Kornimate/medical-research-clean huggingface dataset:
emtricitabine for prevention of vertical transmission of hbv in chinese pregnant hbsag positive patients

Conditions: Hepatitis B, Chronic; Pregnancy

Summary: this study evaluates generic emtricitabine(ftc) efficacy and safety in chinese naive pregnant hbsag positive patients in prevention of hbv vertical transmission. single group patients were enrolled to receive emtricitabine till 24 weeks after delivery.

single group patients were enrolled to receive emtricitabine till 24 weeks after delivery, which include hbeag positive patients. patients and their newborns were followed till 48 weeks after delivery to evaluate the efficacy of prevention of vertical transmission.

Eligibility criteria:
inclusion criteria: * hbsag positive for more than 6 months * hbeag positive patients: hbv dna ≥ 5log10 copies/ml * hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4 * hbeag negative patients: hbv dna ≥ 4log10 copies/ml * hbeag postive patients: alt≥2×uln;or liver biopsy g≥2;or liver biopsy s ≥2;or liver biopsy knodell hai ≥ 4 * nucleoside/nucleotide naive paitents * diagnosed as ≥ 28 weeks pregnancy exclusion criteria: * diagnosed hcc with afp and ultrasound, ct or mri * creatine \>130μmol/l or ccr \< 70ml/min * hemoglobin \<100g/l * coinfected with hav,hev,hcv,hdv or hiv * ana \> 1:100 * uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer * drug abuse or alcohal addiction * previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine * long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial * underwent liver transplantation or liver transplantation in schedule * allergic to nucleoside or nucleotide analogues * family history of genetic defects disease * abnormal results in fatal defects screening * hbsag positive sperm provider pregnancy

Keywords: hepatitis b virus emtricitabine pregnancy vertical transmission
multicenter clinical research for early diagnosis of lung cancer using blood plasma derived exosome

Conditions: Lung Cancer

Summary: lung cancer is a leading cause of cancer death worldwide. early diagnosis is linked to a better prognosis. further, surgical resection at the early stages of non-small cell lung cancer (nsclc) results in markedly improved survival rates. computed tomography (ct)- or bronchoscopy-guided needle biopsies are standard definitive diagnostic procedures for lung cancer and are used to obtain tissue for pathological examination. however, these procedures are invasive, difficult to repeat, expensive, and risk exposure to radiation. conversely, liquid biopsies, such as circulating tumor cells (ctcs), circulating tumor dna (ctdna), and extracellular vesicles (evs), are simple and less invasive procedures that can be repeated more frequently than tissue biopsies. to analyze the exosomes abundantly present in the blood and to conduct clinical studies to determine whether it is possible to diagnose lung cancer. to this end, blood samples from normal people (n = 150) and lung cancer patients (n = 320) are obtained from the human biobank of five hospitals participating in the study.


Eligibility criteria:
inclusion criteria: 1. patients with primary adenocarcinoma of lung with permanent pathology of n0 or n1 2. patients with t1mi, tsi, t1a, t1b, t1c, t2a, and t2b stage 3. an adult of korean nationality 4. patients without prior chemo/radiation treatment prior to lung cancer surgery 5. patients who have not been diagnosed with other cancers prior to lung cancer surgery exclusion criteria: * patients who do not meet the inclusion criteria

Keywords: blood plasma exosome liquid biopsy lung cancer biomarker deep-learning analysis
characteristics and treatment trends of young breast cancer in china

Conditions: Breast Cancer

Summary: to describe the clinical characteristics, the diagnosis and treatment, the survival status and change trend of young breast cancer patients in china from 2000 to 2015, and to explore and discuss the main influencing factors.

in this study, medical records and follow-up information of young breast cancer patients (age ≤35 years at first diagnosis) who were first diagnosed and treated in the years (2000, 2003, 2006, 2009, 2012 and 2015) were collected from multiple hospitals in china from 2000 to 2015, to establish a retrospective cohort of young breast cancer patients. clinical characteristics, diagnosis and treatment, and survival rates of young breast cancer patients from 2000 to 2015 were analyzed. to explore the main factors affecting the clinical diagnosis and treatment and the survival of patients.

