Kornimate/medical-research-clean huggingface dataset:
radiotherapy combined with tislelizumab and irinotecan in mss/pmmr recurrence and metastatic colorectal cancer

Conditions: Mismatch Repair-proficient; Colorectal Cancer Metastatic; Microsatellite Stable

Summary: explore the efficacy of radiotherapy combined with tislelizumab and irinotecan in mss/pmmr inoperable recurrent and metastatic colorectal cancer patients; to evaluate the safety and tolerability of radiotherapy combined with tislelizumab and irinotecan in mss/pmmr inoperable recurrent and metastatic colorectal cancer; to evaluate the radiosensitization effects of tslelizumab and irinotecan;


Eligibility criteria:
inclusion criteria: 1. voluntary signing of informed consent; 2. aged 18-70 years old, regardless of gender; 3. histologically confirmed as inoperable recurrent or metastatic colorectal adenocarcinoma; 4. previously received oxaliplatin and fluorouracil based chemotherapy; no previous treatment with irinotecan; 5. ngs sequencing or immunohistochemistry prompts mss/pmmr 6. at least one measurable lesion; 7. palliative radiotherapy is required for clinical evaluation (except radiotherapy for bone or brain metastasis); 8. ecog scores 0-2; 9. expected survival ≥ 6 months; 10. the organ function of the patient was normal within 7 days before treatment, and the function of important organs met certain requirements. exclusion criteria: 1. pregnant or breastfeeding women; 2. there were primary lesions or metastases in the radiation field and had received radiotherapy before; 3. previously received pd-1, pd-l1 or pd-l2 for any indication; 4. those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ; 5. if there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance; 6. clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, new york heart association (nyha) class ii or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months; 7. organ transplantation requires immunosuppressive therapy severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 8. subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / l; absolute neutrophil count (anc)≥ 1.5 × 109 / l; alanine transaminase (alt), aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (alp).

Keywords: tislelizumab irinotecan colorectal cancer mismatch repair-proficient microsatellite stable
pragmatic urinary sodium-based treatment algorithm in acute heart failure

Conditions: Heart Failure Acute

Summary: administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. unfortunately, there is a lack of evidence of how to guide diuretic treatment. recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. the hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.

objective: to assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes study design: randomised, controlled, open label study study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics. intervention: natriuresis guided treatment versus standard of care main study parameters/endpoints: co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in nt-probnp at 48 and 72 hours. safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age 2. primary diagnosis of acute /decompensated heart failure as assessed by treating physician a. acute heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the esc hf guidelines 3. requirement of intravenous diuretic use exclusion criteria: 1. dyspnoea primarily due to non-cardiac causes 2. patients with severe renal impairment receiving dialysis or requiring ultrafiltration 3. inability to follow instructions 4. any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study

Keywords: loop diuretics natriuresis
clinical evaluation of the performance of a difluoroethane-based cyto-selective cryotherapy to treat dark spots on the hand in 30 volunteers.

Conditions: Solar Lentigo

Summary: this study evaluates the performance of "cryobeauty mains", a cyto-selective cryotherapy based on difluoroethane as a treatment of solar lentigines in 30 volunteers. only one application of "cryobeauty mains" in one hand (right or left hand according to the randomization code).


Eligibility criteria:
inclusion criteria: * phototype ii to iv * subjects having brown spots (solar lentigo) on both hands, diameter ≤ 6 mm (at least 1 spot per hand). * accepting not to expose themselves to the sun (or artificial uv) during the study. * affiliated to a health insurance scheme in accordance with the french law on research involving the human subjects * informed, having undergone a general medical examination attesting to his / her ability to participate in the study. * having given informed written consent for their participation in the study. non inclusion criteria: * having carried out aesthetic care (exfoliants, scrubs or self-tanning, manicure, hand care, uv ...) in the month prior to the start of the study, on the hands. * having applied a depigmenting product in the month prior to the start of the study, on the hands. * having carried out aesthetic care at a dermatologist (laser, ipl, peeling, depigmenting creams, cryotherapy ...), on the hands, during the last 6 months. * presenting dermatosis, autoimmune disease, systemic, chronic or acute illness, or any other condition that may interfere with the treatment or influence the results of the study (diabetic, circulatory, cold allergic, raynaud's syndrome ...) * any general or local treatment (dermocorticoids, corticosteroids, diuretics, etc.) likely to interfere with the evaluation of the parameter studied. * participating in another study or being in an exclusion period from a previous study * being unable to comply to the protocole. * having received over 4,500 euros compensation for his / her participation in clinical trials in the previous 12 months, including participation in this study. * vulnerable: being unable to give or refuse consent. * protected by the law (guardianship, curatorship, safeguard of justice ...). * unable to write or read in french. * can not be contacted by telephone. * for female subjects: * pregnant woman (or wanting to be pregnant during the study) or during breastfeeding. * female not willing to use contraceptives.

