Kornimate/medical-research-clean huggingface dataset:
frequency of zoledronic acid to prevent further bone loss in osteoporotic patients requiring androgen deprivation therapy for prostate cancer

Conditions: Osteoporosis

Summary: the aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer

androgen deprivation therapy is the mainstay of treatment for advanced prostate cancer. however they are associated with accelerated bone loss, osteoporosis and fractures. previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. however, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with lhrh agonists and with antiandrogens.peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. the first year with the patients on lhrh or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration. the study will also involve monitoring serum and urine bone turnover markers.

Eligibility criteria:
inclusion criteria: * patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on lhrh agonists (lhrh group). also patients who have been commenced on bicalutamide due to osteoporosis at presentation (bicalutamide group) exclusion criteria: * patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.

Keywords: bisphosphonates, prostate cancer, bone density, osteoporosis
safety and efficacy of traction robot-assisted endoscopic submucosal dissection for early gastric cancer

Conditions: Early Gastric Cancer; Endoscopic Submucosal Dissection; Robot Surgery

Summary: the goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (faster) system can improve the safety of the endoscopic submucosal dissection (esd). it will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. the main questions it aims to answer are: does the use of the faster system reduce the number of muscular injuries, improving the safety of the esd procedure? does the use of the faster system reduce the procedure and dissection time, improving the efficacy of the esd procedure? researchers will compare faster-assisted esd and conventional esd to evaluate the safety and efficacy of the faster system. participants will: be randomly assigned to the group with esd using the traditional procedure or to the group with esd assisted by the faster system. keep a diary of their symptoms after the procedure. esd has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of esd. the faster system is designed to overcome this technical difficulty.


Eligibility criteria:
inclusion criteria: * patients aged 18-80. * patients with pathologically verified high-grade intraepithelial neoplasia (hgin) or intramucosal carcinoma of the stomach. exclusion criteria: * patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis. * patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery. * patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure. * patients have lesions with local recurrence after endoscopic resection. * patients unable to obtain informed consent.
nocturnal hypoxia in geriatric patients after hip fracture

Conditions: Delirium; Hypoxia

Summary: delirium is a common complication following hip fracture surgery (hfs) in older people. postoperative hypoxia has also been associated with delirium, but not specifically in geriatric patients. the aim of the study is to demonstrate that post-operative hypoxia is associated with in-hospital complications in patients with hfs.

patients hospitalized in orthogeriatric unit after hfs will be monitored for nocturnal spo2 with a pulse oximeter continuously during 3 nights. in-hospital complications will be recorded prospectively in all patients, especially the occurrence of delirium with the cam scale. the hypoxia vs non-hypoxia (more than 20% of the time spent with spo2\<90%) groups will be analyzed for clinical characteristics, comorbidities and medication use. the statistical association between severe post-operative nocturnal hypoxemia and occurrence of delirium will be assessed. the dependance between this association and daytime spo2 will also be assessed. the potential confirmation of an association between post-operative nocturnal hypoxemia in patients with hfs and the occurrence of delirium will lead the reflection on a clinical trial testing the benefit of oxygen therapy in the prevention of post-operative delirium, to improve the medical care of orthogeriatric patients.

Eligibility criteria:
inclusion criteria: * age over 70 years old, * hospitalized in orthogeriatrics for hip fracture surgery * information about the study and expression of non opposition * expected hospital stay of 5 nights or more exclusion criteria: * patient under guardianship, * any other type of fracture associated, * oxymetry recording not possible (behavioral disorders, night stirring,...)

Keywords: nocturnal hypoxia delirum developpement
the effect of rhomboid intercostal block and serratus anterior plane block on postoperative respiratory functions

Conditions: Breast Cancer; Postoperative Pain; Respiratory Function Impaired

Summary: rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between t3 and t9 dermatomes. serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between t2 and t6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. both of the blocks are usually performed for postoperative analgesia following breast surgery. the primary hypothesis of the study is that fev1 value of the patients who will receive modified radical mastectomy (mrm) and rhomboid intercostal plane (rip) block combined with serratus anterior plane (sap) will be higher than fev1 value of the patients in the no-block group. the secondary hypothesis is that rip+sap blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.

the patients who are scheduled for mrm under general anesthesia, aged between 18-65 years and asa scores i-ii will be included in the study. respiratory functions (fev₁, fvc, fev₁/fvc, pef, fef25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. the induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. one group will receive rip+sap block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. the standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. pain intensity of the patients will be evaluated by numerical rating scale (nrs) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). nrs scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.

