Kornimate/medical-research-clean huggingface dataset:
multidisciplinary approach to novel therapies in cardiology oncology research

Conditions: Breast Cancer; Heart Failure

Summary: while trastuzumab has been shown to prevent recurrences of breast cancer, some women may also experience damage to their heart muscle (including heart failure) as a result of their treatment. the investigators hope to learn if standard medications used in heart failure can prevent heart damage caused by trastuzumab in women with breast cancer. the investigators would also like to know if there are any ways to detect this damage earlier using magnetic resonance imaging (mri) and blood tests.

we propose a randomized, placebo-controlled, double-blind study evaluating the efficacy of an ace-inhibitor (perindopril) or a beta blocker (bisoprolol) for the prevention of lv remodeling among women with early breast cancer scheduled for chemotherapy and one year of trastuzumab. participants will undergo cardiac mri at baseline and 3 and 12 months, replacing the usual muga, as well as a post-treatment cardiac mri at 24 months to evaluate long-term effect.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of her2 positive breast carcinoma * eligible to receive trastuzumab * age \> 18 years * able to give informed consent * no contraindications to mri exclusion criteria: * known contraindication to beta-blocker therapy * known contraindication to acei therapy * current treatment with acei or beta blocker for other indication * history of heart failure, cardiomyopathy or baseline lvef \< 50%

Keywords: trastuzumab cardiac mri beta-blocker biomarkers angiotensin converting enzyme inhibitor cardiotoxicity her2 positive
screening and follow-up study of neonatal jaundice based on mobile network

Conditions: Hyperbilirubinemia, Neonatal

Summary: at least 13 hospitals in china will participate in the study, which aims to clarify the natural history of jaundice in chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. the study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.

this is a prospective cohort study of healthy term and near-term infants. the mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. firstly，the tcb values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in china. secondly, by establishing an online registry for severe hyperbilirubinemia and "follow up of jaundice" on wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.

Eligibility criteria:
inclusion criteria: * term or near-term neonates with gestational age ≥35w and birth weight ≥2000g. exclusion criteria: * biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.

Keywords: hyperbilirubinemia screening follow-up
efficacy and safety of timolol for tki induced paronychia

Conditions: Paronychia

Summary: this study would assess the clinical efficacy of add-on topical timolol 0.5% gel to betamethasone valerate 0.1% for the treatment of egfr-tki induced paronychia. eligible patients, who develop paronychia (affecting fingernails, toenails or both), will be included in this study. they will be randomized in 1:1 ratio using computer-generated randomization list to receive either combination of topical timolol 0.5% gel and betamethasone valerate 0.1% lotion application twice daily or betamethasone valerate 0.1% lotion application twice daily. patients in timolol combination treatment group will receive topical timolol 0.5% gel twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% lotion twice daily with occlsuion for 1 month. patients in routine arm would receive the management according to routine clinical practice, including prescription of betamethasone valerate 0.1% lotion twice daily for 1 month with occlusion. for patients who do not have paronychia completely resolved after 4 weeks, the treatment assigned will be continued for another 4 to 8 weeks , up to 12 weeks to see the effect.

the aim of this study ist o assess the clinical efficacy of add-on topical timolol 0.5% gel to betamethasone valerate 0.1% for the treatment of egfr-tki induced paronychia.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or above, either males or females. 2. received egfr-tki, namely gefitinib, erlotinib, afatinib, osimertinib, amivantamab, dacomitinib and mobocertinib. 3. paronychia (fingernails, toenails, or both) as an adverse event from egfr-tki use. 4. written informed consent obtained from patient. exclusion criteria: 1. age below18. 2. patients who are allergic to, or contraindicated to topical timolol use. 3. pregnant women or nursing mother. 4. non-consenting patients.

