Kornimate/medical-research-clean huggingface dataset:
molecular mechanisms underlying prostate cancer disparities

Conditions: Prostate Cancer

Summary: the purpose of this study is to further elucidate the molecular mechanisms underlying prostate cancer disparities. in previous work the investigators have identified a set of differentially deregulated genes in african american versus caucasian american prostate cancer. based on these findings, they hypothesize that they will be able to validate these targets, originally identified in the previous work conducted at the george washington university medical center, in an independent duke university medical center cohort of prostate cancer specimens. in addition, the investigators hypothesize that they will be able to discover novel targets in the duke university medical center cohort of prostate cancer specimens because of regional differences.

individual patient african american and caucasian american prostate biopsy cores or surgical specimens will be obtained from the following procedures: transrectal ultrasound biopsy of the prostate (trusbxp), mr fusion biopsy, intra-operatively (io) at the time of prostatectomy. using cellular dna and rna, isolated from prostate cancer and patient-matched normal prostate biopsy cores or surgical specimens, the investigators will perform ancestral genotyping, exon arrays, targeted rna sequencing, and epigenetic analyses. as controls, blood will also be collected. genomic data from blood and tumor tissue will be compared.

Eligibility criteria:
inclusion criteria: * suspected malignancy of prostate cancer * self-reported race of african american or caucasian american * age \>/= 18 years * able to read, understand and sign an informed consent document exclusion criteria: * collected tumor tissue is inadequate for dna and rna analysis and/or is not positive for adenocarcinoma of the prostate. * patients with prior systemic therapy will not be eligible for the study, i.e. radiation or chemo or immunotherapy.

Keywords: prostate cancer prostate biopsy prostatectomy
safety study of liris in interstitial cystitis (ic) patients

Conditions: Interstitial Cystitis

Summary: the purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (liris) in patients who have moderate to severe symptoms of interstitial cystitis.

approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in canada. liris is being developed to provide drug therapy directly into the urinary bladder. liris contains lidocaine, a marketed drug (approved by health canada) which is commonly used for local (skin or oral)anaesthesia. liris is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period. two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose liris, and the second group will receive high dose liris. all patients receive liris treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. additional telephone follow-up occurs at approximately 6 and 10 weeks after liris treatment. the maximum duration of participation, including a screening period of up to 14 days, will be 104 days.

Eligibility criteria:
inclusion criteria: * female patients ≥ 18 years of age * if of child-bearing potential, agrees to use effective contraception defined by protocol * capable of understanding and completing symptom diaries and questionnaires as required in the study * diagnosed with ic, as defined by protocol criteria exclusion criteria: * bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of liris * history or presence of any medical condition that would interfere with ability to assess symptoms * pregnant or lactating patients
home nasal pressure for sleep apnea management in primary case

Conditions: Obstructive Sleep Apnea Syndrome

Summary: primary objectives: to determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (osas) carried out in primary or specialist healthcare. in the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (dnp) channel and oximetry while the specialist healthcare arm will use polysomnography (psg) in a hospital. patients with an intermediate-high suspicion of osas will be included, taking as primary variables the epworth scale, for efficacy, and the epworth scale and euroqol 5d, for cost-effectiveness. secondary objectives: efficacy of the two sahs management programs according to the following secondary variables: a) quality-of-life tests: fosq questionnaire, sf36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.

design: prospective, randomized, controlled, open, parallel, non-inferiority. a total of 280 patients will be randomized for management on the basis of dnp (primary) or psg (specialist), thereby giving rise to 4 groups: two treated and two not treated with cpap. the former will undergo a home auto-titration. the follow-up will last 6 months and include 4 evaluations.

Eligibility criteria:
inclusion criteria: 1. snoring or apneas objectively observed during sleep by a partner; 2. symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with cpap. in operative terms, epworth scale ≥12 or previous cardiovascular disease; 3. age between 18 and 70 years; 4. absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness. exclusion criteria: 1. psycho-physical incapacity to complete questionnaires; 2. documented structural or coronary heart disease uncontrolled by any medical treatment; 3. cheyne-stokes syndrome; 4. patients subjected to uvulopalatopharyngoplasty; 5. significant nasal obstruction impeding the use of cpap; 6. pregnancy; 7. lack of informed consent.

