Kornimate/medical-research-clean huggingface dataset:
intensive versus standard blood pressure lowering to prevent functional decline in older people

Conditions: Hypertension, Systolic; Cerebrovascular Disease

Summary: this randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \ 0.5% wmh fraction of intracranial contents). the study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmhg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmhg) for a total of 36 months.

the study patients will be enrolled and randomized to one of two levels of ambulatory bp control (intensive to achieve a goal 24-hour systolic bp of \< 130 mmhg or standard to achieve a goal 24-hour systolic bp of \< 145 mmhg) for a total of 36 months. similar antihypertensive regimens will be used in both of the treatment groups. titration of antihypertensive therapies will be performed at monthly intervals for the first 3 to 6 months post-randomization to achieve goal systolic bp. the primary and secondary outcomes will be evaluated at baseline, and following 18 months and 36 months of therapy.

Eligibility criteria:
inclusion criteria: * 75 years of age or older * seated clinic systolic bp \>150 mmhg in the untreated state (see criterion d) * at risk for cerebrovascular disease (history of smoking, dyslipidemia, type 2 diabetes, longstanding hypertension, family history). patients must have visible (0.5% wmh or more)white-matter hypertensity lesions on screening magnetic resonance imaging * to achieve success in maintaining a 24-hour systolic bp of \ 170 mmhg and they are taking 0 to 1 antihypertensives exclusion criteria: * uncontrolled diabetes mellitus (hba1c \>10%) * history of stroke, dementia or clinically impaired gait (mini-mental status exam score (mmse) \<24, short physical performance battery for gait (sppb) \< 9,) * body mass index \> 45 kg/m2 and/or arm circumference \> 44 cm) * poor kidney function (defined as estimated gfr \<30 ml/minute) * active liver disease or serum transaminases \>3 times the upper limit of normal * major cardiovascular event (e.g. myocardial infarction) or procedure (e.g. cardiac bypass surgery) in past 3 months; stroke with residual gait abnormality * uncompensated congestive heart failure (nyha class iii or iv or documented ejection fraction \<30%) * chronic atrial fibrillation that disallows ambulatory bp monitoring to be successfully performed * medical conditions that limit survival to \< 3 years * non-dermatologic cancer diagnosed within 2 years * organ transplantation requiring anti-rejection drug therapy * severe and unexplained weight loss (\>15%) in past 6 months * medical need to undergo recurrent phlebotomy or blood transfusions * current participation in another investigational trial * unable to obtain informed consent * factors limiting adherence to the interventions * mri contraindications (including mri-incompatible implants, severe claustrophobia).

Keywords: hypertension, systolic elderly (> or equal to 75 years) cerebrovascular disease
body composition and adipose tissue in hiv

Conditions: HIV Lipodystrophy Syndrome; Growth Hormone Deficiency; Body Composition

Summary: in this study, the investigators will examine the effect of therapy with the growth hormone releasing hormone (ghrh) analog tesamorelin on body composition in patients with hiv lipodystrophy and central adiposity. this study is a single arm prospective study of tesamorelin therapy of patients with hiv lipodystrophy. subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.

hiv lipodystrophy is increasingly recognized as a common and clinically significant long-term sequelae of hiv treatment. in the hiv lipodystrophy lipohypertrophy phenotype, visceral adipose tissue (vat) is increased and this is associated with reduced growth hormone (gh) secretion. mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (cv) disease in patients with hiv disease. the etiology of hiv lipodystrophy (hivld) with central adiposity is unclear, but this phenotype is increasingly common with newer, less lipotoxic combination anti-retroviral therapy (cart) use. vat and hepatic lipid accumulation, are important health concerns for hivld patients. this body composition pattern may contribute to the increased cardiovascular risk that has been demonstrated in patients with hiv lipodystrophy. patients with hivld and central adiposity have been shown to have reduced gh secretion. thus, a medication has been developed to augment gh secretion. this medication is tesamorelin. gh supplementation in other clinical settings has been shown to reduce visceral adiposity and may reduce hepatic lipid content.

