Kornimate/medical-research-clean huggingface dataset:
investigation of optimal dosage regimen for hrs9531 tablets in healthy subjects

Conditions: Overweight or Obese, Type 2 Diabetes

Summary: the study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of hrs9531 tablets in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures, be able and willing to provide a written informed consent. 2. male subject aged 18-55 years (both inclusive) at the time of signing informed consent. 3. body weight ≥50.0 kg, body mass index (bmi) of 24.0-35.0 kg/m\^2 (both inclusive) at screening. 4. weight change does not exceed 5 kg within 3 months before screening. 5. good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ecg). exclusion criteria: 1. known or suspected hypersensitivity to trial product(s) or related products. 2. with previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study. 3. abnormal and clinically significant blood pressure at screening. 4. history of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization. 5. blood donation within 1 month prior to screening, or blood donation ≥400 ml or blood loss ≥400 ml within 3 months prior to screening. 6. presence of any clinically significant results in examination at screening visit. 7. hepatitis b surface antigen (hbsag), hiv antibody detection, treponema pallidum specific antibody detection, hepatitis c virus antibody (hcvab) positive. 8. presence of - clinically significant ecg results. 9. known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodthose who are positive. 10. addiction to tobacco and alcohol. 11. individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period. 12. in the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
monitoring hypertensive patients's cerebral oxygen saturation

Conditions: Surgical Complications From General Anesthesia; Hypertension; Cerebral Ischemia; Cerebral Anoxia

Summary: the purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.


Eligibility criteria:
inclusion criteria: * patients have hypertension more than 3 year,whether well-controlled or uncontrolled, * scheduled for major abdominal surgery for at least 2 h * under general anesthesia * american society of anesthesiologists（asa）physical status : ii \~ iii * age \> 30 exclusion criteria: * pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke; * asa physical status \>iv * hepatic failure * renal failure * preoperative mini-mental state examination (mmse) score less than 24 * a history of cardiovascular surgery or craniotomy * cardiac failure * respiratory failure

Keywords: hypertension cerebral oxygen saturation near-infrared spectroscopy cognitive function
a single-arm pilot study of tislelizumab combined with anlotinib in patients with advanced nsclc with driver-negative after progression to immunotherapy

Conditions: Advanced NSCLC

Summary: immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。targeted angiogenesis therapy has always been the focus of research on the treatment of nsclc patients with progressive disease after immunotherapy. from the mechanism of action, angiogenesis and immunosuppression are interrelated processes.


Eligibility criteria:
inclusion criteria: 1. voluntary participation in clinical research; fully understand and informed the study and sign the informed consent form (icf); be willing to follow and be able to complete all trial procedures; 2. age of 18-75 years old (including boundary value), regardless of gender; 3. pathologically confirmed locally advanced, metastatic non-small cell lung cancer (nsclc), including squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. patients with non-squamous non-small cell lung cancer should exclude known egfr mutation or alk gene rearrangement. 4. patients with resistance to first-line pd-(l)1 inhibitors combined with chemotherapy; 5. patients with tumor response of cr/pr/sd after at least one first-line immunotherapy; 6. subjects' ecog ps score was 0-1 (including boundary value); 7. patients had to have ≥1 measurable lesion (according to recist1.1 criteria). 8. predicted survival time ≥6 months; exclusion criteria: 1. frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule tki drugs; 2. central lung cancer with large blood vessel invasion; 3. patients with any signs or history of bleeding that may affect treatment according to the investigator's judgment; patients with bleeding events ≥ctcae grade 3, unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug; 4. hemoptysis \> 50ml/d; 5. inability to swallow capsules or diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction; 6. poorly controlled hypertension (defined as systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>100 mmhg) 7. other known malignant tumors that are developing or require active treatment; 8. currently participating or has participated in the clinical research of other drugs; 9. interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy

Keywords: progress in first-line immunotherapy
immune response to shingles vaccination

Conditions: Shingles

Summary: the purpose of this study is to learn more about the immune response to varicella zoster virus (vzv).

participants 70 years of age or older will receive the fda-approved shingles vaccine (zostavax). blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.

Eligibility criteria:
inclusion criteria: * 70 years of age or older. * history of chickenpox. exclusion criteria * previous vaccination with zostavax or with the chickenpox vaccine. * history of ever having had shingles. * been in close contact with a person who had chickenpox or shingles in the past 5 years. * vzv seronegative * taking systemic suppressive regular doses of drugs with anti-vzv activity such as acyclovir, famciclovir, or valacyclovir. episodic use is allowed. for cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving zostavax per cdc recommendations. * hiv seropositive. * hepatitis c infection or active hepatitis b infection. * history of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. neomycin allergy manifested as contact dermatitis is not an exclusion. * has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy. * has long-term use of oral or parenteral steroids (\>7 days), or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed). * women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination * donated blood in the past 8 weeks or planning to donate blood during the study * weighs less than 110 lbs * has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. additional exclusions for optional skin biopsy: 1. has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe 2. history of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin) 3. history of keloid formation or excessive scarring 4. history of frequent cellulitis or boils (\>3 episodes in past 2 years) requiring antibiotic therapy. 5. allergy to lidocaine, silver nitrate, or mupirocin.
fatty liver in pregnancy

