Kornimate/medical-research-clean huggingface dataset:
systematic intervention to improve sexual dysfunction

Conditions: Breast Cancer Female; Localized Cancer

Summary: the aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.

the aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand. all included patients are evaluated at baseline and m18 following initiation of antineoplastic treatments associated with surgery. patients who accepted additional oncosexological care were also assessed at m4, m8 and m12. the content of support care is detailed in section "arms and interventions". oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years (menopausal or not), * localized breast cancer with or without lymph node involvement, * initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-parp inhibitors, etc.), * patient affiliated or benefiting from the social security system, * patient informed and informed consent signed. exclusion criteria: * history of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years, * pregnant or breast-feeding women, * patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards, * patients unable to comply with the study schedule for social, medical or psychological reasons.

Keywords: sexual dysfunction
acceptance of different thickeners in dysphagia

Conditions: Dysphagia; Dysphagia, Oropharyngeal

Summary: randomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring.

background: in patients with dyaphagia the modification of viscosity of oral liquids with thickeners ia needed to guarantee an effective and safe swallowing, and to ensure a proper state of hydration. there are two types of thickeners: thickeners obtained from modified starch or from food gums (suchxanthan gum) aim: to evaluate the acceptance of different types of thickeners, with and without the addition of flavorings, and their relationship with water intake. methods: randomized, controlled, pilot study of nutritional intervention. forty hospitalized patients with oropharyngeal dysphagia were randomized to 4 parallel groups: modified starch without flavoring, modified starch with flavoring, xanthan gum without flavoring, xanthan gum with flavoring. each patient was asked to assess the odor, taste, appearance, and overall valoration of the thickened liquid with the different preparations, using a structured questionnaire. the number of glasses consumed by the patient over 3 consecutive days was also recorded to calculate de volume of liquid they consumed.

Eligibility criteria:
inclusion criteria: * patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener. exclusion criteria: * patients with expected hospital length of stay less than 24 hours. * patients with food allergy to any of the ingredients of the thickener or flavorings used in the study. * patients with cognitive impairment that prevents collaborating in obtaining data. * patients in terminal situations, in which death is expected in the following hours.

Keywords: thickener flavoring dysphagia
deep dive randomized control trial

Conditions: Chronic Disease; Arthritis; Uterine Diseases; Spinal Diseases; Preventive Health Services

Summary: compare two care management support program models on medical costs and utilization.


Eligibility criteria:
inclusion criteria: * all employees, dependents and retirees in one of seven large employer groups, including a state university system, a state employee group, two manufacturing companies, a natural resource extraction company, a public educational service agency, and a nonprofit multiple employer association for independent colleges were eligible for inclusion. exclusion criteria: * no financial information was available from their facility and professional claims; * they were in an employer sub-group ineligible for care support services; * they asked not be to contacted or were deceased; * gender information was missing from their eligibility files; * their claims data from the year prior to the start of the study indicated diagnoses of hiv, aids, end-stage renal disease (esrd), organ transplants, or necrotizing fasciitis (intended to improve the likelihood of a balanced distribution of costs and conditions); or * they were in an employer sub-group with less than four months of enrollment prior to the study start date (resulting in too little information for stratification).
neurofibromatosis type 1 tumor early detection study

Conditions: Neurofibromatosis Type 1; Neurofibromatosis 1; Plexiform Neurofibroma; Plexiform Neurofibromas; Malignant Peripheral Nerve Sheath Tumor; Malignant Peripheral Nerve Sheath Tumors; Atypical Neurofibroma

