Kornimate/medical-research-clean huggingface dataset:
prospective stuy in evaluating hepatic fibrosis related to hepatitis b virus using non-invasive parameters

Conditions: Hepatitis B; Liver Fibrosis

Summary: the aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, fibroscan, and radiological parameters for evaluating liver fibrosis caused by hepatitis b virus in mainland china.

up to oct, 2015,total of 1800 patients with chronic hbv infection were enrolled. paired blood and liver biopsy samples were collected. blood samples stored at -80 degree celsius. liver biopsy samples were judged by three pathology experts.

Eligibility criteria:
inclusion criteria: 1. hbsag positive for at least 6 months 2. agree to have liver biopsy 3. male or female aged 18 to 65 years old exclusion criteria: 1. patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease 2. platelet count \< 80000/l 3. prothrombin activity ≤ 60% 4. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Keywords: fibrosis liver cirrhosis non-invasive biopsy hepatitis b virus
a phase 3 study to evaluate the efficacy of xw003 compared with placebo in t2dm patients

Conditions: T2DM; Type 2 Diabetes Mellitus

Summary: the main purpose of this study is to investigate the efficacy and safety of xw003 versus placebo in patients with type 2 diabetes mellitus (t2dm) inadequately controlled by diet and exercise alone

in this phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous xw003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. the core treatment phase will be followed by a 28-week open-label period where all participants receive xw003.

Eligibility criteria:
inclusion criteria: 1. ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures. 2. sex: male or female; age: 18 to 75 years, inclusive 3. bmi: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive 4. have been diagnosed with t2dmthat is inadequately controlled with at least 3 months of diet and exercise prior to screening. 5. hba1c ranging from 7.5% to 11.0% at screening, inclusive 6. fpg ≤13.9 mmol/l at screening. exclusion criteria: 1. history of type 1 or other types of diabetes mellitus. 2. use of any glp-1 analogue during the 3 months preceding to screening. 3. history of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening. 4. history of acute or chronic pancreatitis or high risk factors for pancreatitis. 5. personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 6. history of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. 7. history of heart attack, stroke, or congestive heart failure of grade 3 or 4 in the past 6 months.

Keywords: t2dm glucagon-like peptide-1 ecnoglutide xw003 glp-1
procalcitonin reveals early dehiscence in gastric surgery: the predigs study

Conditions: Gastric Cancer

Summary: background. gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. anastomotic leak (al) is one of the worst complications associated with relevant short and long-term sequelae. procalcitonin (pct) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of al after colorectal surgery than c-reactive protein (crp) and white blood cell count (wbc). purpose. investigators designed a monocentric pilot study to test if pct might be a sensitive and reliable marker of al after gastric surgery


Eligibility criteria:
inclusion criteria: * patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, with an anastomosis performed * elective setting exclusion criteria: * age \< 18 years * pregnant women * patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed

Keywords: gastric cancer procalcitonin
the effects of core stabilization exercises with swisball in stroke patients

Conditions: Stroke, Cardiovascular

Summary: stroke is often associated with secondary complications such as nutritional and metabolic disorders, endocrine dysfunction, mental problems, and cardiopulmonary disorders caused by neurological and musculoskeletal deficits. the absence of the paretic side muscles and the difficulty of movement together with restrictive pulmonary disorders trigger a secondary decrease in cardiopulmonary function and expose insufficient energy associated with gait resulting in a decrease in asymmetric trunk exercise endurance.

studies have shown that these patients have muscle weakness and delayed activity of trunk muscles, significant loss of trunk position sense, insufficient pressure control center while sitting, decreased trunk performance, and trunk asymmetry during walking. it has been reported that trunk function with balance and walking ability in stroke patients is a useful determinant of daily life activities, balance and walking ability. balance disorders may be the result of changes in the sensory and integrative aspects of motor control. in the subacute phase, more than 80% of the subjects who have had stroke for the first time have an imbalance in their balance. after a stroke, upper motor neuron damage can cause unconditioned. this results in physical inactivity and decreased cardiorespiratory fitness. respiratory muscle weakness and changes in thoraco-abdominal motion may be associated with a decrease in tidal volume and lower exercise tolerance.

