Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of enzalutamide in combination with exemestane in patients with advanced breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

this is a phase 2, randomized, double-blind, placebo-controlled, multicenter study of efficacy and safety of enzalutamide in combination with exemestane in patients with advanced breast cancer that is estrogen or progesterone receptor positive and her2-normal.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent; * postmenopausal; * advanced histologically confirmed breast cancer that is er+, pgr+, or both, and her-2 normal; * up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed; * availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report; * measurable disease. patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible; * eastern cooperative oncology group (ecog) status of 0 or 1; exclusion criteria: * any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator; * any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator; * current or previously treated brain metastasis or leptomeningeal disease; * prior therapy (\> 28 days) with exemestane in the metastatic setting (patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible); * requires treatment for tuberculosis or hiv infection; * radiation therapy within 7 days before randomization; * history of another invasive cancer within 5 years before randomization; * history of seizure or any condition that may predispose to seizure; * clinically significant cardiovascular disease; * active gastrointestinal disorder; * major surgery within 28 days prior to randomization; * treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization; * treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor; * treatments with any of the following medications within 14 days before randomization: estrogens, androgens, or systemic radionuclides; * hypersensitivity reaction to exemestane.

Keywords: advanced breast cancer enzalutamide mdv3100 estrogen receptor positive (er +) progesterone receptor positive (pgr +) her-2 normal
observational study evaluating the management of chronic coronary occlusions in france

Conditions: Coronary Occlusion

Summary: data from the literature on the management of chronic coronary occlusions (cto) in france highlight a lack of epidemiological data on these patients at the national level. for this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in france, to study the prevalence of ctos in france as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, cto angioplasties in terms of success rates, complications, medico-economic impact.

this exhaustive and descriptive study of cto patients, performed on a set of approximately 100 interventional cardiology centers in france, will be conducted in two steps: * 1st step: this collection will be done over one month, the objective of which will be to photograph the therapeutic choice in the management of cto (drug, surgical, endovascular approach). * 2nd step: a second collection will be carried out over a period of two months, the objective of which will be to evaluate, in patients presenting a cto with an attempt at angioplasty, the success of the procedure.

Eligibility criteria:
phase i inclusion criteria: * patient over 18 years old * patient with cto exclusion criteria: * patient with acute occlusion or subocclusive lesion or cto of less than 3 months * patient expressing his refusal to participate in the observatory phase ii inclusion criteria: * patient over 18 years old * patient with cto who has attempted angioplasty exclusion criteria: * patient with acute occlusion or less than 3 months. * patient demonstrating refusal to participate in the observatory

Keywords: chronic coronary occlusion peripheral component interconnect coronary angioplasty
study to evaluate the safety and efficacy of cj-12420 in patients with gastric ulcer

Conditions: Gastric Ulcer

Summary: to demonstrate non-inferiority of cj-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of cj-12420, after once daily oral administration of cj-12420 50 mg, 100 mg or lansoprazole 30 mg capsule in gastric ulcer patients.

this is a double blind, randomized, placebo-controlled, phase 3 study. subjects will be randomly assigned to one of the three treatment groups (cj-12420 50 mg, 100 mg or lansoprazole 30 mg).

Eligibility criteria:
inclusion criteria: 1. diagnosis of 1 or more active gastric ulcers (≥3 mm \~ ≤30 mm using open biopsy forceps) according to the sakita-miwa classification (a1 or a2 stage) from upper gi endoscopy at the same institution within 14 days prior to initiation of the investigational product administration. exclusion criteria: 1. finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, barrett's esophageal of \>3 cm (long segment barrett esophagus, lsbe), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper gi endoscopy. 2. ulcer caused by an endoscopic surgery (e.g., ulcer after emr/esd) 3. requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(nsaids) or aspirin during the course of the study 4. scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation 5. subjects who participated in the other clinical trial within 4 weeks prior to randomization
a bct intervention for an hourly activity habit among caregivers for persons with ad/adrd

Conditions: Sedentary Behavior

Summary: this 12-week trial will test the efficacy of a personalized, multi-component, personalized text-message delivered behavior change technique (bct) intervention to encourage habitual hourly physical activity among care providers of persons with alzheimer's disease and alzheimer's disease related dementias (ad/adrd) via the key mechanism of behavior change (mobc) of automaticity. the main question it aims to answer is whether a multi-component, personalized bct intervention to increase habitual walking of \>250 steps/hour will lead to successful development of habitual hourly walking among 50% of caregivers.