Keywords: egfr tki paronychia timolol
diagnostic study of lateral ligament complex injury of ankle

Conditions: Chronic Instability of Ankle Joint; Lateral Ligament Complex Injury of Ankle

Summary: comparative study on accuracy of different diagnostic methods of lateral collateral ligament injury of ankle

background: the lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (atfl), the calcaneofibular ligament (cfl), and the posterior talofibular ligament (ptfl), is often injured by an ankle sprain. improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function. method and objective: this study is a prospective diagnostic test. by comparing the sensitivity and specificity of stress x-ray, b-ultrasound, computed tomography (ct), and magnetic resonance imaging (mri), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, we aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.

Eligibility criteria:
inclusion criteria: * chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age. exclusion criteria: * acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage iv).

Keywords: lateral ligament complex ankle diagnostic methods chronic lateral instability of ankle
postpartum readmission

Conditions: Postpartum Hypertension

Summary: this is a retrospective chart review of women who labored and delivered in a single health care center. from that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. the study will also look at "controls," a group of women with similar risk factors but did not require readmission.

preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. the disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. it is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. there is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. management before the onset of labor includes close monitoring of maternal and fetal status. management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. delivery remains the ultimate treatment. preeclampsia leads to eclampsia. symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness current obstetric treatment in the united states has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. during the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. this results in re-admission to the hospital for some women. the investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.

Eligibility criteria:
inclusion criteria: * women who labored and delivered at a single hospital readmitted (within 6 weeks post partum (pp) or less)to the hospital for hypertension disorder, with or without hypertension (htn in pregnancy), gestational hypertension (ghtn), pre eclampsia (pree), severe pre eclampsia (spree), hellp ("hellp" is an abbreviation of the three main features of the syndrome: hemolysis. elevated liver enzymes. low platelet count.). controls group with pree, not readmitted or no pree exclusion criteria: * hospital readmission for other complications.
dose-ranging study of a single administration of t-cell add-back depleted of host alloreactive cells in patients undergoing a peripheral blood stem cell transplant from a related, haploidentical donor

Conditions: Hematologic Diseases; Hematologic Malignancies

Summary: the purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive t-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.

allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. however, a major limitation of this therapy is that for a significant number of patients no fully hla-matched donor can be found. the application of partially hla-matched (haploidentical) family donors, who are virtually always available, has some complications. if there is no t-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of t-cell add-back the risk of graft-versus-host disease is raised. kiadis pharma has developed a method to selectively deplete host alloreactive t-cells through photodynamic therapy, using th9402 ex vivo. the donor lymphocyte preparation depleted of functional alloreactive t-cells (atir) are administered to the patient 4-6 weeks after the stem cell transplant. this method enables early immune reconstitution while preventing graft-versus-host disease.

Eligibility criteria:
inclusion criteria: * any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (cml), lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds) * incompatibility at two to three loci (hla-a, b and/or dr) or a single dr locus of the unshared haplotype between the donor and recipient * life expectancy of at least 3 months * satisfactory performance status (ecog ≤ 2); exclusion criteria: * possibility of performing an allogeneic transplant with an hla (human leukocyte antigen) matched sibling donor * availability of an 6/6 hla-a, b and drb1 matched unrelated donor within 2-3 months; * pregnancy * viral hepatitis (b or c) * active serious infectious process * hiv positivity; * systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation * prior allogeneic transplantation * prior autologous transplantation within twelve months of baseline visit * any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome * active central nervous system (cns) disease at baseline * participation in a trial with an investigational agent within 30 days prior to entry in the study * malignant cells in circulating peripheral blood (\> 25%) * other active malignant disease that would severely limit life expectancy

Keywords: haploidentical stem cell transplantation graft-versus-host disease immune reconstitution alloreactive t-cells photodepletion th9402 transplant related mortality hematologic malignancy
effect of light color temperature applied during breastfeeding on mother's stress, anxiety, peace and breastfeeding motivation

