Kornimate/medical-research-clean huggingface dataset:
spanish registry of patients with igm monoclonal gammopathies

Conditions: Waldenstrom Macroglobulinemia

Summary: waldenström's macroglobulinemia (wm) is a b-cell lymphoproliferative disorder which is defined by bone marrow infiltration by small lymphocytes, lymphoplasmacytoid and plasma cells together with the presence of a detectable monoclonal immunoglobulin m (igm).the clinical presentation of wm is variable. symptoms can be related to tumor infiltration, or they can be related to the monoclonal igm component. the therapeutic options are heterogeneous and there are no well-established in both first line or relapse/refractory settings. in spain, the incidence of mgus-igm and wm in the last decade is unknown. the aims of this retrospective, observational, multicentric study is: * to develop a national registry of patients diagnosed with waldenström's macroglobulinemia and monoclonal gammopathy of uncertain significance -igm in spain in the past 30years. * to evaluate the most relevant clinical characteristics, long-term safety and efficacy of different therapeutic schemes and long-term prognosis of patients with wm * to help in the design of future therapeutic strategies, risk prognostic factors and clinical trials in spain. methods: the investigators will collect data from the patient clinical files after prior informed consent providing from patients with diagnosis of mgus-igm and wm in the past 30 years in spain, according to the who classification of lymphoid tumors (2008) revised in 2016. data from patients not able to provide ic (i.e., already dead patients) will be included only after the permission of the ethics review board. the collected data will be included in a database of the spanish myeloma and lymphoma intergroup (smali) team created ad-hoc by the spanish society of hematology and hemotherapy (sehh). each principal investigator in each center will conduct their technical supervision. the evaluation of the treatment protocols will be done following the indications of the intergroup committee according to the guidelines of the international waldenström's macroglobulinemia group.


Eligibility criteria:
inclusion criteria: * age ≥18 years * patients having a confirmed diagnosis of either in the las 30 years: * monoclonal gammopathy of uncertain significance -igm * asymptomatic waldenström's macroglobulinemia * symptomatic waldenström's macroglobulinemia exclusion criteria: * other subtypes of lymphoproliferative diseases.
assessment by the cans score versus anthropometry and impact on early neonatal morbidities

Conditions: Fetal Malnutrition

Summary: assessment of malnutrition within 48 hours of birth through anthropometric indices as weight, length and head circumference, proportionality indices as mac/hc ratio, ponderal index and body mass index, clinical assessment of nutritional status (cans) score. detection of early neonatal morbidities within the first week of life including hypoglycemia ,polycythemia, respiratory distress syndrome, neonatal sepsis, hyperbilirubinemia and feeding intolerance

within the 1st 48 hours of birth, all live born, singleton neonates with gestational ages between 28-40 weeks will be included in the study after obtaining an informed consent from their legal guardians. assessment of malnutrition within 48 hours of birth: 1. anthropometric indices: weight (using the infant weighing scale). length (using the infant measuring board). head circumference (using non-metallic non-stretchable tape). 2. proportionality indices: mac/hc ratio (calculation for each infant and value will be plotted on and compared with a standard curve). ponderal index body mass index 3. clinical assessment of nutritional status (cans) score: a total score \<25 is considered as fetal malnutrition. 3. detection of early neonatal morbidities within the first week of life (for those who will require nicu admission): 1. hypoglycemia (random blood sugar) 2. polycythemia (hematocrit level) 3. respiratory distress syndrome 4. neonatal sepsis (clinically, laboratory: cbc with diff., crp, c/s) 5. hyperbilirubinemia (serum bilirubin level, need of phototherapy or exchange transfusion) 6. feeding intolerance (abdominal distension with prominent intestinal loops, gastric residue more than 3ml/kg before feeding at least 2 times/ day)

Eligibility criteria:
inclusion criteria: neonates of both genders. gestational age between 28-40 weeks. singleton pregnancies. exclusion criteria: presence of congenital anomalies. infants of diabetic mothers
probiotics in hospitalized patients study

Conditions: Antibiotic Associated Diarrhea; Clostridium Difficile Associated Diarrhea

Summary: the purpose of this study is to compare the effect of enhanced probiotic (ep, live rx) versus placebo (pl) on the incidence of clostridium difficile associated diarrhea (cdad) or antibiotic associated diarrhea (aad) in hospitalized patients initiated on antibiotics.


