Kornimate/medical-research-clean huggingface dataset:
multiple dose study for a new medication to potentially treat liver diseases

Conditions: Healthy Volunteers; Hepatic Steatosis

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of nnc0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). nnc0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). participants will either get nnc0581-001 or placebo (dummy treatment). which treatment participants get is decided by chance. nnc0581-0001 is a new medicine which cannot be prescribed by doctors. the study will last about 58 weeks.


Eligibility criteria:
inclusion criteria: * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * male or female (of non-childbearing potential) aged 18-64 years (both inclusive) at the time of signing the informed consent. * body mass index (bmi) 25.0 to 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (mri-pdff) greater than or equal to (\>=) 10 percent and liver stiffness greater than 8 kilopascal (kpa) as measured by fibroscan® (vibration-controlled transient elastography \[vcte™\]). additional inclusion criteria for participants in the open-label liver biopsy cohort apply: * alanine aminotransferase (alt) in men greater than (\>) 30 units per liter (u/l), women \> 19 u/l * liverstiffness, measured by fibroscan® (vcte) \> 8 kpa and less than (\<) 12 kpa * informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment. note: participants with confirmed metabolic dysfunction-associated steatohepatitis (mash), based on a prior liver biopsy, can be included in the open-label cohort. exclusion criteria: * any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). of note, re-screening or re-sampling is not allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters: * alt \>= 3 × upper limit of normal (uln) * aspartate aminotransferase (ast) \>= 3 × uln * bilirubin \> 1.5 × uln * estimated glomerular filtration rate (egfr) \< 60 milliliter per minute per 1.73 square meters (ml/min/1.73 m\^2) at screening.
manual lymphatic drainage breast massage in breast cancer patients after breast conserving surgery

Conditions: Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Localized Breast Carcinoma

Summary: this phase ii trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. manual lymphatic drainage is a gentle massage technique used to reduce swelling. it may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.

primary objective: i. evaluate the feasibility of breast manual lymphatic drainage (mld) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery. secondary objectives: i. evaluate the tolerability of breast manual lymphatic drainage (mld) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery. ii. preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (rif). outline: patients undergo mld breast massage over 30-60 minutes twice a week (biw) for the duration of standard of care (soc) radiation therapy and for 1 month thereafter. after completion of soc radiation therapy, patients are followed up at 2-4 weeks and 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation * age \>= 18 years * ability to understand and the willingness to sign a written informed consent in english or spanish exclusion criteria: * underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * inability to provide written informed consent in english or spanish * patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded
imaging quality and potential clinical relevance of phase contrast mammography in-vivo: a single-center, prospective study

Conditions: Breast Cancer; Microcalcification; Image

Summary: conventional mammography, breast sonography and breast mri have specific weaknesses. in particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. phase contrast mammography could help to overcome some of these limitations. observational study.

category c2 medicine product without ce label. objective(s): phase 0: imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. phase 1: determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. evaluation of cohort size for phase 2. phase 2: assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography. ouctomes: sensitivity and specificity of phase contrast mammography compared to conventional digital mammography. measurements and procedures: phase 0: phase contrast mammography of the mastectomy, tumorectomy or breast biopsy samples is performed after breast surgery in addition to the standard clinical procedures phase 1: phase contrast mammography is performed before the operation in case of known breast carcinoma in addition to the standard clinical procedures phase 2: phase contrast mammography is performed directly in the clinical routine. the result is compared with the result of the conventional digital mammography and the ultrasound examination. number of participants with rationale: phase 0: expected to be 30 phase 1: expected to be 20 phase 2: expected to be 300 (correct number will be defined according to phase 1)

