Kornimate/medical-research-clean huggingface dataset:
five-year incidence of age-related macular degeneration in the central region of portugal

Conditions: Age-Related Macular Degeneration

Summary: to assess the five-year incidence of amd in a population from the central region of portugal, previously phenotypically characterized.

subjects who participated in the epidemiologic coimbra eye study (nct01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.

Eligibility criteria:
inclusion criteria: * subjects who participated in the epidemiologic coimbra eye study (nct01298674) and that were phenotyped; * subjects capable of understanding the information about the study and to give their informed consent to enter the study; * subjects willing and able to comply with the study procedures. exclusion criteria: - not applicable

Keywords: age- related macular degeneration; diabetic retinopathy; glaucoma; cataract
human epidermal growth factor receptor 2 (her2) positive unresectable locally advanced or metastatic breast cancer disease registry study

Conditions: Breast Cancer

Summary: this disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (labc) or metastatic breast cancer (mbc) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.


Eligibility criteria:
inclusion criteria: * initially diagnosed with her2-positive unresectable labc or mbc no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time * able and willing to provide written informed consent and to comply with the study protocol exclusion criteria: - there are no exclusion criteria for entry into this study
study of hrs-1167 as monotherapy in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is designed to determine if treatment with hrs-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18； 2. ecog performance status 0-1; 3. life expectancy is not less than 12 weeks; 4. dose escalation and pk expansion part: subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists； 5. efficacy expansion part：ovarian cancer、breast cancer、pancreatic cancer、prostate cancer or other cancer types with hrr gene mutation； 6. at least one target lesion (except maintenance therapy); 7. adequate organ and marrow function as defined by the protocol. exclusion criteria: 1. surgery or chemotherapy within 4 weeks of the first dose of study treatment； 2. subjects that are unable to swallow, or dysfunction of gastrointestinal absorption； 3. active hbv/hcv/hiv infection; 4. untreated and/or uncontrolled brain metastases.
attention & memory impairments in menopausal women

Conditions: Symptomatic Menopause; Cognitive Impairments

Summary: the purpose of this study is to determine whether a medication called vyvanse® (lisdexamfetamine; ldx) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. ldx is a medication used to treat attention deficit hyperactivity disorder (adhd). the cognitive difficulties that menopausal women report experiencing are typical of adults who are diagnosed with adhd. the investigators will assess whether or not ldx is effective in alleviating those cognitive disruptions when compared to a placebo.

midlife decline in cognitive function, particularly attention and working memory, is a frequent complaint for which menopausal women seek clinical intervention. many of the cognitive complaints detected in menopausal women including, short-term memory, organization of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms frequently reported by adults with adhd. these impairments are reported by many women who have no previous history of adhd, and appear to be linked to reduced estrogen levels occurring in menopause. this is a double-blind, placebo-controlled, cross-over study testing whether ldx, a stimulant medication, would be effective in alleviating midlife onset impairments of attention and working memory among menopausal women. there will be 3 days in which subjects will undergo a brief cognitive testing assessment; the first testing period will occur at baseline prior to beginning ldx or placebo treatment (pt) in trial a; the second testing period will occur following 4 weeks of double blind ldx or pt; and the final testing period will take place after another 4 weeks of double blind ldx or pt in trial b. each cognitive test period will involve 2 separate cognitive testing batteries that will take approximately 120 minutes total to complete.

Eligibility criteria:
inclusion criteria: women ages 45 to 60 will be eligible for this study if they: * are within 5 years of their last menstrual period; * are able to give written informed consent; * must have clear urine toxicology screen upon recruitment; * are fluent in written and spoken english; * must have negative urine pregnancy test if still menstruating. exclusion criteria: * history of seizures; * history of cardiac disease including known cardiac defect or conduction abnormality; * abnormal electrocardiogram during screening; * use of estrogen therapy within previous 6 months; * current pregnancy or planning to become pregnant. * presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension, coronary disease, atrial fibrillation, and arrhythmia.

Keywords: menopause aging memory women
age of red blood cells in premature infants study (aripi)

Conditions: Premature Birth

Summary: to determine if the age of blood transfused to new borns in the nicu setting has an impact on their outcome.


