Kornimate/medical-research-clean huggingface dataset:
pilot investigation of a multinutrient supplement on skin aging and aging metabolites in healthy women

Conditions: Skin Diseases

Summary: we are seeking healthy female volunteers to determine if multinutrient supplementation affects visible signs of skin aging as well as blood measurements of aging. we are seeking smokers and non-smokers.

skin antioxidant levels as well as blood metabolites may change as the human body ages1,2. although the chronological aging process is unstoppable, the physical signs of aging, particularly characteristics of the skin, may be delayed through a variety of medical interventions such as topical medications or resurfacing lasers. it is not currently known whether skin carotenoid antioxidant levels correlate with skin aging characteristics, although studies with other antioxidants suggest this may be true 3. in addition, while selected blood metabolites correlate with changes in age2, we do not know if this correlates with skin changes. our current study focuses on whether differences in skin carotenoid levels and blood metabolite levels correlate with skin aging characteristics in age-matched subjects. furthermore, we will explore whether three months consumption with a commercial multi-nutrient formulation (lifepak nano) affects metabolic markers of aging, skin aging characteristics including skin elasticity and transepidermal water loss. we will also examine whether smokers respond differently from nonsmokers in the above parameters after supplementation.

Eligibility criteria:
inclusion criteria:- fitzpatrick skin type i or ii * nonpregnant females, age 18-30 or 50-70 * body mass index normal or overweight * if age 18-30, must be non-smoker * willing to fast for 8 hours prior to a blood draw; exclusion criteria:- history of cosmetic surgery * use of anti-aging medications within 3 months of enrollment * use of over-the-counter anti-aging creams (not sunscreens) more than once per week within one month of enrollment * use of dietary supplements including vitamins within one month of enrollment * use of tanning beds or excessive uv exposure (greater than 2 hours per day) within one month of enrollment * use of sunless tanners within one month of enrollment * uncontrolled or ongoing serious medical condition * participation in another clinical study involving use of an investigational drug or product * medical condition which, at the discretion of the investigator, will have a significant impact on ability to judge participant's skin characteristics, including age.
hrd tests for ovarian cancer

Conditions: Ovarian Cancer

Summary: the study concerns patients with invasive epithelial ovarian cancer, primary fallopian tube carcinoma, ovarian-type peritoneal carcinoma, and with an indication of a first-line platinum-based chemotherapy. to determine hrd status, 2 separate tests will be performed in the study: 1. giscar assay : developed by the sponsor 2. mychoice assay if one or two tests identifies a hrd status : a parp inhibitor treatment may be initiated according to current recommendations


Eligibility criteria:
inclusion criteria: * patient aged 18-year or more * histologically documented high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer * newly diagnosed advanced (international federation of gynecology and obstetrics \[figo\] stage iii or iv) ovarian carcinoma, candidate to a first line platinum-based chemotherapy * tumor tissue must be available for hrd analyses (ffpe tissue block) and * collected if possible during the initial surgery or the initial biopsy (before chemotherapy) * with sufficient tumour surface area (\> 25 mm²), with a final cellularity of at least 20% * patient affiliated to an appropriate social security system * patient signed consent form before any trial related activities exclusion criteria: * recurrent high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer * non epithelial or borderline ovarian cancer * other tumor, for which the treatment may interfere with the ovarian cancer treatment and/or that may have a major impact on prognosis * exclusive palliative setting * patient deprived of liberty or placed under the authority of a tutor

Keywords: hrd (homologous recombination deficient) giscar mychoice platinum chemotherapy
identification of novel biomarkers to aid in the detection of occult cancer in patients with venous thromboembolism

Conditions: Cancer; Venous Thromboembolism

Summary: venous thromboembolism is a common and serious complication in cancer, and is associated with a substantially increased morbidity and mortality. furthermore, vte may be the earliest sign of cancer. recent studies, however, fail to show a clinical benefit of extended cancer screening in this patient population. better risk prediction models are therefore warranted to identify vte patients who would benefit from a rapid and extensive cancer screening. inflammation and hypercoagulability are considered hallmarks of cancer, and emerging light is being shed on the potential of various markers of inflammation and coagulation in cancer diagnostics and prognostics. among the inflammatory and thrombotic processes linked to cancer is the neutrophil release of web-like nuclear chromatin (dna and histones), referred to as neutrophil extracellular traps (nets). driven by the tumor environment, nets have recently been shown to play a central role in tumor progression, metastasis, and tumor-associated thrombosis. the investigators hypothesize that an enhanced inflammatory state may be predictive of an underlying cancer in patients presenting with vte. the present study is an ongoing prospective study with the primary aim to investigate the diagnostic potential of markers of inflammation, including markers of nets, in detecting occult cancer in patients presenting with vte. secondary aims are to include other biomarkers of cancer, and to assess whether any or a combination of these biomarkers may be prognostic of occult cancer, recurrent thrombotic events, mortality, or cancer disease progression in vte patients with an underlying malignancy.


