Kornimate/medical-research-clean huggingface dataset:
a trial to demonstrate bioequivalence between two insulin degludec/liraglutide formulations, b5 and v2 in healthy subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (ideglira) with identical active ingredient in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers * body mass index (bmi) between 18.5 and 27.0 kg/m\^2 (both inclusive) * body weight between 60 and 90 kg (both inclusive) exclusion criteria: * female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner * history or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders * use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial * drug or alcohol abuse
efficacy and safety of vaginal radiofrequency for vulvovaginal atrophy in breast cancer patients

Conditions: Vaginal Dryness; Breast Cancer; Vulvovaginal Atrophy

Summary: this phase iii, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. the study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without lhrh agonists, for breast cancer. patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment: the first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators. the second group will receive the same reference treatment combined with vaginal radiofrequency therapy. this intervention consists of three sessions, each spaced 4 to 6 weeks apart.

this study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer. the participants are divided into two groups: one group will use a non-hormonal vaginal moisturizer (hyaluronic acid) three times a week. if needed, they can also use other supportive treatments like physiotherapy or vaginal dilators. the other group will receive the same moisturizer treatment but will also have three sessions of vaginal radiofrequency therapy, with each session spaced 4 to 6 weeks apart. after six months, researchers will compare the two groups to see if vaginal radiofrequency provides additional benefits in relieving vaginal dryness.

Eligibility criteria:
inclusion criteria : * patient over 40 years * presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3 * patient undergoing adjuvant treatment for breast cancer * patient treated with aromatase inhibitors +/- lhrh agonist for at least 3 months with a planned remaining duration of at least 12 months * patient affiliated to a social security organization * patient having signed the informed consent for the present study exclusion criteria: * contraindications related to the radiofrequency technique: * ongoing urinary tract infection * pacemaker * iud intrauterine device * pregnancy * mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc. * neurodegenerative disease with perineal involvement * current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, prp injection, hyaluronic acid injection or lipo-modeling. * pregnant or breast-feeding women * patients under guardianship or trusteeship.

Keywords: vaginal dryness vaginal atrophy vaginal radiofrequency breast cancer
malignant wounds, wound treatment, psycho-social support and relaxation therapy

Conditions: Cancer; Malignant Wounds

Summary: the purpose of this study is to investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions including wound treatment, psycho-social support and relaxation therapy.

objective: to investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions: 1. wound treatment (silver product, alginate and foam dressing \>\< honey product, alginate and foam dressing) in combination with, 2. psycho-social support (based on the structure in cognitive therapy) and 3. relaxation therapy. furthermore to investigate coping strategies, body image, stigma and quality of life in cancer patients with malignant wounds. design: a hypothesis testing prospective randomized clinical intervention study (n=70) and an explorative qualitative interview study method: digital photographing, measurement of wound size with quantify-image-one, wound morphology registration (the extent of malodour, infection, seepage, bleeding, pain, the healing process), grafting, vas-score, quality of life questionnaire (eortc-qlq-c30, dlqi), hospital anxiety and depression scale (had), mental adjustment to cancer (mac), interview. patients will fill out a diary focusing on wound related problems. perspectives: the results will determine whether the honey treatment is an improvement, and whether the silver treatment has statistical and clinical significance. the qualitative study will contribute new knowledge about conditions of life for cancer patients with cancer wounds, their feelings and impositions. in spite of proving positive effect, the project will contribute with new required knowledge on treatment and support for cancer patients suffering from malignant wounds.

Eligibility criteria:
inclusion criteria: * cancer with evidence of disease. * cancer wound \>2 cm. * receiving antineoplasm treatment. * \> 18 years. * receiving antineoplasm treatment in out-patient clinic. * read, speak and write danish. exclusion criteria: * no radiation therapy the last 6 month (on the wound). * life expectancy \> 3 month. * not psychotic.

Keywords: cancer malignant wounds quality of life body-image cancer patients
multi-center, prospective, cohort study to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients

Conditions: Ischemic Stroke

Summary: this cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients


Eligibility criteria:
inclusion criteria: 1. men and women over 60 years old at the time of written consent 2. those admitted to the hospital within 72 hours after acute cerebral infarction and treated with aspirin 100 mg and clopidogrel 75 mg 3. written informed consent voluntarily signed exclusion criteria: 1. those with evidence other brain lesions such as brain tumors 2. those who need oral anticoagulants other than vitamin k antagonists or anticoagulant therapy of warfarin 3. contraindicate to aspirin or clopidogrel or allergic to the drug 4. subjects who are at risk of active pathological bleeding such as digestive ulcer and intracranial hemorrhage 5. cancer disease that can shorten life expectancy 6. patient's condition that may interfere with participation in study such as mental illness, mental retardation, dementia, drug abuse, and alcoholism 7. subjects other than the above unsuitable for this clinical study identified by investigator
pyrotinib combined with trastuzumab subcutaneously compared intravenous administration in the treatment of her2-positive early breast cancer

Conditions: HER2+ Breast Cancer

Summary: this study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of her2-positive early breast cancer


