Kornimate/medical-research-clean huggingface dataset:
human pilot study - ha35 (hyaluronan molecular weight 35) dietary supplement for promoting intestinal health

Conditions: Gastrointestinal Microbiome

Summary: the purpose of this study is to evaluate whether oral ha35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of ha35.


Eligibility criteria:
inclusion criteria: * bmi 19-25 (lean), and bmi 30-35 (obese) * age 18-45 years old * willingness to take oral supplement and adhere to study requirements exclusion criteria: * diabetes * oral antibiotics within 4 weeks of study initiation * history of cardiac disease, and medications for cardiac disease * use statins and antihypertensive drugs * inflammatory bowel disease including irritable bowel syndrome * history of intestinal surgery, excluding hernia repair and appendectomy * active cancer diagnosis (except skin cancer) * chronic acid suppression treatment (proton pump inhibitors, histamine h2 receptor antagonists) * immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic nsaids) * vegetarian or vegan diet7 * abnormal liver or kidney function as measured by routine serum chemistry testing * severe anemia or significant white blood cell or platelet abnormalities * no additional blood or blood product donations during the study
effects of a moisturizing cream on vaginal and vulvar mucous membranes

Conditions: Vaginal Dryness; Vaginal Atrophy; Vulvar Dryness; Vulvar Atrophy

Summary: vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. the objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.


Eligibility criteria:
inclusion criteria: * symptoms of vaginal dryness, burning or itching * symptom severity at least moderate exclusion criteria: * systemic hormonal replacement therapy during the last 12 months * local hormonal replacement therapy during the last 4 weeks * known allergy to ingredients of the study creams * pregnancy * breast-feeding
multicenter clinical study on the optimal treatment protocol and outcome of cough variant asthma with chinese and western medicine

Conditions: Cough Variant Asthma

Summary: to explore the disease outcome prognosis of cough variant asthma by observing the outcomes of cough variant asthma and the effects of chinese and western medicine interventions, and to provide a scientific basis for optimizing the treatment protocol of combined traditional and western medicine for cough variant asthma. this is a multi-center, non-randomized, prospective cohort study. this study started in march 2022 and is going on now. on an informed consent basis, a cohort of 164 patients with diagnosis of cva are engaged. all patients will receive 8-week treatment (ics/laba plus chinese herbal medicine for trial group while ics/laba only for control group) and be observed in next 24 weeks. patients will be followed up every 2 weeks during treatment period and every 4 weeks in observation.the feasibility and correctness of the study will be supervised by two supervisors. to ensure that participants adhere to their follow-up plans, we remind them of their fixed visiting by phone or message. additionally, incentives are used to appreciate participants for their cooperation.


Eligibility criteria:
inclusion criteria: 1. conform to diagnosis of cva; 2. 18 years≤age≤65 years; 3. agree to participant in this trial. exclusion criteria: 1. comorbidity of respiratory and pulmonary infections; 2. history of mental illness; 3. comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases; 4. participants of other clinical trials who may make a difference in our trial; 5. treatment with other chinese herb.

Keywords: cough variant asthma traditional chinese medicine clinical trial
dose-response and pharmacokinetics of gabapentin enacarbil (gen [xp13512 / gsk1838262]) in restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of gen (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with restless legs syndrome (rls).

this was a multicenter, randomized, double blind, placebo controlled, parallel group study, comparing 4 doses of gen (xp13512) with placebo given once daily to subjects with rls. eligible subjects were randomized in equal numbers into 1 of 5 treatment groups (gen 600 mg, 1200 mg, 1800 mg, or 2400 mg or placebo) for 12 weeks of treatment. data from this study will be utilized as part of a larger pharmacokinetic (pk) pharmacodynamic (pd) analysis of data from several studies (xp084/rxp111495) that are part of the gen rls clinical development program. safety and tolerability were also assessed.

