Kornimate/medical-research-clean huggingface dataset:
fish oil and green tea extract in preventing prostate cancer in patients who are at risk for developing prostate cancer

Conditions: Precancerous Condition; Prostate Cancer

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. the use of fish oil and/or green tea may prevent prostate cancer. purpose: this randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.

objectives: * determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples. outline: this is a randomized, double-blind, placebo-controlled study. patients are stratified according to age (under 65 vs 65 and over). patients are randomized to 1 of 4 treatment arms. * arm i: patients receive oral fish oil three times daily and oral green tea extract twice daily. * arm ii: patients receive an oil placebo three times daily and oral green tea extract twice daily. * arm iii: patients receive oral fish oil three times daily and a placebo twice daily. * arm iv: patients receive an oil placebo three times daily and another placebo twice daily. treatment in one of the above-listed arms continues for up to 20 weeks in the absence of disease progression or unacceptable toxicity. all patients undergo a prostate biopsy on the last day of study treatment. after completion of study treatment, patients receive a follow-up phone call at/around 30 days later. projected accrual: a total of 144 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * clinician recommends repeat biopsy of the prostate ("repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate) exclusion criteria: * definitive invasive prostate cancer on initial biopsy * significant active medical illness that in the opinion of the clinician would preclude protocol treatment. * history of ventricular tachycardia or ventricular fibrillation * subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before day 1 of study treatment * subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial * use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial. * subject reported allergy or sensitivity to fish oil, olive oil or green tea * subject reported history of hemophilia, van willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated. * total bilirubin greater than institutional upper limit of normal * concurrent high risk study participation

Keywords: prostate cancer precancerous condition
quality of life after eye surgical removal

Conditions: Evisceration; Traumatic, Eye

Summary: studies have shown that health-related quality of life (hrqol) was worse among patients who underwent surgical eye removal compared to the general population in denmark. a third of eye amputated patients suffered from anxiety and depression. most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases. moreover, in the literature, there are no data concerning postoperative psychological and visual impact.


Eligibility criteria:
inclusion criteria: * patient who underwent an eye removal surgery: evisceration, enucleation or exenteration exclusion criteria: * patient who underwent bilateral eye removal surgery

Keywords: enucleation
mitigating suicide risk with single session 'brief skills for safer living'

Conditions: Suicidal Ideation; Suicide; Mental Health Issue; Depression

Summary: mental health concerns have been on the rise since the onset of the covid-19 pandemic. the pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. timely and easy access to mental health services is a dire need, and this study will test the efficacy and feasibility of a brief clinical intervention, brief skills for safer living (brief-sfsl), at reducing suicide risk. the goal of this study is to investigate whether brief-sfsl, delivered online, is a suitable, acceptable and effective method for reducing suicide risk and providing timely mental health services. the results from this study will provide vital insight into effective interventions for suicide risk that are accessible and can be widely distributed.

this study will test a brief online clinical intervention targeting suicide risk that will be delivered widely, remotely, rapidly and with minimal load on the healthcare system in canada. the "skills for safer living" (sfsl) intervention, a transdiagnostic 20-week group therapy intervention designed to teach concepts, skills and coping strategies through modules targeting common areas of deficits (personal safety, emotional literacy, interpersonal relationships and problem-solving), will be adapted into a single session "brief-sfsl" that can be delivered in an online format. the proposed study will test the effectiveness of brief-sfsl on reducing suicide risk, as measured by reductions in suicidal ideation after 3 months, and will provide evidence for a scalable intervention that can broadly reach urban and rural communities. lack of suicide intervention services is an immense unmet need that is especially pronounced during this pandemic and is associated with increased burden on individuals and on the healthcare system. considering the long wait times to access consistent psychiatric services, this proposed intervention is an essential step in providing evidence-based accessible suicide risk services during and even beyond the pandemic.