Eligibility criteria:
inclusion criteria: 1. unilateral and first time stroke 2. ability to understand and follow verbal instructions 3. brunnstrom healing phase being above 3 for lower limbs; 4. ability to walk 10 m distance independently, with or without a mobility assistant. 5. patients who can sit on a stable surface for 30 seconds 6. patients without respiratory diseases or injuries exclusion criteria: 1. neurological disorders other than stroke that could potentially affect balance and ambulation; 2. body failure scale score below 10 points 3. apraxia and hemineglect 4. 80 years and older 5. orthopedic disorders or rib fracture 6. patients with neglect syndrome 7. a history of seizures or a family history of epilepsy
renal denervation using stereotactic radiotherapy system for the treatment of refractory hypertension

Conditions: Hypertension

Summary: this study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.

this will be a single centre, single arm, prospective cohort study. patients with refractory hypertension will receive single fraction stereotactic radiotherapy for renal denervation. the study has been designed in a careful and stepwise dose escalation fashion in order to minimize the potential risks associated with this innovative technique. the dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as optimal dose of maximal effect. low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies. safety is the primary endpoint of this study. safety will be assessed by incidence and evaluation of any serious adverse events using ctcae v5.0 criteria associated with the procedure through 90 days. efficacy will be evaluated by assessing mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment.

Eligibility criteria:
inclusion criteria: age ≥ 55 and ≤ 75 years. systolic blood pressure of 160 mmhg or greater despite being treated with at least three hypertensive drugs for more than 3 months. exclusion criteria: gfr \< 45 ml/min/1.73 m2. known causes of secondary hypertension. hospitalized for hypertensive crisis within 1 year. history of acute coronary syndrome or cerebrovascular accident within the last 6 months. pregnancy or have a pregnancy plan. contrast media or iodine allergy. history of abdominal radiotherapy or adhesive intestinal obstruction. severe valvular heart disease. stenosis \>50% or renal artery aneurysm in either renal artery. others.
study to evaluate safety, tolerability, and efficacy of gs-0976 in adults with nonalcoholic steatohepatitis

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: the primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (nash).


Eligibility criteria:
key inclusion criteria: * meets all of the following conditions: * a clinical diagnosis of nonalcoholic fatty liver disease (nafld) * screening magnetic resonance imaging - proton density fat fraction (mri-pdff) with ≥ 8% steatosis * screening magnetic resonance elastography (mre) with liver stiffness ≥ 2.5 kpa * or * a historical liver biopsy consistent with nash and non-cirrhotic fibrosis * platelet count ≥ 100,000/mm\^3 * creatinine clearance (clcr ) as calculated by the cockcroft-gault equation ≥ 60 ml/min key exclusion criteria: * pregnant or lactating females * alanine aminotransferase (alt) \> 5 x upper limit of the normal range (uln) * other causes of liver disease including autoimmune, viral, and alcoholic liver disease * cirrhosis of the liver * prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding * body mass index (bmi) \< 18 kg/m\^2 * international normalized ratio (inr) \> 1.2 unless on anticoagulant therapy * total bilirubin \> 1 x uln, except with diagnosis of gilbert's syndrome note: other protocol defined inclusion/ exclusion criteria may apply.
evaluation study of fear of cancer recurrence: detection, measure and risk factors in lymphoma survivorship

Conditions: Lymphoma

Summary: cancer survivorship has become an important aspect of oncology research due to the risk of physical and psychosocial complications. these latter concerns 50 % of patients. so, the aim of this research is to measure frequency and intensity of one of these issues: the fear of cancer recurrence (fcr) in the lymphoma survivorship beginning, at m0.

indeed, in a recent work published by our team, several complication types in cancer survivorship has been identified: physical but also psychosocial disorders, which can lead to quality of life deterioration. the fcr in lymphoma pathology isn't yet documented and only a few studies concern the risk factors determination (age, sex, disease stage, treatment type, level of education, co-morbidity, isolation (familial status), financial resources, character trait in others cancers. moreover, the fcr can be amplified by familial (young children) or professional responsibilities (self-employed profession). the consequences of fcr are poorly evaluated and are, however, potentially manifold: psychologic disorders, psychotropic consummation, delay of return to work and quality of life deterioration. so, fcr is an innovating research project, which studies the fcr incidence in the beginning of lymphoma after-cancer (ac) m0 and also the associated risk factors we can class in three types: 1. "patient" factors (age, sex, habitat: rural/urban, familial status, level of education, financial resources, co-morbidity), 2. "disease" factors: histological type, disease stage, risk factor, 3. "treatment" factors : conventional versus intensified. moreover, we will study the consequences of fcr m0 upon quality of life and if there is a need of psychotherapy from the very beginning of after-cancer phase, for high intensity fcr. this present study is based on an interventional (with an analysis of human blood sample) prospective cohort, treated with anthracycline-containing regimens. this is a monocentric study which takes place in the institut university du cancer of toulouse. the evaluation uses the scale of fear of cancer recurrence inventory (fcri). the inclusion period lasts 2 years and patients will be followed during 2 years with a measure at m0, m12 and m24.

