Kornimate/medical-research-clean huggingface dataset:
metabolic consequences of moderate weight gain - role of dietary fat composition (lipogain)

Conditions: Healthy

Summary: the purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. hypothesis: the type of dietary fat can modify the effects of weight gain.

specific goals: * investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain * investigate if polyunsaturated fat (pufa) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain * investigate effects of weight gain and dietary fat composition on markers of vascular health

Eligibility criteria:
inclusion criteria: * healthy, * body mass index 18-27 exclusion criteria: * liver disease, * coronary heart disease, * diabetes mellitus, * malignant diseases, * alcohol or drug abuse, * magnetic resonance-incompatibility, * abnormal clinical chemistry, * use of drugs that significantly effects energy metabolism, * heavy exercise, * pregnancy or lactation, * allergy of gluten, egg or milk protein

Keywords: liver fat polyunsaturated fatty acids (pufa) saturated fatty acids (sfa) weight gain overfeed dietary fatty acids palm oil sunflower oil
assessment of prostatic tissue concentration of ertapenem after a pre-operative administration

Conditions: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Summary: the purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.

ertapenem is an antibiotic belonging to carbapenems family and used in infections with gram-negative bacilli with extended spectrum beta lactamase (esbl). its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance. the purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection. patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia. concentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery. to demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (mic) for 40% of the time of injection interval.

Eligibility criteria:
inclusion criteria: * acceptance and understanding of the consent form (signed) * 18-80 years old patients * bph needing endoscopic resection according to french urology association recommendations * procedure and follow up made in investigator center * normal digital rectal examination * psa : * patient \> 69 years old, not necessary * patient \ 10% * patient with renal clearance \>60 estimated with mdrd * patient affiliated to the social security exclusion criteria: * personal or familial history of prostatic or genito-urinary cancer * personal history of pelvic irradiation * personal history of hormone-therapy * personal history of prostatic adenomectomy by abdominal approach * personal history of allergy to beta-lactamines * urinary tract infection or bacterial colonisation at the time of procedure * carbapenems treatment in the two weeks before surgery * hyperresponsivness to ertapenem or other carbapenems antibiotic * patient with renal clearance estimated with mdrd \<60 * patient with catheter or probe permanently

Keywords: ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia
tdf vs lam + adv in lam + adv treated lam-resistant chb patients with undetectable hepatitis b virus dna

Conditions: Chronic Hepatitis B

Summary: this study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in lamivudine plus adefovir treated lamivudine-resistant chronic hepatitis b patients with undetectable hepatitis b virus dna

recently, in korea, long-term medication of antiviral agents and their resulting resistance expression have been the most serious cause of failure to treat chronic hepatitis b. exp. in particular, the annual resistance rate to lamivudine currently widely being used in korea amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in four to five years. the guidelines by the american association for the study of liver disease (aasld) and the european association for the study of the liver (easl) recommend a combination therapy with adefovir or tenofovir for patients with lamivudine resistant hbv . in korea, however, in case of combined prescription of lamivudine and adefovir, only one of them is covered by the health insurance and therefore many patients are difficult to continue treatment due to their economic conditions. tenofovir that has been developed most recently and will be placed on sale sooner or later in korea has strong antiviral effects, causes little or no emergence of resistant viruses, and is known to have lower nephrotoxicity than adefovir. in particular, several papers reported that tenofovir has effective and sustaining antiviral effects in patients who had other antiviral agents resistant hbv as well as those who received initial treatment. this shows that patients only with lamivudine resistant hbv can be treated only with tenofovir without a combination therapy and when they have low levels of hbv dna, treatment is relatively effective despite their resistance to adefovir. therefore, it is considered that tenofovir switching therapy in patients with undetectable hbv dna after lamivudine plus adefovir combination therapy to maintain their virus response. the results of this study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in such patients.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 or older * the chb patients (both hbeag-positive and - negative) who have at least 6 months undetectable hbv dna (serum hbv dna ≤ 20 iu/ml) after lamivudine plus adefovir combination therapy. exclusion criteria: * patients with decompensated liver disease * patients with hcv, hdv or hiv * patients with hcc * serum alt \> 2x uln level * serum creatinine \> 2.0mg/dl * pregnant or lactating women * women who have a plan for pregnancy within the three coming years * patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection * those who have no capabilities to understand and sign an informed consent

Keywords: tenofovir lamivudine adefovir chronic hepatitis b
effects of baduanjin sequential therapy on post cabg patients.