Eligibility criteria:
inclusion criteria: * 18 years or older * experiencing suicidal ideation in the past week (beck suicide scale\>10) * ability to undergo psychotherapy in english * access to a computer with a camera or a mobile phone with a camera * access to internet * access to an emergency contact and hospital within commuting distance * not receiving other psychotherapy concurrently * willing to have the session recorded to review therapy fidelity * follow-up visits with a psychiatrist or family doctor where a psychotherapeutic modality (e.g. dbt, psychodynamic therapy, etc.) is not being used are allowable. exclusion criteria: * the presence of cognitive impairment that would limit consent or understanding of brief-sfsl * the presence of active psychosis * current substance use disorder * unwilling or unable to provide informed consent

Keywords: suicide suicide prevention suicide risk suicidal ideation psychotherapy covid-19 depression
an enhanced protein (dairy) weight loss intervention for dynapenic obesity: impact on muscle quality and composition

Conditions: Dynapenia; Obesity

Summary: the purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from dairy and other animal source proteins) with calorie restriction and low-intensity exercise on muscle quality and muscle adipose infiltration (along with bone mineral density \[bmd\] and a number of secondary outcomes) in frail, obese, older adults participating in a 6 month intervention. the investigators will compare these effects to those of a traditional control regimen of calorie restriction and low-intensity exercise over the same duration.

obese older adults (≥60 yrs) with moderate functional impairment will be randomized to 1 of 2 study arms. outcomes to be measured at 0, 3 and 6 months are as follows: primary outcomes- (1) muscle quality (mq): muscle power (time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity) in relation to muscle mass (ct-scan) and (2) muscle adipose infiltration (mai) (ct-scan). secondary outcomes- bone mineral density (bmd; dxa scan) physical function (short physical performance battery (sppb); 6 minute walk; 8-foot up and go; and 30 second chair stands; handgrip strength; body weight; fat mass; waist circumference; activity (accelerometers); mental health (sleep, depression, quality of life); and feasibility factors (adherence, protein intake, nutrition adequacy). bmd will only be accessed at 0 and 6 months. study arms: * weight loss plus low-intensity exercise intervention (wl-loex; n = 35): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d. subjects will also participate in three 30-minute low-intensity exercise sessions weekly. one serving of dairy protein/day will be provided to wl-loex participants. * high protein weight loss plus low-intensity exercise intervention (pro-wl-loex; n = 35): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. intakes of \> 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from dairy foods that will be provided. subjects will also participate in three 30-minute low-intensity exercise sessions weekly.

Eligibility criteria:
inclusion criteria: * bmi \>30; * sppb score of ≥4 to \<10; * gfr \<45 ml/min exclusion criteria: * body weight \>495 lbs. (bodpod limits); * estimated glomerular filtration rates (egfr) less than 45 ml/min; * symptomatic cardiac disease; * receiving chemotherapy; * hemophilia; * presence of unstable or symptomatic life-threatening illness; * neurological disease or disorder causing functional impairments; * inability to walk, * dementia; * prescription weight loss medications; * use of monamine oxidase inhibitors (maois); or * primary medical provider advises against participation.
effects of using e-cigarettes on lungs in people with hiv (hbs ancillary)

Conditions: Hiv; Lung Injury

Summary: this is an ancillary study, thus participants will be recruited from participants in the hbs study. this project acutely assesses the role of the e-cigarettes and vaping on lung health. the proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.


Eligibility criteria:
this project is an ancillary study to the hbs study. inclusion criteria for that irb approved study are: * documented hiv-infection * in care at an hiv specialty clinic * age ≥ 18 years. exclusion criteria for the hbs study are: * a pacemaker or other implanted electronic device * pregnant women, prisoners, cognitively-impaired subjects. for this ancillary, the experimental group must actively use at least one of the following: e-cigarettes, e-liquid vapes, burning leaf tobacco cigarettes, or inhaled burning leaf marijuana (cannabis). the control group will have no use of e-cigarettes or vape or active smoking in the past year. participants must be willing to archive data and biological samples for future use. exclusion from the ancillary are: * overt respiratory or oral cavity disease * acute illness in the past 4 weeks * active cancer * active weight loss program * any other medical, psychiatric or behavioral factors that, in the judgment of the pi may interfere with study participation or ability to follow the protocol
evaluating raised intracranial pressure using mr elastography

