Kornimate/medical-research-clean huggingface dataset:
an investigation into the anti-hypertensive and potential anti-inflammatory actions of dapagliflozin

Conditions: Type 2 Diabetes

Summary: this is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.

two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be included in the study. one group will be randomized to dapagliflozin (a dose of 5 mg daily will be titrated to 10 mg daily during the first week) while the other will be placebo. the patients will be treated for 12 weeks. only half the patients (equal numbers in both groups) will be tested for the secondary endpoints related to postprandial and single dose induced changes. the primary endpoint of the study is to detect a significant difference in the percent change in fasting nuclear factor-k b (nfκb) activation (dna binding activity) in mononuclear cells (mnc) before and after dapagliflozin use (0 week vs. 12 weeks) as compared to placebo.

Eligibility criteria:
inclusion criteria: * age 20-80 years inclusive. * type 2 diabetes * bmi ≥30 kg/m2 * subjects on statins, ace inhibitors, arbs, thiazolidinediones and -antioxidants will be allowed as long as they are on stable doses of these -compounds and the dosage in not changed during the course of study. -patients will be evenly distributed between the 2 groups based on statins, -arbs, tzds and ace inhibitors use. * hba1c ≤ 8.0% exclusion criteria: * use of glp-1 agonists or dpp-iv or sglt-2 inhibitors therapy in the last 3 -months. * risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and -hypertriglyceridemia. * coronary event or procedure (myocardial infarction, unstable angina, coronary -artery bypass, surgery or coronary angioplasty) in the previous 3 months. * hepatic disease: severe hepatic insufficiency and/or significant abnormal liver -function defined as: * aspartate aminotransferase (ast) \>3x upper limit of normal (uln) and/or -alanine aminotransferase (alt) \>3x uln * total bilirubin \>2.0 mg/dl (34.2 µmol/l) * positive serologic evidence of current infectious liver disease including hepatitis b viral antibody igm, hepatitis b surface antigen and hepatitis c virus antibody * (liver function tests more than 3 times the upper limit of normal) * renal impairment (serum egfr \<60 ml/min) * any other life-threatening, non-cardiac disease * uncontrolled hypertension (bp \> 160/100 mm of hg) * congestive heart failure class iii or iv. * use of an investigational agent or therapeutic regimen within 30 days of study * participation in any other concurrent clinical trial * pregnant or breastfeeding patients * volume depleted patients. patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics
clinical sequencing project for metastatic cancer patients for personalized cancer clinic.

Conditions: Metastatic Cancer

Summary: the next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. the genome analysis needs systematic infra and database based on personal genetic information. therefore, a big data of genome-clinical information is important. to determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(response rate,pfs, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.


Eligibility criteria:
inclusion criteria: 1. subject is at least 19 years of age. 2. subject has a histologically or cytologically confirmed diagnosis of hepatocellular carcinoma/rare cancer, melanoma, neuroendocrine tumor, sarcoma etc. 3. prior treatment with anti-pdl1 antibody or immune check point inhibitor or ramucirumab therapy in the first-line or maintenance setting is allowed 4. they must have refractory or progressive disease for which there is no further curative therapy available. 5. be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. 6. must have a life expectancy of 3 months or more 7. written and voluntary informed consent understood, signed and dated. exclusion criteria: 1. patients who do not have enough tissue for acquisition
study of alto-300 in mdd

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine efficacy differences between alto-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate to severe major depressive disorder (mdd) * at visit 2, currently taking a single ssri, snri, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks * willing to comply with all study assessments and procedures * must not be pregnant or breastfeeding at time of enrollment or throughout study exclusion criteria: * evidence of unstable medical condition * nightly use of sleep medication * diagnosed bipolar disorder, psychotic disorder, or dementia * current moderate or severe substance use disorder * has a history of hypersensitivity or allergic reaction to alto-300 or any of its components/excipients * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
implementation of a registry for patients with stroke

Conditions: Stroke

Summary: pathology registers are scientific research tools for the development of epidemiological and clinical studies and health planning, which allows access to useful elements for planning adequate health services. the registry collects demographic, clinical and functional data of stroke patients and arises from the need to order and update this information for epidemiological and research purposes, for a better knowledge of this pathology from a rehabilitation point of view and to accelerate the development of new treatments.

