Kornimate/medical-research-clean huggingface dataset:
the efficacy on overweight with oral supplemenation of probiotics and prebiotics

Conditions: Overweight

Summary: the goal of this interventional study is to evaluate the efficacy of probiotics with prebiotics on overweight. 200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months. reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.

this study is a multi-center, four arms, randomized, double-blind controlled trial. 200 eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. all participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to ctms (clinical trial management system). data will be analyzed and reported after the completion of the study.

Eligibility criteria:
inclusion criteria: * chinese males or females, age between 25-45; * overweight population: bmi 24-27.9; * blood lipids in high potential risks but without medication; tg \> 5mol/l, ldl \>= 3.4 mmol/l, tc \>= 5.2 mmol/l. * understand the test procedure, read, and sign an appropriate informed consent form indicating their willingness to participate; * agree to avoid medication treatment for weight management, including blood lipids and sugar control. exclusion criteria: * have used any medication for weight management at least one month before this study. * subject having done plastic surgery for weight management. * be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product. * have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently. * have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease. * have a history of any disease or the presence of health condition on the study sites that the investigator feels would interfere with the study. * be taking antihistamines (\> 3x/week) or anti-inflammatory (\> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrollment. * have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis. * have any cuts/abrasions on the test site at baseline. * the subject is an employee of sponsor or the site conducting the study.

Keywords: probiotics prebiotics overweight
pain sensitivity and outcome in arthroscopic shoulder surgery

Conditions: Anomaly; Shoulder

Summary: the purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.

arthroscopic shoulder surgery is increasingly performed on a daycase basis. optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. however, optimal postoperative pain control in daycase surgery remains a challenge. there is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. recent work has produced a simple questionnaire alternative to pain intensity testing, the pain sensitivity questionnaire (psq). we hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome. the aim of our study is to correlate a patient's pain sensitivity, as measured by the pain sensitivity questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.

Eligibility criteria:
inclusion criteria: all patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent. exclusion criteria: * unable to give informed consent * documented sensory abnormality (e.g. peripheral neuropathy) * contraindication to proposed anaesthetic/analgesic regimen * no telephone or unable to communicate in english * documented psychiatric disorder * documented/suspected substance abuse

Keywords: shoulder surgery pain sensitivity rowe score constant score surgical outcome postoperative pain
pharmacodynamic effects of ranolazine versus amlodipine on platelet reactivity

Conditions: Coronary Artery Disease

Summary: no previous study has assessed the potential of ranolazine to interfere with levels of platelet reactivity in patients with coronary artery disease who are treated with dual antiplatelet therapy. aim of this study is to compare the pharmacodynamic effects of maintenance doses of ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease who are treated with dual antiplatelet therapy.

patients with coronary artery disease (cad) are often treated with dual antiplatelet therapy (dat), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events. levels of platelet reactivity in patients on dat can be influenced by concomitant treatment with medications that inhibit the cyp3a4 system involved in the activation of clopidogrel, such as calcium channel blockers, potentially interfering with its clinical benefits. importantly, calcium channel blockers, such as amlodipine, are commonly used for relief of ischemic symptoms in patients with cad. ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation and constitutes a pharmacologic alternative to calcium channel blockade. however, no previous study has assessed the potential of ranolazine to interfere with levels of platelet reactivity in cad patients on dat. the primary objective of this study is to compare the pharmacodynamic effects of maintenance doses of ranolazine versus amlodipine on platelet reactivity in patients with cad on dat.

Eligibility criteria:
inclusion criteria: * angiographically-proven coronary artery disease * class i indication to dual antiplatelet therapy because of recent (\<12 months) percutaneous coronary intervention and/or recent acute coronary syndrome (\<12 months) * stable clinical conditions * able to understand and willing to sign the informed consent form exclusion criteria: * use of other drug interfering with cyp activity such as proton pump inhibitors * women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Keywords: platelet reactivity aspirin clopidogrel
sunitinib + docetaxel as second-line treatment in gastric cancer

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is to determine whether sunitinib and docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.

this is a randomized phase ii trial of sunitinib and docetaxel in advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach) 2. patients must present with stage iv disease not amenable to surgery, radiation or combined modality therapy with curative intent. patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred 3. prior chemotherapy wit fluoropyrimidine and platinum 4. measurable or evaluable disease according to recist 5. age, 18 years or older 6. ecog performance status 0 - 2 7. adequate organ function as defined by the following criteria absolute neutrophil count (anc) ≥ 1,500/ul platelets ≥ 100,000/ul ast/alt ≤ 2.5 x uln, ≤ 5.0 x uln if liver involvement total serum bilirubin ≤ 2.0 mg/dl 8. life expectancy of ≥ 3 months 9. signed written informed consent exclusion criteria: 1. more than one prior chemotherapy for metastatic disease 2. severe co-morbid illness and/or active infections 3. nci ctcae grade 3 hemorrhage from any cause \< 4 weeks before enrollment 4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart 5. pregnant or lactating women 6. active cns metastases not controllable with radiotherapy or corticosteroids 7. active and uncontrollable bleeding from gastrointestinal tract 8. known history of hypersensitivity to study drugs 9. prior treatment with sunitinib

Keywords: advanced gastric cancer sunitinib docetaxel fluoropyrimidine platinum based chemotherapy
treatment with the ketone body 3-hydroxybutyrate in patients with acute heart failure

Conditions: Acute Heart Failure

Summary: background: acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. the investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. however, there are no data showing the effects of ketone on patients with acute heart failure objectives: to investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements. methods: the investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock. perspectives: the present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.


