Kornimate/medical-research-clean huggingface dataset:
saw palmetto extract in benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to test whether an extract of the saw palmetto plant is effective for relieving symptoms of benign prostatic hyperplasia (bph).

this proposal describes a double-blind, placebo-controlled randomized clinical trial of the effect of saw palmetto extract on symptoms, objective parameters of disease severity, and quality of life in men with moderate-to-severe benign prostatic hyperplasia. bph, one of the most common morbid medical conditions in middle-aged and elderly men, is generally treated with alpha-adrenergic blocking agents, finasteride, surgical interventions, or no specific therapy ("watchful waiting"). in the past several years, however, many patients have begun to self-medicate with an extract of the saw palmetto plant (serenoa repens), a medicinal herb grown in the southeastern united states. saw palmetto has become the fifth leading medicinal herb consumed in the u.s. and is considered first-line therapy for bph in several western european countries. several small studies suggest that saw palmetto may have clinical benefit, but the methodologic quality of most prior studies has been poor. very few side effects of the herb have been observed, but few studies have been conducted for more than three months. we propose to conduct a high-quality clinical trial of saw palmetto, with careful attention to the methodologic deficiencies of prior studies. after a single-blind placebo run-in period, 224 patients with mode moderate-to-severe bph (american urological association symptom index score greater than or equal to 8) and objective measurement of urinary obstruction, will be randomized to receive either 160mg bid of the herbal extract or an identical placebo. patients will discontinue any other medical therapy for bph prior to enrollment and all participants will undergo a trans-rectal ultrasound examination at baseline and closeout. participants in the trial will be seen at 3-month intervals for a total one-year follow-up. outcome measurements include changes in the auasi score (the primary outcome measurement), the peak urinary flow rate, the post-void residual urine volume, the bph impact index, the olmstead county study questionnaire of bph-specific symptoms and quality of life, and the short-form 36 (a generic health status instrument). numerous laboratory parameters will measured at intervals throughout the trial and symptomatic side effects will be assessed.

Eligibility criteria:
eligibility criteria: * participants must be men, aged 50 years or older with moderate-to-severe bph. * participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (lasix), warfarin (coumadin), or hormone medications. individuals taking medicine for their bph must stop them for one month (prazosin, terazosin (hytrin), doxazosin (cardura), tamsulosin (flomax)) or six months (saw palmetto, finasteride (proscar or rogaine)) prior to entering the study.

Keywords: benign prostatic hyperplasia herbal therapies complementary and alternative medicine men's health
adjuvant whole breast radiotherapy (rt) with intensity modulated radiotherapy (imrt) and a simultaneous integrated boost versus conventional rt and a sequential boost

Conditions: Breast Cancer

Summary: the imrt-mc2 study is a prospective, two armed, multicenter, randomized phase-iii-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized in two arms: patients in arm a will receive imrt in 28 fractions delivering 50.4 gy to the breast and 64.4 gy to the tumor-bed by an integrated boost, while patients in arm b will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 gy and a consecutive boost in 8 fractions to a total dose of 66.4 gy. primary aim of the study is the assessment of the cosmetic outcome and local control after breast radiotherapy. the study hypothesis is that intensity modulated radiotherapy (imrt) is, in spite of the reduced treatment duration, at least equivalent to conventional therapy.


Eligibility criteria:
inclusion criteria: * all patients aged \>18 years and \< 70 years after breast conserving surgery. * patients aged ≥ 70 years with following risk factors: * tumor stadium ≥ t2 * multifocal disease * lymphangiosis * extended intraductal component * resection margin ≤3mm exclusion criteria: * refusal of the patients to be included in the study * karnofsky performance score ≤ 70% * metastatic disease (m1) * other malignancies * previous radiotherapy of the breast * pregnancy

Keywords: imrt integrated boost adjuvant radiotherapy breast cancer breast conserving surgery
a study to evaluate the safety and efficacy of raltegravir (mk0518) in hiv-infected patients failing current antiretroviral therapies (0518-019)

Conditions: HIV Infections

Summary: this study will investigate the safety and efficacy of raltegravir as a therapy for human immunodeficiency virus (hiv)-infected patients failing current therapy with 3-class antiviral resistance.

the primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. participants who had viral failure after week 16 may have received open-label raltegravir until week 240.

