Kornimate/medical-research-clean huggingface dataset:
evaluation the safety and efficacy of lyophilized fecal microbiota transplantation administered orally for prevention of relapse or intestinal inflammation in adults with ulcerative colitis

Conditions: Adults With Ulcerative Colitis

Summary: the purpose of the study is to evaluate the efficacy and safety of lyophilized prim-dj2727 capsules given orally in subjects with ulcerative colitis at remission stage. this study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active fmt or placebo administration.


Eligibility criteria:
inclusion criteria: 1. adult ≥18 years of age 2. history of active uc in the past 12 months based on standard clinical, endoscopic, or histologic criteria. 3. remission of uc based on clinical grounds (partial mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy. 4. sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study. 5. female subjects of childbearing potential must have a negative urine qualitative hcg pregnancy test at enrolment and on the week 1, day 1 of the treatment prior to administration of study drug. 6. willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls. 7. subject has an attending physician who will provide the non-fmt care. exclusion criteria: 1. unable to take multiple capsules orally. 2. females who are pregnant, breastfeeding, or planning to become pregnant during the study. 3. receipt of systemic non-topical antibiotics within 14 days of treatment day 1. 4. positive results for active hiv, hepatitis b, or hepatitis c infections. 5. history of recurrent clostridium difficile infection or fmt in the past 6-months. 6. history of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitis etc. 7. known history of bile acid diarrhea 8. compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking oral prednisone \>20 mg a day or prednisone-equivalent) 9. history of active cancer and/or ongoing chemotherapy (superficial non-metastatic cancers and maintenance chemotherapy are permitted). 10. history of use of an investigational drug within 90 days prior to the screening visit. 11. history of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives. 12. life expectancy of \< 1 year. 13. in the opinion of investigator, subject for any reason, should be excluded from the study.
concomitant and sequential radiohormonotherapy in adjuvant breast cancer

Conditions: Breast Cancer

Summary: this trial will compare grade 2 or greater late skin toxicities of concomitant letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for postmenopausal women with receptor (estrogen receptor \[er\] and/or progesterone receptor \[pgr\]) positive tumors. each drug will be prescribed for 5 years.

this trial is an open-label randomized multicenter phase ii study. a ratio of 1 to 1 will be used for the randomization process between the two arms: * arm a : letrozole 2.5 mg daily for 5 years started three weeks before the first day of adjuvant radiotherapy. * arm b : letrozole 2.5 mg daily for 5 years started three weeks after the last day of adjuvant radiotherapy. all patients will be followed every 3 months for toxicities, disease status and for survival until death.

Eligibility criteria:
inclusion criteria: * compliant postmenopausal women * conservative breast cancer surgery * extension evaluation of disease will be proven negative * patients with tumor negative margins * patients will be classified as t1, t2, t3; sentinel node negative, n0, n1 or n2; m0. * receptor positive tumors (er and/or pgr = 10 fmol/mg cytosol protein; or = 10% of the tumor cells positive by immunocytochemical evaluation). * adequate marrow function (polynuclear neutrophils \>= 1200.10\^9/l, platelets \>= 100.10\^9/l, and hemoglobin \>= 10 g/dl). * hepatic function (bilirubin \>= 30 µmol/l, alt (sgpt) or ast (sgot) \>= 1.5 x upper limit of the institution) and cholesterol level \<2 x upper limit of the institution. * must be geographically accessible for follow-up. * written and dated informed consent exclusion criteria: * patients with distant metastases. * bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast. * patients staged t4 or n3 or treated by not conservative surgery (radical mastectomy). * patients with neoadjuvant chemotherapy or hormonal therapy. * patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. patients who have had a previous other malignancy must have been disease free for at least five years. * patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up. * patients treated with systemic investigational drugs within the past 30 days. * breast cancer chemoprevention with anti-estrogens * hormone replacement therapy (hrt) not stopped at least 4 weeks before randomization * patients known to be hiv positive (no specific tests are required to determine the eligibility).