Eligibility criteria:
inclusion criteria: * hiv-infected subjects with hiv lipodystrophy (hivld) * abdominal fat accumulation defined as: waist circumference (wc) 102 cm for men, 88 cm for women, except in subjects of east/south asian ethnicity in whom this will be defined by wc 90 cm for men and 80 cm for women. * weight stable for 8 weeks prior to enrollment, * cd4 count \>100 cells/mm3 * hiv rna load \<1000 copies/ml * fasting plasma glucose \<120 mg/dl * stable combination anti-retroviral therapy (cart) of any regimen for ≥ 8 weeks prior to study enrollment exclusion criteria: * diabetes mellitus requiring medication * history of any malignancy * abnormal renal or liver function * pregnancy or women of childbearing age who are not using an acceptable means of contraception * history disorder of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery * head irradiation or head trauma or adrenal insufficiency * systemic glucocorticoid use * known hypersensitivity to tesamorelin and/or mannitol

Keywords: hiv lipodystrophy tesamorelin body composition visceral adiposity
study of pain control in hemorrhoidectomy

Conditions: Hemorrhoid

Summary: patients will get an injection of either sky0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.


Eligibility criteria:
inclusion criteria: * age \> 18 years of age at the screening visit * american society of anesthesiologists (asa) class 1-3 * scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the milligan-morgan technique * for female subjects, surgically sterile or at least two years menopausal, or using an acceptable method of birth control; must have a documented negative blood or urine pregnancy test within 24 hours before surgery * clinical lab values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the investigator. * ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments * able to speak, read, and understand the language of all subject-facing documents, including the icf and study questionnaires * able and willing to comply with all study visits and procedures exclusion criteria: * single-column hemorrhoidectomy or hemorrhoidectomy without an internal component * body weight less than 50 kilograms (110 pounds) * history of hypersensitivity or idiosyncratic reactions or amide-type local anesthetics, opioids, or propofol * current painful physical condition or concurrent surgery other than hemorrhoids that may require analgesic treatment (such as non-steroidal anti-inflammatory drug \[nsaid\], opioid, selective serotonin reuptake inhibitor \[ssri\], tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the hemorrhoidectomy procedure and may confound the postoperative assessments * concurrent fissurectomy * use of any nsaid including selective cox-2 inhibitor, opioid, ssri, tricyclic antidepressant, gabapentin, or pregabalin within three days of surgery * use of acetaminophen within 24 hours of surgery * chronic users of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week * history of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years * current use of glucocorticosteroids or use of glucocorticoids within one month of enrollment into this study * hiv infection or hepatitis * currently pregnant, nursing, or planning to become pregnant during the course of the study or within one month of study drug administration * any psychiatric, psychological, medical, or laboratory condition that the investigator feels makes the subject an inappropriate candidate for this clinical trial * subjects who have received another investigational drug within the longer of the last 30 days or 10 elimination half-lives * previous participation in a sky0402 study * failure to pass drug and alcohol screen

Keywords: hemorrhoid hemorrhoidectomy postoperative pain analgesia
vrh pain reduction during burn wound care and physical therapy

Conditions: Burn

Summary: using virtual reality hypnosis to relief pain and anxiety for burn patients.

the purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with virtual reality hypnosis with post-hypnotic suggestion.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 7 years * able to complete subjective evaluations of pain * english-speaking * not demonstrating delirium, psychosis, or any form of organic brain disorder * able to communicate orally exclusion criteria: * age less than 7 years * incapable of indicating subjective evaluation of pain * non-english-speaking * demonstrating delirium, psychosis, or organic brain disorder * unable to communicate verbally * significant developmental disability * extreme susceptibility to motion sickness

Keywords: virtual reality hypnosis
study of sonrotoclax (bgb-11417) plus zanubrutinib (bgb-3111) compared with venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (cll)

Conditions: CLL

Summary: the main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (cll)

chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. people with cll suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. they have shorter life expectancy compared to healthy people. there is an urgent need for new treatment to prolong life and control disease-related symptoms. in this study, participants with cll without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. it is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating cll. the main purpose of this study is to compare the duration the participants live without the cll getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. approximately 652 participants will be included in this study around the world. participants will have equal chance to be allocated to receive either of the treatment combinations.