Eligibility criteria:
inclusion criteria: * young breast cancer patients (≤35 years old) in china exclusion criteria: * breast cancer patients (\>35 years old) in china
determination of clotpro paediatric reference range study

Conditions: Clotting and Bleeding Disorders; Child Development; Infant Development; Coagulopathy

Summary: a new thromboelastometry analyser (clotpro, enicor gmbh, munich, germany) with improved technology was developed. this device has an improved new-generation viscoelastometric testing technique and enables the detection and assessment of factor deficiencies, low fibrinogen, platelet contribution (to whole blood coagulation), heparin and direct oral anticoagulants effects, fibrinolysis and antifibrinolytic drugs. this study aims to determine reference ranges for the clotpro device for all paediatric age groups.

viscoelastic testing as a relatively novel method to assess coagulation status appears favourable in reducing blood product transfusions. the tests are performed on whole blood instead of plasma, which saves time and gives a quick sight at the interaction between cellular and plasmatic clotting factors. reviews of the literature suggest that transfusions of packed red blood cells (prbc), plasma, and platelets are all decreased in patients whose transfusions were guided by viscoelastic tests rather than by clinical judgement or conventional laboratory tests. the benefits of viscoelastic coagulation monitoring have been described in many fields of surgery and intensive care. current literature and a guideline for the treatment of massive haemorrhage in perioperative bleeding and trauma patients recommend the use of viscoelastic tests to guide haemostatic resuscitation.

Eligibility criteria:
inclusion criteria: * paediatric patients attending hospital for elective surgery or diagnostic imaging undergoing general anaesthesia are going to be eligible to participate. * children whose parents agree to participate are provided with oral and written information and written informed consent has to be obtained. exclusion criteria: * problematic blood collection * age over 16 years * emergency surgery * systemic infection * known bleeding disorders * history of congenital or acquired coagulopathy including renal, liver and bone marrow disease, * any medication interfering with haemostasis * prophylactic or therapeutic anticoagulant therapy (acetylsalicylic acid within the last 10 days or low-molecular-weight heparins within the last 48 h) * administration of colloids hydroxyethyl starch (hes)/albumin, or blood products before the blood withdrawal

Keywords: thromboelastometry viscoelastic testing reference ranges
the effect of transcranial magnetic stimulation in patients with stroke

Conditions: Stroke

Summary: this study is aimed to investigate the effect of continuous theta burst stimulation (ctbs) and low frequency repetitive transcranial magnetic stimulation (rtms) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.

a sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rtms group (n=7), active ctbs group (n=7) and sham ctbs group (n=6). in the active rtms group, 10 sessions of intact hemispheric upper extremity motor area (m1) were targeted and inhibitor rtms was applied with a frequency of 1 hz consisting of 1200 pulses for 20 minutes. in the active ctbs group, 10 sessions of intact hemispheric upper extremity motor area (m1) were targeted and ctbs was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 hz repeated every 200 milliseconds for 40 seconds. sham ctbs was applied in the same protocol but using sham coil. within 30 minutes after tms sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. upper extremity fugl-meyer motor function scale, modified ashworth scale (mas), functional independence measure (fim), motor activity log-28 (mal-28) and brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.

Eligibility criteria:
inclusion criteria: * ischemic stroke with a disease interval of 6 months to 2 years * aged between 18-80 years * mini mental test score ≥ 24 * upper limb brunnstrom recovery stage 3 to 5 * upper extremity (elbow, wrist and finger) spasticity level modified ashworth scale (mas) 1+ to 3 exclusion criteria: * hemorrhagic stroke * history of epilepsy * a cardiac pacemaker * pregnancy * history of previous stroke or ischemic attack * neurological diseases other than stroke * metallic implant in brain or scalp (including cochlear implant) * previous brain surgery * orthopedic disease that prevents upper extremity movements * poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.) * diagnosis of malignancy * injections of botulinum toxin in the last 6 months for the affected upper extremity * drug or dosage changes of anti-spasticity medications in the last 1 month period

Keywords: stroke repetitive transcranial magnetic stimulation continuous theta burst stimulation functional recovery spasticity
better arterial cannulation technique with different hemodynamics

Conditions: Acute Respiratory Failure; Shock

Summary: purpose two techniques of radial artery cannulation, ultrasound guided (usg) and conventional method (cm) were compared to find the better technique in general and in different hemodynamic subsets of patients. method this is a prospective randomized, single center study of 100 patients. the details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with systolic blood pressure \ 100 mm hg.


Eligibility criteria:
inclusion criteria: * all adult patients worthy of radial artery cannulation, who consented exclusion criteria: * no consent

Keywords: radial artery cannulation ultrasound guided first success rate systolic blood pressure shock
global safety and efficacy registration study of crinecerfont for congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia

Summary: this is a phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic cah due to 21-hydroxylase deficiency. the study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active treatment with crinecerfont. subsequently, participants may elect to participate in the open-label extension (ole) period. the duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per participant for the ole (estimated to be approximately 3 years).


