Kornimate/medical-research-clean huggingface dataset:
a real-world study of staging and grading of clinical immune status in chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this is a prospective, multicentre observational study of chronic hepatitis b （chb）in different clinical stages. we intend to compare the immune status of various types of chb patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with chb.

two groups were included in this study: untreated patients who met the staging subgroups according to chinese guidelines for the prevention and control of chronic hepatitis b, 2022 edition or hbsag negativity（group 1). the another is those who achieved hbv dna suppression by na（group 2）. patients in group 1 will be followed up once every six months, and in group 2 will be followed up once every three months. and patients treated or not treated will be followed up in the study. the treatment with na or combined with interferon will be decided by the consensus of doctors and patients. this study does not intervene the treatment, but will register the clinical indicators. we follow up the patients at each follow-up time point, record the subjects' clinical indicators at each visit and obtained serum and pbmc specimens for further immune study after the consents of the patients.

Eligibility criteria:
inclusion criteria: 1. patients with chb who were older than 18 years old and younger than 50 years old with hbsag positivity more than 6 months; 2. group 1 untreated group fulfils any one of the four natural history types of the chinese guidelines for the prevention and control of chronic hepatitis b, 2022. 3. group 2 nucleos(t)ide-treated chb patients are required to have sustained control of their hbv dna (\<100 iu/ml). exclusion criteria: 1. pregnancy status; 2. has been diagnosed with compensated/lost compensated cirrhosis, hepatocellular carcinoma by imaging or other indicators; 3. combined hav, hcv, hev infection, schistosomal liver disease, drug-induced liver injury, autoimmune hepatitis, alcoholic liver disease, severe fatty liver, hiv infection; 4. being on immunosuppressants or immunomodulators or hormonal drugs or biological agents, etc; 5. previous history of oncology, organ transplantation, etc., history of alcoholism (\>30 g/d for men, \>20 g/d for women); 6. inadequate follow-up time and inadequate clinical/laboratory information; 7. combined heart, brain, kidney, lung and other organ insufficiency or combined endocrine and haematological system and other major diseases; 8. comorbid serious psychiatric diseases including severe anxiety or depression; 9. unwilling to participate in this study.
gemcitabine/cisplatin for resected pancreas cancer: establishing the role of ercc1 in treatment decision

Conditions: Pancreatic Neoplasms; Pancreatic Cancer

Summary: the purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer. the investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

the study will specifically be looking at ercc1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving gem / cis as adjuvant therapy after resection.

Eligibility criteria:
inclusion criteria: 1. adults (≥ 18 years) at the time of signing informed consent form 2. understand and voluntarily sign informed consent form 3. able to adhere to study visit schedule and other protocol requirements 4. eastern cooperative oncology group (ecog) performance status of ≤ 2 5. absolute neutrophil count ≥ 1500 / mm³ 6. platelet count ≥ 100,000 / mm³ 7. resectable pancreatic adenocarcinoma 8. pathologic diagnosis of pancreatic adenocarcinoma exclusion criteria: 1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form 2. a history of renal dysfunction (serum creatinine \> 1.8 mg/dl) 3. presence of active infection 4. untreated second malignancy 5. pregnant or breast feeding females (a urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)

Keywords: pancreatic neoplasms pancreatic cancer
the effect of virtual reality on patients with anxiety over surgeries under spinal anesthesia

Conditions: Virtual Reality

Summary: the main purposes of this study are as follows: first, to understand the effect of virtual reality on the subjective feelings of anxiety in patients with orthopaedic lower limb surgery for spinal anesthesia. second, to understand the effects of virtual reality on the systolic blood pressure, diastolic blood pressure, mean arterial pressure, heartbeat, respiration and other physiological parameters in the operation of orthopedic lower extremity surgery patients with spinal anesthesia. third, to understand the effect of using virtual reality in surgery to reduce the use of sedative drugs and the degree of pain in patients with orthopedic lower extremity surgery.