Eligibility criteria:
inclusion criteria: * 18 years of age or older admitted to ssh and prescribed antibiotics for an expected duration \>3 days (may include patients on antibiotics prior to admission). exclusion criteria: * 1. history of chronic diarrhea illness (irritable bowel disease (ibd), irritable bowel syndrome (ibs), celiac disease, chronic pancreatitis 2. diarrhea at screening 3. active colitis of any etiology 4. history of colectomy 5. regular consumption of probiotics within 72 hours 6. unable to provide written consent 7. history of or active pancreatitis 8. severe sepsis or septic shock (sepsis with end organ failure e.g. renal failure, ards, ms changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. hypersensitivity to any ingredient in probiotic product 10. severe immunosuppression (anc \<1000, aids/cd4 count \<200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. acute burn injuries
digitalized clinical decision support for the prevention of postoperative delirium (pod)

Conditions: Postoperative Delirium

Summary: the project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. subprojects regarding delirium are implementes as well.

postoperative delirium (pod) is the most common post-operative complication in the 70+ age group, affecting approximately fifteen percent of elderly patients. pod is characterized by impaired attention, awareness, and cognitive function. both patients and their families are severely affected by the effects of this condition. while symptoms of pod occur during hospitalization, they have a critical impact on post-hospitalization quality of life, dependency on long-term care, and life expectancy. the overarching goal of the digi-pod project consortium is to develop a digital decision support system that makes current evidence-based guideline recommendations for pod machine-readable and allows automated, real-time validation against clinical data. sub-projects such as a point prevalence analysis on the incidence of delirium on 2 days at the charité and a staff survey conducted by aktionsbündnis patientensicherheit e.v. in all study centers accompany this study.

Eligibility criteria:
study patients: inclusion criteria: * age ≥ 70 years * male and female patients * patients who are insured through statutory health insurance * patients capable of giving consent for inclusion: by the patient, preoperatively * patients under guardianship for inclusion: written declaration of consent by guardian * operation (elective) exclusion criteria: * insufficient language skills * moribund patients study relatives inclusion criteria: * age ≥ 18 years * male and female relatives * relatives capable of giving consent for inclusion exclusion criteria: * insufficient language skills * no consent for data entry substudy of the charité - university berlin: inclusion criteria: - all inpatients ≥ 18 years of age who have undergone delirium screening with a validated delirium screening instrument

Keywords: clinical decision support system, delirium risk factors, recommendations, surgery
postoperative discomfort after dental general anesthesia

Conditions: Postoperative Pain

Summary: the aim of this prospective, randomised, controlled clinical trial was to compare immediate postoperative discomfort, emergence delirium and recovery time of the patients intubated using either laryngeal mask airway or nasotracheal intubation.

a total of 70 children aged 3 to 7 years received full mouth dental rehabilitation under general anesthesia. children were randomly grouped into laryngeal mask airway (lma) group (n=35) and nasotracheal intubation (nti) groups (n=35). in lma group lma was inserted after anesthesia induction using 8% sevoflurane. in nti group rocuronium and remifentanil were given intravenously during %8 sevoflurane induction and the patients were intubated by a nasotracheal tube. after completion of the dental treatments patients were transferred to the post anesthesia care unit (pacu). duration of dental operation ,duration of anesthesia, recovery time, postoperative discomfort, emergence delirium, pediatric dentist's access were recorded.

Eligibility criteria:
inclusion criteria: * aged 3-7 years, * asa i and ii * lack of chairside cooperation for dental treatment in clinical setting. exclusion criteria: * a history of of anticipated difficult entubation , * patient with pharyngeal pathology patients with known pulmonory or cardiovascular disease, * when the expected dental procedure was more than two hours * mental retardation and those whose parents did not consent to their participation in the study.

Keywords: laryngeal mask airway nasotracheal intubation dental treatment
rate of bronchopulmonary dysplasia in preterms neonates: a trial comparing smoflipid and medialipide

Conditions: Preterm Neonates

Summary: smof is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (bpd) at 36 weeks corrected age in premature infants \< 29 weeks and / or with birth weight \< 1000 g receiving either smoflipid® or medialipide® 20%. this study will offer new information for optimizing the management of preterms requiring parenteral nutrition. the investigators hypothesis is that the composition of smoflipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of bpd.


