Kornimate/medical-research-clean huggingface dataset:
long-term extension of phase 3 study of alz- 801 in apoe4/4 early ad subjects

Conditions: Early Alzheimer's Disease

Summary: this study is being conducted to evaluate the long-term safety and efficacy of alz-801 in early alzheimer's disease (ad) subjects with the apoe4/4 genotype. this is an open-label trial of treatment with alz-801.

this is a long-term extension study of the phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of alz-801 in subjects with early alzheimer's disease and apoe4/4 genotype. subjects who at initial screening for the phase 3 study were 50-80 years old, had a clinical diagnosis of ad, carried the apoe4/4 genotype, and were at the early stage of disease (early ad\], who complete at least 78 weeks of the phase 3 study while on study medication, were eligible for enrollment. subjects will be treated for 104 weeks with alz-801, followed by a 4-week safety follow-up visit after the last dose of alz-801. clinical trial sites, subjects and their study partner will remain blinded to the treatment (alz-801 or placebo) that they received in the core phase 3 study. the primary efficacy outcome assessment is a measure of cognition (adas-cog 13). additional measures of global and functional impairments will also be assessed. imaging and biomarkers of ad and neurodegeneration will be measured.

Eligibility criteria:
inclusion criteria: * subject has completed the week 78 of the phase 3 core study (alz-801-ad301) while on study drug. * subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities. exclusion criteria: * significant worsening of medical conditions that may preclude completion of this study. * evidence of symptomatic or new moderate-severe radiologic aria at baseline. * has received (or plans to receive) amyloid antibodies since completing phase 3 core study (alz-801-ad301). * subject taking any prohibited medications per protocol.

Keywords: dementia central nervous system diseases nervous system diseases tauopathies neurodegenerative diseases neurocognitive disorders mental disorders alzheimer disease
design of an integrative algorithm for staging tuberculosis

Conditions: Tuberculosis

Summary: tuberculosis is a chronic infectious disease that affects 10 million people, 300 in the city of barcelona, every year. with serious consequences at public health level, it is associated with other diseases, and generated and influenced by many social and psychological factors. this study aims to stage tuberculosis disease by an integrative approach.

tuberculosis is a chronic infectious disease that affects 10 million people, there are 300 new cases 300 in the city of barcelona, every year. tuberculosis has serious consequences at public health level. it is associated with other diseases, and generated and influenced by many social and psychological factors. this study aims to stage tuberculosis disease by a novel integrative approach.

Eligibility criteria:
inclusion criteria: * tb diagnosis (all forms), microbiologically confirmed (by afb+, genxpert+ or culture+) * clinical management of the patients being done at servicios clínicos, hospital universitari vall d'hebron-drassanes or hospital universitari germans trias i pujol. exclusion criteria: * not consenting to data/samples donation

Keywords: tuberculosis, infectious diseases
effectiveness and safety of amisulpride in chinese patients with schizophrenia

Conditions: Schizophrenia

Summary: primary objective: to evaluate the effectiveness of amisulpride in chinese patients with schizophrenia secondary objective: to evaluate the overall safety of amisulpride in chinese patients with schizophrenia.

the study duration by subject will include a 8-week treatment period with 3 follow-up visits.

Eligibility criteria:
inclusion criteria : * satisfying international classification of disease-10 (icd) diagnostic criteria of schizophrenia; * positive and negative syndrome scale (panss) total score ≥ 60 exclusion criteria: * refractory schizophrenia or patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement; * participation into another clinical trial within the last month; * patients previously or currently treated with amisulpride; * patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months; * patients receiving electric convulsive therapy or physical therapy within the past 1 month; * patients with coexisting severe systemic diseases; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
regenerative endodontics for non-vital primary molars

Conditions: Pulp and Periapical Tissue Disease

Summary: non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups: group 1: conventional root canal treatment group 2: regenerative endodontic treatment using mta group3: regenerative endodontic treatment using biodentine each group will be followed up for 12 months

Eligibility criteria:
inclusion criteria: * non-vital mandibular primary second molar. * restorable tooth exclusion criteria: * patients allergic to medicaments or antibiotics necessary to complete the procedure. * special health care needs * excessive mobility * presence of internal or external root resorption.