Keywords: sleep apnea portable monitor primary care cost-effectiveness osas
randomized, controlled multicenter trial of vacuum assisted closure therapy™ in diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: to determine if topical negative pressure therapy delivered by the v.a.c.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers. the purpose of this study is to compare the effectiveness of v.a.c.® therapy to moist wound therapy of diabetic foot ulcers. the primary objective is to determine the effect of v.a.c.® therapy on the incidence of complete wound closure.


Eligibility criteria:
inclusion criteria: * presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (if more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.) * dfu equivalent to stage 2 or greater, as defined by wagner's scale system (see appendix e) * evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):dorsum transcutaneous oxygen test (tcpo2) with results of ≥30 mmhg, or abis with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmhg, or doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg. * age ≥ 18 years of age * hba1c ≤ 12% (collected within the last 90 days.) * evidence of adequate nutrition by one of the following: * lab results reflecting pre-albumin \>16 mg/dl and albumin level is \>3 g/dl (during the seven days prior to the study period), or a nutritional consult will be done and with appropriate supplementation started. proper documentation on crfs is needed. exclusion criteria: * patients with recognized active charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group * ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency * untreated infection or cellulites at site of target ulcer * presence of untreated osteomyelitis * collagen vascular disease * malignancy in the ulcer * presence of necrotic tissue * uncontrolled hyperglycemia * concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy) * open amputations * prior v.a.c. therapy within 30 days. * current or prior normothermic (warm-up®) or hbo therapy within 30 days. * current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (examples: regranex or procuren) * current or prior treatment with skin or dermal substitutes and dressings (examples: apligraft, dermagraft, or integra) with living cells capable of producing growth factors (example: oasis) within the past 30 days. * current use of any enzymatic debridment agent (example: acuzyme /panafil) during the active treatment phase of the study * pregnant or nursing mothers.

Keywords: wound closure accelerated healing
re-irradiation of diffuse midline glioma patients

Conditions: Diffuse Midline Glioma, H3 K27M-Mutant; Diffuse Intrinsic Pontine Glioma; Diffuse Glioma; Pontine Tumors; Thalamic Tumor; Brain Tumor, Pediatric

Summary: the remit (re-irradiation of diffuse midline glioma patients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (dmg). the study will introduce a standard re-irradiation treatment schedule for dmg patients who have progressed following primary treatment.

remit is a non-randomized, prospective, investigator-initiated, phase ii, multi-centre observational study with two inclusion groups, arm a and b. arm a and b will be offered the same treatment. patients treated with primary radiotherapy 54gy/30 fractions, either enrolled in the biomede 2.0 protocol or not, will be included in arm a. dmg patients treated with any other total dose and fractionation than 54gy/30f will be included in arm b. the re-rt and follow up will be the same in both arms. as treatment 20gy/10 fractions is given as first time re-irradiation with extended follow up on toxicity, performance status and quality of life.

Eligibility criteria:
inclusion criteria: * diffuse midline glioma diagnosis: verified radiologically or histologically biopsy is not mandatory for remit * age ≥ 12 months to ≤21 years. * min. 180 days/6 months have elapsed from the first day of the 1st rt course * 1st course of radiotherapy * full recovery from all acute and subacute toxicities of 1st rt course * clinical progression of symptoms and/or radiographic progression * karnofsky performance status scale or lansky play scale \> 50% the performance status should not take the neurological deficits per se into account. nb: children and adults with a worsening performance status due to glioma-related motor deficit can be included. * life expectancy \> 12 weeks after start of rert * signed informed consent by patient and/or parents or legal guardian exclusion criteria: * presence of leptomeningeal spread or multifocal disease on mri at progression * other co-morbidity that according to the treating physician would impair participation in the study * \>1 course of radiotherapy * neurofibromatosis type 1 * inability to complete the medical follow-up (geographic, social, or mental reasons)
efficacy and safety of anluohuaxian in the treatment of rehabilitation patients with corona virus disease 2019

Conditions: COVID-19

Summary: to evaluate the efficacy and safety of anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with covid-19.

in clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. patients are divided into two groups, anluohuaxian combined with regular treatment group and regular treatment group. 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( anluohuaxian combined with regular treatment group): 1(regular treatment group).

