Kornimate/medical-research-clean huggingface dataset:
effects of chemoradiation and surgery on cardiopulmonary fitness and tumor neoplastic phenotype in gastrointestinal malignancies

Conditions: Pathologically Proven Gastrointestinal Malignancy; Plan of Care Must Include Chemoradiation

Summary: there is growing evidence of the integral role of exercise following cancer treatment. randomized trials show that exercise improves post treatment symptoms and quality of life in breast and prostate cancer patients.regular exercise reduces cancer specific and all cause mortality for patients with breast, prostate, brain or colorectal cancer. nearly a 40-50% relative risk reduction in cancer specific death and 20-50% relative risk reduction in all cause mortality have been reported with exercise. at present it is unknown if preclinical pleiotropic effects on tumors through aerobic exercise are clinically relevant. before launching into further studies of exercise training on changes in tumor hypoxia and response to crt in rectal cancer patients, it is first important to understand: 1. whether measures of exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are associated with markers of tumor hypoxia at diagnosis (prior to initiation of crt) and 2. whether changes in measures of exercise exposure over the course of crt are related to changes in tumor hypoxia and response to crt.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed gastrointestinal malignancy 2. plan for chemoradiation 3. at least 18 years old 4. karnofsky performance status of at least 70% at study entry 5. ability to read and understand english 6. signed informed consent prior to initiation of study-related procedures 7. all women of childbearing potential must have a negative serum pregnancy test prior to study entry exclusion criteria: 1. significant cardiac disease (i.e., left ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months) 2. contraindications to a cardiopulmonary exercise test as recommended by the american thoracic society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases 3. kps\<70% 4. females who are pregnant

Keywords: gastrointestinal malignancy cardiopulmonary fitness chemoradiation therapy
effect of seminal fluid on the colon wall; implications for hiv transmission

Conditions: Human Immunodeficiency Virus (HIV)

Summary: this research is being done to learn how seminal fluid affects the lining of the colon, and whether this might make it easier for hiv to get into the body and cause infection.

design of effective rectal microbicides to prevent hiv infection requires an understanding of rectal hiv transmission and the location within the lower gastrointestinal (gi) tract (luminal and mucosal) of hiv (cell-free and cell-associated) following exposure to infected seminal fluid. these basic details of hiv transmission have yet to be determined in human subjects, yet they are essential to select microbicide candidates if they are to be rationally designed to achieve effective concentrations at sites of hiv transmission. rational development of a rectal microbicide also requires an understanding of those factors that may contribute to colonic mucosal injury - potential confounders of microbicidal effect. such factors include exposure to seminal fluid which has been shown in animal and in vitro studies to cause histologic and permeability changes that might facilitate hiv transmission.

Eligibility criteria:
inclusion criteria: * able to provide signed informed consent * men of 21 years or older. * prior history of receptive anal intercourse. * laboratory values within the last 28 days: * negative for hiv antibodies * lymphocyte count within normal limits * neutrophil count \> 1,000 cells/ml * cluster of differentiation 4 (cd4) cell count \> 500 cells/ml * platelet count ≥ 150,000 cells/mm3 * prothrombin time (pt) within normal limits * partial thromboplastin time (ptt) within normal limits. * no childbearing intentions. exclusion criteria: * active anorectal disease or recent (3 months) anorectal surgery; * diarrhea, defined as three or more loose stools per day, for at least three days prior to admission. * history of sleep apnea, or airway problems with previous sedation procedures. * history of significant adverse reaction to sedation medications. * other history, including significant occupational radiation exposure, history of inflammatory bowel disease or any other diseases and lab results, such that, in the judgment of the investigator, study procedures are not considered safe for the subject's participation.
minimization of intradialytic hypotension using cardiography-guided intervention

Conditions: Intradialytic Hypotension

Summary: this is a research study to test the application of fda-approved, non-invasive device (nicas) that measure the performance of your heart during hd treatment.

the incidence of intradialytic hypotension (idh) events, reported to occur in 15% to 50% of hemodialysis (hd) treatments, is still high despite major technical advances in hd technology. by definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of idh. chronic hd patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. specifically, hemodynamic instability during hd can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. an idh event can lead to myocardial cerebral and other organ ischemia. long- and short-term adverse outcomes have been associated with idh, a common hd complication and significant cause of morbidity. recent pilot studies suggest that in idh-prone subjects, measurements of hemodynamic variables during hd can be used to categorize the hemodynamic response into three subgroups: cardiac power index (cpi) reduction with stable total peripheral resistance (tpr), tpr reduction with stable cpi, and reduction in tpr and cpi groups. it is hypothesized that targeted intervention for each subgroup can reduce idh.