Keywords: regenerative endodontic treatment
immediate and early single dental implants

Conditions: Single Tooth Lost; Dental Implant

Summary: the objective of the research project will be to compare immediate and early unitary implants for the rehabilitation of missing teeth in the upper aesthetic region. a randomized controlled trial will be conducted in parallel with 120 individuals (60 per group) who are above 18 years of age, periodontally healthy, and who need to perform only one unit implant in the upper aesthetic region between the second premolars. in the immediate implant group, the tooth will be extracted in a minimally traumatic manner and the implant will be installed immediately after the fresh alveolus. bovine bone replacement will be inserted into the gap between implant and vestibular wall of the alveolus, and an immediate temporary will be installed immediately. the provisional will be maintained for 3 months when the definitive crown will be made. in the early implant group, the tooth will be extracted, and after 2 months the implant will be installed with the use of bovine bone substitute to restore the buccal bone contour. the implant will be submerged, and 3 months of osseointegration will be performed reopening and final crown making. in both groups, the individuals will be followed for 1 year after the installation of the definitive crown. the outcomes evaluated will be patient satisfaction (main outcome), gingival phenotype, visible plaque, depth of probing, submucosal bleeding, proximal radiographic bone level, tomographic vestibular bone volume, perimplant clinical aesthetic indexes (esthetic pink score and papillary index), evaluation three-dimensional tissue from intra-oral scanning and 3d printing, implant-related quality of life, and early and late implantation failures. linear and logistic models of generalized estimating equations that take into account the longitudinal character of the study will be used for data analysis.


Eligibility criteria:
inclusion criteria: * patients above 18 years old who require only one single implant in the upper aesthetic area between the second premolars will be included. * the region from which the tooth will be extracted should have bone quality and quantity compatible with implant placement with a minimum diameter and length of 3.0 mm and 8.0 mm, respectively. exclusion criteria: * who present compromise immunology of any nature; * who have been exposed to head and neck radiotherapy; * who have uncontrolled diabetes (glycated hemoglobin above 6.5 mg/dl); * who present active periodontitis, defined by the presence of bleeding on probing \>10% and probing depth and clinical attachment loss \> 4mm; * who have performed or are being treated with intravenous bisphosphonates.

Keywords: dental implant esthetics quality of life
project active a clinical intervention

Conditions: Alcohol Abuse; Obesity

Summary: this is a clinical randomized controlled trial where the study personnel will run a personalized prevention clinic with patients in attempts to improve their preventive health outcomes and compare their health outcomes with a matched control sample of patients who do not receive the clinical intervention.

the project active intervention was constructed around the following framework, and then adapted to suit workflow demands of a busy inner-city clinic: (1) identify patients who could most benefit from improvements in adherence to evidence-based preventive care, (2) use a validated mathematical model that was published in annals of internal medicine to quantify and rank the estimated amount of health benefit that would arise from improved adherence to each uspstf preventive care guideline, with estimates personalized based on that patient's risk factors and medical history, (3) communicate this information in a manner informed by risk communication studies relevant to patients from disparate cultural groups and with low literacy and numeracy, (4) engage the patient in a shared decision making process in which the patient identified which preventive health goals patient aimed to achieve, and (5) set particular action steps for the next visit that were congruent with these goals. the program supplements rather than substitutes for normally scheduled primary care visits, and is coordinated with these visits whenever possible.

Eligibility criteria:
inclusion criteria: * non-elderly non-pregnant adults already in care at bellevue ambulatory adult care clinic * subjects with at least one of twelve unfulfilled clinical management goals from uspstf grade a and b recommendations * english or spanish speaking * capable of understanding informed consent. exclusion criteria: * age \>65 * pregnant * dominant comorbidity (one that disproportionately impacts care plans and/or life expectancy).
achalasia and dysplasia

Conditions: Dysplasia in Longstanding Achalasia; Relation Between Food Stasis and Dysplasia

Summary: patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell carcinoma (escc). early diagnosis of escc is essential, and detection of an earlier dysplastic stage is preferred. endoscopic detection is however difficult and often delayed. chromoendoscopy with lugol dye increases detection rates dysplasia and escc to 91-100%. the aim of this study was therefore to evaluate a screening program using chromoendoscopy with lugol to detect dysplasia in patients with idiopathic achalasia. a second objective is to study the relationship between foodstasis and the development op dysplasia


