Kornimate/medical-research-clean huggingface dataset:
evaluation of clinical performance and ivd test of lifeos digital pcr liquid biopsy kits for egfr t790m mutation

Conditions: Non Small Cell Lung Cancer; EGFR T790M

Summary: liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. established in 2015, lifeos genomics co., ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital polymerase chain reaction (pcr) technology. the company's automated nucleic acid amplification quantitative analysis platform (qloci™ md1000 analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per pcr chip. integrating digital pcr technology, it elevates analytical sensitivity beyond 0.1%. lifeos commissioned the core laboratory of pharmacogenomics at the national taiwan university to conduct clinical validation assessments for their developed "egfr t790m mutation detection assay kit." this assay kit secured official registration by the taiwan food and drug administration (tfda) as a laboratory developed test (ldt) in 2023, permitting the issuance of medical testing reports. this initiative aims to validate the detection capabilities of lifeos genomics co., ltd.'s "egfr t790m mutation detection assay kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.


Eligibility criteria:
inclusion criteria: 1. aged ≥18 years old. 2. patients with stage iiib or iv non-small cell lung cancer (nsclc) with egfr mutations. exclusion criteria: 1. pregnant women. 2. any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.

Keywords: liquid biopsy digital polymerase chain reaction (pcr) egfr t790m
ghrelin levels in children with poor growth

Conditions: Idiopathic Short Stature; Failure to Thrive

Summary: the investigators hypothesize that low serum ghrelin levels may characterize a group of patients with poor weight gain and/or linear growth who do not have any other identified cause for growth failure. these patients may present with a variety of complaints and are often evaluated by both pediatric endocrinologists and pediatric gastroenterologists. the investigators hypothesize that ghrelin has a physiologically important role in linear growth and that chronic diseases of the gastrointestinal system, such as h. pylori infection or celiac disease, may alter serum ghrelin levels in children. low ghrelin levels may be a factor leading to poor growth, potentially by altering growth hormone secretion and/or by decreasing appetite. by measuring ghrelin levels in children with short stature and in children with gastrointestinal disease, the investigators will further elucidate the possible physiologic role of ghrelin in childhood growth and how it may be altered in conditions causing short stature and in certain gastrointestinal diseases.


Eligibility criteria:
inclusion criteria: * to be included in the short stature group, subjects must have had short stature, defined height less than -2 sd for gender and age or an abnormal growth velocity for gender and age). * to be included in the failure-to-thrive group, subjects must have had poor weight gain, defined as weight less than -2 sd for gender and age or an abnormal weight velocity for gender and age. * patients in both groups will be evaluated for the presence of chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms. patients who were affected in both weight and height will be stratified by which measurement was more severely affected, with poor weight gain being the primary problem in the "failure-to-thrive" grouping (group 2) and "poor linear growth" being the primary problem in the short stature group (group 1). * patients who have had chronic gastrointestinal symptoms, defined as symptoms of gastrointestinal disease for greater than 6 weeks or recurrent symptoms, but normal stature and growth, will be analyzed separately (group 3). exclusion criteria: * must not have a known diagnosis as an etiology for growth failure or gi symptoms prior to presentation.

Keywords: ghrelin short stature failure to thrive
safety, tolerability, pharmacokinetics of evp-0962 and effects of evp-0962 on cerebral spinal fluid amyloid concentrations in healthy subjects and in subjects with mild cognitive impairment or early alzheimer's disease

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: this study is being conducted to determine the safety, tolerability, pharmacokinetics, and effects of evp-0962 on cerebral spinal fluid amyloid concentrations in healthy subjects and in subjects with mild cognitive impairment or early alzheimer's disease.

this is a randomized, double-blind, sequential escalating repeat daily dose study conducted in two parts. the first part is being conducted in healthy subjects and will evaluate safety, tolerability, and pharmacokinetics and pharmacodynamics of escalating evp-0962 doses (10, 50 100 and 200 mg) or matching placebo following once-daily administration for 14 days. the second part will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of evp-0962 following once-daily administration for 14 days in patients with mild cognitive impairment or early alzheimer's disease at the dose level selected based on the available safety, pharmacokinetics and pharmacodynamics observations in the first part.

