Kornimate/medical-research-clean huggingface dataset:
cholate clearance in fontan and heart failure

Conditions: Fontan; Right Heart Failure

Summary: the goal of this study is to use the hepquant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of fontan-associated liver disease (fald). this study aims to understand the role impaired blood flow to the liver plays in liver function in fontan patients compared to patients with right heart failure and healthy controls. the study will also determine whether cholate clearance is a good measure to use in this population, and whether it will be able to predict clinical outcomes. participants will undergo a hepquant dual cholate clearance assay and a cardiac magnetic resonance imaging (mri) at the beginning of the study, and then data on health status will be collected for 5 years.


Eligibility criteria:
inclusion criteria: * fontan: adult fontan patients ≥ 18 years of age who have undergone right heart catheterization within the past 1 year. * rhf controls: non-fontan adults with two ventricle anatomy with systemic left ventricle, cvp estimate ≥ 8 mmhg and left ventricle (lv) function ≥ 50% by echocardiogram performed within the past 1 year. can include those with congenital heart disease- repaired or unrepaired. * normal controls: non-fontan adults with normal cardiac anatomy, normal biventricular function, \< moderate tricuspid regurgitation and cvp estimate \< 5 mmhg by echocardiogram performed within the past 1 year. exclusion criteria: * pregnant or breastfeeding * unable to comprehend and/or give informed consent * sensitivity to human serum albumin, or its preparations * participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis * participants on non-selective beta blockers, angiotensin converting-enzyme (ace) inhibitors, angiotensin receptor blockers (arbs), ursodeoxycholic acid, cholic acid, or other bile acids who are unwilling or unable to delay taking their normal dose the morning of their dual cholate clearance testing. * participants on dietary supplements, bile acid sequestrants, glp-1 agonists, narcotics, and other medications affecting gastric emptying or intestinal absorption who are unwilling or unable to delay taking or withhold as outlined in the instructions on deviating from the shunt test. * contraindication to cardiac mri * for rhf and normal controls: diabetes, chronic liver disease, \>moderate alcohol use, bmi \>30, oxygen-dependent, pulmonary hypertension22 on therapy, known porto-pulmonary hypertension
genetic predictors to acupuncture response for arthralgia induced by aromatase inhibitors in patients with breast cancer

Conditions: Breast Cancer

Summary: purpose:acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer associated with screening of snps.

aromatase inhibitor-induced arthralgia (aia) is the most common side effect of aromatase inhibitors (ais) used in breast cancer , may cause poor adherence to ais. studies have shown that acupuncture has a certain therapeutic effect on aia in breast cancer. in this study, acupuncture was used to relieve the symptoms of arthralgia in patients, and the efficacy of acupuncture was observed by using relevant scales. currently, studies have shown that aia in breast cancer patients is related to some biological factors. at the same time, we collected peripheral blood samples of patients, combined with the reported relevant literature, screened out the single nucleotide polymorphisms(snp) related to aia and to guide acupuncture treatment of aromatase inhibitors induced arthralgia, balance the toxicity of endocrine therapy, and improve compliance and effectiveness.

Eligibility criteria:
inclusion criteria: 1. history of stage i-iii breast cancer and free of disease by clinical examination;currently receiving aromatase inhibitors (anastrozole, letrozole, or exemestane) treatment; 2. ai-assisted treatment has lasted for more than one month, and there are obvious symptoms of arthralgia ; 3. voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent); 4. eastern cooperative oncology group (ecog) score of physical condition (0-1); 5. patients with previous local recurrence were eligible, but not patients with distant metastasis; 6. the basic indexes were consistent, and the blood routine and ecg were normal. exclusion criteria: 1. patients with needle phobia; 2. low platelet count (\<50000); comorbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels \<10 g/dl and haematocrit \<30; anaemia on active pharmacological treatment orreceiving blood transfusion or steroids; 3. lymphoedematous of limbs; 4. patients have a history of acupuncture treatment for 6 months; 5. patients were reluctant to participate in the study; 6. a prior history of inflammation, metabolic disease, or neurotic joints, except for previous treatment with bisphosphonates, steroids, or opioid analgesics.

