Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of s95011 in primary sjögren's syndrome patients

Conditions: Primary Sjögren's Syndrome

Summary: the purpose of this study is to assess the effect of multiple intravenous infusions of s95011 compared to placebo in reducing disease activity in patients with primary sjögren's syndrome.


Eligibility criteria:
inclusion criteria: 1. diagnosis of primary sjögren's syndrome based on 2016 american college of rheumatology-eular criteria 2. essdai total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematologic and biologic, 3. positive anti-sjögren's syndrome a (ro) antibodies or anti-nuclear antibodies (ana) ≥ 1:320 or rheumatoid factor (rf) \>20 iu/ml during screening period, measured in a central laboratory 4. stimulated whole salivary flow rate \> 0 ml/minute exclusion criteria: 1. prior administration within the timeframe described in the protocol of any of the following: * belimumab, * rituximab or other b cell depleting agents, * abatacept, * tumor necrosis factor inhibitors, * tocilizumab, * cyclophosphamide, * cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (mmf), azathioprine, or leflunomide * janus kinase (jak) inhibitors 2. meeting any of the following conditions: * corticosteroids: \> 10 mg/day oral prednisone (or equivalent) within 4 weeks prior to randomisation (w000); any change or initiation of new dose of oral prednisone (or equivalent) within 4 weeks prior to randomisation (w000); intramuscular, iv, or intra-articular corticosteroids within 4 weeks prior to randomisation (w000); any change or initiation of new dose of topical corticosteroids within 2 weeks prior to randomisation (w000), * antimalarials: any change or initiation of new dose of antimalarials (e.g. chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to randomisation (w000), * methotrexate: \> 25 mg/week of methotrexate; any initiation or change of dose of methotrexate within 12 weeks prior to randomisation (w000); any change in route of administration within 4 weeks prior to randomisation (w000), * non-steroidal anti-inflammatory drugs (nsaids): any change or initiation of new dose of regularly scheduled nsaids within 2 weeks prior to randomisation (w000), * cevimeline or pilocarpine and cyclosporine eye drops (restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (w000). 3. secondary sjögren's syndrome

Keywords: sjögren sjögren's syndrome autoimmune disease systemic xerostomia xerophthalmia salivary gland disease arthritis joint disease monoclonal antibody
study to assess the safety and tolerability of single doses of regn1500

Conditions: Hypertriglyceridemia

Summary: phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of regn1500


Eligibility criteria:
inclusion criteria: 1. body mass index 18.0 to 40.0 kg/m2, inclusive 2. normal standard 12-lead ecg 3. willing to refrain from the consumption of alcohol for 24 hours prior to each study visit 4. willing to consistently maintain his/her usual diet for the duration of the study 5. willing to refrain from strenuous exercise for the duration of the trial 6. willing and able to comply with clinic visits and study-related procedures 7. provide signed informed consent 8. for sexually active men and women, willingness to utilize adequate contraception and not have their partner\[s\] become pregnant during the full duration of the study. exclusion criteria: 1. any clinically significant abnormalities observed during the screening visit 2. history of drug or alcohol abuse within 1 year of screening 3. receipt of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit. 4. significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subjects participation in this study 5. known history of human immunodeficiency virus (hiv) antibody; and/or positive hepatitis b surface antigen (hbsag), and/or positive hepatitis c antibody (hcv) at the screening visit 6. hospitalization for any reason within 60 days of screening 7. history or presence of malignancy within 5 years prior to the screening visit (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix 8. any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results 9. any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol 10. pregnant or breast-feeding women (the inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
epic(effect of phoslo on phosphorus levels in chronic kidney disease)

Conditions: Hyperphosphatemia; Kidney Failure

Summary: the purpose of this study is to determine if calcium acetate (phoslo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.

in patients with impaired kidney function, dietary phosphorus can not be completely excreted, which leads to elevated levels of serum phosphorus. elevated serum phosphorus leads to increased levels of parathyroid hormone (pth), and is associated with bone disease and other adverse consequences such as soft-tissue and vascular calcification, and increased morbidity and mortality. it is therefore important to prevent hyperphosphatemia and maintain serum phosphorus levels within the range recommended by k/doqi. in patients on dialysis, phosphate binders are routinely used to control serum phosphorus by absorbing dietary phosphate during the transit through the intestine. however, the use of phosphate binders for non-dialyzed patients with chronic kidney disease (ckd) is not an fda approved indication, although some physicians treat patients prior to dialysis based on clinical judgment. the goal of this study is to demonstrate the efficacy of calcium acetate (phoslo) in controlling serum phosphorus in patients with moderate to severe decrease in kidney function.