Eligibility criteria:
inclusion criteria: * asa i-ii patients * female * ages between 18-65 * patients who will receive breast cancer surgery under general anesthesia exclusion criteria: * known respiratory diseases * rhinitis and atopic dermatitis story * new york heart association class equal to higher than class 2 * respiratory diseases story in the last two weeks * alchol or substance or chronic opioid consumption story * any pain killers intake in the last 24 hours prior to surgery * active smokers or ex-smokers * body mass index over 35 kg/m2 * i̇nfection at the injection sites * known allergy to local anesthetics * known psychiatric diseases * operations longer than 3 hours

Keywords: analgesia postoperative pain rhomboid intercostal block serratus anterior plane block respiratory function
sleep disorders and psychophysical well-being in hiv+ patients

Conditions: HIV Infections

Summary: the primary goal of this observational study is to investigate sleep quality in patients living with hiv+. the secondary objective is to measure the influence of sleep quality on indicators of mental health (anxiety, depression and stress) and quality of life. the main questions it aims to answer are: * measuring the effects of poor sleep quality on mental and physical health in hiv+ patients. * monitor the sleep pattern in the hiv+ population. participants will fill out an online cross-sectional survey. the online questionnaire survey will collect: * sociodemographic and clinical data related to hiv infection, * sleep quality, * mental health, * quality of life.


Eligibility criteria:
inclusion criteria: * hiv diagnosis. * being treated at the infectious diseases outpatient clinic of policlinico gemelli in rome. * ongoing antiretroviral therapy. * age \> 18 years. * native italian speaker. * informed consent to participate in the study exclusion criteria: * absence of an hiv diagnosis. * not being treated at the infectious diseases outpatient clinic of policlinico gemelli in rome. * absence of ongoing antiretroviral therapy. * age \> 18 years. * not being a native italian speaker. * refusal to sign informed consent
effect of vitamin a and calcium in patients with non-alcoholic fatty liver disease

Conditions: Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Patients

Summary: non-alcoholic fatty liver disease (nafld) has become the most common liver disease at a global scale and is strongly associated with the obesity and metabolic syndrome . it is recognized as a hepatic manifestation of the metabolic syndrome, and characterized by lipid infiltration in the hepatocytes. nafld comprises a range of diseases from simple steatosis to non-alcoholic steatohepatitis (nash), fibrosis, cirrhosis, and may progress to hepatocellular carcinoma (hcc) . the worldwide prevalence of nafld is estimated to be 24% while it is reported to have much higher incidence in patients with metabolic syndrome and type 2 diabetes (t2d) (5). the mortality rate and the number of liver transplantations owing to nafld and nash are increasing, making it the second leading cause of liver transplant in the united states . tow significant metabolic abnormalities commonly linked to nafld are insulin resistance (ir) and increased supply of fatty acids to the liver . chronic liver diseases (cld), including nafld, are commonly associated with nutrient and vitamins deficiencies such as those of vitamins d and a (8,9). almost all studies documenting vitamin a status in metabolic syndrome (mets) report reductions in serum retinol, retinoic acid, and/or β-carotene that are inversely correlated with mets features, including obesity, insulin resistance, glucose intolerance, and hypertriglyceridemia . in line with these observations, inadequate serum retinol levels (\<1.05 μmol/l) were found in 11-36% of morbidly obese adults with ultrasonography-proven nafld, and a significant association between low retinol levels and insulin resistance (ir) was found . moreover, serum retinol levels were inversely associated with body mass and serum transaminases in patients with nafld, suggesting a link between retinol inadequacy and development of disease. the liver plays a critical role in lipid metabolism by taking up serum free fatty acids (ffa) that are involved in the synthesis, storage, and transport of lipid metabolites. the accumulation of excess triacylglycerol (tg) within the liver due to the entry of excess ffa from the obese adipose tissue due to increased lipolysis leads to the development of non-alcoholic fatty liver diseases (nafld) .


Eligibility criteria:
inclusion criteria: * nafld patients exclusion criteria: * • chronic viral hepatitis or other chronic liver diseases. * hepatocellular carcinoma or other malignancies. * chemotherapy or radiotherapy within the last three months.
clinical safety, tolerability, pharmacokinetics and pharmacodynamics of lez763

Conditions: Type II Diabetes

Summary: this study is a three part study to assess the safety and efficacy of lez763 on normal healthy volunteers and patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * all subjects: (suggest this will reduce duplication) * male or female aged 18-65 yr, * subjects must weigh at least 50 kg to participate in the study. body mass index (bmi) must be within the range of 18-37 kg/m2 (inclusive * only postmenopausal females or female subjects who report surgical sterilization (women without child bearing potential) will be allowed in this study. * subjects with stable conventional sleep-wake cycle normal healthy volunteers * healthy male or female subjects, * must be in good health (as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening). type ii diabetic patients * type 2 diabetes diagnosed by american diabetes association criteria for at least 3 months prior to screening. * patients either drug naïve or on stable dose of metformin (stable dose for at least 4 weeks prior to screening). the metformin dose should remain constant during the course of the study. * hba1c 6.5 to 9.5 % inclusive at screening exclusion criteria: all subjects: * smokers (use of tobacco products in the previous 3 months). * donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation. * significant illness within two weeks prior to dosing. * have (or have history of) drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations normal healthy volunteers • history of diabetes, or adrenal disorders. type ii diabetic patients * type 1 diabetes mellitus; positive anti-gad antibodies; acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes * evidence of clinically significant diabetic complications (such nephropathy, retinopathy, neuropathy) other protocol defined inclusion/exclusion criteria may apply

Keywords: healthy volunteers, diabetes glucose pharmacokinetics
barberry and cardiometabolic risk factors in individuals with hypertriglyceridemia

