Kornimate/medical-research-clean huggingface dataset:
observational study of rebismart®2.0 + msdialog™ in subjects with remitting multiple sclerosis (adherqol)

Conditions: Multiple Sclerosis, Relapsing-remitting

Summary: this is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with rrms treated with rebif (interferon beta-1a) using the rebismart®2.0 and msdialog™.


Eligibility criteria:
inclusion criteria: * diagnosed with rrms according to mcdonald criteria 2010 * relapse free within 30 days before baseline data collection * treatment with rebif for 6 months or more prior to informed consent * already using rebismart®2.0 + msdialog™ for patient reported outcome (pro) assessments (at least once prior to informed consent) * females of childbearing potential must be willing to use appropriate contraception for the duration of the study * edss score less than (\<) 6 * written informed consent obtained prior to any protocol-required data collection exclusion criteria: * participation in other studies within 30 days before baseline * female who is pregnant or breast feeding * significant psychiatric symptoms that, in the opinion of the investigator, would impact subject ability to comply with treatment (as per standard clinical practice) * any contraindication for interferon (ifn) beta-1a therapy as per summary of product characteristics (spc) * administration of any multiple sclerosis (ms) therapy, other than rebif, within 6 months prior to informed consent

Keywords: multiple sclerosis, relapsing-remitting rebif interferon beta-1a rebismart®2.0 msdialog™
evaluation of the efficacy of macitentan in the treatment of coronarymicrovascular angina (macmic)

Conditions: Coronary Microvascular Angina; Macitentan

Summary: coronary microvascular angina (mva) significantly reduces quality of life and increases the risk of heart problems in patients with angina. unfortunately, there are no effective treatments available yet. the endothelin-1 (et-1) - endothelin receptor (etrs) system plays a critical role in mva. preclinical studies demonstrate that etrs antagonists or pericyte-specific knockdown of etrs can improve coronary microvascular function in myocardial ischemia/reperfusion mice and diabetic mice. foreign clinical drug trials have shown that etrs antagonists may alleviate patients' symptoms. however, these studies predominantly rely on conventional coronary angiography rather than direct assessment of coronary microvascular function. early experimental trials using etrs antagonists reported a high incidence of side effects, such as sodium retention and headaches, which negatively impacted treatment satisfaction. to address these limitations, a pilot study is proposed to evaluate the efficacy of macitentan in mva treatment. this investigation will implement thermodilution-based coronary microcirculation function testing to precisely characterize the severity and subtype of coronary microvascular lesions in mva patients. by administering macitentan - a safer etrs antagonist - the study aims to systematically assess improvements in coronary microvascular function, angina symptom relief, and adverse event incidence. the findings are expected to provide critical evidence regarding the therapeutic potential and safety profile of macitentan, while establishing foundational data for subsequent large-scale clinical trials.


Eligibility criteria:
inclusion criteria: * age 18-75 years old. * with typical angina symptoms. * excluding obstructive coronary lesions (coronary stenosis ≤50% or ffr ≥0.8) by cag. * coronary microcirculatory function cfr\ 25 assessed by temperature dilution method. exclusion criteria: * pregnant or lactating women. * history of heart attack within the last 90 days. * severe heart disease (e.g., moderate to severe heart failure, severe heart valve disease). * severe renal impairment (gfr \<30 ml/min/1.73m2). * severe liver disease (child-pugh class c). * moderately severe anaemia (haemoglobin concentration \<90 g/l). * participation in another drug intervention trial study within the last 90 days.

Keywords: coronary microvascular angina angina with non-obstructive coronary arteries macitentan endothelin-receptor antagonists
inpatient capture: a mixed methods study to develop an inpatient lung cancer screening program in a safety net hospital.

