Kornimate/medical-research-clean huggingface dataset:
non-hormonal medical device for treatment of vulvovaginal atrophy (vva) in post-menopausal women

Conditions: Vulvovaginal Atrophy

Summary: randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat vva in post-menopausal women.

after screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. after the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an active device for week 13 to 1 year to collect further effectiveness and safety data.

Eligibility criteria:
inclusion criteria: * women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum fsh levels \> 40 miu/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy. * sexually active women. * participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse. * participant experiencing subjective moderate-to-severe vaginal dryness. * gynecological exam confirming vaginal atrophy. * willingness to give voluntary written informed consent to participate in the study and comply with protocol requirements. exclusion criteria: * use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study. * use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period. * investigational drugs and also prescription and nonprescription medications/remedies known to treat vva within 60 days of enrollment or during the study. * vaginal stenosis. * pelvic floor disorders. * prior pelvic radiation therapy including radiation or surgery to the vulva/vagina. * active urinary tract, yeast, or other active gynecologic infections. * active connective tissue disorders such as lupus or sjogren's syndrome. * active malignancies. * diagnosis of vulvodynia or other pelvic pain in the vagina or vulvar area. * vulvar dermatoses. * laser or radio frequency vaginal rejuvenation treatment or planned treatment during the study. * any medical condition that, in the investigator's opinion, would interfere with their participation and/or completion in the study.
second trimester maternal serum homocysteine levels and uterine artery doppler for prediction of preeclampsia and placentation disorders

Conditions: Preeclampsia

Summary: the current study included the singleton pregnancies (without history of previous risk factors), had their homocysteine measured as part of a serum-screening program in addition to uterine artery doppler. sensitivity, specificity, positive and negative predictive values, for development of preeclampsia and other adverse pregnancy outcomes were assessed as follows; (1) homocysteine cutoff level at 6.3 µmol/l; (2) bilateral notches on doppler with a mean ri \>0.5, all unilateral notches with a mean ri \>0.6, in addition, absence of notches with a mean ri \>0.7; (3) doppler assessment combined with the homocysteine cutoff (6.3 µmol/l).

these participants had uterine artery doppler investigations, as part of a routine scan between the 18th and the 22nd week of pregnancy. the investigators were blinded to the results of the biochemistry results. all samples of the thcy measurement were collected between 15 and 19 weeks of gestational age, as calculated from the last menstrual period or from early ultrasound dates (when the menstrual dates differed from the specified gestation). the plasma thcy concentrations were measured by means of a fluorescence polarization immunoassay (9). uterine artery flow velocity waveforms were obtained using an sd 800 doppler system (philips medical systems, gland, switzerland) with a 3.5/5-mhz linear array probe. the high-pass filter was set at 100 hz. one operator performed the measurements. the use of mean resistance index (ri) cutoff points with bilateral and unilateral notches has already been shown to improve the efficacy of uterine artery doppler screening using qualitative assessment (10). a screen-positive or abnormal result was defined as bilateral notches and a mean ri \>0.55 (50th centile), unilateral notches and a mean ri \>0.65 (80th centile), and absence of notches and a mean ri \>0.7 (95th centile) (11). women with these abnormal results were offered growth scans, amniotic fluid volume assessment, and umbilical artery doppler every 4 weeks until 36 weeks in view of the recognized increased risk of isolated iugr (12), unless there were other clinical indications, which necessitated closer surveillance

Eligibility criteria:
inclusion criteria: * spontaneous pregnancies without history of previous risk factors for preeclampsia exclusion criteria: * multiple pregnancy, non-intact renal function, and hypertension before 20 weeks of gestation, diabetes mellitus and/or chronic diseases, women taking folic acid supplementations, women using antifolate drugs, and maternal age more than 40 years

Keywords: homocysteine preeclampsia poor placentation
portuguese registry on interventional cardiology

