Kornimate/medical-research-clean huggingface dataset:
a study of kl340399 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(pk) profile, and antitumor efficacy of kl340399 injection in patients with advanced solid tumors.

this is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(pk) profile, and antitumor efficacy of kl340399 injection in patients with advanced solid tumors.the dose increasing method of "blrm" is used to explore the safety, tolerance and determine the maximum tolerated dose(mtd).

Eligibility criteria:
inclusion criteria: 1. patient is at least ≥18 years of age (male or female); 2. patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care. presence of at least one measurable lesion based on response evaluation criteria in solid tumors (recist) v1.1; 3. eastern cooperative oncology group (ecog) score of 0 or 1, estimated survival ≥ 3 months; 4. adequate organ and bone marrow function (no blood components and cytokines are allowed within 14 days prior to the first dose) ; 5. more than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, and toxicity from previous antitumor therapy returned to baseline or ctcae≤ grade 1; 6. patients of childbearing potential (male or female) must use effective medical contraception during the study and for 3 months after the end of dosing; 7. patients voluntarily participate in the study, sign the icf, and will be able to comply with the protocol-specified visits and relevant procedures. exclusion criteria: 1. known history of severe allergies, or allergy to any component of kl340399; 2. received any previous therapy of sting-activating, or received any immunostimulant therapy within 28 days； 3. have other malignancies within 5 years; 4. concomitant or known metastases to brain or central nervous system; 5. active autoimmune disease; 6. history of major cardiovascular diseases; 7. uncontrolled systemic diseases； 8. known of coagulation disorders, hemorrhagic disease; 9. confirmed serious lung disease or lung disease; 10. subjects with third space fluid that can not be controled by drainage or other methods; 11. known active infection; 12. known hiv, active hepatitis b/c virus; 13. pregnant or lactating women; 14. received immunotherapy and had immune related adverse reactions ≥ grade 3; 15. have received stem cell transplantation or organ transplantation; 16. receive any live or attenuated live vaccine within 4 weeks; 17. history of serious dementia, altered mental status, or any psychiatric disorder; 18. evidence of alcohol or drug abuse; 19. participated in any other clinical trials and received treatment within 4 weeks; 20. have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
perioperative immunonutrition for patients undergoing crs and hipec

Conditions: Peritoneal Metastases

Summary: patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. this results in poor oral intake leading to these patients often presenting in a malnourished state. crs and hipec can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. the risk is especially high in poorly nourished patients. the study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. to the investigators' knowledge, it has not been evaluated in patients undergoing crs and hipec.


Eligibility criteria:
inclusion criteria: 1. all patients planned for crs and hipec, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible 2. all patients must be able to provide informed consent 3. there are no restrictions to use of contraception exclusion criteria: 1. patients who are not able to provide informed consent will be excluded. 2. patients with a diagnosis of diabetes mellitus will be excluded. 3. patients not fit for surgery or those who undergo surgery under emergency situations will be excluded. 4. patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.
automatic and conventional methods of hypertensive patients monitoring

Conditions: Primary Hypertension

Summary: comparing automatic blood pressure measurments methods with conventional office methods in follow up and monitoring of hypertensive patients and predicting hypertension mediated organ damage .

close monitoring of hypertensive patients using home and ambulatory blood pressure measurments and its role in predicting hypertention mediated organ damage. echocardiography assessment for hypertensive patients and its important role in early detection and prevention of changes such as left ventricular hypertrophy,left atrial enlargement ,systolic and diastolic dysfunction and left ventricular mass . microalbumiuria and early detection of renal impairment. important role of close monitoring in management and control of hypertention and reduction of hypertensive emergencies and improvement of outcomes ,addherence to treatment , reduce of office consultation , improvement of psycosochial life ,reduce hospitalization cost and mortality rates . digital apps has a good role in improve healthy life style and rapid detection of blood presssure changes during daily activities.

Eligibility criteria:
inclusion criteria: * patients who were screening for suspected hypertention or white coat hypertention . * medically underserved population . * primary arterial hypertention . * high risk hypertensive patients \[resistant hypertension ,patients with poor medication adherance \] exclusion criteria: * patients with secondary causes of hypertention * patients with other cardiac diseases \[heart faliure ,valvular heart diseases \] * chronic illness affect blood pressure as chronic kideny disease .

Keywords: htn , hmod ,bp , lvh ,lae
acute immune modulation by probiotic strain

Conditions: Immune Surveillance

Summary: clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. this study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.

clinical proof-of-concept study comparing the acute immune effects of 3 doses of a probiotic compared to a placebo. the probiotic strain is characterized as bacillus coagulans jbi-yz6.3 (bc4u). 24 subjects will participate in a placebo-controlled, escalating dose, cross-over study design, wherein they will be taking placebo, dose 1, dose 2, and dose 3, each separated by a 1-week washout period. blood samples are taken 1 hour after participants arrive; the dose is then administered. samples are taken 1 hour, 2 hours, and 3 hours following administration. a series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.