Conditions: Post-cardiac Surgery

Summary: to determine the effects of baduanjin sequential therapy (bst) on physical functioning and quality of life among post-cabg patients. many studies have focused on the effects of standing baduanjin on chronic diseases and it's an evidence-based therapy.

there exists limited data from large-scale randomized trials that have addressed the effect of baduanjin exercise on the quality of life and cardiac function in the patient with cabg. therefore, this study aims to determine the effects of baduanjin sequential therapy (bst) on physical functioning and quality of life among post-cabg patients.

Eligibility criteria:
inclusion criteria: * vitally open heart surgery patients discharged from the hospital and enrolled as outpatient able to perform 6mwt exclusion criteria: * prolonged intubation unstable vitals patient needs maximum assistance for mobility decline consent

Keywords: baduanjin sequential therapy cabg physical functioning quality of life
observational study in localized osteosarcoma

Conditions: Localized Osteosarcoma

Summary: observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized osteosarcoma (os) treated according the aieop/italian sarcoma group (isg) os 2021

osteosarcoma is the most frequent primary malignant bone tumor in children and adolescents and is considered a rare disease. the overall incidence of os is 0.2-3 / 100,000 inhabitants per year with a bimodal distribution by age, with a first peak in adolescence. currently, the treatment strategy for localized os includes courses of neo-adjuvant chemotherapy based on 3 agents: adriamycin (adm), cisplatin (cdp) and high dose methotrexate (hdmtx) followed by surgical removal of the primary tumor and subsequent adjuvant chemotherapy treatment. the map (methotrexate, adriamycin, cisplatin) regimen, with or without ifosfamide (ifo) and etoposide (eto), is considered the "gold standard" for the treatment of localized osteosarcoma. given the rarity of the disease, it is considered appropriate to collect information prospectively on the diagnosis, chemotherapy and surgical treatment and outcomes on patients treated by the network of aieop and isg centers according to the recommendations on the treatment of localized os aieop/isg os 2021. this study will be active up to the next interventional prospective protocol aimed at the therapy of high-grade, non-metastatic os.

Eligibility criteria:
inclusion criteria: * diagnosis of high grade os of the extremities * age at diagnosis ≤ 40 years at the time of diagnosis * localized disease (skip metastases are allowed) * adequate organ function according the aieop/isg os 2021 recommendation * patients or parents oe guardians of minors who have given their written informed consent to participate in the study exclusion criteria: * presence of metastases * diagnosis of periosteal os, of parosteal os or secondary os * any medical condition which can not allowed the use of the treatments recommended by aieop/isg os 2021

Keywords: osteosarcoma
bone density in patients with schizophrenia

Conditions: Schizophrenia; Alcohol Abuse

Summary: people with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis. to evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.

people with schizophrenia has been known as a high risk groups for developing osteoporosis, because of lack of exercise, poor nutrition and high rate of smoking. those with alcohol abuse may be higher risk group than one with schizophrenia without alcohol abuse, because they frequently have several medical problems such as liver dysfunction, vitamin d deficiency, hyperparathyroidism and those medical condition increase risk for developing osteoporosis. also alcohol itself can increase bone loss too by disturbing bone remodeling and enhancing bone fragility. to compare the prevalence of bone mineral density in patients with schizophrenia with alcohol abuse to those without alcohol problem, we will investigate bmd in large population of korean patients with those illnesses.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia * onset of illness more than 5 years. exclusion criteria: * no severe medical and endocrinological disorder

Keywords: schizophrenia alcohol abuse bone density
amniotic membrane in total knee replacements to reduce scarring

Conditions: Scarring

Summary: the overall objective of this study is to evaluate the effectiveness of dhacm in reducing scar tissue formation in total knee replacement patients.


