Kornimate/medical-research-clean huggingface dataset:
phase ii clinical study to assess the efficacy and safety of nemonoxacin malate in treating adult patients with community-acquired pneumonia (cap)

Conditions: Community-acquired Pneumonia

Summary: the purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (cap) subjects.

evaluate clinical efficacy, microbiological efficacy and safety of nemonoxacin adult patients with community-acquired pneumonia (cap); and a study on the population pharmacokinetics (ppk) of continuous oral administration of nemonoxacin in adult patients with cap.

Eligibility criteria:
inclusion criteria: 1. age of 18\~70, bmi ≥ 18 kg/m2 2. female patients must avoid pregnancy 3. patients who are clinically diagnosed with community-acquired pneumonia (cap) 4. chest x-ray shows inflammatory exudation or infiltration image. 5. patients who used antibacterial agents (excluding quinolones) within 72 hours before 6. the patient's disease condition permits oral administration exclusion criteria: 1. patients who have any of bronchiectasis and pulmonary disease. 2. hospitalized within 14 days before enrollment 3. have a history of allergy to any quinolone or fluoroquinolone antibiotic 4. patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases. 5. renal, liver insufficiency 6. malabsorption syndrome or other gastrointestinal diseases 7. immune system diseases,such as a history of human immunodeficiency virus (hiv) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen 8. steroids longterm use, the dose is at least 20mg of prednisone daily 9. patients under critical condition. 10. shows significant abnormality of the cardiac conduction system (ccs) or other abnormalities, or prolonged qtc 11. have a medical history of prolonged qtc, or require concomitant medication of drugs that will lead to prolongation of qtc 12. patients who received chemotherapy or anti-tumor therapy within 6 months 13. alcohol abused or drugs banned 14. patients who used quinolones within two weeks before enrollment 15. donated more than 500ml of blood within 3 months 16. co-medication of other antibacterial agents required. 17. by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.

Keywords: cap
tdcs and cognitive training for restrictive eating disorders

Conditions: Anorexia Nervosa; Atypical Anorexia Nervosa

Summary: this study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tdcs) can enhance brain training. participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.


Eligibility criteria:
inclusion criteria: * age 18-65 years * self-reported enrollment in outpatient-level treatment at local eating disorder treatment centers in the twin cities region, and meeting dsm-5 criteria for an (mild severity, based on bmi greater than or equal to 17.0 kg/m2) or atypical an diagnosis (based on mini and ede assessments). * participant must be capable of giving informed consent, based on ucsd brief assessment of capacity to consent (ubacc) risk assessment. * sufficient spoken english so as to be able to comprehend testing procedures. normative ranges on a c-renal blood panel (panel and ranges specified here: https://labguide.fairview.org/showtest.asp?testid=3321) exclusion criteria: * substance abuse in the participant * neurological condition or other developmental disorder * serious psychiatric disorder known to affect brain functioning and cognitive performance (e.g., schizophrenia, schizoaffective disorder) * medical instability, which will be evident based on required outpatient treatment status. in standard eating disorders treatment, individuals who are not medically stable are referred to higher levels of care (e.g., residential treatment, inpatient). therefore, if a participant is enrolled in higher level care for their eating disorder diagnosis, this indicates medical instability and they will be excluded from enrollment in this study. * tdcs contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices). * acute suicidality (suicidalideation with a plan or intent), assessed via mini suicidality module and beck depression inventory suicide item * acute homicidality (homicidal ideation with a plan or intent), assessed via mini * moderate, severe or extreme an diagnostic severity, based on bmi as per dsm-5 criteria (e.g., bmi \<17.0 kg/m2)

Keywords: anorexia nervosa eating disorder brain training brain stimulation fmri
knowledge and perception of clinical trial participation in breast cancer patients in egypt

Conditions: Breast Cancer; Clinical Trials

Summary: * clinical trials are essential to translate new therapy concepts or rather any intervention into the medical routine. beside the well designed trial protocol, the success of clinical trials depends on patient recruitment and participation. * this study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in breast cancer female patients in egypt, as an example to low/middle income countries.


Eligibility criteria:
inclusion criteria: * female breast cancer patients exclusion criteria: * patients who refuse participation
study in rheumatoid arthritis for subjects who completed preceding study m13-390 with adalimumab

Conditions: Rheumatoid Arthritis

Summary: a phase 2b, open-label extension (ole) study in rheumatoid arthritis (ra) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

all participants who completed study nct01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

Eligibility criteria:
inclusion criteria: 1. subject has completed the preceding study m13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study. 2. if female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. examples of approved methods of birth control include the following (see local informed consent for more detail): * condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud); * hormonal contraceptives for 90 days prior to study drug administration; * a vasectomized partner. 3. subjects must be able and willing to self-administer subcutaneous (sc) injections or have a qualified person available to administer sc injections. 4. subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, physical examination, laboratory profile performed at baseline. 5. subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol. exclusion criteria: 1. ongoing infections at week 0 that have not been successfully treated. subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated. 2. subject currently uses or plans to use anti-retroviral therapy at any time during the study. 3. subject plans to use any live vaccine during the study. 4. positive pregnancy test at baseline (week 0). 5. subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Keywords: rheumatoid arthritis
alveolar macrophage programming following endotoxin exposure

Conditions: ARDS, Human

Summary: the histologic hallmarks of lung inflammation include accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. macrophages are key players in all of these. here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).