surgery is a serious source of stress for the general patient and can increase the patient's anxiety. which is it is normal to show obvious anxiety in patients undergoing surgery, but if the degree of anxiety is serious, it may lead negative physiological manifestations, such as slow wound healing, increase the risk of infection and may affect the induction of anesthesia it requires more anesthesia dose during surgery, which hinders recovery time. most studies have confirmed surgery playing music in the room can alleviate the anxiety and pain of the patients, but the music preference is subjective and some people like it. there must be people who hate it, and the operating room is not a quiet space. there are many sound sources in the operating room., such as the sound of surgical instruments, the warning sound of physiological monitors, the voice of the staff, these it will be a source of anxiety for patients. instrument noise averages up to 60 decibels, including neurosurgery, orthopedics it can even exceed 100 decibels. foreign scholars believe that playing music at this time will only aggravate the noisy environment.the attention of the staff. therefore, it is hoped that by using virtual reality to provide images and sounds during surgery, hijacking the patient's auditory, visual, and proprioception creates an immersive, distracting approach that reduces the cause of the ring anxiety brought by the environment helps spinal anesthesia patients to reduce anxiety during surgery and increase psychological comfort to reduce the use of sedative drugs during surgery.

Eligibility criteria:
inclusion criteria: 1. population: acceptance of lower extremity fractures in patients with spinal anesthesia. 2. anesthesia classification (asa): i-iii. 3. age: 20 years old to 70 years of age. exclusion criteria: 1. mental illness and taking related drugs. 2. visually impaired and hearing impaired. 3. being unable to communicate or illiterate. 4. the condition changes or is critical, and the intensive care unit is admitted after the operation. 5. contact isolation. 6. trauma of the head and wounds on the head. 7. history of motion sickness and vertigo.

Keywords: virtual reality；anxiety
a cohort study on the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

Conditions: Gastrointestinal Stromal Tumors

Summary: the purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

there is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric gist over 5cm. a multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (gist) compared to laparoscopic resection of gist of less than 5cm. the primary evaluation parameter is overall postoperative morbidity.

Eligibility criteria:
inclusion criteria: 1. 18 years \< age \< 75 years 2. primary gastric lesion diagnosed as gastric gsit by endoscopic biopsy histopathology or suspected gastric gist by preoperative endoscopy, ultrasound endoscopy, or ct or mr, and confirmed as primary gastric gist by postoperative pathology 3. patient informed consent and willingness to undergo laparoscopic resection 4. expected laparoscopic outcome of r0 resection 5. performance status: eastern cooperative oncology group (ecog) ≤ 2, preoperative american society of anesthesiologists（asa） score i-iii exclusion criteria: 1. women during pregnancy or breast-feeding 2. severe mental disorder 3. history of upper abdominal surgery (except the history of laparoscopic cholecystectomy) 4. history of gastric surgery (except esd/emr for gastric cancer) 5. history of other malignant diseases within the past five years 6. history of unstable angina or myocardial infarction within the past six months 7. history of a cerebrovascular accident within the past six months 8. history of continuous systematic administration of corticosteroids within one month 9. requirement of simultaneous surgery for other diseases 10. emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

Keywords: gastrectomy laparoscopic gastrointestinal stromal tumor
study of ono-1101 in patients scheduled for coronary angiography

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of ono-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.


Eligibility criteria:
inclusion criteria: * 20 years of age or older * heart rate less than 90 beats/min and more than 70 beats/min at entering the ct room exclusion criteria: * previous allergic reactions to contrast agent * renal failure * asthma * concomitant beta-receptor blocking agent

Keywords: ono-1101 coronary artery disease multi-slice ct
study to compare standard perimetry with the new scotoma-oriented perimetry (scope) using a new fast german adaptive threshold estimation (gate) in glaucoma patients

Conditions: Primary Open Angle Glaucoma (POAG)

