Kornimate/medical-research-clean huggingface dataset:
prospective study of patients with thrombocytopenia following hsct

Conditions: Thrombocytopenia; Hematologic Diseases

Summary: isolated thrombocytopenia is a common and severe complication of hsct, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. current treatments for thrombocytopenia after hsct are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after hsct. previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (mds) patients. the investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhtpo and decitabine in the treatment of thrombocytopenia following hsct.

isolated thrombocytopenia is a frequent and severe complication of hematopoietic stem cell transplantation (hsct). it often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. current treatments for thrombocytopenia after hsct, including thrombopoietin, interleukin-11, immunoglobulin, methylprednisolone and rituximab, are frequently unsatisfactory in platelet recovery. therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after hsct. thrombopoietin (tpo) is a cytokine that drives thrombopoiesis by stimulating the differentiation of stem cells into megakaryocytes and promoting megakaryocyte proliferation and polyploidization. decitabine was approved for the treatment of myelodysplastic syndrome (mds) as a dna methylation inhibitors. studies in vitro show that decitabine enhances platelet release and megakaryocyte maturation. here, the investigators performed a prospective clinical trial, in order to investigate the safety and efficiency of rhtpo and decitabine in the treatment of thrombocytopenia following hsct.

Eligibility criteria:
inclusion criteria: 1. platelet count ≤ 30 × 109/l persistently at day 60 post-hsct or later; 2. neutrophil and hemoglobin were well recovered; 3. full donor chimerism was achieved; 4. no response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks; exclusion criteria: 1. patients with malignancy relapse; 2. active infections; 3. grade ⅲ-ⅳ acute gvhd or severe chronic gvhd according to national institute of health criteria; 4. severe organ damage; 5. thrombosis requiring treatment; 6. received decitabine following the current transplantation.

Keywords: isolated thrombocytopenia decitabine rhtpo
phenylephrine prophylaxis for postspinal anesthesia hypotension in parturients with preeclampsia

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. in preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. practical guidelines for obstetric anesthesia from the american society of anesthesiologists and an international consensus statement on the management of hypotension with vasopressors indicate either iv ephedrine or phenylephrine may be used to correct hypotension. but the suitable infusion dose of phenylephrine in parturients with preeclampsia is still unknown. the purpose of this study is to investigate the suitable infusion dose of phenylephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification ii to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥180 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: phenylephrine postspinal anesthesia hypotension preeclampsia cesarean section dose-finding
celiac disease and quality of life in children and adolescents (celiaqlife)

Conditions: Celiac Disease in Children; Nutritional Deficiency; Quality of Life

Summary: celiac disease is a disorder commonly diagnosed during childhood. the treatment is a lifelong gluten-free diet. both the condition and the diet can influence the children's physical and emotional well-being. the main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children. the nutritional assessment includes information on diet, biochemical measurement, and body composition. quality of life will also be assessed. the study can contribute to ensure good health and well-being in children on a gluten-free diet.

* a 24-hour dietary recall will be done by a clinical dietician to assess intake of energy and micro- and macronutrients. * blood will be drawn for assessment of vitamin- and mineral status. * feces and urine samples will be collected to measure gluten immunogenic peptides (gip) to assess exposure to gluten. * a self-developed interview will be used for assessment of adherence to the gluten-free diet and compared with the results from a 11-item questionnaire. * weight and height will be measured. * bone mineral density and body composition will be measured by dual-energy x-ray absorptiometry (dxa). * health-related quality of life (qol) will be measured by the pedsql.

Eligibility criteria:
inclusion criteria: * eating a regular diet exclusion criteria: -
observational study to evaluate the efficacy and safety of bortezomib, melphalan, prednisone (vmp) in participants with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to assess the 2-year progression-free survival rate.

this was a prospective, open-label, multicenter, observational study. participants who received bortezomib, melphalan, prednisone(vmp) therapy for multiple myeloma (mm) that was not eligible for autologous stem cell transplantation will be enrolled in the study. the study will consist of screening phase; vmp therapy phase (9cycles); follow-up phase (2 years from the day when the first cycle was started). participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first vmp administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment). participants receiving vmp therapy will be primarily evaluated for 2-year progression-free survival rate. participants safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation * participants with symptomatic multiple myeloma: a) intramedullary monoclonal plasma cells greater than or equal to (\>=) 10% or histologically confirmed plasmacytoma; b) presence of monoclonal protein in the serum or urine; c) myeloma-related organ impairment as defined in protocol * participants with presence of an illness that is detectable by definitions as defined in protocol * postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial exclusion criteria: * participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone \< 160mg in total) * participants with severe peripheral neuropathy (grade \>= 2 by nci ctc version 4.0) * pregnant or breastfeeding mothers * participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial * participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)

Keywords: multiple myeloma bortezomib melphalan prednisone
hemodynamics during the soccer championship 2012

Conditions: Severe Cardiomyopathy; Angina, Unstable; Myocardial Infarction; Angina, Stable

Summary: the purpose of this study is to determine in soccer fans whether and to which extend positive or negative emotions during the european soccer championship affects central hemodynamics, arterial stiffness, heartrate and endothelial dysfunktion.