Summary: the goal of this observational study is to determine if a liquid biopsy (i.e. blood test) is an effective clinical tool for monitoring the development of malignant peripheral nerve sheath tumor (mpnst) among adults (18 years and older) with neurofibromatosis type 1 (nf1), compared to the current standard of care. the main questions it aims to answer are: how effective is liquid biopsy compared to the current standard of care (clinical surveillance and imaging) for early detection of mpnst development among people with nf1? can liquid biopsy offer a cost-effective method for early detection of mpnst in people with nf1? also, can liquid biopsy provide earlier detection that potentially leads to better outcomes? also, can offering liquid biopsy improve access to care for people experiencing barriers to access (such as minority populations or people in rural areas)? at baseline, participants will be asked to: * complete surveys to provide their demographic and nf1-related health information. * report whether or not they are experiencing mpnst-related symptoms. * provide blood samples (15 ml blood total between three tubes, which is approximately one tablespoon). every six months during the five-year follow-up period, participants will be asked to: * complete additional surveys to report whether or not they are experiencing mpnst-related symptoms and/or if they have been diagnosed with a new mpnst. * provide an additional blood sample (10 ml blood total in one tube). if diagnosed with an mpnst by their healthcare provider during the follow-up period, participants will be asked to: * complete an additional survey regarding their diagnosis and symptoms. * provide an additional blood sample (10 ml blood in one tube). * in parallel, the study team will request a sample of tumor tissue from the care provider, if available.


Eligibility criteria:
inclusion criteria: * 18 years and older (adults only) * neurofibromatosis type 1 (nf1) diagnosis (2021 revised diagnostic criteria, pmid: 34012067) * history of plexiform neurofibroma (pn) * able to read and understand english or spanish * live in the usa exclusion criteria: * are children (younger than 18 years old) * do not have nf1 * have no evidence of pn * are not able to read and understand english or spanish

Keywords: liquid biopsy cancer surveillance tumor early detection
oral gabapentin in management of chronic pelvic pain in females: a randomised placebo-controlled study.

Conditions: Pelvic Pain

Summary: aim :the aim of this study is to evaluate the efficacy of oral gabapentin in the treatment of chronic pelvic pain in females. the study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be enrolled each arm. group a (cases): this group will include (32) women according to inclusion and exclusion criteria and will receive a card of gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia. group b (controls):this group will include (32) women . assessment of the patient's pain during the physical examination will be done using the visual analogue scale (vas). the patient will be asked to place a mark on a drawn 10 cm line at a point which is corresponding to the intensity of her pain. one end of the line denotes no pain and the other end of the line indicates that pain is as bad as it can be (the worst pain).the distance in cm from the low end of vas to the patient's mark will be used (it gives a number.questionnaire: will be given to all participants at randomization (0 months) , at 3 months and at 6 months to assess the degree of pain improvement via vas. patients' overall satisfaction with their pain treatment \&side effect recording (e.g., dizziness, somnolence, mood changes, appetite and poor concentration).


Eligibility criteria:
inclusion criteria: * moderate to severe chronic pelvic pain for at least 6 months. * pain was unrelated exclusively to menstruation. * pain incompletely relieved by non-steroidal ant-inflammatory drugs. * patients had regular menstrual cycles for 3 months. * patient receiving regular, effective contraceptive method. exclusion criteria: * pregnancy or planning of pregnancy in next 6 months. * breast feeding. * acute pelvic infection. * known history of hypersensitivity to gabapentin. * patients with severe renal or hepatic failure. * women with previous diagnosis of endometriosis confirmed by laparoscopy. * women with previous diagnosis of malignancy. * plans for surgery in next 6 months. * women with chronic or recurrent gastrointestinal disease, including irritable bowel syndrome. * women with histories of alcohol use or other chronic tranquilizers. patients refuse to sign an informed consent form.

Keywords: gabapentin, chronic pelvic pain.
african-american diabetes intervention project

Conditions: Insulin-Dependent Diabetes Mellitus

Summary: a controlled trial to assess the potential benefit of a home based worker in improving control in african-american children with insulin dependent diabetes.


Eligibility criteria:
inclusion criteria: * insulin dependent diabetes mellitus
use of abbott high sensitivity troponin i assay in acute coronary syndromes

Conditions: Acute Coronary Syndrome; Myocardial Infarction; Troponin

Summary: hypothesis: high sensitivity ctni assays will have improved diagnostic accuracy for type 1 mi compared to contemporary ctni assays. the primary objective of the study is to determine the performance of a high sensitivity cardiac troponin i (hs-ctni) assay compared to a contemporary ctni assay for the diagnostic accuracy of type 1 acute myocardial infarction (ami). the diagnostic performance of abbott's hs-ctni assay will be evaluated. investigators will assess the assay's ability to diagnose ami earlier and to rule out ami earlier. the sensitivity, specificity, positive predictive value and negative predictive value of the hs-ctni assay will be evaluated with both a universal cut off as well as with gender and potentially age derived 99th percentile upper reference limits (url). investigators will evaluate delta hs-ctni values (pre-specified absolute concentration and percent changes over time) for their ability to contribute to the negative predictive value and hence potentially lead to an earlier rule out of ami (improved specificity). additionally, investigators will assess delta changes of the hs-ctni assay for their potential contribution to the clinical differentiation of type 1 and type 2 (supply demand mismatch) mis. lastly, investigators will compare the diagnosis of ami based on the currently used contemporary assay to the hs-assay, to assess both the incidence of ami as well as for the time to diagnosis.


