Kornimate/medical-research-clean huggingface dataset:
sbrt for ventricular arrhythmia

Conditions: Ventricular Arrythmia

Summary: the aim of this study is to demonstrate the safety and efficacy of star (stereotactic antiarrhythmic radiotherapy) in patients with vt (ventricular tachycardia) who are unresponsive to standard treatments. additionally, the planned study aims to provide further insights into the effects of star on vt burden, icd interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.


Eligibility criteria:
inclusion criteria: * recurrent vts/ves with significant burden despite guideline-directed therapy * existing protective icd (implantable cardioverter-defibrillator) implantation except in the presence of contraindications * and lack of response or intolerance to antiarrhythmic medication * and status post ≥1 catheter ablation due to monomorphic vt(s) and vt early recurrence (\<12 months after the last catheter ablation) or contraindication for endocardial ablation (mechanical valve prosthesis, lv (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate) * minimal vt burden: the patient must have had at least 3 vt episodes (sustained vt, icd-atp, or icd shock) in the last 3 months prior to study enrollment. * presence of suitability for radiation therapy with respect to sbrt * age ≥ 18 years * existing informed consent exclusion criteria: * acute myocardial infarction or percutaneous coronary intervention or heart surgery (\<3 months before study enrollment) * status post intra-thoracic pre-radiation * immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer * advanced symptomatic heart failure (nyha class iv) * polymorphic vt or ventricular fibrillation (confirmed in 12-lead ecg and/or icd interrogation) * extensive myocardial scar substrate that would result in too large of a radiation volume * life expectancy \< 6 months considering all comorbidities and in the seattle heart failure model * presence of a left ventricular assist device (lvad) * use of cytotoxic medications * pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential

Keywords: stereotactic radiotherapy
evaluation of mitral valve insufficiency under general anesthesia

Conditions: Mitral Regurgitation; Mitral Valve Disease; Mitral Valve Insufficiency

Summary: observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using nexfin (bmeye, amsterdam, the netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data


Eligibility criteria:
inclusion criteria: * all patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition * adult patients (\>18 years) exclusion criteria: * no informed consent
effect of hpipc for the treatment of ischemic ulcers in subjects with pad

Conditions: PVD; Arterial Ulcers

Summary: to evaluate the effects of hpipc for the treatment of symptoms of pad


Eligibility criteria:
inclusion criteria: * intermittent claudication \>6mo * ischemic ulceration or ulcer of mixed (venous) etiology * abi \< 0.7 * ambulatory * able to comply exclusion criteria: * gangrene * m.i. within 6mo * inability to walk * wound infection * systemic corticosteroids * hbo, apligraf, dermagraft within 6mo * falsely elevated ankle to brachial index (abi) * inflammatory condition affecting healing

Keywords: ischemic ulcers pad intermittent claudication pain
prospective observational study to predict the response of biliary tract tumors to immunotherapy

Conditions: Biliary Tract Tumor; Cholangiocarcinoma

Summary: a prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy in biliary tract tumors

patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive pd-1/pd-l1 inhibitors combined with chemotherapy as first-line treatment. to explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mihc. meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.

Eligibility criteria:
inclusion criteria: 1. over 18 years old; 2. imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma); 3. confirmed as adenocarcinoma by histology; 4. has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled); 5. at least one measurable lesion according to recist 1.1 standard; 6. plan to receive pd-1/pd-l1 inhibitors combined with chemotherapy as first-line treatment; 7. sign informed consent, has good compliance and can cooperate with follow-up. exclusion criteria: 1. suffering from other active malignant tumors within 5 years or simultaneously; unable to collect baseline plasma or tissue samples.
comparison of eccentric training on injury prevention and hamstring strength in football players

Conditions: Sport Injury; Exercise Therapy

Summary: to determine the effect of the eccentric exercise training on injury prevention and hamstring strength in football players.

hamstrings injuries are common among footballers with a higher prevalence rate in male footballers. despite the relatively high incidence of hamstring injuries in sports, no clear prevention methods have been identified. most hamstring muscle injuries occur during an eccentric phase of any activity. eccentric hamstring training has been used for injury prevention in recent years. the two distinguishing characteristics of eccentric muscle contractions have been well understood: 1) great force output; and 2) low energy cost to produce the force. due to these distinguishing characteristics, eccentric exercise is widely used in injury prevention programs. the aim of this study is to determine the effectiveness of eccentric training as compared to conventional training in hamstring muscle injury prevention and strengthing in football players.

