Kornimate/medical-research-clean huggingface dataset:
effect of prophylactic use of silymarin on hepatotoxicity induced by anti-tuberculosis drugs

Conditions: Tuberculosis

Summary: tuberculosis is a worldwide common infectious disease and effective first line anti-tuberculosis (tb) drugs were available such as isoniazid, rifampicin, ethambutol, and pyrazinamide. however, anti-tb drugs may induce hepatic injury resulting in discontinuation of anti-tb drugs or changing anti-tb drug regimen. silymarin has been widely studied for the effect on hepatitis and it has been used in hepatology. therefore, the investigators hypothesized that prophylactic administration of silymarin with anti-tb drugs may decrease the incidence and severity of hepatotoxicity induced by anti-tb drugs.


Eligibility criteria:
inclusion criteria: * subjects who are diagnosed with tuberculosis based on microbiological, biomolecular, pathological, or radiographical findings and are expecting to be administered with anti-tuberculosis drugs including inh, rfp, or pza. * adults \>=35 years old exclusion criteria: * basal ast \>40 iu/ul or alt \>40 iu/ul * pregnancy * lactating women * cases with history of adverse events to silymarin

Keywords: silymarin hepatotoxicity tuberculosis hrez
efficacy and safety of covid-19 vaccine in cardiac patients

Conditions: COVID-19 Vaccine

Summary: efficacy and safety of covid-19 vaccine in cardiac patients

investigate the efficacy and safety of covid-19 vaccine in cardiac patients and its possible assocciated morbidity

Eligibility criteria:
inclusion criteria: * subjects diagnosed as stemi undergo ppci as (fourth universal definition of myocardial infarction (2018) kristian thygesen) 10 * with age range from 18 to 80 years after 1 month of stemi . exclusion criteria: * patients with previous covid infection confirmed by swap or ct chest or icu addmision. * patients with previous covid infection confirmed by qualitative antibdy test . * patients with history of anaphylaxis to any component of the vaccine should not take it . * patients with febrile illness or acute , ongoing infection . * immunosuppressive diseases .
duragen plus® adhesion barrier for use in spinal surgery

Conditions: Spinal Injuries; Adhesions

Summary: to evaluate the safety and effectiveness of duragen plus® adhesion barrier matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.

for more information, please visit www.duragenstudy.com

Eligibility criteria:
inclusion criteria (abstracted from clinical protocol): * patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine * require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs * requires removal of herniated disc fragment exclusion criteria (abstracted from clinical protocol): * current or historic open traumatic injury to the spine * any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures * women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study * any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial * clinically significant structural disorders * known positive for hiv * insulin-dependent diabetes mellitus patients * morbid obesity (body mass index greater than or equal to 40 kg/m2) * history of alcohol or drug abuse within 2 years prior to randomization
a study protocol for research investigating how geriatric risk assessment and shared decision-making conversations affect treatment decisions and quality of life in patients eligible for open-heart surgery.

Conditions: Frail Elderly Persons; Cardiac Surgery

Summary: the goal of this study is to determine whether intervention by the prime clinic influences cardiac treatment decisions, as well as patients quality of life and healthcare utilization. the main questions this study aims to answer are: * does prime consultation influence treatment recommendations? * does a personalized treatment plan for cardiac patients influence health-related quality of life? * does a personalized treatment plan influence healthcare costs (in terms of quality-adjusted life years)? participants will: * visit the prime clinic once * complete quality of life questionnaires twice * track their healthcare usage over the course of a year and complete a corresponding questionnaire four times.

the primary outcome of this study is the difference between treatment recommendations; the first treatment recommendation (the decision before the patient visits the outpatient clinic) will be compared with the treatment recommendation after the assessment at the outpatient clinic. secondary and other outcomes that will be collected are baseline demographic data including age, gender, body mass index, education level, european system for cardiac operative risk evaluation ii (euroscore ii) and co-morbidities such as stroke, reduced cognitive function, chronic obstructive pulmonary disease (copd) gold iii or iv, renal failure (a reduced renal function prior to surgery with a kreatinine level ≥150mmol/l), a reduced left ventricular function, reduced mobility, cardiac reoperation and type of surgical procedure (cabg, valve replacement or repair, surgery of the thoracic aorta or a combination of several procedures). data will be collected using several questionnaires: * health-related quality of life (the rand-36 questionnaire) * the katz index of independence in activities of daily living to assess functional status * the cognitive impairment test * the timed up and go test * outcome prioritization tool to assess the most important goals of treatment the rand-36 and katz-adl will be completed by all patients, including those receiving standard care.

