Kornimate/medical-research-clean huggingface dataset:
samsung medical center-lymphoma cohort study

Conditions: Lymphoma

Summary: the purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. thus, this study is going to assess following factors which amy probably affect the treatment outcome and the risk of treatment-related morbidity. 1. biologic factors associated with the aggressiveness of lymphoma * molecular markers in serum, cytogenetic markers 2. factors associated with the risk of treatment-related morbidity * comorbidity, nutrition status, performance status, quality of life at diagnosis

Eligibility criteria:
inclusion criteria: * patients who were diagnosed as lymphoma * over 15 years old * patients who agreed the enrollment of study * informed consent for sampling exclusion criteria: * patients who do not want to join the study

Keywords: lymphoma prognosis morbidity
comparison of high-dose il-2 and high-dose il-2 with radiation therapy in patients with metastatic melanoma.

Conditions: Metastatic Melanoma

Summary: the purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose il-2 to patients treated with high-dose il-2 along with radiation therapy.

all patients will receive high-dose il-2. half the patients enrolled will be randomly selected to receive radiation therapy to up to three tumors prior to receiving high-dose il-2. among the first 20 patients enrolled, those assigned to receive radiation will receive a single dose of radiation and for patients 21-44, those assigned to receive radiation will receive 2 doses of radiation.

Eligibility criteria:
inclusion criteria: * histological confirmation of melanoma will be required by previous biopsy or cytology. * patients must be ≥ 18 years of age. * patients must have tumors amenable to sbrt in lungs, mediastinum, chest wall, bones (other than long bones), or liver (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. patients may have other metastases but only a maximum of 3 will be treated. * ecog performance status of 0-1. * women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. the results of this test must be negative in order for the patient to be eligible. in addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy. * patients must sign a study-specific consent form. exclusion criteria: * no metastatic site amenable to sbrt. * patients with brain metastases not candidates for radiosurgery. * previous radiation to sites proposed for radiation as part of this study. * patients with active systemic, pulmonary, or pericardial infection. * pregnant or lactating women. * evidence of ischemia on exercise tolerance test, stress thallium study, or baseline ekg. * dlco, fev1 or fev1/fvc less than 70% of predicted due to clinically significant underlying pulmonary disease. for any pulmonary function test values less than predicted values, the pi will review, and document the patient's suitability for high dose il-2 therapy. * wbc \< 3.0 x 109/l * hgb \< 9.0 g/dl * ast/alt \> 3 times the upper limit of the normal range * total bilirubin \> 1.9 g/dl * creatinine \> 1.9 g/dl * patient requires chronic steroids.

Keywords: metastatic melanoma il-2 interleukin 2 radiation stereotactic body radiation treatment sbrt immunotherapy
a study of aeb1102 (pegzilarginase) in patients with arginase i deficiency

Conditions: Arginase I Deficiency; Hyperargininemia

Summary: the purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous aeb1102 in patients who complete study caeb1102-101a.

purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous aeb1102 in patients who complete study caeb1102-101a.

Eligibility criteria:
inclusion criteria: 1. complete treatment in study caeb1102-101a without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing 2. confirmation by the investigator and the sponsor determine that it is acceptable for the patient to continue dosing with aeb1102 3. if female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment 4. if sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration 5. patient or legal guardian is able and willing to provide written informed consent and where required assent, and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification), prior to any screening procedures exclusion criteria: 1. clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
tacrolimus combined with prednisone treatment of idiopathic membranous nephropathy and nephrotic syndrome

Conditions: Idiopathic Membranous Nephropathy; Nephrotic Syndrome

Summary: idiopathic membranous nephropathy (imn) is one of the most common forms of nephrotic syndrome (ns) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory ns. whether it is effective in imn has not been reported. we therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

idiopathic membranous nephropathy (imn) is one of the most common forms of nephrotic syndrome (ns) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. however, the effect was not satisfying and the side-effects of the above immunosuppressive agents were often a worrying problem. tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory ns especially fsgs. whether it is effective in imn has not been reported. we therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