Eligibility criteria:
inclusion criteria: 1. be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit. 2. have a medically confirmed diagnosis of classic cah due to 21-hydroxylase deficiency. 3. be on a stable steroid regimen. 4. participants of childbearing potential must agree to use an acceptable method of contraception during the study. exclusion criteria: 1. have a diagnosis of any of the other known forms of classic cah. 2. have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy. 3. have a clinically significant unstable medical condition or chronic disease other than cah. 4. have a history of cancer unless considered cured. 5. are pregnant. 6. have a known history of clinically significant arrhythmia or abnormalities on ecg. 7. have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists. 8. have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study. 9. have current substance dependence, or current substance (drug) or alcohol abuse. 10. have had a blood loss ≥550 ml or donated blood or blood products within 8 weeks prior to the study.
dexamethasone for post traumatic headache

Conditions: Post-Traumatic Headache

Summary: this is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.


Eligibility criteria:
inclusion criteria: meet international classification of headache disorders criteria for acute post-traumatic headache as follows: * traumatic injury to the head has occurred * headache has developed within 7 days of injury to the head * headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache) * the headache must be rated as moderate or severe in intensity at the time of initial evaluation exclusion criteria: * more than ten days have elapsed since the head trauma * headache has already been treated with an anti-dopaminergic medication * medication allergies * contra-indications including pheochromocytoma, seizure disorder, parkinson's disease, use of mao inhibitors, and use of anti-rejection transplant medications
let's be well red: efficacy of gudness bars in improving the hemoglobin and hematocrit levels of anemic subjects

Conditions: Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar

Summary: to test the efficacy of gudness bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally. to quantify the demographics of subjects attending anemia testing camps through lbwr and to explore correlations with the demographics data.


Eligibility criteria:
inclusion criteria: * female * ages 18-35 years age exclusion criteria: * known allergy towards nuts.

Keywords: anemia
prospective randonmized comparison of needlescopic versus conventional laparoscopic adrenalectomy

Conditions: Adrenal Tumors

Summary: the study is a prospective radonmized comparison between needlescopic adrenalectomy and conventional laparoscopic adrenalectomy for benign adrenal tumors less than 5 cm. the operative success rate, operative time, intraoperative blood loss, intraoperative or postoperative complication, postoperative pain, postoperative hospital stay, convalescence, and wound cosmesis were compared.

needlescopic instruments, defined as those with a diameter of no more than 3 mm. they result in smaller incisions than conventional 5- to 12-mm instruments, and thus better cosmesis. it may further reduce postoperative pain, hospital stay, and recovery time. all operations were performed with the lateral transperitoneal approach. a 12-mm port was created near the umbilicus for a 30-degree telescope, and another two(for left lesions) or three (for right lesions) 2-mm working ports (tyco healthcare, norwalk, connecticut, usa) were created along the ipsilateral subcostal region. careful dissection was done with the use of a 2-mm hook or scissors electrocoagulator. the adrenal vein of the lesion side was isolated and controlled with a 2-mm mini-bipolar coagulation apparatus (tyco healthcare) for a long segment. the vein was then transected closer to the adrenal gland, leaving the coagulated stump at the renal vein or vena cava as long as possible, even when a short right adrenal vein was encountered. then the adrenal gland with the tumor was dissected from its surrounding tissues after several tiny vessels were transected with the needlescopic instruments mentioned above. the specimen was put into a retrieval bag and removed through the umbilical port.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of benign adrenal tumors exclusion criteria: * suspected adrenal malignancy clinically * bilateral adrenal disease * pregnant female

Keywords: laparoscopy, needlescopy, adrenalectomy
berberine hyperglycemic clamp

Conditions: Diabetes Mellitus

Summary: berberine (bbr) is a traditional chinese medicine used to treat diabetes mellitus for thousands of years in china. the glucose-lowering effect of bbr has been confirmed in numerous studies. nevertheless, the detailed mechanisms of action through which bbr exerts its effects are not yet fully elucidated. in previous data, jin-kui yang found that bbr could promote insulin secretion in mice and isolated islets. in this current study, investigators plan to examine the insulinotropic effect of bbr in human through hyperglycemic clamp method.


