Kornimate/medical-research-clean huggingface dataset:
lactobacillus reuteri dsm 17938 in gut microbiota development in infant born by caesarean section

Conditions: Dysbiosis; Prophylaxis

Summary: the aim of this study is to assess influence of probiotic lactobacillus reuteri dsm 17938 on formation of gut microbiota in infant born by caesarean section. it is anticipated that daily using of probiotic lactobacillus reuteri dsm 17938 can prevent development of early dysbiosis of gut microbiota induced by caesarean section.

this is a single-center prospective randomized double-blind placebo-controlled clinical study. the planned duration of the study for each included infant will be 16 weeks, 4 weeks of study drug intake and 12 weeks of follow-up. 140 healthy infants born by caesarean section will be included in the general group of the study, and 60 healthy infants born by natural vaginal delivery will be included in the control group. for infants included in the control group, all the same protocol requirements and procedures will be applied as for infants in the general group, except for randomization and the study product / placebo intake. infants included in the general study group will be randomly assigned into the study product / placebo subgroups in 1: 1 ratio. during the study the gut microbiota will be analyzed. feces samples should be collected no later than 72 hours after birth, and also on 14th day of life ± 3 days, 30th day of life ± 3 days and 112th day of life ± 3 days. short-chain fatty acids (scfa) will be analyzed in feces samples.

Eligibility criteria:
inclusion criteria: * gestational age more than 37 weeks and less than 41 weeks * age of enrolment is not more than 48 hours * birth weight is corresponded to gestational age * apgar score ≥8 at 5 minutes * absence of congenital anomaly and/or clinical or physical abnormalities identified during clinical examination * primarily breastfeeding during the first days of life (more than 50%) * parent(s) are willing to comply with the exclusive breastfeeding regime during study period * parent(s) are willing to follow dietary recommendations during study period * parent(s) are willing to fill in the diary every day * availability of the parent(s) and the infant during study period * written informed consent of the parent(s) exclusion criteria: * chronic diseases or serious health problems of mother or child * gastrointestinal tract diseases of mother or child * delay in development * congenital abnormalities * intake of antibiotics by mother orally and / or vaginally during the last trimester of pregnancy * intake of probiotics by mother during the last trimester of pregnancy * using of general anesthesia during caesarean section * emergency caesarean section

Keywords: gut microbiota cesarean section dysbiosis
a study assessing the long-term safety and tolerability of galegenimab (fhtr2163) in participants with geographic atrophy secondary to age-related macular degeneration

Conditions: Macular Degeneration, Age-Related; Geographic Atrophy

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (itv) injections of galegenimab (fhtr2163) administered every 4 weeks (q4w) or every 8 weeks (q8w) in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd) who completed the parent study (nct03972709/gr40973).


Eligibility criteria:
inclusion criteria: * completed the parent study (nct03972709/gr40973) through the week 76 visit without early treatment discontinuation * sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging. ocular inclusion criteria: study eye - if the study eye best corrected visual acuity (bcva) letter score is ≥69 letters (snellen equivalent of 20/40 or better), the non-study eye must have a bcva letter score of ≥44 letters (snellen equivalent of 20/125 or better) on visit day 1 of the open label extension (ole)/week 76 of parent study. ocular inclusion criteria: non-study eye - the non-study eye must have a bcva letter score of ≥44 letters (snellen equivalent of 20/125 or better) if the study eye bcva letter score is ≥69 letters (snellen equivalent of 20/40 or better) on visit day 1 ole/week 76 of parent study. exclusion criteria: ocular exclusion criteria: * active uveitis and/or vitritis (grade trace or above) in either eye * active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * active or history of choroidal neovascularization (cnv) in study eye that requires anti-vascular endothelial growth factor (anti-vegf) treatment * active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye * retinal pigment epithelium (rpe) tear that involves the macula in either eye * moderate or severe non-proliferative diabetic retinopathy in either eye * proliferative diabetic retinopathy in either eye * central serous retinopathy in either eye * recent history of recurrent infectious or inflammatory ocular disease in either eye * recent history of idiopathic or autoimmune-associated uveitis in either eye * any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.
a clinical trial of recombinant covid-19 bivalent (xbb+prototype) protein vaccine (sf9 cell) in booster vaccination

Conditions: COVID-19

Summary: a clinical trial of recombinant covid-19 bivalent (xbb+prototype) protein vaccine (sf9 cell) in booster vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.

to evaluate safety of recombinant covid-19 bivalent (xbb+prototype) protein vaccine (sf9 cell) (wsk-v101c) and immunogenicity superiority of wsk-v101c to recombinant covid-19 vaccine (wsk-v101) after booster.

Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects. 2. basic or booster immunization with covid-19 vaccine ≥6 months. 3. ≥3 months of sars-cov-2 infection history, or never infected. 4. have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols. exclusion criteria: 1. axillary temperature ≥37.3℃. 2. sars-cov-2 antigen or nucleic acid screening positive within the last 48 hours. 3. anti-sars-cov-2 igm antibody was positive during the screening period. 4. it is in the advanced stage of malignant tumor and the disease control is unstable. 5. female pregnancy (pregnancy test results are positive), lactation period. 6. have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs. 7. have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions. 8. have been diagnosed with congenital or acquired immunodeficiency, hiv infection. 9. people who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past. 10. congenital or acquired angioedema/neuroedema. 11. asplenia or functional asplenia. 12. thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications). 13. received another investigational drug within 1 month prior to receiving the investigational vaccine. 14. received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month. 15. fertile female subjects did not use effective contraception within 1 month prior to enrollment. 16. fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization. 17. abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine. 18. medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
using urine samples to identify lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the researchers are doing this study to test the ability of an animal biosensor platform (abp) to detect nsclc. participants in this study will either be diagnosed with nsclc, suspected to have nsclc, or have not been diagnosed or suspected to have nsclc. the abp test uses laboratory animals that are trained to detect (by smell) different chemicals in urine. studies show that people with lung cancer have unique chemicals in their urine that are not present in people without lung cancer, and researchers think these chemicals can be used to identify people with lung cancer without the need for invasive procedures (like biopsy).


Eligibility criteria:
inclusion criteria: * phase i (with nsclc): aged 18 to 90 years with histologically proven, previously untreated stage i, ii, or iiia nsclc °note: single, monolateral nodule of at least 50% solid composition visible on a chest ct scan that is suspicious for a primary neoplasm as confirmed by an official msk radiologist read * phase i (without nsclc): aged 18 to 90 years with patient confirmed absence of nsclc * phase ii: aged 18 to 90 years with suspected but undiagnosed stage i, ii, or iiia nsclc by ct and/or pet scan criteria exclusion criteria: * aged \<18 years * lack of available results from low-dose ct * receipt of radiation, chemotherapy, biological therapy, resection, or any other treatment for any cancer in the previous year * pregnant (for women) * taking drugs that affect the immune system * chronic disease related to the immune system * missing clinical data (i.e., current clinical staging)

Keywords: urine samples stages i, ii, and iiia 23-111
breath analysis & malnutrition

Conditions: Malnutrition

Summary: the purpose of this research study is to understand how breath is related to nutritional status. the procedures involved in this study include blood and breath sampling, questionnaires about health history, medications, nutritional status and diet, and a physical examination. breath markers will be compared between individuals with and without malnutrition and be compared to indicators of malnutrition. some individuals will undergo an interventional study involving 2 days of consuming study beverages and fasting along with providing additional breath samples to see if the breath changes in response to short-term changes in nutritional status.

research summary: this research involves a cross-sectional study investigating whether breath molecules (in particular ammonia and nitric oxide) are related to the presence and magnitude of malnutrition as measured by the gold-standard nutrition focused physical examination (nfpe). it also involves an interventional study in a subset of cross-sectional participants looking at whether acute changes in nutritional status through anabolic feeding protocols or fasting protocols is related to short term changes in breath molecules. purpose of the research: the purpose is to identify early evidence of breath biomarkers of malnutrition. it uses a combination of breath analysis and current malnutrition screening tools (questionnaires).

Eligibility criteria:
inclusion criteria: 1. age: 18-95 years 2. malnutrition group (cross-sectional study only); not involved in intervention: diagnosed with malnutrition (verified in medical history) exclusion criteria: 1. chronic kidney, liver or pulmonary disease 2. anabolic steroid use other than testosterone (e.g., oxandrolone) 3. patients judged unsuitable for enrollment by the study medical investigator 4. pregnant women or women who are nursing 5. unable or unwilling to consume study beverages or fast for 24 hours each arm
chronic presence of epstein barr virus in sulcular and junctional epithelial tissue from gingiva is associated with severe periodontitis

Conditions: Parodontitis Aggressive; Parodontitis Chronic

Summary: the etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. however it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. the main hypothesis is that herpesviruses, such as epstein-barr virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.


Eligibility criteria:
inclusion criteria: * men exclusively * 12 years minimum * 2 patients affected by chronic periodontitis * 2 patients affected by aggressive periodontitis * 2 healthy patients (orthodontics extraction) * subject who have read and understood the information note relative under investigation and who have signed the informed consent * subject whose legal representative signed the parental consent (if minor patient) exclusion criteria: * patient with contre-indication to dental extraction * patient witn serious blood disease * patient who exhibits systemic condition incompatible with the realization of the study * patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants * patient who presents za buccal carcinoma treated with radiotherapy * patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy * patient who presents a linguistic or psychic incapacity to understand information * female patient
chidamide combined with angiogenesis inhibitors and fulvestrant for advanced hr-positive, her2-negative breast cancer

Conditions: Advanced Breast Cancer

Summary: this phase ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced hr-positive, her2-negative breast cancer patients after the failure of cdk4/6 inhibitor.