Eligibility criteria:
inclusion criteria: * men or women at least 18 years of age * rls, based on the irlssg diagnostic criteria * history of rls symptoms occurring at least 15 nights in the month prior to screening or, if on rls treatment, this frequency of symptoms must have been applicable prior to start of treatment * documented rls symptoms for at least 4 of the 7 consecutive evenings/nights * total rls severity score of 15 or greater on the irls rating scale * if taking dopamine agonists, gabapentin, or other treatments for rls (e.g., opioids, benzodiazepines) medications must have been discontinued at least 2 weeks prior to screening; * if taking any prescription medication, therapy must have been stabilized for at least 3 months prior to screening with no anticipated changes for the duration of the study; * body mass index (bmi) of 34 or below * estimated creatinine clearance of at least 60 ml/min exclusion criteria: * a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of rls * history of rls symptom augmentation or end of dose rebound with previous dopamine agonist treatment * neurologic disease or movement disorder (e.g., diabetic neuropathy, parkinson's disease, multiple sclerosis, dyskinesias, and dystonias); * other clinically significant or unstable medical condition or conditions which could affect rls treatment efficacy assessments * serum ferritin level below 20 ng/ml * currently suffering from moderate or severe depression using the diagnostic and statistical manual of mental disorders and treatment iv (dsm iv tr)
immune function monitoring and immunotherapy in sepsis

Conditions: Sepsis; Septic Shock

Summary: at present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. in order to further understand the current status of immunotherapy in china, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.


Eligibility criteria:
inclusion criteria: * patients with sepsis or septic shock according to sepsis 3.0 exclusion criteria: * none
metformin use in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: metformin has been used clinically for over 50 years, as a glucose lowering agent. direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and this effect is independent of its hypoglycemic effect. animal studies showed that metformin decreased serum c-reactive protein (crp) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (il)-1β, il-6 and tumor necrosis factor (tnf-α) in obese mice . moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint. the objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (dmards) in patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to acr / eular 2010 criteria . * patients with moderate to high disease activity (das - 28 . score greater than 3.2) * patients received the standard therapy (i.e. one or more conventional dmards) for at least three months. exclusion criteria: * known hypersensitivity to metformin. * patients who have a prior diagnosis with diabetes mellitus. * patients receive metformin for any other indications. * patients with congestive heart failure. * patients with a history of myocardial infarction. * patients with severe anemia. * patients with active infections or other inflammatory diseases. * patients receiving biological therapy. * pregnancy or lactation. * patients with impaired liver functions. * patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dl in males and females respectively). * patients with malignancies.
effect of free ticagrelor fraction on platelet membrane post mi

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to assess: * the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor * ticagrelor and its metabolite levels by lc-ms/ms

ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. it is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. contrary to other p2y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. it had been previously showed that stimulation of platelets by adp or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and p2y12 receptors towards the lipid rafts. this suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor. in this context, the aim of the study is to assess: * the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor * ticagrelor and its metabolite levels by lc-ms/ms.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years and less than 90 years, * patients admitted for myocardial infarction treated with ticagrelor in association with aspirin. * patients affiliated to a social security system (or be a beneficiary thereof); * sign written informed consent indicating that they have understood the study procedures and objectives, and that they accept to participate and adhere to the study requirements. exclusion criteria: * patients with limited legal capacity or patients under legal guardianship * patients under judicial protection * patients not affiliated to any social security system * patients taking any antiplatelet agent other than ticagrelor patients taking ticagrelor for \<48 hours (treatment not stabilised) patients with hemoglobin concentration \<10 g/dl on the most recent blood test

Keywords: ticagrelor acute coronary syndrome anti-platelet drug
evaluation of the latella knee implant system for medial osteoarthritis pain reduction (latella-2 study)

Conditions: Osteoarthritis

Summary: the objective of the latella-2 study is to demonstrate the safety and efficacy of the latella knee implant system for the reduction of medial osteoarthritis knee pain.


Eligibility criteria:
inclusion criteria: * history of pain due to medial osteoarthritis * qualifying baseline pain scores * kellgren-lawrence grades 2-3 exclusion criteria: * osteoporosis * rheumatoid arthritis * joint instability * metal ion allergy * permanent implant in or around the knee joint * prior anterior cruciate ligament reconstruction
the effect of royal vaginal gel compared to iui technique on fertility rate of women with low-fertility husbands

Conditions: Asthenozoospermia

Summary: the present pocock clinical trial study was conducted in the city of mashhad in iran between 2015 and 2016. the study inclusion criteria were men with low fertility of sperm motility\<25% and total motility \<50% (asthenozoospermia), no history of endocrine diseases, no diabetes men, no hormonal problems in their wives, and a healthy salpingography in their wives. the study subjects were voluntarily assigned to royal gel and iui groups. in royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. iui group received 75 units of fsh from the second day of the cycle. then vaginal ultrasound was performed from the sixth day of menstrual cycle to determine the right size of follicle. 10000 units of hcg was administered when follicle diameter reached 16mm, and the study subject was prepared for iui 32-36 hours later. each subject alternately swapped groups following fertility failure.