Eligibility criteria:
inclusion criteria: * all patients were diagnosed as idiopathic membranous nephropathy according to renal histology, with nephrotic syndrome, serum creatinine less than 2.5mg/dl, 18\~70 years old, signed the informed consent and willing to be followed up according to the protocol. exclusion criteria: * patients who had received immunosuppressive therapy within the previous 3 months, complicated other severe renal diseases, serum creatinine higher than 2.5mg/dl, severe infection, diabetes mellitus, liver disease, pregnancy, lactating, and anticipated poor compliance with the protocol.
irinotecan, carboplatin, bevacizumab in the treatment of patients with extensive stage small cell lung cancer

Conditions: Carcinoma, Small Cell Lung

Summary: this multicenter phase ii trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. this clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.

eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. the interval between chemotherapy courses will be 28 days. if after 6 courses of treatment, patient's response is a cr/pr/sd they will continue on bevacizumab until tumor progression or up to 6 cycles (6 months) total. treatment sequence: * irinotecan 60mg/m2 on days 1, 8, and 15 * carboplatin auc=4 day 1 only * bevacizumab 10 mg/kg days 1 and 15

Eligibility criteria:
inclusion criteria: * histologically confirmed small cell lung cancer,extensive stage disease. * measurable or evaluable disease * no previous chemotherapy * able to perform activities of daily living with minimal assistance * adequate hematological, live and kidney function * provide written informed consent exclusion criteria: * limited stage disease * peg or g tubes * hemoptysis * abdominal fistula, perforation, or abscess within the previous 6 months * women who are pregnant or lactating * proteinuria * serious nonhealing wound, ulcer, or bone fracture * evidence of bleeding diathesis or coagulopathy * uncontrolled or serious cardiovascular disease * uncontrolled brain metastasis * major surgical procedure, open biopsy, or significant traumatic injury within 28 days; fine needle aspiration within 7 days * patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment

Keywords: lung cancer, small cell extensive
female sexual dysfunction in breast cancer patients

Conditions: Female Breast Cancer

Summary: breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females.

in egypt, cancer breast is one of the commonest cancers among females representing 38.8%.cancer breast among females ranked the top with a high frequency in lower, middle, upper egypt (33.8%,26.8%,38.7% resp.). women who developed breast cancer were more amenable than women who remained free of breast carcinoma to experience reduced physical function, vitality, social function. difficulties related to sexuality and sexual functioning were common and occurred soon after surgical and adjuvant treatment. addressing these problems is essential to improve the quality of life of young women with breast cancer. sexuality is a basic and important domain of human experience that can be damaged during and following cancer treatment. the risk of sexual dysfunction is even of greater importance among young cancer patients and survivors, with young breast cancer patients at particularly high risk. in cancer breast patients, various factors can induce sexual dysfunction. some of these factors; hormonal alterations induced by chemotherapy and radiotherapy, or physiological and functional disturbances are related to the deterioration of physical condition. these factors are strictly clinical. other factors which induce disturbances in sexual behavior, such as anxious\\ depressive reactions in adapting to illness and treatment and cancerophobic reactions and loss of self esteem that accompany any illness are more psychological\\ psychiatric in nature. having sexual problems (or dysfunction) includes experiencing disturbances in sexual desire and physiological changes associated with loss of sexual desire and arousal, reduction in sexual pleasure, difficulty achieving orgasm, anxiety about sexual performance and pain during intercourse.

Eligibility criteria:
inclusion criteria: * age: 18-40 years old. * social status: married. * (performance status): who 0-1 * 0-asymptomatic (fully active, able to carry on all predisease activities without restriction) * 1-symptomatic but completely ambulatory (restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature. for example, light housework, office work) exclusion criteria: * pregnant women. * comorbidities (diabetes mellitus., hypertension). * female genital tract disease.
periodontal health status in patients with systemic sclerosis

Conditions: Systemic Sclerosis; Periodontitis

Summary: the aim of the research will be to evaluate the effects of nspt on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (vegf, tgf-β, il-17) in the gcf in ssc patients in comparison with systemically healthy controls. twenty systemic sclerosis patients with periodontitis (ss group) and twenty systemically healthy periodontitis patients (p group) will be enrolled in the present study. the results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.


