Kornimate/medical-research-clean huggingface dataset:
prophylactic irradiation of the para-aortic lymph nodes and supraclavicular lymph nodes in locally advanced uterine cervical cancer

Conditions: Cervical Cancer

Summary: this study is an open-label, randomized study, which is designed to investigate the efficacy of extended-field irradiation (efi) on reducing recurrences at the para-aortic lymph node (pan) and supraclavicular lymph nodes, and also on improving disease-free survival of locally advanced uterine cervical cancer. this study includes a translational research component in that all the primary tumors and lymph node are stained with sema4c, before randomization. according to the investigators study result, patients with more pelvic lymph node metastasis are more likely to develop distant metastasis including the recurrences at pan and supraclavicular lymph node. primary cervical cancer tissues and lymph nodes are examined for expression of sema4c just after registration, and before the patients are randomized to each arm (pelvis only vs. efi). the investigators expect a higher benefit of efi in patients with sema4c-positive lymph node.


Eligibility criteria:
inclusion criteria: * patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, figo stage ib1 with pelvic lymph node metastasis, ib2, iia(≥4cm in tumor size, or pelvic ln metastasis), iib, iiia, iiib? with only unilateral pelvic wall extension * patients with negative, para-aortic lymphadenopathy determined by pelvic mri and/or pet/ct scan. * patients with adequate bone marrow function: anc greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning. * patients with adequate renal function: creatinine equal to or less than 2.0 mg/dl. * patients who have signed an approved informed consent and authorization * patients with ecog performance status of 0, 1, 2 and karnofsky performance scale of 100, 90, 80, 70, 60, 50 * age: 18≤age≤80 exclusion criteria: * stage iiib with bilateral pelvic wall extension and stage ivb lesions are not eligible. * patients with histology other than squamous, adeno, adenosquamous cell carcinoma * patients who have received prior radiotherapy of pelvis or total hysterectomy patients who have diagnosis of other malignant tumors other than non-malignant melanoma skin cancer or stage i. ii papillary, follicular thyroid cancer.

Keywords: cervical cancer,semaphorin 4c (sema4c), prophylactic irradiation
the delivery of "doing what matters in times of stress: an illustrated guide"

Conditions: Stress; Quality of Life; Depressive Symptoms

Summary: the feasibility study for the delivery of the "doing what matters in times of stress: an illustrated guide" will be carried out for turkish and syrian individuals with psychological stress. this feasibility study's sample will be adult turkish and the syrian refugees. the informed consent form and screening questionnaire of the feasibility study will be sent to the participants who have given this approval and 128 (64 turkish and 64 syrian) participants who meet the inclusion criteria will be included in the feasibility study. the psychological problems will be measured twice, before and after the intervention.

studies about the impact of epidemics such as severe acute respiratory syndrome (sars) on the psychological health of individuals show that psychological problems have been observed in individuals who are affected by the epidemic. today, studies on the effects of covid-19 on psychological health are also available in the literature, and the results of these studies are in line with those of previous studies on epidemics. the aim of this project is to deliver the "doing what matters in times of stress: an illustrated guide" that is developed by the world health organization within self help plus (sh+) intervention to decrease their psychological problems for a feasibility study. the feasibility study for the delivery of the sh+ book will be carried out and the psychological problems of the participants will be measured twice, before and after the intervention to evaluate the results. the most important contribution of the project is conducting a feasibility study with the "doing what matters in times of stress: an illustrated guide" which will be adapted to the turkish culture based on the determination of turkey's current psychological status, provide a form of intervention to the turkish psychological intervention literature and to improve the psychological status of the participants in this project.

Eligibility criteria:
inclusion criteria: * being 18 years or above * being literate * being a turkish citizen or a syrian refugee * scoring 15 or above on kessler psychological distress scale (k10) exclusion criteria: * imminent suicidal risk * being illiterate
elevate! : an elderly breast cancer cohort study

Conditions: Breast Cancer

Summary: this study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer.

this study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer, a group of participants who often have low risk cancers, but who may do worse than younger participants with the same kind of cancers. researchers want to better understand the experiences, barriers, and changes in physical function older participants with breast cancer have.