the italian society of physical and rehabilitation medicine has published a minimal assessment protocol for stroke patients1 (pmic2020) to share the evaluation of stroke rehabilitation needs and outcomes at any time of the rehabilitation pathway, as grounds for a national stroke rehabilitation registry (srr). the strategy multicentric study aims to verify the feasibility of implementing a pmic2020-based srr in a routine clinical setting, and develop data-driven prognosis prediction models. demographic, functional and clinical variables will be collected at the admission and the discharge of the patient; in addition, two telephone follow-ups (three months and six months from the event) will be carried out the study will involve several rehabilitation centers of the don gnocchi foundation, italy

Eligibility criteria:
inclusion criteria: * adult patients (over 18 years of age) with ischemic or haemorrhagic stroke, first event or with relapse, time to onset of stroke less than 6 months, signature of informed consent by the patient or family member. exclusion criteria: * patients from severe acquired brain injuries units and / or with diseases that threaten the patient's life

Keywords: registry outcome predictors
anterior glenoid nerve block versus pericapsular nerve group block versus interscalene brachial plexus block for postoperative pain management in shoulder arthroscopic surgeries

Conditions: Anterior Glenoid Nerve Block; Pericapsular Nerve Group Block; Interscalene Brachial Plexus Block; Postoperative Pain; Shoulder Arthroscopic Surgeries

Summary: this study aims to compare between anterior glenoid nerve block, pericapsular nerve group (peng) block and interscalene brachial plexus (isb) block for post-operative pain management in shoulder arthroscopic surgeries

major surgeries of the shoulder constitute some of the most commonly performed orthopedic procedures. they often result in moderate to severe postoperative pain thereby requiring a multimodal analgesic approach centered around peripheral nerve blocks. postoperative pain management is the part of shoulder surgery to improve patient satisfaction, start rehabilitation process rapidly and decrease for hospital stay. interscalene blocks (isb) are well-studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia and post-operative pain management in shoulder surgeries. a novel technique: pericapsular nerve group (peng) block can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. in addition, peng block targets articular branches with less motor effect compared with interscalene brachial plexus block providing anesthetic and analgesic effect with less complication and better and sooner ambulation.

Eligibility criteria:
inclusion criteria: * age from 18 to 70 years. * no sex predilection. * american society of anesthesiology (asa) physical status i-ii. * undergoing shoulder arthroscopic surgeries. exclusion criteria: * patient's refusal. * patients with a history of drug allergies to study drugs. * evidence of local infection at the site of injection. * inability to cooperate * neuromuscular pathology (example: - multiple sclerosis) * previous trauma or surgery to the shoulder
trial on treatment of patients with primary hyperoxaluria type i with pyridoxal-phosphate

Conditions: Primary Hyperoxaluria Type I

Summary: in this study the investigators will prospectively analyze the reduction of urinary oxalate excretion under the treatment with plp in dosages of 5mg/kg/day up to 20 mg/kg/day and serum level response relationship with plp as an i.v. solution used orally in 12 patients with primary hyperoxaluria type i as an inherited autosomal-recessive-disorder leading to increased endogenous oxalate production, urolithiasis and end stage renal disease.


Eligibility criteria:
inclusion criteria: * documentation of diagnosis of ph i by any one of the following: * liver biopsy confirmation of deficient liver specific peroxisomal alanine-glyoxylate aminotransferase, (agt or mislocalization of agt from peroxisomes to mitochondria) * homozygosity or compound heterozygosity for a known mutation in the causative gene (agxt) for ph i * male or female subjects between 5 years and 60 years of age * renal function defined as an estimated gfr \> 60 ml/min normalized to 1.73 m2 body surface area * subjects receiving pyridoxal-phosphate before the study must be willing to discontinue therapy with pyridoxal-phosphate for a wash out phase of at least 4 weeks but always until normalization of serum pyridoxal-phosphate levels * written informed consent from patients and/or legally acceptable representatives exclusion criteria: * pregnant or lactating women * women of child-bearing potential who are not using a highly effective contraception method with a pearl-index \< 1. highly effective contraception methods are oral, transdermal, injectable, or implanted contraceptives, iud, abstinence, or sterile sexual partner and must agree to continue using such precautions during the pyridoxal-phosphate study * subjects post liver or kidney transplantation or combined transplantation * chronic diarrhoea with the risk of malabsorption * any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator, is indicative of a disease that would compromise the safety taking pyridoxal-phosphate per os and the absorption * subjects participating in other clinical trials with investigational products 4 weeks prior to trial entry, during the trial and 4 weeks after the trial * subjects who are unable to take the trial medication * subjects who are unable to collect 24-hour urine samples or follow other study procedures * subjects who are under treatment with l-dopa, isoniazid, d-penicillamine (interactions between these drugs and pyridoxal-phosphate are known and might influence serum pyridoxal-phosphate levels) * subjects with known allergies to substances of contents (e.g. potassium sorbet, raspberry syrup) * subjects confined to an institution on judicial or official behalf * subjects who are in dependency to the sponsor or the pi of the trial

