Kornimate/medical-research-clean huggingface dataset:
gonorrhoea resistance assessment by nucleic acid detection (grandii)

Conditions: Drug Resistance, Microbial; Antimicrobial Stewardship; Gonorrhea

Summary: three sexual health clinical services across australia and their associated pathology testing laboratories are implementing a new management program for gonorrhoea infection. the services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone.

this study aims to demonstrate the feasibility of a new approach to antibiotic stewardship based on individually tailored antibiotic prescribing. three sexual health clinical services in new south wales australia with high caseloads of gay and bisexual men will adopt a new management practice for gonorrhoea infection involving provision of tailored antibiotic therapy by clinicians at the time of gonorrhoea diagnosis and treatment, guided by the results of resistance testing. the services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. this differs from existing practice where the prolonged turn-around times for drug resistance testing results mean clinicians must prescribe drug therapy without knowing these results. this can lead to increasing levels of drug resistance to ceftriaxone. the drug resistance test used in the new program detects genetic material (nucleic acids). it was developed and validated in australia and is as accurate as existing culture-based drug resistance testing but provides quicker results. patients treated presumptively at their first clinic visit will be treated with standard of care ceftriaxone. however, for cases treated at the return visit, clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone. this will preserve ceftriaxone for situations where it must be used as the only effective drug available. established patient follow-up procedures at clinical services will confirm that treatment has been successful. quantitative data from the clinical and laboratory services in the study will be used to assess the proportion of all cases treated with ceftriaxone. the cure rate in gonorrhoea cases within the new management program versus standard care will also be assessed which will help illustrate the impact of the new management program.

Eligibility criteria:
inclusion criteria: * patients diagnosed with gonorrhoea infection at the return visit exclusion criteria: * patients for whom ciprofloxacin is contraindicated
usability of the cp950 sound processor

Conditions: Hearing Loss

Summary: studying usability and gaining feedback of the cp950 sound processor in experienced cochlear implant recipients.

one month protocol, with 2 study visits. the aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

Eligibility criteria:
inclusion criteria: 1. at least 6 months experience with a nucleus 24 series or later implant in at least one implanted ear 2. subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff 3. at least 3 months experience with the cp810,cp920 or cp910 sound processor 4. ability to use 2 zinc air batteries with their current program (map) 5. willingness to participate in and to comply with all requirements of the protocol for the duration of the trial exclusion criteria: 1. unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device 2. additional disabilities that would prevent participation in evaluations 3. implant types not currently supported by the cp950 sound processor (i.e.,n22)

Keywords: cochlear implant sound processor
abraxane and rt for non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer, Stage III

Summary: for patients with stage iii lung cancer, we propose one cycle chemotherapy using abraxane and carboplatin, followed by pulsed low-dose sensitizing abraxane chemotherapy and daily radiation. this will be followed by more hi-dose chemotherapy. we anticipate this regimen to target early distant microscopic spread by using one cycle of chemotherapy prior to radiation, and to achieve control of the disease in the lung by combining pulsed low-dose sensitizing abraxane, with radiation.