Keywords: postmenopausal breast cancer, radiohormonotherapy sequences er+ and/or pgr+, postmenopausal breast cancer, adjuvant setting
safety, tolerability, pharmacokinetics and pharmacodynamics of mk-8655 in participants with type 2 diabetes (mk-8655-002)

Conditions: Type 2 Diabetes

Summary: this study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of mk-8655, after single and multiple daily oral administrations to participants with type 2 diabetes (t2dm). the study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of mk-8655.


Eligibility criteria:
inclusion criteria: * male or female of non-child bearing potential * body mass index ≤40 kg/m\^2 * diagnosis of type 2 diabetes (t2dm) and is either drug naive or is being treated with metformin only * in good health except for t2dm * willing to follow a standard diet * nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months exclusion criteria: * mentally or legally incapacitated * history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine (except t2dm), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * history of neoplastic or myeloproliferative diseases * has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety * has a history of type 1 diabetes and/or history of ketoacidosis * use of any lipid-lowering therapies in the past 3 months * non-permitted medication for a co-morbid condition * excessive alcohol or caffeine use * participation in another investigational study within 4 weeks prior to this study * a history of significant multiple and/or severe allergies or anaphylactic reactions * regular user of any illicit drugs or history of alcohol abuse within 6 months

Keywords: type 2 diabetes
trifocal intraocular lens in high myopic patients with different meta-pm grading

Conditions: Myopia; Intraocular Lens Complication

Summary: study the postoperative visual quality and safety of trifocal intraocular lenses implanted in patients with different levels of myopic maculopathy stages according to meta-pm staging (stage 0-2).

cataracts occur in patients with high myopia who are younger than age related cataract patients. these relatively young cataract patients have a higher demand for lens removal, and therefore have a higher acceptance of multifocal intraocular lenses. some current studies have shown that the implantation of multifocal intraocular lenses in patients with high myopia has achieved good visual effects after surgery. as we all know, high myopia is associated with a higher incidence of postoperative complications, and high myopia macular degeneration can affect postoperative visual effects and patient satisfaction. however, there is no research to evaluate the clinical effect of multifocal intraocular lens implantation in patients with high myopia according to different fundus meta-pm classifications.therefore, the purpose of this study is to study the postoperative visual quality and safety of trifocal intraocular lenses implanted in patients with different levels of myopic maculopathy stages according to meta-pm staging (stage 0-2).

Eligibility criteria:
inclusion criteria: age-related cataract 26mm ≤ al ≤ 30mm pre-op corneal astigmatism ≤ 1.0 d (iolmaster 700, carl zeiss meditec ag); eyes with angle kappa ≤ 0.50 mm (itrace); eyes with corneal spherical aberration ≤ 0.30 (itrace); high order aberration ≤ 0.3 (itrace). 2.2 ≤ pupil size ≤ 5.5mm meta-pm classification grade 0, 1 and grade 2 with low risk of mm progression no maculopathy(complete and continuous macular retinal structure revealed by oct) exclusion criteria: combined with glaucoma, serious fundus pathological change, intracranial tumor any systemic disease may cause secondary vision impair synechia other ocular surgery history history of serious cardiopulmonary or cerebrovascular diseases, and serious mental and psychological diseases sensitive, anxiety perfectionist any myopic macular lesion, posterior staphyloma, any plus lesions in meta-pm classification, including but not limited to cnv, lacquer cracks, dome-shaped macula, fuchs spot, etc.
effect of his-ventricular (hv) interval optimisation in cardiac resynchronisation therapy