Keywords: primary hyperoxaluria pyridoxal-phosphate
fitbit pilot study in post-operative lumbar degenerative spinal stenosis patients

Conditions: Lumbar Degenerative Spinal Stenosis

Summary: spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. surgical treatment can alleviate leg pain and improve function such as increasing physical activity. this study will use fitbit technology to monitor patient's post-operative physical activity. it will evaluate the efficacy of a fitbit incentive based walking program on improving post-operative physical activity and rehabilitation.


Eligibility criteria:
inclusion criteria: * 60 years of age and older * diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between l3-l5 confirmed by ct or mri * consent for surgical treatment exclusion criteria: * traumatic stenosis from a pathologic fracture * inflammatory spine disease * peripheral arterial disease * hip or knee arthritis or pulmonary or circulatory diseases for which exercise is contraindicated * severe or progressive neurologic deficit effecting ambulatory ability * cancer * no access to a computer or mobile device * inability to complete the questionnaires or provide follow-up (i.e. lack of permanent address, substance abuse, interfering psychiatric illness).
neoadjuvant dalpiciclib plus aromatase inhibitors in luminal b/her2-negative breast cancer (dancer)

Conditions: Luminal B/HER2-negative Breast Cancer

Summary: evaluate the efficacy and safety of dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in luminal b/her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years-old at the time of consent to participate this trial * famale stage i-iii breast cancer patients * hr-positive（er≥10%）, her2-negtive invasive breast cancer, either ki67≥20% and/or pgr\<20% * no prior anti-cancer treatment * ecog 0-1 exclusion criteria: * known to have other aggressive malignant tumor in the past 5 years. * bilateral breast cancer; inflammatory breast cancer; occult breast cancer; distant metastasis confirmed by pathology. * there are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * female patients during pregnancy or lactation. * the investigator determines that subjects are not appropriate to participate in the study due to other factors.
immunoglobulin levels and occurrence of infections after lung transplantation and impact of igg replacement

Conditions: Infections After Lung Transplant

Summary: immunosuppressive therapies have led to remarkable improvements in survival in lung transplantation (lt) patients. however, one important adverse effect of these therapies has been the increasing emergence of hypogammaglobulinemia (hgg) which has been previously seen mostly in patients with primary immunodeficiency (pid). the goal of treatment of hgg in pid has been to maintain the trough igg level above 500 mg/dl which might provide better protection against infections than do lower igg serum concentrations. although igg therapy is of substantial benefit, the doses and trough levels of igg that are optimal are not yet clearly established. the impact of high versus low igg dosing on the frequency and severity of infections and rejection has not been studied before in lt patients with hgg. the specific aims for this study are to compare the incidence of infections in lung transplant recipients receiving higher versus lower dose of sq igg and to compare the incidence of infections in lung transplant recipients with mild hypogammaglobulinemia versus normal igg levels. this study will be a single center study of all lung transplant recipients, age 18 years or older, at the university of pittsburgh medical center (upmc), with a randomized treatment arm and an observational arm. the hypotheses for the research study are: * therapy with iv or sq igg is of substantial benefit in reducing the number of infections in lung transplant recipients with severe hypogammaglobulinemia (igg \< 500) * a higher dose of sq igg, with subsequent higher trough igg levels, may have a higher impact on the frequency and severity of infections and rejection episodes, compared to a lower dose of sq igg, with subsequent lower igg trough levels * lung transplant recipients with mild hypogammaglobulinemia ( igg= 500-750) have a higher incidence of infections compared to patients with normal igg levels


Eligibility criteria:
inclusion criteria: * adult recipients of lung transplantation at the university of pittsburgh medical center, who are able to provide written informed consent prior to transplantation or on the day of lung transplant surgery. exclusion criteria: * age less than 18 years-old * history of anaphylaxis to ivig * subjects already on iv or sq igg treatment
the effect of music therapy on preoperative anxiety in elective surgery

Conditions: Anxiety; Music; Preoperative

Summary: anxiety is a common phenomenon among patients who are undergoing surgery. it is a condition characterized by stress, nervousness, fear, unpleasant feeling, and higher activity of autonomic nervous system. the current studies demonstrated that listening to music, reduces anxiety levels.