Eligibility criteria:
inclusion criteria: * established diagnoses of systemic sclerosis and periodontitis (study group), * age ≥ 18 * presence of minimum 12 teeth exclusion criteria: * concurrent inflammatory mediated rheumatic diseases * pregnancy or lactation * active cigarette smokers * a history of periodontal, antibiotics or non-steroidal drug therapy in the past 6 months.

Keywords: systemic sclerosis periodontitis antioxidants saliva
banding without resection in small subepithelial tumours

Conditions: Gastrointestinal Subepithelial Tumors

Summary: to analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.

multicenter prospective study analysing the effectiveness and safety of endoscopic band ligation without resection in small (≤15-mm) gastrointestinal subepithelial tumours. this endoscopic technique will be complemented with a sink (single-incision needle-knife) biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old. * endoscopic ultrasound (eus) image of a gastrointestinal subepithelial tumour (set) ≤15-mm. * patient capable of understanding and signing informed consent form. * patient understanding the type of study and complying with the follow-up of complementary tests during the study duration. exclusion criteria: * sets \>15-mm. * sets with clear diagnosis of eus benign semiology: ie., lipoma, ectopic pancreas. * patients with multiple sets (e.g., carcinoids). * vascular sets (doppler effect by eus). * severe coagulation disorder: inr \>1.5 not correctible with administration of plasma and/or platelets \<50,000/mm3. * conditions that preclude upper digestive endoscopy, such as stenosis. * pregnancy or breast-feeding. * failure to sign informed consent form. * patients with functional diversity who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative. * patients unable to adhere to subsequent follow-up requirements. * patients with a life expectancy of less than 12 months.

Keywords: endoscopic ultrasound small gastrointestinal subepithelial tumours endoscopic band ligation without resection single-incision needle-knife biopsy pre-cancerous tumours multicenter observational cohort study
estrogen in postmenopausal women with er positive metastatic breast cancer after failure of sequential endocrine therapy

Conditions: Breast Cancer; Cancer of the Breast; Neoplasms, Breast

Summary: this trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.

prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common technique used to treat post-menopausal women with hormone sensitive metastatic disease that resulted in durable responses with regression of disease. a randomized trial comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of response with long-term follow-up data confirming a survival benefit for those treated with the estrogen preparation. additional data has shown that post-menopausal women with hormonally sensitive tumors that have progressed on prior endocrine therapies responded to treatment with pharmacologic doses of estrogen. these data, coupled with pre-clinical data that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death within the tumor) and tumor regression in exhaustively treated endocrine resistant disease form the rationale for the proposed clinical trial. this trial seeks to confirm the response rate for estrace treatment in a patient population heavily pre-treated with modern endocrine therapies.

Eligibility criteria:
inclusion criteria: * histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer * clinically determined evaluable disease * post-menopausal woman * previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies. * may have had chemotherapy for adjuvant \&/or metastatic disease. * may have had radiation therapy but not to the only site of disease. * ecog performance status \</= 2. * life expectancy of \> 6 months exclusion criteria: * chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial * brain metastasis * prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus * current vaginal bleeding * hypercalcemia or hypocalcemia * history of or active hepatic adenoma * no other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix

Keywords: breast cancer metastatic breast cancer er positive breast cancer hormonal therapy
breathing with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of amyotrophic lateral sclerosis (als) patients evaluated via peak expiratory flow on cough (pefc) measurements. the evolution of their pefc is monitored to see if the curative management can have a positive impact on the latter.