Conditions: Fatty Liver

Summary: non alcoholic fatty liver disease (nafld) is one of the main causes of development of chronic liver disease and cirrhosis. there are no published studies which have investigated the incidence of nafld in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon. we aimed in our study to explore the incidence of nafld in pregnancy by ultrasonography (us) during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a correlation between fatty liver and demographic, clinical, nutritional and laboratory data during pregnancy.

fatty liver in pregnancy-protocol: non alcoholic fatty liver disease (nafld) is one of the main causes of development of chronic liver disease and cirrhosis. the incidence of nafld among the general population is about 17-30%. there are no published studies which have investigated the incidence of nafld in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon. we aimed in our study to explore the incidence of nafld in pregnancy by ultrasonography (us) during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a correlation between fatty liver and demographic, clinical, nutritional and laboratory data during pregnancy. methods: us examination will be performed by an experienced technician. the liver will be scanned by b mode us using a 2-5 mhz transducer. in those with fatty liver as seen by us, a repeat examination will be performed after 6 weeks and 24 weeks. for women with the diagnosis of fatty liver, serum lipid profile, glucose, liver function tests and insulin will be done. homa score as well as bmi will be calculated for each woman with fatty liver. all participants will sign an informed consent which has been approved by the hospital ethical committee.

Eligibility criteria:
inclusion criteria: * pregnant women during the end of the pregnancy or immediately after birth (after 36 weeks) exclusion criteria: * pregnant women before 36 weeks of pregnancy. * known diabetes or treatment by drugs known to cause fatty liver.

Keywords: fatty liver pregnancy ultra sound pregnant women at the end of pregnancy or immediately after birth. controls-women with normal liver correlation between ultrasonography and nutritional, obsthetric and laboratory data.
providing online counseling for home-based hiv testing with transgender youth

Conditions: Hiv; Transgender Youth

Summary: this research study will recruit 200 transgender youths between the ages of 15-24. there are two arms to the research study: the control and the intervention arm. each eligible participant will be randomized into either arm. the control arm participants receive an oraquick hiv testing kit sent to an address of their choice and instructions of how to conduct the test. they will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. participants in the intervention arm will receive an oraquick hiv testing kit sent to them and will receive video-based counseling called motivational interviewing and certified testing and referral. after this counseling session, the results from the oraquick hiv test will be logged by study staff. then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.


Eligibility criteria:
inclusion criteria: * male sex at birth, identifies as female, trans feminine, trans woman, female * female sex at birth, identifies as male, trans male, trans masculine, male * agender, genderfluid, genderqueer * between the ages of 15-24, * negative or unknown hiv status and not having tested in the least 3 months * willingness to have hiv test kit delivered to an address they provide * wilingness to be tested for hiv * willingness to be randomized to either study arm * willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, internet access) exclusion criteria: * same sex assigned at birth and currently identifies as that same sex * aged 14 years or younger, or 25 years or older * reports having a positive hiv status during the baseline survey or screener survey before testing unwillingness to have hiv test kit delivered to an address they provide * unwillingness to test for hiv * unwillingness to be randomized * unwillingness or inability to participate in video-based counseling

Keywords: hiv transgender trans youth home testing
physical activity and screen-time regulations in childcare centers - aim 3

Conditions: Childhood Obesity

Summary: the objective is to establish community priorities for strategies to improve young children's health behaviors based on focus groups of stakeholders in the greater baton rouge area.

pause and play (aim 3) objective will be achieved through a series of taskforce and focus group meetings administered by the mayor's healthy city initiative (mhci). meetings will include monthly meetings of the mhci advisory boards composed of community stakeholders and focus groups of childcare center directors and parents. stakeholders will create dissemination and implementation plans to leverage the findings of the project. we plan to conduct 2-3 focus groups of 8-10 parents and childcare directors, for a total of 16-30 participants. participation in the focus group part of the study will last approximately 1 day.

Eligibility criteria:
inclusion criteria: * either a director of a licensed childcare center in east baton rouge parish or a legal guardian and/or primary caretaker of a child aged 3 to 5 years who is enrolled in a licensed childcare center * able to understand and speak english * willing to be audio-taped during the focus group (for transcription purposes) exclusion criteria: * being affiliated with 1 of the 10 childcare centers being assessed for pause and play aims 1 or 2, either as a director/teacher or as a parent of a student * cognitive impairments that interfere with participation in a group discussion

Keywords: childcare center regulations physical activity sedentary behavior screen-time behavior focus groups
adaptation of alveolar-capillary diffusion at effort of subjects suffering from complex congenital heart disease

Conditions: Complex Congenital Heart Disease; Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass; Systemic Right Ventricle; Pulmonary Failure

Summary: an injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. there is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (vo2 max). this injury is a new follow-up parameter of cardiac function for the adult. the nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (co) associated to nitric oxide (no). today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.it is impossible to predict if membrane damage will be the best factor correlated to the vo2max in patients suffering from complex congenital heart disease. assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with vo2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.these results would have an early prognostic value that would permit to refine the follow-up and the treatment. the main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.