Conditions: Heart Failure

Summary: cardiac resynchronisation therapy (crt) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. approximately one third of patients treated with crt do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony). the investigators propose a new method to achieve atrioventricular synchrony in crt based on measurements of electrical conduction from within the heart. patients referred for crt implantation at castle hill hospital are eligible to participate. during crt implantation, additional measurements, will be recorded from within the heart. after implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months. the investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure * referred for cardiac resynchronisation therapy (crt) with or without defibrillator * in sinus rhythm * patients must have a telephone * ability to give informed consent * ability to complete the study exclusion criteria: * severe valve disease or previous valve replacement * previous atrial flutter ablation * chronic kidney disease stage 3 or above * recent myocardial infarction * ongoing cardiac ischaemia * infiltrative cardiomyopathy * wolff-parkinson white syndrome * presence of second or third degree heart block * \<90% biventricular pacing at 3 months * hypertrophic cardiomyopathy * pregnancy or breastfeeding * on treatment for hypothyroidism or hyperthyroidism
post-market clinical follow-up study of a-spine's products

Conditions: Degenerative Disc Disease; Kyphosis; Scoliosis; Trauma; Tumor; Stenosis; Pseudoarthrosis of Spine; Deformity

Summary: this is a post-market clinical follow-up study that use questionnaires such as visual analog scale (vas), the neck disability index (ndi), or the oswestry disability index (odi) to compare the clinical improvement effects before and after surgery.

the purpose of study is to confirm the safety and and performance of the a-spine's products for using 2 years. this post-market clinical follow-up study use questionnaires such as visual analog scale (vas), the neck disability index (ndi), or the oswestry disability index (odi) to evaluate the clinical improvement effects. subjects will be evaluated at pre-operation, 6 months, 12 months, and 2 years post treatment. finally, analyze the clinical outcome, fusion rate, and adverse events.

Eligibility criteria:
inclusion criteria: * subject is above 20 years of age; * subject is indicated for a-spine spinal fixation system; * subject is willing and able to provide informed consent to participate in the study; * subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits. exclusion criteria: * subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or subject inclusion criteria.
effects of mindfulness, mobilization of resources, or biofeedback on stress before osce

Conditions: Exam Stress; Stress, Psychological; Stress, Physiological

Summary: stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. objective and structured clinical examinations (osces) will be incorporated soon in the certification process as a final national undergraduate ranking examination. this exam will be an additional major stressor for medical students. stress coping strategies could be implemented to help them better prepare for this examination. the aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the osce.

this randomized, controlled and monocentric study will be conducted during the osce tests contributing towards the final exam grades for 4th year medicine students at the claude bernard lyon 1 university.all the students will receive information for the study and sign consent before being randomized into four interventions groups. all the interventions will last six minutes long. the randomisation groups are: * mindfulness through watching/listening video tape * mobilization of inner resources through watching/listening video tape * cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score * unemotional video tape as controlled group psychological stress will be measured using short questionnaires and self-rated visual analogue scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. for measuring physiological stress, all the student will be equipped with emwave® devices that allows us to record heart rate variability during the time of intervention. students will also answer a questionnaire of personality. main objective is to show that interventions are better than control to reduce stress level before osce. the main outcome is to compare the effect of the interventions on physiological stress, using hrv as physiological stress marker. secondary outcomes are to compare the effects of the interventions on psychological stress and to compare the specified aspect of the intervention. finally, our project will permit to assess if the personality modulates the effectiveness of the intervention.

Eligibility criteria:
inclusion criteria: * adult person * registered as medical student at the university * participating at osce examination * have signed an informed consent form. exclusion criteria: * none
the influence of cytoreduction on pro in eoc

Conditions: Epithelial Ovarian Cancer

Summary: based on an improved understanding of how the extent of successful cytoreduction is influenced both by inherent tumor biological characteristics as well as the aggressiveness of the surgical approach this project aims to better define the value of cytoreduction and to use the knowledge gained to develop more individualized therapy and follow-up. this will be achieved through a translational biomedical research approach. due to the research group's traditions clinical phenotyping, biomarker identification, and clinical trials will be the focus.

the patients will be recruited at their follow-up appointment after their surgery. at this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. all patients will be offered carboplatin auc 5 and paclitaxel 175mg/m2 q3w for 6 cycles \[+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (iiic not maximal debulked with a rest tumor of \>1 cm2 and stage iv)\]. in they fulfill the inclusion criteria and agree the inform consent formula will be signed. during the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. after inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. the patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).

