Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and efficacy of deferasirox in mds

Conditions: Myelodysplastic Syndromes; Hemosiderosis

Summary: open label, single arm study on deferasirox treatment in mds patients with chronic transfusional hemosiderosis. patients receive daily oral dosis of deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron. after an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.

it has been widely shown that an appropriate chelating therapy in chronic anemias transfusion dependent can prevent the overstock of iron and can reduce the already existing overstock reducing, then, the co-morbidity and improving survival. in particular, some authors have shown in mds affected patients undergoing intensive chelating therapy with deferoxamine haematological recovery with a reduction of the need of transfusions. with the present study, we plan to evaluate the safety and efficacy of a therapy with the new oral chelating deferasirox in mds patients with transfusional hemosiderosis. this is an open label, single arm study on deferasirox treatment in mds patients with chronic transfusional hemosiderosis. patients will receive daily oral dosis of deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron. after an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.

Eligibility criteria:
inclusion criteria: * patients, both males and females, with low and intermediate i risk (ipss score) myelodysplastic syndrome and transfusion-induced hemosiderosis. * age \>=18 years * patients who never received chelation therapy or who received a therapy with desferal after a day of wash out * medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate). * availability of data concerning blood transfusions during the 12 weeks before screening * serum ferritin \>= 1000 µg/l at least twice (at least 2 week interval between the 2 analysis) during the year before the screening * life expectancy \> 12 months * availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening exclusion criteria: * diagnosis different from mds (i.e. myelofibrosis) * severe renal impairment (creatinine clearance \< 60 ml/min) * alt/ast \> 500 u/l * active b and/or c hepatitis * patients treated during the past 4 weeks with experimental drugs for mds (including thalidomide, azacitidine, arsenic trioxide). these patients become eligible after a "wash out" of at least 4 weeks * concomitant treatment with another iron-chelating agent

Keywords: mds chronic transfusional hemosiderosis deferasirox
workload evaluation (via nasa task load index) of robotic assisted and laparoscopic surgery

Conditions: Workplace Stress

Summary: workload evaluation (via nasa task load index) of robotic- assisted and laparoscopic surgery

evaluation of individual and overall workload during robotic visceral surgeries using nasa task load index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures

Eligibility criteria:
inclusion criteria: * robotic and laparoscopic procedures exclusion criteria: * decline of participation (patients, medical stuff) * paparoscopic appendectomies, laparoscopic cholecystectomies
digital support for mental health intervention in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Anxiety; Depression; Ulcerative Colitis; Crohn Disease

Summary: this is a small, exploratory study that will investigate using an artificial intelligence (ai) and virtual reality (vr), digital wellness application (app) to deliver a mental health support session in outpatient and hospitalized patients with inflammatory bowel disease (ibd) and co-existing symptoms of mild to moderate anxiety or depression. the purpose of this study is to explore if a mental health support session using the app is feasible, safe, and acceptable to ibd patients and whether it could possibly help with physical and comorbid psychological symptoms of these patients.

the mental health support session is delivered by a virtual reality digital wellness application (app). the app is a chat gpt-4 powered ai and vr platform called xaia (extended reality artificially intelligent ally). \[chat gpt is an ai program that generates dialogue.\] the app is publicly available on the apple vision pro (a vr tool). it was developed by a group of providers, including a psychiatrist, at cedars-sinai medical center to devise a scalable solution for the increasing demand for mental wellness experiences. the application uses the combination of an ai-powered virtual avatar, named "xaia," and a vr environment to deliver immersive and personalized mental health support in mixed-reality environments. this is a mixed method study with primarily a qualitative focus. patients with ibd who self-report mild to moderate levels of anxiety or depression will be invited to try a single ai-vr mental health support session using the xaia app. participant observations, experiences, and opinions of the application will be collected through surveys and semi-structured interviews. pre- and post- session pain and state anxiety scores will be collected.