Eligibility criteria:
inclusion criteria: * treatment-naïve (tn) adults with confirmed diagnosis of cll which requires treatment * eastern cooperative oncology group (ecog) score 0, 1, or 2 * measurable disease by computer tomography/magnetic resonance imaging * adequate liver function as indicated by aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x the institutional upper limits of normal (ulns) value; serum total bilirubin \< 3.0 x uln * adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute exclusion criteria: * previous systemic treatment for cll * known prolymphocytic leukemia or history of, or currently suspected, richter's transformation * known central nervous system involvement * history of confirmed progressive multifocal leukoencephalopathy (pml) * uncontrolled hypertension note: other protocol defined criteria may apply

Keywords: cll chronic lymphocytic leukemia
remicade in the treatment of patients with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the aim of the study was to evaluate the efficacy of infliximab (ifx) treatment, 5 mg/kg every 6 weeks, in patients with active ankylosing spondylitis (as) and to determine whether ifx dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year sustained the treatment effect. the study was started in 2003 an finished in 2008.


Eligibility criteria:
inclusion criteria: the patients had to fulfill the following four inclusion criteria: (i) age between 18 and 60 years, (ii) proven diagnosis according to the modified new york criteria 12 for definitive as, (iii) active disease with bath as disease activity index (basdai) score above 4 and (iv) current or previous treatment with conventional non-steroidal anti-inflammatory drugs (nsaid) in adequate doses without sufficient effect. exclusion criteria: * current signs or symptoms of severe, progressive or uncontrolled hepatic, hematological, pulmonary, cardiac, neurological or cerebral disease; * ongoing or past serious infection (including hiv and past or current tuberculosis); * pregnancy or breast feeding; * current malignancy or history of malignancy within the past five years; * congestive heart failure and any contraindication to mri.

Keywords: ankylosing spondylitis infiximab single armed trial
a study of sim0270 combined with everolimus vs. treatment of physician's choice in patients with er+/her2- advanced breast cancer (simrise)

Conditions: Locally Advanced or Metastatic Breast Cancer

Summary: this phase iii, randomized, open label, multicenter study will evaluate the efficacy and safety of sim0270 combined with everolimus compared to physician's choice of treatment in subjects with er+/her2- locally advanced or metastatic breast cancer who have had previous treatment with cdk4/6 inhibitor.


Eligibility criteria:
inclusion criteria: 1. subjects with histologically or cytologically confirmed er+/her2- locally advanced or metastatic breast cancer 2. subjects must have at least one recist 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion 3. for women who are post menopausal must meet criteria as defined in the protocol.for women who are premenopausal or perimenopausal and for men: treatment with approved lhrh agonist therapy for screening period and the duration of study treatment 4. have disease that has demonstrated progression on or after prior treatment: 1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy 2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting. 5. eastern cooperative oncology group performance status 0-1 6. adequate organ function exclusion criteria: 1. prior treatment with a oral selective estrogen receptor degrader (serd) or other investigational-er-directed therapy, or any pi3k-aki-mtor inhibitors 2. treatment with any investigational therapy within 28 days prior to study treatment.treatment with moderate/strong cyp3a inhibitors or p-gp inhibitor within 14 days prior to first dose or moderate/strong cyp3a inducer within 28 days prior to first dose 3. advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term 4. known active uncontrolled or symptomatic cns metastases, carcinomatous meningitis, or leptomeningeal disease 5. active cardiac disease or history of cardiac dysfunction, as defined in the protocol 6. pregnant or breastfeeding
safety and efficacy of two different doses of asacol in the treatment of moderately active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study is a prospective clinical study to evaluate the safety and efficacy of two different doses of asacol for the treatment of moderately active ulcerative colitis. in addition, a new tablet formulation will be evaluated at one of the two doses.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years of age; * have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis; * currently demonstrating moderately active disease exclusion criteria: patients will be excluded from admission to the study if they have/are: * a history of allergy or hypersensitivity to salicylates or aminosalicylates; * a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome; * current renal or hepatic disease; * participated in any drug or device clinical study within 30 days of entry; * currently enrolled in any other clinical study; * received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the baseline visit; * received any other topical rectal therapy during the week prior to the screening visit; * received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the baseline visit; * received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the screening visit (note: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine); * received antibiotics, other than topical antibiotics, within 1 week prior to the screening visit; * received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or nsaids within 1 week prior to the baseline visit; * if female, positive pregnancy test, or lactating.
the polymerase chain reaction (pcr) analysis of nasal polyps for fungal dna