Eligibility criteria:
inclusion criteria: * hospitalized with worsening hf or de novo diagnosis of hf * lvef \< 50% * treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics. exclusion criteria: * cardiogenic shock * systolic blood pressure \<85 mmhg * acute myocardial infarction other than type ii \<5 days prior to randomization \* * severe uncorrected cardiac valve disease * expected or possible need for hemodialysis as judged by the investigator * ongoing inotropic treatment * possible need for advanced heart failure treatment (lvad, heart transplantation) as judged by the investigator. * ongoing, severe infection * severe respiratory distress (sat\ 24/min or receiving more than 2 l o2/min or intubated) * atrial fibrillation with heart \>120 beats per minute * inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort. * if suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.
seasonal variation of ambulatory blood pressure

Conditions: Hypertension

Summary: this is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.

two 24hour ambulatory blood pressure monitorings, 4 to 6 months apart, will be performed on hypertensive subjects on a stable antihypertensive drug therapy for at least 4 weeks. the correlation of weather and temperature with the 24hour ambulatory blood pressure monitoring will be explored.

Eligibility criteria:
inclusion criteria: * age \> 40 yrs * treated hypertension on stable treatment for at least 8 weeks * average home blood pressure (at least 5 days, 20 readings) \< 130/80 mmhg exclusion criteria: * congestive heart failure * use of loop diuretics

Keywords: treatment of hypertension
a retrospective observational study on the effects of probiotics on hbsag clearance

Conditions: Chronic Hepatitis B

Summary: the goal of this retrospective observational study is to find out the effects of probiotics on hbv clearance. the main question it aims to answer is: are the probiotics have an effect in promoting hbv clearance? the participants will observe the hbv clearance rate in chronic hepatitis b patients receive probiotics in addition to the routine antiviral therapy. researchers will compare the hbv clearance rate in chronic hepatitis b patients receive probiotics and antiviral therapy with those receiving solely antiviral therapy.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b patients exclusion criteria: * patients with malignancies * patients with other liver diseases * pregnancy patients
nasal carrying by staphylococcus aureus st398 strains in community and hospital settings

Conditions: Staphylococcus Aureus Nasal Carriage

Summary: the aim of this study was to compare the prevalence of nasal carrying of sa st398 strains in community and hospital settings, identify the factors associated with colonization of sa st398, determine the distribution of imported and acquired cases among sa st398 hospital cases and characterize the genetic structure of the st398 sa population involved in colonization.

staphylococcus aureus (sa) is a ubiquitous bacterium, part of the human commensal flora. the mucosa of the anterior nasal cavities represents the preferred site of colonization of sa. the sa st398 clone, belonging to cc 398, was initially described as a zoonotic agent initially identified in france and the netherlands. in fact, st398 strains are separated into two distinct populations: a methicillin-resistant sa population (samr) with notion of contact with animals and a more virulent methicillin-sensitive sa population (sams) than its counterpart, isolated from serious human infections and without notion of exposure to farm animals. recently, we have shown that, in sa bacteremia, all strains of sa st398 are sensitive to methicillin and that the prevalence of st398 among all sams responsible for bacteremia at besançon university hospital increased between 2009 and 2014, increased from 4 to 15%. however, we were unable to study nasal colonization to support the mode of acquisition of sa st398 (community vs. healthcare acquisition).

Eligibility criteria:
for community patients : inclusion criteria: * the selection criteria for blood donation * age ≥ 18 years old * no refusal of the person exclusion criteria: * none for hospitalized patients : inclusion criteria: * age ≥ 18 years old * hospitalization in one of the services participating in the study * no refusal of the person exclusion criteria: * none
efficiency study of s-tenatoprazole-na to treat erosive or ulcerative esophagitis

Conditions: Esophagitis, Reflux

Summary: stu-na belongs to the proton pump inhibitors (ppi), a group of drugs that reduce gastric acidity. ppi are used to treat acid related diseases like erosive or ulcerative esophagitis. this trial aims to find out the therapeutic dose of stu-na required for healing patients with erosive or ulcerative esophagitis. one of four dosages of stu-na (15 mg, 30 mg, 60 mg, or 90 mg daily), or esomeprazole 40 mg daily, an already marketed ppi, will be given to patients. the attribution to one of the 5 treatment groups will be by chance. neither the patient nor the study physician will know, which treatment is administered to the patient.