Eligibility criteria:
inclusion criteria: * informed consent * age \> 8 years- female and male patients * heart-rate exercise tolerance test planned in the usual patient's follow-up * congenital heart disease: single ventricle with fontan circulation or bicavo-bipulmonary bypass or systemic right ventricle or pulmonary failure exclusion criteria: * chronic or acute intercurrent respiratory disease * in exclusion period in relation with another trial or for * participation to another study * patient doesn't benefit from an insurance disease regimen * pregnant woman or breast-feeding, law-protected person, vulnerable person

Keywords: double pulmonary diffusing capacity to carbon monoxyd (co) associated to nitric oxide (no) evolution of membrane and capillar damages early pronostic value of congenital heart disease
the effects of fractional carbon dioxide (co2) laser treatment prior to wound closure

Conditions: Scars

Summary: the purpose of this study is to determine if fractional carbon dioxide laser treatment of a fresh wound at the time of surgery, decreases scar formation. scar revision is commonly done at 6-10 weeks following surgery. therefore, it may be more beneficial, for both the patient and physician, to perform scar revision at the time of surgery.


Eligibility criteria:
inclusion criteria: * undergoing skin cancer surgery * will have a straight-line incision * fluent in english * must reside in the los angeles vicinity for the duration of the study exclusion criteria: * non-english speakers * pregnant or cognitively impaired subjects

Keywords: scar revision intraoperative fractional carbon dioxide laser
safety, toleration and pharmacokinetics of single intravenous doses of peptide yy in overweight adults

Conditions: Obesity

Summary: the purpose of this trial is to evaluate the safety and tolerability of single escalating doses of peptide yy3-36 and to determine effects on food intake and serum hormones when administered by intravenous infusion to otherwise healthy overweight adult subjects.


Eligibility criteria:
inclusion criteria: * bmi 27-35 kg/m2 exclusion criteria: * women of childbearing potential
intermittent fasting on body fat and quality of life

Conditions: Healthy

Summary: the purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

start of study: informed consent, body fat analysis, questionnaires on quality of life, sleep, and stress. for the next four weeks, participants will eat their normal food intake with no restrictions on when to eat. participants will keep their normal weekly exercise routine. midway of study: body fat analysis, questionnaires on quality of life, sleep, and stress. for the next four weeks, participants will do the intermittent fasting program. this program has participants fasting 16 hours from their last meal of the previous evening's meal to the first meal of their next day. then for 8 hours, participants are able to eat. during the fasting, participants are allowed to consume water and black coffee/tea. participants will also keep their normal weekly exercise routine. end of study: body fat analysis, questionnaires on quality of life, sleep, and stress.

Eligibility criteria:
inclusion criteria: • in good health exclusion criteria: • diabetes or metabolic syndrome
immunoclassification of psoriasis: a strategy for precision medicine

Conditions: Immunoclassification; Psoriasis

Summary: through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide the precise treatment of psoriasis.

psoriasis is a heterogeneous condition that can affect skin and other structures. over the past decade, considerable advances have been made both in our understanding of the pathogenesis of psoriasis and in the revolutionized immunotherapy of its diverse manifestations. psoriasis heterogeneity and its cutaneous microenvironment is the leading cause of resistance in patients. novel approaches, including single-cell rna sequencing technology and cytof, are proposed as methodological solutions. by their combination with immunotherapy, we can specifically evaluate the mechanism of psoriasis in the face of immunotherapy agents at the single-cell resolution by detecting the transcriptional activity of cytokines, immune checkpoints, screening neoantigens with high transcription levels, identifying rare cells, and assisting the dissection of the critical immune-metabolic pathways in this complex disease. we aim to improve short-term and long-term precision treatment strategies for patients with psoriasis.

Eligibility criteria:
inclusion criteria: 1.18 to 75 years of age 2.moderate to severe chronic psoriasis, bsa≥3% 3.duration of psoriasis≥6 months 4.patients must be candidate for systemic therapy 5.informed consent must be obtained 6.for female, ß-hcg test is negative and contraception is accepted exclusion criteria: 1. having severe infections, including hepatitis, hiv and tuberculosis 2. having significant allergies to biological agents 3. having a history of malignancy 4. refusal of contraception 5. having serious or unstable/uncontrolled illnesses
quantra qplus sample type comparison

Conditions: Coagulation Defect; Bleeding

Summary: this is a single center prospective observational study to compare qplus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.

in this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the quantra system with the qplus cartridge.

Eligibility criteria:
inclusion criteria: * subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device * subject is ≥18 years * subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr. exclusion criteria: * subject is younger than 18 years * subject is pregnant * subject is incarcerated at the time of the study * subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks * subject, or subject's legally aurthorized representative is able to provide written informed consent

Keywords: cardiac surgery quantra viscoelastic testing coagulation