Eligibility criteria:
inclusion criteria: * two or more ctni values ordered for any clinical indication with specimen available for hs ctni assay * 18 years of age or older * ekg done on admission / presentation * agree to research disclosure exclusion criteria: * admission through any venue other an emergency department * repeat admission for the same patient, only primary admission will be assessed * pregnancy

Keywords: prospective cohort study diagnostic accuracy high sensitivity versus contemporary troponin i assay gender renal function
safety and durability of sirolimus for treatment of lam

Conditions: Lymphangioleiomyomatosis

Summary: the midas study aims to follow male and female lam patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mtor inhibitors (sirolimus or everolimus) as part of their clinical care. adult female tsc patients may also enroll, with or without lung cysts.

lymphangioleiomyomatosis (lam) is an uncommon disease affecting women. it is associated with cystic lung destruction and progressive respiratory failure. the multicenter international lam efficacy of sirolimus (miles) trial, led by the investigators' research team, demonstrated that mtor (mammalian target of rapamycin) inhibition with sirolimus was an effective therapy that stabilized decline in fev1 (forced expiratory volume). however, lung function decline resumed when the drug was stopped at the one year point in miles, suggesting that therapy is suppressive rather than remission-inducing, and may need to be lifelong. there is therefore a need to understand whether long-term therapy with sirolimus is safe and effective. to accomplish this goal, the investigators will conduct the multicenter international durability and safety of sirolimus in lam trial (midas). this is an observational, real world registry. the investigators propose to enroll 600 lam patients who are on, have previously failed or been intolerant of or are considering taking sirolimus or everolimus for clinical reasons in a longitudinal observational study. this registry will follow lung function tests and adverse events that are obtained for clinical purposes over periods of at least 2 years. the decision to treat with mtor inhibitor therapy is made by the clinician and the patient, and will be managed by the participant's clinician. this study will help us to refine treatment for patients with lam and determine if long term suppressive therapy with sirolimus can prevent progression to later stages of disease. this research will be accomplished as part of the nih/ncats rare lung disease consortium, with data stored and analyzed by the database management coordinating center (dmcc) at the university of south florida.

Eligibility criteria:
inclusion criteria: * female or male, age 18 or over * diagnosis of lam based on ats/jrs criteria * signed and dated informed consent * on chronic therapy, newly treated or may be considered for therapy with mtor inhibitors or previously intolerant of or having failed mtor inhibitor therapy exclusion criteria: * inability to attend at least one rld clinic visit per year * inability to give informed consent * inability or unwillingness to perform pulmonary function testing

Keywords: lymphangioleiomyomatosis lam rare lung rare lung disease
the role of ct-pet-mri image fusion in determining radiation treatment volumes of head-and-neck cancer patients

Conditions: Head and Neck Neoplasms

Summary: technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy. therefore it is becoming even more relevant to accurately define the radiation target volumes. the current standard in defining radiation target volumes in patients with head-and-neck cancer is to combine physical examination data with a ct-scan in the treatment position. the goal of this investigation is to analyse the rol of ct-pet-mri image fusion in defining radiation target volumes.