Conditions: Lung Cancer Screening Program

Summary: lung cancer continues to be the leading cause of cancer death in the united states. there are several important disparities in lung cancer mortality: racial and ethnic minorities, those with serious mental illness and those with lower socioeconomic status experience higher lung cancer mortality compared to the general population. lung cancer screening (lcs) with annual low dose chest ct can reduce lung cancer mortality by 20% for high-risk patients, but has been generally underutilized with uptake of 5-15% by eligible patients across the united states. half of all patients eligible for lcs remain current smokers, and the additional benefits of tobacco cessation services can increase the benefits of lcs clinical encounters in these patients. despite the proven benefit of lcs and tobacco cessation, it remains out of reach for many with barriers across the patient, provider, and health-care system levels with resultant disparities in uptake of lcs and effective tobacco cessation that may exaggerate disparities in clinical lung cancer early detection and mortality. the majority of lcs care occurs across several visits in an outpatient clinical setting, which may make it inaccessible to the most vulnerable patients. our central objective is to extend the reach of lung cancer and tobacco screening through the implementation and evaluation of a program extending these services inpatient in a public hospital that serves a known high-risk and diverse population in east harlem. preliminary data obtained from a retrospective quality improvement project examined data from patients admitted over a 3 month period in early 2022. of 1374 unique patients were admitted to our hospital, 112 patients met lcs eligibility criteria and over 80% had no evidence of having been screened. forty-seven percent identified as black and 33.9% as hispanic, groups known to have worse lung cancer outcomes. while smoking data was incomplete on a majority of patients, 75% of all inpatient admissions were noted to be currently smoking. this, our preliminary data suggest that an inpatient program to provide smoking cessation and lcs in a safety-net hospital may be an effective tool to increase the reach of lcs in a known high-risk demographic and address disparities in lcs and tobacco cessation services. this proposal represents a prospective pilot study to develop, implement and evaluate an inpatient lcs and tobacco cessation program.


Eligibility criteria:
inclusion criteria: * 50-80 years of age * greater than or equal to 20 pack year history * currently smoking or have quit within the last 15 years exclusion criteria: * \ 80 years of age * \< 20 pack year history * quit smoking greater than 15 years
neuromodulation and fatigue

Conditions: Healthy Aging; Fatigue

Summary: in this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation. healthy individuals will participate in one familiarization followed by three experimental sessions. fatigability and motor function will be assessed in each test session.


Eligibility criteria:
inclusion criteria: healthy individuals between 18 and 50 years old exclusion criteria: metal implants or joint replacement. presence of neuromuscular disease. skin hypersensitivity.

Keywords: transcutaneous spinal direct current stimulation tsdcs fatigability
laparoscopic or abdominal radical hysterectomy for cervical cancer(stage ib3,iia2)

Conditions: Cervical Cancer

Summary: the purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (lrh) and abdominal radical hysterectomy (arh) in patient survival for cervical cancer (stage ib3, iia2).

the purpose of this study is to compare lrh (or robotic-assisted) and arh in patients with cervical cancer (stage ib3, iia2), by a multicenter stratified randomized controlled study, mainly including the following aspects: 1. to compare the differences in pfs and os between patients receiving lrh and arh. 2. to investigate whether pfs and os in lrh can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. to assess postoperative complications and quality of survival.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (stage ib3,iia2). 2. age ≥ 21 years and ≤ 70 years. 3. surgery type b and c (refer to q-m surgical staging) 4. normal range of liver and kidney function and blood count (specific details below) hemoglobin \> 60g/l platelets \> 70\*109/l leukocytes \> 3\*109/l creatinine \< 50mg/dl transaminase abnormal indicators ≤ 3 maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. no history of other malignancies. 6. non-pregnancy. 7. physical strength classification: karnofsky score ≥ 60; 8. subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. no psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, hiv infection, etc.) (note: maximum diameter measurement of cervical lesions is based on pet-ct, or ct, or mri) exclusion criteria: 1. those who are contraindicated for various surgeries and cannot undergo surgery. 2. patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. patients with recurrent cervical cancer 4. patients with ct, mri or pet-ct suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.

Keywords: cervical cancer abdominal radical hysterectomy laparoscopic radical hysterectomy
an intervention to improve mobility of older hospitalized patients

Conditions: Hospital Mobility; Mobility Limitation; Life-Space; Functional Status; Hospital-Acquired Condition; Muscle Atrophy or Weakness; Sarcopenia; Iatrogenic Disease

Summary: low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. however, increasing hospital mobility remains challenging because of the multiple existing barriers. the goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources. this study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status. the multilevel intervention will target: 1. the patients, who will receive an information booklet, a customizable diary, an exercise booklet and an ipad with access to the videos of the exercise booklet. 2. the healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility. 3. the hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults. in a first phase, the intervention will be pilot-tested in one ward of each hospital. the intervention will then be adapted based on patient and healthcare professional feedback. in a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.