Eligibility criteria:
inclusion criteria: * 18 years old or older * have been on maintenance hemodialysis at the facility for at least six months * have not had un-excused missed treatments for six months * is symptomatic to hd treatments * males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential exclusion criteria: * patient refusal * currently on midodrine at the start of the phase 1, observation period * any known contraindications to midodrine
complex imaging assessment of steatosis

Conditions: Fatty Liver

Summary: the main objective is the assessment of mri (magnetic resonance imaging) spectroscopy in patients diagnosed with hepatic steatosis in treatment with combination silimarin, phyllanthus niruri and choline.

in the study will be included patients with alcoholic and non-alcoholic steatohepatitis evaluated in research center of gastroenterology and hepatology and gastroenterology clinic of university of medicine and pharmacy of craiova. all the patients will undergo mri and mri spectroscopy (3 tesla) using philips ingenia 3t system for exact steatosis quantification. the eligible patients will be treated with combination silimarin, phyllanthus niruri and choline (stoptoxin forte) for 6 months (in conformity product characteristics). after the treatment a new irm spectroscopy examination will be performed. all the acquired data will be analyzed and published.

Eligibility criteria:
inclusion criteria: * steatosis described on abdominal ultrasound exclusion criteria: * chronic viral hepatitis * liver cancer * abusive alcohol consumption

Keywords: steatosis, fatty liver, steatohepatitis
evaluate the effectiveness of intravitreal (ivt) aflibercept injection in clinical practice in naïve patients with neovascular age-related macular degeneration (namd)

Conditions: Macular Degeneration

Summary: there is a need to investigate the effectiveness of ivt aflibercept injection in routine clinical practice. the aim of this study is to collect 12-month real-world clinical data from treatment-naïve namd patients who started first-line treatment with ivt aflibercept injection, according to the smpc (summary of product characteristics) and the serv (spanish society of retina and vitreous) guidelines. the effectiveness of ivt aflibercept will be assessed by the changes in va (visual acuity) and crt (central retinal thickness) during treatment.


Eligibility criteria:
inclusion criteria: * adult patient aged 50 years or more at aflibercept treatment initiation. * treatment-naïve patients with namd * patients who initated treatment with ivt aflibercept injection between 1st april 2014 to 31st may 2016 * patients that have been decided to be treated with ivt aflibercept with a minimum treatment follow-up with ivt aflibercept injection of at least 12-months, in accordance with the approved smpc. * patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent. exclusion criteria: * patients who have previously been treated with anti-vegf intravitreal injections, systemic anti-vegf or pro-vegf treatments, as well as other intravitreal steroids or steroid implants for the study eye. * patients that switched to another treatment alternative different from ivt aflibercept injection during observation period of 12 months * patients with another retinal disease: diabetic retinopathy, diabetic macular edema (dme), myopic choroidal neovascularization, retinal vein occlusion (rvo), central serous chorioretinopathy (csc), angioid streaks. * patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation * patients with advanced cataract or advanced glaucoma * patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation. * patients who do not meet the local guideline criteria for aflibercept treatment. contraindications listed in the smpc must be taken into account.

Keywords: namd: neovascular age-related macular degeneration
predictive monitoring - impact in acute care cardiology trial

Conditions: Clinical Deterioration

Summary: hypothesis: display of predictive analytics monitoring on acute care cardiology wards improves patient outcomes and is cost-effective to the health system. the investigators have developed and validated computational models for predicting key outcomes in adults, and a useful display has been developed, implemented and iteratively optimized. these models estimate risk of imminent patient deterioration using trends in vital signs, labs and cardiorespiratory dynamics derived from readily available continuous bedside monitoring. they are presented on lcd monitors using software called comet (continuous monitoring of event trajectories; amp3d, advanced medical predictive devices, diagnostics, and displays, charlottesville, va) to test the impact on patient outcomes, the investigators propose a 22-month cluster-randomized control trial on the 4th floor of uva hospital, a medical-surgical floor for cardiology and cardiovascular surgery patients. clinicians will receive standard comet device training. three- to five-bed clusters will be randomized to intervention (predictive display plus standard monitoring) or control (standard monitoring alone) for two months at a time. in addition, risk scores for patients in the intervention clusters will be presented daily during rounds to members of the care team of physicians, residents, nurses, and other clinicians. data on outcomes will be statistically compared between intervention and control clusters.