Eligibility criteria:
inclusion criteria: * complete response of lymphoma (cheson criteria 2007) after initial treatment * malin lymphoma (hodgkin or not) treated with anthracyclines for at least 6 cycles : adriamycin, bleomycin, vinblastine, and dacarbazine (abvd) or beacopp, cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone (chop) et rituximab (r-chop), minichop et rminichop, racvbp having received or not an intensification with autologous hematopoietic stem cell transplantation in first-line * registered the consent to be included in this study exclusion criteria: * person under judicial protection

Keywords: lymphoma cancer survivorship fear
ngs in the diagnosis of neonatal diseases

Conditions: NICU Infants; Conventional NBS-positive Infants; Premature Infants

Summary: to investigate the application of ngs in neonatal disease screening and diagnosis, two studies was conducted (the other id is: shercru-20220003). this study is to evaluate the application of ngs in the diagnosis of neonatal disease.

as health care has improved, genetic diseases have become the leading cause of infant death in hospitalized neonatal. however, due to extensive clinical and genetic heterogeneity, differential diagnosis of all known genetic disorders is often a challenging and lengthy process. current clinical potential genetic diagnosis of ill baby often undergo repeated consulting, several times repeated invasive testing and/or metabolic examination, and efficiency is not high, which lead to children's and family's heavy mental pressure and economic burden. targeted sequencing, also known as next generation sequence (ngs), has the advantages of fast sequencing, wide sequencing range, high sensitivity, high accuracy and low cost compared with traditional sequencing technology (sanger sequencing). ngs has been widely used in tumor diseases, prenatal screening, drugs and the diagnosis of various genetic diseases. in prenatal screening, targeted sequencing is gradually used to detect free fetal dna in pregnant women's peripheral blood, with an accuracy of 95%, which is much better than traditional amniocentesis karyotype analysis and improves the detection rate of secondary birth defects. compared with traditional methods, ngs can provide diagnosis and classification, rich genetic disease gene spectrum, accurate direction for treatment, as well as the predict the risk of the next generation of children of the same disease. therefore, targeted sequencing technology has great advantages for the diagnosis of children and prevention of newborn birth defect diseases. to evaluate the efficacy of ngs in the screening and diagnosis of neonatal disease, the investigator lauched the "budding action". this study is to evaluate the application of ngs in the diagnosis of neonatal disease.

Eligibility criteria:
inclusion criteria: * subjects: conventional nbs+ infants nicu infants premature infants * after fully understanding the program, the guardian signs the informed consent and agrees to participate in the program. exclusion criteria: * other similar clinical research projects are under way for the examined neonates; * neonates have received transfusion of allogeneic blood products; * newborns whose guardians explicitly refuse to participate in the program after receiving the mission.
dermal thermometry and self-care of high risk diabetic patients

Conditions: Diabetes Mellitus; Ulcer; Diabetic Polyneuropathy

Summary: foot ulcers remain the most common reason for hospital admission among veterans with diabetes. healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer.

background: foot ulcers remain the most common reason for hospital admission among veterans with diabetes. healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer. objectives: the purpose of this project is to evaluate the utility of a novel personal dermal thermometry system to empower patients and caregivers and thereby reduce the risk for lower extremity ulceration and amputation in veterans at high risk for these complications. methods: in this randomized clinical trial, 384 patients are being enrolled and assigned to either standard of care (sc) or sc plus a personal dermal thermometer (dt) to evaluate and log their plantar skin temperatures. all patients are given access to a 24 hour "hot foot line" to call for immediate access to care if they identify a hot spot (dt group) or a site of concern on standard self-evaluation (sc). all patients are assigned a sophisticated computerized activity monitor, which allows investigators access to time and magnitude of activity, downloaded at regular patient visits. status: project work is complete

