Kornimate/medical-research-clean huggingface dataset:
a pilot, open-label, phase ii, randomized study to determine the effects of viracept on the outcome of cutaneous and mucosal ks in aids patients with cd4 <= 500 cells/mm3

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to determine the effect of viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal kaposi's sarcoma (ks).

this is an open-label, randomized, pilot, phase ii study of the safety and efficacy of viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal ks. patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add viracept or remain on their current background antiretroviral therapy for a 2 month period. initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 viracept, 6 control) for a 2 month period. response to therapy will be evaluated at the end of the 2 month control phase. at this point, patients who were initially assigned to the control arm will continue on open label viracept for an additional 10 month period.

Eligibility criteria:
inclusion criteria patients must have: * hiv-positivity. * diagnosed ks proven by biopsy. * note: * patients must not opt for immediate topical, systemic or radiation treatment. * at least 4 cutaneous lesions not treated within the previous 4 weeks. * life expectancy \> 6 months. * signed, informed consent from parent or legal guardian for those patients \< 18 years of age. exclusion criteria co-existing condition: patients with the following conditions and symptoms are excluded: * neoplastic disease (excluding ks) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies. * unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral ks. * clinically significant malabsorption syndrome. * renal insufficiency. patients with any of the following prior conditions are excluded: significant fever (\> 101 degrees f (38 degrees c) for \>= 7 days) and/or diarrhea (\> 6 loose stools/day for \>= 7 days) within one month of baseline. 1. immediate topical or systemic treatment for ks lesions. * use of retinoid class drugs, either topically or systemically, or beta-carotene compounds or vitamin a doses of more than 15,000 iu (5,000 mcg) per day concurrently. immediate radiation treatment. 1. treatment of ks lesions with intra-lesional chemotherapy within 4 weeks of entry. * history of \> 2 weeks of prior therapy with indinavir or ritonavir. * use of retinoid class drugs, either topically or systemically, or beta-carotene compounds or vitamin a doses of more than 15,000 iu (5,000 mcg) per day within 4 weeks of entry. treatment of ks lesions with radiation within 4 weeks of entry. active substance abusers; urine drug tests may be performed if drug abuse is suspected.

Keywords: skin neoplasms aids-related opportunistic infections sarcoma, kaposi drug therapy, combination hiv protease inhibitors mucous membrane nelfinavir anti-hiv agents
responders and non-responders in the management of heart failure - significance of genetic influence and identification of novel informative biomarkers

Conditions: Heart Failure; Pathophysiology

Summary: a biobank within the swedish national heart failure quality registry swedehf.

the national heart failure quality registry swedehf started in 2003. it is the world's largest continuous hf registry enrolling clinician-judged hf (regardless of lvef) at time of hospital or clinical visit. eighty variables are entered into an electronic database managed by the uppsala clinical research center (ucr). there are \>140,000 registrations from \>110,000 unique patients from 70 hospitals in sweden. university hospitals in sweden with access to central biobanking will collect a high-quality biobank linked to swedehf consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for hf patients. this will provide unique opportunities for future research within the national swedehf registry.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. heart failure defined by symptoms and signs of heart failure as judged by the local investigator 3. registered in swedehf exclusion criteria: 1. plasma donation within 1 month of enrolment or any blood donation/blood loss \>500 ml during the 3 months prior to enrolment 2. previous allogeneic bone marrow transplant (genetics) 3. in the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
manual therapy techniques on cervical spine and psychological interaction

Conditions: Neck Pain

Summary: manual therapy (mt) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms. there is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the fear-avoidance model of pain one of the most tested models in this field.


Eligibility criteria:
inclusion criteria: * neck pain exclusion criteria: * myelopathy * fracture * infection * dystonia * tumor * inflammatory disease * fibromyalgia * or osteoporosis

Keywords: neck pain manual therapy psychological interaction
clinical efectivity of two different sensor-augmented pumps with low predictive suspension function

Conditions: Type 1 Diabetes

Summary: observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in type 1 diabetes mellitus (t1dm) adult patients in routine clinical practice.