Eligibility criteria:
inclusion criteria: * identify as a caregiver (formal/paid or informal/unpaid) for persons with alzheimer's disease or alzheimer's disease related dementias (ad/adrd) * age \>=18 and \<=85 * speak english or spanish as primary language * self-report low levels of physical activity or walking exclusion criteria: * individuals who self-report having been informed by a clinician it is medically or physically unsafe to engage in a walking intervention * does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet * does not own or have access to an email address * lives outside the united states

Keywords: caregiver alzheimer's disease alzheimer related dementia behavior change techniques habit formation sedentary behavior
comparative effects of aerobic and aviva exercises in primary dysmenorrhea

Conditions: Dysmenorrhea Primary

Summary: primary dysmenorrhea is a cramping pain in the lower abdomen occurring just before or during menstruation without pelvic pathology. primary dysmenorrhea is not a life-threatening condition and does not cause organ failure. however, it can affect the quality of life of women and cause inability to carry out daily functioning consequently, absence from school or workplace. exercise is one of the non-conservative methods to reduce the severity of primary dysmenorrhea. the aim of this study is to compare the effects of aerobic and aviva exercises on primary dysmenorrhea. this study emphasizes the importance of aerobic exercises and aviva exercise to reduce the severity of primary dysmenorrhea. this will help in patients over all recovery and will improve general well-being. this will be a randomized clinical trial conducted on 42 participants. the data will be collected from sharif medical complex and kasrat gym lake city by using non-probability convenience sampling technique. patients with primary dysmenorrhea diagnosed with walid score questionnaire of age 20-40 will be included. a sample will be divided into two groups, each group will have 21 participants. the group a will be given aerobic exercise and group b will be given aviva exercises. participants will be assessed using the mc gill pain questionnaire for pain, women health initiative insomnia rating scale will be used for sleep, and brief pain inventory short form for daily functioning and quality of life enjoyment and satisfaction questionnaire short form for quality of life. data will be analyzed by using spss version 26.0.


Eligibility criteria:
inclusion criteria: * unmarried females * regular menstrual cycles (every 21-35 days) * moderate to severe menstrual cramp pain exclusion criteria: * pelvic pathology (endometriosis, chronic pelvic inflammatory disease, adenomyosis) * history of pelvic surgery or inflammatory disease * chronic pain or pain disorders (e.g., fibromyalgia) * current use of pain medication or muscle relaxants * history of mental health disorders (e.g., depression, anxiety) * inability to understand or complete study assessments * any underlying medical condition that may be contributing to dysmenorrhea (e.g., thyroid disorders, kidney disease)

Keywords: exercise quality of life sleep pain
pleth variability index in pulmonary embolism

Conditions: Pulmonary Embolism

Summary: pulmonary embolism(pe) is a ventilation/perfusion disorder caused by obstruction of the pulmonary artery, usually by a thrombus. the pleth variability index(pvi) is a continuous, noninvasive indicator of dynamic perfusion index changes in photoplethysmography that occur in at least one respiratory cycle. the aim of this study is to evaluate the prognostic and mortality indicator role of pvi in patients with pe, hypothesizing that pvi could serve as a valuable guide in this disease where perfusion impairment is fundamental. based on our study, we determined that pvi could be a non-invasive, rapid, and objective tool for predicting disease progression and mortality in pe patients in the emergency department. our study is the first to evaluate the pvi in pe.