Eligibility criteria:
inclusion criteria: best fit: * cardiomyopathy "severe myocardial disease leading to heart failure" * angina, stable for at least 7 days * myocardial infarction during 4 weeks before inclusion, actually stable condition * angina, stable, ccs ii-iv exclusion criteria: * not interested in soccer championship * age \<18y * dementia * atrial tachycardia * drug/alcohol abuse * chronic kidney disease, stage 5 * pulmonary/tricuspid valve insufficiency/stenoses * non compliant
a study of vedolizumab in adults with crohn's disease (cd)

Conditions: Crohn's Disease

Summary: the main aim of this study is to see if adults with cd treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography. participants will be treated with vedolizumab according to their clinic's standard practice.

this is a non-interventional, prospective study of participants with moderately to severely active cd who are initiating treatment with vedolizumab according to the current summary of product characteristics (smpc) in the real world setting. the study will enroll approximately 100 participants. the data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: participants with cd this multi-center study will be conducted in canada, italy, and israel at specialized gastroenterology centers. the overall duration of the study will be 18 months.

Eligibility criteria:
inclusion criteria: 1. has moderately to severely active cd with a bwt of \>3 mm, based on ius performed within the previous 4 weeks from baseline. 2. newly initiating iv vedolizumab induction treatment in accordance with the current smpc either at enrolment or within 2 weeks after enrolment (switch to sc is acceptable at maintenance treatment stage). exclusion criteria: 1. prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab. 2. active severe infections such as tuberculosis (tb), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (pml). 3. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. current or previous participation in an interventional clinical trial for cd within the past 30 days, or planned to be enrolled in an interventional clinical trial for cd. 5. ongoing or planned pregnancy or breastfeeding participants. 6. active perforating complications or significant current strictures (assessed by ius, with or without pre-stenotic dilatation) as per clinical judgement. 7. characteristics precluding ius visualization of affected bowel segments or normal bwt of \<=3 mm for all segments.

Keywords: drug therapy
intralesional tolerogenic dendritic cells in crohn's disease treatment

Conditions: Crohn's Disease

Summary: intralesional tolerogenic dendritic cells in crohn's disease treatment.

the main objective is to evaluate the safety and clinical response of intralesional injection of autologous peripheral blood differentiated adult dendritic cells expanded tolerogenic in patients with refractory crohn's disease treatment.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of crohn's disease ( lennard -jones criteria ) 2. active crohn's disease in the last six months to the inclusion defined as : cdai? 220 and endoscopic or radiological criteria of activity 3. refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha 4. presence of visible lesions by endoscopy 5. acceptance to participate in the study and written informed consent exclusion criteria: 1. no injuries in pre-screening resonance 2. pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures 3. patients hiv + and hepatitis c virus + hepatitis b virus + 4. serious concomitant disease: * renal failure with creatinine clearance \< 40ml / min * heart disease: congestive heart failure with ejection fraction \< 45 % , atrial fibrillation treated with oral anticoagulants, uncontrolled ventricular arrhythmias , pericarditis , pleural effusion with hemodynamic * neoplasms or myelodysplasia * psychiatric disorders including alcohol and drugs 5. symptoms attributable to fibrotic strictures in crohn's disease at the discretion of the investigators 6. diarrhea attributable to " short bowel syndrome" 7. active infection , including tuberculosis 8. participation in research studies of new drugs in the 3 months prior to inclusion. 9. vaccination with live/attenuated germs in the previous 3 months 10. personal history of cancer (active or complete remission) or known family history of hereditary cancer. 11. patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis

Keywords: tolerogenic dendritic cells
stereotactic multiple fraction radiotherapy for non-spine bone metastases

Conditions: Radiation Therapy; Bone Metastases; Pain

Summary: to investigate, whether multi-fraction stereotactic body radiation therapy (sbrt) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction sbrt regarding pain response at 3 months after radiotherapy.


Eligibility criteria:
inclusion criteria: * personally signed and dated written informed consent, * histological diagnosis of malignancy, * histologically or radiologically diagnosed bone metastasis, * age ≥ 18 years * pain or under pain control medication exclusion criteria: * pregnant or lactating women, * women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment, * inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc., * prior radiotherapy to the intended treatment site, * lesions \> 5cm in maximum diameter, * prior treatment with radioactive isotopes within 30 days of randomisation, * spinal column, hands, feet, or head as intended treatment site,- fracture at the intended treatment site, * surgery required or previous surgery at the intended treatment site * instability of the intended treatment site.
covid-19 in nursing homes 2020 and 2021

Conditions: Comorbidities and Coexisting Conditions; Frailty; Covid19

Summary: to describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination.

retrospective descriptive cohort study in östergötland county council, sweden comprising 136 nursing home facilities with a possibility to host 4500 residents. all residents in any of these nhs who had a laboratory confirmed covid-19 diagnosis between march 2020 to april 2021 and who died within 30 days after the verified diagnosis are included. the study is undertaken as a retrospective record review. from the records patient-level data on demographic variables, clinical signs, comorbidity, performance status, and cause of death are collected.