Eligibility criteria:
inclusion criteria: * age 70 years and older * eligible for cardiac surgery * having two or more risk factors: stroke; reduced cognitive function; chronic obstructive pulmonary disease (copd); obesity; reduced left ventricular ejection fraction; renal failure; reduced mobility; cardiac reoperation; and the complexity of the procedure. exclusion criteria: * unable to read or understand dutch

Keywords: cardiothoracic surgery decision-making quality of life frailty
gene biobank of sports injuries

Conditions: Gene Insertions; Gene Deletion

Summary: preserve biological samples and gene extracts of all sports medicine-related diseases. to study related gene mutation sites and regulation. to study related molecular mechanisms and signaling pathways. a storage platform for sports medicine-related diseases research sample database has been established.


Eligibility criteria:
inclusion criteria: 1. patients with joint sports injuries. 2. follow-up patients after sports injury. 3. patients with genetic predisposition to sports injuries. 4. patients with family genetic predisposition to exercise-related diseases and their relatives. exclusion criteria: 1. patients with joint damage caused by external force. 2. the patient is accompanied by other injuries at the same time.

Keywords: sports medicine platform sample database gene
dose finding study of a dna vaccine delivered with intradermal electroporation in patients with prostate cancer

Conditions: Prostate Cancer

Summary: this study will assess the feasibility and safety of vaccination with increasing doses of xenogenic dna administered intradermally in combination with electroporation in patients with relapse of prostate cancer. the dna encodes prostate specific antigen (psa) from rhesus macaque (macaca mulatta), a protein that is 89% homologous to human psa. the study will also assess the safety and functionality of the derma vax™ (cyto pulse sciences) dna vaccine delivery system.


Eligibility criteria:
inclusion criteria: * male patients. age \>18 years. * hla-a\*0201 positive. * histologically confirmed prostate cancer. * minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy. * serum testosterone within normal range. * increasing psa from a previous reference value on two (2) consecutive occasions at least one month apart and with a minimum of 2 ng/ml above nadir. * psa doubling time is one (1) year or less. * no evidence of metastatic prostate cancer. * karnofsky performance status ≥ 80. * adequate organ function: * ast and alt ≤ 2.0 x upper limit of normal (uln); total serum bilirubin ≤ 1.5 x uln * calcium ≤ 2.6 mmol/l, serum creatinine ≤ 1.5 x uln * hb ≥ 100 g/l; absolute leukocyte count ≥ 3.0 x 109 /l; platelets ≥100 x 109 /l * life expectancy ≥ 12 months. * swedish or english speaking subjects only. * written informed consent (subjects must be capable of providing their own informed consent). exclusion criteria: * previous ablation of testis. * radiologic evidence of metastatic disease. * prior chemotherapy or investigational therapy/agents within 4 weeks. * active bacterial, viral or fungal infection. * carrier of hiv, hbv, or hcv. * immunosuppressed (post splenectomy, post stem cell transplantation) or on immunosuppressive therapy other than inhaled or replacement corticosteroids. * any other major illness or peripheral blood vein status that, in the investigator's judgement, will substantially increase the risk associated with sampling or participation in this study. * subjects with cardiac demand pacemakers. * any reason why, in the opinion of the investigator, the patient should not participate.

Keywords: dna vaccine electroporation xenogenic psa
an exploratory study of the safety and efficacy of prophylactic immunomodulatory treatment in myozyme-naive cross-reacting immunologic material (crim[-]) patients with infantile-onset pompe disease

Conditions: Pompe Disease; Glycogen Storage Disease Type II

Summary: the purpose of this study was to evaluate the efficacy, clinical benefits and safety of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa (myozyme®) in patients with infantile-onset pompe disease. the objectives were to assess the efficacy of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa, as assessed by anti-recombinant human acid alpha-glucosidase (anti-rhgaa) antibody titers, and antibodies that inhibit the activity and/or uptake of alglucosidase alfa; to evaluate the clinical benefit as measured by overall survival, ventilator-free survival, left ventricular mass index (lvmi), gross motor function and development, disability index and the incidence of adverse events (aes), serious adverse events (saes), and clinical laboratory abnormalities.


