Kornimate/medical-research-clean huggingface dataset:
effect of socheongryong-tang and yeongyopaedok-san in upper respiratory tract infection

Conditions: Upper Respiratory Tract Infections

Summary: the purpose of this study is to determine whether socheongryong-tang (scrt) and yeongyopaedok-san (yps) are effective in the treatment of upper respiratory tract infection.

upper respiratory tract infections (urtis) are the most prevalent disease of human beings, it incur a significant health burden on populations in terms of human suffering and economic losses. usually, antibiotic therapy is not helpful since most infections are virally induced. over 200 serologically different viral types are responsible for human urtis, so that preventions of urtis including vaccination are impassable. scrt and yps are widely used to treat the respiratory disease. the objective of this study is to determine the efficacy of scrt and yps in symptomatic relief of patients with urtis.

Eligibility criteria:
inclusion criteria: * 18\~60 years old * clinical diagnosis of common cold * occurring no longer than 48 hours before enrollment * presented with runny nose, sore throat, plugged nose, scratchy throat, cough, hoarseness, headache, muscle ache (runny nose, sore throat and at least 1 of others or 1 of runny nose, sore throat and at least 3 of others) exclusion criteria: * allergic rhinitis, asthma, copd, sinusitis (2 and more recurrence per year), septal deviation, anatomical otitis media, exudative pharyngitis * received antihistamines, nsaids, corticosteroids, antibiotics, decongestants * hepatic cancer, liver cirrhosis, renal failure, congestive heart failure * pregnant or lactation

Keywords: upper respiratory tract infections herbal medicine
therapy pathways in the treatment of hormone naïve prostate cancer patients with and without comorbidities treated with degarelix or luteinizing-hormone-releasing-hormone (lhrh) agonists.

Conditions: Advanced Prostate Cancer

Summary: the purpose of this study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy (degarelix or lhrh agonists).


Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer and indicated for adt according to summary of product characteristics (smpc) * decision made to prescribe adt (degarelix or lhrh agonist) prior to enrolment exclusion criteria: * patient had previous or is currently under hormonal management of prostate cancer, except for a curative intention, where the duration of the neoadjuvant/adjuvant therapy did not exceed 6 months and treatment should have been terminated at least 6 months prior to baseline. * participation in a clinical trial at baseline and during the follow-up period
study of efficacy and safety of lnp023 in participants with active lupus nephritis class iii-iv, +/- v

Conditions: Lupus Nephritis

Summary: the overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (lnp023) in addition to standard of care treatment.

the overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (lnp023) in addition to standard of care treatment.

Eligibility criteria:
inclusion criteria: unequivocally positive ana test result and/or a positive anti dsdna at screening active biopsy-proven lupus nephritis within 3 months of screening demonstrating class iii or iv lupus nephritis with or without co-existing features of class v lupus nephritis. documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with mmf/mps. egfr ≥ 30 ml/min/1.73 m2 vaccination against neisseria meningitidis and streptococcus pneumoniae infections vaccination against haemophilus influenzae infection supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, acei or arb at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. doses should remain stable throughout the study. first presentation or flare of lupus nephritis. exclusion criteria: induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization. presence of rapidly progressive glomerulonephritis (rpgn) as defined by 50% decline in egfr within 3 months prior to screening. renal biopsy presenting with interstitial fibrosis/tubular atrophy (if/ta) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy. participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other than sle or ln e.g. acute asthma, inflammatory bowel disease. participants being treated with systemic corticosteroids for sle or ln will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment) other protocol-defined inclusion/exclusion criteria may apply

Keywords: lnp023 iptacopan lupus nephritis proteinuria urine protein-to-creatinine ratio complete renal response estimated glomerular filtration rate renal flares systemic lupus erythematosus
to document the burden of illness on the quality of life and the impact on healthcare utilization in (beta) β-thalassemia subjects who are transfusion dependent (td) and non-transfusion dependent (ntd) receiving standard of care

Conditions: Beta-Thalassemia

Summary: this is a multi-site, prospective, observational study implemented in β-thalassemia treatment centers from 5 countries (italy, turkey, greece, lebanon, and thailand). approximately one to two study sites will be identified per country and approximately 20 β-thalassemia subjects will be enrolled per country (10 transfusion dependent (td) and 10 non-transfusion dependent (ntd) with a total of approximately 100 subjects. this study will not interfere with or influence the routine clinical management of β-thalassemia patients. outcomes of interest will be collected prospectively for up to 6 months.