cross-sectional multicenter analysis about clinical effectiveness of two different sensor-augmented pumps, tandem t slim x2 with basal iq (ttsx2) and medtronic minimed 640g with smartguard (mm640g) in adult patients with type 1 diabetes mellitus. all clinical variables are gathered from three emr softwares and two sensor-augmented pumps sotwares. data analysis is conducted using spss (chicago, il) statistics software. results are presented as mean ± sd values or percentages. a kruskal-wallis or a friedman test were used for the analysis of differences. comparisons between proportions were analyzed using a chi-squared test. a "p" value \< 0.05 was considered statistically significant. the protocol was approved by the reference castilla-la mancha public health institute ethic committee. all participants provided written informed consent.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * treated with ttsx2 or mm640. exclusion criteria: * other kind of diabetes. * serious mental disease.
a study evaluating the efficacy and safety of ap30663 for cardioversion in participants with atrial fibrillation (af)

Conditions: Atrial Fibrillation

Summary: this study will evaluate the efficacy, safety, tolerability and pharmacokinetics (pk) of one or more doses of ap30663 for cardioversion in adult participants with af.


Eligibility criteria:
key inclusion criteria: * clinical indication for cardioversion of af * current episode of symptomatic af lasting between 3-hour and 7 days (inclusive) at randomization * adequate anticoagulation according to international and/or national guidelines key exclusion criteria: * significant clinical illness or surgical procedure within 4 weeks preceding the screening visit * history of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator. * any cardioversion attempt of af or atrial flutter within 4 weeks preceding randomization * use of any antiarrhythmic drug class i and/or iii within 6 months before randomisation other protocol defined inclusion/exclusion criteria may apply
a phase 1 study of an intravenously administered cyclin-dependent kinase inhibitor in patients with advanced cancer

Conditions: Neoplasms; Lymphoma, Non-Hodgkin

Summary: ag-024322 may work in cancer by stopping cancer cells from multiplying. ag-024322 is and intravenous drug from a new class of drugs call cyclin-dependent kinase (cdk inhibitors). this research study is the first time that ag-024322 will be given to people.

the study was prematurely discontinued due to the inability of the compound to adequately differentiate from other treatment options in the clinical endpoint and necessary product profile on april 13, 2007. safety profile was not the reason that led to the discontinuation of the program.

Eligibility criteria:
inclusion criteria: * advanced solid tumors or follicular of diffuse large cell non-hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition * adequate blood cell counts, kidney function and liver function and and ecog score of 0 or 1. exclusion criteria: * prior high-dose chemotherapy requiring hemapoietic stem cell rescue * previous radiation therapy to \>25% of the bone marrow * active or unstable cardiac disease or history of heart attack within 6 months
allogeneic mesenchymal stem cells transplantation for primary sjögren's syndrome (pss)

Conditions: Sjogren's Syndrome; Mesenchymal Stem Cells

Summary: this study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (msct) to treat patients with diagnosis of primary sjögren's syndrome (pss) who have been resistant to multiple standard treatments. the underlying hypothesis is that the pss condition is caused by an abnormal immune homeostasis that can be restored by msct.

* to test a new approach using allogeneic derived mesenchymal stem cell based therapy (msct) to treat refractory primary sjögren's syndrome (pss) * to determine the disease-free survival in pss patients treated with msct in terms of disease activity index, pss serology and salivary gland function * to assess adverse events of allogeneic msc transplantation * to assess the association of disease activity index, pss serology levels, and saliva flow rate at baseline with disease-free survival

Eligibility criteria:
inclusion criteria: * all patients fulfilled the international classification criteria (2002) for primary sjögren's syndrome, man or woman aged from 15 to 70 years old, sjögren's syndrome disease activity index (ssdai)≥8. * stimulated whole saliva flow rate less than 1\~6ml/6min. * patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines. * women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial and for 12 months following treatment. women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment. exclusion criteria: * end-stage renal failure. * severe cardiopulmonary compromise, or other system failure. * active, uncontrolled infections. * pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.

