Kornimate/medical-research-clean huggingface dataset:
a single-center clinical trial of bortezomib in management of immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia

Summary: primary immune thrombocytopenia (itp) is a disorder caused by autoantibody-mediated platelet destruction and decreased platelet production. it has been reported that refractory itp is closely related to long-lived plasma cells (pcs), which are resistant to glucocorticoids, conventional immunosuppressive and cytotoxic drugs, irradiation and b-cell depletion therapies. proteasome inhibition bortezomib is one of the most promising therapeutic approaches to target pcs, since this strategy has been shown to efficiently eliminate multiple myeloma cells, that is, transformed pcs. it also has been successfully used in sle-like mice, experimental autoimmune mg rats and experimental hemophilia-a mice that develop anti-factor viii antibodies in preclinical models by depleting both short-lived and long-lived pcs. additionally, treatment with bortezomib resulted in a rapid clinical response in a patient with refractory thrombotic thrombocytopenic purpura associated with the depletion of inhibitory autoantibodies against adamts13, a metalloproteinase that cleaves the von wille-brand factor, which is produced by plasma cells. hence, the elimination of autoreactive pcs by proteasome inhibitors might represent a new treatment strategy for autoantibody-mediated diseases. to date, refractory itp is lacking of effective treatments and these findings encouraged us to conduct a study of bortezomib in management of itp with high anti-platelet antibodies level. data from this study may provide some idea of bortezomib in the treatment of itp.

the investigators are undertaking a single-center, single-arm study of 20 primary itp adult patients from shandong university qilu hospital . all the participants are selected to receive bortezomib treatment (given intravenously at a dose of 1.3mg/m2 on days 1,4,8,11). platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * failure to achieve at least response * need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. need of on-demand or adjunctive therapy alone does not qualify the patient as refractory * primary itp confirmed by excluding other supervened causes of thrombocytopenia exclusion criteria: * pregnancy * hypertension * cardiovascular disease * diabetes * liver and kidney function impairment * hcv, hiv, hbsag seropositive status * patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Keywords: bortezomib immune thrombocytopenia
the accuracy of infrared thermographic imaging for assessment of periodontal status

Conditions: Periodontal Diseases

Summary: the diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. the produced thermal images correlate with variations in local blood supply and tissue metabolism. thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. however, the validity of this tool compared to standard tools should be evaluated.

a total of 45 of consecutive patients attending the periodontology outpatient clinic will be examined using standard periodontal clinical parameters including; plaque index (pi), gingival index (gi), probing depth (pd), clinical attachment level (cal), and standardized periapical radiograph, to identify patients with gingivitis, periodontitis, or healthy periodontium , these 45 patients will be clustered into 3 clusters consisting of 15 patients each to represent each category. the same patients will be examined using an infrared thermal camera (fluke pti120 pocket thermal imager), the settings will be all according to the standards of infrared medical diagnosis then the acquired images will be analyzed with (fluke smartview ir analysis reporting software and mobile application). the images will be interpreted to detect the temperature changes in each mm in tissues in order to determine the patients with gingivitis, periodontitis, or healthy periodontium by an investigator blinded to clinical diagnosis. then the diagnostic sensitivity and specificity of thermographic images for diagnosis of periodontal diseases will be calculated

Eligibility criteria:
inclusion criteria: * the patients will be enrolled into the study based on the following inclusion criteria: 1. patients with generalized gingivitis 2. patient with generalized periodontitis . 3. patient with healthy periodontium . 4. both genders above 18 y to 60 y . exclusion criteria: * the patients will not be enrolled into this study based on the following exclusion criteria: 1. pregnant women . 2. smokers . 3. patients on medications that cause xerostomia as diuretics , antidepressants ,bronchodilators ,antihistaminics , antiepileptic ( etc ..) 4. patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the during the study . 5. molars according to camera specifications 6. handicapped patients 7. para functional habits as mouth breathing and tongue thrusting

Keywords: thermography thermal changes periodontal disease
prevent inability to control urination

Conditions: Urinary Incontinence

Summary: the purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

this is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Eligibility criteria:
inclusion and exclusion criteria 1. female 55 through 80 years old 2. post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy. 3. continent of urine (using the mesa definition of continence) defined as: 1. no previous incontinence episode except during pregnancy and/or postpartum period. 2. urine loss less than 6 days during the last 365 days 3. no previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy. 4. no history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma. 5. no reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating. additional criteria are applied at a physical examination: 1. mini mental status of at least 24 2. negative for objective urine loss during coughing.