Keywords: single nucleotide polymorphisms breast cancer aromatase inhibitors arthralgia acupuncture
curcumin paste as an adjunctive therapy in periodontitis

Conditions: Periodontitis

Summary: the turmeric (curcuma longa) plant, a herb belonging to the ginger family. the most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. this study will be carried out to examine the effect of curcumin when used in conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it may have positive effect)

the present study entailed twenty four patients having stage ii or stage iii, grade a periodontitis with 24 intrabony defects. patients were divided into two groups; group i was subjected to open flap debridement only. group ii was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. moreover, radiographic examination was performed by cone beam computed tomography (cbct) just before the surgery . vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. group ii received local application of curcumin paste.the same initial clinical parameters were recorded three and six months postoperatively. radiographic measurements were recorded six months post surgically.

Eligibility criteria:
inclusion criteria: 1. male or female with age range 25-45 years. 2. at least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, intrabony component ≥ 3 mm and with plaque index ≤1 (löe 1967) and bleeding index ≤1 (mühlemann \& son 1971). all the previous criteria were determined 2 weeks after phase i conventional periodontal therapy. 3. systemically healthy as evidenced by burket's oral medicine health history questionnaire (glick et al., 2008). exclusion criteria: * 1- smokers. 2- pregnant. 3- patient unwilling to comply to periodontaloral hygienic instructions. 4- vulnerable groups. (e.g: decisionally impaired individual)

Keywords: curcumin cbct hplc periodontitis
we-intervention among chinese hiv-serodiscordant male couples

Conditions: HIV

Summary: hiv-serodiscordant male couples, in which one male partner is hiv-seropositive and the other is hiv-seronegative, experience multiple risks in hiv care and prevention. as stigma often hinders such couples' access to support and services, leveraging their relational resources is crucial for optimizing their outcomes. the proposed study will assess the efficacy of the three-session we-intervention focusing on their relationship dynamics to enhance chinese hiv-serodiscordant male couples' health and well-being. a total of 160 chinese hiv-serodiscordant male couples (320 individuals: 160 hiv-seropositive and 160 hiv-seronegative) will be randomized at a 1:1 ratio to either the intervention or control arm. in the intervention arm, the we-intervention will be delivered to both partners of each couple separately. in the control arm, each couple will receive health information pamphlets.

a pilot randomized controlled trial has already demonstrated the feasibility, acceptability, cultural sensitivity, and preliminary efficacy of the we-intervention in improving the quality of life, psychological well-being, relationship satisfaction, and health behaviors of both partners in hiv-serodiscordant male couples. the proposed randomized controlled trial will extend the pilot study to examine the effects of the we-intervention on stigma perception and other hiv-related behavioral outcomes, the mediators that account for the intervention effects, and the conditions under which the intervention is most effective. the we-intervention, if found to be effective, will be a valuable supplement to existing medical care modules.

Eligibility criteria:
inclusion criteria: 1. both partners are male, 2. both partners are aged 18 or above, 3. both partners report being in a committed relationship for at least 3 months, 4. one partner is hiv-seropositive and the other partner is hiv-seronegative (i.e., serodiscordant couple), 5. both partners have disclosed their serostatus to each other, and 6. both partners are willing to participate in this study. exclusion criteria: 1. either partner is unable to complete the assessment due to a low education level or to physical or psychological constraints and 2. either partner has been diagnosed with another chronic disease (e.g., cancer and coronary heart disease).
long term, extension study of the safety and efficacy of avp-786 for the treatment of agitation in patients with dementia of the alzheimer's type

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type

Summary: this is an extension study of the phase 3 studies 15-avp-786-301, 15-avp-786-302, and 17-avp-786-305, which also allows participants from the phase 2 study 12-avr-131 to be included.