Eligibility criteria:
inclusion criteria: * birthweight of less than 1250g * admitted to participating nicu * consent acquired from proxy for the patient exclusion criteria: * already received one or more transfusions * requirement for an exchange transfusion * will be receiving directed donations * have rare blood types/difficult cross-match * proxy has refused consent * moribund on admission to nicu/expected to die * mitigating child protection issues

Keywords: transfusion
evaluation of spo2 measurement using a smartwatch

Conditions: Hypoxia; Hypercapnia

Summary: the aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.

recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. the newest models of smartwatches even measure peripheral blood oxygen saturation (spo2). the study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. healthy participants will breathe oxygen-reduced mixtures (the hypoxic gas mixture of 12% o2 and 88% n2 and the hypercapnic and hypoxic gas mixture of 12% o2, 5% co2, and 83% n2), which will temporarily reduce their blood oxygen saturation. spo2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. the agreement of the measurements of both devices will be evaluated.

Eligibility criteria:
inclusion criteria: * healthy volunteers from the czech technical university exclusion criteria: * pregnancy * severe cardiovascular conditions * severe asthma or other severe respiratory conditions * injury to the upper limbs or hands that could affect the peripheral perfusion * diabetes * hypotension or hypertension

Keywords: spo2 pulse oximetry smartwatch
comparative efficacy of escitalopram monotherapy and escitalopram in adjuvant with pizotifen in depressive disorder

Conditions: Depression

Summary: to compare the efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder(mdd).the levels of depressive symptoms as measured by the patient health questionnaire (phq-9) at base level and during follow-up.

this is an open-label study assessing the comparative efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder efficacy of antidepressants in combination therapy. the plan is to enroll 84 patients with depression based on the patient health questionnaire (phq-9) score of 9 and above is a valid and reliable structured clinical interview. the investigators will collect data from the enrolled patient populations. the participants will be able to receive their results, on request, upon completion of the study. the investigators hypothesize that depressive symptoms can be improved by the addition of the above-mentioned drug with antidepressant medication.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients of depressive disorder (phq-9).6 * males and female patients from age 14-70 years. * the same drug brand will be used throughout the study period. exclusion criteria: * schizophrenia, bipolar disease, active delirium, dementia. * pregnant and lactating females. * history of renal and hepatic disease, myasthenia gravis, gastrointestinal (gi) disease, asthma, cardiovascular disease, and diabetes mellitus. * mentally handicapped or terminally ill patients. * age less than 14 years or above 70 years. * patients already taking multiple nutritional supplements. * patients taking medications known to interact with the drugs in this study.
a multidisciplinary weight loss program at aub-mc

Conditions: Obesity; Weight Loss

Summary: the current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the american university of beirut medical center (aub-mc). such intervention is expected to enhance patients' compliance and adherence to lifestyle changes. in addition, the program includes supervised exercise sessions and behavioral therapy. therefore, our project proposes an evidence based approach to close the obesity treatment gaps.


Eligibility criteria:
inclusion criteria: * lebanese adult with obesity (≥18 years), obesity being defined as bmi ≥ 30 kg/m2 * patients who can commit to frequent visit trials as per study protocol * patients not traveling outside lebanon for at least the 6-month period of the trial * patients tolerating metformin after a run-in period of 2 weeks exclusion criteria: * patients who have taken other weight reducing drug therapy in the previous 6 months * patients who have undergone bariatric therapy or endoscopic procedure, or planning to do so in the near future (at \< 6 months) * patients with diabetes * patients working at aub-mc, as we will not be able to assess the adherence to study visits nor the feasibility of such a program in the general population, presenting to aub-mc only for clinical care * a family member of a patient already enrolled in the study, as the participants will not be independent * pregnant obese patients * patients with pacemakers * patients known to have hypertension, cardiac, pulmonary, renal or liver disease, active cancer or psychiatric illnesses * history of any surgery of less than 6 weeks duration * patients known to have disabling osteoarthritic or orthopedic problems * patients secondary uncontrolled endocrine disorders (thyroid disorders, polycystic ovary, cushing disease), or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy).
aa4500 (xiaflex™, proposed name) in the treatment of advanced dupuytren's disease