Conditions: Idiopathic Intracranial Hypertension

Summary: investigators will compare magnetic resonance (mr) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (oct) imaging measurements of the retinal nerve fiber layer (rnfl) and indirect signs of raised intracranial pressure on magnetic resonance imaging (mri).

the goal of this study is to evaluate the brain elasticity in patients with idiopathic intracranial hypertension (iih) and other forms of raised intracranial pressure, such as obstructive hydrocephalus. investigators will evaluate for a correlation between brain stiffness and opening pressure on lumbar puncture. investigators will also evaluate for changes in brain stiffness after interventions that are aimed at lowering intracranial pressure, including lumbar punctures, medications, and surgical interventions, such as ventriculoperitoneal shunts. lastly, investigators will compare mr elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (oct) measurements of the retinal nerve fiber layer (rnfl) and indirect signs of raised intracranial pressure on mri.

Eligibility criteria:
all subjects will have the following inclusion criteria: * group 1: papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus * group 2: patients without raised intracranial pressure. all subjects will have the following exclusion criteria: * age \<18 * pregnancy (self-reported) * individuals for whom mr is contraindicated
neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma


Eligibility criteria:
inclusion criteria: * ages 18-75; * radical operation for esophageal cancer; * esophageal squamous cell carcinoma was confirmed by postoperative pathology; . preoperative imaging (enhanced cervical, thoracoabdominal ct+ bone scan) and postoperative pathological evaluation were performed, and the stage was piib-iva (ajcc eighth edition staging criteria: t≥3 or n+). * more than or equal to 12 lymph nodes were surgically removed; * postoperative ecog score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy; * informed consent signed by patient or family member. exclusion criteria: * less than 18 years old, more than 75 years old; * did not receive radical resection of esophageal cancer, including palliative resection; * postoperative pathology showed non-esophageal squamous cell carcinoma; * after preoperative imaging (enhanced cervical, thoracoabdominal ct+ bone scan) and postoperative pathological evaluation, the stage was pi, iia, ivb (ajcc eighth edition staging standard); e. less than 12 lymph nodes were surgically removed; * postoperative ecog score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy; * the patient or family member did not sign the informed consent.

Keywords: esophageal squamous cell carcinoma locally advanced chemoimmunotherapy radioimmunotherapy
selenium in mild thyroid eye disease in north america

Conditions: Thyroid Associated Ophthalmopathies

Summary: the purpose of this study is to determine whether sodium selenite is helpful in the treatment of mild thyroid eye disease in north america.

thyroid eye disease (ted) is a disease in which the soft tissues surrounding the eye can become inflamed, scarred, and at times permanently damaged in an autoimmune reaction highly associated with abnormal thyroid hormone levels. some patients have much more severe ted than others, but overall, most patients reach a point with relatively stable ted after 1 to 2 years. a recent european study showed that oral selenium, a trace mineral involved in anti-oxidation and immune regulation, could actually alter the course of mild ted, lessening its signs and symptoms and even improving the quality of life of those who took it. the investigators would like to perform a sister study throughout north america. in this randomized, double-blinded, multi-center trial, some subjects with mild ted would be given 100 micrograms of sodium selenite twice a day; others would receive a placebo. signs, symptoms, and quality of life would be measured at regular intervals throughout the 6 month period of drug administration, and for 6 months thereafter.

Eligibility criteria:
inclusion criteria: * age 18 or older * able to provide informed consent * able to swallow pills * mild thyroid eye disease requiring no past treatment other than ophthalmic drops or ointment * euthyroid: at least 2 months if on medication irregardless of thyroidectomy status; at least 6 months after radioiodine therapy; if euthyroid for the year prior to enrollment, needs normal thyroid-stimulating hormone (tsh) within last 3 months; if uncontrolled for the year prior to enrollment, needs normal tsh and free t4 within last 3 months; if tsh low, needs normal t3 and free t4 * if you are currently taking any selenium supplementation, you will be asked to discontinue its usage, "wash out", for 1 month before you are enrolled. exclusion criteria: * moderate or severe thyroid eye disease (based upon international thyroid eye disease society visa form), including: grade 2 chemosis or lid edema; corneal exposure with threat of or resulting in perforation; optic neuropathy; grade 3 restriction of any extraocular muscle * double vision (diplopia) in primary or reading positions * duration of thyroid eye disease greater than 12 months (as per patient history) * drug or alcohol abuse * severe systemic illness (defined by treating physician) * pregnant or breastfeeding