Eligibility criteria:
inclusion criteria: * age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy) * no more than 67 patients (1/3) will be aged 70-74, with the remaining patients on study ages 75 or older * any gender is eligible * invasive, non-metastatic breast cancer at diagnosis * those with prior diagnoses of pre-invasive (dcis) or invasive breast cancer are eligible as long as their current diagnosis is felt by the treating provider to represent a new non-metastatic primary invasive breast cancer (e.g. someone with a nodal recurrence from prior disease are not eligible but those with a new contralateral breast cancer 3 years after a first breast cancer would be eligible) * any breast cancer subtype is allowed * breast cancer-diagnosing biopsy within 90 days of enrollment * receiving or will receive medical oncology care (+/- surgical and radiation oncology treatments) at the participating center: dfci/satellites and affiliate sites * patients must be able to understand, speak, and read english or assign a designated caregiver/proxy for the duration of the study who understands, speaks, and reads english and who is willing to assist with filling out the survey components which do not have a validated, translated version. this is because the surveys are not readily available in multiple languages as a whole, although some components (such as the geriatric assessment and pros are readily available in multiple languages). * if a patient scores 11 or higher on the baseline orientation-memory-concentration test done at baseline (appendix e), a proxy/designee must then be assigned to help the patient fill out the questionnaires for the duration of the study in order to participate. the treating provider will also be notified about the cognitive impairment. * ability to provide informed consent exclusion criteria: * pathological or clinical stage 0, iv disease * those with nodal or metastatic recurrences at the time of enrollment * unable to speak and read english and no designee who speaks and reads english, as above * unable to provide informed consent

Keywords: breast cancer
open-glottis pushing technique versus the valsalva pushing technique in the second stage of labor

Conditions: Evidence-Based Practice; Labor; Prolonged, Second Stage; Labor; Fetal Acidosis Complicating Labor and Delivery

Summary: pushing has been discussed for decades, primarily in terms of facilitating care in the second stage of labor and maternal/fetal outcomes. valsalva-type pushing is the pushing performed by a pregnant woman by holding her breath. various physiological findings argue against the valsalva maneuver may adversely affect the acid-base balance and cerebral oxygenation of the fetus. it has been shown that a long apnea period (long closed glottis) associated with the valsalva maneuver during the expulsive stage of labor increases lactate concentration in the mother and the fetus and adversely affects the fetal acid-base balance. spontaneous pushing is the pushing movements that occur naturally in the second stage of birth. spontaneous pushing is part of the natural birth process and encourages women to trust the natural functioning of their bodies. when pushing with an open glottis, fetal placental circulation is preserved since the pressure on the chest does not increase and there are fewer hemodynamic effects. the world health organization (who) recommends that women in the second stage of labor should be encouraged and supported to follow their pushing urges. the who states that healthcare professionals involved in obstetric care should avoid the valsalva maneuver due to the lack of evidence that this technique has any benefit in the second stage of labor. the who supports spontaneous pushing in its recommendations for a positive birth experience. safe termination of labor for both the mother and fetus is one of the primary duties of all healthcare professionals. there are few studies examining the maternal and fetal effects of the pushing types used during labor, especially their effects on the acid-base balance in the fetus. to contribute to the quality of evidence on the subject, the effects of valsalva-type and spontaneous pushing techniques in the second stage of labor on fetal acid-base level and maternal outcomes were examined. hypotheses of the research h1: spontaneous pushing reduces the mother's pain level. h2: spontaneous pushing increases the mother's birth satisfaction. h3: spontaneous pushing positively affects the acid-base balance of the fetus. h4: valsalva-type pushing increases the mother's pain level. h5: valsalva-type pushing reduces the mother's birth satisfaction. h6: valsalva-type pushing negatively affects the acid-base balance of the fetus.


