Kornimate/medical-research-clean huggingface dataset:
a phase ⅲ clinical study of mil62 in primary membranous nephropathy

Conditions: Primary Membranous Nephropathy

Summary: this study will evaluate the efficacy, safety, pharmacokinetics(pk) ,pharmacodynamics and anti-drug antibodies（ada） of mil62 compared with cyclosporine in participants with primary membranous nephropathy (pmn).


Eligibility criteria:
inclusion criteria: 1. age 18-80; 2. diagnosis of primary membranous nephropathy (pmn) according to renal biopsy prior to or during screening; 3. 24 hours urinary protein \> 3.5g at initial screening and confirmation assessment; 4. epidermal growth factor receptor (egfr ) by chronic kidney disease epidemiology collaboration (ckd-epi) formula ≥40 ml/min/1.73 m\^2; 5. if taking acei(angiotensin converting enzyme inhibitors), arb(angiotensin receptor blocker), a stable dose within 4 weeks before screening is required; 6. sufficient organ function; 7. able and willing to provide written informed consent and to comply with the study protocol. exclusion criteria: 1. participants with a secondary cause of mn; 2. cyclosporine resistance; 3. received treatment drugs for membranous nephropathy; 4. concomitant with other serious diseases； 5. received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug; 6. infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c(including hbsag,hbcab positive with abnormal hbv dna ); 7. subjects with cd4+ t lymphocyte count \< 300 cells/μl; 8. those who have a clear history of tuberculosis or have received anti-tuberculosis treatment; 9. subjects with known history of severe allergic reactions to humanized monoclonal antibodies，mil62，or cyclosporine； 10. breastfeeding or pregnant women; 11. childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method 12. other conditions unsuitable for participation in this study determined by the investigator.
comparison of successful spinal needle insertion between obese and non-obese pregnant women

Conditions: Caesarian Section

Summary: the study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section

approval from ethical committee of faculty of medicine university of indonesia was acquired prior conducting the study. subjects were given informed consent before enrolling the study.subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. the back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. lumbal puncture was done using quincke needle 25g/27g at l4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. data was analyzed by using statistical package for social scientist (spss), for numerical data using unpaired t-test or mann-whitney-u test, for categorical data using chi-square test or fischer exact's test. data normality was tested by kolmogorov-smirnov test. significant value is p\<0.05.

Eligibility criteria:
inclusion criteria: * subjects aged 18-45 years old, with american society of anesthesiologists (asa) physical status i-iii who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position. * subjects have been explained about the study, have agreed to enroll and have signed the informed consent form exclusion criteria: * subjects with contraindications for spinal anesthesia * subjects with fetal's head trapped, umbilical prolapse, and foot presentation * subjects with pre-eclampsia * subjects with cardiovascular diseases * subjects with scoliosis * subjects with recent lumbal surgery history * subjects who cannot sit in crossed leg sitting position. drop out criteria: * subjects with worsening conditions before spinal anesthesia * subjects with failed spinal needle insertion and thus received general anesthesia * subjects with twin pregnancy * subjects drop out the study.

Keywords: spinal anesthesia spinal-bone contact caesarian section crossed leg sitting position
evaluation of risk factors for early termination of injection treatment with betaferon in patients suffering from multiple sclerosis

Conditions: Multiple Sclerosis

Summary: non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. betaferon) that are used in multiple sclerosis patients. certain patients omit single injections or even totally discontinue therapy that normally should be long-term. it is therefore crucial to identify the factors which have the most significant effect on regularity of administration of betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures. this study is conducted in routine practice setting and aims to identify those risks. pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. monitoring of omitted doses of the prescribed medication (betaferon) is carried out by the study nurse.


Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis * age \>/= 18 years * start of treatment with betaferon not earlier than 60 days prior to inclusion exclusion criteria: * synonymous with contraindications to betaferon

Keywords: multiple sclerosis interferon beta-1b compliance to treatment premature treatment discontinuation
drug-eluting balloon or drug-eluting stent in acute myocardial infarction: a randomized controlled trial

Conditions: ST Elevation Myocardial Infarction (STEMI)

Summary: the objective of the study is to compare drug-coated balloon (dcb) with the gold standard drug-eluting stent (des) in percutaneous coronary intervention (pci) for patients presenting with st-elevation myocardial infarction (stemi). randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. patients will be randomly assigned in a 1:1 fashion to receive either treatment with a paclitaxel-coated balloon alone or second or third-generation des.


