Kornimate/medical-research-clean huggingface dataset:
high dose rate (hdr) brachytherapy salvage after prostatectomy

Conditions: Prostate Cancer; Prostatectomy; Local Recurrence of Malignant Tumor of Prostate; Radiotherapy; Complications; Brachytherapy

Summary: the goal of this observational study is to learn about the long-term effects of hdr brachytherapy in men with isolated local relapses after radical prostatectomy. the main question it aims to answer is: does hdr brachytherapy increase control rates and decreases complications compared with conventional external irradiation? participants will be asked to receive hdr brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy

hdr brachytherapy appears to be an ideal technique for dose escalation in pet/mri+ (positron emission tomography) , small, well-defined ipbr that can be accessed and visualized through the perineal route with transrectal ultrasound (trus) guidance. additionally, hdr brachytherapy can spare from high dose irradiation most of the vesicourethral anastomosis, the external urinary sphincter (eus) and the penile bulb. this may be crucial in circular structures such as eus that are particularly sensitive to whole-volume irradiation but tolerate well high small-volume doses provided that the rest of the eus is spared. in this study, hdr brachytherapy will be combined with external beam radiation and 6 months of androgen deprivation therapy to decrease the prostate bed volume irradiated at high-doses while increasing the radiation dose in the pet/mri+ areas.

Eligibility criteria:
inclusion criteria: * patients with increasing psa after rp and clinical evidence of pet psma/choline+ and mri+ isolated prostatic bed relapse (ipbr) that is implantable via transperineal route . the ipbr should be visible on trus imaging to allow proper implant placement. * pathological confirmation is advised in all cases but it is not mandatory . * brachytherapy mri-based dosimetry * patient written informed consent of the institutional review board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options. exclusion criteria: * distant metastases * isolated nodal relapses * prior irradiation to the ipbr area * multicentric ipbrs * life expectancy of less than 5 years or inability to tolerate and comply with an hdr procedure
efficacy study of temsirolimus to treat head and neck cancer

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to determine whether temsirolimus is effective in the treatment of relapsed/recurrent squamous cell cancer of the head and neck (hnscc)

temsirolimus is an inhibitor of the mammalian target of rapamycin (mtor), a crucial regulator of cell cycle progression. it was approved in the treatment of advanced renal cell carcinoma. temsirolimus demonstrated also antitumor activity in a variety of other human cancer models, such as gliomas, rhabdomyosarcomas, neuroblastomas, prostata and breast cancer through induction of apoptosis or inhibition of proliferation. a similar effect was noted in hnscc cell lines. this is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory hnscc.

Eligibility criteria:
inclusion criteria: * signed written informed consent must be given prior to study inclusion * histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (hnscc) * measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy * patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion * cetuximab must have been included in at least one prior line of therapy * disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy * at least one measurable lesion according to recist (version 1.0) criteria * age \> 18 years * ecog performance status 0-2 * brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment * if of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose * willingness and ability to comply with the protocol * adequate bone marrow function, liver and renal function exclusion criteria: * live expectancy less than 3 months * anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery * participation in a clinical trial within the last 30 days prior to study treatment * serious illness or medical condition other than the disease under study * other malignancies within 3 years, with exception of hnscc, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons * pregnancy or breast feeding * known allergic/hypersensitivity reaction to any component of the treatment * concurrent treatment with oral anticoagulants * uncontrolled diabetes: fasting serum glucose \> 2.0 uln * active or uncontrolled infection

Keywords: hnscc
spanish bacteriemia cohort 2016: epidemiology, clinical management and prognosis factors

Conditions: Bacteremia

Summary: bacteremia the hypothesis of the study are the followings: * to demonstrate relevant epidemiologic and clinical changes with potentially impact in the management and prognosis of the patients with bacteremia. * since the diagnosis and management is heterogeneous between centers, we could identify a scenario to improve. * to identify quality indicators in the management of bacteremia. * to demonstrate that some interventions made by bacteremia team pose relevant impact in the prognosis of bacteremia.


