D Deficiency

Summary: while there have been a considerable number of studies on the impact of additional vitamin d in the diets of hens on the resulting egg vitamin d content, the effect of consumption of such vitamin d-enhanced eggs on vitamin d status of healthy human subjects has not been tested in a rct.

the aim of this study was to investigate the effect of consumption of vitamin d3 versus 25-hydroxyvitamin d3 biofortified eggs on winter serum 25(oh)d in adults using a 8-wk randomized controlled trial. this research will provide new data on the potential of vitamin d enriched eggs as a food-based strategy for prevention of vitamin d deficiency.

Eligibility criteria:
inclusion criteria: - consenting white men and women aged 45-70 years exclusion criteria: * consumption of vitamin d-containing supplements throughout the study. planning to take a winter vacation (during the course of the 8-wk intervention) - to a location at which either the altitude or the latitude would be predicted to result in significant cutaneous vitamin d synthesis from solar radiation * planning to use tanning facilities of any type. * a severe medical illness, * allergy to egg products, * medically advised to limit egg intake in relation to managing hypercholesterolemia, * hypercalcaemia, * known intestinal malabsorption syndrome, * excessive alcohol use, * the use of medications known to interfere with vitamin d metabolism

Keywords: vitamin d-biofortified eggs vitamin d status rct