Kornimate/medical-research-clean huggingface dataset:
transit bipartition after sleeve gastrectomy

Conditions: Obesity, Morbid; Weight Gain; Bariatric Surgery Candidate

Summary: retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (tb) procedure ("single anastomosis sleeve ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. data were collected prospectively in strictly pseudonymous form. the primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after tb. a subgroup analysis evaluates the effect of the length of the common channel. secondary endpoints include impact on obesity related comorbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux) as well as safety.

prospective data base of 100 consecutive morbidly obese patients who had undergone transit bipartition (tb, also termed "single anastomosis sleeve ileal bypass") after a previous sleeve gastrectomy (lsg). inclusion criteria were tb for excess weight loss (ewl) \ 5 kg/qm with a body mass index (bmi) \> 30 kg/qm. patients with endocrine disorders other than type 2 diabetes mellitus (t2d), major psychiatric disorders, american society of anesthesiologists (asa) iii and higher or pregnant patients were excluded from the study. data were prospectively collected in strictly pseudonymous form. follow up time points were at 1, 3, 6 and 12 months following tb. the primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after tb. a subgroup analysis evaluates the effect of the length of the common channel. secondary endpoints include impact on obesity related comorbidities such as t2d, hypertension, sleep apnea, gastroesophageal reflux as well as safety.

Eligibility criteria:
inclusion criteria: * tb for excess weight loss (ewl) \ 5 kg/qm with a body mass index (bmi) \> 30 kg/qm. exclusion criteria: * endocrine disorders other than t2dm, major psychiatric disorders, asa ≥ iii, pregnancy.

Keywords: obesity weight regain sleeve gastrectomy sasi bypass
biological factors associated with subclinical valvular thrombosis

Conditions: Aortic Stenosis

Summary: a prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (tavi). - the main objective is to determine whether the high residual platelet reactivity rates in patients undergoing tavi is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography

for the purpose of the study, platelet reactivity will be measured with the commercial kit plt vasp/p2y12 at baseline, 1day and 3 months postprocedure. secondary objectives include: -determine the variability of platelet aggregation measured at baseline before the procedure, 1-day post-procedure and at 3-6 and 1 year follow-up. * to determine whether the pro-thrombotic inflammatory response measured by the cd14 + and cd16 + quantification observed after tavi is associated with the appearance of prosthetic thrombosis. * to evaluate the correlation of von willebrand factor levels and distribution of von willebrand multimers with the appearance of prosthetic thrombosis at baseline before the procedure, 1-day post-procedure and at 3, 6 months follow-up and 1 year. * to determine whether the residual platelet reactivity rates in patients undergoing tavi are associated with the occurrence of clinical events, at baseline before the procedure, 1-day post-procedure and at 3,6 months follow-up and 1 year * to evaluate the clinical factors associated with the appearance of early prosthetic thrombosis.

Eligibility criteria:
inclusion criteria: * patients with severe symptomatic aortic stenosis who it was accepted to be treated with tavi by a multidisciplinary team "heat team". * tavi was successfully implanted (according to valve academic research consortium ii criteria) and are under treatment with double antiplatelet therapy. * signed informed consent to participate in this study. exclusion criteria: * age under 18 years and pregnant or of childbearing age. * acute recent stroke recent \<14 days before tavi. * the patients with proven allergy to aspirin, clopidogrel * patients that after tavi cannot undergo a double antiplatelet regimen for 6 months due to a new post-tavi medical indication or are anticoagulated. * knowledge of pregnancy or lactation thrombocytopenia (\<50,000 platelets u / l) well documented and clinically relevant. * the patients with documented moderate or severe hepatic insufficiency * severe chronic renal insufficiency with creatinine clearance \<30 ml / min. * the patients who can not attend the follow-up visits scheduled in the study
the safety and efficiency of luspatercept in chinese adults with transfusion dependent β-thalassemia: a real-world study

Conditions: Thalassemia Major; Transfusion-dependent Anemia

Summary: this is a prospective, single-arm, open-label study. twenty adult patients with transfusion-dependent β -thalassemia will be enrolled to receive luspatercept with optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice. the main objective of this study was to evaluate the efficacy and safety of luspatercept in the treatment of adult patients with transfusion-dependent β -thalassaemia in chinese clinical practice, and to provide evidence reference for subsequent clinical use.

twenty adult patients with transfusion-dependent β -thalassemia will be enrolled to receive luspatercept with optimal supportive care, being injected subcutaneously every 3 weeks ,by the dose of 1-1.25 mg/kg. the main objective of this study was to evaluate the efficacy and safety of luspatercept in the treatment of adult patients with transfusion-dependent β -thalassaemia in chinese clinical practice, and to provide evidence reference for subsequent clinical use.