Eligibility criteria:
inclusion criteria: * age \>18 years with a life expectancy of \>1 year; * patients fulfilling criteria for stemi (\>20 min of chest-pain; at least 1 mm st-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ecg or echocardiography; reperfusion is expected to be feasible within 12 h after onset of symptoms) * infarct related artery eligible for primary pci (de novo lesion in a native coronary artery; reference-vessel diameter ≥2.5 mm and ≤ 4 mm; absence of severe calcification; residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; absence of coronary dissection type ≥c. exclusion criteria: * killip class\>ii on admission * known contraindication for aspirin, clopidogrel, ticagrelor, heparin or gp iib/iiia inhibitor * previous myocardial infarction * previous pci in the territory of the infarct-related artery (ira) * previous cabg * 3-vessel disease requiring revascularization * left-main disease * extremely angulated or severely calcified vessels * history of ischemic stroke within the past 6 months or hemorrhagic stroke * planned cabg for a non-culprit vessel * participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

Keywords: stemi des dcb
efficacy and safety of irbesartan and atorvastatin in hypertension and hyperlipidemia

Conditions: Hypertension; Hyperlipidemia

Summary: the purpose of this study is to evaluate efficacy and safety of coadministered irbesartan and atorvastatin in patients with hypertension and hyperlipidemia.


Eligibility criteria:
inclusion criteria: * aged between 19 and 75 years * signed informed consent exclusion criteria: * at screening, spb ≥ 180mmhg or dbp ≥ 110mmhg or ldl-c \> 250mg/dl or tg ≥ 400mg/dl * has a history of hypersensitivity to angiotensin ⅱ receptor blocker or hmg-coa reductase inhibitor or component of this drug * has a history of multi-drug allergy

Keywords: irbesartan atorvastatin hypertension hyperlipidemia
iressa/docetaxel in non-small-cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: patients will receive 250 mg iressa by mouth daily each day while on this study. patients will also receive docetaxel 30 mg/m2 by by vein (iv) on day 1 weekly for the first 3 weeks of each course of therapy. a course of therapy is 4 weeks. patients will not receive docetaxel during week 4. a maximum of 8 full cycles of docetaxel plus iressa are planned. patients may continue on daily iressa until progressive disease and/or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * pathologically confirmed non-small cell lung cancer. * measurable, evaluable disease outside of a radiation port. * ecog performance status 0-2. * adequate hematologic function as defined by an absolute neutrophil count \>= 1,500/mm3, a platelet count \>= 100,000/mm3, a wbc \>= 3,000/ mm3, and a hemoglobin level of \>= 9 g/dl. * one prior chemotherapy regimen. this may include chemoradiation treatment. * disease progression or recurrence within 6 months of last dose of chemotherapy in first chemotherapy regimen. * at least a 2-week recovery from prior therapy toxicity. * signed informed consent. * prior cns involvement by tumor are eligible if previously treated and clinically stable for two weeks after completion of treatment. exclusion criteria: * prior iressa or other egfr inhibiting agents * prior docetaxel therapy * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. * any unresolved chronic toxicity greater than ctc grade 2 from previous anticancer therapy. * incomplete healing from previous oncologic or other major surgery. * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, st john's wort, anti-coagulants. * absolute neutrophil counts less than 1500 x 109/liter (l) or platelets less than 100,000x 109/liter (l). * serum bilirubin greater than 1.25 times the upper limit of reference range (ulrr). * in the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). * a serum creatinine \>= 1.5 mg/dl and calculated creatinine clearance \<= 60 cc/minute. * alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 2.5 times the ulrr if no demonstrable liver metastases or greater than 5 times the ulrr in the presence of liver metastases. * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. * pregnancy or breast feeding * the patient has uncontrolled seizure disorder, active neurological disease, or grade \>= 2 neuropathy * the patient has received any investigational agent(s) within 30 days of study entry. * the patient has signs and symptoms of keratoconjunctivitis sicca or incompletely treated eye infection.