Conditions: Sinusitis; Nasal Polyps

Summary: the objective of this study is to determine whether the amount or type of fungal dna present in the nose and home environment can be correlated with the outcomes of the following quality of life (qol) instruments: medical outcomes study 36-item short form (sf-36) and the sino-nasal outcomes study - 20 questions (snot-20).

the objective of this study is to determine whether the amount or type of fungal dna present in the nose and home environment can be correlated with the outcomes of the following quality of life (qol) instruments: medical outcomes study 36-item short form (sf-36) and the sino-nasal outcomes study - 20 questions (snot-20). the study design involves case control polymerase chain reaction (pcr) analysis of nasal mucosal swabs, saliva swabs, blood serum, and home vacuum cleaner bags in patients with sinusitis and normal controls. the hypothesis is that the quantity and type of fungal dna present in the nose and home environment are directly correlated with quality of life. our research aims to both quantify the amount of fungi present in the nasal mucosa as well as to measure the severity of the patient's chronic rhinosinusitis (crs) as a function of snot-20 and sf-36 outcomes questionnaires. we hypothesize that the amount and type of fungi present in the nose and home environment will correlate with the severity of the patients' symptoms of crs.

Eligibility criteria:
inclusion criteria: * subjects with no sinus disease and subjects with chronic rhinosinusitis. exclusion criteria: * immunocompromise * pregnancy * minors

Keywords: pcr analysis allergic fungal sinusitis chronic rhinosinusitis nasal polyps
project health link: connecting patients with services

Conditions: Alcohol Abuse

Summary: this study will compare three alternative interventions in the emergency department (ed) to promote substance abuse assessment, referral, and treatment entry: 1) a 5 session strengths-based case management model (sbcm); 2) a 2-session motivational enhancement therapy (met); or 3) a one-time brief informational feedback (bif) session. the primary outcome variables for this trial include follow-through on receiving an assessment and referral, and treatment engagement. additional outcomes include degree of treatment completion, alcohol-related measures, health service utilization, health status changes, and psychosocial factors.


Eligibility criteria:
inclusion criteria: * (1) adults age 19 - 60 presenting to the emergency department at hurley medical center within 24 hours of an injury; (2) ability to provide informed consent. for intervention portion of the project: (1) meets dsm-iv criteria for alcohol abuse or dependence in the following year. (patients who meet abuse/dependence criteria for alcohol may also be using other drugs. they will be included in the study only if they do not meet criteria for past year drug abuse/dependence). exclusion criteria: * (1) adult patients who do not understand english; (2) prisoners; (3) pregnant women; (4) institutionalized patients (e.g. nursing home residents); (5) adults classified by medical staff as "level 1 trauma"; (6) adults deemed unable to provide informed consent (e.g. intoxication, mental incompetence, under guardianship); (7) patients treated in the ed for suicide attempts and sexual assault; (8) patients meeting past year drug abuse/dependence criteria; and (9) patients who have been in treatment for alcohol or other drug abuse/dependence in the previous year.