Keywords: solar lentigo, cryotherapy, difluoroethane
hemodynamic responses in hemodialysis patients to blood flow restriction using non-pneumatic anti-shock garments

Conditions: Blood Pressure

Summary: study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.

primary aim: to determine how blood flow restriction to the lower extremities using non-pneumatic anti-shock garments affects hemodynamic and cardiovascular parameters such as blood pressure in hemodialysis (hd) patients while they are not on dialysis. investigators propose a pilot study to assess the effects of blood flow restriction using non-pneumatic anti-shock garments in hd patients while they are not on dialysis. outcomes: the primary objective will be a measurement of blood pressure upon application of the non-pneumatic anti-shock garments. secondary outcomes will include the following: baroreflex sensitivity; trends in beat-to-beat blood pressure upon application of the anti-shock garments; patient tolerability of the non-pneumatic anti-shock garments, ejection fraction via echocardiogram analyses.

Eligibility criteria:
inclusion criteria: healthy participants 1. male and female, age≥18 years old 2. no clinical diagnosis of ckd ckd patients not on dialysis 1. male and female, age≥18 years old 2. stage 4 or stage 5 ckd patients ckd patients on dialysis 1. male and female, age≥18 years old 2. patients having haemodialysis treatment at least 3 times per week at a london health sciences centre facility exclusion criteria: 1. not meeting inclusion criteria 2. severe heart failure (new york heart association grade iv) 3. pulmonary hypertension 4. mitral stenosis 5. cardiac transplant recipients 6. mental incapacity to consent 7. declined to participate 8. absence of lower limbs or lower limb injury 9. pregnancy

Keywords: antishock garment
recovery from dexmedetomidine-induced unconsciousness

Conditions: Anesthesia; Healthy; Consciousness, Level Altered

Summary: this pilot study in healthy volunteers aims to determine if biological sex has an impact on recovery from dexmedetomidine-induced unconsciousness, and if transcranial magnetic stimulation combined with electroencephalography (tms-eeg) can be used to measure brain complexity during dexmedetomidine sedation without arousing study participants.


Eligibility criteria:
inclusion criteria: * between the ages of 18 to 65 * normal body weight and habitus, body mass index (bmi) 18 to 30 kg/m2 * non-smoker * no history of taking stimulants or substance abuse * for women: either use of hormonal contraception, or \> 45 years old and last menstrual period \> 12 months ago in the absence of any contraceptives. * american society of anesthesiologists (asa) physical status classification 1 (asa 1) * fluent in english (sufficient to communicate with the study team and understand the consent form) exclusion criteria: * neurologic: epilepsy or positive history of a seizure, stroke, central disorders of hypersomnolence, neuroimmunological disorder (e.g. multiple sclerosis), meniere's disease, parkinson's disease, peripheral neuropathy, no significant visual or hearing impairments, findings in the clinical examination suggesting a neurologic disorder * psychiatric: history or treatment for an active psychiatric problem (including attention-deficit / hyperactivity disorder (adhd) and anxiety disorder) * cardiovascular: hypertension, symptomatic hypotension or bradycardia, myocardial infarction, coronary artery disease, peripheral vascular disease, dysrhythmias, congestive heart failure, cardiomyopathy, valvular disease, familial history of sudden cardiac death * respiratory: bronchitis, asthma, chronic obstructive pulmonary disease, smoking, shortness of breath, sleep apnea * gastrointestinal: esophageal reflux, hiatal hernia, ulcer * hepatic: hepatitis, jaundice, ascites * renal: acute or chronic severe renal insufficiency * reproductive: pregnancy, breast-feeding * endocrine: diabetes, thyroid disease, adrenal gland disease * hematologic: blood dyscrasias, anemia, coagulopathies * musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia * medications: regular use of prescription and non-prescription medications expected to affect central nervous function, anticoagulant or thrombocyte-aggregation inhibiting therapy; exception: oral hormonal contraception * allergies: dexmedetomidine, phenylephrine, betablockers (including labetalol and esmolol), hydralazine, glycopyrrolate potential participants will not be enrolled in our study if they fail to pass a standard drug screening test (toxicology).