Eligibility criteria:
inclusion criteria: * patient must be hiv positive with hiv rna values that are within ranges required by the study * patient must have documented failure of certain antiretroviral therapy * patient must be on the same antiretroviral therapy for at least the past two months exclusion criteria: * patient less than 16 years old * additional study criteria will be discussed and identified by the study doctor

Keywords: treatment experienced
personalized phage treatment in covid-19 patients with bacterial co-infections microbials for pneumonia or bacteremia/septicemia

Conditions: Covid19; Bacteremia; Septicemia; Acinetobacter Baumannii Infection; Pseudomonas Aeruginosa Infection; Staph Aureus Infection

Summary: phage treatment in covid-19 patients with bacterial co-infections

the treatment approach will be to make phage therapy available to institutions who care for covid-19 patients with bacterial co-infections due to a. baumannii, p. aeruginosa or s. aureus. patient bacterial isolates will be tested to determine phage susceptibility prior to and during phage therapy. the primary objectives are to determine the feasibility of developing, producing and providing a personalized intravenous phage for covid-19 patients who have pneumonia, bacteremia or septicemia due to a. baumannii, p. aeruginosa or s. aureus and to evaluate the safety of intravenous phage in covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to a. baumannii, p. aeruginosa or s. aureus.

Eligibility criteria:
inclusion criteria: * covid-19 patients with pneumonia or bacteremia/septicemia who have culture-confirmed bacterial co-infection with a. baumannii, p. aeruginosa or s. aureus. * patient provided informed and signed consent. exclusion criteria: * patient eligible for another apt sponsored trial. * patient participating in another clinical trial at the same time or patients \< 4 weeks from participating in an alternative investigational protocol/study * patient with known allergy to infusion of phage products * patients with a history of meningitis or encephalitis at time of study entry, primary immune deficiency disease or tuberculosis or stroke, transient ischemic attack (tia), or untreated deep vein thrombosis.

Keywords: covid19 bacteriophage phage bacteremia septicemia acinetobacter baumannii pseudomonas aeruginosa infection staph aureus
gemcitabine combinations in metastatic breast cancer (mbc), 1st line

Conditions: Breast Cancer

Summary: the gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of mbc; however, the optimal dosing schedules for these combinations have not yet been determined. the primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female patients with histological or cytological proven diagnosis of breast cancer * stage iv disease * performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease * adequate organ function exclusion criteria: * prior chemotherapy for metastatic disease * previous radiation therapy is allowed but must not have included whole pelvis radiation * known or suspected brain metastasis. serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator * concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (herceptin)) * peripheral neuropathy of common toxicity criteria (ctc) grade greater than 1. history of significant neurological or mental disorder, including seizures or dementia
tdcs and cognitive retraining to augment pharmacotherapy for the treatment of nicotine dependence

Conditions: Nicotine Dependence

Summary: the purpose of the phase 1 translational pilot study proposed here is to gather preliminary data investigating the efficacy of transcranial direct current stimulation (tdcs) and cognitive retraining to enhance nicotine replacement therapy for smoking cessation. the recent use of tdcs over task relevant regions to alter behavior holds incredible promise for use in cognitive retraining intervention protocols. previous studies of cognitive retraining have focused on implicit training techniques. this proposed study will attempt to enhance these implicit training techniques through the use of tdcs during implicit retraining in order to increase learning of avoidance-related action tendencies towards tobacco. the objective of this pilot study is to establish the feasibility and obtain preliminary data on the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette smoking in individuals with nicotine addiction.


Eligibility criteria:
inclusion criteria: * consume 10 or more cigarettes/day average for the past 60 days * able to provide informed consent * less than 3 months smoking abstinence in the past year * right handed exclusion criteria: * serious medical illness within 6 months (e.g. cancer, hepatic, or renal disease) * significant cardiovascular disease (e.g. recent stroke or heart attack, arrhythmias, worsening angina pectoris, uncontrolled hypertension) generalized skin disorders, or sensitivity to the nicotine patch * use of illicit drugs (excluding marijuana) in the previous 30 days * psychosis, psychotic disorder, or bipolar disorder * current active major depression (depressive episode within last month) * clinically significant suicidal ideation * prior seizure * current bupropion or tricyclic antidepressants * current pregnancy, trying to become pregnant, or breastfeeding * current active alcohol dependence (symptoms in last 30 days) * left-handedness * current medication known to interact with nicotine replacement therapy (nrt) or smoking cessation (e.g. adenosine, cimetidine, conivaptan, cyproterone, peginterferon alfa-2bg, tocilizumab, theophylline) * metal in the head * implanted brain medical devices * electromedical devices * latex allergy
health promotion model, fertility awareness, preconception knowledge and attitude