Eligibility criteria:
inclusion criteria: * football players with age 18 to 40 * male * players playing football for \> 1 year exclusion criteria: * having history of injury and surgery in past * those players having any kind of musculoskeletal, neurological, cardiovascular, or degenerative problems * those players who have any medical conditions
early feasibility study of the reia vaginal pessary

Conditions: Pelvic Organ Prolapse; Prolapse

Summary: this is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (pop). recruited patients will have stage ii pop or greater and will be current users of a legally marketed vaginal pessary. in a single visit, data will be collected on the performance and comfort of the subject's current pessary. after placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. the study pessary's function will be assessed under controlled circumstances. the patient will have her current pessary replaced at the conclusion of the visit. results will be used to inform future design modifications of the study pessary.


Eligibility criteria:
inclusion criteria: * women with stage ii pelvic organ prolapse or greater * current ring style or gellhorn pessary users inclusive of sizes 1.5"-3.5" * capable of giving informed consent exclusion criteria: * pregnancy * deep vaginal erosion noted with removal of current pessary * presence of vesicovaginal fistula * presence of rectovaginal fistula * vaginal, rectal, or bladder tumor * inflammatory bowel disease * presence of open wound or tear near vagina or anus by exam prior to removal of current pessary * current vaginal or urinary infection requiring treatment * previous pelvic floor surgery in last 12 months * congenital malformation of bladder, rectum, or vagina * significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.) * planning pregnancy in next 6 months
the effect of mandala activity on postoperative pain and anxiety levels in gynecological oncology patients

Conditions: Cancer Pain; Cancer, Treatment-Related; Cancer

Summary: this study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.

this study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients. the study was conducted with 42 patients who underwent open abdominal hysterectomy surgery in the gynecological oncology surgery clinic of a training and research hospital in istanbul between 1 february 2023 and 1 august 2023. patients in the intervention group (n=21) received mandala activity at least once a day during their postoperative hospitalisation (days 0-2). patients in the control group (n=21) did not receive any intervention. introductory information form, visual analogue scale (vas), state-trait anxiety inventory (stai-i), postoperative patient evaluation form and mandala activity booklet were used in the study.

Eligibility criteria:
inclusion criteria: * having a gynecological oncology disease diagnosis, * having had open abdominal hysterectomy surgery, * being over 18 years of age, * ability to communicate in turkish, * having a gynecological oncology operation for the first time, * there is no physical disability related to the upper extremities. exclusion criteria: * readmission due to any complications that develop after discharge, * having visual, hearing and speech disabilities

Keywords: pain anxiety midwife gynecological oncology mandala
doac adrs retrospective study on genetic variations

Conditions: Drug-Related Side Effects and Adverse Reactions; Treatment Failure

Summary: the purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots from forming in the blood vessels.

genes can have variants or mutations that can increase the participant's risk for bleeding when receiving a direct oral anticoagulant (doacs). the investigators will be studying participants on doacs who have had bleeding and also participants who are on doacs who did not have bleeding (control group). the goal of the study is to determine the accuracy of cipherome's drug safety score (dss) in it's ability to predict adverse drug reactions (adrs). a dss score ranges from 0 to 1, with scores less than 0.3 correlated with a higher risk of adrs and scores more than 0.7 correlated with a lower risk of adrs. the participant's dss score will be compared with the actual clinical outcome using a statistical test to determine the accuracy of the dss.