Eligibility criteria:
inclusion criteria: * preterm neonates with gestational age \< 29 weeks and / or birth weight \< 1000 g * admission in the intensive care unit within 6 h after birth * iv lipid emulsion (le) started latest at first day of life * anticipated duration of parenteral nutrition \>10 days * informed consent from legal representative exclusion criteria: * inherited metabolic diseases * major congenital malformations * participation to another study evaluating any kind of medications

Keywords: preterm neonates
rad001 in advanced sarcoma

Conditions: Soft Tissue Sarcomas; Bone Sarcomas

Summary: this trial intends to test the efficacy and safety of rad001 in patients with advanced sarcoma who failed to conventional chemotherapy.

this multicenter, phase ii trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response. * any of above drugs is allowed to be used as adjuvant treatment. * unidimensionally measurable disease * 3 or less than prior chemotherapies * age 17 years old or older * ecog performance status 2 or less, life expectancy 6 month or less * adequate bone marrow, liver, kidney, and cardiac function * written informed consent exclusion criteria: * pregnant or lactating patients * patients with resectable metastasis * patients with history of cns metastasis * gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma * hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. * any preexisting medical condition of sufficient severity to prevent full compliance with the study

Keywords: soft tissue sarcomas bone sarcomas rad001 refractory to conventional chemotherapy
efficacy and safety study comparing cd07805/47 gel 0.5% to azelaic acid gel 15% in subjects with erythema of rosacea

Conditions: Erythema; Rosacea

Summary: the purpose of this study is to compare the efficacy and assess the safety of cd07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at baseline/visit 1 in a 1:1 ratio to receive either cd07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). subjects will re-qualify based upon inclusion/exclusion prior to period 2 treatment.

Eligibility criteria:
inclusion criteria: 1. subject is male or female aged 18 years or older. 2. subject has a clinical diagnosis of facial rosacea. 3. subject has a clinician's assessment score of moderate to severe erythema prior to enrollment. 4. subject has a self assessment score of moderate to severe redness prior to enrollment. 5. subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment. exclusion criteria: 1. female subjects who are pregnant, nursing or planning a pregnancy during the study. 2. subjects with a condition or who are in a situation, which in the investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study. 3. subjects with conditions causing facial erythema which would confound the assessment of treatment. 4. subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists. 5. subjects with known allergies or sensitivities to one of the components of the investigational products.
lees screen in concomitant strabismus

Conditions: Strabismus

Summary: preoperative and postoperative lees screen was done after concomitant horizontal strabismus surgery to detect any limitation in the field of operated muscle

preoperative and postoperative lees screen was done for concomitant esotropia and exotropia patients to record any change in ocular motility as regards underaction or overaction in the operated extra ocular muscles

Eligibility criteria:
inclusion criteria: * concomitant esotropia * concomitant exotropia * above 10 years old patients exclusion criteria: * restrictive and paralytic strabismus * previous strabismus surgery * mental disability
effects of kinesiotaping and electrical muscle stimulation on low back pain and disability

Conditions: Low Back Pain

Summary: to compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.


Eligibility criteria:
inclusion criteria: * diastasis recti more than 2 or 2.5cm * 6 weeks' postpartum cesarean section females * primigravida females * low back pain due to dr exclusion criteria: * normal vaginal delivery * episiotomy * multigravida women's * history of abdominal hernia * history of any abdominal surgery

Keywords: kinesiotaping electrical muscle stimulation low back pain diastasis recti exercises
a phase 2 study of tas-303 in female patients with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to evaluate the efficacy and safety of tas-303 in female patients with stress urinary incontinence.

the main purpose of this study is to assess the efficacy of tas-303 in female patients with stress urinary incontinence (sui) compared with placebo as measured by the percent change in the average sui episode frequency per 24 hours from baseline at week 12.

Eligibility criteria:
key inclusion criteria: * patient has symptoms of stress urinary incontinence (sui) for at least 12 weeks prior to study entry * urinary incontinence in the 1-hour pad weight test exceeds 2.0 g * the average number of sui episodes is 1 or more per day * the average number of urge urinary incontinence (uui) episodes is 0.43 or less per day * the number of "sui episodes" exceeds the number of "other episodes" * the average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day key exclusion criteria: * patient has been diagnosed with mixed urinary incontinence (mui) that is predominantly uui * patient has treated medication or therapy for sui within 14 days before prior to study entry * patient is considered to have sui that would not be expected to improve unless treated with surgical therapy * patient had a history of surgical treatment for urinary incontinence (trans-obturator tape surgery, tension-free vaginal tape surgery, etc.) * patient has stage ii or more of pelvic organ prolapse (pop), or had a history of pop repair surgery within 180 days before prior to study entry * patient has a serious illness or medical condition