Eligibility criteria:
inclusion criteria: * 18+ years of age * patients with inflammatory bowel disease (crohn's disease or ulcerative colitis) * english-speaking * patients with score of 5-14 on general anxiety disorder-7 (gad-7) questionnaire or 5-19 on patient health questionnaire-9 (phq-9) within 3 months * able to provide written consent exclusion criteria: * unwilling and/or unable to participate * non-english speakers * self-reported history of severe motion sickness * the presence of a facial/head deformity that will prohibit comfortably wearing of a vr headset * legally blind or deaf * having had a seizure in the past year * unable to understand the instructions or to consent to participation in the study. * those who are pregnant
efficacy of extremely low magnetic field (elf) in fibromyalgic patients

Conditions: Fibromyalgia

Summary: this is a randomized double-blind crossover study. the investigators applied elf with a device named "limfa therapy®" to 48 fibromyalgic patients, assigned in two groups (true-sham and sham-true). fibromyalgia severity was assessed with the fibromyalgia impact questionnaire (fiq), quality of sleep with the pittsburgh sleep quality index (psqi) questionnaire and global quality of life with short form-12 of physical and mental health summary (sf-12) questionnaire.

in the first part of the protocol the group true-sham received 6 twice a week sessions of true elf therapy of 1 hour, following the antinflammatory, analgesic and biorhythm settings of the device "limfa therapy®". the sham-true group patients received 6 twice a week sessions of sham therapy (no therapy). during the second part of the protocol, the true-sham group received the sham therapy twice a week for 3 weeks and the sham-true group received the actual true therapy twice a week for 3 weeks. for the assessment of pain, sleep quality and global quality of life, a set of questionnaires were administrated at specific stages of the protocol. questionnaires were administrated every three weeks: before the first therapy, after the first course of therapy, after the washout period, after the second course of therapy, and 3 weeks after the end of treatment.

Eligibility criteria:
inclusion criteria: * patients with an established fibromyalgia diagnosis of at least three months according to american college of rheumatology 2010 modified criteria and no responsive to their current therapy. * patients were not responsive to amitryptiline, selective serotonin reuptake inhibitor (ssri) or duloxetine and pregabalin (with a pain reduction below 50% compared to pre-therapy or intolerant to these drugs) * patients with a pain level measured with visual analogue scale for pain (vas) \> 50/100. * patients that had been taking other drugs or food supplements for the treatment of fibromyalgia for at least 6 months. exclusion criteria: * patients that completed either physiotherapy or acupuncture or behavioral treatment in the last 6 months * patients that were affected by other painful syndromes or potentially painful syndromes other than fibromyalgia. * pregnant women * pace-maker carriers * oncologic patients * tuberculotic patients.

Keywords: extremely low magnetic field (elf) fibromyalgia impact questionnaire (fiq) pittsburgh sleep quality index (psqi) short form-12 of physical and mental health summary (sf-12) "limfa therapy®" machine from eywa srl system
the effect of therapeutic touch on pain and comfort after cesarean section

Conditions: Therapeutic Touch; Postpartum Period; Midwifery; Comfort

Summary: this study was conducted as randomized controlled study to evaluate the effect of therapeutic touch on acute pain and comfort level in women who delivered by cesarean section. personal information form was used as data collection form, vas was used to assess pain, and ppcq was used to assess comfort. when power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). experimental group received deep therapeutic touch by investigators two time at 10th and 40nd hours after cesarean section.

cesarean section rate is increasing in the world and in our country, and it might bring other problems with it. pain, breastfeeding problems and decrease in comfort problems have high chance to happen after cesarean section. the insufficiency of pharmacological methods in reducing the problems experienced after cesarean section and having many side effects increase the using percentage tendency to non-pharmacological methods. this study was conducted as randomized controlled study to evaluate the effect of therapeutic touch on acute pain and comfort level in women who delivered by cesarean section. personal information form was used as data collection form, vas was used to assess pain, and ppcq was used to assess comfort. when power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). experimental group received deep therapeutic touch by investigators two time at 10th and 40nd hours after cesarean section.

Eligibility criteria:
inclusion criteria: * • those between the ages of 18 and 45 * multiparous women * at the 8th postoperative hour * women who have not developed any complications during pregnancy, birth and postpartum for themselves or their newborns. * having a single, healthy newborn at term, * does not react negatively to any attempt to touch, * able to speak and communicate in turkish * agreeing to participate in the study exclusion criteria: * those with any problems diagnosed before or at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa) * those who develop any complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.). * those who receive different analgesics other than routine post-operative analgesics (75 mg diclofenac sodium in the first 30 minutes post-op).

Keywords: therapeutic touch comfort midwifery pain postpartum period
a study of the efficacy and safety of efsubaglutide alfa in overweight or obesity patients

Conditions: Overweight or Obesity

Summary: this is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of efsubaglutide alfa at difference dose range once-weekly in patients with overweight or obesity.

this study will look at the adverse events and the change in participants' body weight from the start of the study to the end. weight loss in participants taking efsubaglutide alfa will be compared to weight loss in participants taking placebo.