Eligibility criteria:
inclusion criteria: -≥18 years old * the patient was clearly diagnosed as transfusion-dependent β -thalassemia, the blood transfusion period was ≤60 days, and the red blood cell infusion volume was not less than 3-12u in the 12 weeks before enrollment, which could provide the red blood cell infusion volume record in the 12 weeks before enrollment * patients who were treated with thalidomide before enrollment were required to stop the treatment for more than 4 weeks, and their hemoglobin decreased to below 90g/l. blood transfusion was required, and records of blood transfusion within 12 weeks could be provided * voluntarily participate in the study and sign the informed consent; exclusion criteria: * (1) pregnant or lactating women * persons known to be allergic to luspatercept and/or luspatercept excipients for injection * severe liver dysfunction (liver enzyme (alt or ast) ≥3 times uln) * severe renal impairment (egfr \< 30 ml/min/1.73m3 or patients with end-stage renal disease) * heart disease, heart failure classified as class 3 or higher by the new york heart association (nyha), or severe arrhythmia requiring treatment, or recent myocardial infarction within 6 months of randomization. * the patient has uncontrolled hypertension. according to nci ctcae version 5.0, controlled hypertension in this protocol is considered to be ≤1. * patients with a history of deep vein thrombosis or stroke within 24 weeks prior to enrollment * erythropoietin, luspatercept or hydroxyurea were used 8 weeks before enrollment * any other significant medical condition, laboratory abnormality, or mental illness that the investigator deems inappropriate for inclusion.
intravitreal injection of mscs in retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to determine the feasibility and safety of adult human bone marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis pigmentosa.

retinitis pigmentosa (rp) is an inherited disorder of the photoreceptor cells in the retina. patients may lose vision since they were young or later in life. currently, there are more than 60 genes identified as the cause of this condition, one of which, rpe65, has been studied in several gene therapy trials for leber congenital amaurosis with promising results. another treatment approach for rp is stem cell therapy. studies in animal models of rp have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells.

Eligibility criteria:
inclusion criteria: * retinitis pigmentosa patients diagnosed by ophthalmologists * age 18-65 years old * central visual field less than or equal to 20 degrees * best corrected visual acuity less than 6/120 by snellen visual acuity chart * electroretinogram nonrecordable or the amplitudes were less than 25% of normal exclusion criteria: * other eye conditions that could mask the interpretation of the results * unable to return for follow up * underlying diseases including asthma, heart failure, myocardial infarction, liver failure, renal failure * pregnant and lactating women

Keywords: retinitis pigmentosa bone marrow-derived mesenchymal stem cells intravitreal injection
multicentric comparative study between a conventional and an intensive follow up strategy after treatment of a head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: phase iii randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including pet-ct for patients ≥ n2) performed 2 to 4 months after the end of treatment. the randomization ratio is 1:1.


Eligibility criteria:
inclusion criteria: * males or females aged superior to 35 years * current or previous smokers (smoked more than 10 packs year) or alcohol drinkers (current or previous, more than 140 g alcohol per week) or both * histologically proven invasive hnscc stage 0 to iva, excluding t4b and nasopharynx. patients with in situ carcinoma are eligible. * treated with curative intent * free of cancer at the post-treatment clinical and radiological examination (negative pet-ct for n≥2) at least 2 months after the end of the last treatment and no later than 4 months after. if there is a strong doubt of lack of complete remission (for example if more exams or longer follow-up are needed to affirm or deny complete remission), the patient is not eligible for the trial. * remark: patients with several head and neck squamous cell carcinoma (concomitant or successive), all treated with curative intent and all in complete remission, are eligible. * agree to have a long term follow-up * signed informed consent * patient affiliated to a social security system or beneficiary of the same exclusion criteria: * pregnant or breastfeeding women * severe psychiatric condition that may inhibit protocol participation and in the judgment of the investigator would make the patient inappropriate for entry into this study. * impossibility to perform the planned exams of the intensive strategy * nasopharyngeal carcinoma * other malignancies within 5 years prior to randomization that needs followup by pet-scan or chest ct or head and neck ct/mri * any disease that needs follow-up by regular upper digestive endoscopy
protein a immunoadsorption for the treatment of acute episodes of neuromyelitis optica spectrum disorder