Eligibility criteria:
inclusion criteria: for the transfusion dependent (td) subjects: 1. male or female, \>18 years of age at the time of signing the informed consent document (icf); 2. documented diagnosis of β-thalassemia or hemoglobin e/ β-thalassemia; 3. td - defined as: ≥6 red blood cells (rbc) units in the 24 weeks prior to study participation and no transfusion free period for ≥35 days during that period; and 4. performance status: eastern cooperative oncology group (ecog) score of 0 to 1. for the non-transfusion dependent (ntd) subpopulation 1. male or female, \>18 years of age at the time of signing the informed consent document (icf). 2. documented diagnosis of β-thalassemia or hemoglobin e/ β-thalassemia 3. ntd - defined as: 0 to 5 rbc units received during the 24-week period prior to study participation (not including rbc transfusions units administered for elective surgery); 4. most recent hemoglobin ≤10 g/dl (hemoglobin values ≤ 21 days post-transfusion will be excluded) 5. performance status: ecog score of 0 to 1. exclusion criteria: for td subpopulation: 1. a diagnosis of hemoglobin s/β-thalassemia; 2. any significant psychiatric or medical conditions not related to thalassemia that would prevent the subject from participating in the study; 3. inability to read or understand the local official languages; or 4. participated in another clinical trial (interventional) \<30 days prior to study participation for ntd subpopulation: 1. received rbc transfusion ≤ 8 weeks prior to study enrollment; 2. a diagnosis of hemoglobin s/β-thalassemia; 3. any significant psychiatric or medical conditions not related to thalassemia that would prevent the subject from participating in the study; 4. inability to read or understand the local official languages; or 5. participated in another clinical trial (interventional) \<30 days prior to study participation.

Keywords: beta-thalassemia quality of life healthcare utilization transfusion dependent (td) β-thalassemia non-transfusion dependent β-thalassemia standard of care transqol sf36v2 fact-an ntd beta-thalassemia pro
car t cell therapy related cardiovascular outcomes

Conditions: Cardiovascular Diseases; B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma Refractory; B-cell Lymphoma Recurrent; Primary Mediastinal Large B-cell Lymphoma (PMBCL); Diffuse Large B Cell Lymphoma; Cardiotoxicity; Cardiovascular Complication

Summary: this will be a cohort study of all patients receiving cluster of differentiation 19 (cd19)-specific car t cell therapy for relapsed/refractory b cell haematological malignancies. patients will receive cardiac assessment and have serum cardiac biomarkers, ecg, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to car t cell therapy, 7 days post car t cell infusion, and 3 months post car t cell infusion. abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to car t cell therapy.

cd19-specific chimeric antigen receptor (car) t cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. however, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. despite this, the full extent of cardiovascular toxicity is poorly understood. this research study seeks to understand the cardiac safety of car t cells in patients who receive this therapy as part of standard care for relapsed/refractory b-cell blood cancer. they will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. these parameters will be repeated at 7 days following administration of the car t cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up. the aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.

Eligibility criteria:
inclusion criteria: * patients with capacity, (aged 16 and older) * undergoing car t cells for treatment for relapsing or refractory haematological malignancies exclusion criteria: * patients under 16 years

Keywords: cardio-oncology car t cell therapy cardiotoxicity
cognitive and emotional factors in visual exploration among patients with post-traumatic stress disorder (saillance2)

Conditions: Post-Traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is characterized by hypervigilance. in particular, previous works suggest that patients tend to scan constantly the environment for possible threats. the present project aims at investigating such attentional bias in patients with ptsd using the change blindness paradigm that offers the interesting possibility of studying sensitivity to sudden changes using ecological stimuli. more precisely, the investigators will investigate whether patients are more sensitive than matched controls to sudden changes in the visual environment and whether this hypersensitivity is specific or even stronger when visual information has an emotional content. the attentional bias will be measured using motor responses (accuracy and speed to indicate the occurrence of a change by pressing a button) as well as eye movements.


Eligibility criteria:
inclusion criteria: * a diagnosis of ptsd based on the standard dsm-iv criteria, * normal or corrected vision. * clinically stable at the testing time exclusion criteria: * history of neurological illness or trauma that occurred in the previous six months, - pregnant and nursing women, * drugs use in the last 24 hours, * an acute ocular disorder. * participants will not be under tutorship, curatorship or deprived of liberty.