Eligibility criteria:
inclusion criteria: 1. women aged ≥18 years and ≤75 years who are newly treated for breast cancer; 2. pathological examination confirmed her2 positive (immunohistochemical staining ich+++ or ich++ and fish positive); 3. patients with invasive breast cancer diagnosed histologically plus imaging as early (t1c-3, n0-1, m0) or locally advanced (t2-3, n2, or n3, m0); 4. ecog score 0-1; 5. plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel lymph node (sn) biopsy or axillary lymph node dissection (alnd); 6. if the major organs function normally, the following criteria are met: (1) the standard of blood routine examination should meet: anc ≥1.5×109/l; plt ≥90×109/l; hb ≥90g/l; (2) biochemical examination should meet the following criteria: tbil≤ upper limit of normal value (uln); alt and ast≤1.5 times the upper limit of normal (uln); alkaline phosphatase ≤2.5 times the upper limit of normal (uln); bun and cr≤1.5×uln and creatinine clearance ≥50 ml/min (cockcroft-gault formula); (3) color doppler ultrasonography and echocardiography: left ventricular ejection fraction (lvef≥55%); (4) fridericia calibrated qt interval (qtcf) for 18-lead ecg \<470 ms; 7. for female patients who are not menopausal or have not been surgically sterilized, they should consent to abstinence or use an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment. 8. volunteer to join the study and sign the informed consent. exclusion criteria: 1. known allergic history of the drug components of this protocol; 2. previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma); 3. has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery; 4. stage iv (metastatic) breast cancer patients; 5. inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 6. serious heart disease or discomfort that cannot be treated; 7. suffering from mental illness or psychotropic substance abuse, unable to cooperate; 8. pregnant or lactating women; 9. patients with severe liver and kidney function diseases and blood system diseases; 10. those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; poor compliance and refusal to cooperate with treatment
physiopathology study of the microbiota biodiversity of hiv seropositive patients

Conditions: HIV-1 Infection

Summary: the bacterial diversity of hiv patients digestive microbiota seropositive is poorly understood, it remains to be defined.


Eligibility criteria:
inclusion criteria: * patient aged 18 or more. * patients with a confirmed diagnosis of hiv infection 1. * patient who signed an informed consent form. * patient affiliated or beneficiary of a social security system. exclusion criteria: * patient known to be suffering from inflammatory bowel disease (crohn's disease or ulcerative colitis). * patient hiv-2 or hiv-1/hiv-2 co-infected * patient having received immunotherapy * patient participating in another research. * pregnant women, parturient or lactating person under guardianship, or deprived of liberty by a judicial or administrative decision.
a social emotion regulation intervention in ms

Conditions: Multiple Sclerosis; Emotional Disturbances

Summary: the current project will examine effectiveness of an intervention based on the concept of the social regulation of emotion. the intervention is designed to improve well-being in individuals with ms by leveraging participants' existing social support. effectiveness will be tested on a sample of 42 individuals with ms, half of whom will receive the intervention and half of which will receive an inactive control. investigators will document changes resulting from treatment on self-reported levels of stress, depression, and quality of life. intervention evaluation will expand scientific knowledge of emotion regulation disruption in ms, and potentially identify a novel and highly efficient means of treatment.

multiple sclerosis (ms) is a progressive and debilitating neurological disease which not only affects a patient's physical health, but also adversely affects their mental health. depressed mood is common in ms, and poor mental health in individuals with ms has wide-ranging consequences on social relationships and community integration. the preponderance of negative emotions and sparsity of positive emotions in ms are attributable in part to ineffective emotion regulation strategies. thus, the clinical trial seeks to evaluate the effectiveness of an intervention which instructs individuals on using the social regulation of emotion. the social regulation of emotion occurs when a one's emotional state benefits from an interaction with another person, such as when seeking comfort from a trusted friend. the current intervention was designed to leverage existing social relationships for emotional support in a manner which should strengthen the perception of social support and also reinforce existing relationships. the primary goal of this trial is to examine changes in mental well-being after treatment.

Eligibility criteria:
inclusion criteria: * multiple sclerosis diagnosis * english language fluency exclusion criteria: * currently taking steroids or benzodiazepines * within 30 days of an exacerbation * history of substance abuse * diagnosis of bipolar, schizophrenia, epilepsy, stroke

Keywords: emotion regulation social regulation of emotion
coronary heart disease incidence: depression & inflammation risk

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression; Inflammation

Summary: to examine the associations among depression, inflammation, and coronary heart disease using an existing data base and associated plasma samples.