after selection of subjects and obtaining their informed consents, the quality of royal gel was examined. the quality of royal gel is determined by the amount of polyphenol it contains. polyphenol in royal gel was assessed in the following stages: first, the sample was diluted with ethanol 50% to 1:10 ratio, and then, 100µl of this preparation was poured into a test tube, and 750µl of 1:10 diluted solution of fcr (folin ciocalteau reagent) was added and left at room temperature for five minutes. then, 750µl of sodium carbonate 6% solution was added to each tube, and after keeping these tubes in the dark for one hour, absorption was measured at 780nm wavelength. negative control consisted of all reaction compounds, except the sample, for which, ethanol 50% was used instead. the sample concentration was determined using the gallic acid standard. by definition, the desirable quality of polyphenol in natural royal gel ranges from 0.15mg (minimum) to 0.75mg (maximum) in every 100 grams, and this was determined 0.5 mg for the sample used in the present study, indicating a good quality (15).

Eligibility criteria:
inclusion criteria: * male-factor infertility (defined as total sperm motility\<40% and sperm motility\<20%) * normal hormonal profile in women * normal hysterosalpingography report * regular sexual relationships exclusion criteria: * ovulation dysfunction * history of sexually transmitted diseases in women and men * hormonal disorders in men and women
erector spinae block vs ketamine-based multimodal analgesia protocol in lumber decompressive surgery

Conditions: Spinal Decompression; Analgesia; Erector Spinae Plane Block; Ketamine

Summary: the aim of this study is to compare the quality of recovery of the erector spinae plane block (espb) versus ketamine-based multimodal analgesia regimen after spine decompressive surgery.

preoperatively, standard monitors will be attached (electrocardiogram, noninvasive blood pressure, and pulse oximetry) and intravenous access will be obtained. dexamethasone will be administered at dose of 4 mg as an antiemetic prophylaxis. thirty min before induction of anesthesia all patients will receive 15 mg ketorolac and 1 gm paracetamol intravenously. general anesthesia will be induced by 1 mcg/kg fentanyl and 2 mg/kg propofol titrated till loss of verbal response. tracheal intubation will be facilitated by 0.5 mg/kg atracurium. general anesthesia will be maintained by isoflurane (end-tidal isoflurane concentration of 1-1.2%) in air-oxygen admixture. fentanyl boluses of 50 mcg will be given in case of inadequate analgesia (heart rate and or systolic blood pressure increase by 20% from the baseline in absence of other causes) intraoperative hemodynamic management will be according to the discretion of the attending anesthetist. postoperatively, all patients will receive oral 1 gm of paracetamol every 6 h and 400 mg ibuprofen every 8 h. pain assessments using nrs (numerical rating scale) at rest and during movement at 0.5 , 4, 10, 18 and 24 h postoperatively. if nrs score is \> 3, intravenous nalbuphine 0.1 mg/kg (lean body weight) titrated to response will be given (maximum single dose is 20 mg and maximum daily dose is 160 mg). intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs. at the end of 24 h postoperatively, patient's quality of recovery will be assessed using qor-15 questionnaire and patient's satisfaction.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) status of i-iii * scheduled for open lumber decompression surgery for degenerative stenosis or trauma involving 1or 2 levels without fusion. exclusion criteria: * refusal to participate * contraindication for peripheral regional anesthesia such as infection and coagulopathy. * inability to comprehend the numeric rating scale (nrs) or patients who has cognitive function impairment * preoperative renal or hepatic insufficiency * history of opioid abuse. * allergy to any of the study drugs
study for hyalobarrier to evaluate anti-adhesive effect and safety compared to guardix-sg after thyroidectomy

Conditions: Thyroid Disease

Summary: this study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery). an eligible patient will be randomized and allocated to either the test group (hyalobarrier) or active-comparator group (guardix-sg). he/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks. during the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked. non-inferiority of the test device (hyalobarrier) compared to the reference device (guardix-sg) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.