Eligibility criteria:
inclusion criteria: * the patient's legal guardian(s) must have provided written informed consent prior to any study-related procedures being performed * the patient must have had a clinical diagnosis of pompe disease as defined by documented acid alpha-glucosidase (gaa) deficiency (deficient endogenous gaa activity) in skin fibroblasts, muscle, or blood, or 2 gaa mutations. consent was also sought from the biological parent(s) for parental gaa mutational analysis, but was not a requirement for study eligibility * the patient must have not received myozyme® or any rhgaa therapies prior to enrollment in the study * the patient must be crim negative via western blot analysis performed on skin fibroblasts or via 2 known crim negative mutations (in which case crim status was to be confirmed by western blot analysis after enrollment) * the patient's legal guardian(s) must have the ability to comply with the clinical protocol exclusion criteria: * the patient had any medical condition that, in the opinion of the investigator, could be exacerbated/precipitated by or interfere with the study regimen or assessments; such conditions may include but were not limited to human immunodeficiency virus, cancer, hepatitis b, hepatitis c, cytomegalovirus, herpes simplex, john cunningham (jc) virus, parvovirus, or epstein barr virus or tuberculosis * the patient had used any investigational product within 30 days prior to study enrollment * the patient had or was required to have any live vaccination within 1 month prior to enrollment

Keywords: glycogenesis 2 acid maltase deficiency
endometrial malignancy in breast cancer patients with or without aub

Conditions: Endometrial Neoplasms

Summary: in order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (aub), as well as to calculate the risk of endometrial cancer in women with or without aub.

20-25% of postmenopausal women undergoing tamoxifen (tam) therapy develop polyps, according to recent studies. many large (\>2 cm) and molecularly changed uterine polyps are usually seen in these women. furthermore, a number of studies have demonstrated that tam therapy raises the risk of endometrial cancer in both premenopausal and postmenopausal women. studies suggest that women who use tam may also have an increase in the prevalence of uterine sarcomas. in addition, the duration of tam administration appears to increase the risk of endometrial cancer and uterine sarcoma. this multicentric cohort study will compare the ultrasonographic, hysteroscopic, and histopathologic findings in postmenopausal women treated for breast cancer with or without aub in order to increase the robustness of a still ambiguous literature on the subject. it will estimate the risk of endometrial cancer in women with aub according to various covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.

Eligibility criteria:
inclusion criteria: * in case of aub: ultrasonographic endometrial thickness \>5 mm at transvaginal ultrasound * in case of non-aub group ultrasonographic suspicion of endometrial or myometrial abnormalities exclusion criteria: * severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders) * receiving any other form of pharmacologic therapy
topical lidocaine after major arthroscopic knee surgery

Conditions: Fracture of Patella; Pain

Summary: pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.

lidocaine is well-known as analgesic treatment on skin and hypodermic veins. since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment. the aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.

Eligibility criteria:
inclusion criteria: * patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and elmslie-trillat procedure for patella instability. * patients with synovectomies and menisci resection lasting more than 25 minutes. * patients \> 18 years * acceptance of informed consent exclusion criteria: * patients with rheumatoid arthritis * patients with a body mass index of \> 35 * patients who can not read and understand danish * fertile women who does not use secure contraception

Keywords: knee arthroscopy lidocaine patch pain management after knee arthroscopy
expanded access use of l-mtp-pe for the treatment of osteosarcoma

Conditions: Osteosarcoma

Summary: this expanded access protocol will allow access to treatment with l-mtp-pe for people with osteosarcoma. l-mtp-pe is an investigational drug that has not been approved by the fda to treat any condition, including osteosarcoma. l-mtp-pe works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of osteosarcoma of any age note: patients with either newly diagnosed or relapsed osteosarcoma are eligible. * surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma * l-mtp-pe is deemed to be of potential benefit by the treating investigator * willing and able to understand and sign informed consent and assent as appropriate * life expectancy \> 6 weeks * adequate organ function as follows: * adequate bone marrow function defined as: * absolute neutrophil count (anc) ≥ 750/mm\^3 * platelet count ≥ 30,000/ mm\^3 * hemoglobin ≥ 8 g/dl * adequate renal function defined as: * creatinine clearance or radioisotope glomerular filtration rate ≥ 70 ml/min/1.73m\^2 or * serum creatinine ≤ 2x the upper limit of normal based on age/gender * adequate liver function defined as: * bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have gilbert's disease * ast or alt ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases * willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant exclusion criteria: * use of chronic steroids of other immunosuppressive agents * pregnant or breast feeding

Keywords: l-mtp-pe expanded access 20-324
evaluation of the effect of wismemo on alzheimer's dementia patients

Conditions: Alzheimer Disease

Summary: the present studies demonstrated that pro-inﬂammation, systemic oxidative stress and dysfunction in the brain-gut microbiota axis were involved in alzheimer's disease (ad) pathogenesis. these results implied the decreased regulation of inflammation-associated risk and microbiota in ad patients could provide the novel strategies for combating the disease. this study was designed to assess the addition of wismemo in treatment of cholinesterase inhibitors (such as donepezil, rivastigmine, galantamine) in the ad patients.