Conditions: Light; Stress; Anxiety

Summary: breastfeeding is an important condition for the health of the mother and the baby, which is the most difficult for mothers after birth. since it is an important practice for both the mother and the baby, the evaluation and reduction of the mother's stress factors can help the hospital to regulate the lighting of the breastfeeding room. in addition, setting the light color temperature to a more appropriate kelvin can make a positive contribution to the hospital in terms of costs. for this purpose, when researchers look at the literature, we have not come across a randomized controlled study examining the effect of the light color temperature applied during breastfeeding on the mother's stress, anxiety, peace and breastfeeding motivation. researchers' purpose is to determine the effect of the light color temperature applied during breastfeeding on the mother's stress, anxiety, peace and breastfeeding motivation.


Eligibility criteria:
inclusion criteria: * mothers who have given birth for the first time, * being 18 years of age and older, * volunteering. exclusion criteria: * being a mother who has given birth to more than one child, * having any problem that prevents communication (such as not knowing turkish, having hearing, speaking and understanding disorders), * receiving psychiatric treatment (pharmacotherapy or psychotherapy), * having a disease that prevents vision.
a phase ii clinical study of treatment with disitamb vedotin plus pyrotinib in her2-positive early breast cancer

Conditions: Breast Cancer

Summary: evaluate the efficacy and safety of disitamb vedotin combined with pyrotinib in her2 positive early breast cancer

the main goal of this clinical trial is to evaluate the efficacy of disitamb vedotin combined with pyrotinib in previously untreated histologically proven her2 positive early breast cancer and evaluate the pcr dfs,os and safety of the subjects.

Eligibility criteria:
inclusion criteria: 1.18 to 75 years old (at the time of signing the informed consent form), regardless of gender. 2. subject type and disease characteristics. histologically confirmed her2 positive ebc subjects: 1. evaluated as her2 positive in local laboratories according to ascocap guidelines. 2. single and multifocal tumors (greater than 1 tumor area limited to the same quadrant as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as her2 positive. 3. multicenter tumors (multiple tumors involving more than one breast quadrant) must sample one lesion from each affected quadrant and be confirmed as her2 positive by the central laboratory. 4. according to ascocap guidelines, tumors are either hr positive or hr negative (er and pgr negative). 5. clinical staging at visit (based on breast x-ray or breast mri evaluation): stage ii-iiic determined by the ajcc staging system, 8th edition. (f) lymph node involvement is determined by fine needle aspiration or coarse needle aspiration biopsy (if applicable). 3. when randomized, ecog physical fitness status is 0 or 1 point. exclusion criteria: 1. previous history of invasive breast cancer. 2. stage iv breast cancer according to ajcc staging system version 8. 3. within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease. 4. dcis medical history, except for the subjects who only received mastectomy 5. according to the judgment of the researchers, there is evidence of any diseases (such as severe or uncontrolled systemic diseases, including persistent or active infections, uncontrolled hypertension, kidney transplantation and active bleeding diseases, and severe chronic gastrointestinal diseases related to diarrhea) that the researchers consider to be unfavorable for the participants to participate in the study or may affect adherence to the protocol. 6. uncontrolled infection requiring intravenous administration of antibiotics, antiviral drug or antifungal drugs.

Keywords: her2-positive rc48
individualized rtms based on fnirs to spasticity

Conditions: Stroke; Spasticity, Muscle; Rehabilitation

Summary: stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. the brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. however, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. neuromodulation techniques such as repetitive transcranial magnetic stimulation (rtms) have been widely used to promote brain network remodeling after stroke. the investigators attempted to evaluate the motor brain network characteristics of spastic patients by fnirs, and used the most active brain regions as rtms stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity.


Eligibility criteria:
inclusion criteria: * aged 40-79 years; * patients with first-onset stroke within 1 to 3 months after onset; * consciousness, sitting balance level 1 or above, can cooperate with fnirs assessment; * the patient or its authorized agent signs the informed consent form. exclusion criteria: * previous seizures; * suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset; * patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rtms.