background: classic risk factors for coronary heart disease (chd) do not yet predict the majority of new cases. of the novel risk factors recently explored, elevated depressive symptoms have been found in a number of prospective studies to predict new chd cases, as have inflammatory markers, including high sensitivity c-reactive protein (crp), interleukin-6 (il-6), and intercellular adhesion molecule. interestingly, depression and inflammatory markers have high covariation, and intervention studies indicate that reducing depression may reduce peripheral inflammation, while successfully treating inflammation may ameliorate depressive symptoms. it becomes critical then to know if these candidate chd risk factors are independent or dependent of the other in the prediction of chd incidence. design narrative: the study will determine if depressive symptoms and inflammatory markers are independent or dependent chd risk factors, when controlling for the other known cad risk factors. a population-based prospective study (the nova scotia health survey; nshs95) was conducted almost 10 years ago, in which participants were randomly selected from the socialized medical registry, which includes all citizens. all classic chd risk factors were obtained at baseline (age, sex, race, fasting lipids, diabetic status, family chd history, resting blood pressure, exercise levels, body mass index, smoking status, and socioeconomic status). depressive symptoms as assessed by the center for epidemiological studies depression scale were also obtained at baseline. plasma blood samples were obtained and maintained in a -80 degree (celsius) freezer. participants gave permission for medical registry records to be linked to their survey data, so that objectively documented previous and future cad events could be detected. the study will assay plasma samples for crp, il-6 and icam-1 and then statistically model the associations among depression, inflammation and chd incidence.

Eligibility criteria:
inclusion criteria: * age 18 and over * able to speak english * enrolled in the nova scotia health study (nshs95) exclusion criteria: * pregnant * active military personnel * lived in nova scotia province for less than 3 months * unable to provide informed consent
brazilian lung immunotherapy study

Conditions: Lung Neoplasm

Summary: immunotherapy with anti-pd-1/pd-l1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. however, it has not been incorporated in the brazilian public health system because of concerns about patient eligibility, safety and costs. it is known that simple biomarkers can be used to select patients for immunotherapy, such as egrf, alk and pd-l1 status in the tumors. we created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a public hospital in brazil. the goal of this project is to identify the prevalence of these markers in the brazilian population (to estimate patient eligibility), outcomes and costs of therapy.

patients with metastatic non-small-cell lung cancer will undergo tumor testing for egfr (by pcr), alk and pd-l1 (by immunohistochemistry) and receive therapy based on these results. * patients with alk-translocated tumors will receive first-line therapy with alectinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel * patients with egfr-mutated tumors will receive first-line therapy with erlotinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel * patients with alk/egfrwt tumors and pd-l1\>=50% will receive first-line pembrolizumab, second-line carboplatin-pemetrexed and third line docetaxel * patients with alk/egfrwt tumors and pd-l1\<50% will receive first-line carboplatin-pemetrexed, second-line nivolumab and third line docetaxel. therapy costs will be estimated, including hospital admissions and reported for each treatment arm.

Eligibility criteria:
inclusion criteria: * stage iiic or iv non-small cell lung cancer * good performance status (ecog 0-2) * available tissue for tumor markers * plan to undergo systemic therapy exclusion criteria: * inadequate cardiac, renal, liver of bone-marrow function * plan to undergo definitive radiation or curative surgery * consent withdraw

Keywords: non-small cell lung cancer nsclc lung adenocarcinoma squamous cell carcinoma of the lung immunotherapy pd-1 nivolumab pembrolizumab
optimization of the treatment of dry eye disease caused by meibomian gland dysfunction

Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction

Summary: an open label, randomized controlled study in a norwegian population with meibomian gland dysfunction. patients will be randomized to one of two groups: thera°pearl eye mask (bausch \& lomb inc., new york, usa) or blephasteam® (spectrum thea pharmaceuticals ltd, macclesfield, uk). all patients will receive hylo-comod (ursapharm arzneimittel gmbh, saarbrücken, germany).


Eligibility criteria:
inclusion criteria: * meibomian gland dysfunction * eligible for heat treatment * ocular surface disease index (osdi) \>12 * quality or expressibility score ≤20 years old: \>1 or \>20 years old: ≥1 * non-invasive tear film break-up time (nitbut) \<10 s in at least one eye * schirmer-1 test \>5 mm after 5 min exclusion criteria: * glaucoma, * ocular allergy * autoimmune disease * contact lens-wear during study * current punctal plugging * pregnant/lactating * candidate for topical anti-inflammatory * cicatricial meibomian gland dysfunction

Keywords: dry eye disease meibomian gland dysfunction blephasteam thera°pearl eye mask
saline challenge in monitoring asthma control

Conditions: Asthma

Summary: it is generally accepted that symptoms and lung function are not sufficient ways to monitor asthma control. therefore, several objective tests have been developed to help asthma control monitoring, each having their own shortcomings. we have developed a new test, the hypertonic saline cough challenge. in our previous publication this test has proven useful in diagnosing asthma. the present study is planned to investigate whether hypertonic saline cough challenge could be used to monitor asthma control. a group of steroid-naive asthmatics will be recruited. a treatment with inhaled budesonide is started. asthma control is monitored at regular intervals utilising a validated questionnaire. at the same time points, hypertonic saline cough challenges will be performed. we will analyse whether changes in the responsiveness to the cough challenge reflects the changes in asthma control


Eligibility criteria:
inclusion criteria: * symptomatic asthma exclusion criteria: * usage of inhaled or oral corticosteroids * recent febrile respiratory infection * severe, unstable asthma