Eligibility criteria:
inclusion criteria: * non-dialyzed male or female patients with ckd, with a gfr of less than 30ml/min/1.73m² who have elevated serum phosphorus or who develop elevated serum phosphorus following washout from phosphorus-binding therapy. * patients must have written informed consent * negative serum pregnancy test if appropriate * expected to be able to comply with protocol procedures and schedule exclusion criteria: * unstable angina pectoris * severe congestive heart failure * severe liver dysfunction * severe malnutrition * severe hyperparathyroidism * aids (hiv positive subjects without aids are not excluded) * active malignancy for which the subject is receiving chemotherapy or radiation * subject unlikely to complete the study * history of obstructed bowels or hypersensitivity to any of the study medications or their components * history of swallowing disorders such as dysphagia (that would prevent the subject from taking the study drug) severe gastrointestinal motility disorders, or major gi tract surgery * participation in an investigational drug or device trial within 30 days of randomization * subjects on vitamin d therapy * subjects with acute symptoms, in the last month, or current radiographic evidence of kidney stones * subjects who have undergone renal transplant or receiving dialysis * or any condition with makes patient participation not in the patients best interest

Keywords: phoslo (calcium acetate)
a multicentre, randomized phase iii study of rituximab as maintenance treatment versus observation in patients with aggressive b-cell lymphoma: nhl-13

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL); Follicular NHL Grade 3b

Summary: this is a randomized, open label, phase iii study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive nhl. patients will be screened after successful standard induction therapy (cr or cru following standard r-chop-like therapy with 8 infusions of rituximab plus chop-like chemotherapy (4-8 cycles). patients will be followed until an event occurs as defined in the protocol. to evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive b-cell non-hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (efs), 440 patients with dlcbl or follicular nhl grade 3 (220 per arm) will be recruited.


Eligibility criteria:
inclusion criteria: * 4 to 8 cycles r-chop/like, total of 8x rituximab * cr, cru * ecog/ 0.1 or 2 * known ipi at time of diagnosis * age \> 18 years * negative pregnancy test * men must agree not to father a child during the therapy exclusion criteria: * transformed lymphoma * secondary malignancy * evidence of cns - involvement * significant cardiac disease * creatinine \> 2.0 mg/dl * hiv, hepatitis positive

Keywords: dlbcl nhl 13 rituximab maintenance
impact of covid-19 pandemic on depression and quality of life

Conditions: Depression; Quality of Life; Covid 19; Social Isolation

Summary: it is aimed to investigate the depression and quality of life of turkish society caused by covid-19 pandemic and reveal the relationship between them

study hypothesis that people are tend to be depressed and the quality of life is affected negatively by covid-19 pandemic. although turkey has affected moderately, the immediate change on depression and quality of life observable and measurable. it is aimed to investigate the depression and quality of life of turkish society caused by covid-19 pandemic and reveal the relationship between them. according to existing data and perspective of psychology and physiotherapy, potential solutions will be aligned.

Eligibility criteria:
inclusion criteria: * being turkish * understanding turkish * currently living in turkey * being between the age of 15 - 65 * being literate * have internet access exclusion criteria: * being diagnosed with a psychological disorder before the pandemic * having missing value on outcome measures * giving incomprehensible answering

Keywords: covid 19 depression quality of life turkish society social isolation
efficacy of fish oil in lupus patients

Conditions: Systemic Lupus Erythematosus

Summary: the investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil will improve disease activity and endothelial function in systemic lupus erythematosus (sle) patients.

patients with sle have a fifty-fold increased risk of myocardial infarction. this risk is not totally explained by traditional cardiovascular risk factors. in a previous double-blind study of atorvastatin in sle, there was no reduction in surrogate measures of coronary artery disease (coronary calcium, coronary imt, carotid plaque) and no effect on inflammatory markers such as icam, vcam, il-6 and crp. we need to find novel approaches to reduce coronary artery disease in sle. in a preliminary study, omega-3 was shown to improve flow mediated dilation of the brachial artery, oxidative stress and disease activity in lupus patients. in this study we will determine if omega-3 improves brachial artery flow dilation, disease activity and other vascular inflammatory markers (il-6, s-vcam-1, s-icam-1) in sle, in a double-blind placebo-controlled trial.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of sle are eligible. * patients must be 18 years of age or older and able to give informed consent. exclusion criteria: * sle patients who are allergic to fish oil or any omega 3 product. * patients who are pregnant or are planning to become pregnant or are nursing. * omega-3 use within the previous 6 weeks of enrollment. * use of warfarin or heparin. * patients who have coronary artery disease.

Keywords: sle atherosclerosis omega-3
efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus assessed by fnirs

Conditions: Tinnitus

Summary: this randomized controlled pilot trial aims to explore the efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus using functional near-infrared spectroscopy (fnirs).

a total of 60 tinnitus patients were randomly assigned to either an acupuncture group or a waiting list group in a 1:1 ratio. subjects in the acupuncture group will undergo 4-week acupuncture treatment, while subjects in the waiting list group will receive no treatment during the 4 weeks.

Eligibility criteria:
inclusion criteria: 1. bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus. 2. male and female, aged between 18 and 60 years. 3. participants can cooperate with experimental procedures and sign written inform consent. 4. not participating in other clinical trials concurrently. exclusion criteria: 1. participants with objective tinnitus 2. participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by resting-state functional connectivity. 3. participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases. 4. participants have any contraindications for acupuncture (such as a bleeding tendency) 5. pregnant or lactating women. 6. participants have received tinnitus treatment with drugs or other therapies in the last four weeks.