Conditions: Coronary Artery Disease

Summary: the purpose of this registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in portuguese hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

cardiovascular disease remains the main cause of death in portugal and approximately one quarter of these are directly to ischemic heart disease. in order to better characterize percutaneous coronary intervention in portugal, the portuguese society of cardiology has promoted the portuguese registry on percutaneous coronary intervention. this will include all adult patients (≥ 18 years), eligible for percutaneous coronary intervention (pci) in accordance with pci state-of-art recommendations (including unstable and stable coronary disease). the cardiology department where the patient has been hospitalized is responsible for the patient inclusion in the study. excluded patients are those in whom the preferred treatment is coronary artery bypass graft (cabg), age under 18 years or life expectancy of less than 12 months.

Eligibility criteria:
inclusion criteria: 1. patients with: * stable angina or, * stabilized angina pectoris or, * atypical chest pain or, * no chest pain but with documented silent ischemia 2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium 3. eligible for pci 4. informed consent exclusion criteria: 1. patients in whom the preferred treatment is cabg; 2. contra-indication to dual antiplatelet therapy 3. coronary artery disease precluding pci 4. a life expectancy of less than 1 year 5. age under 21

Keywords: pci coronary disease ischemia
hallmarks of protective immunity in sequential rhinovirus infections in humans

Conditions: Healthy Volunteers

Summary: the primary objective of this study is to assess the relationship between rhinovirus specific t-cell immunity and the human host response to primary rhinovirus challenge and subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes.

the primary objective of this study is to assess the relationship between rv-specific t-cell immunity and the human host response to primary rv challenge and subsequent secondary challenge with either homologous or heterologous rv serotypes. the overall hypothesis that will be addressed by the mechanistic studies in this proposal is that t helper (th) and t follicular helper (tfh) cells directed against conserved rv epitopes expand upon rv exposure and some of these cells persist as stable cross-reactive memory populations capable of displaying lineage-specific protective functions upon re-infection with related or unrelated strains of rv. the human specimens collected in this study will be analyzed with a variety of state-of-the-art techniques to provide an in depth description of t-cell responses to rv infection, and the correlation of these responses with viral infection, antibody responses, and illness. beyond this objective, by using a systems biology approach, we aim to gain new insight into the role of diverse cell types involved in adaptive immunity to rv. .

Eligibility criteria:
inclusion criteria: 1. subject must be 18-40 years of age 2. subject must read and sign a copy of the approved consent form 3. subject must have a serum neutralizing antibody titer of ≤1:2 to rhinovirus type 39 and rhinovirus type 16 4. female subjects must be using an effective birth control method. 5. total ige \<150 iu/ml. exclusion criteria: 1. any clinically significant abnormalities of the upper respiratory tract 2. any clinically significant acute or chronic respiratory illness 3. any clinically significant bleeding tendency by history 4. hypertension that requires treatment with antihypertensive medications 5. history of angina or other clinically significant cardiac disease 6. any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study 7. any medical condition that in the opinion of the investigator is cause for exclusion from the study 8. use of any anti-inflammatory (steroids or nsaids) or cough/cold preparation in the 1 month prior to the study 9. regular use of tobacco in the last 6 months (ie. more than 2 days out of 7) or inability to refrain from smoking during the study 10. inability to refrain from the use of common cold therapies in the 5 days after each rhinovirus challenge. 11. participation in any other clinical drug trial in the month prior to the study 12. female subjects with a positive urine pregnancy screen.
detecting auricular points in ofp by a novel apd ( apd-ofp)

Conditions: Orofacial Pain

Summary: this is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel apd for auricular point detection among patients with orofacial pain, as compared with an already commercialized device.

the present study is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel apd for auricular point detection among patients with orofacial pain (ofp), as compared with an already commercialized device. this study will examine if the novel apd is more reliable than the traditional devices currently available in the market. moreover, this study will also use the apd device to test the cutaneous electrical impedance of the ear and further assess whether the orofacial auricular points is with the lowest electrical impedance in the ofp population. this pilot study will enroll 12 ofp patients from the department of anesthesiology, queen mary hospital, the university of hong kong. 12 healthy subjects will be recruited as control from the university community. auricular acupoint detection will be accomplished with the new device and a control device. the electrical impedance will be detected and recorded. patient's condition will also be evaluated by the penn facial pain scale-revised (2018). the specificity and sensitivity of the auricular point detection by the apd device will be calculated. cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. moreover, the pearson correlation coefficient will be used to test the correlation between the electrical impedance of the auricular point of the orofacial area and the penn facial pain scale score.