Eligibility criteria:
inclusion criteria: * epithelial ovarian cancer * stage \> ii * ecog \< ii * treated with primary surgery followed by chemotherapy * willing to participate and to sign the informed consent exclusion criteria: * \< 18 years old * borderline and non-epithelial ovarian tumors * stage \< ii * advanced ovarian cancer submitted to neoadjuvant chemotherapy * ecog 3-4 * pregnancy * severe cardiopulmonary disease * patients participating in qol intervention studies

Keywords: epithelial ovarian cancer surgery quality of life
effects of transcranial direct current electrical stimulation on the recovery of ideomotor apraxia of the upper limbs

Conditions: Apraxia, Ideomotor

Summary: limbs apraxia is a motor disorder whose characteristic is the inability or difficulty to perform intentional movements of the limbs (gestures), most frequently involving the upper limbs. recent literature indicated promising effects of transcranial direct current stimulation (tdcs) in the recovery of limbs apraxia, showing that, in stroke patients, excitatory anodal tdcs over left inferior parietal lobe (ipl) may improve limb apraxia. despite this encouraging evidence, the need for larger well powered and sham-controlled clinical trials has also been identified. for these reasons, the objective of this study is to investigate the effects of tdcs application on the left posterior parietal cortex, associated with the treatment for apraxia made by smania et al. in 2000, on the recovery of the upper limbs ideomotor apraxia in patients with left brain lesion of vascular origin.


Eligibility criteria:
inclusion criteria: * subjects of both gender, with ischaemic stroke; * left hemispheric injury documented by neuroimaging examination; * cerebrovascular disease onset within the first 30 days; * presence of ideomotor apraxia as documented by a score \< 53 in the de renzi's test; * intact semantic skills as documented by normal performance on the auditory or visual word comprehension subtest of the neuropsychological examination for aphasia (e. n. p. a.); * full comprehension skills as documented by normal performance in the sub-test of oral or orthographic comprehension (auditory or visual words comprehension) of the neuropsychological examination for aphasia (e. n. p. a.); * age between 20 and 80 years; * any schooling; * patient's informed consent signature. exclusion criteria: * comprehension and/or semantics deficit as documented by e. n. p. a.; * pre-existing psychiatric and/or neurological pathology; * failure to sign the patient's and/or caregiver's informed consent.

Keywords: transcranial direct current stimulation stroke rehabilitation
evaluation of myocardial improvement in patients supported by ventricular assist device under optimal pharmacological therapy

Conditions: Heart Failure

Summary: cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (vad). reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the vad. however, some questions continue to await definitive answers. this study is designed to assess the myocardial recovery under vad support with optimal pharmacological therapy (high doses \[group i\] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses \[group ii\]). the study is a randomized, single-blind trial performed at the department of cardiac surgery, university of strasbourg, france. twenty patients with end-stage heart failure who will be supported by vad (thoratec paracorporeal device) as a bridge to heart transplantation will be included. reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. myocardial biopsies will be obtained at the time of vad implantation and heart transplantation. the follow-up will be performed every 4 weeks during the vad support period. the hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.

evaluation of myocardial improvement (reverse left ventricular remodeling, mitochondrial respiratory function) in patients supported by ventricular assist device under optimal pharmacological therapy

Eligibility criteria:
inclusion criteria: * patients with end-stage heart failure refractory to medical therapy and who fulfill criteria for vad implantation as a bridge to heart transplantation * age \> 18 exclusion criteria: * myocarditis

Keywords: end-stage heart failure heart failure; ventricular assist device; statin; heart transplantation; myocardial function; mitochondrial respiratory function;