Eligibility criteria:
inclusion criteria: 1. written, informed consent 2. age 18-50 exclusion criteria: 1. current or recent illness (past 2 weeks) 2. presence or prior history of cardiac, pulmonary or systemic disease 3. bleeding disorder, use of systemic anticoagulants or antiplatelet therapy 4. american society of anesthesiology (asa) class 2 or greater 5. immunocompromised state (hiv, immunoglobulin deficiency, systemic immunosuppressants) 6. use of any inhaled substance, including tobacco, marijuana, e-cigarrettes, cocaine, methamphetamines, or toxic vapors in the past 3 months or greater than 10 pack-year smoking history 7. alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months 8. allergy or prior adverse reaction to lidocaine, midazolam or fentanyl 9. abnormal spirometry or electrocardiogram at time of screening 10. pregnant (based on urine pregnancy test) or breast feeding
can 4 weeks of exercise program change quadriceps architecture in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid; Knee Osteoarthritis; Quadriceps Muscle Atrophy; Ultrasonography; Exercise

Summary: quadriceps femoris (qf) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (oa) patients. exercise therapy is mile stone in knee oa patients also it can help thicken qf muscle of ra patients. we primarily aimed to demonstrate the influence of 4 weeks of knee isometric home-based training on qf muscle parts thickness and pennation angle measurements of ra patients with ultrasonography (usg). this study included 12 patients with ra, 12 patients with knee oa as positive control group and 13 volunteers as healthy control group. all participants were given 4 weeks of quadriceps-hamstring isometric home-based training. at baseline and at the end of the program, womac and lequesne algofunctional index scores of knee oa patients and das28-crp scores of ra patients were recorded. dominant knee thickness and pennation angle measurements of qf muscle parts were evaluated by ultrasonography.


Eligibility criteria:
the inclusion criteria for all participants were being between 18-65 yy. the inclusion criteria for ra patients were: confirmed diagnosis of ra according to 2010 acr/eular classification criteria and lack of any other inflammatory articular diseases. the inclusion criteria for knee oa patients were: diagnosis according to acr classification criteria of knee oa with grade 2-3 according to the kellgren-lawrence grading system and lack of any other inflammatory articular diseases. volunteers who did not have any knee pain, no clinical degenerative or inflammatory signs were included in the healthy control group. - exclusion criteria for all participants were: being out of age range, history of knee joint trauma, surgery or knee joint injection in the previous 6 months, presence of any other disease that can affect thigh muscles (radiculopathy, myopathy, hip problems). patients with secondary knee oa were not included. -
a study to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

this is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (ckd) or cardiovascular (cv)/renal death.

Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study specific procedures * female or male aged ≥18 years at the time of consent * egfr ≥25 and ≤75 ml/min/1.73m2 (ckd-epi formula) at visit 1 * evidence of increased albuminuria 3 months or more before visit 1 and uacr ≥200 and ≤5000 mg/g at visit 1 * stable, and for the patient maximum tolerated labelled daily dose, treatment with ace-i or arb for at least 4 weeks before visit 1, if not medically contraindicated, exclusion criteria: * autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anca-associated vasculitis * receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment * history of organ transplantation * receiving therapy with an sglt2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an sglt2 inhibitor * type 1 diabetes mellitus * new york heart association (nyha) class iv congestive heart failure at the time of enrolment * mi, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

Keywords: chronic kidney disease (ckd) cardiovascular events (cv) phase iii outcome trial
biomarkers and neurological outcome in neonates (banon)

Conditions: Asphyxia Neonatorum

Summary: validation of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. these biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

the aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. the population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in turkey (aambi) using a metabolomics approach.