Eligibility criteria:
inclusion criteria: * male or female outpatients aged 18 to 75 years inclusive * symptomatic ulcerative or erosive esophagitis * presence of heartburn (daytime and/or nighttime). * understanding the study and agreeing to give a written informed consent * able to communicate well with the investigator him(her)self or his/her representatives * able and agreeing to comply with all study requirements exclusion criteria: * gastrointestinal bleeding * gastric or esophageal surgery * zollinger-ellison syndrome * primary esophageal motility disorders, * esophageal stricture, * inflammatory bowel disease, * upper gastrointestinal malignancy, * pancreatitis, * malabsorption * barrett's esophagus (\> 3 cm) * severe disease/condition such as malignancy * hypersensitivity to ppis

Keywords: esophagitis, reflux s-tenatoprazole-na heartburn esophageal endoscopy
development of attentional biases for affective cues in infants of mothers with depression

Conditions: Depression - Major Depressive Disorder

Summary: the goal of this study is to examine attentional biases for facial displays of emotion as a mechanism of risk in infants of mothers with postpartum major depression, and the potential role of infant arousal in the development of these attentional biases.

as part of the study protocol, infants will complete a computer-based task in which they view facial displays of emotion (angry, happy, sad, neutral) while an eye tracker records their gaze. mother and infants will also complete a standardized interaction task during which the investigators assess infant gaze and psychophysiology. the task consists of three stages, each of which lasts three minutes. for the first stage (free play 1), infants sit in a highchair and mothers are asked to play with their baby as they normally would, without any toys or other objects. in the second stage (sad), mothers are asked to think about times when they are sad or depressed and do not feel able to effectively play with their child. mothers are instructed to look at their child but speak in a monotone and minimize body movement or any physical contact with the infant. in the third stage (free play 2), mothers again interact with their infants normally for three minutes. these two tasks are consistent with the definition of a basic experimental study in humans (besh).

Eligibility criteria:
inclusion criteria: * the high-risk group (n = 150) will consist of women with at least one episode of mdd since their baby's birth. * to qualify for the low-risk group (n = 75), women cannot have a history of any depressive disorder or any current psychiatric diagnoses. * infants will be required to be singleton children born full-term (\> 37 weeks) and normal weight (\> 2,500 grams) with no birth complications or health problems to avoid medical complications contributing to infants' attention, reactivity, and regulation measures. * the two groups will be matched on demographic factors (e.g., age, race/ethnicity, income). exclusion criteria: * additional exclusion criteria are diagnoses of alcohol or substance use disorders currently or at any point during pregnancy, or lifetime history of bipolar or psychotic disorders.

Keywords: postpartum infant attention psychophysiology
a switch to doravirine/islatravir (dor/isl) in participants with human immunodeficiency virus type 1 (hiv-1) who are virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) (mk-8591a-052)

Conditions: HIV-1 Infection

Summary: the primary objectives of this study are to evaluate the antiretroviral activity of a switch to doravirine/islatravir (dor/isl) compared with continued bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) at week 48; and to evaluate the safety and tolerability of a switch to dor/isl compared with continued bic/ftc/taf, through week 48. the primary hypotheses are that (1) dor/isl is non-inferior to continued bic/ftc/taf, as assessed by the percentage of participants with hiv-1 ribonucleic acid (rna) ≥50 copies/ml at week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) dor/isl is superior to bic/ftc/taf, as assessed by the percentage of participants with hiv-1 rna ≥50 copies/ml at week 48.


Eligibility criteria:
the key inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * is hiv-1 positive with plasma hiv-1 rna \<50 copies/ml * has been receiving bic/ftc/taf therapy with documented viral suppression (hiv-1 rna \<50 copies/ml) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen * female is not a participant of childbearing potential (pocbp); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration exclusion criteria: * has hiv-2 infection * has a diagnosis of an active acquired immunodeficiency syndrome (aids)-defining opportunistic infection within 30 days prior to screening * has active hepatitis b virus (hbv) infection * has chronic hepatitis c virus (hcv) infection with laboratory values consistent with cirrhosis * has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous kaposi's sarcoma * is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome p450 3a (cyp3a ) inducers * has a documented or known virologic resistance to dor * has taken long-acting hiv therapy at any time (e.g., cabotegravir, lenacapavir) * is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing dor/isl study
single and multiple ascending dose study for nktr-118 and cross-over study to investigate the effect of food for nktr-118 in japanese healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety and tolerability of nktr-118 with healthy subjects.

a phase i, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of nktr-118 following single and multiple ascending oral dose administration in healthy young and elderly japanese subjects, and an open randomized, crossover study to investigate the effect of food on the pharmacokinetics after single oral doses of nktr-118 in healthy male japanese subjects

Eligibility criteria:
inclusion criteria: * 20 years to 45 years, 65 years to 80 years * body mass index (bmi): 18 to 27 kg/m * male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product. * non-smokers or ex-smokers (not smoked in the past 3 months). exclusion criteria: * clinically relevant disease and/or abnormalities (past or present) * clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis as judged by the investigator * use of any prescribed or non-prescribed medication including herbal remedies, vitamins and minerals during the two weeks prior to the first administration of investigational product

Keywords: phase i japan sad mad