Keywords: urinary incontinence urinary incontinence, stress lower urinary tract symptoms
open label extension assessing the tolerability of bci-024 in combination with bci-049 in patients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the objective of this study is to allow patients who have participated in the precursor study of bci-024 in combination with bci-049 versus placebo or bci-024 alone (protocol #cbm-it-01) to receive 6 weeks of open-label treatment with an increased dose of bci-024 in combination with an increased dose of bci-049. the safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with mdd.

up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Eligibility criteria:
inclusion criteria: * subjects who are willing to provide written informed consent and who have completed participation in protocol cbm-it-01 are eligible for the study. * eligible subjects will have demonstrated compliance with all cbm-it-01's protocol requirements. exclusion criteria: - subjects who did not complete their participation in protocol cbm-it-01 are not eligible for the study.

Keywords: depression combination
evaluating the risk of postoperative venous thromboembolism in cervical cancer patients

Conditions: Venous Thromboembolism

Summary: the aim of this study is to develop a machine learning model to accurately predict the risk of venous thromboembolism in patients with cervical cancer after surgery.

venous thromboembolism (vte) is a common and life-threatening complication in patients with cervical cancer following surgery. the objective of this study is to develop a machine learning model with the potential to predict the risk of vte in these patients postoperatively. we plan to employ partial dependence (pd) curves, breakdown (bd) curves, ceteris-paribus (cp), and shapley additive explanations (shap) values for a comprehensive analysis. the goal is to explore how different machine learning algorithms can be utilized as tools for personalized postoperative vte risk assessment in cervical cancer patients.

Eligibility criteria:
inclusion criteria: * confirmation of cervical cancer through pathological examination. * receipt of surgical treatment for cervical cancer at chongqing university cancer hospital in china. * provision of comprehensive case information. exclusion criteria: * patients under the age of 18. * history of vte caused by other reasons before surgery. * secondary cervical cancer or accompanying primary malignant tumor.

Keywords: machine learning postoperative vte cervical cancer
home food delivery for diabetes management in patients of rural clinics

Conditions: Diabetes Mellitus, Type 2; Diet, Healthy

Summary: our long-term goal is to transform rural residents' management of t2dm. this study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. our specific aims are: 1. compare the effectiveness of the healthy food delivery intervention (hfdi) plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with t2dm. hypothesis: compared with standard care alone, patients receiving the hfdi plus standard care will demonstrate improved: h1 glycemic control as measured by hba1c; h2 cardio-metabolic risk factors: blood pressure, fasting glucose, fasting lipids, and bmi; h3 self-management: self-efficacy, adherence to self-management behaviors, and medication adherence; h4 patient-centered outcomes: diabetes-related distress, diabetes-related quality of life, and diabetes-related complications. 2. compare the effectiveness of the hfdi plus standard care and standard care alone to improve diet quality among rural food insecure patients with t2dm. hypothesis: compared with standard care alone, patients receiving the hfdi plus standard care will demonstrate improved: h1 healthy eating index 2015 (hei-2015) scores; h2 fruit and vegetable consumption. 3. compare cost-effectiveness to understand hfdi plus standard care costs in relationship to outcomes in relation to standard care alone. hypothesis: the hfdi will be cost-effective based on traditional cost per additional quality-adjusted life year gained.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * report food insecurity * report t2d (confirmed by having an hba1c equal to or greater than 6.5 at initial data collection immediately following consent) * speak english or spanish * currently lives at a rural address exclusion criteria: * conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region * pregnant

Keywords: food insecurity
clinical efficacy and safety of benjakul recipe in treating primary osteoarthritis of knee compared with diclofenac

Conditions: Osteoarthritis, Knee

Summary: efficacy and adverse effects of benjakul recipe in treating primary osteoarthritis of knee compared with diclofenac. this study was designed as double blind, randomized controlled trial. approval from the ethical committee of human research ethics committee of thammasat university (no: 1 faculty of medicine)


Eligibility criteria:
inclusion criteria: 1. patients with primary osteoarthritis of knee with grade i-iii of kellgren \& lawrence criteria 2. not during breast feeding 3. not during pregnancy with a good contraception 4. volunteer have a normal complete blood count laboratory, lipid profiles,liver function tests and renal funtion tests 5. do not abuse drugs 6. good cooperation exclusion criteria: 1. bmi \> 32 2. history of peptic ulcer, gastroesophageal reflux disease (gerd), heart disease, liver disease or kidney disease 3. history of allergy diclofenac or allergy herbal medicine

Keywords: osteoarthritis of the knee benjakul alternative medicine