Eligibility criteria:
inclusion criteria: * healthy adults; * age 18-75 years (inclusive); * veins easy to see in one or both arms (to allow for the multiple blood draws); * willing to comply with study procedures, including: * maintaining a consistent diet and lifestyle routine throughout the study, * consistent habit of bland breakfasts on days of clinic visits, * abstaining from exercising and nutritional supplements on the morning of a study visit, * abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; * abstaining from music, candy, gum, computer/cell phone use, during clinic visits. exclusion criteria: * previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder); * taking anti-inflammatory medications on a daily basis; * currently experiencing intense stressful events/ life changes; * currently in intensive athletic training (such as marathon runners); * currently taking antipsychotic medications such as clozapine, risperdal, abilify, zyprexa or seroquel; * an unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); * unwilling to maintain a constant intake of supplements over the duration of the study; * anxiety about having blood drawn; * pregnant, nursing, or trying to become pregnant; * known food allergies related to ingredients in active test product or placebo.
fermented milk drink on human intestinal microflora

Conditions: Signs and Symptoms, Digestive

Summary: fermented milk is a popular drink. recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. lactobacillus casei strain shirota (lcs) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. lcs has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. yakult®300 is a fermented milk containing at least 3x10\^10 live lcs cells per 100 ml bottle. this study aimed to evaluate the effects of a fermented milk drink containing lactobacillus casei strain shirota on the human intestinal microflora.


Eligibility criteria:
inclusion criteria: * healthy adult volunteers and willing to give voluntary written informed consent exclusion criteria: * major systemic disease * pregnancy, parturient and feeding woman, or expect to be pregnant * abnormal liver function * abnormal renal function * abnormal gastrointestinal function * take medication for gastrointestinal function * stroke, myocardial infarction, * poor compliance for study protocol

Keywords: probiotics lactobacillus intestine flora
exacerbation study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure * patients diagnosed with copd at age 40 and over and with a current diagnosis of severe copd and including: 1. smoking history of at least 10 pack years, both current and ex-smokers are eligible 2. a documented history of at least 1 moderate or severe exacerbation in the previous 12 months exclusion criteria: * patients who have received systemic corticosteroids and/or antibiotics for a copd exacerbation in the 6 weeks prior to screening or during the run-in period * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria may apply

Keywords: indacaterol tiotropium copd
a safety and efficacy evaluation of bli400 laxative in constipated adolescent subjects

Conditions: Constipation

Summary: the objective of this study is to evaluate the safety and efficacy of bli400 laxative in constipated adolescent subjects.


Eligibility criteria:
inclusion criteria: * male or female subjects at between 12-17 years of age * weight more than 40 kg (88 lbs.). * constipated, defined by the following criteria 1. fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months: 1. straining during \> 25% of defecations 2. lumpy or hard stools in \> 25% of defecations 3. sensation of incomplete evacuation for \> 25% of defecations 2. loose stools are rarely present without the use of laxatives 3. there are insufficient criteria for irritable bowel syndrome - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements criteria a, b and c must be fulfilled for the last 12 weeks with symptom onset at least 6 months prior to diagnosis. * otherwise in good health, as determined by physical exam and medical history * if female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, intrauterine device, double-barrier method, depot contraceptive, sterilized, or abstinence) * negative urine pregnancy test at screening, if applicable * in the investigator's judgment, subject is mentally competent to provide informed consent to participate in the study exclusion criteria: * subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon * subjects who have had major surgery 30 days before visit 1; appendectomy or cholecystectomy 60 days before visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before visit 1; bariatric surgery or surgery to remove a segment of the gi tract at any time before visit 1 * subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of visit 1 * subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from visit 1 until after completion of visit 3 * subjects who are pregnant or lactating, or intend to become pregnant during the study * subjects of childbearing potential who refuse a pregnancy test * subjects who are allergic to the study medication * subjects taking narcotic analgesics or other medications known to cause constipation * subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures * subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days * subjects with an active history of drug or alcohol abuse * subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before visit 1 * subjects who withdraw consent at any time prior to completion of visit 1 procedures
9-valent hpv vaccine in postpartum women

Conditions: Human Papilloma Virus

Summary: this study will evaluate the immunogenicity of the 9-valent hpv vaccine in post-partum women age 16-45.

women age 16-45 who are pregnant or who have just delivered will be eligible to participate in a study involving the 9-valent hpv vaccine. for clarification, women who are pregnant are eligible to sign consent, but the first vaccine will not occur until after delivery. vaccine # 1 must occur within seven days of delivery. the main objective of the study is to determine the immunogenicity of the vaccine in postpartum women. the immunogenicity results will be compared to that of non-postpartum women of the same age, 16-45. women will participate for approximately 12 months and will complete a total of 4 visits during that time frame.