Conditions: Fertility Issues; Preconception Injuries; Health Behavior

Summary: the effect of education given to preconceptional women in line with the health promotion model on fertility awareness, preconceptional knowledge and attitude levels

the research is a randomized controlled trial. the research will conducted with 128 women (intervention group n=64, control group n=64). it will consist of women between the ages of 18-35 who applied to the community health unit of güneysınır district health directorate between december 2024-may 2025. women who accept the research and are assigned to the intervention group will be given a five-day training to increase fertility awareness and preconceptional knowledge levels in line with the health promotion model. at the end of the fifth day, the fertility awareness scale, preconceptional knowledge and attitude scale, and the clinical evaluation form of the health promotion plan for the health promotion model will be applied to women who complete the training with a face-to-face interview technique. the women in the intervention group will be reached by phone at the end of the first and second months to remind them of their health promotion behaviors and to answer their questions and carry out follow-ups. at the end of the third month, women who have completed the training will be invited to the institution and the forms will be filled out again.

Eligibility criteria:
inclusion criteria: * women between the ages of 18-35, * planning to get pregnant within a year, * literate, * can understand and speak turkish, * agree to participate in the research. exclusion criteria: * women who are pregnant, * women who are breastfeeding, * women who have been diagnosed with infertility, * women who have a history of chronic disease (hypertension, diabetes mellitus, hypothyroidism, etc.), * women who have a sexually transmitted disease (hiv, hpv, etc.), * women who have a physical disability, * women who have a psychiatric disease, * women who have a history of gynecological disease.

Keywords: fertility awareness preconceptional knowledge and attitude health promotion model
osteoarthritis cardiovascular risk factors

Conditions: Osteoarthritis; Cardiovascular Risk Factors; Cardiovascular Disease; Metabolic Syndrome

Summary: we analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.


Eligibility criteria:
inclusion criteria: * patients referred for symptomatic hand or knee osteoarthritis * all patients referred in the same period for soft tissue disease * \> 50 years old exclusion criteria: * any other rheumatologic condition * secondary osteoarthritis

Keywords: osteoarthritis cardiovascular disease
a study of evaluating the effects of pyrotinib after adjuvant trastuzumab in women with early stage breast cancer

Conditions: Breast Cancer

Summary: this is a randomised, double-blind multicenter phase iii study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. the main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed her-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility criteria:
inclusion criteria: * female patients, 18 years ≤ age ≤ 75 years； * performance status- eastern cooperative oncology group (ecog) 0-1 * histologically confirmed invasive her2 positive breast cancer. * known hormone receptor status. * cardiovascular: baseline left ventricular ejection fraction (lvef)≥55% measured by echocardiogram. * been treated for early breast cancer with standard of care duration of trastuzumab. * if been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response. * signed informed consent form (icf) . exclusion criteria: * positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. * history of heart disease. * bilateral breast cancer. * corrected qt (qtc) interval ≥0.47 seconds. * history of gastrointestinal disease with diarrhea as the major symptom.
natural history of peripheral arterial disease

Conditions: Atherosclerosis; Coronary Disease; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Cardiovascular Diseases

Summary: the veterans administration patient study examined the progression of peripheral arterial disease (pad) in patients with large vessel pad or isolated small vessel pad. the community follow-up study following subjects with and without pad from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.

background: peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases. design narrative: veterans administration patient study: the progression of pad was followed in patients diagnosed at the san diego va medical center from july 1984 to june 1989. four non-invasive tests used in the initial diagnosis were repeated after a five year interval. the tests included segmental blood pressure flow velocity by doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. risk factors examined for related to pad included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin e, and creatinine. the degree of concordance between pad and carotid disease was evaluated using phonoangiography. community follow-up study: the study was conducted in a cohort first examined for pad in 1978-1981 and followed for morbidity and mortality. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
effects of different coffee amounts on energy intake, appetite, glucose metabolism and inflammatory markers

Conditions: Obesity; Inflammation

Summary: the purpose of the study is to investigate whether different doses of caffeinated coffee consumption has acute effects on subjective appetite feelings, energy intake and biochemical markers related to appetite, inflammation and glucose metabolism compared to water consumption in normal weight and overweight/obese participants.