Eligibility criteria:
inclusion criteria: * admission to a general internal medicine (gim) ward of a participating hospital * age ≥60 years * being ambulatory during the 2 weeks before admission (self-report) * living in the community (not in a nursing home or another institution) for at least the last 30 days prior to admission * ability to understand french or german * planned length of stay at least 3 days after enrollment * for the pilot-study only: possibility to start the study within 48 hours after admission to the gim ward exclusion criteria: * medical contraindication to walk (e.g., wound not allowing loading weight) * wheelchair-bound * end-of-life * severe psychiatric disorder (severe depression, schizophrenia, psychosis) * delirium (according to the confusion assessment method \[cam\]) additional exclusion criterion for the pilot-study only: - dementia (defined as mini-cog \<3) additional exclusion criteria for the rct only: * cognitive impairment making impossible to use study material (=implement the intervention) and to understand and sign informed consent, based on clinical judgement, except if a proxy can be actively involved in the study and provides consent * severe visual impairment

Keywords: hospital mobility life-space functional status hospital-acquired disability exercise movement ambulation
individualized brain stimulation using transcranial direct current stimulation simulation in stroke patients

Conditions: Stroke

Summary: this study is to investigate the effect of transcranial direct current stimulation (tdcs) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.


Eligibility criteria:
inclusion criteria: * unilateral stroke patients * chronic patients over 6 months after onset * patients with motor evoked potential of the first dorsal interosseous muscle * patients with the movement of fingers exclusion criteria: * history of psychiatric disease * significant other neurological diseases except for stroke * difficult to perform this experiment * patients who are deemed difficult to participate in this research by the investigator * patients with metal implants and medical devices * history of epilepsy * pregnancy * skin defect at the site of electrode attachment
innovative models in the rehabilitation of the elderly with parkinson's disease through technological innovation

Conditions: Parkinson Disease; Frail Elderly; Robotic Devices in Rehabilitation

Summary: the final goal of the present study is to propose a new approach in the parkinson's disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

parkinson's disease is one of the most frequent causes of disability among the elderly. it is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. the balance disorder is a symptom that involves the body axis; it is due to a reduction in the straightening reflexes, so the subject is not able to correct any imbalances. balance disorders do not respond to dopaminergic therapy used in parkinson's disease. therefore, physiotherapy becomes an important intervention for the management of motor disorders. originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidence suggests that neuronal plasticity is exercise-dependent. in this context, robotic rehabilitation performs an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. this protocol study aims to evaluate an innovative rehabilitation treatment of the elderly patients with parkinson's disease, designed to improve the gait and to reduce the risk of falling. the treatment involves the use of two robotic devices: tymo system and walker view. this study is a single-blinded randomized controlled trial. 195 patients with pd will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using tyro system or walker view in addition to the traditional therapy. assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. a 10 treatment sessions will be conducted, divided into 2 training sessions per week, for 5 weeks. the control group will perform traditional therapy sessions lasting 50 minutes. the technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.

Eligibility criteria:
inclusion criteria: * hoen and yahr scale: 1-3 stage * fac ≤ 2 * ranking scale score ≤ 3 * stability of drug treatment for at least 1 month * geriatric depression scale 5-items: negative exclusion criteria: * concomitant participation in other studies * lack of written informed consent * clinical dementia rating (cdr) score ≥ 3 * history of syncopal episodes, epilepsy and vertigo not controlled pharmacologically * serious dysfunction of the autonomic system * severe behavioral syndromes not compensated by drugs * concurrent neurological diseases * severe systemic diseases with life expectancy \< 1 year * patients unable to follow up.

Keywords: parkinson disease robotics elderly rehabilitation
effect of probiotics on pain and oral wound healing after third molar surgery

Conditions: Postoperative Complications

Summary: the aim of this research is to study the effect of probiotic supplements (lactobacillus reuteri) on post-surgical complications and oral wound healing after extraction of impacted third molars.

healthy volunteers are consecutively randomized to the test or placebo group. after a standardized surgical procedure, conducted under local anesthesia, the participants are instructed to take three lozenges daily (one in the morning, one at lunch time and one in the evening) containing either two strains of l. reuteri (dsm 17938 and atcc pta 5289; \>108 cfu per lozenge) or placebo for 2 weeks. the subjects are instructed to let the tablet slowly melt in the oral cavity and to fill in a personal log-book on a daily basis throughout the postoperative period. the patients are recalled to the clinic for follow-up after 1, 2 and 3 weeks for examination. the post-surgical events (pain, swelling, discomfort, feeding problems) are registered daily by the patient in a custom-made logbook. furthermore, the type and frequency of painkillers and antibiotic prescriptions are noted in the logbook. at the follow-ups, the healing of the wounds/lesions is scored with a clinical healing index. stimulated saliva samples are collected at baseline and after 2 weeks and kept frozen until further analysis. in addition, smear samples are collected after 1 and 2 weeks from the extraction socket for bacterial analysis. any subjectively perceived side- or adverse effect in connection with the intervention should be reported to the surgeon. the participants are encouraged to maintain their normal tooth brushing habits.