Eligibility criteria:
inclusion criteria: * inclusion criteria -phase 0: * \>18 years * mastectomy, tumorectomy or biopsy planned * informed consent of the patient inclusion criteria -phase 1: * \>18 years * bi-rads 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy); * scheduled for mastectomy or breast conserving surgery with radiotherapy. * informed consent of the patient inclusion criteria - phase 2: * \>40 years * undergoing mammography for screening or diagnostic purpose. * informed consent of the patient exclusion criteria: * exclusion criteria for all three phases: * breast implants. the women will be asked, if they have a breast-implant. * inability to understand the study procedure due to cognitive or linguistic deficits. exclusion criteria for patients, participating in phase 1 and phase 2: * pregnancy * breast-feeding. * re-staging after neoadjuvant chemotherapy. patients who participated in prior research projects with ionizing radiation in the past 12 months

Keywords: mammography
comparative safety and efficacy of two treatments in the treatment of vulvar and vaginal atrophy

Conditions: Atrophy

Summary: to compare safety and efficacy of perrigo's drug product compared to an fda approved drug product in the treatment of vulvar and vaginal atrophy.


Eligibility criteria:
inclusion criteria: * postmenopausal female and otherwise healthy, 30 - 75 years of age. * ≤ 5% superficial cells on vaginal smear cytology at visit 1/screening. * vaginal ph \> 5.0 at visit 1/screening * have at least one self-assessed moderate to severe symptom of vulvar and vaginal atrophy identified by the subject as being the most bothersome * for women with an intact uterus, vaginal ultrasonography confirmation at visit 1/screening of an inactive endometrial lining with an endometrial thickness less than 4 mm. * systolic blood pressure no greater than 150 mm hg and diastolic blood pressure no greater than 90 mm hg at visit 1/screening and at visit 2/randomization exclusion criteria: * undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer. * known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer. * vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more * history of hypersensitivity or allergy to estradiol or any of the other study medication ingredients. * known or suspected estrogen-dependent neoplasia. * has deep vein thrombosis, pulmonary embolism or history of these conditions. • subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions. * known acute or chronic hepatic disease or dysfunction
application of plasma circulating hpv dna testing to management of cervical intraepithelial neoplasia

Conditions: Cervix Lesion; Cervical Cancer

Summary: the purpose of this study is to see if circulating hpv dna (chpvdna) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (cin) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.

chpvdna is detectable in plasma of patients with invasive disease and cin 1-3, and with the development of a highly sensitive and specific droplet digital polymerase chain reaction (pcr) assay, it is hoped to be identified more prevalently and thus can improve risk stratification and help produce personalized treatment decisions and may be more cost-efficient. plasma samples and cervical swabs will be collected from patients in university of north carolina (unc) gynecology clinics, and some patients will also provide a urine sample. those receiving biopsies or colposcopies and will come back to clinic 2-4 weeks post-excision for collection of another blood specimen. using plasma samples and pathology results, we will characterize the relationship between plasma chpvdna levels and 1) cin 1 versus cin 2-3 pathology 2) cin 2-3 pre-excision and 2-4 weeks post-excision. we will accrue three cohorts of 25, 30, 30 patients corresponding to 1) control 2) cin 1 3) cin 2-3. the control cohort will establish background signal in the assay. we will compare the proportion of detectable chpvdna levels between cin 1 and cin 2-3 cohorts using fisher's exact test with 80% power, significance level of 10%. paired t-test will be used to compare pre- and post-excision chpvdna levels.

Eligibility criteria:
inclusion criteria: * no history of previously treated cervical cancer * subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee exclusion criteria: * women who are pregnant or nursing
vitamin d deficiency epidemiological research in sichuan, china

Conditions: Healthy

Summary: vitamin d insufficiency and deficiency is pandemic in the world.sichuan basin has a subtropical monsoon climate with china's lowest sunshine totals. inferably, the prevalence of vitamin d insufficiency/deficiency in sichuan basin is high, and possibly the highest in china. this study will research the serum 25ohd level to get the prevalence of vitamin d deficiency and insufficiency of urban and rural residents in sichuan province, china.