Eligibility criteria:
inclusion criteria: * when pain attacks, the average unilateral orofacial pain severity \>=5 point measured by a 10-point vas scale; * patient with trigeminal neuralgia can be diagnosed according to trigeminal neuralgia: new classification and diagnostic grading for practice and research (neurology, 2016); * other kinds of orofacial pain can be diagnosed based on the patient's symptoms; * provide written inform consent; * free of any other diagnosed psychological conditions; exclusion criteria: * with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease; * pregnancy or lactation; * participation in a clinical study that may interfere with participation in this study; * history of or current tobacco, alcohol use; * anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study; * unable to provide written informed consent due to any reason;

Keywords: orofacial pain auricular point electrical impedance
yunzhi essence to improve the quality of life of patients with advanced stage of cancer

Conditions: Cancer; Palliative Care

Summary: a randomized, double-blinded, placebo-controlled clinical trial using a chinese medicine 'coriolus versicolor for improving the quality of life of patients with advanced-stage cancer. subjects will be randomized into a treatment group or placebo group for 6 months.

according to the compendium of materia medica, a classic encyclopedia for chinese medicines written by the venerated physician li shizhen of the ming dynasty, yunzhi (coriolus versicolor) is treasured as a superbly valuable herb as it not only can strengthen and consolidate the body's resistance, as well as reinforce and nourish a person's marrow and kidney essence and also is harmless to patients. recent research found that the extract from yunzhi, named as polysaccharide-peptide (psp), could inhibit the growth of human hematoma cell line \& sarcoma and was proved to have direct anti-cancer effects. quality of life (qol) of patients is the ultimate goal of palliative care as endorsed by the world health organization (who) in 1990. when survival is limited in advanced incurable diseases, quality of life is most important. patients with advanced cancer (palliative) often manifest numerous physical and psychological symptoms and a poor quality of life. while maintenance of the quality of life of advanced cancer patients is important, the physical dimension of quality of life still needs improvement, especially in the palliative stage. to date, there is no specific supportive traditional chinese medicine(tcm)-related products that have been proven in randomized controlled trials for alleviating these debilitating symptoms and improving their quality of life. the present study aims to scientifically evaluate whether a yunzhi product named g.e. yunzhi-essence is effective and safe in improving the qol of palliative patients with advanced cancer.

Eligibility criteria:
inclusion criteria: * diagnosed with advanced cancer according to the definition from american cancer society; * according to the experience of the doctor, by using palliative prognostic index (score\>4), integrated with past cases and professional knowledge judged to have life expectancy not less than six months to two years; * abbreviated mental test (amt) score of 6 or above; * voluntarily participate in this clinical trial and sign the informed consent form (acceptance of close relatives signed informed consent on behalf of the patient); * refer to the national standard for clinic terminology of traditional chinese medical diagnosis and treatment-part 2:syndromes/patterns, syndrome of "damp heat spleen" and "spleen deficiency with water stop" (fulfill 2 of the main symptoms and 2 of the secondary symptoms). exclusion criteria: * patients with a history of allergy to traditional chinese medicine or yunzhi; * patients who required nasal feeding or difficulty swallowing; * patients with comatose/semi-conscious, cognitively impaired with dementia/confusion, physically too ill with extremely poor general condition, or there was a language barrier.
folfox-cetuximab-radiotherapy for the treatment of esophageal cancer

Conditions: Esophageal Cancer Stage III

Summary: this phase ii trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage iii esophageal cancer.