Eligibility criteria:
inclusion criteria: * any adult patient 18 years and older, who experienced major bleeding, clinically relevant non major bleeding or treatment failure while taking a doac during the study time frame and is able to provide informed consent. control patients will be recruited from all adult patients who are on doac therapy. exclusion criteria: * failure to provide informed consent
electrical muscle stimulation and bicycling combined to early standard rehabilitation in the icu

Conditions: ICU-acquired Muscle Weakness

Summary: early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. the early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the icu. it can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization. we hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the icu may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.


Eligibility criteria:
inclusion criteria: * age over 18 yrs * expected length of stay in the icu higher than 72 hours * motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview exclusion criteria: * opposition expressed by the patient, his/her legal representative or a member of his/her family * pregnant woman * resuscitated cardiac arrest before inclusion * patient carrying a pacemaker or an implantable defibrillator * patient under extracorporeal membrane oxygenation * severe acute cerebral disease requiring deep sedation * brain death * guillain-barré syndrome * myasthenia gravis * known dementia than can affect the main endpoint assessment * deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins * unstable traumatic injuries of the spine * severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days * amputation of a lower limb at the trans-metatarsal level or higher * inclusion in another interventional study with muscle strength assessment as the primary endpoint * moribund patient

Keywords: critical illness/*rehabilitation humans *intensive care units muscle weakness/diagnosis/*etiology/physiopathology/prevention & control polyneuropathies/diagnosis/*etiology/physiopathology
evaluate and monitor physical performance of adults treated with asfotase alfa for hypophosphatasia

Conditions: Hypophosphatasia

Summary: hypophosphatasia is a rare inherited metabolic disorder due to inactivating mutations of the alpl-gene. particularly among adult patients, clinical manifestation exhibits a broad range of signs and symptoms, most commonly associated with musculoskeletal disabilities and compromised quality of life. enzyme replacement therapy with asfotase alfa (aa) is available and approved for patients with pediatric onset of the disease. this single-center observational cohort study aims at collecting clinical routine data regarding the course treatment, quality of life and physical performance in patients treated with asfotase alfa in line with the label for pediatric-onset hypophosphatasia.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at the time of enrollment * clinical diagnosis of pediatric-onset hpp based on low alp (age- and sex-adjusted) and/or genetic confirmation of alpl mutation(s), and clinical symptoms consistent with hpp * participant currently receiving commercial asfotase alfa treatment for hpp at the orthopedic institute of the julius-maximilians-university würzburg, as per standard of care * willingness to participate in the study * signed informed consent exclusion criteria: * unwillingness / anticipated inability to attend further visits * off-label treatment with asfotase alfa * current participation in an alexion sponsored trial * experimental drug/treatment
diffusion tensor breast mri (dti)

Conditions: Breast Cancer

Summary: the breast mri is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. the scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. the investigators aim to evaluate a novel mri sequence of images that does not use contrast, diffusion tensor imaging (dti). addition of dti sequence does not add significantly to the time of standard breast mri exam. this novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. hence, the investigators hypothesize that dti may decrease the false positive rate when compared with standard dynamic contrast-enhanced (dce) mri.


Eligibility criteria:
inclusion criteria: * female of any race, ethnicity and lifetime risk. * eighteen years or older. * known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side. * self-detected lump suspicious for breast cancer that it has not been biopsied yet. exclusion criteria: * inability to understand the consent form * pregnant or nursing * currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention * physically unable to lie down on her belly for at least 10 minutes. * have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to mri exam.