Eligibility criteria:
inclusion criteria: being at least a primary school graduate, being between the 38th and 42nd weeks of gestation, having a single fetus in a vertex position, giving vaginal birth, not developing any complications during labor, and volunteering to participate in the study. exclusion criteria: high-risk pregnancy, developing complications during labor, and having a diagnosed psychiatric disease.
comparison of transfers of thawed blastocysts versus blastocysts derived from thawed bipronuclear oocytes

Conditions: Infertility

Summary: the purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (ptec), and blastocyst transfer. effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.

subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (ivf). in one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. in the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.

Eligibility criteria:
inclusion criteria: 1. female patient seeking autologous in vitro fertilization (ivf) treatment. 2. cycle day 3 serum concentration of follicle stimulating hormone (fsh) less than 10.0 iu/l. 3. baseline total antral follicle count observed on ultrasound with at least eight antral follicles. 4. 18 to 40 years of age. 5. ability to read and understand english. exclusion criteria: 1. embryo biopsy (a.k.a. pre-implantation genetic diagnosis (pgd)). 2. any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject. 3. no minors will be enrolled in this study.

Keywords: ivf, assisted reproduction, embryo transfer
relational agents in cervical cancer education (race)

Conditions: Cervix Cancer; Human Papilloma Virus; Vaginal Cancer; Vulvar Cancer

Summary: the goal of this clinical trial is to assess the feasibility of using interactive teaching to educate cervical cancer patients about human papillomavirus (hpv) and hpv vaccinations.


Eligibility criteria:
inclusion criteria: * adults aged 18 and older * patients with an icd9 diagnosis of cervical/vaginal/vulvar cancer or dysplasia receiving care at karmanos cancer institute or ou health stephenson cancer center exclusion criteria: * patients who are recorded in the ehr as requesting to be removed from research * non-english speakers * any cognitive disability that prevents informed consent * any individual recruited in previous phases of the study will be excluded.
effect on cerebral oxygenation by sevoflurane or propofol using near-infrared spectroscopy in carotid endarterectomy

Conditions: Carotid Stenosis

Summary: the aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. cerebral oxygenation is measured by near-infrared spectroscopy. sevoflurane and propofol reduce the cerebral metabolic rate for oxygen in similar degree. propofol decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the cerebral blood flow in the concentration of avobe 1 mac. both drugs are widely used in general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are acceptable. there is little data about the effect of general anethetics on cerebral oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral circulation. our hypothesis is sevoflurane will show better cerebral oxygenation than propofol in patient have impaired cerebral circulation.

this study is performed by monitoring the cerebral oxygenation using near-infrared spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery clipping. study group: sevoflurane - remifentanil anesthesia group (s) propofol - remifentanil anesthesia group (r) monitoring: near-infrared spectroscopy (soma sensor) bis, hr, arterial blood pressure, spo2, body temperature patient seletion * inclusion criteria * american society of anesthesiologist (asa) physical status 1-3 * 18 \~ 70 years * patient who agree with informed concent * exclusion criteria * asa physical status \> 4 * preoperative spo2 \< 97% * patient who has other neurologic disease not related to carotid endarterectomy

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist (asa) physical status 1-3 * 18 \~ 70 years * patient who agree with informed consent exclusion criteria: * asa physical status \> 4 * preoperative spo2 \< 97% * patient who has other neurologic disease not related to carotid endarterectomy
oral hygiene and maternity outcomes multicenter study (ohmom)

Conditions: Gingivitis; Pregnancy

Summary: this study will track changes in oral health in pregnant women. subjects will be assigned to either regular oral care or advanced oral care and be given oral care products to use until they deliver. a comparison between the two groups (regular and advanced oral care) will be made to see if the oral care products impacted oral health and maternity variables.