pulmonary embolism(pe) is a ventilation/perfusion disorder caused by obstruction of the pulmonary artery, usually by a thrombus. the pleth variability index(pvi) is a continuous, noninvasive indicator of dynamic perfusion index(pi) changes in photoplethysmography that occur in at least one respiratory cycle. the aim of this study is to evaluate the prognostic and mortality indicator role of pvi in patients with pe, hypothesizing that pvi could serve as a valuable guide in this disease where perfusion impairment is fundamental. in the emergency department, data were recorded for patients over 18 years of age diagnosed with pulmonary embolism, demographic data, risk scores and measurements. pvi and pi values were analyzed across different scoring systems, hospitalization statuses, and mortality groups. a survival analysis was conducted to evaluate the impact of pvi and pi on 1-year mortality in patients. the study was assessed with the strobe checklist. a total of 49 patients were included in this prospective, single-center study. the pvi value was significantly higher, whereas the pi value was significantly lower in the exitus group compared to the living group (p=0.027, p=0.011). the area under the curve values for pvi, pulmonary embolism severity index (pesi) score, and pi were determined to be 0.714, 0.820, and 0.745, respectively. it was observed that the negative predictive value of pesi was 100%, while the positive predictive value of pvi was the highest at 53.5%. in the. the mean survival time was significantly shorter for patients with pvi \>40 and pi \<1.9 (p=0.001, p=0.002). an increase in pvi was associated with a 4.04-fold increase in the risk of death (hr: 5.04, 95% ci: 1.50-16.92, p=0.009). pvi can be considered a noninvasive, rapid, and objective tool for predicting the course and mortality of the disease in pe patients in the emergency department. our study is the first to evaluate the pvi in pe.

Eligibility criteria:
inclusion criteria: * to be over 18 years old * diagnosis of pulmonary embolism exclusion criteria: * patients had asthma and chronic obstructive pulmonary disease exacerbation * patients had acute decompensated heart failure * patients were pregnant * patient was under 18 years old

Keywords: pulmonary embolism perfusion index plethysmography mortality
genetic characterization of individuals with limb girdle muscular dystrophy

Conditions: Limb-Girdle Muscular Dystrophy

Summary: the objective of this study is to identify and maintain a registry of well-characterized limb-girdle muscular dystrophy (lgmd) patients. patients seen as part of this study may be candidates for future treatment trials based on their defined genetic classification of lgmd. in the course of this study, the investigators will perform a muscle biopsy and dna testing in an unlimited number of patients with clinically diagnosed lgmd. the genetic testing will be extended to the family of the study subject in order to better understand true genetic defect.


Eligibility criteria:
inclusion criteria: * any subject with clinical diagnosis of lgmd * must visit columbus children's hospital for 2-day study visit * muscle biopsy tissue must be available; either from previous biopsy, affected relative, or willing to have biopsy at columbus children's exclusion criteria: * diagnosis of a neuromuscular disorder other than lgmd * unable to provide muscle tissue from previous or current biopsy * incapable of giving consent and not having a legal guardian willing or able to do so
efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in hiv-1 infected adolescents

Conditions: HIV

Summary: the primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (e/c/f/taf) in hiv-infected virologically suppressed adolescents 12 to \< 18 years of age.


Eligibility criteria:
key inclusion criteria: * currently on a stable antiretroviral regimen for ≥ 6 consecutive months * weight ≥ 35 kg (77 lbs.) * plasma hiv-1 rna levels \< 50 copies/ml for ≥ 6 months * cd4+ cell count \> 100 cells/μl * no resistance to elvitegravir (evg), emtricitabine (ftc), lamivudine (3tc) or tenofovir (tfv) * hepatic transaminases (ast and alt) ≤ 5 x upper limit of normal (uln) * no evidence of current hepatitis b virus (hbv) infection * no evidence of current hepatitis c virus (hcv) infection note: participants from gilead study gs-us-162-0112 were allowed to roll over into this study gs-us-292-1515 even if they were 18 years or older at the time of screening. key exclusion criteria: * a new aids-defining condition diagnosed within the 30 days prior to screening * evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening * pregnant or lactating subjects note: other protocol defined inclusion/exclusion criteria may apply.
multi-level approach of brain activity using intracranial electrodes in epileptic patients

Conditions: Focal Epilepsy; Electrodes, Implanted; Cognitive Function; Neurophysiology

Summary: the main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation. the recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.