Keywords: dexmedetomidine eeg transcranial magnetic stimulation cognition
pamidronate, vitamin d, and calcium for the bone disease of kidney and heart transplantation

Conditions: Transplant Bone Disease

Summary: bone is lost rapidly and fractures occur in 10-20% of patients who receive organ transplants within 2 years. the purpose of this study is to evaluate long-term effects of a pamidronate-vitamin d-calcium regimen on bone loss, fractures, and safety in recipients of kidney and heart transplants.

pamidronate improves bone mass in numerous disorders of bone. other bisphosphonates, as well as pamidronate, have been proven to be beneficial in steroid-related bone disorders. steroid treatment is a major cause of bone loss after organ transplantation. small, short-term studies suggest that pamidronate prevents bone loss in kidney and heart transplant recipients. many bisphosphonates cannot be used in patients with decreased kidney function. however, pamidronate can be given to these patients. this is an advantage of pamidronate in kidney and heart transplantation because of the frequent occurrence of decreased kidney function in these groups. another advantage of pamidronate is that it is administered intravenously. oral bisphosphonates commonly produce esophagitis, which is a challenging problem in the transplant population. potential side-effects of pamidronate include transient hypocalcemia, lymphopenia, low-grade fever, myalgias and nausea. recently, rare cases of proteinuria and kidney failure were reported in cancer patients receiving high-dose pamidronate. although this side effect has not been reported in other types of patients receiving pamidronate, this is a safety concern that warrants further scrutiny in the transplant population. in addition to bisphosphonate treatment, supplementation with calcium and vitamin d may preserve bone after organ transplantation. prior studies have compared bisphosphonates to calcium and vitamin d regimens. however, a combination regimen including each of these treatments may preserve bone mass better than a single treatment. data regarding treatment with a combination of a bisphosphonate, calcium, and vitamin d are lacking in kidney and heart transplantation. comparison(s): in a prospective, open-label, single arm trial, pamidronate (60-90 mg) is administered within 2 weeks after kidney or heart transplant and every 6 months for 2 years. participants are prescribed vitamin d 800 units/d or calcitriol 0.25 microgram/d if serum creatinine is greater than 2 mg/dl, and calcium carbonate 1500 mg/d. the primary outcome is bone mineral density measured by dual-energy x-ray absorptiometry at baseline and after years 1 and 2. fracture events and serum calcium, parathyroid hormone, creatinine, and dipstick proteinuria are also measured.

Eligibility criteria:
inclusion criteria: * kidney or heart transplant recipients exclusion criteria: * hyperparathyroidism

Keywords: bisphosphonates vitamin d calcium supplement corticosteroid therapy fractures
effects of aerobic and resistance training on abdominal fat loss

Conditions: Obesity, Abdominal

Summary: study the effects of different exercise modes on total and regional adiposity variation in subcutaneous and visceral adipose tissue (vat and sat). the investigators hypothesize that total abdominal will improve for all the exercise groups compared to the control group. when comparing intervention groups: 1) no differences on the degree of improvement in total abdominal fat depots (vat and sat) 2) different degree of change when comparing specific sections at vat and sat are expected.


Eligibility criteria:
inclusion criteria: * 30 - 39.9 kg/m2 bmi * white/caucasian * female * sedentary exclusion criteria: * known cardiovascular, pulmonary, metabolic disease * pregnant females * any excluded criteria with mri scans (i.e. certain metal implants, recent tattoos) * diabetic * hypertension * cigarette smoking * mri related contraindications (metal, no removable devices, etc.)

Keywords: abdominal fat visceral adipose tissue subcutaneous adipose tissue exercise intervention
does vilazodone help with antidepressant-associated sexual dysfunction?

Conditions: Sexual Dysfunction; Major Depressive Disorder

Summary: this is a three-center, randomized, double-blind, fixed dose study designed to assess the efficacy, safety, and tolerability of a switch to vilazodone for sexual dysfunction associated with use of a selective serotonin reuptake inhibitor (ssri) and serotonin-norepinephrine reuptake inhibitor (snri)compared to switching to sertraline in patients with major depressive disorder (mdd). vilazodone is a newly introduced, fda approved antidepressant that is a combined serotonin specific reuptake inhibitor and serotonin 1a receptor partial agonist. in contrast to the ssris and snris, appears to have low adverse effects on sexual functioning when compared to placebo.

the design will be a randomized, double blind study with patients being randomized to switching to either vilazodone or sertraline. this will consist of a 1-week screening phase, a 2-week cross taper phase, an 8-week treatment phase, and an optional 2-week down taper phase. the total duration of each patient's participation will be 13 weeks. seventy-two patients will be randomized at the baseline visit to either vilazodone or sertraline, 24 at each of the 3 sites. patients will be recruited over 12 months.