cetuximab is a monoclonal antibody which can block the ability of tumor cells to grow and spread cetuximab may also make tumor cells more sensitive to radiation therapy. drug used in chemotherapy such as oxaliplatin leucovorin and fluorouracil work in different way to stop the growth of tumor cells either by killing the cells or by stopping them form dividing. radiation therapy uses high energy x rays to kill tumor cells. giving cetuximab could improve the efficacy of chemotherapy and radiation therapy and may make the tumor smaller this phase ii trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage iii esophageal cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the esophagus stage iii (according to uicc classification) * measurable disease according to the recist criteria * who performance status of 0 or 1 * age 18-80 years old * reference imaging within the 2 weeks prior to the treatment * hematological and biochemical assessment within the 2 weeks prior to the treatment * neutrophils \>1.5 10 9/l, platelets \>150.10 9/l, haemoglobin ≥10g/dl, bilirubin ≤ 1.25 uln, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3 uln woman of childbearing potential must use effective contraception methods written informed consent obtained no prior chemotherapy or radiation therapy for esophageal cancer exclusion criteria: * stage i, ii or iv (according to uicc classification) * esophageal carcinoma with small cells or endocrine cells or esophageal stromal tumor * visceral metastasis * orotracheal fistula weight loss \>15% within the previous 6 months pregnancy or breast feeding contra indication to the study treatment history of coronary heart disease uncontrolled, or myocardial necrosis within the previous 6 months * peripheral neuropathy nci \>1 * liver failure * prior thoracic radiation therapy * history of cancer within the previous 5 years (except removed skin carcinoma, removed local melanoma located, and carcinoma cervix of uterus esophageal endoprosthesis

Keywords: esophageal neoplasms cetuximab oxaliplatin fluorouracil radiotherapy
a multi-center, observational registry of subjects with secondary hyperparathyroidism (hpt) and chronic kidney disease (ckd)

Conditions: Nephrology

Summary: objectives include description of current practices; assessment over time of k/doqi goals, clinical outcomes, health resource utilization(hru) and patient reported outcomes (pro) and the impact of sensipar® on these parameters


Eligibility criteria:
inclusion criteria: * 3 month history of stage 4 or stage 5 ckd * a pth value within 3 months of enrollment * if relevant, completion of sensipar® study prior to enrolling in registry exclusion criteria: * females who are pregnant or breast feeding

Keywords: chronic kidney disease, ckd, secondary hyperparathyroidism, hpt
well-being and health-related quality of life in melanoma patients during covid-19 pandemic

Conditions: COVID-19 Infection; Melanoma

Summary: the primary purpose of this study is to gain an understanding of how experiences during the covid-19 pandemic, regardless of covid-19 status, may have impacted multiple domains of health-related quality of life and other areas such as covid-19 specific psychological distress, and disruptions to health care, finances and social interactions. we will also evaluate the extent to which resiliency factors such as social support, perceived benefits under times of stress, and ability to manage stress may buffer associations between covid-19 experiences and hrqol. to meet these objectives, we have developed a 10-minute questionnaire that taps into these areas and is based on prior work addressing concerns of other pandemics or national crises. participants will have previously consented to protocol pa15-0336 and have provided prior lifestyle data. this will allow us to connect the covid-19 survey data with prior existing data.

primary objectives: i. assess experiences during the covid-19 pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); covid-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and health-related quality of life (hrqol) in melanoma patients who participated in protocol pa15-0336. ii. evaluate the extent to which covid-19 experiences are associated with covid-19-specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and hrqol. iii. evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of covid-19 experiences on covid-19-specific psychological distress and hrqol. iv. explore the association between prior lifestyle data collected as part of pa15-0336 and covid-19-specific psychological distress and hrqol. outline: patients complete a survey over 10 minutes.

Eligibility criteria:
inclusion criteria: * patients who have signed consent for pa15-0336 * has an active email address and can be contacted via mychart * documentation of being alive per the cancer registry