Keywords: sjogren's syndrome mesenchymal stem cells transplantation
platelet aggregation and adenosine levels among patients taking ticagrelor or prasugrel

Conditions: Coronary Artery Disease

Summary: prospective, single-center, double blind, double dummy, randomized trial. platelet function tests and adenosine levels were assessed at baseline and 15 days after taking ticagrelor with prasugrel placebo or prasugrel with ticagrelor placebo in stable patients with coronary artery disease

this was a prospective, double blinded, randomized trial that compared platelet inhibition and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg bid) versus prasugrel (60mg loading dose, followed by 10 mg qd) . patients were eligible if they were between 18 and 75 years old, were on aspirin without p2y12 inhibitor at baseline and \> 1 year after documented acs. platelet aggregation was compared with the multiplate adp® assay, performed at baseline and after 15 days on study medication. adenosine plasma levels were measured with high performance liquid chromatography at the same time points

Eligibility criteria:
inclusion criteria: * between 18 and 75 years old * were on aspirin * without p2y12 inhibitor at baseline * \> 1 year after documented acute coronary syndrome exclusion criteria: * use of oral anticoagulation or p2y12 at baseline * weight \< 60kg * history of tia or stroke * any coagulation disorders * refuse to sign the written consent
comparision of retinal function and macular structure after 27g pars plana vitrectomy with minimal illuminiation

Conditions: Epiretinal Membrane

Summary: purpose: to analyze the clinical benefits of using the ngenuity 3d visualization system in vitreoretinal surgery with low levels of endo-illumination, focusing on functional and structural retinal protection in patients with idiopathic epiretinal membranes (erm). design: prospective, randomized, comparative study. methods: forty pseudophakic patients (29♀, 11♂; age 60-80 years) with erm underwent 27g pars plana vitrectomy (ppv) and were randomly divided into two groups: group i (20 eyes, stand-ard microscope \[hi-r 900\], endo-illumination 3.2 lm) and group ii (20 eyes, 3d heads-up nge-nuity system, endo-illumination 0.5 lm). preoperative and 6-month postoperative evaluations included slit-lamp examination, intraocular pressure (iop, pascal tonometer), distance best correct-ed visual acuity (dbcva, logmar), central subfield thickness (cst), retinal nerve fiber layer thickness (rnfl, oct), pattern erg (perg), multifocal erg (mferg), flash erg (erg, is-cev standards), and retinal sensitivity (hfa macula test). surgery time, xenon light exposure, erm/ilm peeling time, fundus autofluorescence (faf), metamorphopsia incidence, and intra-/postoperative adverse events were analyzed. results were statistically evaluated (p \< 0.05).


Eligibility criteria:
inclusion criteria: * dbcva \> 0.1 (snellen charts) * pseudophakia * erm without other abnormalities * patient's consent to participate in the project with a 6-month follow-up after surgery. exclusion criteria: * glaucoma * amd * systemic diseases known to influence retinal function (e.g., diabetes) * psychiatric disorders * advanced stages of cardiovascular diseases * previous ppv * high myopia.
evaluation of syncope,its diagnosis, treatment, outcome and prognosis

Conditions: Syncope

Summary: the investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.


Eligibility criteria:
inclusion criteria: * all adult patients (age 18 or older) admitted with syncope or near-syncope exclusion criteria: * patients who do not speak/read the language of the consent form * prisoners * patients who are of altered mental status or had head trauma * refusal or inability to sign consent

Keywords: syncope pre-syncope fainting
a pilot study of 123i-mip-1072 spect/ct imaging with optional compact gamma camera probe imaging in men with prostate cancer undergoing prostatectomy

Conditions: Prostate Cancer

Summary: this is a single arm, open label study of up to 20 patients with prostate cancer scheduled for prostatectomy at the nih clinical center. 123i-mip-1072 image data will be evaluated for visible uptake and compared with histopathology.

this is an exploratory, single arm, open label pilot study evaluation of 123i-mip-1072 intraprostatic uptake determination by spect/ct imaging (and optional cgcp imaging), with histological confirmation of disease localization and staging. methodical evaluation of 123i-mip-1072 in intraprostatic tumorous and non-tumours regions will provide important preliminary data upon which further clinical studies can be based. the optional additional cgcp imaging was added, because of its inherent potential for higher resolution scintigraphic detection of 123i-mip-1072 localization. this imaging feasibility data will provide important preliminary information for the use of cgcp imaging in prostate cancer.