Eligibility criteria:
inclusion criteria: 1. are adults ages 18 or older. 2. are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement. 3. have a willingness to comply with follow-up examination. 4. have ability to give full written consent. exclusion criteria: 1. has had a previous total or partial joint replacement performed at the same site 2. has a planned bilateral procedure at this time. bilateral patients can be enrolled if the procedures are staged. 3. has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past. 4. has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. 5. is pregnant or may become pregnant during the study. 6. is a prisoner. 7. has any condition(s) which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment. 8. is currently taking medications which could affect allograft incorporation (supervising physician's discretion). 9. is confined to bed or a wheelchair. 10. has clinical signs and symptoms of local infection at the site. 11. has autoimmune disease or a known history of having acquired immunodeficiency syndrome (aids) or hiv. 12. has current diagnosis of cancer at the site. 13. has had prior radiation therapy treatment at the site. 14. is currently taking anticoagulant therapy. 15. is unable to sign or understand informed consent. 16. has a history of drug or alcohol abuse within last 12 months. 17. is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment

Conditions: Acquired Pure Red Cell Aplasia

Summary: this is an open-label, single-arm study to evaluate the safety and efficacy of bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.


Eligibility criteria:
inclusion criteria: * ecog ≤ 2. * age from 18 to 70. * diagnosed with acquired pure red cell aplasia. * meets the criteria of first-line treatment failure or relapse. * organs in good function. * signed informed consent. exclusion criteria: * nursing woman. * active bacterial, virus, fungal or parasitic infection, including hiv infection, hbsag or hbv dna positive, hcv dna positive, etc. * secondary prca caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc. * secondary prca caused by either smoldering multiple myeloma or symptomatic multiple myeloma. * secondary prca caused by either abo major mismatched stem cell transplantation or organ transplantation. * secondary prca caused by solid tumors except for thymoma. * secondary prca caused by drugs or pregnancy. * secondary prca caused by the b19 virus. * have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities. * previously received treatment in other trials within 4 weeks before enrollment. * previously treated with the proteasome inhibitor. * experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment. * have a history of malignant tumors. * have a history of mental illness. * inability to understand or to follow study procedures.

Keywords: acquired pure red cell aplasia prca failure or relapse after first-line treatment
the nolix feasibility efficacy and safety study

Conditions: Stress Urinary Incontinence

Summary: this study is an open label, prospective, feasibility study with the nolix device used for temporary treatment of stress urinary incontinence (sui) in subjects, serving as their own controls.

this is an open label, prospective, feasibility study with the nolix device used in subjects with sui, serving as their own controls. the objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the nolix device when used for the temporary management of sui in women. in addition, the study is aimed to evaluate changes in the quality of life (qol) and comfort during use of the nolix device. the primary effectiveness endpoint is the percent change in the mean pad weight gain (%pwg) between the device (during the last 7 days of the 14-days nolix use period) and control periods , with the success criterion defined as at least \>-50% of the mean %pwg change during the last 7 days of the treatment phase as compared to the control phase. additional effectiveness endpoints include the number of self-reported sui episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the qol, leak scores and overall satisfaction levels. the safety of the nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.

Eligibility criteria:
inclusion criteria: * females aged 22 and above. * suffering from stress urinary incontinence. * women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written informed consent form prior to participation in the study. exclusion criteria: * age ≤ 21 years. * pregnant or planning to become pregnant during the study. * vaginal birth or cesarean section for the last 3 months prior to entering the study. * severely atrophic vagina. * a history of toxic shock syndrome (tss). * active urinary tract or vaginal infection. * patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year). * has experienced unusual or unexpected vaginal bleeding within the last 6 months. * vaginal surgery within the last 3 months prior to entering the study. * has experienced difficulties with the use of intra-vaginal devices, including tampons. * presence of any condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * average daily pwg as measured in the baseline pad period is less than 4 grams /12 hours.
prospective evaluation of self-testing to increase screening

Conditions: Cervical Cancer; Human Papillomavirus Infection

Summary: regularly attending for pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. this study evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (hpv) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

regularly attending for pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. using mailed self-sampling kits to test for high-risk human papillomavirus (hpv), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. this study is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. the three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample hpv testing kits; and 3) telephone recall with mailed self-sample hpv testing kits and patient navigation.