Eligibility criteria:
inclusion criteria: * male and female between 18 and 79 years of age * patients diagnosed with thyroid disease who will undergo total thyroidectomy * naive patients to thyroid surgery * given written informed consent * childbearing potential female patients who give the consent for contraception during the study exclusion criteria: * pregnant or breast-feeding female patients * abnormal coagulation panel test * clinically abnormal laboratory values * inappropriate general health conditions * past or current medication history for hyperthyroidism * medication with aspirin (or anti-platelet) before surgery * current medication with anticoagulants * inoperable (thyroidectomy) concurrent diseases * concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes * participating in other interventional clinical trial

Keywords: thyroid disease hyalobarrier thyroidectomy anti-adhesive effect
evaluation of the minimum effective concentration of bupivacaine (ec50) in femoral block for analgesia by ultrasound after knee surgery

Conditions: Knee Surgery; Postoperative Pain

Summary: the purpose of the study is to determine the minimum effective concentration of bupivacaine (ec50) in femoral block for analgesia by ultrasound after knee surgery.

45 patients classified as asa p1 or p2 aged between 18 and 65 candidates for elective knee operation via arthroscopy were included in the study. all patients received femoral nerve block guided by ultrasound with bupivacaine, 22 ml. the first patient at a concentration of 0.25%. the other patients with higher or lower concentrations if the first patient has pain\> 3 or \<3 on visual analogic scale respectively after awakening of surgical anesthesia. for surgical anesthesia each patient will undergo general anesthesia. at the end of the surgical procedure and anesthetic awakening patients will be evaluated for analgesia by verbal numeric scale. the modified dixon method was used to find the ec50 and ec95 of bupivacaine for analgesia of femoral nerve block guided by ultrasound. concentration still correlated with motor block and side effects.

Eligibility criteria:
inclusion criteria: * patients to undergo knee surgery exclusion criteria: * patients with coagulopathy * pregnant * infection at the puncture site * chronic pain

Keywords: knee surgery femoral block bupivacaine ultrasound
study on the evolution of genes mutation related with gastrointestinal stromal tumors

Conditions: Full Gene Sequences of c-KIT、PDGFRA and DOG1 Are Analyzed With the Screening-sequencing Approach; Investigate the Characteristics and Variations Associated With the Different Gene Mutations of c-KIT、PDGFRA and DOG1 in GIST Patients

Summary: mutations of tumor-related genes are dynamic. gastrointestinal stromal tumor cells often are obviously more invasive in case of recurrence. the great majority of relapses may be associated with secondary mutation in the gist related genes. full gene sequences of c-kit、pdgfra and dog1, which is extracted from the specimen cells of repeated surgical resection or biopsy tissue in gist patients with postoperative recurrence, are analyzed with the screening-sequencing approach, in order to investigate the characteristics and variations associated with the different gene mutations of c-kit、pdgfra and dog1 in gist patients and be likely to find out the evolutionary pattern, try to learn the facts about the effect of tyrosine kinase inhibitors on the gist related genes, make a survey of any association of c-kit、pdgfra and dog1 gene mutations and provide the basis for seeking molecular marker of gist for monitoring course of disease, and offer a theoretical basis and new therapeutic strategies for application of clinical treatment.


Eligibility criteria:
inclusion criteria: * patients with gist at the department of gastrointestinal and glands surgery of the first affiliated hospital of guangxi medical university in china. exclusion criteria: * patients with hepatitis and tuberculosis

Keywords: gist,c-kit,pdgfra,dog1,mutation
adherence-suppression-resistance relationships for atripla compared to historical antiretroviral regimens

Conditions: HIV Infections; Adherence

Summary: the study is recruiting 50 patients initiating or switching to atripla and comparing them to 250 individuals previously followed in a prospective study of hiv+ low income individuals recruited from homeless shelters, single room occupancy hotels and free meal food lines as part of the ucsf reach study. adherence will be measured through monthly unannounced pill counts and electronic medication monitors.


Eligibility criteria:
inclusion criteria: * 18+ years old; * hiv+; * initiating atripla within 6-months of recruitment; * lives in the tenderloin, south of market, or mission district san francisco; * capable of providing informed consent; and * willing to complete all study procedures. exclusion criteria: * intoxication, cognitive dysfunction or psychosis will preclude potential subjects from informed consent.

Keywords: hiv treatment experienced