Conditions: Hyperlipidemias; Hypertriglyceridemia

Summary: barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. the present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.

this study is an open-label, randomized, controlled clinical trial and will recruit those who are willing to participate and meet the inclusion criteria. inclusion criteria are fasting serum triglycerides 150-499 mg/dl, body mass index 25-40 kg/m2, age range 18-75 years. exclusion criteria are regular use of drugs of the fibrate family, regular use of fish oil supplements or omega-3 supplements or flax seed or chia seed, treatment with glucocorticoids, end-stage renal disease. subjects who agree to participate in the study will be randomly assigned to one of two study groups. all patients in both groups will be prescribed a low-calorie diet. in the first group, 10 grams of powdered seedless barberry will be consumed daily in addition to the low-calorie diet. the second group (control group) will continue with the low calorie diet. the study will last 8 weeks. patients are asked to refrain from using over-the-counter herbal medicines and dietary supplements during the study. a baseline fasting blood sample, blood pressure measurements, and anthropometric indices will be obtained. subsequent assessments will be made at four-week and eight-week intervals.

Eligibility criteria:
inclusion criteria: * fasting serum triglycerides 150-499 mg/dl, * body mass index 25-40 kg/m2 * age range 18-75 years exclusion criteria: * regular use of drugs of the fibrate family, fish oil supplements or omega-3 supplements * regular consumption of flax seed or chia seed * treatment with glucocorticoids * end-stage renal disease
romiplostim (amg 531) versus medical standard of care for immune (idiopathic) thrombocytopenic purpura

Conditions: Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic Purpura

Summary: this is a phase 3b, multi-center, randomized, standard of care (soc)-controlled, open-label, 52-week treatment study to compare romiplostim to medical soc for idiopathic thrombocytopenia purpura (itp), with a 6-month safety follow-up. patients randomized to romiplostim must complete the taper or discontinuation of medical soc for itp as soon as medically feasible after the initiation of romiplostim. after the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month safety follow-up period.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject has a diagnosis of idiopathic thrombocytopenia purpura (itp) according to the american society of hematology (ash) guidelines * if subject is \> 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of itp * subject has received at least 1 prior therapy for itp * subject has a platelet count \< 50,000 or their platelet count falls to \< 50,000 during or after a clinically-indicated taper or discontinuation of current itp therapy * before any study-specific procedure, the appropriate written informed consent must be obtained exclusion criteria: * subject has had a splenectomy for any reason * subject has an active malignancy * subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years * subject has a known history of bone marrow stem cell disorder * subject has participated in any study evaluating polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor (peg-rhumgdf), recombinant human thrombopoietin (rhutpo), amg 531, or a thrombopoietic protein * subject is receiving other investigational agents or procedures * subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study * subject is pregnant or breast feeding * subject is not using adequate contraceptive precautions * subject has known sensitivity to any recombinant e. coli-derived product * subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative * subject has any kind of disorder that compromises the ability of the subject to comply with study procedures

Keywords: splenectomy platelet amg 531 thrombopoietin blood disorder bleeding disorder immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura tpo thrombopoietic protein
a study of niclosamide enemas in subjects with active ulcerative proctitis or ulcerative proctosigmoiditis

Conditions: Ulcerative Colitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis

Summary: this will be a phase i/iia, open-label, three-stage, single center study aimed at investigating the safety, the efficacy (clinical and endoscopic effects) and the pharmacokinetics of niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with mild-to-moderate up and ups, defined as a modified mayo score (mms) ≥ 4 and \< 8, with a stool frequency subscore (sfs) ≥ 1, a rectal bleeding sub-score (rbs) = 1 or 2, and an endoscopic subscore (mucosal appearance) = 1 or 2. at the endoscopic sub-score any degree of friability will be classified as having a sub-scale score of 2.


Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥ 18 years at the time of signing the informed consent; 2. must understand and voluntarily sign an informed consent from (icf) prior to any study-related assessments/procedures being conducted. 3. must be able to adhere to the study visit schedule and other protocol requirements; 4. diagnosis of up or ups with a duration of at least 3 months prior to the screening visit 5. mms score ≥4 to \< 8 (range: 0-9) prior to enrolment in the study. 6. availability to perform an endoscopy (colonoscopy or flexible rectosigmoidoscopy); exclusion criteria: 1. diagnosis of crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis; 2. uc extended more than 40 cm from the anal verge; 3. subjects who have had surgery as a treatment for uc or who, in the opinion of the investigator, are likely to require surgery for uc during the study; 4. history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, psychiatric, endocrine, hematological disorder or disease or any other medical condition that, in the investigator's opinion, would preclude participation in the study; 5. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study; 6. pregnant or breast feeding females; 7. known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (hiv), or any major episode of infection requiring hospitalization or treatment with intravenous (iv) or oral antibiotics within 4 weeks of screening; 8. subjects who have received any investigational drug or device in the last 3 months; 9. history of alcohol, drug, or chemical abuse within the last 6 months; 10. known hypersensitivity to niclosamide or any excipients in the formulation.