Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of abiraterone acetate in participants with prostate cancer who have failed hormone therapy

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[mtd\]) of abiraterone acetate (also known as cb7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (hrpc).

this is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with hrpc. the study will consist of a dose escalation stage (phase 1) that will be conducted to determine the mtd of abiraterone and an activity evaluation stage (phase 2) to evaluate the activity of abiraterone in participants with hrpc. escalated doses of abiraterone (starting at 250 milligram \[mg\] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the mtd. participants will be given mtd of abiraterone for up to 12 cycles (28 day each) in phase 2 of the study. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * histologically (pertaining to the disease status of body tissues or cells) documented adenocarcinoma of the prostate, clinically refractory (not responding to treatment) or resistant to hormone therapy, as documented by progression following at least one hormonal therapy * prostate specific antigen (psa) evidence for progressive prostate cancer * participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one psa higher than the last pre-withdrawal psa or 2 increases in psa documented after the post-withdrawal nadir(value) greater than or equal to 4 weeks from treatment withdrawal if treated with flutamide and greater than or equal to 6 weeks if treated with bicalutamide or nilutamide * eastern cooperative oncology group (ecog) performance status score equal to 0 or 1 * life expectancy of greater than or equal to12 week exclusion criteria: * participants with central nervous system (the brain and spinal cord) disease and/or brain metastases * no currently active second malignancy (cancer or other progressively enlarging and spreading tumor) other than non-melanoma skin cancer * myocardial infarction within the 6 months prior to start of study * no active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy during protocol treatment * major surgery or significant traumatic injury within 4 weeks of start of study

Keywords: abiraterone acetate cb7630 prostatic neoplasms hormone refractory prostate cancer castration resistant prostate cancer castration refractory prostate cancer
yang yin fu zheng jie du therapy in hbv associated hepatocellular carcinoma based on the platelet count/splenic length-diameter ratio

Conditions: Hepatocellular Carcinoma

Summary: clinical research of yang yin fu zheng jie du therapy in hbv associated hepatocellular carcinoma based on the platelet count/splenic length-diameter ratio.the purpose of this study is to establish the efficacy evaluation system combined with platelet/splenic length-diameter ratio, and to clarify the effect of this method on relieving hepatitis b cirrhosis and delaying the progression of hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: meet the criteria of hepatocellular carcinoma patients who tested positive for hepatitis b surface antigen (hbsag) for \>6 months liver function grade child-pugh a/b patients who have agreed to select local treatment according to the guidelines for the diagnosis and treatment of primary liver cancer (2017) tcm syndrome differentiation belongs to deficiency of qi and yin, stasis and toxin accumulation syndrom informed consent from the patient. exclusion criteria: patient with other hepatitis virus infections or alcoholic liver, autoimmunity liver, primary biliary cirrhosis, genetic metabolic liver disease, and previous liver transplantation; serious problem of heart, lung, brain, blood and other important organs; patients with metastatic liver cancer; pregnant or child breast feeding women; mental or cognitive disorders; who are allergic to the study drug.
nyu langone health headache center learning migraine self-management techniques study

Conditions: Migraine

Summary: the investigators aim to determine the feasibility of a migraine self-management program.

patients with migraine seen by neurologists/headache specialists within or affiliated with the nyu langone health system will be identified via electronic medical record system, or in person. the investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. the investigators will examine benefits through follow-up at 2, 4, and 6 month time points.

Eligibility criteria:
inclusion criteria: * english speaking. (at this time, the validated app is only available in english.) * 18-65 years of age * meets international classification of headache disorder (ichd)-3 migraine criteria based on a headache specialist or neurologist * headaches for ≥1 year * has not begun a new migraine preventative medication in the last month * agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (note - acute medications may be changed if needed. changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds) * 4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment \[\>4 headache days/month\] and those with more frequent migraines including chronic migraine \[15 days or more/month\] but exclude those with continuous headaches) exclusion criteria: * diagnosis of medication overuse headache (moh) * patients who have had cognitive behavioral therapy, biofeedback, or other relaxation therapy for migraine in the past year * alcohol or other substance abuse as determined by self-report or prior documentation in the medical record * current opioid or barbiturate use * phq-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the phq-9 (in this group, more intense psychological intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to develop medication overuse headache) * unable or unwilling to follow a treatment program that relies on written and audio-taped materials * coronary heart disease, heart attack, stroke, diabetes mellitus type 1 or ii * pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes) * other physical limitations which would prevent participating in the standard protocol of biofeedback being studied

Keywords: migraine self-management headache behavioral intervention
video-based climate change program

Conditions: Anxiety State; Efficacy, Self

Summary: climate change represents a global crisis with far-reaching implications for health, including mental health. among vulnerable populations, such as nursing students, climate change anxiety is emerging as a noteworthy concern. recognizing the need to address this issue, our research aims to investigate the impact of a virtual-based program on climate change awareness, anxiety levels, and self-efficacy among nursing students. as future healthcare professionals, nursing students play a pivotal role in promoting sustainable health practices and addressing the health impacts of climate change. this study seeks to contribute valuable insights into the effectiveness of virtual interventions in raising awareness and enhancing the coping mechanisms of nursing students in the face of climate change challenges.

aim: to investigate the effect of a video-based climate change program on revitalizing eco-cognizance, emotional response, and self-efficacy among nursing students in rural communities when compared to a group who received flyers related to climate change across the globe. research hypothesis * hypothesis 1: the video-based climate change program will significantly improve climate change perceptions among college students in rural communities. * hypothesis 2: the video-based climate change program will significantly improve environmental self-efficacy among college students in rural communities. * hypothesis 3: the video-based climate change program will significantly reduce climate change anxiety among college students in rural communities.