Eligibility criteria:
inclusion criteria: * fully understood the study, signed the informed consent. * male or female patients aged from 18 to 75 years at the time of signing informed consent. * body mass index (bmi) greater than or equal to 28 kg/sqm or greater than or equal to 24 kg/sqm with the presence of at least one of the following weight-related comorbidities: prediabetic state, hypertension, dyslipidemia, non-alcoholic steatohepatitis (nash), obstructive sleep apnea or cardiovascular disease. * a self-reported change in body weight less than 5% within 90 days before screening irrespective. exclusion criteria: * glycated hemoglobin (hba1c) greater than or equal to 6.5%, or previously diagnosed with type 1 diabetes or type 2 diabetes. * have history of clinically significant abnormal gastric emptying, severe chronic gastrointestinal diseases, long-term use of medications that directly affect gastrointestinal peristalsis, or gastrointestinal surgery within 6 months prior to screening, and deemed unsuitable for participation by the investigator. * have history of hyperthyroidism or hypothyroidism, or a thyroid-stimulating hormone (tsh) level below the lower limit or above 1.5 times the upper limit of the normal range. * calcitonin greater than or equal to 50 ng/l, or have history of medullary thyroid carcinoma, multiple endocrine neoplasia (men) type 2a or 2b syndrome, or a related family history. * any other condition that, in the judgment of the researchers, may affect the patient's ability to provide informed consent or comply with the trial protocol.
clinical and radiographic assessment of photobiomodulated mta pulpotomy in immature first permanent molars with irreversible pulpitis

Conditions: Dental Caries; Irreversible Pulpitis

Summary: this study evaluates the effectiveness of photobiomodulation (pbm) in conjunction with mineral trioxide aggregate (mta) pulpotomy for treating irreversible pulpitis in immature first permanent molars. pbm, also known as low-level laser therapy (lllt), is used to enhance healing, reduce inflammation, and manage pain in young teeth. the randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving mta pulpotomy alone and the other receiving mta pulpotomy with pbm. clinical and radiographic outcomes will be assessed at intervals over 15 months. this research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to mta alone.

this randomized controlled trial evaluates the clinical and radiographic outcomes of mta pulpotomy, with and without pbm, for immature permanent molars diagnosed with irreversible pulpitis. the study includes two parallel groups of 36 children each. group i will undergo mta pulpotomy alone, while group ii will receive pbm treatment alongside mta pulpotomy. pbm employs low-level laser therapy to stimulate pulp tissue regeneration, enhance mitochondrial activity, and reduce inflammation and pain, thereby potentially improving mta pulpotomy outcomes. key inclusion criteria involve children with deep carious lesions and clinical signs of irreversible pulpitis but without pulpal necrosis. follow-up will occur at 3, 6, 12, and 15 months post-treatment to evaluate success based on the absence of clinical symptoms (e.g., pain, tenderness) and radiographic indicators of healing. by comparing these two approaches, the study aims to provide insights into pbm's role as an adjunctive therapy for vital pulp preservation, particularly in pediatric dentistry.

Eligibility criteria:
inclusion criteria: * children aged 6 to 9 years. * non-contributory medical history (healthy otherwise). * presence of carious first permanent molars with the following characteristics: * deep caries extending to ≥2/3 of dentin. * positive response to cold testing. * clinical diagnosis of irreversible pulpitis (moderate or severe), with or without periapical periodontitis. * restorable tooth. * probing pocket depth and mobility within normal limits. * no signs of pulpal necrosis, including sinus tract or swelling. exclusion criteria: * insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp). * presence of systemic or medical conditions that may contraindicate participation. * teeth with unrestorable structure. * teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.