pre-operative anxiety is recognised as a potential and preventable risk factor for post-operative complications. it is estimated that between 25% to 80% of patients admitted to hospital for surgery experience pre-operative anxiety, and anxiety can negatively influence patient recovery.physiologically pre-operative anxiety can lead to autonomic dysfunction and can modify inflammatory responses, platelet activity, and immunologic functioning. the beck anxiety inventory(bai), created by aaron t. beck is a 21 questions multiple choice self report inventory which measures the severity of an anxiety in adults and adolescents. it has been widely used in clinical research in mental health care mainly to measure general anxiety. the total score for all 21 symptoms can range between 0 and 63 points. a total score of 0 - 7 is interpreted as "minimal" level of anxiety, 8 - 15 as "mild"; 16 - 25 as "moderate" and 26 - 63 as "severe" level of anxiety. this study aims to compare the alleviation of pre-operative anxiety in patients undergoing surgery with or without music.

Eligibility criteria:
inclusion criteria: * age more than 18 years scheduled for elective surgery * american society of anaesthesiologists physical status i, ii exclusion criteria: * patient's refusal * patient's with known auditory disability * psychiatric disorder * altered mental status * patients routinely taking cns depressant drugs (eg : diazepam, clonazepam)

Keywords: anxiety music preoperative
a phase 1 study of ft819 in b-cell mediated autoimmune disease

Conditions: Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV); Idiopathic Inflammatory Myositis (IIM); Systemic Sclerosis (SSc); Systemic Lupus Erythematosus (SLE)

Summary: this is a phase 1 study designed to evaluate the safety, pharmacokinetics (pk), and anti-b-cell activity of ft819 following treatment with or without auxiliary medicinal product (amp) in participants with moderate to severe active systemic lupus erythematosus (sle), antineutrophilic cytoplasmic antibody (anca)-associated vasculitis (aav), idiopathic inflammatory myositis (iim), and systemic sclerosis (ssc). the study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of ft819.


Eligibility criteria:
key inclusion criteria: * age: 12 to 70 years old. * diagnosis: must have active b-cell mediated autoimmune disease (sle, aav, iim, or ssc) confirmed by standard criteria. * disease severity: moderate to severe, requiring at least two prior treatments that were ineffective. * health status: adequate organ function to tolerate treatment. * consent: able to provide informed consent or assent/obtain parental consent and comply with study procedures. key exclusion criteria: * pregnancy/breastfeeding: women must not be pregnant or nursing. * severe organ dysfunction: significant heart, lung, liver, or kidney impairment. * active infections: no recent or ongoing serious infections. * recent cancer or prior cell therapy: no active/recent malignancies, prior car t-cell therapy, or organ transplant. * allergies: no known allergies to study treatments. * weight restriction: must weigh at least 50 kg (110 lbs).

Keywords: ft819 fate therapeutics idiopathic inflammatory myositis (iim) systemic lupus erythematosus (sle) systemic sclerosis (ssc) antineutrophilic cytoplasmic antibody (anca)-associated vasculitis (aav) allogeneic car-t cd19-targeted therapy cell therapy for autoimmune diseases b-cell depletion in autoimmune disease phase 1 clinical trial allogeneic car cells autoimmune diseases a phase 1 study of ft819 in b-cell mediated autoimmune diseases
metabolic impact of fat digestion

Conditions: Obesity

Summary: in this study, the investigators are interested in investigating how the emulsification state and amount of fat in a meal can modify the kinetics of postprandial lipemia and inflammatory outcomes (including endotoxemia) in obese vs lean subjects. 10 lean and 10 obese volunteers will come 3 times (\>3 weeks apart) at the investigation center to receive a standard breakfast containing milk fat (10 g non emulsified, or 40 g non emulsified, or 40 g finely emulsified). 13c triglyceride stable isotopes will allow to follow the metabolic fate of fatty acids and calculate lipid oxidation by breath test. blood sampling throughout digestion will allow to measure metabolic, lipid and inflammation parameters. stool will be analysed to determine lipid losses in faeces and to phenotype microbiota.


Eligibility criteria:
inclusion criteria: * no smokers * bmi 18 to 35 kg/m2 * moderate physical activity * safety subject during medical consultation exclusion criteria: * medical history which may affect lipid metabolism and gut microflora (renal -cardiovascular -hepatic- endocrine-inflammatory diseases) * drug use that could affect lipid metabolism and gut microflora (steroids, antilipemic agent, anorectic, antibiotic) * inflammatory or infectious disease in the last three month * c reactive protein \> 20 * prebiotic or probiotic high consumers (several times a day) * eating disorder * claustrophobic subjects

Keywords: nutrition lipid digestion endotoxemia inflammation metabolism stable isotope obesity