Eligibility criteria:
inclusion criteria: patients eligible for definitive radiotherapy with a head and neck neoplasm (squamous cell carcinoma) in one of the following anatomical sites: * oral cavity * oropharynx * hypopharynx * larynx exclusion criteria: * age \< 18 years * pregnancy
18f-fch (fluorocholine)-pet/mr in staging of high-risk prostate cancer

Conditions: Prostate Cancer

Summary: this is a single centre, single arm feasibility study of 18fch pet-mr imaging for staging patients with high risk prostate cancer. study hypothesis: fch-pet/mr will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.

up to 60% of patients treated with radical prostatectomy or external beam radiotherapy for prostate cancer will have biochemical failure at 5 years. this may be due to several reasons, including presence of sub-clinical metastases at time of local therapy. currently, patients with high risk prostate cancer are staged by mri of the prostate (to assess local extent of disease), ct of the abdomen(to detect spread to lymph nodes) and bone scan (to assess for spread to bones). however, these standard imaging exams do not always identify all sites of disease. recent research has suggested that performing positron emission tomography (pet) scanning with a tracer called fluorocholine (fch) improves identification of lymph node and bone metastases in prostate cancer, resulting in more accurate diagnosis. the main goal of this study is to find out whether staging high risk prostate cancer patients with fch pet-ct and mri of the whole body will improve detection of primary tumors and metastases compared to current standard imaging exams. improved staging of patients with prostate cancer may impact patient care as it will help to select more appropriate therapy. in this study, participants will undergo either combined pet/mri or pet-ct and mri after standard evaluations. the accuracy of each staging approach (standard vs. pet and mri) will be evaluated. in addition, we will incorporate novel methods for data interpretation by creating imaging maps combining data from pet and mri (termed "multiparametric maps"). the goal of this novel approach is to find out whether mapping 2 or more characteristics of a tumor at the same time will improve tumor detection and accuracy of diagnosis. about 40 men from the princess margaret hospital will take part in this study. the study should take about 2 years to complete enrollment and the results should be known within 36 months of completion of enrollment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologic diagnosis of carcinoma of prostate * high risk disease: defined as gleason ≥8, or t3 disease, or psa \>20ng/ml * no prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy). * ability to provide written informed consent to participate in the study exclusion criteria: * prior surgery or radiation therapy for prostate cancer * prior or ongoing hormone or other systemic therapy for prostate cancer * inability to lie supine for 90 minutes * any contraindication to mr as per joint department of medical imaging policies. * impaired kidney function with glomerular filtration rate \< 30ml/min * previous anaphylactic reaction to gadolinium or other contraindications to mr.

Keywords: fluorocholine (fch) positron emission tomography (pet) magnetic resonance imaging (mri)
intradermal lps and antibiotics

Conditions: Inflammation; Skin

Summary: erythromycin and clindamycin are believed to have anti-inflammatory aspects. this study investigates the possible anti-inflammatory effects of erythromycin and clindamycin.

convincing mechanistic reports on the immunomodulatory action of erythromycin and clindamycin are scarce, rarely based on experiments in freshly isolated human immune cells, and potentially contradicting. moreover, direct immunomodulatory effects of both antibiotics have never been demonstrated in vivo. the centre for human drug research biomarker lab has studied in depth the immunomodulatory actions of erythromycin and clindamycin in vitro. these in vitro experiments on primary human immune cells demonstrated that both erythromycin and clindamycin are able to modulate the immune response of peripheral blood mononuclear cells upon stimulation with different immune triggers such as lipopolysaccharide (lps) and polyi:c. in this current study the in vitro work will be translated to an in vivo study where it will be made into an intradermal lps skin challenge model in healthy volunteers.

Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects, 18 to 45 years of age, inclusive. healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemistry, blood serology and urinalysis; 2. body mass index (bmi) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg; 3. fitzpatrick skin type i-iii (caucasian); 4. able and willing to give written informed consent and to comply with the study restrictions. 5. able to work with the ediary app. exclusion criteria: 1. any disease associated with immune system impairment, including auto-immune diseases, hiv and transplantation patients; 2. type 1 or type 2 diabetes mellitus; 3. any vaccination within the last 3 months; 4. family history of psoriasis; 5. history of pathological scar formation (keloid, hypertrophic scar); 6. have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis); 7. hypersensitivity for dermatological marker at screening; 8. requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study; 9. excessive sun exposure or a tanning booth within 3 weeks of enrollment; 10. participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year; 11. loss or donation of blood over 500 ml within three months prior to screening. or the donation of plasma within 14 days prior to screening; 12. current smoker and/or regular user of other nicotine-containing products (e.g., patches); 13. history of or current drug or substance abuse considered significant by the pi (or medically qualified designee), including a positive urine drug screen.