Keywords: thyroid eye disease thyroid orbitopathy graves' orbitopathy graves' ophthalmopathy
a study to evaluate the efficacy and safety of pregabalin (lyrica) for the treatment of nerve pain

Conditions: Neuralgia

Summary: the purpose of this study is to evaluate the efficacy and safety of lyrica in indian patients with nerve pain


Eligibility criteria:
inclusion criteria: * peripheral neuropathic pain * score of at least 40 mm on the vas of the sf-mpq at screening and baseline * completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline exclusion criteria: (none)
reduced anti-platelet therapy with pimecrolimus drug eluting stent (rapid)

Conditions: Coronary Disease

Summary: non-randomized, single arm, multi-center, clinical trial evaluating the corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.

the registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the corio™ drug-eluting stent.

Eligibility criteria:
inclusion criteria: general inclusion criteria 1. eligible for percutaneous coronary intervention (pci). 2. documented stable or unstable angina pectoris 3. left ventricular ejection fraction (lvef) ≥25% 4. acceptable candidate for coronary artery bypass graft surgery (cabg). 5. target lesion \ = 50 and \< 100 %. exclusion criteria: general exclusion criteria 1. known sensitivity to pimecrolimus, the polymer (plga) or cobalt chromium. 2. planned treatment with any other pci device in the target vessel(s). 3. mi within 72 hours prior to the index procedure 4. the patient is in cardiogenic shock. 5. cerebrovascular accident (cva) within the past 6 months. 6. acute or chronic renal dysfunction 7. contraindication to asa or to clopidogrel. 8. thrombocytopenia 9. active gastrointestinal (gi) bleeding within the past 3 months. 10. any prior true anaphylactiod reaction to contrast agents 11. patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus. 12. female of childbearing potential. 13. life expectancy of less than 24 months due to other medical conditions. 14. co-morbid condition(s) 15. currently participating in another investigational drug or device study

Keywords: percutaneous coronary intervention (pci) drug eluting stent (des)
denosumab and osteoporotic vertebral compression fracture

Conditions: Osteoporotic Vertebral Compression Fracture

Summary: this study aimed to investigate the effect of denosumab on bone mineral density(bmd), bone turnover markers(btms), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (ovcf) patients after vertebroplasty during a 12-month follow-up period.

we performed a single-center, placebo-controlled, randomized clinical trial in the department of spinal surgery located at the first affiliated hospital of southern university of science and technology (shenzhen people's hospital). all patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. the bmds (lumbar, total hip, and femoral neck) and btms were assessed at baseline, 6, and 12 months post-operation. the visual analog scale (vas) score for back pain, and function status questionnaires, including euroqol five-dimension (eq-5d), the quality of life questionnaire of the european foundation for osteoporosis-31 (qualeffo-31), and the roland-morris disability functioning questionnaire (rmdq),secondary fracture rate, and adverse effects in ovcf patients after vertebroplasty during a 12-month follow-up period.

Eligibility criteria:
inclusion criteria: * must be age between 50 and 90 years old * x-ray diagnosis of 1 or 2 segment vertebral compression fractures from t4 to l5 * bone mineral density t value less than -1 via dual-energy x-ray * a recent fracture history less than 6 weeks * mri show bone marrow edema of fractured vertebrae * low back pain, local paravertebral tenderness exclusion criteria: * must be able to have no intervertebral fissure * must be able to have no infection * must be able to have no malignancy * must be able to have no neurological dysfunction * must be able to have no previous use of anti-osteoporosis drugs * must be able to have no inability to perform magnetic resonance imaging * must be able to have no prior back open surgery * must be able to have no other established contraindications for elective surgery

Keywords: denosumab vertebroplasty