Eligibility criteria:
inclusion criteria: * venous thromboembolism (thrombosis in the deep venous system of upper or lower extremities or iliac veins and/or pulmonary embolism) as detected by ultrasonography, phlebography, computer tomography, or angiography; * \> 18 years or older; * written informed consent exclusion criteria: * \> 2 days after vte diagnosis; * no blood withdrawal at baseline

Keywords: occult cancer venous thromboembolism biomarkers early diagnosis neutrophil extracellular traps
phase ii safety and efficacy study of single-agent at-101 in patients with relapsed or refractory b-cell malignancies

Conditions: Follicular Lymphoma; Diffuse Large Cell Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Summary: this is an open-label, multicenter, phase ii study to evaluate the safety and efficacy of single-agent at-101 in patients with relapsed or refractory b-cell malignancies.

this is an open-label, multicenter, phase ii study to evaluate the safety and efficacy of single-agent at-101 in patients with relapsed or refractory b-cell malignancies. for the purpose of this study, b-cell malignancies can include one of the following disease sub-types: follicular lymphoma (fl), diffuse large b-cell lymphoma (dlbcl), mantle cell lymphoma (mcl), small lymphocytic lymphoma (sll)/chronic lymphocytic leukemia. patients will be enrolled according to disease subtype into one of four groups in two stages. the first stage of each group will enrolled 13 patients. if patients within any group experience disease response, an additional 14 patients will be enrolled into that group.

Eligibility criteria:
inclusion criteria: * must have a histologically confirmed b-cell malignancy (defined as fl \[any grade\], dlbcl, mcl or sll/cll); * male or non-pregnant, non-lactating females age ≥18 years; * ability to swallow and retain oral medication.; * have failed at least one prior therapy and have documentation of either, relapsed disease, or refractory disease (i.e., no response or stable disease on their last regimen of therapy); * ecog performance status 0 or 1; * all clinically significant toxicities from prior therapy must have fully resolved; * must have discontinued treatment with monoclonal antibodies for a minimum of 90 days prior to first dose of at-101, or have objective documentation of disease progression if within 90 days of monoclonal antibody administration; * patients with fl, dlbcl, mcl, and sll with normal lymphocyte counts must have at least one bi-dimensional lesion that is radiographically measurable (skin lesions, palpable lymph nodes, and bone marrow as the only site of disease are not considered measurable disease); * patients with sll whose lymphocytes are elevated at baseline or cll must have palpable lymph nodes and/or disease localized to the bone marrow per the nci-sponsored working group guidelines for cll. exclusion criteria: * requirement of systemic corticosteroids within 7 days prior to and during at-101 administration; * must not have received anti-cancer therapy within 28 days of first dose of at-101. cannot have received hormonal agents or biologic dose modifiers (with the exception of hrt) or any investigational treatments within 28 days of treatment with at-101; * patients with cns lymphoma, hiv-related lymphoma, symptoms suggesting hiv infection or active auto-immune hemolytic anemia are excluded; * previous treatment with gossypol, or are hypersensitive to its excipient are excluded; * patients who have an uncontrolled, concurrent illness are also excluded.

Keywords: cancer at-101 at101 b-cell malignancies non-hodgkin lymphoma lukemia
intestinal microbiome and psychological correlates in irritable bowel syndrome and inflammatory bowel disease

Conditions: IBS; IBD

Summary: longitudinal investigation of intestinal microbiome, fecal inflammation markers, stress and psychological variables in patients with irritable bowel syndrome and inflammatory bowel disease undergoing gut-directed hypnotherapy (ght).