Keywords: acupuncture moxibustion tinnitus randomized controlled trial
efficacy of pilocarpine as a secretagogue versus artificial tears for the treatment of dry eye

Conditions: Dry Eye Disease (DED)

Summary: management approaches for dry eye disease (ded) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. as the condition worsens, treatment progresses to more advanced therapies for severe forms of ded. this study aims to compare the effectiveness and safety of pilocarpine as a secretagogue versus artificial tears in the treatment of dry eye disease. our goal is to provide reliable, high-quality evidence regarding the efficacy of secretagogues, thereby contributing to the development of recommendations that aid clinicians in their decision-making process


Eligibility criteria:
inclusion criteria: * patients diagnosed with ded exclusion criteria: * previous occular surgery. * refuse to particupate. * patients with sjogren syndrome
virtue® male incontinence sling study

Conditions: Stress Urinary Incontinence

Summary: this study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.


Eligibility criteria:
inclusion criteria: * male subject at least 18 yrs old with an estimated life expectancy of more than 5 years * confirmed sui (stress urinary incontinence) through medical history, urodynamics, and/or physical exam * subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant * subject has intrinsic sphincter deficiency due to one of the following: post-turp (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date * subject is willing to have the virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol * subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site exclusion criteria: * subject is unable or unwilling to sign the informed consent form and/or comply with provisions of the study * subject has active urogenital infection or active skin infection in region of surgery * subject has serious bleeding disorders * subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,cva (cerebrovascular accident), detrusor-external sphincter dyssynergia, parkinson's disease, or similar conditions * subject has previous implant to treat sui * subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months * subject has active urethral or bladder neck stricture disease requiring continued treatment * subject has urge predominant incontinence

Keywords: male sling stress urinary incontinence urinary incontinence
adjuvant therapy with letrozole in induction of ovulation with polycystic ovarian syndrome

Conditions: Polycystic Ovary

Summary: the aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women pcos, focusing specifically on rates of ovulation and pregnancy.

the study will be a randomized controlled clinical trial. once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to beni-suef university hospital. * before initiation of the study, the population will be divided randomly into 4 equal groups: group a, b, c and d. the adjuvant therapy of each group will be group (a) metformin 1000mg, group (b) dapagliflozin 10mg, group(c) combined dapagliflozin-metformin 10/1000mg and group (d) with no adjuvant therapy (control group). * the adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. all groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days. this treatment regimen will continue for three cycles unless positive pregnancy is achieved. no diet restriction will be recommended during the study or change in the lifestyle. the population will be asked to inform about any side effects that may happen during the study. a written informed consent will be obtained from each woman participating in the study.

Eligibility criteria:
inclusion criteria: * pcos will based on european society of human reproduction and embryology/american society for reproductive medicine (eshre/asrm) criteria, the diagnosis is made when at least two of the following criteria are met: * oilgo and/or anovulation (infrequent or no ovulation), * clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels * polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml). exclusion criteria: * other causes of hyperandrogenism mimic pcos such as congenital adrenal hyperplasia, cushing's syndrome, or androgen secreting tumors are excluded. * persistent hyperprolactinemia, * thyroid dysfunction defined as tsh \ 5.5 miu/ml) * patients with menopausal levels of fsh (\> 15 miu/ml) (a normal level within the last year is adequate for enter the study). * liver disease is defined as ast or alt \> 2 times normal or total bilirubin \>2.5 mg/dl, #kidney disease defined as bun \> 30 mg/dl or serum creatinine\> 1.4 mg/dl or significant

Keywords: sodium-glucose co-transporter-2 inhibitors letrozole ovulation polycystic ovarian syndrome
two center study to determine effect of g17dt on plasma gastrin levels in patients with colorectal cancer.

Conditions: Colorectal Cancer

Summary: pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. the hypothesis of this study is that g17dt will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed colorectal carcinoma for whom no other anti-cancer treatment was anticipated during the three month period of study. * patients taking a proton pump inhibitor at a fixed daily dose which had remained unchanged for at least six weeks preceding screening and was not anticipated to change during the study. * proton pump inhibitor compliance of \~70% (to be measured between screening and baseline (week 0)). * male or female patients from 18 to 65 years of age. * patients with a life expectancy of over three months. * world health organisation (who) performance status of 0 to 1. * written informed consent given. exclusion criteria: * patients in receipt of histamine h2-receptor (h2 receptor) antagonists or any other antacid therapy, other than a proton pump inhibitor at a stable dose. * patients with any other factor likely to alter intra-gastric acidity e.g. previous gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal tract. * history of other malignant disease within the previous five years, except non- melanomatous skin cancer or in situ carcinoma of the uterine cervix. * previous use within the last four weeks, concomitant use or anticipated use in the period of the study of radiotherapy or chemotherapy. * concomitant use of immunosuppressants, including systemic (i .e. oral or injected) corticosteroids. * females who were pregnant, planning to become pregnant or lactating. women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration. * patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study. * previous g 17dt treatment. * haematological indicators: haemoglobin \<10.0 g/dl white blood cell count \<4.0 x 109/l platelets \< 100 x 1 09/l