Eligibility criteria:
inclusion criteria: to be eligible for the study, students had to be from 2nd academic year to 4th year, not enter any educational program about climate change, owning a smartphone, and willingness to participate in program. exclusion criteria: * students who have psychological problems

Keywords: awareness, emotion, self-efficacy, climate change.
a comparison of neuromuscular electrical stimulation and intermittent pneumatic compression in terms of lower limb blood flow

Conditions: Venous Thrombosis

Summary: deep vein thrombosis (dvt) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. it involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. three mechanisms underlie dvt, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as virchow's triad. intermittent pneumatic compression (ipc) and neuromuscular electrical stimulation (nmes) have been shown to improve lower limb blood flow. however, few studies have directly compared the two methods and those that have, have used dated nmes techniques. the objective of this study is to compare the two methods in terms of blood flow.

deep vein thrombosis (dvt) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. it involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. three mechanisms underlie dvt, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as virchow's triad. intermittent pneumatic compression (ipc) involves the use of an inflatable cuff placed around the limb. this cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. neuromuscular electrical stimulation (nmes) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle. both ipc and nmes have been shown to improve lower limb blood flow. however, few studies have directly compared the two methods and those that have, have used dated nmes techniques. the objective of this study is to compare the two methods in terms of lower limb haemodynamics.

Eligibility criteria:
inclusion criteria: * free from any known illness. * between 18 and 40 years of age. exclusion criteria: * history of heart/respiratory problems * pregnancy * presence of implants, including cardiac pacemakers or orthopaedic implants * history of a neurological disorder * history of severe arterial disease or known dermatological problems.

Keywords: deep vein thrombosis neuromuscular electrical stimulation intermittent pneumatic compression doppler ultrasound
chemotherapy followed by surgery and neoadjuvant hemothoracic intensity modified radiation therapy (imrt) for patients with malignant pleural mesothelioma

Conditions: Mesothelioma; Solitary Fibrous Tumor of the Pleura

Summary: the purpose of this study is to determine the response rate and overall survival in patients that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and intensity modified radiation therapy (imrt) as part of their standard of care.

the investigators will consent patients that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then imrt as their standard of care. the investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and ct scans.

Eligibility criteria:
inclusion criteria: * subject provides informed consent * subject is \>18 years of age * subject is deemed competent for making medical decisions * subject is scheduled to undergo chemotherapy followed by surgery and then imrt * subject is a surgical candidate * a negative pregnancy test is required in women of child-bearing potential, as standard of care. exclusion criteria: •subject is \<18 years old.
transdisciplinary intervention integrating geriatric and palliative care with oncology care for older adults with cancer

Conditions: Cancer

Summary: the purpose of this research study is to pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer. the investigators will explore their perceptions of the supportive care needs of older patients with cancer. using these data, the investigators will finalize the transdisciplinary intervention and perform a pilot, randomized trial of the transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed, incurable cancer.

while evidence suggests that older adults with incurable cancer have unique geriatric and palliative care needs, models of care that are focused on these needs are lacking. the investigators propose to pilot test an intervention targeting the geriatric and palliative care needs of older adults with incurable cancer, referred to as a "transdisciplinary intervention." the goals of the proposed study are: (1) conduct focus groups with clinicians (from oncology, geriatrics and palliative care) and interviews with patients to explore their perceptions of older patients' supportive care needs and finalize the transdisciplinary intervention; (2) to demonstrate the feasibility and acceptability of delivering the transdisciplinary intervention to older patients with incurable gi and lung cancers; and (3) to estimate the effect size of the transdisciplinary intervention for patient-reported outcomes (e.g., between-group differences from baseline to week 12 in quality of life, physical function, physical and psychological symptoms).

Eligibility criteria:
inclusion criteria: * age 65 or older * diagnosed with incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease) * verbal fluency in english * planning to receive care at massachusetts general hospital (mgh) exclusion criteria: * unwilling or unable to participate in the study * significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study * no medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)

Keywords: cancer care palliative care geriatrics quality of life
a study to investigate vamikibart in participants with uveitic macular edema

Conditions: Uveitic Macular Edema

Summary: this study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.