amyotrophic lateral sclerosis (als) is a rare neurodegenerative pathology without curative treatment at present, the outcome is fatal after 3 to 5 years of evolution on average. the disease results in progressive paralysis of the muscles involved in voluntary motricity (progressive and intricate impairment of locomotor, phonation and swallowing capacities as well as ventilatory function). in france, the management of als is based on a diversified multidisciplinary follow-up (physiotherapy, speech therapy, occupational therapy, neuropsychology) in the als reference center in conjunction with the city care networks. it is centered on the evaluation, and the early compensation of the various symptoms, especially the respiratory problems. thus, this study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of these patients, evaluated via cough peak expiratory flow measurements (cpef). the study is conducted in collaboration with the physiotherapists of each patient enrolled, to evaluate the respiratory function by peak expiratory flow on cough (pefc) after 4 weeks of treatment with mechanical in-exsufflator (mie) (3 weekly sessions for two weeks, then one daily session for 2 weeks) in als patients presenting with a poorly effective cough (pefc between 160 and 255 l/min) and having an indication of punctual mie.

Eligibility criteria:
inclusion criteria: * confirmed als categorized as probable or certain according to the revised awaji-shima criteria \[27\]. * als of spinal, bulbar or respiratory forms * peak flow measure between 160 and 255 l/min (recommendation of mie in case of congestion, with the possibility of daily sessions) * patient who has not benefited from treatment by mie in the past year (less than 10 sessions in total) * patient able to use the mie and perform the collection, or having a caregiver able to help * patient receiving physiotherapist treatment greater than or equal to twice a week exclusion criteria: * psychiatric (dsm-5) or cognitive disorders incompatible with participation in the study * contraindication to the use of an mie (pneumothorax for example) * insufficient level in french for understanding the study and completing the questionnaires * current or past participation in another innovative research or care program relating to respiratory functions * emergency situation for which the mie must be set up within less than a week exclusion during the study : * appearance of a serious contraindication to the practice of mie during the study (for example rib fracture during a fall) * patient's physiotherapist refusing to do the study

Keywords: mechanical in-exsufflator physiotherapy cough peak expiratory flow on cough
serum vitamin d and gingival crevicular fluid levels of osteocalcin and n-terminal telopeptide

Conditions: D Vitamin Deficiency; Osteocalcin; Gingival Crevicular Fluid

Summary: this study examines the relationship between serum vitamin d levels and bone metabolism markers-osteocalcin and n-terminal telopeptide (ntx)-in gingival crevicular fluid (gcf) of periodontally healthy and periodontitis patients. a total of 120 male participants (60 healthy, 60 with periodontitis) aged 25-40 were included and categorized based on their serum vitamin d levels.

recent evidence suggests that vitamin d, a key regulator of bone metabolism, may play a role in periodontal health by influencing bone turnover markers such as osteocalcin and n-terminal telopeptide (ntx). this study aims to investigate the effects of serum vitamin d levels on these bone metabolism markers in gingival crevicular fluid (gcf) of periodontally healthy and periodontitis patients. a total of 120 male participants aged 25-40 years were enrolled, comprising 60 periodontally healthy individuals and 60 patients diagnosed with periodontitis. participants were further categorized into subgroups based on their serum vitamin d levels (0-10 ng/ml, 11-20 ng/ml, and 21-30 ng/ml). gcf samples were collected from maxillary premolar and molar sites and analyzed using enzyme-linked immunosorbent assay (elisa) to measure osteocalcin and ntx concentrations.

Eligibility criteria:
inclusion criteria: * one hundred and twenty male patients, consisting of 60 periodontally healthy patients and 60 patients with periodontitis, aged between 25 and 40 years, non-smoking, who had not received periodontal treatment in the last 6 months, with no systemic diseases, and whose vitamin d levels had been determined, were included in the study. exclusion criteria: * female individuals * smokers * individuals with systemic diseases (diabetes mellitus, hyperthyroidism, -malabsorption, liver and renal failure, or those receiving osteoporosis treatment) * individuals who have undergone periodontal treatment within the last 6 months * individuals on regular medication * individuals who did not provide informed consent * individuals with poor cooperation

Keywords: vitamin d osteocalcin n-terminal telopeptide gingival crevicular fluid