Kornimate/medical-research-clean huggingface dataset:
mechanisms, predictors, and social determinants of cardiotoxicity in prostate cancer

Conditions: Prostate Cancer; Cardiotoxicity; Drug-Related Side Effects and Adverse Reactions; Cardiovascular Diseases

Summary: this is an observational study for patients with prostate cancer that will be treated with androgen deprivation therapy. the study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. patients will be followed on this study for up to 5 years.

the investigators propose a prospective longitudinal cohort of prostate cancer patients treated with androgen deprivation therapy (adt) to determine the associations between social determinants of health (sdoh) and cardiotoxicity risk and to determine wither associations between sdoh and cardiotoxicity risk differs according to race. patients will be followed with serial echo, blood draw, and surveys prior to start of adt and then 6 months, 1 year, 2 years, 3 years, and 5 years after start of adt.

Eligibility criteria:
inclusion criteria: men older than 18 years of age prostate cancer diagnosis planned for treatment with ≥6 months of adt (with or without rt) for clinically localized, biochemically recurrent, or oligometastatic disease. planned adt regimens may include: gnrh agonists (goserelin, histrelin, leuprolide, triptorelin) with or without first-generation anti-androgens and gnrh antagonists (degarelix). additional systemic agents, including second-generation androgen receptor signaling inhibitors, may be used in combination with gnrh agonist/antagonist therapies per provider clinical discretion. ability to provide informed consent exclusion criteria: prior adt injection within 6 months prior to enrollment inability or unwillingness to provide consent

Keywords: cardiotoxicity of chemotherapy cardio-oncology social determinants of health
efficacy and safety of transarterial therapies+donafenib + anti-pd-1 antibody for uhcc: a retrospective real-world study

Conditions: Hepatocellular Carcinoma Non-resectable

Summary: this retrospective real-world study was designed to evaluate the clinical efficacy and safety of the combination of transarterial therapies with donafenib plus anti-pd-1 antibody for unresectable hepatocellular carcinoma.

data of patients who have received triplet therapy ( transarterial therapies+donafenib+anti-pd-1 antibody）will be collected，excluding incomplete data. the primary endpoint was the objective response rate (orr)，secondary endpoints included disease control rate (dcr), progression-free survival rate (pfsr) \[ time frame: 6- and 12-month\], overall survival rate (osr) \[ time frame: 6- and 12-month\], the median progression-free survival time (mpfs) and median overall survival time (mos)， as well as adverse event.

Eligibility criteria:
inclusion criteria: 1. clinically or histopathologically diagnosed hcc; 2. not suitable for curative surgery, or local ablation; 3. age 18\~75 years； 4. barcelona clinic liver cancer (bclc) stage-b or c hcc; 5) child-pugh score a or b7; 6) eastern cooperative group (ecog) performance status ≤1.; 7）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified response evaluation criteria in solid tumors (mrecist) exclusion criteria: 1）comorbidity with other severe systemic diseases; 2）life expectancy is less than 3 months; 3) discontinuation of treatment for personal reasons or inability to tolerate; 4）incomplete data. -
study to evaluate the safety, pk, and pharmacodynamics of lib003

Conditions: Hypercholesterolemia

Summary: randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 sc and 2 iv cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of lib003 in subjects with moderately elevated ldl-c levels.

after meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of lib003. seven (7) cohorts will receive lib003 escalating doses of lib003, or placebo, by sc injection and 2 cohorts lib003 or placebo by iv infusion. dose escalation will be based on the assessment of safety and tolerability data. all cohorts will each first enroll a sentinel group of subjects who will receive lib003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.