Eligibility criteria:
inclusion criteria: * part 1: male and female subjects between the ages of 45 to 65 (inclusive) in good health with a bmi of 18-32 kg/m2 and negative urine drug screen of abuse test. * part 2: male and female subjects between the ages of 45 to 85 (inclusive), mri/ct scans compatible with diagnosis of mci or early ad, meets the classification of mci due to ad as defined by the national institute on aging-alzheimer's association, and a bmi of 18-32 kg/m2(inclusive). subjects must meet the following cognitive criteria: subject memory complaint, cognitive impairment in one or more areas, cdr-sb score less than or equal 1.0, mmse greater than 24, and no impairment in social or occupational functioning. exclusion criteria: * history of seizure disorder, symptomatic orthostatic hypotension, qtc values greater than 450 ms, positive drug screening tests * pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study * c-ssrs suicidal ideation score of 4 or 5 * unwilling to abstain from vigorous exercise * concurrent disease other than mci or early ad that is attributing to patient's cognitive impairment. * lumbar spine x-rays show anatomic contraindications to lumbar puncture * history of spinal surgery or chronic low back pain * history of migraine headaches
rct of russian idu peer network hiv prevention intervention - 1

Conditions: HIV Infections

Summary: the purpose of this study is to conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. we expect that participants who receive the intervention will demonstrate a reduction in the rate of hiv infection and hiv risk behaviors and members of their risk network will also demonstrate reductions in risk behaviors compared to those in the control group.

intravenous drug use (idu) is driving the hiv epidemic in russia; over 90% of all hiv-1 infections have occurred within communities of idus. in st. petersburg (population 5 million), the prevalence of hiv infection in idus (estimated population 100,000) leapt from 4% in 1999 to 12% in 2000. at present there are an estimated 5-7 million idus, a four-fold increase since the end of the soviet union. in st. petersburg, there has been a three-fold increase in regular idus and a nine-fold increase in teenage idus during the past five years. the intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. providing peer educator training to idus may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the idu educators' social networks. prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of hiv transmission among the peer educators and the members of their social networks. comparison condition: informed by the centers for disease control model of best practice" standard of care of hiv testing and counseling, participants in the comparison condition will receive risk reduction education and motivational counseling to reduce their risk behaviors.

Eligibility criteria:
inclusion criteria: * of legal age to independently provide written informed consent for research * report having injected drugs at least 12 times in the last three months * hiv seronegative (elisa confirmed) * willing and able to recruit at least three hiv risk network members who are eligible for study participation exclusion criteria: * prior or concurrent enrollment in the last 6 months in another hiv behavioral or biomedical prevention study * psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff * any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives

Keywords: hiv injection drug use social networks
patient and clinician reported outcomes for tirbanibulin effectiveness and safety in actinic keratosis

Conditions: Keratosis, Actinic

Summary: the purpose of the study is to evaluate patient reported outcomes (pros) in terms of health-related quality of life (hrqol) among subjects with actinic keratosis (ak).