Eligibility criteria:
inclusion criteria: * need for resuscitation after birth: for \>1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only cpap), or cardiac compressions * 5 min apgar-score ≤ 5. * perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a ph≤7.1 in arterial umbilical cord blood or early postnatal blood collected at \<30min of age * perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at \<30min of age. exclusion criteria: * age \>1.5h * gestational age \< 36 weeks * birth weight \<2000g * congenital malformation * missing valid written informed parental consent * unsuccessful resuscitation * infant considered not-viable * decision for palliative care only

Keywords: biomarkers
quadratus lumborum block versus transversus abdominus plane block for pain management after donor nephrectomy

Conditions: Kidney Donor

Summary: to evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic assisted donor nephrectomy * patients that have elected to have a nerve block * 18 years of age or older * patients of asa status i - iii exclusion criteria: * chronic pain or narcotic usage during the preceding 30 days * infection at or near the intended needle insertion site * complex or altered abdominal wall anatomy * weight \<45kg
the influence of peripheral nerve blocks in patients undergoing limb orthopedic surgery

Conditions: Pain, Postoperative; Change; Circulatory; Surgical Injury

Summary: to investigate pre-op peripheral nerve block in reducing peri-op il-6 level and post-op pain

in orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. in this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. sixty patients undergoing limb orthopedic surgery will be enrolled. peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (study group) underwent surgery with nerve blocks and another 30 patients (control group) underwent surgery with morphine. the anesthetic protocol was standardized for both groups by experienced anesthesiologists. surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. pain intensity was measured by numeric rating scale (nrs) score for 24 hours

Eligibility criteria:
inclusion criteria: * diagnosis of limb fracture * must receiving orthopedic surgery exclusion criteria: * with the comorbidity of chronic heart, lung, liver and renal disease, chronic alcoholism, allergy to bupivacaine

Keywords: peripheral nerve block il-6 post-operative pain limb surgery
maintaining bone strength in men with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. all participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. both patient and doctor will know which treatment a patient is receiving. after 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. all participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.


Eligibility criteria:
inclusion criteria: histologically confirmed diagnosis of carcinoma of the prostate * no distant metastases * patients must be candidates for androgen deprivation therapy (adt) * patient with a baseline bmd t-score at or below -1 standard deviations in the lumbar spine (l2-l4) are eligible exclusion criteria: patients with normal bmd at trial entry * patients who received any prior bisphosphonate therapy in the past 12 months * treatment with anti-androgen mono- or combination therapy * patients who are currently receiving diethylstilbesterol (des) or who have previously received pc-spes * patients who have received prior treatment with systemic corticosteroids within the past 12 months * patients with prior exposure to anabolic steroids or growth hormone within the past 6 months * patients with any prior treatment for osteoporosis other protocol-defined inclusion/exclusion criteria may apply.

Keywords: prostate cancer cancer treatment induced bone loss (ctibl) androgen deprivation therapy (adt)
independent studies of dextromethorphan and of donepezil hydrochloride for rett syndrome

Conditions: Rett Syndrome

Summary: rett syndrome (rtt) is a disorder in which the nervous system does not develop properly. rtt generally affects girls, but there are some boys who have been diagnosed with rtt. symptoms of rtt include small brain size, poor language skills, repetitive hand movements, and seizures. this study will evaluate the effectiveness of two drugs in treating the symptoms of rtt.

rtt is a neurodevelopmental disorder characterized by apparently normal early development followed by loss of purposeful hand use, distinctive hand stereotypies, slowed brain growth, loss of language, respiratory irregularities, gi disturbances, gait abnormalities, seizures, and mental retardation. these symptoms appear between ages 6 and 18 months (stage 2 of the disease) following apparently normal development (stage 1). subsequently, there is gradual stabilization of severe mental retardation and motor compromise (stage 3). the majority (70% to 80%) of patients demonstrate mutations in the methyl-cpg-binding-protein-2 (mecp2) gene, a transcription repressor located on chromosome xq28. the disorder predominantly affects females, but a few males with mutations in mecp2 have been identified, even though many of them do not have the classic symptoms recognized in females. recent studies demonstrate increased brain n-methyl-d-aspartate (nmda) receptors in stages 2 and 3 of the disease. this age-specific increase in glutamate levels and their receptors contribute to brain damage. this first study will examine the effectiveness of dextromethorphan, an nmda receptor antagonist, to ameliorate symptoms. participants will be randomized to receive one of three doses of dextromethorphan. all participants will be admitted to the hospital for three days at the beginning of the study. during the hospitalization, participants will undergo physical exam, dexascan, mri, eeg, behavioral assessment, laboratory testing, and neuropsychological evaluations. six months after baseline assessment, participants will be rehospitalized for 3 days for similar assessments. reduction in choline acetyltransferase activity in rtt patients may also contribute to disturbed cortical development and psychomotor retardation in rtt. therefore, the second part of the study will evaluate the effect of donepezil hydrochloride, an inhibitor of acetylcholine-esterase, on acetylcholine levels. this portion of the study will not begin until pharmacokinetic data for donepezil in children is available.

Eligibility criteria:
inclusion criteria * diagnosis of rett syndrome * mutation in mecp2 gene * typical eeg abnormalities (disorganized background, frontal central spikes, rhythmic theta) exclusion criteria * features of rett syndrome with absence of mecp2 mutation * non-specific eeg changes

Keywords: glutamate/nmda receptors cholinergic upregulation dextromethorphan donepezil hydrochloride aricept