Eligibility criteria:
inclusion criteria: * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be at least the age of legal consent; * be between 8 and 24 weeks of pregnancy; * have at least 20 natural teeth; * have moderate-to-severe gingivitis during pregnancy, including at least 30 intraoral sites with evidence of marginal gingival bleeding. exclusion criteria: * evidence of multiple gestations; * history of hiv infection, aids, autoimmune disease, or diabetes other than gestational diabetes; * indication for use of antibiotic pre-medication prior to dental procedures; * systemic corticosteroid or immunosuppressive therapy within 1 month of baseline; * severe periodontal disease, rampant untreated dental caries, or other oral conditions that necessitate immediate dental care; * ongoing dental care that in the opinion of the investigator could impact study participation; * a history of allergies or hypersensitivity to mouth rinse products containing cpc; * any disease or condition that in the opinion of the investigator could interfere with the safe completion of the study; * randomization to a treatment in study 2011001 during a prior pregnancy.
fentanyl for treatment pain caused by radiotherapy

Conditions: Pain

Summary: the purpose of this study is to assess the clinical utility and safety of fentanyl for pain treatment caused by radiotherapy. fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.

the study is a phase iv, open label, single arm study. the purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. the patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. the study medication will be used for 4 weeks. vas (visual analog scale), bpi q9 (quality of life) and global assessment have been used to assess the effectiveness. vas will be assessed every week. bpi q9 will be assessed at week 1 and week 4. global assessment will be assessed at week 4. the safety of the study drug will be evaluated using adverse event (ae) report. the investigator will assess the pain intensity of patients and increase or even decrease fentanyl dosage every week. fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. fentanyl will be administered for 4 weeks.

Eligibility criteria:
inclusion criteria: * patients have the history of head and neck tumor * patients who are proceeding radiotherapy * patients who are administered weak opioids and pain score (visual analog scale) of 4 exclusion criteria: * patients who have been administered fentanyl for pain treatment within 2 weeks before the study * patients who will have surgery within 1 month * known presence of distant metastasis

Keywords: radiation pain duragesic fentanyl pain
the "light for the brain" study

Conditions: Hematopoietic Stem Cell Transplantation; Cognitive Impairments; Sleep; Depression; Fatigue; Quality of Life

Summary: cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. the proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (hsct) survivors and will investigate how it works. this study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.


Eligibility criteria:
inclusion criteria: 1. have a history of hsct, 2. 1 to 5 years post-hsct, 3. relapse-free since most recent hsct, 4. age 21 or older, 5. english language proficient 6. able to provide informed consent 7. endorse subjective cognitive impairment. exclusion criteria: 1. diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment), 2. visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation, 3. have a history of whole brain irradiation or surgery, 4. active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes, 5. chronic use of oral steroid medication, 6. history of systematic light exposure treatment, 7. diagnosed sleep apnea or narcolepsy, 8. use of photosensitizing medications, 9. plan to travel across meridians during the study, 10. work night, early morning, or swing shifts, 11. adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.
ability of a molecule (prima) to restore physiological differentiation in epithelium expressing gene p63

Conditions: Ectodermal Dysplasia

Summary: ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. the most common forms are called ectrodactyly, ectodermal dysplasia, palate key for cleft lip and palate (eec) and ankyloblepharon, ectodermal dysplasia, cleft lip and palate (aec). apart from symptomatic treatment, no cure is available. to understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming eec and aec patient fibroblasts in pluripotent stem cells (ipsc), then induced ipsc differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients. p63 gene belongs to the family of p53 gene. the functions of the two proteins are very similar. data suggest that molecule prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.


Eligibility criteria:
inclusion criteria: * patient with genetic pathology of the ocular surface * age ≥ 7 years exclusion criteria: * agonal glaucoma * low vision mostly related to retinal pathology * pregnant or breast-feeding patient
long term surveillance of islet transplant recipients following complete graft loss

Conditions: Type 1 Diabetes Mellitus

Summary: this is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

after complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, mmf and/or myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (pra) levels and monitor the persistence of elevated pra levels. primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide \<0.3mg/ml) and monitor the persistence of elevated pra levels (≥ 20%) at year 3, 6, and 9. timing, frequency and level of change in pra will be monitored after all immunosuppression is discontinued.

Eligibility criteria:
inclusion criteria: 1. history of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant). exclusion criteria: 1. inability to provide written informed consent. 2. mentally unstable and/or unable to comply with the procedures of the study protocol. 3. history of any solid organ transplant.