Eligibility criteria:
inclusion criteria: * longstanding achalasia (\> 15y) * \> 18y old * informed consent exclusion criteria: * allergy to iodine * esophageal carcinoma
topical chamomile in preventing chemotherapy-induced oral mucositis

Conditions: Oral Mucositis Due to Chemotherapy

Summary: the main aim of this study is to clinically assess the effectiveness of topical chamomile oral gel in the prevention of chemotherapy-induced oral mucositis.

the study was designed as a randomized, controlled, clinical trial. patients who were undergoing to receive chemotherapy were divided into three groups: group i: was given conventional treatment. group ii: was given topical oral gel of chamomile. group iii: was given topical oral gel of chamomile in combination with the conventional treatment. all patients have clinically evaluated at the start of the chemotherapy and three weeks later for pain and oral mucositis severity.

Eligibility criteria:
inclusion criteria: * patients who are going to receive 5-fluoroucil (5-fu) based chemotherapy regime. males and females with an age of not less than 20 years and not exceeding 70 years. exclusion criteria: * 1. patients suffering from any uncontrolled systemic diseases that affect integrity of the epithelium (such as diabetes, cardiovascular, liver disorder and renal dysfunction) 2. pregnant and lactating women 3. patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure

Keywords: oral mucositis, chemotherapy, chamomile.
prehabilitation for patients awaiting liver transplantation

Conditions: Cirrhosis, Liver; Liver Transplantation; Frailty

Summary: this study will assess the feasibility, safety and effectiveness of a structured prehabilitation program combining exercise training, nutritional optimization and psychological support for patients with cirrhosis awaiting liver transplantation.

due to their chronic liver disease, patients with cirrhosis awaiting liver transplantation develop low muscle mass, poor nutritional status and decreased reserves putting them at high risk of postoperative complications, prolonged hospital stay, and failed discharge home after liver transplantation. prehabilitation aims to optimize a patient before they undergo a major surgery. these programs combine exercise training, with nutritional optimization and psychological support. together, these contribute to improve their muscle mass, tolerance to exercise, and nutritional status. the current study will assess whether an individualized and structured prehabilitation program combining supervised exercise training, nutritional optimization and psychological support will benefit patients with cirrhosis awaiting liver transplantation.

Eligibility criteria:
inclusion criteria: * age above 18 years * diagnosis of cirrhosis, based on a combination of clinical, laboratory, imaging, or histology * active on the liver transplant waiting list of the muhc exclusion criteria: * biological model for end stage liver disease \>20 * hepatic decompensation within the last month * high risk varices not on primary or secondary prevention * recurrent large volume paracentesis * persistent hepatic encephalopathy * platelets \<20,000/µl, or hemoglobin \<80g/l * altered hemodynamics * significant heart disease * awaiting combined organ transplantation * awaiting repeat liver transplantation * condition limiting mobilization and/or exercise, or recurrent falls

Keywords: prehabilitation nutrition quality of life exercise cirrhosis
vaginal prasterone in vaginal atrophy in breast cancer survivors

Conditions: Vulvar Atrophy; Breast Cancer; Genitourinary Syndrome of Menopause

Summary: vaginal prasterone in the treatment of vaginal atrophy in patients with breast cancer treatment with aromatase inhibitors (vibra study)

verify a clinical improvement of avv without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.

Eligibility criteria:
inclusion criteria: * breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (ia) (letrozole, anastrozole or exemestane) ± analogues of the gnrh (agnrh) * menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy * cytology and / or determination of human papillomavirus (hpv) negative * intention or willingness to have sex exclusion criteria: * to have received topical hormonal treatment in the last 6 months or have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment * to have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study * to have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of ii degree or greater

Keywords: breast cancer genitourinary syndrome of menopause
a phase iii efficacy study of the symptomatic treatment of seasonal allergic rhinitis with bilastine

Conditions: Seasonal Allergic Rhinitis

Summary: the objective of the study was to determine the efficacy and tolerability of 20 mg of bilastine, compared to desloratadine and placebo for the treatment of seasonal allergic rhinitis.

pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.the primary endpoint was the change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. a total of 720 patients with seasonal allergic rhinitis were enrolled. duration of treatment was 14 days, preceded by one week (7 days) of placebo.