Eligibility criteria:
inclusion criteria: 1. adult healthy male, aged ≥18 and ≤45 years old. 2. subject/ legal representative is able to understand and sign informed consent form. 3. body mass index (bmi) 18-25 kg/m2. 4. normal oral glucose tolerance test prior to study. 5. no family history of diabetes mellitus. 6. no medication treatment within 4 weeks prior to baseline visit and during the study. 7. willing and able to comply with all study-related procedures, including not incorporating significant changes in diet. exclusion criteria: 1. infection with hepatitis (a, b, or c), hiv and syphilis. 2. history of allergic reaction to berberine or any component in the formulation of the study drugs. 3. cumulative amount of blood loss (eg. blood donation) over 400ml within 3 months prior to baseline visit and during the study. 4. alcohol drinking within 2 weeks prior to baseline visit and during the study. 5. use of illegal drugs or positive in urine drugs screen. 6. smoke during the study.

Keywords: hyperglycemic clamp
the use of hiv self-tests to promote partner and couples testing: a randomized trial

Conditions: HIV

Summary: this randomized controlled trial will explore whether the provision of oral hiv self-test kits to women can increase hiv testing among their male partners. the study will recruit adult women from antenatal care and post-partum clinics in kisumu. each participant will be randomized to either receive two hiv self-tests or to receive counseling referring their partner to hiv testing (standard of care). over a 3 month period, we will obtain information from study participants on how many sexual partners they offered the tests to, the receptivity of their sexual partners to using self-tests, and the incidence of any adverse events. we will compare partner testing rates in intervention and control groups.

this randomized controlled trial will enroll women, ages 18-39, attending antenatal care (anc) and post-partum care (ppc) at 3 sites in kisumu, kenya. the study's purpose is to investigate whether offering multiple hiv self-tests to women can increase the likelihood that either partner or couples hiv testing takes place. women who are randomized to the intervention group will be provided with multiple oral self-tests as well as information about how to use the tests and where to seek care if necessary. these women will be encouraged to give the self-tests to their sexual partners and encourage those partners to take a self-test. women who are randomized to the control group will be offered the standard counseling to refer their partners for clinic-based hiv counseling and testing. our hypothesis is that the intervention group will have higher uptake of hiv testing by women's partners within 3 months of enrollment in the study than the control group. participants in the study will complete a baseline interview and a follow-up interview at 3 months post-enrollment. qualitative in-depth interviews will be conducted with a subset of participants in the intervention group.

Eligibility criteria:
inclusion criteria: * primarily resides in or near kisumu * reports having a current, primary partner (someone that the woman has been in a relationship with for at least 6 months and is identified as her primary partner) * reports that primary partner has not tested for hiv in past 6 months * have undergone the opt-out hiv testing at the anc or ppc clinic * intends to continue living in or around kisumu for the next 3 months (follow-up period). exclusion criteria: * believes that her partner will hurt her if she gives him an hiv self-test and encourages him to use it * reports having an hiv+ partner * intends to relocate from kisumu area within the next 3 months

Keywords: hiv self-testing randomized controlled trial kenya
decitabine in treating patients with advanced solid tumors

Conditions: Male Breast Cancer; Recurrent Bladder Cancer; Recurrent Breast Cancer; Recurrent Melanoma; Stage III Melanoma; Stage IV Bladder Cancer; Stage IV Breast Cancer; Stage IV Melanoma; Unspecified Adult Solid Tumor, Protocol Specific

Summary: this phase i trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

primary objectives: i. determine the maximum tolerated dose of decitabine in patients with advanced solid tumors. ii. determine the toxic effects of this drug in these patients. iii. determine the dose of this drug with biologic activity in these patients. iv. determine the pharmacokinetics of this drug in these patients. v. determine clinical response to this drug in these patients. outline: this is a dose-escalation, multicenter study. patients receive decitabine iv over 30 minutes on days 1-5 weekly for 4 weeks. courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. patients are followed at 2 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following: * stage iii or iv melanoma * mucosal melanoma allowed * no resectable stage iii melanoma * bladder cancer * breast cancer * no active symptomatic cns disease * no radiographically evident cerebral edema * hormone receptor status: * not specified * male or female * performance status - ecog 0-1 * hemoglobin at least 9.0 g/dl * platelet count at least 100,000/mm\^3 * wbc at least 3,500/mm\^3 * absolute granulocyte count at least 1,500/mm\^3 * no coagulation disorders * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot and sgpt less than 2.5 times uln * hepatitis b surface antigen negative * hepatitis c antibody negative * creatinine no greater than 1.5 times uln * no major cardiovascular system illness * no major respiratory system illness * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * hiv negative * no major systemic infection * at least 1 month since prior radiotherapy * at least 1 month since any prior anticancer therapy or adjuvant therapy * no other experimental treatment within 30 days prior to, during, and for 30 days after study therapy