Eligibility criteria:
inclusion criteria: * patients with focal drug-resistant epilepsy * patients who undergo a presurgical evaluation with intracranial electrodes in the videoeeg unit of the neurology department at the pitié-salpêtrière hospital. * patients who have been informed and provided written informed consent to take part in the study exclusion criteria: * contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy) * pregnant or parturient woman * breastfeeding woman * minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)

Keywords: microelectrodes seizures eeg
low dose β-carotene supplementation diminishes oxidative stress in type 2 diabetics and healthy individuals

Conditions: Diabetes Mellitus; Oxidative Stress; Iron Metabolism Disorders

Summary: since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.

type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. the objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement. a total of 117 volunteers participated in the study. type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, hdl, ldl, oxidized ldl, copper, zinc, tbars, frap, nitrites, gpx, sod, folates, retinol and β-carotene.

Eligibility criteria:
inclusion criteria: patients with a diagnose of type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics patients in regular control (once a month) in the hospital exclusion criteria: * hospitalized patient * diabetic patient with diabetes related acute complications (ketoacidosis, hyperosmolar coma)in the 3 months previous to the study. * individuals with infections that required antibiotics in the 3 weeks previous to the study. * individuals with antibodies anti-insulin, autoimmune diseases or in treatment with immunosuppressive drugs. * individuals with viral infections such as hepatitis b, hematological, renal or hepatic diseases. * pregnancy

Keywords: type 2 diabetes β-carotene oxidative balance oxidants antioxidants
oncolytic virus ad-td-nsil12 for primary pediatric diffuse intrinsic pontine glioma

Conditions: Oncolytic Virus; Diffuse Intrinsic Pontine Glioma; Adverse Drug Event

Summary: this is a drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus ad-td-nsil12 intratumoral injection in primary dipg patients (nci-ctcae v5.0).


Eligibility criteria:
inclusion criteria: 1. informed consent of the parents or patient. 2. patient must be, in the investigator opinion, able to comply with all the protocol procedures. 3. age 1-18 years. 4. a negative pregnancy test in fertile women (women are considered of childbearing potential (wocbp) after menarche, unless permanently infertile, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). 5. patient newly diagnosed of dipg in mri. 6. pre-enrollment patients lps (patients aged ≥1 and \<16 years) and kps (patients aged ≥16 years) ≥ 50. 7. lesion considered by the investigator to be accessible for stereotactic biopsy. the location of the lesion allows injection without virus entering the ventricular system. 8. no previous treatment for dipg. exclusion criteria: 1. serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow failure, which are not permitted for inclusion according to the investigator's criteria. patients must be afebrile at baseline (\<38℃). 2. other investigational medications within 30 days prior to viral treatment. 3. participants with immunodeficiency, autoimmune disease, or active hepatitis. 4. any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism. 5. tumor with multiple location. 6. pregnant or breast-feeding females. 7. severe bone marrow hypoplasia. 8. transaminases (aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)) or total bilirubin \> 3 times the upper limit of normal. 9. neutrophils \< 1x10\^9/l. 10. platelets ≤ 100x10\^9/l. 11. hemoglobin \< 9 g/dl. 12. patients with li-fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways. 13. administer any type of vaccine within 30 days prior to ad-td-nsil12 administration. 14. blood transfusions or drugs (such as g-csf) within 28 days before baseline to treat pancytopenia or other blood disorders.
yoga nasal irrigation in the treatment of chronic tension type headache

Conditions: Chronic Tension-Type Headache

Summary: to evaluate the effectiveness of yoga nasal irrigation (jalaneti) on patients with chronic tension-type headache reducing pain and disability.


Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria of chronic tension type headache as per international classification of headache disorders, 3rd edition (beta version) (ichd-3 beta criteria) * aged 18-60 years; * ability of understand and completing the headache dairy; * volunteering to the study * provide written informed consent. exclusion criteria: * not having tension-type headache during the pervious 3 months or having less than 8 episode of tension type headache in serious month. * taking any prophylactic headache medication or complementary and alternative medicine in last 3 month; * secondary headaches * in pregnancy, lactation, or planning to be pregnant in 6 months * having nose bleeding disorders or recurrent infections; * psychiatric diagnosis or medication history