Keywords: self care behavior modification
clinical study on safety and efficacy of anti-cll1 /+cd33 car t cells in the treatment of acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.

the primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-cll1 /+cd33 car t cells in patients with refractory/recurrent acute myeloid leukemia. a total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00\~2.50x10\^6/kgcar-positive t cells.

Eligibility criteria:
inclusion criteria: 1. the patient or his/her legal guardian volunteers for the trial and signs an informed consent form; 2. age range 1-18 years; 3. acute myeloid leukemia (aml) with cll1 and cd33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ; 4. the main organ functions of the patients were good: (1) liver function: alt/ast \< 3 times the upper limit of normal (uln) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine \< 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (lvef)≥40% ; 5. the blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection; 6. ecog score was 0-2. exclusion criteria: 1. the patients had uncontrollable infectious diseases within 4 weeks before the enrollment; 2. active hepatitis b/c virus; 3. hiv infection, treponema syphilis positive patients; 4. pathological diagnosis of primary tumors other than acute myeloid leukemia; 5. suffering from serious autoimmune diseases or immunodeficiency diseases; 6. the patient is allergic to antibodies or cytokines and other macromolecular biological drugs; 7. pregnant or lactating women; 8. patients who were considered ineligible for study for other reasons.

Keywords: aml cll1 cd33
medical therapy of prostatic symptoms

Conditions: Prostatic Hyperplasia; Prostatic Hypertrophy, Benign

Summary: the medical therapy of prostatic symptoms (mtops) is a clinical research study sponsored by the national institutes of health (nih). the study will test whether the oral drugs finasteride (proscar) and doxazosin (cardura), alone or together, can delay or prevent further worsening of symptoms in men with benign prostatic hyperplasia (bph). mtops is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of bph. seventeen u.s. medical centers recruited 2,931 men diagnosed with symptomatic bph between december 1995 and march 1998. study doctors will continue to follow these men through november 2001 on a quarterly basis. in addition to the clinical progression of bph, mtops will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.


Eligibility criteria:
inclusion criteria: * peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided volume is at least 125 ml. * american urological association symptom score is greater than or equal to 8 and less than or equal to 30. * voluntarily signed the informed consent agreement prior to the performance of any study procedures. exclusion criteria: * serum prostate specific antigen level greater than 10 ng/ml. * supine blood pressure less than 90/70 mmhg. orthostatic hypotension. * any prior medical or surgical intervention for bph. * received any prior experimental intervention (either medical or surgical) for prostate disease or enrolled in any other study protocol.

Keywords: bph progression medical therapy finasteride doxazosin randomized multi-center clinical trial proscar cardura
comparision of various biomarkers between peripheral and pulmonary blood

Conditions: Lung Cancer; Diagnosis

Summary: lung cancer is a leading cause of cancer death worldwide. early diagnosis is linked to a better prognosis. further, surgical resection at the early stages of non-small cell lung cancer (nsclc) results in markedly improved survival rates. computed tomography (ct)- or bronchoscopy-guided needle biopsies are standard definitive diagnostic procedures for lung cancer and are used to obtain tissue for pathological examination. however, these procedures are invasive, difficult to repeat, expensive, and risk exposure to radiation. conversely, liquid biopsies, such as circulating tumor cells (ctcs), circulating tumor dna (ctdna), and extracellular vesicles (evs), are simple and less invasive procedures that can be repeated more frequently than tissue biopsies. this study is a retrospective blood sample obtained and prospectively comparative analysis of various biomarkers (cancer markers, and exosome markers) derived from peripheral blood and pulmonary venous blood from patients who underwent lung cancer surgery. and treatment monitoring using biomarkers compare with peripheral and pulmonary blood.