Eligibility criteria:
inclusion criteria: vibration perception threshold needs to be greater than 25, palpable pulse, over 18 years of age has diabetes and neuropathy exclusion criteria: no ulcers. unable to walk without assistance of wheelchair or crutches

Keywords: activity cycles amputation prevention temperature
intensified treatment regimens for tb meningitis: pk, pd and tolerability study

Conditions: Meningitis, Tuberculous; Pharmacokinetics; Pharmacodynamics; Tolerability

Summary: tuberculous meningitis (tbm) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of tb patients. the incidence of tbm has increased considerably during the last decade, partly due to the hiv epidemic. without treatment, virtually all patients with tb meningitis will die. with the current treatment regimens, tbm is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors. worldwide, indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. representative data are lacking, but it is clear that tbm is a growing problem. for instance, in hasan sadikin hospital, the top-referral hospital for west java province (population 40 million), indonesia, 40-50 cases of tbm were treated yearly in the late 90's compared to approximately 100 in recent years. there is very little evidence for the current treatment regimen for tbm, which dates back to the late 60's. therefore, there is an urgent need to evaluate intensified treatment of tbm in randomized trials. we hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of tbm. to determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with tbm in indonesia.


Eligibility criteria:
inclusion criteria: * tuberculous meningitis, diagnosed based on clinical and/or csf criteria * age 15 years old or more * hospitalized for the treatment exclusion criteria: * pregnancy/lactation * on tb treatment within 7 days before inclusion * elevated liver enzyme (\> 5x than normal values) * known hypersensitivity/intolerance to rifampicin or moxifloxacin * prolonged qtc interval in ecg or other detectable cardiac arrythmias, in the absence of hypokalemia * refusal to be included in the study

Keywords: meningitis, tuberculous intensified regimen pk/pd and tolerability outcome
evaluation of endoscopic thyroidectomy via axillo-breast approach in thyroid nodules

Conditions: Safety and Cosmetic Issues in Endoscopic Thyroidectomy

Summary: evaluation of endoscopic thyroidectomy via axillo-breast approach in thyroid nodules regarding safety and cosmetic outcomes


Eligibility criteria:
inclusion criteria: * benign thyroid nodules unilateral or bilateral normal thyroid function exclusion criteria: * malignant thyroid nodules recurrent goitre toxic goitre
the effect of the gm-csf gel on the endometrial thickness in infertile women with thin endometrium

Conditions: Thin Endometrium

Summary: the purpose of this study is to investigate the efficacy of the granulocyte-macrophage colony stimulating factor(gm-csf) gel on the endometrial thickness in infertile women with thin endometrium.

the thin endometrium is detrimental to embryo implantation, probability of clinical pregnancy for an endometrial thickness ≤ 7 mm was significantly lower compared with cases with endometrial thickness \> 7 mm. it has been reported the granulocyte colony stimulating factor (g-csf) increased the endometrial thickness and pregnancy rate of infertile women with thin endometrium during ivf cycle. however, most of the researches were retrospective and small sample size, and the results were conflicted among them. gm-csf is another member of csf superfamily, recalling more macrophage than g-csf, which could be more effective in local homeostasis maintain and wound repair. gm-csf has been widely used in skin repair after burn. it was also found the gm-csf and its receptor in endometrium. in the past year, the investigators tried gm-csf irrigation in 21 women with thin endometrium and most of them received gm-csf after hysteroscopic examination or slight adhesion relaxing, and the preliminary data suggested that the gm-csf may promote the endometrial growth. does the gm-csf gel can improve the endometrial thickness? therefore, this study was conducted.

Eligibility criteria:
inclusion criteria: 1. woman undergoes ivf treatment, 18-40 years old 2. the endometrial thickness \<7mm on the day of human chorionic gonadotropin during ivf or after taking oral estradiol valerate 6mg/d for 14 days. 3. embryo transfer is cancelled because of thin endometrium 4. no intrauterine adhesion according to the 3-d ultrasonography exclusion criteria: 1. systemic diseases unable to conceive 2. chromasome abnormal 3. history of g-csf or gm-csf allergy or untoward effect 4. thin endometrium related to clomid 5. severe or moderate uterine adhesion 6. the influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus 7. uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm. 8. patients who is allergic to granulocyte-macrophage colony stimulating factor 9. patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia

Keywords: gm-csf frozen embryo transfer