Eligibility criteria:
inclusion criteria: * histologically confirmed nsclc. * clinical or pathologic stage iiia (t1-3n2m0, t3n1m0) and iiib (any t n3m0, t4 any n m0) diseases according to the american joint committee of cancer criteria. * patients with malignant pleural effusion will be excluded. * the primary tumor must be radiographically measurable. * age \> 18. * karnofsky performance status \> 70 or zubrod ps 0 or 1. * fev1 sufficient for patients to tolerate radiation therapy, which is at the discretion of the radiation oncologist, usually \> 800 ml, but may be higher or lower depending on the volume of radiotherapy portal, which is a variable of the tumor extent. * wbc \> 3000; platelet count \> 100,000; absolute neutrophil counts \> 1,500; hgb \> 9.0 g/dl, serum creatinine \ 60 ml/min. laboratory values must be obtained \< 4 weeks prior to registration. * patients with equivocal enlargement of adrenal gland(s) on ct scan, or a few equivocal regional or distant lesions on any imaging studies need further imaging study (pet, bone scan, or others) or biopsy to rule out distant metastasis. * patients must have adequate liver functions: ast and alt \< 2.5 x upper limit of normal, alkaline phosphatase \< 2.5 x upper limit of normal, unless bone metastasis is present in the absence of liver metastasis. bilirubin \<1.5 mg/dl. * pre-existing neuropathy must not be worse than grade i. * a signed informed consent. * normal organ function including ekg findings deemed acceptable for chemotherapy by the medical oncologist. exclusion criteria: * patients with distant metastasis (stage iv disease). * patients without measurable disease. * patients with medical contraindication to chemotherapy or radiotherapy. * patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia. * patients with bilirubin elevated above institutional upper limit of normal (uln) must be excluded. * women who are pregnant or breastfeeding are not eligible. * other serious illnesses or medical conditions
role of progesterone in hypoactive sexual desire disorder in menopausal women

Conditions: Menopause; Sexual Desire Disorder; Hypoactive Sexual Desire Disorder

Summary: the objective of this study is the role of vaginal progesterone gel in the treatment of menopausal hypoactive sexual desire disorder. half of the study participants will receive a standard dose of self applied vaginal progesterone gel and the other half will receive oral vitamin tablets.

steroid hormones play fundamental roles in sexual behaviour. sexual activity is related to hormone concentrations and ovulation in women. women's sexuality, unlike that of most mammals, is not solely defined by sexual receptivity during the short window of fertility. women are also prone to initiate luteal-phase sex when serum levels of progesterone are highest in the menstrual cycle.as a result of ovarian hormonal cessation after menopause women may face alterations in sexual desire. the role of progesterone supplementation in improving sexual desire in the menopausal period is investigated.

Eligibility criteria:
inclusion criteria: * menopausal status * sexually active exclusion criteria: * medical history of chronic psychiatric disease * medical conditions associated with female sexual dysfunction; cardiovascular disease, uncontrolled chronic ht (hypertension) ,dm (diabetes mellitus), history of gynecologic surgery, female gynecological cancer ( breast, ovarian, uterine, cervical) * medications associated with female sexual dysfunction; antidepressants opiates, beta blockers, antiepileptics ( gabapentin, topiramate,phenytoin) benzodiazepines

Keywords: hypoactive sexual desire disorder
eating habits of adults during the quarantine

Conditions: Health Behavior; Eating Behavior

Summary: the aim of this study is to assess the changes in the dietary habits of adults spending most of their time in their homes due to the coronavirus (covid-19) outbreak. eating habits of individuals may vary greatly depending on several factors such as geographic location, socioeconomic conditions, education level, knowledge about nutrition and psychological factors. since this period of quarantine is economically and psychologically stressful, we hypothesise that individuals may alter their usual eating habits.

since the world health organisation (who) declared the latest coronavirus outbreak as a 'pandemic', most countries had to take strict measures such as travel bans and lock-downs to prevent the spread of the virus. unfortunately, this unexpected situation has caused many people around to globe to panic buy and stock up on food for an unpredictable period of time as it cannot be estimated when the outbreak will be controlled. nutrition plays an important role in our everyday life; it makes up a large part of a healthy life, it brings individuals together to socialise around a table and sometimes it can be used in times of stress as a coping mechanism leading to emotional eating. in this study it is hypothesised that adults may tempt to change their everyday eating habits due to social isolation. humans are generally sociable beings and this period of social isolation will psychologically pressurise humans and may cause some of them to eat more in quantity or frequency as a mechanism to cope with the growing fear and anxiety. on the other hand, it is also hypothesised that, some individuals may prefer healthier ways of eating, such as consuming more fruits and vegetables, drinking more water etc, believing that if they can improve their immunity they will be less likely to contract the virus. the study may also show that some individuals will be highly impacted economically and this will alter their dietary preferences. within the scope of this study an online survey consisting of 20 questions will be asked to volunteers who are over the age of 18 and spend most of their time at home in social isolation because of the coronavirus outbreak. the survey does not include any personal questions but only general demographic data including gender, age range, the country they are currently residing, quarantine duration and whether or not they have observed any changes in their eating patterns since the beginning of this period. in some questions, observed changes, if any, are further investigated to include details such as increase/decrease in portion size, frequency of meals etc.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-80 * spending most of their time at home in quarantine because of the coronavirus outbreak not to contract the virus * having internet access * being able to read and comprehend english language exclusion criteria: * having any mental impairment or degeneration * having any life-threatening health condition