Eligibility criteria:
inclusion criteria: * all residents in any of 136 nursing homes in östergötland county council, sweden who had a laboratory confirmed covid-19 diagnosis and who died within 30 days after the verified covid-19 were included in three separate periods: first period from march 31 to june 30 2020; second period from october 15 2020 to january 15 2021; third period from january 16 to april 18 2021. exclusion criteria: -
end-to-end compression anastomosis for left-sided colectomy endo-car study

Conditions: Colorectal Cancer; Diverticulitis

Summary: the purpose of this study is to evaluate the safety and effectiveness of the niti car-device in the creation of colorectal anastomosis


Eligibility criteria:
inclusion criteria: * patient age over 18 * patient schedule for colonic surgery requiring e-t-e anastomosis * patient is able to understand and to sign the informed consent form exclusion criteria: * patient has known allergy to nickel * patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection * patient on regular steroid medication * patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis * patient following radiation (that compromised the anastomosis) * patient who are undergoing a defunctioning stoma * patient with contraindication to general anesthesia * patient who is currently participating in other clinical trial * patient who refuse consent
"efficacy of intermittent enteral nutrition versus continuous administration in intensive care"

Conditions: Enteral Nutrition; Critical Care; Feeding Methods; Gastric Feeding Tube

Summary: the goal of this clinical trial is to determine efficacy of intermittent enteral nutrition vs continuous enteral nutrition in adults patients with a nasogastric tube in a intensive care unit. the main question\[s\] it aims to answer are: * reduction of gastrointestinal and respiratory complications * evaluate the achievement of the caloric objective informed consent will be requested from participants who meet the inclusion criteria. the participants will be randomized into two groups: control group (continuous enteral nutrition) or experimental group (intermittent enteral nutrition) researchers will compare intermittent enteral nutrition vs continuous to see if there is a reduction in gastrointestinal and respiratory complications.


Eligibility criteria:
inclusion criteria: * patients admitted to icu of university general hospital of albacete * need for enteral nutrition by nasogastric tube in the first 48 hours * signed informed consent exclusion criteria: * insulin dependent diabetic patients * abdominal surgery * dire prognosis

Keywords: gastric emptying diarrea vomiting respiratory aspiration of gastric content caloric intake enteral nutrition critical care
postprandial glucose response using mass-market no-added-sugar ice cream

Conditions: Type 2 Diabetes

Summary: kdd is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. the recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.

the consumption of highly ultra-processed foods has been identified as having detrimental effects on human metabolic health, leading to various adverse health outcomes. the metabolic matrix represents a highly quantified, science-based tool for reengineering products with the aim of promoting positive metabolic outcomes. this approach may also contribute to creating shared value by solving important social problems such as obesity and type 2 diabetes by scalable products that are profitable. kdd is committed to addressing the pandemic of metabolic diseases in kuwait and would like to develop products that benefit the collective metabolic health of the kuwait population. kdd is working with partners to assist in its ground-breaking work and to support its efforts with a strong evidence-base rooted in leading-edge science in metabolic health and nutrition. we hypothesise that no-added sugar-flavored ice cream have a substantially different postprandial glycaemic response compared to conventional products in patients with type 2 diabetes.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. aged over 18 years 3. hba1c 6.5-8.5% (48-69 mmol/l) exclusion criteria: 1. lactose intolerant 2. not liking chocolate ice cream

Keywords: type 2 diabetes no added sugar-flavored ice cream conventional ice cream postprandial glycemic response
a pilot study to determine safety & efficacy of autologous human platelet lysate (hpl) in treatment of acne scarring

Conditions: ACNE SCARRING

Summary: this is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human platelet lysate (hpl) in subjects with acne scarring. the study is being conducted at 2 centers in india. the primary endpoint is change in the global acne scarring classification scores from screening to end of the study. the secondary endpoints are photographic assessment, physicians assessment score and patients self assessment score.


Eligibility criteria:
inclusion criteria: * subjects (male and female), aged 18 to 40 years (both inclusive). * subject willing to refrain from any other treatment of acne scarring during entire study duration. * non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study. * subjects who are willing to give informed consent and adhere to the study protocol. exclusion criteria: * subjects with active infection or active acne. * subjects receiving treatment: nsaids treatment within the last 7 days prior to the study. * subjects with history of connective tissue disease. * subjects with metabolic or hematopoietic disorders. * subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia. * subjects who have received prior chemotherapy and radiotherapy * subjects unwilling to or unable to comply with the study protocol. * subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days