Kornimate/medical-research-clean huggingface dataset:
asct versus chemotherapy as first-line consolidation therapy int-cell lymphoma

Conditions: T-cell Lymphoma Adults

Summary: to compare the effectiveness of autologous hematopoietic stem cell transplantation and chemotherapy as first-line consolidation therapy after obtaining a complete therapeutic response in t-cell lymphoma through a multicenter retrospective real-world study in china.

t-cell lymphoma is characterized by high molecular heterogeneity, high disease aggressiveness, and high chemotherapy resistance rate, and the prognosis is extremely poor. autologous hematopoietic stem cell transplantation (asct) is an important consolidation therapy for patients with t-cell lymphoma who have achieved therapeutic response to chemotherapy, but it is still controversial whether the efficacy of asct is significantly better than that of chemotherapy consolidation in patients who have achieved a complete therapeutic response. in this study, the investigators compared the efficacy of asct with that of chemotherapy as a first-line consolidation therapy for t-cell lymphoma patients who had achieved a complete therapeutic response in a multicenter real-world study in china. this study included patients with primary t-cell lymphoma diagnosed during 2015-2021 at shanghai ruijin hospital, peking university people's hospital, and wuhan tongji hospital, and based on electronic case information, the investigators retrieved the diagnosis, staging, extranodal and bone marrow involvement, and induced and consolidated the efficacy of chemotherapy. the participants were divided into asct group and consolidation chemotherapy group according to the consolidation therapy adopted after obtaining complete therapeutic response, and the primary endpoint was adopted as progression-free survival, and the secondary endpoints included overall survival, non-recurrent death, and disease progression/recurrence, so as to explore the efficacy of asct and chemotherapy as a first-line consolidation therapy after obtaining a complete therapeutic response in t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of t-cell lymphoma, including, but not limited to, peripheral t-cell lymphoma, not otherwise specified (ptcl-nos), angioimmunoblastic t-cell lymphoma (aitl) , alk-negative anaplastic large cell lymphoma (alcl, alk-negative), enteropathy-associated t-cell lymphoma (eatl), hepatosplenic t-cell lymphoma (hstcl), and extranodal nk/t-cell lymphoma (enktl ) * 18-75 years old; * achievement of a complete response (cr) post-chemotherapy; * obtaining a complete response (cr) after chemotherapy;-consistent follow-up visits post-treatment, with comprehensive follow-up data available; exclusion criteria: * initially diagnosed with alk-positive anaplastic large cell lymphoma (alcl, alk- - -cr was not achieved after treatment; * lack of complete follow-up information or lack of consent for follow-up and data collection * t-cell lymphoma secondary to other malignancies

Keywords: nhl t-cell lymphopma adults
a study of mezigdomide in healthy participants and participants with hepatic impairment

Conditions: Hepatic Impairment

Summary: the aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: hepatic impaired participants: * participants have mild, moderate, or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use. * participants have mild (group a), moderate (group b), or severe (group c) hepatic impairment as defined by child-pugh score. matched healthy participants: * participant must be free of any clinically significant disease that would interfere with the study evaluations. * participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator. exclusion criteria: all participants: * history of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide. * contraindication or intolerance to first-generation antihistamine medications. hepatic impaired participants: -clinical laboratory test results: * platelet count lower than 30,000/microliter (μl) at screening or day -1. * absolute neutrophil counts lower than 1,500/μl at screening or day -1. matched healthy participants: -history of or suspected benign ethnic neutropenia. other protocol-defined inclusion/exclusion criteria apply

Keywords: mezigdomide bms-986348 cc-92480
effect of the hiv protease inhibitors atazanavir and lopinavir/ritonavir on cardiovascular disease risk factors

Conditions: Endothelial Dysfunction

Summary: hiv protease inhibitors (pis) are a class of antiretroviral drugs used to inhibit viral replication. they do so by interfering with a key step in the replication process. some hiv pis have been associated with an increased risk of adverse cardiovascular side effects. further study is needed, however, to assess the full extent of effect of newer hiv pis, including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. this study will compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease risk factors in healthy people without hiv.