Conditions: Advanced Dupuytren's Disease

Summary: study aux-cc-858 was an open-label continuation of the double-blind study aux-cc-857 (nct00528606). subjects who complete the day 90 visit after their initial injection in study aux-cc-857 (nct00528606) entered into study aux-cc-858. subjects who required further treatment in study aux-cc-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (pip) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of aa4500, or they had other eligible cords that received no treatment in aux-cc-857 (nct00528606), had the option to receive up to five injections of aa4500 in this extension study. subjects requiring further treatment were followed for efficacy and safety on days 1, 7, and 30 after each injection, with injections separated by four weeks. follow-up visits for the determination of efficacy and safety were conducted on day 90, month 6, and month 9. this study was designed to be part of the larger clinical program, for adult patients with dupuytren's contracture with a palpable cord, where the data from 2 pivotal placebo-controlled studies (aux-cc-857 (nct00528606) and aux-cc-859 (nct00533273)) and 7 non-pivotal studies were evaluated.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of advanced dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for mp (80° for pip) joints, caused by a palpable cord. * had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. * were naïve to aa4500 treatment or had received only one or two injections of aa4500 for the treatment of advanced dupuytren's disease in aux-cc-857 ((nct00528606). * were judged to be in good health. * must have participated in protocol aux-cc-857 (nct00528606). exclusion criteria: * had a chronic muscular, neurological, or neuromuscular disorder that affected the hands. * had received treatment for advanced dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of aa4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon. * had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
a family-based primary care intervention to enhance older men's depression care

Conditions: Major Depression

Summary: despite the public health importance of clinical depression, more than 50% of depressed adults receive inadequate or no treatment, with even higher rates of under-treatment in men and minorities. family members and/or friends often assist older adults in their health care and may help overcome barriers to formal care, yet there is a lack of primary care-based interventions that mobilize family members and friends to improve depression treatment. in partnership with a community-based clinic, this research will address this scientific gap by developing and then testing the feasibility and acceptability of a family-based intervention that can be delivered pragmatically in a primary care setting serving large numbers of older minorities.

the family-based intervention will be tested in a 6 month randomized controlled trial of 24 depressed older men-family member dyads (18 intervention and 6 controls). the purpose of the rct is to test the acceptability of the intervention, as well as the feasibility of the study methods. patients from the rct will be identified from a family practice clinic based on their scores on the phq-9 as well as additional inclusion and exclusion criteria. once they and their family member have agreed to participate, patients will be randomized either to the family based intervention or a usual care control condition augmented by family psychoeducation. the investigators will recruit english and spanish speaking age 60 and above older men from sjgh who have 1) significant depressive symptoms (i.e. phq \> 15, 2) have at least one criteria a symptom (depressed mood or anhedonia), 3) depression-related functional impairment) and 4) an adult family member willing to participate in the study. we have chosen a higher cut-off to minimize false positives. we will exclude psychotic, demented or institutionalized men. after enrollment, 24 dyads (i.e. older man and family member) will be randomized one of two groups: intervention or usual care augmented by written psychoeducational materials on depression. dyads will be randomized to achieve a 2:1 ratio of intervention versus usual care dyads (i.e. 18 intervention and 6 control dyads). to ensure adequate numbers of ethnic minority patients in each arm of the trial, we will conduct a stratified randomization such that each arm of the rct is 50% english language preferring and 50% spanish language preferring (i.e. 3 in control and 9 in intervention arm). the research assistant will conduct subject assessment at baseline, 1-month, 3-months and 6 months.