Conditions: Neuromyelitis Optica Spectrum Disorders

Summary: to clarify the efficacy and safety of protein a immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(nmosd), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with nmosd. we plan to treat patients with acute nmosd using protein a immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. the aim is to observe the impact and safety of protein a immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of nmosd, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of nmosd.


Eligibility criteria:
inclusion criteria: * the inclusion criteria for the study are as follows: 1. clinical diagnosis of acute neuromyelitis optica spectrum disorders (nmosd) 2. age and gender: participants must be between 18 and 65 years old, inclusive, with no gender restrictions. 3. serological marker: participants must test positive for aqp4-igg using the cell-based assay (cba) method. 4. understanding and consent: participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form. exclusion criteria: 1. women who are pregnant or breastfeeding. 2. participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis. 3. participants with contraindications to intravenous methylprednisolone treatment. 4. participants who have used monoclonal antibodies in the last 6 months, or fcrn antagonists in the last 3 months. 5. participants who must use ace inhibitors (acei) within 1 week before the start of treatment or during the study, and cannot discontinue their use. 6. severe bleeding or bleeding disorders 7. severe heart failure 8. severe infections

Keywords: neuromyelitis optica spectrum disorders immunoadsorption acute episodes treatment
combined exercise and nutrition intervention for sarcopenia

Conditions: Sarcopenia

Summary: this study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. this study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using dexa, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention

the definition of sarcopenia is age-related loss of skeletal muscle and physical functions. sarcopenia is emerging health problem and increases medical expenditure as the population ages. sarcopenia is closely related to chronic diseases and geriatric diseases. in particular, patients with hip fracture showed a high prevalence of muscle loss and muscle weakness. it has been reported exercise in sarcopenia patients helped the treatment of the diseases. also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients. however, there is still not established standard protocol for the combined exercise-nutrition intervention. therefore, the aim of this trial is to compare the effects of combined exercise nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.

Eligibility criteria:
inclusion criteria: * patients older than 65 years and under 90 years * patients who meet the criteria for the asian working group for sarcopenia (awgs) 2019 * patients who had metabolic syndrome exclusion criteria: * patients with less than estimated glomerular filtration rate (egfr) 30 * patients with musculoskeletal or chronic lung disease incapable of exercise * patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise * patients less than 5 years after treatment of malignant tumor * patients with liver cirrhosis, diabetes and other chronic disease * patients who cannot perform combined exercise nutrition intervention for other reasons

Keywords: sarcopenia older adults exercise nutrition standard intervention
outcome of women with cervical cancer

Conditions: Cervical Cancer

Summary: squamous cell carcinoma (scc) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (ac) of the uterine cervix over the same period. our understanding of the natural history and optimal management of ac is limited. it appears that ac and scc of the cervix behave differently. they are different in epidemiology, prognostic factors, and patterns of failure after similar treatments. available data suggest that they may also differ in their response to treatment. we postulate that new treatment strategies specifically tailored to ac should be explored. however, there is few data about outcome of cervical cancer in taiwan. so we propose this proposal for retrospective analysis of clinicopathological parameters and outcomes in patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous carcinoma.