study design is a within-subject design with assessment at 4 points in time. data will be collected 3-1 month before first ght session (t1), immediately before first session (t2), at the last session (t3), and 3-6 months after last session (t4). study patients will be recruited consecutively at the special outpatient-clinic for psychosomatics at the division of gastroenterology and hepatology, department for internal medicine iii, university hospital vienna. patients undergo ght in group setting, which has been shown to reduce irritable bowel syndrome (ibs) symptoms and to increase psychological wellbeing. the ght protocol used will be the manchester protocol of gut-directed hypnotherapy and consists of 10 weekly sessions (45 minutes) with six up to eight patients per group over a treatment period of 12 weeks. the following variables will be assessed using standardized questionnaires: anxiety and depression (hads-d), perceived stress (psq), resilience (cdrisc), and quality of life (visual analogue scales). ibs symptoms will be captured by the ibs severity scoring system (ibs-sss), inflammatory bowel disease (ibd) disease activity via harvey-bradshaw-index. additionally, medication intake and food supplements will be assessed. microbiome data will be gained by frozen stool samples, collected by patients at home. patients will be provided with a delivery kit to keep the samples frozen. patients are asked to collect the first stool of the day and not to change diet, medication and intake of pre/probiotics during the hole study period, if possible (documented). at each time point (t1-t4) patients are ask to bring two immediately frozen (stored in their home freezer) double samples (2 stool samples within 1 week) to the hospital to be immediately stored at minus 20 degree celsius. if patients do not have a home freezer, stool will be collected and frozen at the hospital. planned analyses comprise longitudinal and cross-sectional comparisons intestinal colonization will enter in the analyses according to an algorithm assigning values for an increase or reduction of dysbiosis. dysbiosis is hereby defined by the following markers: reduction of fecal biodiversity, lowered occurrence of the species bifidobacterium, lactobacillus and faecalibacterium prausnitzi, increased occurrence of enterobacteriaceae, and a higher quotient firmicutes:bacteroidetes.

Eligibility criteria:
inclusion criteria: * diagnosis of ibs or ibd * eligible for gut-directed hypnotherapy * adult age (18-89) * sufficient knowledge of german language exclusion criteria: * severe somatic or psychiatric illness * operations of the gi tract

Keywords: psychosomatics gastroenterology psychoneuroimmunology
broccoli sprouts for mild ulcerative colitis

Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic Mild

Summary: the goal of this study is to determine the number of servings of broccoli sprouts sufficient to (1) increase sulforaphane levels in the stool and blood and (2) reduce inflammatory markers in patients with mild ulcerative colitis. this is a pilot feasibility study to prepare for a larger randomized controlled trial.


Eligibility criteria:
inclusion criteria: * documented endoscopic diagnosis of ulcerative colitis * currently being treated with a stable dose of 5-asas, steroids, or any other medication approved for ulcerative colitis * if on 5-asa, no dose changes within 2 weeks before the day 0 visit * if on steroids, prednisone dose not more than 20 mg daily and entocort not more than 9 mg daily, with no dose changes within 2 weeks before the day 0 visit * all other medications require a stable dose for at least 8 weeks prior to enrollment. * no dose changes to any ibd medication anticipated for the duration of the study * body mass index (bmi) values 18.5-40 kg/m2 * not on total parenteral nutrition (tpn) or receiving tube feeds. * ability to understand the study procedures, benefits and risks, and sign a written informed consent document. * able to fill out questionnaires regarding dietary intakes, bowel symptoms, and study experience exclusion criteria: * taking non-steroidal anti-inflammatory drugs (nsaids) * following a medically-prescribed diet, on total parenteral nutrition (tpn), or tube feeds * newly diagnosed (within past month), or uncontrolled diabetes or cardiovascular disease * antibiotics in the previous 2 weeks * consumption of more than 5 ½ cups of servings/day of fruits and vegetables as assessed by the national cancer institute (nci) diet history questionaire iii online food questionnaire. * a known allergy or sensitivity to cruciferous vegetables like arugula, bok choy, broccoli, cabbage, cauliflower, or collard greens

Keywords: sulforaphane inflammatory markers inflammatory bowel disease diet ulcerative colitis
impact of body weight on the immediate health of the pediatric population

Conditions: Childhood Obesity

Summary: objective: obesity amongst children is a public health issue in the united states and is rising at an alarming rate. the purpose of this study is to determine if there is any correlation between at risk body weight (overweight and obese) and immediate health of the pediatric population. methodology: as part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. a report was run monthly to calculate the bmi of all patients for whom data is available. the data were plotted on the year 2000 gender based bmi for age percentile growth charts from cdc. a retrospective electronic chart review was conducted for patients at risk body weight (bmi ≥ 85%), and were compared to "control" or healthy (bmi of 25 - 75 %) group for six groups of final ed diagnoses of infectious diseases.

a. background and significance: obesity is a public health issue in the united states. obesity amongst children is rising at an alarming rate. thirty percent of us children aged 6 to 19 are over weight and 15 % are obese1. it is estimated that over 18 million us children are over weight. the long-term impact of childhood obesity on such diseases as diabetes, asthmaand hypertension, is well studied. the effects of childhood obesity on the current health status of the pediatric population have not been studied. b. methodology: as part of routine patient care, we measured length in addition to weight of patients 2 years to 18 years of age presenting to the pediatric emergency department. a report was run monthly to calculate the bmi of all patients for whom data is available. the data were plotted on the year 2000 gender based bmi for age percentile growth charts from cdc. a retrospective electronic chart review was conducted for patients at risk body weight (bmi ≥ 85%), and were compared to "control" or healthy (bmi of 25 - 75 %) group for six groups of final ed diagnoses of infectious disease (id). data were entered and analyzed via spss 14.0 for windows 2000 software systems.