Eligibility criteria:
inclusion criteria: * the study disease was diagnosed on the basis of clinical criteria: nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering. * patients with history of seasonal allergic rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination.. exclusion criteria: * patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed. * patients were not allowed to take forbidden medications or not comply the study requirements. * patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded. * pregnant or breast-feeding women were also excluded. * women of childbearing potential had a pregnancy test done

Keywords: rhinitis allergic seasonal hay fever pollen allergy pollinosis rhinoconjunctivitis sneezing nasal itching nasal congestion rhinorrhea ocular itching ocular redness tearing
directly observed therapy in high risk populations in newark, nj

Conditions: Directly Observed Therapy; HIV Infections

Summary: 30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at saint michael's medical center and be given directly observed therapy.

30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at saint michael's medical center. consent will be obtained, their regimens will be switched to qd based on previous therapies and resistance patterns if available. patients will be placed on direct observed therapy.each patient will be placed on fortovase/ritonavir (1600mg/100mg)qd plus two or three nrtis based on a phenotypic baseline testing to a protease inhibitor. patients will visit the office at baseline, weeks 1, 4, 8, 12, 16, 24, 32, 40, and 48. patients will also be visited daily by the social worker (or designee) to observe patients taking their antiretroviral therapy for 6 months. after six months of direct observed therapy patients will be given a diary card to record administration of medications and the social worker ( or designee) will visit the home twice weekly. if the patient experiences a change in therapy secondary to virologic failure, the patient will return to baseline visit for the new once a day regimen. virologic failure will be defined as \ 400 copies/ml at week 24 on two separate occasions at least 14 days apart

Eligibility criteria:
inclusion criteria: 1. men and women \> 18 years of age with a confirmed hiv-1 diagnosis 2. cd4 count \ 55000 and \>55,000 on one occasion in last 12 months 4. patients with poor compliance (poor compliance will de defined as taking less than 80 percent of prescribed medication 5. patients with mental illness, hiv dementia, substance abuse or social factor prohibiting compliance 6. willingness to sign informed consent or legal guardian - exclusion criteria: 1. alt/ast \> 5x uln 2. creatinine \>2.0 -

Keywords: invirase hiv dot treatment experienced
respiratory muscle performance and functional capacity in primary stage iiib and iv lung cancer

Conditions: Lung Cancer

Summary: the purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage iiib and iv lung cancer.

background and purpose: respiratory muscle function is important in sustaining the levels of physical activity required for daily life. the purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage iiib and iv lung cancer. methods: a total of 120 patients with newly diagnosed primary stage iiib and iv lung cancer will be recruited from the national taiwan university hospital. demographic and clinical signs/syndromes will be obtained from the chart. pain and dyspnea will be measured using visual analog scale. respiratory muscle strength will be tested by measuring maximal inspiratory and expiratory pressure (pimax and pemax, respectively). spirometric variables, forced expiratory volume in one second (fev1) and forced vital capacity (fvc) will be measured. functional capacity will be measured using karnofsky performance status and simmonds functional assessment. anxiety/depression symptom will be measured using hospital anxiety and depression scale. one year respiratory complication morbidity and 1-year mortality will be recorded in prospective nature. spearman's and pearson correlation coefficient will be used to test the relationship between respiratory muscle performance and multiple variables. univariate and stepwise multiple regression analyses will be used to identify factors associated with respiratory muscle performance, functional capacity, one-year respiratory morbidity and one-year mortality rate in patients with primary stage iiib and iv lung cancer. clinical relevance: the prevalence of lung cancer is increasing in the recent years. the attempt to understand the relations between respiratory muscle performance, functional capacity and associated clinical courses will shed light on whether chest physical therapy intervention will be beneficial for patients with primary iiib and iv lung cancer.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stage iiib/v lung cancer * normal cognition (a mini mental state examination score of more than/equal to 24 points) * able to finish all tests exclusion criteria: * a clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)

Keywords: lung cancer respiratory muscle strength dyspnea functional capacity