Keywords: non-small cell lung cancer
a study to provide continued access to and assess long-term safety of the study drug(s)

Conditions: Advanced Cancer; Metastatic Cancer

Summary: this open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by daiichi sankyo, inc. (ds) or ds/astra zeneca (az)-sponsored study (eg. ds8201-a-j101, ds8201-a-u201, ds8201-a-u204, ds8201-a-u207, ds8201-a-u303).

this master rollover study includes sub-protocols with different study drugs. this master rollover protocol describes core study elements that are applicable to all study drugs that will be provided under the rollover study.

Eligibility criteria:
inclusion criteria: * signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements. * currently enrolled in a ds or ds/az-sponsored parent study that has met eos definition. * no evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a ds or ds/az alliance study drug(s). exclusion criteria: * participants with any unresolved/ongoing ae(s) that meets the study drug discontinuation criteria * participant who has been off t-dxd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study

Keywords: advanced cancer metastatic cancer t-dxd ds8201a
effect of whole body vibration in young females with smartphone addiction

Conditions: Smart Phone Addiction

Summary: young adults have a high prevalence of smartphone addiction. many adolescents use their smartphones extensively for communication, which starts out as a habit but eventually turns into an addiction. numerous studies have shown that adolescents use social media for roughly ten hours every day.


Eligibility criteria:
inclusion criteria: * high smartphone users according to the smartphone addiction scale short version (sas- sv) * body mass index (bmi) less than 30 kg/m² * didn't receive regular exercise in the last 6 months. exclusion criteria: * medical history of median nerve release, hand or thumb tendon lesion * prior hand or wrist fractures * medical history of hand injuries, and upper limb skin diseases * wbv contraindications include (joint issues, acute inflammations, back pain, epilepsy, diabetes, or neuromuscular disorders, or dizziness, any discomfort, and nausea)

Keywords: whole body vibration hand grip strength muscle activity upper limb function smart phone addiction
long term follow-up for rgx-111

Conditions: Mucopolysaccharidosis I

Summary: rgx-111-5101 is a long-term follow up study that evaluates the long term safety of rgx-111 in participants who have received rgx-111 (a gene therapy intended to deliver a functional copy of the alpha-l-iduronidase gene (idua) to the central nervous system) in a separate parent study.

this is a prospective, multicenter, observational, follow-up study to evaluate the long-term safety of rgx-111 after a single administration. eligible participants are those who previously participated in a clinical study where they received a single ic or icv administration of rgx-111. enrollment of each participant in this study should occur on the same day or after the participant has completed the end of study (eos) visit or early discontinuation visit (edv) from a previous (parent) clinical study. participants will be followed for up to five years after rgx-111 administration (inclusive of the parent study) or until rgx-111 is commercially available in the participant's country, whichever occurs first. no treatment will be directed under this observational protocol. the total study duration for each participant may vary depending on when s/he enrolls in the current study following rgx-111 administration in the parent study.

Eligibility criteria:
inclusion criteria: * to be eligible, a participant must have previously received rgx-111 in a separate parent trial. * participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent. exclusion criteria: * none.

Keywords: mps i hurler syndrome gene therapy
color doppler u/s vs msct venography in may-thurner syndrome

Conditions: May-Thurner Syndrome

Summary: may-thurner syndrome is the result of compression of the left common iliac vein between the right common iliac artery and overlying vertebrae. in this study , we will detect the role of color doppler us in the diagnosis of may-thurner syndrome in comparison to direct ct venography

may-thurner syndrome (mts) is a venous compression syndrome in which the left common iliac vein is compressed between the lower lumbar spine and the right common iliac artery. while asymptomatic compression is very common, the process can lead to morbidity in selected individuals, most commonly deep venous thrombosis (dvt) and the sequelae thereof. radiologists must recognize the diagnosis because of the unique management, which differs from dvt without iliac vein compression. the most common clinical presentation is unilateral leg swelling due to acute dvt. it can also present as chronic venous insufficiency or chronic thrombosis with symptoms of venous hypertension and venous stasis namely claudication, pain, swelling, varicose veins and / or ulceration. conventional invasive catheter venography remains the gold standard for diagnosis,but the decision to undertake invasive venography should be made only after reviewing all available clinical data and alternative, less invasive imaging options have been exhausted. when visualization of the common iliac veins is possible, mts may be diagnosed with transabdominal color doppler u/s. mdct with iv contrast is a fast, widely available examination for the diagnosis of mts and accompanying complications . magnetic resonance imaging (mri) with mr venography is an attractive modality for the diagnosis, however, mri is expensive, time consuming, has more limited availability than computed tomography (ct) and ultrasound, and may be impossible in select patients.