Eligibility criteria:
inclusion criteria: * assigned for clinical purposes to a beds which is part of a randomized cluster exclusion criteria: * none
a study to evaluate the superiority, efficacy and tolerability of combination pantovigar with 2% minoxidil vs 2% minoxidil in women with female pattern hair loss

Conditions: Female Pattern Hair Loss; Androgenetic Alopecia (AGA); Ludwig Type 1; Ludwig Type 2

Summary: pantovigar - a high effective product designed primarily for the treatment of diffuse hair loss in women as well as for the treatment of damaged hair, in the combined therapy can be successfully applied in other types of alopecia. the purpose of this study is to evaluate efficacy and tolerability of combination therapy pantovigar plus 2% minoxidil vs 2% minoxidil. to collect tolerability data for combined treatment pantovigar plus 2% minoxidil course therapy.


Eligibility criteria:
inclusion criteria: * female patient complaint of hair loss and/or hair density reduction for more than 3 months. * more than 15 % of telogen frontoparietal hair as shown in the phototrichogram. exclusion criteria: * symptomatic diffuse alopecia (screening for iron and thyroid function, thyroid stimulating hormon, triiodothyrine, ferritin , total iron-binding capacity) * active or history of systemic autoimmune disease, e.g. lupus erythematodes etc. * hyperandrogenic alopecia (polycystic ovary syndrome, adrenogenital syndrome, tumors with androgenic activity) (testosterone, prolactin hormone, androstenedione, dehydroepiandrosterone) * initiation or termination of hormone therapy within 6 months prior to entering study * hormone therapy with androgenic action, e.g. norethisterone etc. * pregnancy or lactation within 6 months prior to entering study * alopecia areata * scarring alopecia * treatment with hair promoting agent within 3 months prior to entering study * known hair loss after drug intake * concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, thyreostatics, cytostatics, etc,)
natural history study of gemin-5 related neurodevelopmental disorder

Conditions: SMN Complex Proteins; GEMIN5 Protein, Human; Neurodevelopmental Disorders

Summary: this study will include a comprehensive retrospective chart review and a longitudinal prospective observational natural history study to characterize the phenotypic spectrum of gemin5-related neurodevelopmental disorder. we aim to define the trajectory of this ultra-rare disease, core clinical features, characteristics at disease onset and diagnosis, neurological symptomatology, and neuroimaging findings over time. in this study, biological specimens (serum) will also be collected in a biorepository for translational research purposes.

this study will include individuals across the lifespan with molecularly confirmed gemin5 biallelic mutations. this study will be ongoing indefinitely. there are three main components to the study as are detailed below: 1. a retrospective chart review of upmc medical records and other institutions' medical records, for all patients in the study. families/patients will provide staff with a signed release of information, so that we can obtain a copy of the participants complete medical record which will be requested from previously treating physicians. this may include records from several disciplines, for example neurological and physical exams, neurodevelopmental testing (cognitive, motor, language and daily living skills), growth parameters, results to previous genetic testing, mri, lab results including lumbar puncture studies, audiologic exam, vision screening, nerve conduction studies, ophthalmologic exam, swallow studies, co-morbidities, and family history. 2. an observational, longitudinal prospective study of patients seen at the upmc center for neuogenomics (ccng) clinic. clinical data obtained as part of a typical ccng visit include vital signs, measurements (weight, head circumference, length), a developmental history, neurodevelopmental testing (eg. cognitive, speech and language, motor skills, developmental skills, vision, hearing), and a comprehensive neurological exam, including an ataxia rating scale. additionally, any neurodiagnostic results obtained clinically are reviewed if available, such as mri brain and spine, eeg, and nerve conductions studies. 3. patients who are seen at the ccng clinic in person may opt to submit an optional research biological samples. primary endpoint: neurodevelopmental outcomes secondary endpoint (if available): mri - presence of cerebellar atrophy survival vision hearing biomarkers of disease