previously studies have shown some probiotics could improve stress-related diseases such as anxiety, autism, depression and schizophrenia might be through regulating brain-gut microbiota axis, pro-inﬂammation and oxidative stress. although recent clinical study indicated that mix-probiotics (containing lactobacillus acidophilus, lactobacillus casei, bifidobacteria bifidum and lactobacillus fermentum) consumption could improve the cognitive function of dementia patients. in this clinical study, whether genmont specific strain probiotics could improve the clinical syndromes and delay worsens in alzheimer's dementia patients with regular treatment were clarified. a randomized, double-blind, placebo-controlled clinical trial would be carried out. ad's patients with regular treatment are additive consumption multi-strain probiotic supplement (wismemo). half of participants will receive wismeno and regular treatment in combination, while the other half will receive placebo and regular treatment in combination. to evaluate of the effect of probiotic supplementation on cognitive, emotional and related status on alzheimer's dementia patients.

Eligibility criteria:
inclusion criteria: 1. subjects with alzheimer's dementia. (according to the national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association diagnostic criteria (nincds-adrda) and new criteria and guidelines to diagnose alzheimer's disease were published in 2011 by the national institute on aging and alzheimer's association) 2. subjects with administrating cholinesterase inhibitors, such as donepezil, rivastigmine, galantamine. 3. subjects in age of 55-95 years old. exclusion criteria: 1. subjects are mixed dementia and vascular dementia. 2. administration of probiotic dietary supplement 2 weeks before inclusion expect for yakult or yogurt. 3. participation in other clinical trials. 4. subjects with thyroid dysfunction. 5. subjects are receiving cancer drugs. 6. subjects are receiving immunosuppressant drugs.

Keywords: alzheimer's disease dementia intestinal microbiota chronic inflammation probiotics
nasogastric/orogastric tube placement verification study using rightspot ph indicator to verify gastric acidity

Conditions: Small Bowel Obstruction; Gastrointestinal Hemorrhage

Summary: this study will evaluate the use of rightbio metrics' rightspot device used to determine if there is proper placement of a nasogastric or orogastric tube.

primary objective: to assess the level of accuracy of the rightspot ph indicator in determining correct placement of ng/og tubes as compared to the gold standard of cxr in emergency department \& icu patients. hypothesis 1: in greater than 90% of the cases, rightspot ph indicator will be successful in confirming the placement of ng/og tubes by demonstrating a ph of 4.5 or less in patients with cxr proven tube placement. hypothesis 2: the time to confirmation of ng/og tube placement will be significantly less using the rightspot ph indicator than using cxr. the time will be calculated by the start time consisting of the time that the ng/og tube was placed until the end time, which will be when the device ph indicator testing is performed. the time to confirmation using the gold standard of a cxr will begin when the ng/og tube is placed and end when the cxr is available on pacs (picture archiving and communication system). secondary objective: to determine via subgroup analysis whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of ng/og placement determination by the rightspot ph indicator.

Eligibility criteria:
inclusion criteria: * patients 18 years and older * patient or proxy willing to provide informed consent * patients who require placement of a nasogastric/orogastric tube, in the ed or icu, as standard of care, and a member of the study staff is available and present for ng/og tube placement. * it is anticipated that the patient will remain in the ed/icu in order to obtain rightspot ph indicator reading and verifying cxr exclusion criteria: * patients less than 18 years of age * patient or proxy unwilling or unable to provide informed consent * patient with known or suspected pregnancy

Keywords: nasogastric tube orogastric tube rightspot ph indicator suction tube rightbio metrics rightlevel rightspot infant ng tube ph gastric acidity
proof-of-concept study of heart habits application for patients with heart failure

Conditions: Heart Failure

Summary: this study assesses the ability of ambulatory patients with heart failure (hf) to use a smartphone application created for the management of patients with chronic hf. this study will aim: * to understand the frequency with which ambulatory hf patients engage with this smartphone application. * to determine whether patient's knowledge of hf and its management has improved with the use of this smartphone application. * to assess improvement in quality of life measures related to the use of this smartphone application. * to assess improvement in lifestyle measures related to the use of this smartphone application.


Eligibility criteria:
inclusion criteria: * diagnosis of hfref or hfpef. hfref defined as clinical signs and symptoms of hf with a left ventricular (lv) ef ≤ 40% by any imaging modality and at least 1 hospitalization or emergency department (ed) visit for hf or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. hfpef defined as clinical signs and symptoms of hf with an lvef ≥ 50% by any imaging modality and at least 1 hospitalization or ed visit for hf or any outpatient escalation of diuretic therapy in the 12 months prior to study enrollment. * adult patients, men and women, \> 18 years old. exclusion criteria: * pregnant