Eligibility criteria:
inclusion criteria: * men and women who are \>/=18 and \</=70 years of age. female subjects must be of non-childbearing potential. * ldl-c \>/=100 mg/dl who are either not on a lipid-lowering therapy or who are on stable statin therapy. * body mass index (bmi) \>18 and \<38 kg/m2 * mild hypertensives on a stable dose of no more than one antihypertensive drug exclusion criteria: * history of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising subject inclusion * systolic blood pressure \ 160 mmhg or diastolic blood pressure \ 100 mmhg at screening * positive blood screen for human immunodeficiency virus (hiv), hepatitis b surface antigen, or hepatitis c virus antibody * abnormal liver function test at screening (aspartate aminotransferase \[ast\] or alanine aminotransferase \[alt\] \>2 × the upper limit of normal \[uln\] * estimated glomerular filtration rate \<60 ml/min/1.73 m2 at screening, as determined by the ckd-epi equation * history of prescription drug abuse, illicit drug use (including marijuana), or alcohol abuse * unable to spend 4 days in confinement unit * history of allergy to protein-based biologics including, but not limited to, mabs and vaccine * any other finding which, in the opinion of the investigator, would compromise the subject's safety or participation in the study
functional tests in individuals with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: objectives: to evaluate and compare the responses to the various functional tests, and the concordance between the six-minute walk test in hallway (6mwt) and the of oval track (6mwtot), of treadmill (6mwtt), and of treadmill with inclination (6mwtti), the six-minute step test (6mst) and the sit-to-stand test (stst), in patients with chronic obstructive pulmonary disease (copd), and to correlate the responses with functional state and quality of life. methods: ten patients with copd (71±8years, fev1\<80%predicted) were assessed using the functional tests. a dyspnea was assessed using the london chest activity of daily living and the medical research council scales; and the quality of life was assessed using the st george's respiratory questionnaire (sgrq).

results: in the interests analysis, there was lower walking distance in the 6mwtt and 6mwtti was observed, to compare in the 6mwt and 6mwtot; the δsp,o2 (delta of arterial oxygen saturation measured by pulse oximeter) in the 6mwtti was significantly greater that in the 6mwt, but not between to change in dyspnea and fatigue/pain in the lower-limbs between rest and exercise of peak (δ). concordance and correlation was observed between the lower sp,o2 of the 6mwt with the 6mwtot, 6mwtt, 6mwtti, 6mst and stst. strong correlations was observed between the performances on the 6mst and 6mwt, 6mwtot and 6mwtt; and between the physical activity domain of the sgrq with the performances in the 6mwt, 6mwtot, 6mwtt,6mst and stst. conclusion: the functional tests produced similar subjective responses; however, the 6mwtti caused greater desaturation that 6mwt. the concordance between the 6mwt and the tests performed, suggests acceptable use of any these tests in the physiotherapeutic clinical routine of the individuals copd. the tests in performed, except the 6mwtti, shown to be indicators of the quality of life (physical activity domain).

Eligibility criteria:
inclusion criteria: * tiffeneau index\<70% e 30%\<fev1\<80% predict; * no presenting exacerbation during the study period; * clinical stability for the four weeks preceding the study outset; * no-smokers or ex-smokers. exclusion criteria: * being incapable of understanding the scales and questionary; * being unable to perform the tests.

Keywords: chronic obstructive pulmonary disease walking exercise test quality of life dyspnea desaturation
the relationship between erythrocyte transfusion and nutrition and necrotizing enterocolitis in preterm infants

Conditions: Necrotizing Enterocolitis of Newborn

Summary: in this study; the aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.


Eligibility criteria:
inclusion criteria: * \<32 gestational week and/or \<1500 g birth weight exclusion criteria: * major congenital anomalies, hemodynamic instability
efficacy and safety of colorectal anastomotic leak testing

Conditions: Colorectal Cancer; Leakage Testing; Colorectal Surgery; Complications; Anastomotic Leakage

Summary: to evaluate the effectiveness of the gastroscopy, air, and methylene blue (gam) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. the primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications. 2. aged between 18 and 85 years. 3. american society of anesthesiologists (asa) physical status classification is i - iii. 4. the patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process. exclusion criteria: 1. patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections. 2. patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests. 3. patients with severely impaired liver and kidney function (liver function child - pugh classification c or above, creatinine clearance rate \< 30 ml/min). 4. patients with coagulation disorders (such as platelet count \ 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted. 5. patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures. 6. patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy. 7. patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.
phase ii study of fluconazole for lymphocutaneous and visceral sporotrichosis

Conditions: Sporotrichosis

Summary: objective: i. evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.