participant has successfully completed studies 15-avp-786-301, 15-avp-786-302, 12-avr-131, or 17-avp-786-305. participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks). approximately 1200 participants will be enrolled at approximately 250 centers globally. all participants enrolled will receive avp-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Eligibility criteria:
inclusion criteria: * participant has successfully completed studies 15-avp-786-301, 15-avp-786-302, 12-avr-131, or 17-avp-786-305. (note: a delay in enrollment may include delays associated with covid-19 restrictions.) * participants with a diagnosis of probable alzheimer's disease (ad) according to the 2011 national institute on aging-alzheimer's association (nia-aa) working group criteria * either out-patients or residents of an assisted-living facility or a skilled nursing home * participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline * participants who delay enrollment must have a diagnosis of agitation that must meet the international psychogeriatric association (ipa) provisional definition of agitation * participants who delay enrollment must have a clinical global impression of severity of illness (cgis) score assessing agitation of ≥ 4 (moderately ill) at screening and baseline * participants who delay enrollment must have a mini-mental state examination (mmse) score between 6 and 26 (inclusive) at screening and baseline exclusion criteria: * participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) * participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator * participants who are currently using or were on nuedexta® in the 2 weeks preceding baseline
histologic evaluation of bone formation after alveolar augmentation by "sandwich osteotomy" procedure for dental implants insertion

Conditions: Dental Implants

Summary: the purpose of this study is to evaluate histologic bone remodeling after interpositional bone graft ("sandwich osteotomy" technique) using xenograft to fill the gap of the bone after moving and fixation it in the proper place.

dental implant use for partially edentolous jaw is a predictable procedure with high success rate. however, implantation procedure requires sufficient bone support both vertically and horizontally, and sometimes there is bone defect that requires bone augmentation prior to dental implant insertion. there are some bone augmentation techniques known and used for this purposes, including: guided bone regeneration (gbr), distraction osteogenesis, split osteotomy, onlay bone graft, and interpositional bone graft. one of the techniques is the interpositional bone graft using "sandwich osteotomy" technique, in which a cut is made in the bone (one horizontal and two vertical) separating a mobile bone portion which is fixed (using bone plate) in its new "ideal" position. the gap between the moved bone and the remaining bone is filled with xenograft ("bio-oss"). there is no documentation in the literature about histological evaluation of the bone after this well known clinical procedure. four months after the bone augmentation procedure - the fixating plate is moved out and dental implants inserted. the first bur of the implantation (the smallest in the diameter) will be a trephine from which a histologic slide will be taken for check. the continuous dental implants insertion is the normal protocol for dental implantation (widening the recipient hole with bur, and insertion of the implant), followed by rehabilitation by prosthodontics.

Eligibility criteria:
inclusion criteria: * age \> 18 years * partially edentulous patients * insufficient bone height (recipient site) * interested in fixed dental rehabilitation using dental implants exclusion criteria: * smoking * unbalanced diabetes

Keywords: edentulous fixed dental rehabilitation insufficient bone height partially edentulous patients patients interested in fixed non removable dental rehabilitation by dental implants. the recipient bone with insufficient bone height for dental implant insertion. adult patients
a safety and immunogenicity trial in adults 65 years of age or over to prevent influenza

Conditions: Influenza

Summary: the objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. the study will last approximately 10 months and will have a total of 7 visits.


Eligibility criteria:
inclusion criteria: * age 65 years of age or older * good general health without significant physical examination findings or clinically significant abnormal laboratory results * available to participate for entire study period * acceptable laboratory parameters * willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available * willingness to refrain from donating blood while participating in the study * willingness to delay receipt of 2008-2009 licensed influenza vaccination until after completing study visit 6 procedures (study week 8) * signed inform consent obtained before screening and before enrollment exclusion criteria: * venous access deemed inadequate for th phlebotomy demands of the study * receipt of any other vaccine within 30 days prior to enrollment * use of any investigational agent within 30 days prior to enrollment * receipt of immunoglobulin or other blood products within 60 days prior to enrollment * use of cytotoxic medications within 6 months prior to enrollment * use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment) * history of serious adverse reactions to any vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain * history of autoimmune disease or splenectomy * history of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment) * psychiatric condition that may interfere with the ability to comply with the protocol requirements or to understand informed consent. specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years. * history of medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months * any condition which leads the investigator to believe that the particpant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for further participation.