Eligibility criteria:
inclusion criteria: * individuals with molecularly confirmed gemin5 biallelic mutations, ages 0 years and above exclusion criteria: * none

Keywords: gemin5 neurodevelopmental disorders
neural exercises vs surgery in patients with carpal tunnel syndrome

Conditions: Neuropathic Pain

Summary: neural exercise in patients with carpal tunnel syndrome

objective: the aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with carpal tunnel syndrome. study design: randomized parallel-group trial. background: carpal tunnel syndrome (cts) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect. methods: in the humans study, 54 patients with cts will be randomly allocated to either a surgery group (n=18) or surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. the primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. secondary outcomes will be hand disability assessed with the boston carpal tunnel questionnaire, pinch-tip grip force, and the symptom severity subscale of the boston carpal tunnel questionnaire, neuropathic pain questionnaire (dn4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment patients were assessed at. analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.

Eligibility criteria:
inclusion criteria: tinel and phalen positive 4/10 in vas scale increase symptoms at night 12 months of symptomatology sensorial and motor dysfunction in the conduction of the median nerve exclusion criteria: previous surgery wrist fractures rheumatoid arthritis or fibromyalgia systemic disease pregnancy

Keywords: neural mobilization surgery pain modulation
validation of the genepoc strep a, c/g assay for detecting group a, c and g β-hemolytic streptococcus from throat swabs.

Conditions: Pharyngitis, Infective

Summary: the primary purpose of this clinical investigation is to establish the performance of the genepoc strep a, c/g assay on the revogene. this will be achieved by comparing the test to a conventional method for detection of group a β-hemolytic streptococcus (gas) and pyogenic group c and g β-hemolytic streptococcus (gcs/ggs) in throat swab samples.

the genepoc strep a, c/g assay will be performed using the revogene™ instrument. the revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences. a dual swab sample is collected when icf is signed by patient. one of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a reference center.

Eligibility criteria:
inclusion criteria: * samples from patients suspected of having signs and symptoms of a pharyngitis infection * patient that signed the approved informed consent form (if applicable) * patient older than 2 years of age * only one (1) compliant sample per patient is allowed * use of dual swab with either liquid stuart or liquid amies transport medium exclusion criteria: • patient/sample not meeting inclusion criteria above
quality of life associated with a low-risk screening program for ovarian cancer

Conditions: Ovarian Cancer

Summary: the goal of this research study is to learn more about how women feel about an ovarian cancer screening program that involves getting a blood test to measure ca 125 levels. this includes finding out about women's quality of life and whether they are concerned or worried about their risk of developing cancer. this study also seeks to find out whether elevated ca 125 levels affect participants in terms of cancer worries or concerns.

participants in this study will be asked to complete several questionnaires. participants will be able to fill out the questionnaires in the clinic or if necessary, they can complete them at home. pre-addressed and stamped envelopes will be provided to mail back if they are completed at home. the questionnaires involve quality of life issues, concerns or worries about cancer risk and beliefs about cancer. it will take 30 minutes or less to complete the questionnaires. the completed questionnaires can be returned to the research nurse or if the participant prefers or they can be returned to the researchers in the self-addressed stamped envelope that is provided. this is an investigational study. this study will involve 2400 women who are participating in an ovarian cancer screening program. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. women enrolled on protocol id01-022 * women \> 50 years of age * postmenopausal (\> 12 months amenorrhea) * willingness to return to clinic for annual blood tests, or earlier if indicated * willingness to undergo transvaginal ultrasound if indicated 2. women who speak and read english exclusion criteria: 1. women ineligible to be enrolled on protocol id01-022 * prior removal of both ovaries * active non-ovarian malignancy * women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for \> 12 months. they will not be excluded if they are on tamoxifen. * high-risk for ovarian cancer due to familial predisposition as defined by the following: * known mutation in brca1 or brca2 * two first or second degree relatives with either ovarian cancer or pre-menopausal breast cancer * ashkenazi jewish ethnicity with one first degree or two second degree relatives with pre-menopausal breast or ovarian cancer, or if patient herself has had breast cancer. 2. women who do not speak or read english

Keywords: ovarian cancer cancer screening quality of life questionnaire screening survey