Keywords: mri
light and sleep fragmentation

Conditions: Sleep; Mild Cognitive Impairment; Mood Disorders

Summary: this trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * mild cognitive impairment * age \>65 exclusion criteria: * severe depression * unstable psychiatric or medical disease * acute infection
impact of regional anesthesia on inflammatory mechanisms during vaso-occlusive crisis in sickle cell patients

Conditions: Sickle Cell; Sickle Cell Disease; Vaso-Occlusive Crises

Summary: sickle cell disease is a chronic disease characterized by multiple vaso-occlusive complications. the basic treatment for patients with a vaso-occlusive crisis (voc) is based on adequate hydration, oxygen therapy and pain control. loco regional anesthesia (lra) is one of the major treatments in resuscitation anesthesia for both anesthesia and analgesia. lra allows effective and almost immediate pain control by blocking nerve afferents in a given area. lra could decrease the inflammatory response during crises and accelerate resolution of the crisis.

regional anesthesia (ra) possesses intrinsic anti-inflammatory properties and can modulate the inflammatory response. for instance, ropivacaine reduces inflammation induced in vitro in rat epithelial cells. at the cellular level, lidocaine decreases free radical production by neutrophils, inhibits leukocyte phagocytic activity, and significantly suppresses cytokine production in response to endotoxemia. the value of ra no longer lies solely in its ability to block nociceptive input via sodium channel inhibition. a peripheral nerve block with local anesthetics inhibits local neurogenic inflammation, thereby reducing sensitization, hyperalgesia, and the risk of pain chronification. a peripheral nerve block is therefore an anti-inflammatory treatment. however, no study has yet demonstrated the anti-inflammatory effects of ra at the cellular level in sickle cell disease patients. the aim of this study is to analyze the evolution of inflammatory markers during vaso-occlusive crises (e.g., mps, cytokines, nets, etc.), by comparing patients who received ra to those who did not during hospitalization.

Eligibility criteria:
inclusion criteria: * patients adult \>18 years * patients with vaso-occlusive crisis exclusion criteria: * pregnant or breastfeeding women * blood transfusion within the last 3 months * lack of affiliation with the french social security system * protected individuals

Keywords: loco-regional anesthesia inflammation vaso-occlusive crises
immune mechanisms of vitamin d to reduce chronic pain after burn

Conditions: Burn Injury; Chronic Pain

Summary: the goal of this pilot clinical trial is to learn whether vitamin d is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by vitamin d following burn injury. the main question\[s\] it aims to answer are: * is the clinical trial protocol feasible? * is vitamin d administration following burn injury safe? * how does vitamin d cause changes in the immune system in the aftermath of burn injury? following informed consent, participants will be asked to: * take 6 capsules by mouth one time following burn injury (vitamin d or placebo) * provide a blood sample at baseline and 6 weeks following injury * fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months. researchers will compare vitamin d and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.


Eligibility criteria:
inclusion criteria * ≥ 18 years and ≤ 70 years of age * mthbi severe enough to warrant admission to burn surgery service (note: surgery may or may not be indicated) * admission and subsequent enrollment occurs within 1 week of mthbi * patients experience a thermal burn injury, not an electrical or chemical burn. * has a smartphone with continuous service \>1 year * alert and oriented * willing to take study medication (6 capsules of vitamin d or placebo) * point of care vitamin d level \<100 ng/ml * able to speak and read english * burn survivors with acute pain severity ≥ 7/10 on the numeric rating scale (initial pain severity reported by patient on screening) * total body surface area burned \<30% exclusion criteria * substantial comorbid injury (e.g. long bone fracture) * pregnancy/breastfeeding * prisoner status * active psychosis, suicidal ideation, or homicidal ideation * requires an emergency/bedside escharotomy or fasciotomy for the treatment of burn injury. * known child-pugh liver disease severity classification b or c. * known chronic kidney disease stage 4 or higher (gfr≤29). * no other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger patient). * intubated and sedated at time of enrollment. * hypersensitivity to vitamin d3, ergocalciferol, calcitriol, alfacalcidol, calcipotriol * known hypercalcemia (based on routine admission laboratory assessment). * sarcoidosis * hyperphosphatemia (based on routine admission laboratory assessment) * taking vitamin d supplements in excess of 800 iu daily.