Eligibility criteria:
inclusion criteria: * adults with korean nationality * patients who did not receive neoadjuvant therapy before surgery * patients not diagnosed with any other cancer before surgery * patients who agreed to the consent form for a donation of human materials during surgery exclusion criteria: * patients who do not meet the inclusion criteria

Keywords: exosome biomarker lung cancer diagnosis prognosis liquid biopsy
srt for residual oligometastases of nsclc after 3rd generation egfr-tkis

Conditions: NSCLC Stage IV; EGFR Activating Mutation

Summary: this study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (srt) for patients with oligo-residual nsclc after 3rd generation egfr-tkis.


Eligibility criteria:
inclusion criteria: * the patient has a diagnosis of pathologically confirmed nsclc by tumor biopsy and/or fine-needle aspiration. * the patient has a diagnosis of american joint committee on cancer (ajcc) 8th edition stage iv nsclc. * the patient receives 3rd generation egfr-tki in the first line setting. * the patient is ≥18 years of age and ≤75 years of age at the time of screening. * the patient's karnofsky performance score (kps) is ≥70 at study entry. * the patient has adequate baseline tumor assessment before initiation of 3rd generation egfr-tki. * the patient has at least one measurable lesion according to response evaluation criteria in solid tumors (recist), version 1.1. * the patient presents with a residual "oligometastatic" state after 3rd generation egfr-tki therapy that would be amenable to consolidative srt in the opinion of the investigator. * the patient has signed informed consent. * egfr exon19 deletion or exon21 l858r mutation exclusion criteria: * history of another malignancy or concurrent malignancy. patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for \> 5 years are eligible. * the patient is pregnant (confirmed by serum b-hcg if applicable) or is breastfeeding. * patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator. * patients with residual metastatic disease after 3rd generation egfr-tki therapy that is deemed not amenable to consolidative srt.
safety, efficacy and cost-efficacy of ranibizumab (monotherapy or combination with laser) in the treatment of diabetic macular edema (dme)

Conditions: Diabetic Macular Edema

Summary: to evaluate, specifically within the canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to dme.


Eligibility criteria:
inclusion criteria: * stable type 1 or type 2 diabetes mellitus * visual impairment due to focal or diffuse dme in at least one eye exclusion criteria: * active conditions in the study eye that could prevent the improvement of visual acuity on study treatment * active eye infection or inflammation * history of stroke, renal failure or uncontrolled hypertension other protocol-defined inclusion/exclusion criteria may apply

Keywords: dme visual impairment diabetes macular edema diabetic macular edema ranibizumab laser photocoagulation retinopathy retina
a study to evaluate safety and efficacy of oral febuxostat in patients with gout

Conditions: Gout

Summary: this is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.


Eligibility criteria:
inclusion criteria: * subjects will also have a history or presence of gout as defined by the american college of rheumatology (acr) criteria * subject has serum urate level \>= 8.0 mg/dl at the screening visit exclusion criteria: * female subject who is breast-feeding or pregnant * subject has a history of xanthinuria * subject who is intolerant of allopurinol, ie hypersensitivity, steven-johnson syndrome/topic epidermal necrolysis * subject who takes allopurinol \> 300 mg/day and with serum urate level \> 8mg/dl * subject who is hla b\*5801 positive * subject who is receiving thiazide diuretic therapy * subject who has secondary hyperuricemia * subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =\< 325mg/day) * subject who requires therapy with prednisone \> 10 mg/ day during the study * subject who has active liver disease or hepatic dysfunction, defined as both alt and ast \> 1.5 times the upper limit of normal * subject who has serum creatinine \>= 1.5mg/dl * subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. a clinically significant ecg result) * subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study * subject who has previously participated in a clinical study in which febuxostat was administered * subject who has participated in another investigational trial within the 30 days prior to the study