Eligibility criteria:
inclusion criteria: * 1.age≥18 years, ≤75, female; 2.histologically confirmed hr positive and her2 negative postmenopausal metastatic breast cancer patients \[her2 negative is defined as immunohistochemistry(ihc) 0 or ihc 1+, and if the score of ihc is 2+, fluorescence in situ hybridization technology (fish) test must be negative, hr positve is defined as er or pr ≥10%\]; 3.prior cdk4/6 inhibitor progression or intolerance to cdk4/6i before enrollment; 4.premenopausal patients need ofs; 5.recurrence and metastasis progressed more than 6 months after receiving endocrine therapy or more than 2 years after receiving adjuvant endocrine therapy; 6.ecog performance status ≤ 1; 7.at least one measurable disease based on recist v1.1 8.adequate organ function; 9.life expectancy is more than 3 months; 10.willing and able to provide written informed consent exclusion criteria: * 1.prior exposed to histone deacetylase inhibitors; 2.received tki before enrollment; 3.exist visceral crisis; 4.received chemotherapy, targeted therapy, chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs; 5.poorly controlled diabetes (fbg\>10mmol/l); 6.poorly controlled hypertension (sbp\>150 mmhg, dbp\>90 mmhg); 7.urinalysis shows urine protein ≥ 2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 8.pt\>16s, aptt\> 43s, tt\>21s, fib\<2g/l; 9.toxicities that did not recover to national cancer institute common adverse event terminology version 5.0 (ncictcaev5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled); 10.pregnant or lactating female. 11.any other conditions deemed inappropriate by the investigator to participate in this study.
study of cpap as intervention after lung resection

Conditions: Lung Cancer; Pulmonary Complications

Summary: the aim of this study was to compare the oxygenation index (oi), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (cp) patients and combined cp and continuous positive airway pressure (cpap) patients.

in pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality. in this study the oxygenation index (oi), borg scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (poi) period and in the first and second postoperative (po1, po2) days in 40 patients who underwent elective lung resection. similar to chest physiotherapy, the preventive application of cpap in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.

Eligibility criteria:
inclusion criteria: * medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy; * aged between 40 and 75 years. exclusion criteria: * patients who refused to participate in the survey; * lung resection with incisions other than posterolateral; * patients who had contraindications to the use of noninvasive ventilation.

Keywords: chest tubes, continuous positive airway pressure, lung resection, thoracic surgery, noninvasive ventilation, postoperative
study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.

Conditions: Pulmonary Arterial Hypertension

Summary: a phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.

subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. inclusion is not based on a specified who functional classification. rather, subjects with who class i-iv symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. subjects with anorexigen or hiv infection related pah are eligible but subjects with congenital heart disease and pediatric subjects are excluded. the study requires a historical cardiac catheterization and other diagnostic procedures.

Eligibility criteria:
inclusion criteria: * 18 years of age or order * current diagnosis of either pph orpah secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or hiv infection at the screening visit * right heart catheterization, completed prior to screening visit must meet pre-specified hemodynamic criteria * female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit * male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking this study drug and queried regarding his understanding of the potential risks as described in the informed consent form exclusion criteria: * pah due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea * portopulmonary hypertension * bosentan within four weeks prior to screening * phosphodiesterase type v inhibitor or chronic prostanoid therapy within four weeks prior to screening * iv inotrope use within two weeks prior to screening * alt or ast lab value that is greater than 1.5 times the upper limit of normal * pulmonary function tests not meeting pre-specified criteria * contraindication to treatment with an era * history of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years * females who are pregnant or breastfeeding
a study to determine the efficacy, safety, and durability of faricimab in participants with neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Summary: this study is a phase iiib/iv, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (namd) that are treatment-naïve in the study eye.


Eligibility criteria:
inclusion criteria: * overtly healthy as determined by medical evaluation that includes medical history and physical examination * agreement to adhere to the contraception requirements described in the protocol ocular inclusion criteria for study eye: * active treatment-naïve macular neovascularization (mnv) secondary to age-related macular degeneration (amd), confirmed by the investigator based on the presence of intraretinal fluid (irf) or subretinal fluid (srf) affecting the central subfield on optical coherence tomography (oct) * bcva of 83 to 24 letters, inclusive (20/25 to 20/320 approximate snellen equivalent, using the early treatment diabetic retinopathy study \[etdrs\] protocol and addressed at the initial testing distance of 4 meters on day 1) * sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis exclusion criteria: ocular exclusion criteria for study eye: * mnv due to causes other than namd, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis * retinal pigment epithelial tear involving the macula on day 1 * current vitreous hemorrhage on day 1 * prior periocular pharmacological or ivt treatment (including faricimab, anti-vascular endothelial growth factor \[vegf\], or complement inhibitor medication) for other retinal diseases ocular exclusion criteria for fellow (non-study) eye: * participants who have a nonfunctioning fellow (non-study) eye, defined as either bcva of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study day 1 visits ocular exclusion for both eyes: * history of idiopathic or autoimmune associated uveitis in either eye * active ocular inflammation or suspected or active ocular or periocular infection in either eye on study day 1