Eligibility criteria:
inclusion criteria:age 2-18 yrs for whom a length and weight is possible - exclusion criteria:under 2 yrs or over 18 yrs of age or inability to weigh and measure pt -

Keywords: children, obesity, emergency medicine
mapping mood in the subthalamic nucleus in parkinson's disease (pd)

Conditions: Parkinson's Disease; Depression; Anxiety

Summary: the goal of this study is to determine the vulnerability of mood-related neurocircuitry in parkinson disease (pd) using deep brain stimulation of the subthalamic nucleus (stn dbs).


Eligibility criteria:
inclusion criteria for stn-dbs subjects: * age 40 or older * dbs stn surgery in past 2 to 36 months * ability to tolerate turning off stimulators * ability to read and comprehend questions * english speaking exclusion criteria for stn-dbs subjects: * other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness * clinically determined dementia ( most recent mmse score of \>24) inclusion criteria for control subject: * age 40 or older * ability to read and comprehend questions * english speaking exclusion criteria for control subject: * other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness * clinically determined dementia ( most recent mmse score of \>24) * plans to have dbs stn surgery in the next 24 months

Keywords: subthalamic nucleus deep brain stimulation depression anxiety parkinson's disease
bivalirudin vs heparin in nstemi and stemi in patients on modern antiplatelet therapy in swedeheart

Conditions: ST-segment Elevation Myocardial Infarction; Non ST-segment Elevation Myocardial Infarction

Summary: in this trial we test the hypothesis that pci and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, mi, and major bleeding in patients with nstemi or stemi at 180 days (primary end point), treated with ticagrelor or prasugrel.

the follow up of endpoints will be performed using swedeheart and national registries. follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. the nurses will also accumulate hospital record information on these endpoints. a central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. every site will prepare source documents for the event and send it to ucr for central adjudication by an independent committee.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of nstemi as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of stemi as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ecg with new st-segment elevation in two or more contiguous leads of ≥0.2 mv in leads v2-v3 and/or ≥0.1 mv in other leads or a probable new-onset left bundle branch block. * pci of culprit lesion is intended (therapeutic pci, not primarily diagnostic pci). * treated with bolus dose of ticagrelor or prasugrel before start of pci. see 2.6 * ability to provide informed consent * age 18 years or older exclusion criteria: * previous randomization in the validate-swedeheart trial. * known terminal disease with life expectancy less than one year. * patients with known ongoing bleeding * patients with uncontrolled hypertension in the opinion of the investigator * patients with known subacute bacterial endocarditis * patients with known severe renal (gfr \< 30 ml/min) and/or liver dysfunction * patients with known thrombocytopenia or thrombocyte function defects * any other contraindication for the study medications. * heparin \> 5000u before arriving to pci lab or \> 3000 u given during angiography before randomization. * gpiib/iiia inhibitors have been given or are pre-planned to be given during the procedure.
pre-operative versus post-operative vaginal cleansing with chlorhexidine solution in prevention post-cesarean section infection

Conditions: Post Cesarean Infectious Morbidity

Summary: maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. this study was done to compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities. randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine.

background: maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. this study was done in a tertiary hospital in abakaliki, ebonyi state, southeast nigeria over a period of 5 months. the state is inhabited mainly by rural farmers and petty traders. literacy is low and poverty is common with poor maternal health indices. aim: to compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities. method: randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine. research randomizer software was used to generate 120 numbers. sixty numbers were randomly generated from a pool of 120 numbers and were assigned to group 1 while the remaining 60 numbers were automatically assigned to group 2. both groups received antibiotics and anterior abdominal wall scrubbing. there were monitored for symptoms and signs of endometritis, wound infection and pyrexia till discharge.

Eligibility criteria:
inclusion criteria: * those that gave consent * term pregnancy exclusion criteria: * refusal of consent * antepartum hemorrhage * cord prolapse * fetal distress * anemia in pregnancy * presence of fever and chorioamnionitis