Eligibility criteria:
inclusion criteria: * no history of hysterectomy or cervical cancer * no pap test in the past 3.5 years or pap/hpv co-test in the past 5.5 years * patient of harris health system in harris county (houston), texas * have at least 2 visits to ambulatory care within harris health system in the past 5 years * be currently enrolled in a healthcare coverage or financial assistance plan accepted by harris health system or have been enrolled in a harris health coverage plan in the past 12 months exclusion criteria: * no valid telephone contact information * unable to communicate in english or spanish\* * currently pregnant * history of cervical dysplasia in the past 3.5 years

Keywords: screening human papillomavirus infection self-testing
a randomized trial of rosuvastatin loading combined with early hydration versus standard-of-care medications for the prevention of ciaki in patient with ami undergoing emergency pci

Conditions: Contrast-induced Acute Kidney Injury; ST Elevation Myocardial Infarction; Primary PCI; Rosuvastatin; Hydration

Summary: the ciaki,as the third complication of pci, was associated with adverse cardiac events after procedure. moreover, because the rate of periprocedure hydration is inadequate in stemi patients before primary pci, the incidence of ciaki is higher significantly in these patients. the cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. the previous studies demonstrated usage of statin in periprocedure could decrease the risk of ciaki. compared with hydration, the usage of statin to prevention ciaki show the advantages in clinical practice, for example，there is no need to consider the cardiac function.the optimal strategies for preventting ciaki in stemi patients undergoing primary pci needed further studies to explore. what's more, whether a synergistic effect of hydration and statin or not is unknown.


Eligibility criteria:
inclusion criteria: * age 18-80 years old * the stemi patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent st-segment elevation or the presence of a new lbbb); * the patients planned primary pci; * at least one of the following: diabetes mellitus, chronic kidney disease, female, elder(age≥65), hypertension class 3, congestive heart failure • voluntary signature of informed consent exclusion criteria: * type 2 myocardial infarction secondary to an ischaemic imbalance * intolerance of statin or iodine contrast * egfr\<30ml/min * administration of any iodinated (e.g.ct angiography) within 14 days before enrollment * hepatic dysfunction, alt 3 times greater than upper normal limit * thyreoid insufficiency * hemodynamic instability * have received pci or cabg within 30 day before enrollment * plan to perform any coronary angiography or pci within 30 days * have received any statins within 7 days before enrollment
supervised perturbation training results in changes in balance and falling in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: physical exercise can prevent falls, certain types of exercise may be more effective. perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. the purpose of this study was to estimate the effect of perturbation- based balance training on falls and balance in daily life.thirty patients with multiple sclerosis (pwms) will assess with regard to dynamic balance, walking and falling. patients randomly will allocate to a personalized (prg) or traditional (trg) rehabilitation group.

thirty patients with multiple sclerosis (pwms) will assess with regard to dynamic balance, walking and falling. patients randomly will allocate to a personalized (prg) or traditional (trg) rehabilitation group.

Eligibility criteria:
inclusion criteria: * an age older than 18 years * stable phase of the disease without relapses or worsening in the last three months * referring fear of falling or a history of falls (at least one fall in the last year). * individuals with a high level of balance. exclusion criteria: * psychiatric disorders * blurred vision * severe cognitive impairment * severely impaired upright postural control or limited participation in a rehabilitation program * cardiovascular and respiratory disorders.

Keywords: rehabilitation multiple sclerosis tailored interventions