Eligibility criteria:
inclusion criteria: 1. patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use; 2. patients with major depressive disorder who are being treated with a selective serotonin reuptake inhibitor (citalopram, escitalopram, fluvoxamine, or paroxetine) or serotonin-norepinephrine reuptake inhibitor (desvenlafaxine, duloxetine, venlafaxine) for a minimum of 8 weeks. 3. the current episode of mdd is in remission (madrs score \< 10 and cgi score of 1 or 2) 4. the duration of the current mdd episode is less than 2 years 5. presence of antidepressant-associated sexual dysfunction (i.e., absence of sexual dysfunction prior to becoming depressed and presence of significant dysfunction while on the ssri or snri despite being in remission from the depression). 6. patient is at least 18 years old and not more than 65 years old 7. patients must have the opportunity for sexual activity during the study period (in the form of availability of a suitable partner for sexual activity and/or openness to masturbation) 8. patients must be willing to attempt some sexual activity (including masturbation) at least once every two weeks during the study exclusion criteria: 1. patients who have previously failed to respond to or to tolerate either vilazodone or sertraline. 2. patients with a history of severe discontinuation symptoms on tapering off the current antidepressant 3. patients with other known causes of sexual dysfunction 4. use of prohibited medications during the study period

Keywords: sexual dysfunction antidepressant major depressant ssri snri vilazodone sertraline
generate - next generation of gynecological surgery - robotic assisted surgery in gynecological indications

Conditions: GYN Disorders

Summary: generate - next generation of gynecological surgery - robotic assisted surgery in gynecological indications generate real-world evidence in the use of the da vinci surgical systems for gynecological indications within the german health care system.

a prospective, non-interventional, multi-center, post market clinical study.

Eligibility criteria:
key inclusion criteria: * woman with 18 years of age or older * patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent * patient is a candidate for a gynecological procedure to be performed with the intuitive surgical system key exclusion criteria: * life expectancy of less than 1 year * pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women * current participation in a clinical study, if not pre-approved by intuitive * individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliation
treating major depression with yoga mono-therapy

Conditions: Depression Mild; Depression Moderate

Summary: the goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial is to evaluate antidepressant efficacy of yoga monotherapy of 12-weeks duration in 180 adults meeting diagnostic criteria for mild-to-moderate major depression at the zuckerberg san francisco general hospital. researchers will compare the yoga interventions to an education control intervention on holistic healthcare.

consenting participants will be randomized equally to one of three in-person group interventions for 12 weeks: standard yoga practice, ayurvedic yoga practice, or educational attention-control modules. the primary outcome is depression severity, measured by beck depression inventory-ii (bdi) scores. secondary outcomes include perceived stress, measured by perceived stress scale (pss) scores, and several biomarker assays associated with depression: methylation of the grimage epigenetic clock, nuclear factor kappa-b (nf-κb) transcription, leucocyte telomere length, interleukin-6 (il-6) and brain-derived neurotropic factor (bdnf). blinded assessors will conduct all outcome analyses at 12 weeks. the primary analysis will test whether the yoga groups combined achieve statistically greater change in bdi scores compared to the control group. secondary analyses will test whether the yoga groups combined, compared to the control group, demonstrate statistically greater change in pss scores and the aforementioned biomarker assays. in sub-analyses, investigators will assess whether ayurvedic yoga participants, compared to standard yoga participants, demonstrate statistically significant improvements in bdi scores, pss scores, and depression biomarker assays over the 12-week intervention period.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to give voluntary, informed consent * english-speaking * diagnosis of clinical depression exclusion criteria: * current use of antidepressant medication * current engagement in psychotherapy * current pregnancy * significant medical issues interfering with yoga practice

Keywords: yoga ayurveda depression
post-cesarean wound drainage is not necessary in women at increased risk of hemorrhage

Conditions: Pregnancy; Hemorrhage

Summary: randomized controlled trial assessing the benefit of cesarean wound drainage in pregnant women at increased risk of hemorrhage. the pregnant women at increased risk of hemorrhage were randomised in two groups. in one group 2 wound drainages were placed during the cesarean section, in the other group none. outcome measures were difference between preoperative and postoperative hemoglobin, postoperative fever, cumulative opiate dose adjusted to body weight, length of stay and operation time. it is postulated that the pregnant women with increased risk of hemorrhage do not profit from the routine placement of wound drainages. * trial with surgical intervention


Eligibility criteria:
inclusion criteria: * all pregnant women with increased risk of hemorrhage carrying singleton pregnancies, who had to undergo cesarean section. exclusion criteria: * twin-pregnancies

Keywords: women increased risk