Keywords: change blindness eye tracking implicit response
detection of visual-auditory reaction rates in individuals with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Cognitive Dysfunction; Nerve Damage

Summary: background: the primary purpose of our study was to understand the damage in the peripheral nerves of patients with diabetes and to determine the change in patients' reaction rates and perceptions by the age groups, duration of diabetes, fasting plasma glucose and hba1c values, and compare these with those of the healthy individuals. methods: this study was carried out at the baskent university hospital endocrinology and metabolic diseases outpatient clinic. a total of 64 patients diagnosed with type 2 diabetes and 64 healthy controls were included in the study. finger tapping, visual, and auditory reaction time tests were performed on the subjects, respectively. the subjects' fasting plasma glucose and hba1c levels, and the duration of their diabetes were recorded. analyses were performed using the spss version 25. differences were considered statistically significant when the p-value is \<0.05.


Eligibility criteria:
inclusion criteria: * right-handed individuals * must be between 18-65 ages * must be type 2 diabetics at least 6 months (for patient group) exclusion criteria: * use of alcohol-drug or similar substances, * the use of any medication that may affect neurological functions, * having color blindness, * retinopathy, * neurological disease, * cancer, * depression, * a recent history of surgery, * rheumatoid arthritis, * osteoarthritis, * and advanced osteoarthritis.
clinical evaluation and assessment of instruments and biomarkers in subjects with wilson disease

Conditions: Wilson Disease

Summary: the primary objective of the study is to determine the relevance and appropriateness of outcome assessments, including biomarkers, within the wilson disease population to inform study design and endpoint selection for future clinical studies.

given the limited information on the frequency and spectrum of disease manifestations and clinical course of wilson disease, the ux701-cl001 study aims to assess the utility and feasibility of various assessments and biomarkers to inform endpoint selection for future clinical studies, better understand the relationship between biomarkers and potential clinical outcomes, and characterize the clinical presentation of wilson disease. ux701-cl001 is a clinical survey study. subjects will complete assessments at the study site and at home to evaluate the clinical manifestations of wilson disease in clinical and real-world environments.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 12 years of age at the time written informed consent is provided. 2. confirmed diagnosis of wilson disease. 3. have a documented history of copper chelator (ie, penicillamine, trientine) and/or zinc therapy or be ≥ 1 year post liver transplant with no active associated complications. 4. willing and able to comply with all study procedures and requirements. if \< 18 years of age (or as required by region), have a caregiver who is willing and able to assist with study requirements if needed. 5. willing and able to provide written informed consent after the study has been explained and before any study-related data are collected or study-related procedures are performed. if \< 18 years of age (or as required by region), willing and able to provide written assent and have a legally authorized representative who is willing and able to provide written informed consent after the study has been explained and before any study-related data are collected or study-related procedures are performed. exclusion criteria: 1. history of liver disease due to a medical condition unrelated to wilson disease. 2. liver fibrosis stage f3 or f4. 3. decompensated hepatic cirrhosis and/or evidence of portal hypertension. 4. marked neurological disease requiring either nasogastric feeding or intensive inpatient medical care. 5. female subject who is pregnant or breastfeeding or who plans to become pregnant at any time during the study. 6. female subject of childbearing potential who has a positive urine pregnancy test on day 1 or is unwilling to have additional pregnancy tests during the study. 7. current or previous participation in a gene transfer study. 8. presence or history of any disease or condition that, in the investigator's opinion, would interfere with the subject's safety or ability to participate in the study or significantly affect interpretation of study results.
primary hyperoxaluria mutation genotyping/phenotyping

Conditions: Primary Hyperoxaluria

Summary: specific mutations relating to hyperoxaluria will be determined via dna analysis by the mayo rksc research staff.

during your study visit, we will draw one tube, about two teaspoons (1 to 1 ½ teaspoons for children), of blood from your arm. white blood cells from the sample will be used as a source of dna for genetic testing. we will use the dna to try to identify mutations (changes) in one of the genes that can cause primary hyperoxaluria. this will be done by comparing it with the structure of these genes in normal individuals, patients with primary hyperoxaluria, and family members of primary hyperoxaluria patients. in family members of primary hyperoxaluria patients, a 24 hr urine test may also be collected.