Keywords: coronavirus quarantine social isolation eating habits nutrition covid-19
wireless assessment of respiratory and circulatory distress in chronic obstructive pulmonary disease - validation study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: for patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to icu admission, or unanticipated cardiac arrest. such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. new continuous and wearable 27/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. as part of the ward-copd project, this validation study aim to assess the accuracy of physiologic parameters derived from standard and wireless patient monitors


Eligibility criteria:
inclusion criteria: - adult patients admitted with aecopd exclusion criteria: * patient expected not to cooperate * patient allergic to plaster, plastic or silicone * patients with pacemaker or implantable cardioverter-defibrillator (icd) unit

Keywords: continuous monitoring wireless monitoring
ultrasound impact in rheumatoid arthritis patient reported outcomes

Conditions: Rheumatoid Arthritis; Patient Reported Outcomes; Musculoskeletal Ultrasound

Summary: evaluate the impact of musculoskeletal ultrasound added to rheumatoid arthritis patients classified in remission/low disease activity in terms of patient reported outcomes.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of ra made at the discretion of the attending experienced rheumatologist. * patients classified in remission/low disease activity exclusion criteria: * \<16 years old. * patient with recent trauma in the evaluated joints. * luxation in the mcp, pip or mtp joints.

Keywords: rheumatoid arthritis ultrasound impact
study of web-based decision aids for increasing breast cancer chemoprevention in the primary care setting

Conditions: Breast Neoplasm

Summary: the purpose of this randomized controlled trial (rct) is to evaluate a decision support website (realrisks) designed to inform patients about breast cancer prevention options. it is coupled with a physician-centered (bnav) decision support website as part of clinical workflow in the primary care setting. the investigators hypothesize that improving accuracy of breast cancer risk perception and understanding of the risks and benefits of breast cancer risk lowering drugs, also known as chemoprevention, will increase the uptake of chemoprevention in the primary care setting.

breast cancer is the most common malignancy among women in the u.s. and the primary prevention of this disease is a major public health issue. the u.s. preventive services task force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators' inability to adequately screen them in the primary care setting. further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies. the investigators hypothesize that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake. we anticipate that the bnav tool will facilitate referrals to the breast clinic by primary care providers (pcps) and that the realrisks decision aid will prime high-risk women to seek these referrals. the primary endpoint is uptake of a selective estrogen receptor modulator (serm) or aromatase inhibitor (ai) for breast cancer chemoprevention at 6 months (after the next primary care appointment) in the active arm compared to usual care.

Eligibility criteria:
inclusion criteria: * 5-year breast cancer risk ≥ to 1.67% or lifetime risk ≥ to 20% according to the gail risk model; or a 5-year breast cancer risk ≥ 1.67% according to the breast cancer surveillance consortium (bcsc) model * the participant understands and is willing to provide informed consent in english or spanish * has a primary care provider at columbia university medical center (cumc) / new york-presbyterian hospital exclusion criteria: * prior use of a selective estrogen receptor modulator (serm) or aromatase inhibitor (ai) for chemoprevention * prior history of breast cancer

Keywords: breast cancer prevention risk assessment chemoprevention decision making
sargramostim for myeloid dendritic cell deficiency

Conditions: Kidney Diseases; Kidney Transplant

Summary: the study will determine whether administration of sargramostim will improve myeloid dendritic cell deficiency in various study groups, including healthy subjects and patients with chronic kidney disease, including those with kidney transplants.

the overall objective of this project is to study the ability of sargramostim to enhance mdc level and function, including subsequent stimulation of t cell responses, in various human subjects with demonstrated myeloid dendritic cell (mdc) and t cell deficiency. single center nonrandomized trial with an interrupted time series design involving measures on blood samples from three separate populations before and after administration of sargramostim. the objective is to determine the safety and dose response of sargramostim administration in healthy participants and in patients with chronic kidney disease (ckd) and kidney transplants. additionally to determine whether reversal of mdc/t cell deficiency by sargramostim results in augmented t cell responses in these three groups.