Eligibility criteria:
inclusion criteria: * every episode of bacteremia in patients older than 13 years old, confirmed microbiologically and clinically significant (presence of clinical sepsis data at diagnosis) should be prospectively included on the basis of standard criteria. * episodes of transient bacteremia may be included. * drugs will be prescribed in the usual way, according to the conditions established in the authorization. the assignment of a patient to a particular therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice, and the decision to prescribe a particular drug will be clearly dissociated from the decision to include to the patient in the study. exclusion criteria: * bacteremias without clinical relevance

Keywords: bloodstream infections, epidemiology
biomarkers in dna samples from patients with chronic lymphocytic leukemia previously treated with fludarabine-based therapy

Conditions: Leukemia

Summary: rationale: studying samples of dna in the laboratory from patients who received fludarabine-based treatment may help doctors learn more about the effects of fludarabine on cells. it may also help doctors understand how well patients respond to treatment. purpose: this research study is studying dna samples from patients with chronic lymphocytic leukemia previously treated with fludarabine-based therapy.

objectives: * to identify genetic characteristics associated with the efficacy and toxicity of fludarabine-based treatment in patients with chronic lymphocytic leukemia who participated on e2997. * to validate these genetic characteristics with a cancer cell model system to confirm association and dissect the mechanism of effect. outline: archived dna samples are analyzed for genetic characteristics associated with the efficacy and toxicity to fludarabine-based treatment using affymetrix 6.0 single nucleotide polymorphism arrays. the results are then compared with data of genes identified in a cancer cell model system, and with clinical data (response, toxicity, overall survival, and progression-free survival) associated with each patient sample.

Eligibility criteria:
disease characteristics: * diagnosis of chronic lymphocytic leukemia * archived dna samples * received fludarabine with versus without cyclophosphamide on clinical trial e2997 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia b-cell chronic lymphocytic leukemia
azacitidine with rituximab, vincristine, and cyclophosphamide in refractory lymphoma

Conditions: Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin

Summary: this is a phase i, prospective, open label, dose escalation study of azacitidine in combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory lymphoma. the investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.


Eligibility criteria:
inclusion criteria: 1. patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines. 2. age ≥ 18 years and without a maximum age. 3. all patients of reproductive potential should not plan on conceiving children during the treatment program and must agree to use a medically accepted form of contraception. 4. women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment. 5. patients must have relapsed lymphoma. 6. ecog performance status of 2 or better. exclusion criteria: 1. pregnant or breast-feeding at the time of proposed study entry 2. clinical aids or ars or known positive hiv serology 3. history of malignant neoplasm, other than lymphoma, treated within two years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease 4. psychiatric or additive disorders that would preclude obtaining informed consent 5. serum bilirubin \> 1.5 times the upper limit of the normal range for the laboratory (uln). higher levels are acceptable if these are attributed to active hemolysis 6. serum glutamic-oxaloacetic transaminase (sgot) (aspartate aminotransferase \[ast\]) or serum glutamic-pyruvic transaminase (sgpt) (alanine aminotransferase \[alt\]) levels \> 2 times uln 7. serum creatinine levels \> 1.5 times uln 8. platelets \< 75,000/mm3 9. absolute neutrophil count \< 1500/mm3 10. active infection including viral hepatitis 11. known or suspected hypersensitivity to mannitol, azacitidine, or rituximab 12. grade 3 or 4 neuropathy 13. advanced hepatic tumors 14. uncompensated heart failure
open-label safety study of axs-05 in subjects with trd (evolve)

Conditions: Treatment Resistant Depression; Major Depressive Disorder

Summary: this study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of axs-05 in subjects with treatment resistant depression (trd) and major depressive disorder (mdd).

eligible subjects must have either completed study axs-05-trd-201 immediately prior to enrollment in this study or meet the dsm-5 criteria for major depressive disorder (mdd) without psychotic features.