protocol outline: patients are treated with daily oral fluconazole for up to 24 months. follow-up continues for at least 1 year.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- presumptive evidence of sporotrichosis culture-proven sporotrichosis determined on study relapsing disease following antifungal therapy eligible if culture positive for sporothrix schenckii prior to entry no life-threatening disease no central nervous system sporotrichosis --prior/concurrent therapy-- no concurrent drugs known to react with fluconazole no more than 3 days of systemic antifungals for current sporotrichosis episode --patient characteristics-- hepatic: liver function tests no greater than 5 times normal other: no hiv infection no pregnant or nursing women

Keywords: fungal infection rare disease sporotrichosis
intraoperative vs. postoperative intravesical epirubicin instillation for prevention of bladder recurrence in high-risk upper urinary tract urothelial carcinoma

Conditions: Bladder Cancer Recurrence; Intravesical Instillation; Upper Urinary Tract Carcinoma

Summary: upper urinary tract urothelial carcinoma (utuc) accounts for 5%-10% of urothelial malignancies, with up to 50% of patients developing bladder recurrence post-rnu. high-risk utuc (≥pt2, high-grade, or n+ disease) necessitates aggressive management. intravesical chemotherapy mitigates recurrence risk, yet optimal timing-intraoperative vs. postoperative-remains unclear. this study evaluates intraoperative epirubicin instillation during rnu compared to postoperative administration and no instillation.


Eligibility criteria:
inclusion criteria: * primary high-risk utuc. exclusion criteria: * prior bladder cancer, * low-risk utuc (managed conservatively), * metastatic disease, * incomplete follow-up

Keywords: bladder cancer bladder cancer recurrence intravesical instillation upper urinary tract carcinoma
incremental vestibulo-ocular reflex adaptation as a novel treatment for dizziness in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study aims to study the effects of a novel treatment for vestibular symptoms in people with multiple sclerosis. the main objective is to determine whether daily personalized gaze stabilization training is more beneficial than intermittent gaze stability training in people with multiple sclerosis.

people with multiple sclerosis (ms) often experience dizziness, caused by problems in how their brain processes balance signals. this dizziness can lead to difficulties keeping their eyes focused on a target while moving their head, known as gaze instability. this makes activities like walking or driving challenging and dangerous. vestibular physical therapy, including gaze stabilization exercises, can help. the team developed stableeyes, a technology that improves gaze stability using a gradual approach to these exercises. in the studies, stableeyes significantly enhanced gaze stability in people with balance issues. preliminary research in people with ms shows promising results, suggesting that tailored gaze stability exercises can further improve their vision stability. this method targets the vestibulo-ocular reflex (vor), a critical reflex for maintaining clear vision during head movements. improved vor function can reduce dizziness and improve the quality of life for people with ms.

Eligibility criteria:
inclusion criteria: * neurologist-confirmed diagnosis of primary progressive or relapsing and remitting ms per the 2017 revision of the mcdonald criteria and the magnetic resonance imaging in ms * fluent in speaking and understanding english * have self-reported vestibular symptoms of dizziness, imbalance, and/or a history of at least two falls in the prior 12 months exclusion criteria: * clinically isolated syndrome or radiologically isolated syndrome. * worsening ms symptoms during the prior 60 days * immunotherapy change in the prior 60 days * self-reported cognitive impairment that limits independence with basic and instrumental activities of daily living * systolic blood pressure \> 180 mmhg and/or diastolic blood pressure \> 90 mmhg at rest * static visual acuity with correction of worse than 1.0 logmar * manifest ocular misalignment ≥ 5 diopters (e.g., tropia, lazy eye, strabismus} * convergence insufficiency * intra-nuclear ophthalmoplegia * benign paroxysmal positional vertigo * major orthopedic conditions that limit cervical spine range of motion or that alter walking * self-reported current or potential for pregnancy during enrollment * ongoing participation in vestibular rehabilitation for dizziness

Keywords: treatment of multiple sclerosis incremental vestibulo-ocular reflex adaptation dizziness in people with multiple sclerosis
study to evaluate the efficacy, safety and tolerability of imu-838 in patients with relapsing multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: multi-center, randomized, double-blinded phase 3 study to evaluate the efficacy, safety, and tolerability of imu-838 versus placebo in adults with relapsing multiple sclerosis (ensure-2)

this study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded main treatment period (mt) and an open label period (ole) to evaluate the efficacy, safety, and tolerability of imu-838 in adult patients with rms. the study will consist of the following periods: screening period: approximately 28 days main treatment period: 72 weeks (approximately 15 months) open label extension period: up to approximately 8 years