Eligibility criteria:
inclusion criteria: * time interval: from 1991 to date. * comprehensive surgical staging, debulking procedure, radiotherapy or chemotherapy. * all female patients with cervical cancer who underwent treatment for cervical cancer at far eastern memorial hospital. * all the patients diagnosed as cervical cancer, especially for women with adeno- and adenosquamous carcinoma. * to review: 1. clinical data: including age at diagnosis, presenting symptoms, gravidity, parity, menstrual history, body mass index, history of diabetes, hypertension, personal history of cancer and staging. 2. pathologic information: deep stromal invasion, lymph-vascular space invasion, lymph node involvement, parametrium invasion, vaginal cut end and tumor size. 3. survival data: disease-free and overall survival. 4. radiation report, chemotherapy treatment, operation, discharge and admission note. exclusion criteria: * not comprehensive staging/debulking procedure. * patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis. * female minors or disabled persons.
effect of virtual reality distraction on symptom control and anxiety in children with leukemia

Conditions: Symptom Cluster; Anxiety

Summary: this study aim to evaluate the effect of virtual reality distraction on symptom management and anxiety in children aged 7-18 years with leukemia.

while the virtual reality initiative was applied to the children in the study group, no harm was given to the children in the control group. the virtual reality distraction method will not be applied to the control group. after the child and his family are informed about the study, their written informed consent will be obtained. when the patients were admitted to the clinic the day before chemotherapy treatment was started, the symptom screening scale and anxiety scale will be applied. control group: the researcher stated that no additional procedure will be applied to the children in the control group and that the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days. vr group; a distraction intervention will be applied for 10-15 minutes once a day with vr glasses. the symptom screening scale and anxiety measurement will be obtained by explaining that he/she should evaluate the scale every day for 3 days.

Eligibility criteria:
inclusion criteria: * pediatric patients aged 7-18 years receiving leukemia treatment in the pediatric hematology service * 4 weeks after diagnosis (not in the induction phase) * no need for blood product transfusion (less than 8 mg/dl for hematological malignancies, less than 7 mg/dl for oncological malignancies) * consent to voluntarily participate in the study and written consent from the child and parent exclusion criteria: * the child has a physical and psychological deficit that will prevent him from wearing glasses to watch virtual reality * having a symptom of nausea and vomiting * being in a terminal period * undergoing a surgical operation * unwillingness to participate in the study * having a history of vertigo (having a history of train, motion sickness) * the child and family do not know turkish
prediction of pain after breast cancer surgery with eeg

Conditions: Breast Cancer; Postoperative Pain; Chronic Pain

Summary: 1. rationale the inter-individual pain experience immediately after surgery is considerable. in addition, a number of patients develop chronic post surgery pain (cpsp). patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as cpsp. recently, in a group of patients with chronic back pain, it was demonstrated how subjectively reported pain is associated with specific electroencephalography (eeg) parameters, namely the n2 and p3 components of the pain event-related potential (erp). it was concluded that erp was associated with self-reported pain in daily life up to two weeks after the measurement. this resulted in the current hypothesis that eeg may be a predictor for postoperative pain. 2. study design prospective cohort study. within 2 weeks before surgery, 150 patients will undergo an eeg measurement with five 'vulnerability' tasks. the experiment will be repeated 6 months postoperatively. study population: female patients with breast cancer who will undergo breast surgery, between the ages of 18 to 65 years. 3. main study parameters/endpoints primary outcome is postoperative pain, measured in a pain diary 4 days postoperatively. secondary outcomes are development of chronic post surgery pain and quality of life. the main goal is to develop a comprehensive prediction model for acute and chronic postoperative pain after breast cancer surgery, based on the eeg results of the five vulnerability experiments.


Eligibility criteria:
inclusion criteria: * age 18 - 65 years. * asa 1-2. * sufficient comprehension of the dutch spoken and written language. * elective curative breast cancer surgery, both mastectomy and breast- conserving therapy * stage i and ii breast cancer. * written informed consent is obtained exclusion criteria: * previous breast surgery, both ipsilateral and contralateral. * stage iii-iv breast cancer. * chronic pain (\>3months) with an average severity of at least a vas score 4 during the last two weeks. * chronic pain for which invasive treatment is needed. * use of (weak / strong) opioids in the last week. * a history of opioid addiction. * regular use of the following medications in the last year: antiepileptics,antipsychotics and anxiolytics. * asa 3 or higher. * consumption of alcohol (\>4 units) and / or drugs the evening before. * alcohol consumption (\>= 5 units/day). * illiteracy, problems with self expression, language barrier. * serious vision and / or hearing problems, interfering the performance of the experimental tasks. * a history of psychiatric complaints and/or epilepsy . * a medical history of cva or tia.

Keywords: eeg breast cancer surgery prediction acute postoperative pain chronic pain