Eligibility criteria:
inclusion criteria: * ages birth to 99 years in whom clinical information is available from medical records * patients with a diagnosis of ph confirmed on previous genetic testing * patients with clinical suspicion of primary hyperoxaluria (elevated urine oxalate of greater than 0.8 mmol/1.73 m2/day (\>70 mg/1.73 m2/day), history of kidney stones, and/or nephrocalcinosis documented by medical history or imaging studies * first or second degree family members of a patient with primary hyperoxaluria exclusion criteria: * stone formers who do not have confirmed ph and do not meet the inclusion criteria for clinical suspicion of primary hyperoxaluria * unwilling or unable to provide consent/assent.

Keywords: ph ph type 1 primary hyperoxaluria hyperoxaluria primary oxalosis ph type 2 ph type 3 genetic testing for ph genetic testing for primary hyperoxaluria hereditary study for ph hereditary study for primary hyperoxaluria agxt grhpr hoga1
pharmacokinetic study of ar882 in subjects with various degrees of renal impairment

Conditions: Renal Impairment

Summary: this is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of ar882 in subjects with various degrees of renal impairment.


Eligibility criteria:
inclusion criteria: all subjects: * males and non-pregnant, non-lactating females * body weight no less than 50 kg * sua greater than or equal to 4.0 mg/dl renal impaired subjects: • history of chronic renal impairment (\> 6 months) exclusion criteria: all subjects: * malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * history of cardiac abnormalities * active peptic ulcer disease or active liver disease * history of kidney stones renal impaired subjects: • requires dialysis
lignocaine vs bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae

Conditions: Lignocaine; Bupivacaine; Postpartum Perineal Pain; Vaginal Delivery; Episiotomy; Primigravidae

Summary: in this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.

episiotomy is the most common procedure used for dilatation of the vaginal opening for giving birth. although episiotomy is associated with benefits for the mother, it may lead to short term and long-term disabilities, including postpartum perineal pain that is secondary to perineal tearing. the perineal pain experienced due to receiving an episiotomy is severe during the first few days after delivery, and it can lead to limitations in movement and difficulties with urination and defecation. bupivacaine is a long-acting local anesthetic that effectively reduces postoperative pain. in practice, bupivacaine is used for infiltration anesthesia, nerve blocks, epidural, and caudal anesthesia. it has a more selective effect on sensory nerve fibers as compared to motor nerve fibers, therefore is preferred in obstetrics. lignocaine infiltration, with the presence or absence of epidural anesthesia, is the most frequently employed local anesthetic in ameliorating postpartum perineal pain. it is a rapid-onset amide local anesthetic with a short duration of action lasting up to two hours.

Eligibility criteria:
inclusion criteria: * primigravidae with the full term undergoing vaginal delivery with episiotomy. * pregnancies and singleton vertex cephalic fetuses. * in the active phase of the first stage of labor. exclusion criteria: * patients with history of drug allergies to study drugs as this will increase the risk of complications. * patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs. * evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications. * inability to cooperate as this will affect our assessment. * patient's refusal. * any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment. * neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia. * drug abuse as they will be tolerant to the used analgesics.
re-adjustment of sweep gas flow to the during the rewarming period of the cardiopulmonary bypass

Conditions: Optimal Sweep Gas Flow; Determination of Optimal Sweep Gas Flow for Different Phases of Cardiopulmonary Bypass

Summary: the investigators designed this prospective observational study with the theory that alkalosis caused by decreased co2 solubility due to temperature increase during the rewarming period of the cardiopulmonary bypass could be prevented by reducing the sweep gas flow during the rewarming period.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * elective cpb surgery exclusion criteria: * patients undergoing minimally invasive surgery * patients undergoing robotic cardiac surgery, * patients undergoing deep hypothermia, * patients undergoing total circulatory arrest, * patients whose fio2 requirement is high that cannot be applied to target gas flow

Keywords: sweep gas flow rewarming cardiopulmonary bypass alkalosis
a randomised trial using highly purified human chorionic gonadotropin (hp-hcg) and recombinant human chorionic gonadotropin (rhcg) in women undergoing controlled ovarian stimulation

Conditions: Infertility

Summary: this trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (hp-hcg) and recombinant human chorionic gonadotropin (rhcg) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation


Eligibility criteria:
inclusion criteria: * pre-menopausal females between the ages of 18 and 39 years * documented history of infertility * body mass index (bmi) between 17.5 and 32.0 kg/m2 * regular menstrual cycles exclusion criteria: * known endometriosis stage iii and iv * known polycystic ovarian syndrome (pcos) * history of recurrent miscarriage * history of more than three previous controlled ovarian stimulation cycles