Eligibility criteria:
inclusion criteria: * diagnosed with ak of the face or scalp * has clinically typical, visible, and discrete ak lesions * considered as a potential candidate for tirbanibulin (klisyri®) treatment to manage their ak * willing to avoid excessive sun or ultraviolet (uv) exposure, and/or use relevant sunscreen protection and protective clothing during the study duration * able to read and write english * provide consent to participate in the study * willing to comply with all study procedures and be available for the duration of the study exclusion criteria: * participants with any dermatological condition of the face or scalp that could interfere with the clinical evaluations. * hypertrophic ak lesions, open wounds or suspected skin cancers within close proximity of the treatment area. * anticipated need for in-patient hospitalization or in-patient surgery within the next 2 months. * participants unable to comply with the requirements of the study or participants who in the opinion of the study physician should not participate in the study. * participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
efficacy of umbilical cord mesenchymal stem cells in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: duchenne muscular dystrophy (dmd) is a genetic disorder caused by an absence of dystrophin and characterized by progressive muscle degeneration. there is no cure for dmd at present but, there are several strategies under-researched for treatment of dmd such as steroid treatment, gene theraphy, exon skipping, stop codon read through and gene repair, cell theraphy and theraphy with drug that help to produce utrophin protein. the aim of this study is investigate the eficacy of human umblical cord mesenchymal stem cells on dmd and understanding if wild type gene can be transfered to the patient.


Eligibility criteria:
inclusion criteria: - patients with diagnosis of dmd that is proven clinically and genetically age between 7-20 patients need partial respiratory support, during the day patients have less than or equal to stage i nih, liver, renal and cardiac function patients without cancer patients without allergic disease patients without bleeding diathesis, exclusion criteria: patients need complete respiratory support patients have more than to stage ii nih, liver, renal and cardiac function patients have bleeding diathesis and allergic disease

Keywords: umbilical cord, mesenchymal stem cell
comparison between letrozole and mifepristone in medical termination of first trimester miscarriages

Conditions: Miscarriage

Summary: prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.


Eligibility criteria:
inclusion criteria : * women older than 18years who will give consent regarding medical management of missed abortion * first trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography * hemoglobin level more than 12mg/dl exclusion criteria : * hemodynamically unstable patient * abnormalities in blood tests including complete blood count (cbc), prothrombin time(pt), internationalised normalized ratio(inr) and fibrinogen * history or clinical evidence of any thromboembolic impairment or deep venous thrombosis * having intra-uterine device * present or previous use of corticosteroids * history of any malignancy * existing cardiovascular disease contraindicating misoprostol
a study of apatinib combined with s1 in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: antiangiogenesis therapy plays an important role in cancer treatment. apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.we conducted this trial to investigate the safety and efficacy of apatinib combined with s1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.


Eligibility criteria:
inclusion criteria: 1. adult patients, aged between 18 and 75 years old; 2. eastern cooperative oncology group (ecog) performance status of ≤ 2; 3. histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(agc) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per recist 1.1; 4. failure or intolerance to at least one prior line of systemic chemotherapy regimen; 5. adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/l, platelets ≥ 100 × 10\*9/l, neutrophil ≥1.5 × 10\*9/l, total bilirubin ≤1.5 ×uln, and serum transaminase≤2.5×uln); 6. expected survival of ≥ 12 weeks. exclusion criteria: 1. subjects with poor-controlled arterial hypertension (systolic blood pressure\> 140 mmhg and diastolic blood pressure \> 90 mm hg) despite standard medical management; coronary heart disease greater than classi; i-level arrhythmia (including qt interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with class i cardiac dysfunction; 2. subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months; 3. abnormal coagulation (inr\>1.5、aptt\>1.5 unl), with tendency of bleed; 4. factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. previous treatment with vegfr inhibitor (i.e. apatinib, sorafenib, sunitinib); 6. with psychotropic drug abuse history and can't get rid of or mental disorder patients; 7. associated with cns (central nervous system) metastases; 8. active bacterial infections; 9. pregnant or breast-feeding women; 10. any other condition that might place the patient at undue risk or preclude a patient from completing the study.