antiretroviral therapy for hiv, particularly with the use of pis, is associated with an increased risk of heart attack. specific cardiovascular side effects seen with the use of some pis include insulin resistance, abnormal blood lipid levels, and endothelial dysfunction (abnormalities in the cells that line the inner surface of blood vessels). past studies have shown that treatment with indinavir, an older pi, results in significant endothelial dysfunction, which may be the main cause for the increase in cardiovascular risk. indinavir is now seldom used in clinical practice, and the newer pis atazanavir and combination lopinavir/ritonavir now account for nearly 70% of total pi use in the united states. it is not known what effect these new pis have on endothelial dysfunction. this study will compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease risk factors, including abnormal glucose metabolism and endothelial dysfunction, in healthy people without hiv. participation in this study will last 4 weeks. all participants will undergo initial assessments that will include various vascular and metabolic evaluations. body weight, height, basal heart rate, and systolic and diastolic blood pressure will also be measured. participants will then be assigned randomly to receive 4 weeks of treatment with 400 mg of atazanavir per day plus placebo, 400 mg/100 mg of lopinavir/ritonavir twice per day plus placebo, or placebos for both drugs per day. upon completing the 4 weeks of treatment, participants will repeat the initial assessments.

Eligibility criteria:
inclusion criteria: * healthy and lean with normal lipids * not infected with hiv or viral hepatitis exclusion criteria:
clinical performance of two different bevel preparations in class iv lesions using nanofilled composite

Conditions: Class IV Dental Caries

Summary: the purpose of the study is to compare and evaluate clinical performance between two different bevel preparations in class iv lesions using nano-filled composite restorations.

the main reason for failure in anterior composite restorations is restoration fracture and aesthetic appearance. restorations in anterior teeth are subjected to high-impact stresses produced through an incisal angle in class iv restorations, require high fracture resistance. it is the biomechanics of restorations that determine their functionality, retention, and functional longevity. stair-step chamfer preparation is a modification of chamfer preparation that follows the vertical and horizontal anatomical contours, hence, achieves high degree of aesthetics along with exposure of enamel for bonding. according to current literature, no studies have analyzed the clinical performance of different bevel design using direct nano-filled composite resin restorations in class iv lesions. therefore, the aim of this study is to compare and evaluate clinical performance between two different bevel preparations in class iv lesions using nano-filled composite restorations. study will be conducted at post graduate institute of dental sciences, rohtak in department of conservative dentistry \& endodontics. time frame of the study will be 12 months. patients ≥ 18 years of age with class iv lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries will be enrolled in the study. after complete carious removal, tooth will be prepared in class iv lesions according to 2mm bevel or 2mm stair-step chamfer preparation group, selective enamel etching and bonding of the tooth using universal adhesive will be done. the cavity will be restored using nanofilled composite by layering technique. the restorations will be undergoing the standard finishing and polishing procedures. follow up of patients will be carried out at 3 months for clinical evaluation, 6 and 12 months for both radiographic and clinical evaluation. restorations will be assessed clinically according to fdi criteria.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age at the time of treatment. * class iv lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries. * patients with complete and normal occlusion and teeth with proximal contacts. * patients not having periodontal or pulpal diseases. * positive response to the cold test and electric pulp test. exclusion criteria: * patients with immunocompromised status or debilitating systemic diseases. * patients with uncontrolled parafunctional habits. * class iv lesion with involvement of pulp.ix * class iv lesions with no involvement of dentin. * patients presenting extremely poor oral hygiene. * patient with high caries index
a577-nm pro -yellow laser in treatment of striae rubra

Conditions: Striae Rubra

Summary: stretch marks or striae are common skin condition occurring in both genders, but they are more prevalent among women. these are linear dermal scars that are accompanied by epidermal atrophy. they usually occur frequently in numerous physiological and pathological conditions, such as adolescent growth, pregnancy, obesity, cushing disease, marfan syndrome, and long-term systemic or topical steroid use. decreased expression of collagen and fibronectin genes has also been associated with striae. the pro-yellow laser systems can be used in a wide range of indications such as facial erythema, facial telangiectasia, port wine stain nevus, rosacea, poikilo derma civatte, and becker's nevus some of these indications are clinical lesions in the vascular pattern; some are related to the factors that trigger vascularity, such as vascular endothelial growth factor (vegf) in etiopathogenesis


Eligibility criteria:
inclusion criteria: * .patients diagnosed with striae rubera. .age groups: at any age. .sex : ( females). * co-operative patient exclusion criteria: * pregnancy . * patient using drugs exacerbating stria as topical or systemic steroid, and patients using other forms of treatment for stria as topical tretinoin, emollients, glycolic acid peel and laser, because that might affect the result of our study. * stria alba. * skin infection (viral, bacterial or parasitic). * immunosuppressed patients or with history of malignancy or radiation therapy and chronic debilitating diseases and cushing syndrome. * hypersensitivity to light and intak of photosensitizing drugs.
a study comparing the safety, tolerance, and efficacy of various doses of sk-0403 versus placebo and sitagliptin 100 mg in patients not well-controlled on metformin therapy

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the safety and efficacy of a range of doses of sk-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.