Eligibility criteria:
inclusion criteria: * female between the ages of 16 and 45 years of age at enrollment * postpartum (day 1 vaccination to occur within 1 week of delivery) * judged to be in good health on the basis of medical history and physical examination * able to fully understand study procedures, alternative treatments available, the risks involved in the study and voluntarily agrees to participate by giving written informed consent * able to read, understand, and complete the questionnaires exclusion criteria: * has a known allergy to any vaccine component, including aluminum, yeast, or benzonase™ * has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, hiv infection, lymphoma, leukemia, systemic lupus erythematosus (sle), rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. * is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, tnf-α antagonists, monoclonal antibody therapies (including rituximab), intravenous gamma globulin (ivig), antilymphocyte sera, or other therapy known to interfere with the immune response. with regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. the use of inhaled, nasal, or topical steroids are considered eligible for the study * has received any immune globulin product (including rhogam™) or other blood- derived product within 3 months prior to day 1 vaccination or plans to receive such product during the study * has received a marketed hpv vaccine * has had a fever of \> 100° within 24-hour period prior to the day 1 vaccination
effects of expiratory pressure on arterial oxygenation during hypoxia

Conditions: Hypoxia

Summary: altitude tolerance correlates with the level of oxygenation achieved. the aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.

two types of procedures will be tested in a random order, interspaced by resting periods : threshold peep set at 5,10 and 15 cm of water and pursed leap breathing. subjects will be tested at rest, and during light exercise (30% of sea level predicted vo2max). fio2 will be set at 12.5% (4000 m). fc, ve, petco2, ta, ecg, cardiac output, and tissular oxygenation will be monitored.

Eligibility criteria:
inclusion criteria : * active (\> 2 hrs/week physical activity) * adult * non smoking volunteers exclusion criteria : * cardiac, respiratory, neuromuscular, metabolic pathology

Keywords: hypoxia o2 diffusion and convection cardiac output peep effects of hypoxia
global clinical study

Conditions: Coronary Artery Disease

Summary: the global study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary ct angiography for assessment of suspected coronary artery disease (cad). the purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.


Eligibility criteria:
inclusion criteria: 1. ages 18-90 2. caucasian and of non-hispanic or non-latino origin 3. referral for coronary ct angiography to evaluate for presence of cad 4. the patient has signed the appropriate institutional review board approved informed consent form exclusion criteria: 1. immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding 30 days (except if steroids are administered as pre-medication prior to contrast administration for ct scan within 24 hours). 2. chemotherapy in the preceding year 3. major surgery in the preceding 2 months 4. blood or blood product transfusion in the preceding 2 months 5. subjects for whom coronary ct angiography is contraindicated per institutional standard of care 6. subjects with previous coronary arterial revascularization (pci or cabg) 7. subjects with atrial fibrillation/flutter or frequent irregular or rapid heart rhythms, which occurred within the past 3 months 8. subjects with a pacemaker or implantable cardioverter-defibrillator implant 9. active congestive heart failure or the presence of known non-ischemic cardiomyopathy 10. known genetic disorders of atherosclerosis, lipid or lipoprotein metabolism
safety & efficacy of encapsulated allogeneic fviii cell therapy in haemophilia a

Conditions: Hemophilia A

Summary: sig-001-121 is a first-in-human (fih), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of sig-001 in adults with severe or moderately severe haemophilia a without inhibitors. up to three dose cohorts (3 patients each) are planned. cohort expansions (up to 3 additional patients) may be triggered to collect additional information about safety and efficacy.


Eligibility criteria:
inclusion criteria: * males aged 18 years or older * diagnosis of haemophilia a defined as ≤2% fviii activity * greater than 150 exposure days to treatment with fviii products * use of reliable barrier contraception if applicable * normal levels of von willebrand factor (vwf) antigen * able and willing to provide informed consent * willing to withdraw from fviii prophylaxis during specified periods in the study exclusion criteria: * body mass index (bmi) ≥35 * current fviii inhibitors (\>0.6 nijmegen bethesda units/ml) or prior immune tolerance induction (iti) * history of allergic reaction or anaphylaxis to recombinant fviii products or sig-001 components * evidence of any bleeding disorder in addition to haemophilia a * abnormal laboratory values as defined in the protocol * active infection with hepatitis b or hepatitis c virus or currently managed with antiviral medications for hepatitis b or c * uncontrolled hiv infection * active alcoholism or drug addiction during the 12 months before the screening visit * active malignancy or history of malignancy in the 5 years prior to study entry * participation in another investigational medicine or device study * prior administration of a gene therapy product * significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure

Keywords: haemophilia a cell therapy gene therapy
free gingival graft versus connective tissue graft

Conditions: Gingival Recession; Gingival Recession, Localized

Summary: this study wil compare fgg and ctg for recession coverage in the anterior mandibula.


Eligibility criteria:
inclusion criteria: * asa type i and ii subjects * localized gingival recessions * recessions cairo rt i-ii-iii * fmps \< 10% * fmbs\< 10% * \<10 cigs/ day * no contra-indication against oral surgical interventions * patient is able to give inform consent exclusion criteria: * infection (local or systemic). each infection will be evaluated prior to study procedure for suitability. patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. in case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests. * asa type \> ii * current pregnancy or breastfeeding women * alcoholism or chronically drug abuse * smokers, ≳ 10 cigarettes per day * immunocompromised patients * uncontrolled diabetes * untreated periodontitis * history of previous periodontal surgery (mucogingival or other) on the teeth to be included * presence of severe tooth malposition, rotation or significant version of the tooth to be treated * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability

Keywords: gingival recession free gingival graft connective tissue graft