Keywords: gastric cancer gastroesophageal junction cancer apatinib s1
the development and clinical verification of intelligent rehabilitation system for leg length discrepancy patients

Conditions: Leg Length Discrepancy, Shoe Lifts

Summary: a structural leg length discrepancy (slld) is a common clinical problem. its prevalence has been estimated at 40-70%. those who have been suffered from limping for a long time may lead to follow-up low back pain and lower limb musculoskeletal disorders. although lower limb triple view of x-ray is considered to be the current technique for determining lld, it is costly and time consuming that not every hospital can afford it, and in case of radiograph, the patient is exposed to radiation. therefore, it is necessary to develop a rapid clinical assessment method by gathering exterior parameters to build up a regression model for measuring the discrepancy and determining lld accurately. while using shoe lifts to correct discrepancy is the easiest conservative intervention for lld, there are still many controversies on how much height should be added clinically and academically. the optimal height should be added depends on feedbacks from users and gait performance. the best gait performance can be measured from kinematic performance of center mass of body during walking. therefore, this project wants to compare treatment responses between two kinds of shoe lift height correction methods for lld: given 80% discrepancy in shoe lift height correction through triple view of x-ray and given optimal shoe lift height correction through analyzing kinematic performance of center mass of body.


Eligibility criteria:
inclusion criteria: * aged 20 to 70 * being able to walk independently * being diagnosed with congenital slld or not * willing to cooperate to wear shoe lifts * has smart phone and willing to record information that investigators need * willing to sign agreement exclusion criteria: * neurological diseases (i.e. parkinson's disease, cva, polio, and lower limb nerve injuries, etc.) * diabetes along with peripheral neuropathy * history of lower limb fracture injury or joint replacement leading to uneven leg length * osteoporosis along with compression fracture * foot, ankle, or knee joint deformity, osteoarthritis or soft tissue pain that disturb gait performance (ex. degenerative osteoarthritis, plantar fasciitis, and etc.) * pregnancy * idiopathic scoliosis * history of psychological disease or drug addiction
assessment of vertebral fracture risk for first time liver transplant candidates

Conditions: Metabolic Bone Disease; Transplant-Related Disorder; Secondary Osteoporosis

Summary: the researchers are trying to compare the effectiveness of vertebral fracture assessment (vfa) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.


Eligibility criteria:
inclusion criteria * first time liver transplant candidates deemed too early for liver transplant * 24 hour urine creatinine clearance of \> 40 mg/dl. however bone turnover markers (beta ctx and p1np) will be measured only in those with creatinine clearance \>60mg/dl exclusion criteria * patients with prior solid organ transplantation * liver/kidney combination will be excluded * patients with 24 hr. urine creatinine clearance \< 40ml/minute * patients who have been on osteoporosis medications - bisphosphonates \[fosamax (alendronate), actonel (risedronate), boniva (ibandronate), or reclast (zoledronic acid)\] teriparatide (forteo), abaloparatide (tymlos), denosumab (prolia), within the past 5 years * use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or serms in the past 6 months * underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases

Keywords: transplant related disorders liver transplant transplant related bone disease
interest of myo-inositol supplementation in women with polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome; Reproductive Medicine

Summary: the main objective will be to check if myoinositol (myo) reduces the total resistance rate to clomiphene citrate (cc). for this, our study will be controlled, randomized and double blinded. it will include patients with pcos (polycystic ovary syndrome, defined by the rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by cc. half of them will receive myo + levomefolic acid (5-mthf) in addition to the cc, while the other half will receive a placebo containing only 5-mthf in addition to the cc. the myo supplementation will be initiated at least one month before taking cc and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.


Eligibility criteria:
inclusion criteria: * wishing pregnancy, * having pcos defined by the rotterdam criteria: high antral follicle count (afc) (\> 19 per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of the three criteria), * having never been treated with cc (or previous treatment with cc interrupted for \> 3 months). * having received complete information and having signed consent. * covered by social security exclusion criteria: * intolerance to cc in previous treatment, * bmi \> 35, * other associated cause of oligoanovulation requiring specific treatment (eg., hyperprolactinemia or functional hypothalamic anovulation), * ongoing pregnancy at the time of cc initiation, * other male or female cause of hypo-fertility, * history of ovarian drilling, * negative rubella serology.

Keywords: polycystic ovary syndrome reproductive medicine