Eligibility criteria:
inclusion criteria: * male or female patient (age ≥18 to ≤55 years). * patients with an established diagnosis of ms according to 2017 mcdonald criteria. * patients with rms comprising of relapsing remitting ms (rrms) and active secondary progressive ms, both defined according to lublin criteria 1996 and 2014. * active disease as defined by lublin 2014 evidenced prior to screening by: 1. at least 2 relapses in the last 24 months before randomization, or 2. at least 1 relapse in the last 12 months before randomization, or 3. a positive gd+ mri scan (brain and/or spine) in the last 12 months prior to randomization. * willingness and ability to comply with the protocol. * written informed consent given prior to any study-related procedure. exclusion criteria: * patients with non-active secondary progressive ms and primary progressive ms. * any disease other than ms that may better explain the signs and symptoms, including history of complete transverse myelitis. * clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (nmo) spectrum disorders or myelin oligodendrocyte glycoprotein (mog)-igg-associated encephalomyelitis * any active and uncontrolled coexisting autoimmune disease, other than ms (except for type 1 diabetes mellitus and inflammatory bowel disease) * use of experimental/investigational drug (with the exception of covid-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to screening * previous or current use of ms treatments lifelong, or within a pre-specified time period. * use of the pre-specified concomitant medications. * clinically significantly abnormal and pre-specified lab values. * history of chronic systemic infections within 6 months before the date of informed consent. * diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study. * known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis. * history or clinical diagnosis of gout. * history or presence of any major medical or psychiatric illness * substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
metastatic tumor cell trap device in patients with advanced ovarian cancer

Conditions: Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV

Summary: m-trap is an implantable medical device designed to capture disseminated tumor cells (dtcs). it is intended for use in advanced-stage ovarian cancer patients. the study objective is to assess the safety and the performance of the m-trap device.


Eligibility criteria:
inclusion criteria: 1. is a female ≥18 years old. 2. presents with a diagnosis of stage iiic ovarian cancer. 3. presents with high-grade serous carcinoma. 4. has one of the following: 1. visible residual tumor ≤1 cm after primary tumor debulking surgery. 2. three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery. 3. three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery. 5. ecog performance status of 0 or 1. 6. is willing to comply with required follow-up study visits. 7. is willing and able to provide written informed consent. exclusion criteria: 1. has a life expectancy of \<3 months. 2. is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating. 3. will be receiving intraperitoneal chemotherapy. 4. has undergone prior treatment with abdominal and/or pelvic radiotherapy. 5. has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. presence of central nervous system or cerebral metastases. 7. recurrent ovarian cancer. 8. complete resection with no residual tumor after primary tumor debulking surgery. 9. suboptimal resection with \>1 cm residual tumor after primary or interval tumor debulking surgery. 10. is simultaneously enrolled in another investigational study. 11. has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer. 12. has a known hypersensitivity to carboplatin or paclitaxel. 13. is concurrently using other antineoplastic agents.
efficacy of repeated low-level red-light therapy in myopia control

Conditions: Myopia; Refractive Errors; Eye Diseases

Summary: the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in chinese schoolchildren.

low level light therapy (lllt) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. the investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in chinese schoolchildren. study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. an interim analysis will be performed at the 3rd month, at which the data will be reported and presented. appropriate adjustment of the p-value and decision on the continuation of the study will be made.

Eligibility criteria:
inclusion criteria: 1. age at enrolment: 8-13 years 2. spherical equivalent refractions (sers): -1.00 to -5.00 diopters (d) 3. astigmatism of 2.50 d or less 4. anisometropia of 1.5 d or less 5. spectacle corrected monocular logmar visual acuity (va): 0 or better 6. parents' understanding and acceptance of random allocation of grouping exclusion criteria: 1. strabismus and binocular vision abnormalities in either eye 2. ocular abnormalities in either eye or other systemic abnormalities 3. prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye 4. other contraindications in either eye