Eligibility criteria:
inclusion criteria: * participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the nih clinical center. * have had or will undergo multiparametric endorectal coil 3t mr at the nih clinical center * recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland * participant must be 18 years or older. * ecog performance grade of 0 to 2. (see appendix 1) * ability to understand and provide informed consent. all subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed. * participants of childbearing potential must agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method until 7 days after the infusion of study drug. exclusion criteria: * participants for whom participating would significantly delay the scheduled standard of care therapy. * subjects must not have prostate biopsies performed within 12 weeks before imaging; or within 8 weeks before imaging providing that the absence of hemorrhage is confirmed by mr imaging. * sgot and sgpt ≥ 2 x of the upper limits of normal; total bilirubin, of ≥ 1.5 x the upper limits of normal or ≥ 3.0 mg/dl in patients with gilbert's syndrome. * administered a radioisotope within 5 physical half lives prior to study enrollment. * patients with severe claustrophobia unresponsive to oral anxiolytics * subjects weighing ≥350 lbs or are unable to fit within the imaging gantry * subjects who have received androgen deprivation therapy. * subjects with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.

Keywords: molecular imaging psma adenocarcinoma prostatectomy
trial of print messages to support the role of partners in promoting provider discussions about prostate cancer screening among aa men

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether female partners of african american men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.

objective: although aa men are at elevated risk for prostate cancer (pca), medical guidelines do not present consistent screening recommendations for this group. however, all guidelines stress the need for screening decision making with a provider. this study evaluated the effectiveness of a brochure designed for the female partners of aa men, designed to help promote such discussion on the part of their mates. we also explored the effect of the partner's monitoring style (i.e., the extent to which the partner typically attends to health threats) on promoting discussion. methods: female partners of aa men (n=231) were randomized to receive either a pca screening cdc brochure for aa men, combined with a "partner" brochure containing strategies to promote men's initiation of a provider visit to discuss screening, or the cdc brochure only, and completed pre- and post-intervention surveys online. conclusions: high monitoring partners may be effective in influencing their aa mates to initiate provider discussion, particularly when tailored messaging is provided.

Eligibility criteria:
inclusion criteria: * u.s. female aged 18 and over, and having an aa male partner between the ages of 35 and 69 with no history of a pca diagnosis exclusion criteria: * none

Keywords: prostate cancer partner communication messages monitoring style aa men
the influence of testosterone on experimental pain perception

Conditions: Acute Pain

Summary: this trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).


Eligibility criteria:
inclusion criteria: * healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study. exclusion criteria: * the following criteria will exclude a participant from the study: * anyone that has a tree nut allergy. * women that are pregnant or may feel that they may be pregnant or breast-feeding. * anyone taking supplements that may influence their testosterone level. * anyone taking any kind of steroid that may increase their testosterone level. * anyone that smokes tobacco or uses smokeless tobacco. * anyone that reports any condition associated with nerve damage. * anyone that is using hormonal contraceptive. * anyone who was sick or unwell at the time of screening. * each participant completed a testosterone pre-screen form. this form asked each participant individually whether they are taking any drugs or have any conditions that might be exacerbated by testosterone. this form was completed before they signed the consent form and each time they arrived in the lab for an experimental session.

Keywords: testosterone pain tolerance estradiol progesterone
identification of gluten sensitivity in irritable bowel syndrome

Conditions: Non-celiac Gluten Sensitivity; Irritable Bowel Syndrome

Summary: the aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (ibs), the clinical picture is attributable to non celiac gluten sensitivity (ncgs) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (fodmaps) intolerance. for this purpose, all subjects with ibs will take a low fodmaps diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of ncgs.

study design: for this study, patients with diagnosis of ibs performed by rome iv criteria and followed as outpatients at the clinical nutrition clinic of "petrucciani" nursing home of lecce (le), italy, will be enrolled. at baseline, the enrolled subjects will follow a balanced normal-caloric low-fodmap and gluten-free diet for a period of 4 weeks. at the end of the 4 weeks patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the salerno criteria.

Eligibility criteria:
inclusion criteria: * a gluten-containing diet for at least six months before enrollment * anti-transglutaminase antibodies (iga and igg) absence * normal serum iga levels * prick and specific ige tests for wheat allergy negative exclusion criteria: * celiac disease * wheat allergy * chronic intestinal inflammatory diseases * psychiatric disorders * major abdominal surgery (in particular intestinal resections) * diabetes mellitus * previous anaphylactic episodes * gluten-free diet in the previous six months * pregnant or lactating women.

Keywords: gluten free diet fodmaps gastrointestinal symptoms