Keywords: xanthine oxidase inhibitor uric acid lowering drug
assessing the feasibility and acceptability of a virtual food skills program for children with type 1 diabetes during covid-19

Conditions: Type 1 Diabetes

Summary: food forms an integral part of diabetes management. as children mature into young adults, they must learn to adopt lifestyle behaviours critical for optimal diabetes care. the development of food preparation and cooking skills at a young age may help to facilitate healthy food choices in children and provide a solid foundation for young adulthood. food skills workshops are effective interventions that have been shown to improve food literacy and healthy eating in the general pediatric population. however, food skills programs have not been adequately evaluated in children with type 1 diabetes. further, virtual programs are not well assessed, which can increase the accessibility of food education during the pandemic and in the future.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for over one year exclusion criteria: * type 1 diabetes for less than one year, non-english speaking, do not have access to a computer or internet
a pilot trial to assess the effects of green tea in the prevention of therapy-induced mucositis

Conditions: Mucositis

Summary: this is a clinical research study that is designed to determine if there is a potential benefit of green tea to help treat and prevent therapy induced mucositis, which is mouth sores caused by chemotherapy.

the overall objective of this study is to assess the effect of green tea on reducing the incidence or severity of chemotherapy (with or without radiotherapy) induced mucositis in patients receiving standard therapy that will produce a very high likelihood of oral, esophageal, or gastrointestinal mucositis (e.g. high dose chemotherapy with stem cell reconstitution in patients with multiple myeloma; concurrent 5-fu/ cisplatin and radiotherapy to the head and neck area; patients receiving paclitaxel).

Eligibility criteria:
inclusion criteria: histologically confirmed diagnosis of cancer for which standard chemotherapy will produce a very high likelihood of oral, esophageal or gastrointestinal mucositis (e.g. high dose chemotherapy with stem cell reconstitution in patients with multiple myeloma; concurrent 5-fu/ cisplatin and radiotherapy to the head and neck area; patients receiving paclitaxel). patients receiving concurrent chemotherapy/radiation therapy for lung or gastrointestinal cancer are eligible. if not receiving a highly mucosally toxic regimen, have had grade 2 mucositis on the prior cycle of chemotherapy have no evidence of active infection in the oral cavity such as thrush, hsv, or aphthous ulcers. patients must be free of known infectious stomatitis or systemic infection (culture not required). if unclear that the patient has infectious stomatitis, cultures may be obtained and the patient entered on study. must be free of grade 3 or 4 vomiting. have no contraindication for buccal scrapings. not be a frequent (\>3 cups per day) tea drinker must be able to speak english. exclusion criteria: xerostomia use of any investigational agent (not fda approved) current use of, allopurinol, prostaglandin inhibitors, sulcralfate, vitamin e or antioxidant supplements during the course of this study. patients receiving an anesthetic "cocktail" regimen or other topical anesthetics. patients with existing oral lesions.

Keywords: mucositis
clinical evaluation of biomedics monthly sphere and avaira vitality sphere

Conditions: Ametropia

Summary: the aim of this study is to compare the short-term clinical performance of two sphere contact lenses.

the aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: 1. is at least 18 years of age and has full legal capacity to volunteer. 2. has read and signed an information consent letter. 3. self-reports having a full eye examination in the previous two years. 4. anticipates being able to wear the study lenses for the required time of the study. 5. is willing and able to follow instructions and maintain the appointment schedule. 6. has refractive astigmatism no higher than -0.75 dc. 7. can be fit with the available lens parameters (sphere +6.00 to -10.00d). 8. can achieve binocular distance vision of at least 20/30 snellen (logmar 0.18) with the study contact lenses. exclusion criteria: 1. is participating in any concurrent clinical or research study. 2. has any known active ocular disease and/or infection that contraindicates contact lens wear. 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable. 4. is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. 5. has known sensitivity to the diagnostic sodium fluorescein used in the study. 6. self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. 7. has undergone refractive error surgery or intraocular surgery.