Keywords: irreversible pulpitis immature permanent molars vital pulp therapy (vpt) mineral trioxide aggregate (mta) photobiomodulation (pbm)
cryolesion in treatment of phantom limb pain

Conditions: Phantom Limb Pain; Stump Neuralgia; Pain, Phantom

Summary: assessment of pain intensity on the nrs. assessment of the quality of life by sf-36 and ais. diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator. reassessment of pain intensity on the nrs 30 minutes after local anesthetic block. cryoablation under real-time ultrasound control if the nrs value is reduced by ≥ 2 points. if pain intensity on the nrs reduced by less than 2 points, reassessment 60 minutes after local anesthetic block. cryoablation under real-time ultrasound control if the nrs value is reduced by ≥ 2 points. if pain intensity on the nrs reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed. cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure. * 24 hours after the procedure - assessment of pain intensity and quality of life * 7 days after the procedure - assessment of pain intensity * 30 days after the procedure - assessment of pain intensity and quality of life * 3 months after the procedure - assessment of pain intensity * 6 months after the procedure - assessment of pain intensity and quality of


Eligibility criteria:
inclusion criteria: * status post amputation of a lower or upper limb * pain related to amputation as determined by referring physician and investigator * informed consent of patient to enter the study * reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure exclusion criteria: * pregnancy * active infection in the area of the planned intervention * blood coagulation disorders * immunosuppression * significant spinal stenosis or spinal anomalies that result in differential nerve root pressures * significant disease or disorder that in the opinion of the principal investigator would preclude the safe performance of the anesthetic block or cryoablation * participation in another investigational trial involving systemic administration of agents of unknown chemical composition. * no reduction of pain after the diagnostic block of the relevant main peripheral nerves

Keywords: cryoablation
drug coated balloon versus stenting in patients with symptomatic vertebral artery stenosis：an observational clinical study

Conditions: Vertebral Artery Origin Stenosis

Summary: there are two arms in our trial, dcb group, bms group.the investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 80 years old; 2. tia or non-disabling ischaemic stroke of the posterior circulation; 3. symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication 4. stenosis of the vertebral artery of 50% or greater, diagnosed by both ct angiography or angiography; 5. nihss≤ 6; 6. score on the modified rankin scale ≤ 3. exclusion criteria: 1. active bleeding or coagulation disorders or severe renal/liver impairment 2. allergy to iodinated contrast agent or related medicines; 3. acute stroke in 3 weeks 4. more than 1 stenosis at the target vessel or distal vascular dysplasia (diameter≤3mm) 5. a potential cause of stenosis other than atherosclerosis 6. severe stenosis was found in the anterior circulation artery(\>70%) 7. intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days; 8. isr patients; 9. severe calcification lesion； 10. obvious thrombosis in vessel; 11. pregnancy; 12. a potential cause of tia or minor stroke other than stenosis in a vertebral artery.

Keywords: vertebral artery origin stenosis drug-coated balloon stenting medical treatment
mediterranean diet and nutritional support in heart failure sarcopenia

Conditions: Sarcopenia

Summary: heart failure (hf) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the qol of the patients. its prevalence is about 26 million people in the world, especially in elderly. sarcopenia has been directly associated with the presence of increased comorbidity in patients with hf. in this study the investigators aim to compare the clinical evolution of patients with hf after receiving nutritional support with mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional supplement

all participants will receive general counseling, education about meddiet and vitamin d supplementation in order to reach levels of sufficiency (25oh vitamin d\>30 ng/dl) for avoiding confounding results. participants (n=50) will be randomly allocated to meddiet or meddiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ons), 2 ons per da). participants will be evaluated at baseline, 12 and 24 weeks after nutritional support

Eligibility criteria:
inclusion criteria: * - patients with a previous admission due to hf in the previous 12 months * moderate or severe lvef * both sexs * age \>18 years old. exclusion criteria: * mdrd \<15 ml/min * end-stage liver disease.

Keywords: heart failure sarcopenia nutritional support
percutaneous nephrostomy versus stent in sepsis trial

Conditions: Ureteric Calculus; Sepsis; Hydronephrosis

Summary: randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

the obstructed kidney in the setting of urosepsis is a urological emergency. stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. therefore, urgent decompression of the collecting system is warranted. there are two options for urgent decompression of an obstructed collecting system: 1. image-guided percutaneous nephrostomy tube placement 2. cystoscopic retrograde placement of a ureteric stent this strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy. both the european association of urology (eau) and the american urological association (aua) provide guidelines for management of an obstructed kidney. both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. however, neither organisation recommend one decompression modality over the other. there is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other. this study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

Eligibility criteria:
inclusion criteria: * ureteric calculus with proximal hydronephrosis confirmed on ct kub * white cell count \>12,000mm3 and/or temperature \>38c exclusion criteria: * uncorrected coagulopathy * urethral or ureteric stricture disease * urinary diversion * pregnancy