Summary: the purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma (poag) * spherical ametropia max. ± 8 dpt * cylindrical ametropia max. ± 3 dpt * distant visual acuity \> 10/20 * pupil diameter \> 3 mm exclusion criteria: * diabetic retinopathy * asthma * history of epilepsy or significant psychiatric disease * medications known to effect visual field sensitivity * infections (e.g., keratitis, conjunctivitis, uveitis) * severe dry eyes * miotic drug * squint * nystagmus * albinism * any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields * keratoconus * intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening * history or signs of any visual pathway affection other than glaucoma * history or presence of macular disease and/or macular edema, ocular trauma, medications known to affect visual field sensitivity

Keywords: visual field perimetry progression poag glaucoma
study of 4 bone turnover markers in patients with multiple myeloma treated with intravenous bisphosphonate in routine care

Conditions: Multiple Myeloma

Summary: the aim of this study is looking at the kinetics of bone turnover markers (c-terminal telopeptides of type i collagene (ctx), amino-terminal telopeptide of type 1 collagen (ntx), dickkopf-1 (dkk-1) and sclerostin (sost)) in serum and urine until 12 months in patients with multiple myeloma treated with intravenous bisphosphonates in routine care.


Eligibility criteria:
inclusion criteria: 1. patient aged 65 to 75 years of age 2. patient with symptomatic multiple myeloma as defined by the criteria of the imwg 3. need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (pet-scanner preferentially) in routine care 4. ability and willingness to follow scheduled visits with requested biological samples exclusion criteria - patients previously treated with intravenous biphosphonate

Keywords: multiple myeloma intravenous bisphosphonate bone markers
hobscotch phase ii

Conditions: Epilepsy

Summary: the purpose of this study is to determine the feasibility and efficacy of the home-based cognitive self-management program "hobscotch" delivered at four new england medical centers. it will test the long-term impact and cost-effectiveness of hobscotch, and whether it can be delivered from a distance utilizing e-health tools for parts of the program.

hobscotch (home based self-management and cognitive training changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. the program is based on problem solving therapy (pst) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. hobscotch phase ii is a replication study of the original hobscotch study, designed to translate the findings of hobscotch into a real world setting. this is a multi-center study, with the hobscotch intervention being implemented at four epilepsy clinics in new england.

Eligibility criteria:
inclusion criteria: * age 18-70 * confirmed diagnosis of epilepsy, with controlled or uncontrolled seizures * subjective memory complaints * no changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video eeg evaluation is acceptable * literate * telephone access exclusion criteria: * subjects age 66-70 with a mention of a dementing illness in their medical record * severe mental disability or estimated iq less than 70 * significant visual impairment precluding reading or writing * no reliable telephone access

Keywords: epilepsy memory problems self-management
effects of talocrural joint mobilizations in the treatment of subacute lateral ankle sprains

Conditions: Ankle Sprain

Summary: the goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.

the purpose of this protocol is to assess the effects of grade iv anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.

Eligibility criteria:
inclusion criteria: * incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt * slight reduction in function * anterolateral ankle tenderness * dorsiflexion rom asymmetry greater than 5° compared to uninvolved limb * posterior talar glide restriction greater than 5° compared to uninvolved limb; or * posterior talar glide less than 19°, which is one standard deviation (7°) from our previously established normative values (26°)9, 10 * suffered from grade 1 or 2 lateral ankle sprain within the last 48hr - 8 days exclusion criteria: * a history of ankle surgery that involves intra-articular fixation, * syndesmotic ankle sprain (to be ruled out based on clinical examination), * history or signs of reflex sympathetic dystrophy, * have received manual therapy for the ankle sprain prior to enrollment * grade iii ankle sprain.