Eligibility criteria:
inclusion criteria: * uncompromised general health * non-smoker * no systemic medications (except contraceptives) * no recent/ongoing episode of antibiotic treatment. exclusion criteria: * any pathological condition associated with the third molars detected on radiographs prior to surgery * regular consumers of probiotics

Keywords: lactobacillus reuteri wound healing third molar postoperative complications
virtual prep: rendering prep delivery more efficient

Conditions: HIV Infections

Summary: gay, bisexual and other men who have sex with men (gbm) account for over half of new hiv infections in canada each year, and have a 131-fold higher risk of hiv than other canadian men. hiv pre-exposure prophylaxis (prep) using regular oral tenofovir disoproxil fumarate/emtricitabine (tdf/ftc) or tenofovir alafenamide/emtricitabine (taf/ftc) is an effective and safe hiv prevention option. despite growing interest, awareness and willingness to use prep there has been numerous challenges to the broader rollout of prep. this study will address some of these challenges by assessing participant satisfaction,feasibility and clinical outcomes associated with a web-based mobile health (mhealth) model of care for daily oral taf/ftc prep compared to standard of care delivery of taf/ftc prep in canadian gbm/tgw, in the era of covid-19. the ultimate goal of this study is to provide a scalable model for remote prep delivery that minimizes the need for in-person interactions; respects guideline recommendations regarding how to optimally monitor patients; and is attractive to both patients and providers. this study is a 1:1 open-label, pragmatic randomized controlled trial using a ab:ba crossover design, comparing the standard of care to an mhealth based model of care (freddie® ) for taf/ftc prep delivery over 72 weeks.


Eligibility criteria:
inclusion criteria: 1. self-reported gay, bisexual or other man who has sex with men (inclusive of transgender men) or transgender woman 2. age ≥16 3. hiv seronegative, as documented by a 4th generation hiv antigen/antibody combination test performed within 14 days of baseline 4. no symptoms of acute hiv seroconversion (fever, myalgias, arthralgias, malaise, headache, rash, pharyngitis and/or diarrhea that is otherwise unexplained) 5. meets clinical criteria for prep according to the prescribing clinician. patients can be enrolled into the study regardless of whether they will be newly initiating prep, or are already receiving prep; those already receiving prep can be using any regimen (eg. daily tdf/ftc, on-demand tdf/ftc, daily taf/ftc) as long as they are willing to transition to the study regimen of daily, oral taf/ftc. 6. egfr \>30ml/min 7. has adequate access to the internet to permit use of the mhealth platform 8. adequate facility in english to communicate with their provider exclusion criteria: 1. known hypersensitivity/allergy to taf/ftc 2. actively participating in another interventional trial related to the delivery of prep or sexual health-related care 3. being unwilling or unable to perform self-collected pharyngeal and/or rectal swabs as part of routine prep care 4. potential to become pregnant 5. currently living in, or planning to move to a location that would render standard of care or ad hoc in-person visits to the study site impractical during the study period.

Keywords: hiv prep hiv prevention
comparison between pregabalin and magnesium sulfate in hypotensive anaesthesia

Conditions: Functional Endoscopic Sinus Surgery

Summary: comparison between pregabalin and magnesium sulfate in hypotensive anaethesia

compare the effect of a single-dose 150 mg oral pregabalin and 2 grams intravenous magnesium sulfate given 30 minutes before induction of anesthesia on the total nitroglycerine used in patients undergoing functional endoscopic sinus surgery

Eligibility criteria:
inclusion criteria: * asa: class 1 or 2 * sex: male and female * age: from 18 to 70 years * patients scheduled for functional endoscopic sinus surgery exclusion criteria: * patient on diuretics, corticosteroid, pregabalin * patients with a history of allergy to the study drug * pregnancy or breastfeeding women patients with hypertension, cardiac, renal endocrinal diseases * uncooperative patients (cant does not administer oral tablet)