Eligibility criteria:
inclusion criteria: * advanced chronic venous insufficiency submitted to clinical treatment for at least 1 year with no response. * subject must be \> 18 and \< 80 years of age. * informed consent document before the planned procedure. * on duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg. exclusion criteria: * previous venous stent implantation involving the study leg or inferior vena cava * previous venovenous bypass surgery involving the study leg * known reaction or sensitivity to iodinated contrast that cannot be managed with premedication. * subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment). * acute deep venous thrombosis involving either leg. * known history of chronic total occlusion of the common femoral vein of the study leg. * venous compression caused by tumor encasement. * venous outflow obstruction caused by tumor thrombus. * elevated baseline blood creatinine (value greater than the upper limit of the normal range).
safety and efficacy study of rt001 to treat moderate to severe lateral canthal lines

Conditions: Lateral Canthal Lines

Summary: the purpose of this study is to evaluate the safety and efficacy of rt001 to treat moderate to severe lateral canthal lines in adults and duration of effect.

this is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of rt001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe lcls. subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. the safety and efficacy of two different doses of rt001, compared to placebo, will be evaluated. at least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. subjects will be enrolled in two (2) sequential cohorts. cohort 1 will consist of 72 subjects; 24 subjects per treatment group. cohort 2 will consist of 108 subjects; 36 subjects per treatment group. in order to confirm the safety of the test articles, cohort 2 will not be enrolled until all cohort 1 subjects have reached day 14 or later with no study pause criteria being observed.

Eligibility criteria:
inclusion criteria: * female or male, 30 to 60 years of age * bilateral lateral canthal lines rated as moderate or severe * willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening and through end of study * women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study exclusion criteria: * muscle weakness or paralysis in the area receiving study treatment -active skin disease or irritation at the treatment areas * undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening * use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through end of study (day 28) * any abnormality on the electrocardiogram (ecg) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure. * previous treatment with botulinum toxin type a in the face area

Keywords: lateral canthal lines crow's feet facial wrinkles
procurement of blood samples for a biomedical research program on t cell functional response to chronic hbv infection

Conditions: Chronic Hepatitis B

Summary: the objective of the study is to procure blood (plasma, serum, rna and pbmc samples) from approximately 40 chronic hbv for biomedical research program led by vgti florida.

during chronic hbv infection, a dynamic balance between viral replication and the host immune response is pivotal to the pathogenesis of liver disease. hbv specific t-cell function is impaired in patients with chronic hbv infection characterized by low levels of antiviral cytokines, impaired cytotoxic t lymphocyte activity, and persistent viremia. however, the mechanism underlying this t-cell malfunction in chronic hbv infection has not been completely understood. the biomedical research on the samples obtained during this study will include, among other studies, advanced flow cytometry to study the treg and activation markers, negative regulatory molecules and phenotype of cd4 and cd8 subsets using the extended panel markers developed at vgti florida. additional antibody panels for measuring functional cd4 responses by ics, dc subsets, activation, and signaling pathways by phos

Eligibility criteria:
inclusion criteria: * patient with chronic hbv infection documented by presence of hbsag for at least 12 months currently untreated for hbv infection or under stable antiviral therapy exclusion criteria: * prior use of hbv therapeutic vaccine * currently treated with interferon alpha or other immune modulator(s) * acute hbv infection * chronic inactive hbv carrier * under an acute flare/reactivation of hbv infection defined as symptoms of acute hepatitis and recent elevation of aminotransferase (over 10 x uln) or bilirubin levels * known co-infection with hcv, hdv, and/or hiv * under renal dialysis * for female patients, pregnant or breastfeeding * cirrhosis, hepatocellular carcinoma or liver transplantation * active autoimmune disease including autoimmune hepatitis