Eligibility criteria:
inclusion criteria: * apparently healthy * habitual coffee drinkers (\>= 1cup of coffee/day) exclusion criteria: * smokers * restrained eaters (as this was evaluated using the dutch eating behaviour questionnaire) * those who reported slimming or any other dietary regime * athletes * participants with a known diagnosis of either hypertension, diabetes, impaired glucose tolerance or a fasting blood glucose concentration above 125 mg/dl * subjects on medication for hypertension or on medication known to alter glucose metabolism * subjects who were on medication that may have an impact on appetite and sensory functioning or who reported a metabolic or * endocrine disease, * gastrointestinal disorders, * a history of medical or surgical events that may have affected the study outcomes

Keywords: coffee overweight/obese appetite energy intake inflammation glucose metabolism randomized controlled trial
progesterone induced blocking factor expression levels in endometrial cancer cells.

Conditions: Progesterone Induced Blocking Factor in Endometrial Cancer

Summary: immune system suppression effect of progesterone induced blocking factor(pibf), it could be questionable whether tumor cells express pibf for escape of immune system. there are some studies in the literature that evaluate pibf expression of different malign cells (e.g. glioblastoma multiforme as a malign central nerve system, leukemia, astrocytoma as a primary brain tumor, lung cancer and chorionic carcinoma). according to previous studies pibf has been used as an anti-tumor immune suppressor by tumor cells. there is no data about the pibf expression of endometrial tumor cells. therefore, the investigators aim to determine the pibf expression levels in the endometrial cancer cells.

this retrospective controlled study will be conducted at both obstetrics and gynecology clinics and pathology clinics of kayseri training and research hospital. this study will be conducted with the use of formalin fixed paraffin embedded tissue blocks immunohistochemically to determine the pibf expression levels in the samples. there are three groups in this study; endometrial cancer, endometrial hyperplasia and normal endometrium and each of the groups contained 20 paraffin embedded blocks provided form the pathology clinic of kayseri training and research hospital archives.

Eligibility criteria:
inclusion criteria: * diagnosed endometrial cancer * diagnosed endometrial hyperplasia exclusion criteria: * diagnosed cancer except endometrial cancer

Keywords: progesterone induced blocking factor endometrial cancer
efficacy and safety of two different aflibercept regimens in subjects with neovascular age-related macular degeneration (namd)

Conditions: Macular Degeneration

Summary: to compare the efficacy of 2 mg aflibercept administered by two different intravitreal (ivt) treatment regimens to subjects with neovascular age-related macular degeneration (namd)

330 patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.

Eligibility criteria:
inclusion criteria: * the following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study): * subject had primary subfoveal choroidal neovascularization (cnv) lesions secondary to namd, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (fa/fp) of the study eye within 3 weeks before the initiation of aflibercept treatment. * the area of cnv occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment. * documented best-corrected visual acuity (bcva) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment. * men and women \>= 51 years of age * the subject's history of aflibercept treatment meets all of the following: * treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed * following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks exclusion criteria: - any prior or concomitant therapy with an investigational or approved agent to treat neovascular amd in the study eye other than aflibercept. * total lesion size \> 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (fa) in the study eye * subretinal hemorrhage that was: 1. 50% or more of the total lesion area, or 2. if the blood was under the fovea, and 3. the blood under the fovea was 1 or more disc areas in size in the study eye. * scar or fibrosis making up more than 50% of the total lesion in the study eye. * scar, fibrosis, or atrophy involving the center of the fovea in the study eye. * presence of retinal pigment epithelial tears or rips involving the macula in the study eye. * causes of cnv other than amd in the study eye.

Keywords: age-related macular degeneration (amd) eylea treatment treat and extend intravitreal