Eligibility criteria:
* completed study axs-05-trd-201 or currently meets the dsm-5 criteria for mdd without psychotic features * continued depression despite treatment with antidepressants in the current depressive episode * agree to use adequate method of contraception for the duration of the study * additional criteria may apply

Keywords: axs-05 treatment resistant depression trd nmda receptor refractory depression resistant depression depression major depression dextromethorphan bupropion mdd
clinical high and genomic low hormone receptor-positive early breast cancer patients with or without adjuvant chemotherapy

Conditions: Early Hormone Receptor-positive Breast Cancer

Summary: a prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early hormone receptor-positive breast cancer patients with clinicopathological high risk and geneswell™ bct low risk at multi-center in korea


Eligibility criteria:
inclusion criteria: 1. adult women aged 19-80 at screening 2. histologically invasive carcinoma 3. hormone receptor positive (estrogen, er+ and/or progesterone, pr+) 4. human epidermal growth factor receptor 2 negative (her2-) 5. axillary lymph node assessment: pn0 or pn1 6. tumor size≥0.5cm 7. clinical high risk (based on modified adjuvant! online) 8. patients who agree to genetic testing 9. patients who have adequate organ function 10. genomic low risk (based on geneswell bct) 11. de novo primary cancer 12. patients how performed surgery with curative aim 13. patients who have provided written informed consent themselves exclusion criteria: 1. hormone receptor negative (estrogen, er- and progesterone, pr-) 2. human epidermal growth factor receptor 2 positive (her2+) 3. axillary lymph node assessment: pn2 or pn3 4. patients who are received chemotherapy prior to operation 5. patients who are received radiotherapy prior to operation 6. tumor size\<0.5cm 7. clinical low risk 8. ffpe tumor sample is not available 9. patients with following conditions: * patient with chronic liver disease * patient with cerebrovascular disease * patient with chronic mental disorder * pregnant women, women of childbearing potential or lactating women 10. patients who are deemed inappropriate as study participants by investigators 11. patients with recurrent breast cancer or treatment history of breast cancer 12. patients who have not undergone surgery
double blind randomized study into the efficacy of codeine phosphate analgesia after cleft palate repair in infants

Conditions: Cleft Palate Repair

Summary: this study examines the analgesic efficacy of codeine phosphate. it is compared to placebo in infants receiving morphine after surgery. codeine may be effective enough to make morphine unnecessary.


Eligibility criteria:
inclusion criteria: * infants with cleft palate

Keywords: codeine phosphate analgesia
an extension study to wa19977 in patients with active polyarticular-course juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: this long-term, interventional, open-label extension study will evaluate the safety and efficacy of roactemra/actemra (tocilizumab) in patients from poland and russia with polyarticular-course juvenile idiopathic arthritis who completed the wa19977 study. patients will receive roactemra/actemra 8 mg/kg every 4 weeks. the anticipated time on study treatment is 104 weeks.


Eligibility criteria:
inclusion criteria: * patients who completed 104 weeks of study wa19977 with at least a jia acr30 clinical response to roactemra/actemra and no serious adverse event or adverse event * written informed consent obtained from patient if patient is 18 years of age and older, or if under the age of 18 years from parents or legal guardian exclusion criteria: * patient did not benefit from roactemra/actemra therapy in study wa19977 * treatment with any investigational drug since the last administration of study drug in the core study wa19977 * patients developed any other autoimmune rheumatic disease other than the permitted jia subsets * any significant medical or surgical condition that would jeopardize patient's safety * current serious uncontrolled concomitant disease or infection
contact lens optics and visual performance

Conditions: Myopia

Summary: this study will evaluate changes in visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer


Eligibility criteria:
inclusion criteria: * able to read and understand the informed consent document * 18 to 39 years of age (inclusive) * best corrected visual acuity of 20/25 or better in the right eye * refractive error from -1.00d to -8.00d with astigmatism less than or equal to -1.00d in the right eye (corneal plane) exclusion criteria: * any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens * history of ocular trauma or surgery causing abnormal or distorted vision * current rigid gas permeable (rgp) contact lens wearers * pregnant and/or lactating females, by self-report
the effect of laughter therapy on the food craving

Conditions: PMS; LAUGHTER; Food Habits

Summary: premenstrual syndrome (pms) is characterized by physical, emotional, and behavioral symptoms in the luteal phase that significantly disrupt women's daily lives, including work and personal activities, and resolve spontaneously within a few days of the onset of menstruation. the premenstrual syndrome causes emotional eating, excessive consumption of certain foods, and increased appetite. these unhealthy eating patterns in eating behavior affect health negatively. women with pms have an increased appetite and food cravings. it has been stated that the increase in appetite and food cravings are reduced by laughter therapy. thus, the laughter therapy method, which has no side effects in pms and negative eating behaviors, can be used and recommended or applied by health professionals.

the universe of the research will be all young women with pms who study at the designated faculty of health sciences in the spring semester of the 2022-2023 academic year. the sample of the study will be all young women studying at the faculty of health sciences, meeting the inclusion criteria and agreeing to participate in the study. all young women with a premenstrual syndrome scale total score of 110 and above will be included in the study. since all women who have a premenstrual syndrome diagnostic scale of 110 and above, volunteer to participate in the study, and meet the inclusion criteria will be included in the study, no additional sample selection will be made. the application and control group will be determined on random.org among the group that constitutes the sample of the study. laughter therapy sessions will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the laughter therapy certificate to the application group. at the end of two months, the personal information form, premenstrual syndrome scale, and the food craving scale will be administered again to both the application group and the control group.

Eligibility criteria:
inclusion criteria: * being a nursing student, * being a female student, * volunteering to participate in the study. * having a pms score of 43 and above exclusion criteria: * not to study as a nursing student * being a male student * not to volunteer to participate in the study * participants who have a pms score of 42 and below

Keywords: pms laughter therapy young women food craving
healthcare provider human papillomavirus education and professional skills intervention

Conditions: Health Personnel Attitude; Health Knowledge, Attitudes, Practice

Summary: healthcare providers (hcp) serving the el paso u.s.-mexico border region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (hpv). our hypothesis is that improving provider knowledge and communication strategies about hpv and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

a sample of emerging \[in training\] and current \[in practice\] health professionals from the el paso u.s.-mexico border region will be recruited to participate in a human papillomavirus (hpv) educational and professional skills intervention. hypothesis: improving provider knowledge and communication strategies about hpv and its vaccine will reduce hesitancy and increase uptake and completion among eligible individuals through a tailored multi-media intervention to strengthen providers' ability to discuss hpv and vaccination in an informed and culturally competent manner, and increase subsequent provider recommendations.

Eligibility criteria:
inclusion criteria: * current (in practice) or emerging (in training - medical student, resident, or fellow) healthcare provider * working/training or living in the el paso u.s.-mexico border region (i.e., el paso county, tx-southern new mexico) * have the authorization to recommend/prescribe/administer the hpv vaccine exclusion criteria: * unaffiliated with the el paso u.s.-mexico border region (i.e., el paso county, tx-southern new mexico) * participation in phases i or ii of the larger research project \[cross-sectional phases\] * does not identify as a current or emerging healthcare provider * declines or is unable to participate in the full intervention and follow-up time-points * unable to complete participation and activities in the english language

Keywords: healthcare professionals health personnel knowledge, attitudes, practices healthcare skills and training human papillomavirus vaccination human papillomavirus cancer screening hpv cancer prevention hpv cancer mitigation sexual and reproductive health u.s.-mexico border health behavioral research community engaged research health disparities health inequities social determinants of health coronavirus disease 2019 (covid-19) pandemic