Keywords: ankle sprain athletic injury arthritis
the effect of lactation on insulin sensitivity and lipolysis in women

Conditions: GDM; Lactation

Summary: this purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.

there are two aims that this research will address. in aim 1, the research question is "does lactation improve insulin sensitivity and increase lipolysis in women?" in this aim, researchers will assess whether lactation amongst women with a history of gestational diabetes mellitus (gdm) will improve whole body insulin sensitivity as well as increase whole body lipid turnover by using hyperinsulinemic-euglycemic clamps combined with \[6,6-2h\]-glucose and \[2h5\]-glycerol infusions. these stable, non-radiating isotopes have been used extensively and safely to study the mechanisms of insulin resistance amongst non-pregnant as well as pregnant humans; however, these techniques have not previously been applied to the study of insulin sensitivity during lactation. therefore, the goals will be two-fold: 1) to determine whether lactation induces similar changes in insulin sensitivity in humans as in mice and 2) to pilot the feasibility of performing larger, more detailed metabolic studies in this population of women post-partum. the second aim (aim 2) will use a retrospective chart review of women with a history of gdm who had an oral glucose tolerance test (ogtt) 6-8 weeks post-partum as part of standard of care. the focus of this protocol registration will be aim 1.

Eligibility criteria:
inclusion criteria: * a history of gdm (as defined as the american diabetes association criteria) * delivered a singleton, live birth at ≥ 35 weeks gestation within the past 18 months * hba1c \< 6.5% at time of screening * delivery within the past 18 months * breast feed group: exclusively or mostly breast-fed (\< 6 ounces of formula/24 hours at 6-9 weeks of delivery) for at least 4-6 months exclusion criteria: * currently lactating or lactation within the past 1 month at the time of the screening visit * diagnosis of diabetes (t1d or t2d) prior to pregnancy * current use of any glucose-lowering agents * pregnancy related medical problems including preeclampsia * major congenital fetal anomalies * creatinine \> 1.5mg/dl, hematocrit \ 2.5x upper limit of normal * known psychiatric disorders, alcohol abuse, hiv, hepatitis, renal disease, hepatic disease, untreated heart disease, untreated thyroid disease, active systemic infection or malignancy * illicit drug use (by the participant's self-report) * history of post-partum depression * use of weight loss supplements or dieting 6 months prior to study * corticosteroid or opiate use within 6 months of study
the efficacy and safety of irbesartan 150/12.5 mg and 300/25 mg in patients with mild hypertension

Conditions: Hypertension

Summary: the purpose of this study is to assess the efficacy and safety of irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.

the primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior htn therapy.

Eligibility criteria:
inclusion criteria: * the patient must have hypertension and uncontrolled sbp on monotherapy. * patients who have read, signed and received a copy of the informed consent prior to any study procedures note: female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study. exclusion criteria: * any history of secondary hypertension * history of hypertensive encephalopathy, stroke, or transient ischemic attack (tia) within the past 12 months * history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
safety and efficacy of levomilnacipran er (f2695 sr) in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran er fixed doses versus placebo in the treatment of outpatients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * men and women, 18-65 years old * currently meet the dsm-iv-tr criteria for major depressive disorder * the patient's current depressive episode must be at least 8 weeks in duration exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control * patients with a history of meeting dsm-iv-tr criteria for: * any manic or hypomanic episode * schizophrenia or any other psychotic disorder * obsessive-compulsive disorder * patients who are considered a suicide risk

Keywords: depression major depressive disorder
avodart® alopecia post-marketing surveillance (pms)

Conditions: Alopecia

Summary: post-marketing surveillance(pms) to monitor the safety and effectiveness of dutasteride in korean androgenetic alopecia patients

an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of dutasteride administered in korean androgenetic alopecia patients according to the prescribing information

Eligibility criteria:
inclusion criteria: * men (18-41 years of age) with male pattern hair loss (androgenetic alopecia) * subjects with no experience of treatment using dutasteride * subjects who the investigator believes that they can and will comply with the requirements of the protocol * subjects who prescribed with dutasteride according to the prescribing information exclusion criteria: * considering the nature of observational study, gsk korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved prescribing information. subject who give informed consent is enrolled. however, if institution waives the requirement for informed consent, informed consent is not required. in this case, monitoring does not proceed.

Keywords: dutasteride