Eligibility criteria:
inclusion criteria: * male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive * screening hba1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies \[dpp-4 inhibitors and glp-1 analogues\]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose. * no antidiabetic medication other than metformin for 3 months prior to randomization. * fasting plasma glucose less than 270 mg/dl (15 mmol/l) at screening. * body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening. exclusion criteria: * history of type 1 diabetes. * received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit. * use of 3 or more oral antidiabetic medications at the time of the screening visit.
a study of enfortumab vedotin in japanese subjects with locally advanced or metastatic urothelial carcinoma

Conditions: Metastatic Urothelial Cancer

Summary: the objective of this study is to assess the safety, tolerability and pharmacokinetics of enfortumab vedotin (asg-22ce) when administered intravenously to japanese subjects with locally advanced or metastatic urothelial carcinoma. this study will also assess the immunogenicity as defined by the incidence of anti-drug antibody (ada) and anti-tumor activity of enfortumab vedotin (asg-22ce) when administered intravenously to japanese subjects with locally advanced or metastatic urothelial carcinoma.

all subjects will receive a single 30 minute intravenous (iv) infusion of enfortumab vedotin (asg-22ce) once weekly for 3 weeks of every 4 weeks (i.e., on days 1, 8, and 15). a cycle is 28 days.

Eligibility criteria:
inclusion criteria: * subject must have histologically confirmed, locally advanced (tnm classification t3b and any n; or t and n2-3) or metastatic transitional cell carcinoma of the urothelium (tccu) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). subjects with urothelial carcinoma with squamous differentiation or mixed cell types are eligible. * subject must be able to submit a tumor tissue samples for nectin-4 expression analysis at central laboratory. * subject must have failed at least one prior chemotherapy regimen for advanced disease. urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy. * subject must have measurable disease according to response evaluation criteria in solid tumor (recist) (version 1.1). * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * preexisting sensory neuropathy grade ≥ 2. * preexisting motor neuropathy grade ≥ 2. * uncontrolled central nervous system metastasis that requires active treatment. * any anticancer therapy within 14 days prior to the first dose of study drug. * subjects with pre-existing immunotherapy-related adverse events requiring high doses of systemic steroids are not eligible.

Keywords: urothelial carcinoma enfortumab vedotin asg-22ce padcev asg-22me metastatic urothelial cancer
a trial evaluating bjt-778 vs delayed treatment for the treatment of chronic hepatitis delta infection

Conditions: Chronic Hepatitis D Infection

Summary: this is a phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a bjt-778; btg) for chronic hepatitis delta virus (hdv) infection. the comparator in this study will be 24-weeks of delayed treatment. during the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. at the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

study will consist of 3 study arms. approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms: * arm 1: participants randomized to arm 1 will receive brelovitug 300 mg subcutaneously once weekly. * arm 2: participants randomized to arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks. * arm 3: participants randomized to arm 3 will attend study clinic visits and delay treatment with brelovitug. at week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent. * chronic hdv infection * hdv rna \>500 iu/ml at screening. * abnormal alt (\>upper limit of normal) at screening. * willing to take or already taking hbv nucleos(t)ide therapy exclusion criteria: * pregnant or nursing females. * unwilling to comply with contraception requirements during the study. * difficulty with blood collection and/or poor venous access for the purposes of phlebotomy * presence of other liver disease(s) (does not include hbv or hdv infection) such as non-alcoholic steatohepatitis (nash), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. * clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). * solid organ or bone marrow transplantation note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis delta virus hdv hepatitis d infection hepatitis d virus
inflammation in women with urgency urinary incontinence treated with anticholinergics

Conditions: Urinary Incontinence; Urgency Urinary

Summary: urinary incontinence (ui) is a very common condition affecting women of all ages. the objective of this pilot study is to better understand the urinary microbiome and associated inflammatory markers in blood and urine in women with urgency ui. the study will assess how inflammation may affect response to standard of care anticholinergic medication treatment for urgency urinary incontinence.