Eligibility criteria:
inclusion criteria: * female participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol * diagnosis of macular edema associated with non-infectious uveitis (niu) * diagnosis of active or inactive, acute, or chronic niu of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) * bcva letter score of 73 to 19 letters (inclusive) on early treatment diabetic retinopathy study (edtrs)-like charts exclusion criteria: * evidence of active or latent syphilis infection * evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current hiv diagnosis * serious acute or chronic medical or psychiatric illness * history of major ocular and non-ocular surgical procedures * uncontrolled iop or glaucoma or chronic hypotony * any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images * prior use of ivt biologics including anti-vegfs less than 2-4 months prior to day 1; received ivt methotrexate within 4 months prior to day 1 * prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of day 1 * topical corticosteroids and/or topical nsaid \> 3 drops per day in the 14 days prior to day 1 (d1); intraocular or periocular corticosteroid injections in the 2 months prior to d1; subconjunctival corticosteroid injection within 1 month prior to day 1; an ozurdex implant in the 4 months prior to d1; yutiq, retisert or iluvien implant in the 3 years prior to d1 * diagnosis of macular edema due to any cause other than niu * any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
assessment of breathing using an under-bed weighing scale

Conditions: Postoperative Respiratory Complication; Respiratory Failure

Summary: the aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, bss) to predict postoperative pulmonary complications in high-risk surgical patients. the study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. undergoing non-cardiac surgery under general anesthesia. 3. score ≥ 25 in the risk prediction score (table1) exclusion criteria: 1. ambulatory (outpatient) surgery 2. transfer directly to the icu 3. remain intubated/ planned to remain intubated after surgery 4. pregnant patients: as detected by patient self-reporting of diagnosed by preoperative pregnancy testing according to institutional policies at bidmc. 5. patients enrolled in other interventional studies which could confound the primary endpoint.
an open label study of multiple doses of cannabidiol in the prevention of acute graft-versus-host disease (gvhd)

Conditions: Prevention aGVHD

Summary: a prospective, open-label, phase 2a study, to evaluate the pharmacokinetic (pk) profile, safety, and efficacy of multiple doses of cannabidiol (cbd) in participants graft-versus-host disease (gvhd) after allogeneic hematopoietic stem cell transplantation (hsct)

the study contains 3 cohorts of 12 participants each: all participants will be orally administered for 105 days with cbd at doses of 75, 150 or 300 mg (po) bid for the prevention of acute gvhd (agvhd) following allogeneic hsct. in addition to the study drug, all participants will receive standard agvhd prophylaxis consisting of a calcineurin inhibitor (cyclosporine or tacrolimus) and a short course of methotrexate (mtx). after completion of 105 treatment days, the participant will be followed-up until day 180.

Eligibility criteria:
inclusion criteria: 1. any malignant hematological disease in cr or myelodysplastic syndrome (mds) 2. age ≥ 18 years 3. karnofsky score (ks) ≥ 60% 4. hsct-comorbidity index (hsct-ci) score ≤ 3 5. no major organ dysfunction 6. myeloablative or reduced intensity conditioning regimen 7. matched (7/8 or 8/8) unrelated donor 8. peripheral blood stem cell graft 9. female subjects of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (iud), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. 10. male subjects with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) during the study. 11. subject's written informed consent exclusion criteria: 1. malignant hematological disease other than mds, not in cr 2. myelofibrosis 3. allogeneic transplantation from a matched or mismatched sibling donor 4. cord blood transplantation 5. positive serology for hiv 6. serious psychiatric or psychological disorders 7. any uncontrolled infection at time of registration 8. active consumption of illicit drugs (such as: crack cocaine, heroin, methamphetamines, cocaine, bath salts, amphetamines, methadone, benzodiazepine, ecstasy) 9. use of cannabis and/or its derivatives fourteen days prior to hsct and for the duration of study participation 10. uncontrolled hepatitis b or active hepatitis c infection. 11. qtc\>450ms per fridericia's correction and impaired cardiac function or clinically significant cardiac diseases 12. inadequate renal function defined as measured creatinine clearance \> 2.0 mg/dl 13. liver enzymes: alt and ast \> 3x upper limit of normal 14. pregnancy or breastfeeding ((positive serum β-hcg 7 days before first dose) 15. treatment with another investigational drug, biological agent, or device within 30 days of first dose, or investigational cell therapy within 6 months of first dose
bostrip: biomarkers of systemic treatment response in psoriasis

Conditions: Psoriasis

Summary: metabolomics of systemic psoriasis treatment


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 - 80 years, body weight ≤ 180 kg * dermatological diagnosis of psoriasis * initiated therapy with tnfα-inhibitor agents (etanercept, adalimumab and infliximab)or fumaric acid ester (fae) within the scope of routine patient care by treating physician * signed informed consent from patient exclusion criteria: * patients with evidence of any skin condition that would interfere with the evaluation of psoriasis * use of systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within 30 days of visit 1 or used fae or other any biologic agent such as etanercept, infliximab and adalimumab within 12 weeks prior to visit 1 * patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits * patients who are unable to complete a patient diary or complete questionnaires on paper * patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule * pregnancy or breast feeding women * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use effective contraception during the study. effective contraception is defined as either: use of established oral, injected or implanted hormonal

Keywords: to identify clinical and metabolomic markers that underlie variability in response to systemic therapy in psoriasis to identify metabolomic signatures associated with psoriasis to identify possible treatment-specific metabolomic signatures