Eligibility criteria:
inclusion criteria: 1. confirmed covid-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours); 2. negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits; 3. high-resolution ct of the lung (hrct) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction); 4. voluntarily participate in research and sign informed consent. exclusion criteria: 1. combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases; 2. have been diagnosed with connective tissue disease; 3. pregnant or lactating women; 4. history of mental disorders, substance abuse or dependence; 5. have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nidanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional chinese medicine; 6. researchers consider it inappropriate to participate in research; 7. participating in other clinical research.

Keywords: anluohuaxian
abdominal breathing training on reducing anxiety

Conditions: Anxiety

Summary: the research purpose is to investigate the effectiveness of abdominal breathing training on reducing anxiety. this study is an experimental research design. using a randomized controlled trial approach. the patients receiving the intervention of abdominal breathing training were in the experimental group, while those who did not receive it were in the control group.

the aim of the study is to investigate the effectiveness of the abdominal breathing training on reducing anxiety. using an experimental randomized controlled trial approach. the experimental group receiving abdominal breathing training, and control group without training. the effectiveness assessment used the beck anxiety inventory, required to be completed by both the experimental group and control group. this study performed the pre-and-post assessments. this study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at week 4 and week 8 the end of abdominal breathing training. during this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). when the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).

Eligibility criteria:
inclusion criteria: 1. who are over 20 years old. 2. the score of beck anxiety inventory at lease of 8. 3. agree to participate in the study and have filled out a written consent form. exclusion criteria: 1. inpatients. 2. copd patients.

Keywords: abdominal breathing training, anxiety, effectiveness
thyroid function in sick and healthy preterm infants admitted in nicu of assiut university children hospital

Conditions: Thyroid Dysfunction

Summary: thyroid hormones are the cornerstones of a complex system that plays an important role in the growth and development of children, especially in the development of the nervous system and brain. therefore, even minimal disruptions of this system can cause permanent damage. thyroid dysfunction is a common problem in pre-term infants. hypothyroxinemia of prematurity within the first month of life may represent important prognostic information about morbidity and mortality. thyroid hormone synthesis may be disrupted in co-morbid conditions . worsening the metabolism of premature infants and causing higher hormone levels compared to healthy infants.

the most common thyroid function disorder in premature infants is physiological hypothyroxinemia, followed by hypothyroidism of non-thyroidal causes. in pre-maturity, several factors can inhibit the conversion of peripheral t4 to t3, including hypoxemia, acidosis, infections, hypoglycemia, hypocalcemia and malnutrition . some rare conditions include transient secondary/tertiary hypothyroidism, transient primary hypothyroidism and permanent primary hypothyroidism. thyroid dysfunction has been reported to be more common in infants with low birth weight due to inadequate intrauterine nutrition, hypoxia, and acidosis.in addition, a meta-analysis found that birth weight and gestation week age closely related to thyroid function tests. plasma t4, ft4, t3, rt3, (thyroid stimulating hormone), and (thyroxin binding globulin) concentrations during the first 8 weeks after birth in infants of 28-30 weeks gestation and in infants of \<28 weeks gestation.