this study is designed as a prospective pilot study of women presenting to the urogynecology clinic with urgency urinary incontinence symptoms who are offered treatment with a standard of care anticholinergic medication for six weeks. the patient will be asked to provide a catheterized urine sample at baseline and 6 weeks and blood draw only at baseline. study participants will fill out a urinary distress inventory-6 (udi-6) questionnaire at baseline and fill a bladder diary for 48 hours before starting the anticholinergic medication. the urine will be assessed by standard and enhanced urine cultures and dna amplification and 16s rrna sequencing for urinary microbiome along with inflammatory markers in the urine. inflammatory markers in both the blood and urine will be measured using immunoenzyme assays. measurements for microbiome will be repeated for all patients at 6 weeks. baseline urinary symptoms at enrollment and variation of symptoms after 6 weeks of anticholinergic treatment will be assessed using the udi-6 questionnaire and a bladder diary.

Eligibility criteria:
inclusion criteria: * postmenopausal (age ≥ 50) women with urgency urinary incontinence (uui) * english speaking * willing to take anticholinergics for at least 6 weeks * willing to complete udi-6 and voiding diary at baseline and 6 weeks * willing to give urine and blood for study at baseline and 6 weeks exclusion criteria: * have taken anticholinergic medication within the last month * have taken antibiotics within the last month * urinary tract infection (uti) in the last three months * neurological disease (eg. parkinson's disease, multiple sclerosis, etc.) * immunological deficiencies * history of sexually transmitted disease (std) * lack of consent * not ambulatory (e.g. uses a wheelchair)

Keywords: urinary incontinence urgency urinary anticholinergic treatment urinary microbiome
igf-1, igfbp3, als normative ranges in healthy pediatric spanish population

Conditions: IGF-1 Deficiency

Summary: to determine the normative ranges of the insulin-like growth factor 1 (igf-1), insulin-like growth factor-binding protein 3 (igfbp-3), acid-labile subunit (als) according to age, sex and pubertal stage of a healthy paediatric spanish population.


Eligibility criteria:
inclusion criteria: * children of either sex of caucasian parents * age: newborns up to and including 18 years of age * length/height, weight and body mass index (bmi) within the mean +/- 2sd (standard deviation) and in accordance with the growth charts of the 2010 spanish cross-sectional growth study (carrascosa lezcano et al 2010) * signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years exclusion criteria: * early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys) * chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes * an acute disease during the last two weeks prior to recruitment * any clinically significant out-of-range lab value * healthy paediatric volunteers who are under medical treatment (contraception permitted) * a family history of short stature (either parent \< p3) * children born small for gestational age (birth weight, length, or head circumference \< p10) * adopted children or conceived through in vitro fertilization ( ivf ) * subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures
long-acting growth hormone in children compared to daily rhgh

Conditions: Growth Disorders

Summary: the trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhgh.

this study is designed as a pivotal study to compare the safety and efficacy of a selected dose regimen of somavaratan to daily rhgh. the study is a randomized, multi-center, open label study of 12 months duration. the primary endpoint is height velocity at 12 months.

Eligibility criteria:
inclusion criteria: * chronological age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys). * pre-pubertal status: absent breast development in girls, testicular volume \< 4.0 ml in boys. * diagnosis of growth hormone deficiency (ghd) as documented by two or more growth hormone (gh) stimulation test results ≤ 10.0 ng/ml. * height standard deviation score (sds) ≤ -2.0 at screening. * weight for stature ≥ 10th percentile. * insulin-like growth factor-i (igf-i) sds ≤ -1.0 at screening. * delayed bone age (≥ 6 months). exclusion criteria: * prior treatment with any growth promoting agent * history of, or concurrent significant disease (for example, diabetes, cystic fibrosis, renal insufficiency). * chromosomal aneuploidy, significant gene mutations (other than those that cause ghd) or confirmed diagnosis of a named syndrome. * a diagnosis of attention deficit hyperactivity disorder. * daily use of anti-inflammatory doses of glucocorticoid. * prior history of leukemia, lymphoma, sarcoma or cancer. * treatment with an investigational drug in the 30 days prior to screening. * known allergy to constituents of the study drug formulation. * ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening. * significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants. * significant abnormality in screening laboratory studies

Keywords: vrs-317 growth hormone deficiency long acting recombinant growth hormone long acting growth hormone pediatric growth hormone deficiency growth hormone replacement therapy versartis xten human growth hormone somavaratan growth failure