Keywords: stroke spasticity, muscle rehabilitation fnirs rtms activation brain network
effects of vitamin d on moderate to severe periodontitis

Conditions: Chronic Peritonitis

Summary: the object of the study was to evaluate the direct effect of high dose vitamin d supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.

periodontitis is a chronic inflammatory disease characterized by periodontal tissues inflammation and alveolar bone loss. vitamin d is involved in stimulating osteoblasts to enable normal bone growth and preservation, also the regulation of cellular proliferation, differentiation, innate immune response and anti-inflammatory effect.previous studies have reported the association of vitamin d levels and gingivitis and periodontitis. this study was designed as a randomized controlled trial to evaluate the effect of vitamin d supplementation on chronic periodontitis. the study was divided into two phases. recruitment including baseline clinical measurements was obtained and standard periodontal treatments were performed in phase one. the randomization and intervention of vitamin d were performed in phase two. the 323 subjects were randomly divided into 3 groups (n=105,110,108) to receive a supplement kit containing 90 capsules of 2000 iu vitamin d, 1000 iu vitamin d, or placebo capsule for 3 months. after intervention, all the subjects were followed up after 3 months and received standard periodontal examination, including attachment loss (al), probing depth (pd), bleeding index (bi), and panoramic radiographs were taken to evaluate alveolar crest height (ach).

Eligibility criteria:
inclusion criteria: 1. age from 30 years old to 70 years old 2. more than 20 teeth remaining in the mouth 3. clinical diagnosis of moderate to severe periodontitis 4. not receiving periodontal treatment within 6 months 5. not taking antibiotic drugs within 3 months. exclusion criteria: 1. diabetes, thyroid and parathyroid endocrine associated diseases 2. severe systemic diseases, such as cancer 3. taking vitamin d and / or calcium drugs during observation 4. taking aspirin, non-steroidal anti-inflammatory drugs, and steroids 5. pregnant or prepare to pregnant within one year 6. have been suffering from hypercalcemia, malabsorption syndrome.

Keywords: vitamin d
a randomized controlled trial of an advanced care planning video decision support tool for patients with end-stage liver disease

Conditions: End Stage Liver Disease

Summary: the goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an advanced care planning (acp) video decision support tool for improving patients' knowledge regarding their goals of care options and end of life (eol) decision-making in patients with end-stage liver disease (esld).


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age with an established diagnosis of end-stage liver disease 2. patient must have either 1) primary hepatologist at the mgh liver center or an mgh-affiliated primary care physician, or 2) a previous inpatient admission at mgh 3. deemed ineligible for liver transplantation as determined by the primary hepatologist 4. ability to communicate in english and provide informed consent 5. a score ≥ 7 on the short portable mental status questionnaire exclusion criteria: 1. severe hepatic encephalopathy which the primary hepatologist believes prohibits informed consent or participation in the study 2. significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary hepatologist believes prohibits informed consent or participation in the study 3. prior history of liver transplantation 4. patient has been referred to or enrolled in hospice care 5. patients who have been referred to palliative care
effects of non-nutritive sweeteners on the composition of the gut microbiome

Conditions: Obesity; Diabetes

Summary: this pilot study is being conducted to evaluate whether consumption of diet soda sweetened with sucralose and acesulfame-potassium leads to changes in the gut microbiota. following a one week run-in period, healthy, young adults are randomized to consume either diet soda or carbonated water (control) three times per day for one week. stool and urine samples are collected at baseline, following the run-in, and after the one-week intervention.


Eligibility criteria:
inclusion criteria: * healthy adults aged 18-35 years * consume less than 1 food/beverage with non-nutritive sweeteners per month * able and willing to consume diet soda three times daily for 1 week exclusion criteria: * recent diet or significant weight change * antibiotic use in the past 3 months * diarrhea in the past two weeks * use of medications known to affect metabolism or weight * weight \< 50 kg (110 lbs.) * history of metabolic complications including high blood sugar, elevated cholesterol, or liver disease