Eligibility criteria:
inclusion criteria: * age \>18 years \< 80 years * absence of acute or chronic medical condition and taking no prescription medications (project i) * stable native or transplant kidney function (project ii/iii) exclusion criteria: * age \ 80 years * history of non-adherence to prescribed medications (projects ii and iii) * active drug or heavy alcohol use (defined as \> 4 drinks/day) * pregnancy or breast feeding * active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the pi, except for cmv viremia in project iii) * active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre-invasive cervical cancer in situ) * unstable cardiovascular status (angina, arrhythmias, congestive heart failure (chf) etc...) * history of liver disease (as defined by a diagnosis of uncompensated cirrhosis) * history of lung disease (including moderate-severe chronic obstructive pulmonary disease (copd), interstitial lung disease, or asthma) * known hypersensitivity to yeast-derived products * hemoglobin \< 10 g/dl and hematocrit \< 30%. * abnormal white blood cell count (wbc) count at baseline (\ 12 x 103 cells/mm3, except project iii) * treatment with wbc growth factors (g-csf or gm-csf) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed for project ii and immunosuppression for project iii) * treatment with lithium within 4 weeks of study * history of arterial or venous thrombosis

Keywords: sargramostim
prediction of the risk of placental vascular pathology and venous thromboembolic disease

Conditions: Placental Vascular Pathologies; Venous Thromboembolism Diseases

Summary: venous thromboembolic (vte) disease is the first cause of maternal mortality in the world. some other pregnancy pathologies called placental vascular pathologies (pvp) are linked to vte by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.

main aim: to evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of pvp and vte.

Eligibility criteria:
inclusion criteria: * previous history of one or more pvc episodes (preeclampsia, hellps, retroplacental hematoma, vascular iugr\ 2, unexplained iufd or iufd after abruption placentae, eclampsia. * previous history of personal vte * diabete (treated with diet or insulin) * chronic hypertension * chronic renal pathology * lupus * obesity * antihopholipids syndrome * early and late pregnancy (\ 38 years) * family history of cardiovascular disease of vte * known biological thrombophilia without any personal past history of pvc or vte exclusion criteria: * multiple pregnancy * past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection * previous history of iugr which etiology was a chromosomal, genic or infectious anomaly

Keywords: preeclampsia eclampsia retroplacental hematoma vascular iugr iufd vte
study on the safety and effectiveness of varian probeam proton therapy equipment in the treatment of solid tumors

Conditions: Solid Tumor; Radiation Therapy; Proton Therapy

Summary: this study is a clinical trial of prospective, single-arm objective performance criteria. this trial will be conducted in clinical trial sites with a total of 47 subjects enrolled. all of subjects will be treated with radiation therapy using the medical device varian probeam proton therapy system (probeam), aim to compare the data with objective performance criteria (opc) to evaluate the effectiveness and safety of probeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. the screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. the period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months. long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.

Eligibility criteria:
inclusion criteria: 1.18≤ age≤ 80 years; 2.first-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology; 3.ecog physical condition is graded as 0 to 2; 4.women of childbearing had negative results in the blood pregnancy test (human chorionic gonadotropin, hcg) 7 days prior to the first treatment; 5.the subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form exclusion criteria: 1. the subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy; 2. the subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment; 3. implanted pacemakers or other metal prosthesis within the scope of proton therapy; 4. other situations that investigator determines not suitable for enrollment

Keywords: varian probeam