Eligibility criteria:
inclusion criteria: * men, age 50 and above * english or spanish speaking * score of \>9 on the phq-9 * non-demented * have an adult family member or close friend who can participate exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: depression family primary health care
prospective analysis of the effect of widowhood on cvd

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to determine the effect of widowhood on cardiovascular disease.

background: widowed persons have been found to have higher mortality rates than married persons in both cross-sectional and longitudinal studies. in many of these studies, excess mortality has been attributed to deaths from cardiovascular disease. despite these consistent findings, the lack of detailed data collected prior to widowhood has hampered our ability to understand the mechanisms to explain this effect. furthermore, an understanding of the mechanisms underlying this effect might help elucidate the apparent gender differences in mortality following widowhood. design narrative: the study took advantage of the data collected as part of the framingham study to investigate the effect of widowhood on cardiovascular disease. the framingham dataset has extensive clinical data related to cardiovascular disease, as well as to health behaviors. these longitudinal data provided the opportunity to prospectively characterize the health of widows prior to and following the loss of a spouse in much greater detail than previously possible. the analyses used a prospective design in which those men and women who had a spouse die during the course of the study (n=626) were compared to men and women who remained married (n=2044). these analyses also provided the opportunity to examine reasons for the beneficial effect found of remarriage. the study addressed the following questions: 1. can the increased risk of mortality from cardiovascular disease often found following widowhood be explained by pre-widowhood health status? 2. can increased mortality following widowhood be explained by changes in health behaviors related to cardiovascular disease risk. 3. what pre-widowhood risk factors place the widowed at greater risk for cardiovascular disease morbidity and/or mortality following the death of a spouse? 4. can pre-widowhood risk factors or post-widowhood behavior change account for gender differences in mortality following widowhood? 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
mk0952 in patients with mild-to-moderate alzheimer's disease (0952-004)(completed)

Conditions: Alzheimer's Disease

Summary: mk0952 is a phosphodiesterase type iv (pde4) inhibitor in development for improvement of cognitive impairment in mild-to-moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * male or females * age \>/= 55 years, with mild-to-moderate ad, with mmse between 18 and 26, inclusive, mhis score \</= 4, global cdr score of 1 or 2 * who have a reliable informant/caregiver to accompany patient to all clinic visits * if using a symptomatic ad treatments, patients must be on stable dose for \>/= 6 months exclusion criteria: * patients must not be living in nursing home or skilled nursing facility * patients must not have current evidence and/or history of crohn's disease, ulcerative colitis, proctitis, gi bleeding, mesenteric arteritis * patients must not have current evidence and/or history of poorly-controlled hypertension, clinically significant cardiac arrhythmia, angina, or chf * patients must not have current evidence and/or history of a psychotic disorder or major untreated depressive disorder * patients must not have current evidence and/or history of stroke or multiple lacunar infarcts, or neurological or neurodegenerative disorder (other than ad) * various concomitant therapy restrictions
the effectiveness of hp and tmz synergism on adult recurrence gbm

Conditions: Glioblastoma Multiforme

Summary: the study of investigators indicated that tmz can up-regulate dopamine d2 receptor (drd2) expression, and mediates ferroptosis inhibition and chemoresistance of gbm. the clinical data also proved that the drd2 expression in recurrent gbm is significantly higher than that in primary gbm. moreover, the drd2 antagonist haloperidol can attenuate the above function of drd2, and increase the sensitivity of gbm to the tmz by inducing fatal autophagy and ferroptosis. in xenograft mice, the combined usage of haloperidol and temozolomide (tmz) can significantly inhibit tumor growth and increase overall survival. the investigators' findings have been published in clinical cancer research. haloperidol known as a butylbenzene antipsychotic drug, has been widely used in several kinds of mental illnesses, such as depression, schizophrenia, and bipolar disorder. and the safe dosage of the haloperidol is clear so far. so in this study, the investigators will recruit the patients who suffered from recurrent gbm, and evaluate the effectiveness of single tmz chemotherapy or combined with haloperidol.


Eligibility criteria:
inclusion criteria: * adult patients * primary gbm underwent surgery and tmz chemoradiotherapy, and mri confirmed the tumor recurrence * without severe cardiac diseases exclusion criteria: * child patients (\<18 years) * recurrence tumors grow fast, which needs surgery removal * h3k27m midline glioblastoma * suffered with severe cardiac diseases

Keywords: chemoresistance autophagy ferropotosis drd2 haloperidol