Eligibility criteria:
inclusion criteria: * all preterm infants (\<37w gestational age) admitted to nicu unit of assiut university children hospital with various problems as : •respiratory distress * hypoxia * sepsis * necrotizing enterocolitis * receiving tpn (total parental nutrition) * infants presented with jaundice. * another group of healthy preterm of comparable gestational age not complaining from any problems coming to routine postnatal checkup and outpatient clinic of neonatal unit will be taken . exclusion criteria: * preterm infants with : • fetal congenital malformations.
allergy experience study

Conditions: Peanut Allergy

Summary: people who are undergoing oral immunotherapy for food allergy treatment can feel anxious about the treatment process, particularly when they have allergic responses (e.g., hives, vomiting, nausea) during the dosing process. people may commonly believe that these symptoms are simply side effects that must be endured or avoided. however, the investigators propose that changing participants' mindsets about the meaning of symptoms-toward viewing them as a sign that the treatment is working and desensitization is increasing-during the treatment process will reduce anxiety and improve treatment outcomes.

participants: the investigators will recruit participants who will receive treatment for peanut allergies through oral immunotherapy at the sean n. parker center for allergy \& asthma research. procedures: the investigators will divide recruited participants into two groups (random assignment). each group will receive different messages about oral immunotherapy, one defined as "symptoms as side effects mindset" (in which symptoms are described as an unfortunate side effect of treatment). the other group will receive messages that help foster a "symptoms as positive signals mindset" (in which symptoms are described as a sign of increasing desensitization). these messages will be conveyed verbally and through activities by the study staff and participants will also receive pamphlets emphasizing these messages. the investigators expect that adopting a "symptoms as positive signals" mindset will improve oit outcomes in five ways: 1. decrease anxiety about symptoms, 2. increase treatment completion, 3. decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms, 4. reduce the experience of non-life-threatening symptoms during the study, and 5. improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood igg4 and ige levels.

Eligibility criteria:
inclusion criteria: * peanut-specific blood ige level \>=60 ku/l * or, if ige levels \ 5 ku/l exclusion criteria: * having previously participated in an oit treatment or having a family member who had done so (since the study focused on educating participants about oit) * being in the updose phase of allergy shots or sublingual therapy * having been intubated or admitted to an icu because of allergic reaction * having a heart disorder * diagnosed eosinophilic esophagitis * being on oral steroids or xolair * diagnosed anxiety disorders, as we expected this group to have higher baseline anxiety about treatment.

Keywords: food allergy oral immunotherapy mindsets patient experience
pg2 phase i/ii clinical study intravenously administered in patients with advanced malignancy

Conditions: Neoplasm Metastasis; Neoplasm Recurrence

Summary: the objectives of this phase i/ii study are: 1. to find out the maximum tolerated dose (mtd) of pg2 in patients with advanced malignancy receiving chemotherapy and to define a "study dose" for phase ii. 2. to evaluate the hematopoietic and immunological responses after administering of pg2. primarily to study the biological response of pg2, defined as wbc count in this study, and secondarily to study the immunological factors, il-2, il-6, tgf-beta, and g-csf.

this study is the first step for pg2 clinical development in taiwan in order to further establish its safety and efficacy profile and to build the basis for larger trials.

Eligibility criteria:
inclusion criteria: * patient must have malignancy with metastatic or recurrent diseases. * patient must have a minimum of thirteen days period elapsed from any previous chemotherapy or radiotherapy and all treatment-related toxicities subsided. * patient must have at least 2 courses of chemotherapy treatment left, and a minimum of 13 days between the administration of the last dose of the chemotherapy with pg2 and the start of the next course of chemotherapy. * performance status is 0-2 by ecog scale. * patient's compliance and geographic proximity that allow adequate follow up. * adequate bone marrow function before the chemotherapy * adequate liver and renal function before the chemotherapy * written informed consent from patients * woman with childbearing potential should use contraception method through the whole pg2 treatment course. * after the previous course of chemotherapy, the nadir of wbc dropped between 1000 to 3000/ mm3 (for phase ii only). exclusion criteria: * pg2 skin test is positive. * active infection * breast feeding * prior radiotherapy more than 30% of the bone marrow involved. * pregnant woman * bone marrow transplantation or brain disease

Keywords: myelosuppression chemotherapy astragalus membranaceus hematopoietic response