Eligibility criteria:
inclusion criteria: * females aged 30 years old living in sichuan province.
effect of family-based prevention on children of depressed parents

Conditions: Depression

Summary: this study will test the protecting families program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.

children of depressed parents are at risk for developing social-emotional problems. despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. this randomized, open-label study will address the research gap by developing and pilot-testing the protecting families program (pfp), a family-based, multi-component prevention program. the pfp will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14. prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. the purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. the interventional phase will compare pfp combined with individual parent training versus parent training alone. participants will be randomly assigned to one of these two intervention groups. the study will last a total of 10 weeks. both groups will meet once each week. pfp will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (cbt) group for the focal child. participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.

Eligibility criteria:
inclusion criteria: * parent is currently in treatment * parent's primary dsm-iv diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified * parent's child lives with him/her at least part time exclusion criteria: * parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome * parent has history of bipolar or schizoaffective disorder * parent's iq is below 70 * parent has any serious medical or neurological disorder or condition that may prevent weekly participation * parent has chronic pain that may prevent weekly participation * parent or child is currently suicidal to the extent that it will interfere with outpatient treatment * parent has a current substance dependence * child is currently seeking psychological treatment * child is mentally retarded (determined by school and clinic records) * child has a clinically severe psychiatric diagnosis

Keywords: family parenting depression group intervention
comparison of quality of life and changes experienced by patients after epilepsy surgery

Conditions: Epilepsy

Summary: epilepsy is one of the most common chronic neurological diseases. according to data from the world health organization (who), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in france. there are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. about 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients. epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 the investigators want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).


Eligibility criteria:
inclusion criteria: * patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the toulouse university hospital. * patient covered by a social security scheme. * patient having given his non-objection to participate in the research. exclusion criteria: * minor under the age of 15 at the time of the questionnaires. * serious psychiatric pathology unrelated to epilepsy surgery. * severe intellectual disability limiting responses to self-questionnaires. * language barrier. * patients under guardianship and protection of justice.
a multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bms-986263 in healthy participants

Conditions: Fibrosis

Summary: the purpose of this study is to assess the safety and tolerability of bms-986263 in healthy volunteers.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy participants as determined by no clinically significant deviation from normal in medical history, physical exam, ecgs, and clinical laboratory determinations * weight within the range of ≥60 and ≤90 kg * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug * wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with bms-986263 (21 days), plus 5 half-lives of bms-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion * males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with bms-986263 (21 days) plus 5 half-lives of bms-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. in addition, male participants must be willing to refrain from sperm donation during this time. azoospermic males are exempt from contraceptive requirements exclusion criteria: * history or evidence of active infection and/or febrile illness within 7 days of study day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.) * history of serious bacterial, fungal, or viral infections that let to hospitalization and iv antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of study day 1 * history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period) * active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history) * history of hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * presence of active tuberculosis (tb), latent tb, or inadequately treated latent or active tb other protocol defined inclusion/exclusion criteria could apply
minimization of bleeding related adverse drug events in plastic & reconstructive surgery

Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolus; Reconstructive Surgery

Summary: plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ades). this study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing afxa levels, bleeding events, and vte events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ades). our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-factor xa (afxa) levels. patients with adequate afxa levels are known to have significantly decreased venous thromboembolism risk (vte), which is desirable. however, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. patients who are over-anticoagulated are significantly more likely to have ades including bleeding requiring return to the operating room, need for blood transfusion, or death. the optimal way to dose enoxaparin to minimize ades remains unknown. this study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing afxa levels, bleeding events, and vte events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

Eligibility criteria:
inclusion criteria: * receiving plastic and reconstructive surgery under general anesthesis * expected post-operative stay of 2 days or more exclusion criteria: * contraindication to use of enoxaparin * intracranial bleeding/stroke * hematoma or bleeding disorder * heparin-induced thrmbocytopenia positive * creatinine clearance less than or equal to 30 ml/min * serum creatinine greater than 1.6 mg/dl * epidural anesthesia * patients placed on non-enoxaparin chemoprophylaxis regimens * gross weight exceeding 150kg