Keywords: influenza flu a/wyoming/03/2003 alphavirus
surgical and conservative treatment in isolated minor rib fractures

Conditions: Rib Fractures

Summary: the purpose of this research is to compare the outcomes of surgical stabilization and conservative treatment in patients with isolated minor rib fractures.

isolated minor rib fractures (imrfs), which is defined by single or two isolated minor rib fractures caused by trauma or stress. traditionally, rib fractures are managed mainly by surgical stabilization or conservative treatment. in 2018, a systemic review and meta-analysis for patients with multiple rib fractures had revealed a shorter duration of mechanical ventilation, shorter hospital length of stay, and fewer trauma-associated complications in the surgical group than in the non-surgical group. in contrast, imrfs are seldom life threatening, and compared to extremity fractures, rib fractures do not require matching accurately. thus, imrfs are usually treated conservatively. however, the investigators have clinically observed that patients suffering severe pain due to progressive rib displacement may take longer to return to normal activity, have lower quality of life, and even an increased risk of complications. moreover, limited studies discussed the efficacy of surgical interventions for imrfs. therefore, the investigators conduct a prospective observational cohort study to compare the outcomes of surgical stabilization and conservative treatment in patients with imrfs. the investigators collect patients with imrfs whose situation were both suitable for surgical and non-surgical interventions. after explanation, patients can decide to undergo conservative or surgical treatment by themselves. the investigators will follow up pain scores, chest x-ray, pulmonary function tests, and duration of return to normal activity. those data will be statistically analyzed by two-tailed two-sample t-test. this prospective cohort study is supposed to provide more evidence for clinical decision making and optimal management of imrfs.

Eligibility criteria:
inclusion criteria: * patient age ≥ 20 years old. * patient was diagnosed with isolated minor rib fractures by thoracic surgeon. * patient was suitable for both surgical stabilization and conservative treatment. exclusion criteria: * severe trauma associated to other systems. * pathologic fractures: such as fracture due to metastasis or steroid therapy. * unconsciousness or disturbed conscious level.

Keywords: surgical stabilization conservative treatment
bindex for osteoporosis diagnostics

Conditions: Osteoporosis, Postmenopausal

Summary: osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. among 200 million osteoporotic patients most are diagnosed only after several fractures. furthermore, the progressively aging population will increase the prevalence of osteoporosis. it is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition. bindex ultrasound device has been developed and validated in caucasian female population. in this study, diagnostic thresholds for density index as determined with bindex will be evaluated in two different ethnic populations.

currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density (bmd), using axial dual energy x-ray absorptiometry (dxa) of the hip and/or the lumbar spine at special healthcare. application of diagnostic thresholds determined against bmd have been suggested by international society for clinical densitometry (iscd) for use with peripheral bone densitometry devices (90% sensitivity and 90% specificity). these thresholds have been determined and validated for bindex in caucasian female population. this study focuses on clinical validation of the ultrasound device (bindex®, bone index finland ltd., www.boneindex.com) device and density index (di), a diagnostic parameter reported by bindex. the predetermined thresholds for di will be evaluated by measuring 70 osteoporotic and 70 healthy patients with bindex and dxa in each selected patient groups. the feasibility of di for diagnostics of osteoporosis in these groups will be assessed.

Eligibility criteria:
inclusion criteria for all: * postmenopausal status * age at 50 years or over * caucasian or hispanic race (number shall be controlled, 140 in each group) * body mass index (bmi \< 35) additional criteria for osteoporotic group - t-score (nhanes database) -2.5 or lower at femoral neck or total femur additional criteria for non-osteoporotic group - t-score (nhanes database) \> -2.5 at femoral neck or total femur exclusion criteria: for non-osteoporotic groups (hispanic or caucasian) * previous osteoporosis diagnosis * previous or current use of anti-fracture medication