Kornimate/medical-research-clean huggingface dataset:
breather (penta 16) short-cycle therapy (sct) (5 days on/2 days off) in young people with chronic hiv-infection

Conditions: HIV

Summary: the overall aim of the breather trial is to evaluate the role of short-cycle therapy (sct) in the management of hiv-infected young people who have responded well to antiretroviral therapy (art) and to determine whether young people with chronic hiv infection undergoing short-cycle therapy of five days on art and two days off maintain the same level of viral load suppression as those on continuous therapy, over 48 weeks. to assess the advantages and disadvantages of the strategy, the incidence of toxicities, immunological control, resistance mutations, acceptability, quality of life and adherence to the randomised strategy will also be compared. importantly, because of insufficient data on short-term viral load rebound after stopping art in this population, the trial will incorporate an initial pilot phase in selected centres, to assess the safety of the sct strategy by evaluating detailed hiv-1 rna profiles of participants on the sct strategy.


Eligibility criteria:
inclusion criteria: * hiv-1 infected young people aged 8 to 24 years inclusive (young people recruited between the ages of 16-21 must either be in regular physical contact with their clinician or be able to transfer to an adult physician at the same site for follow-up or to an affiliated adult site). * parents/carers and/or young people, where applicable, willing to provide informed consent. * on a stable first-line art treatment containing at least 2 nrtis/ntrtis and efv for at least 12 months and willing to continue the regimen throughout the study period. young people on regimens containing nevirapine (nvp) or a boosted protease inhibitor with undetectable viral load for over one year who wish to enrol should switch to efv. once they are stable on the efv containing regimen for more than 12 weeks they may be enrolled (must have 2 subsequent hiv-1 rna measurements \ 1000 c/ml) subsequent to virological control having been achieved on art. * viral suppression (hiv-1 rna \ 50 but \<1000 copies/ml (preceded and followed by vl\<50 c/ml) in the last 12 months can be enrolled. * cd4 cell count ≥350 106/l at screening visit. * centre must routinely use an assay which detects hiv rna-1 viral load ≥50 c/ml. exclusion criteria: * pregnancy or risk of pregnancy in females of child bearing potential. * acute illness (young people may be enrolled after illness). * receiving concomitant therapy for an acute illness (young people may be enrolled after finishing therapy). * a creatinine, ast or alt of grade 3 or above at screening. * on a regimen including nevirapine or a boosted pi (young people may switch to an efv based regimen). * previous art monotherapy (except for the prevention of mother-to-child transmission)

Keywords: short cycle therapy young people hiv
the effect of bilateral sphenopalatine ganglion block on postoperative pain in patients to be subject to septorhinoplasty surgery

Conditions: Anesthesia of Mucous Membrane

Summary: the aim of this study is to examine the effects of bilateral sphenopalatine ganglion block on surgical conditions, hemodynamics, intraoperative and postoperative analgesic use, recovery characteristics, and postoperative pain during septorhinoplasty under general anesthesia. the study was planned as double-blind, randomized, controlled. 72 patients who will undergo septorhinoplasty surgery will be collected. (g power analysis was performed.) evaluation of the effectiveness of bilateral sphenopalatine ganglion block was planned. patients will be divided into 2 equal groups (36 patients). after the induction of general anesthesia, one group (group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, the other group (group:2) will be administered 4 cc saline. aspects will be evaluated.


Eligibility criteria:
inclusion criteria: - patients with an asa score of i-ii and between the ages of 17-45 years, who were to undergo general anesthesia with desflurane, were included in the study. exclusion criteria: * patients aged \ 45 years, patients with liver and/or kidney failure, obese patients (bmi \>30), trauma patients, asa iii-iv patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.

Keywords: sphenopalatine ganglion block septhorhinoplasty general anesthesia
a 12-week treatment, multi-center, randomized, double-blind, parallel-group, placebo and active controlled study to assess the efficacy, safety, and tolerability of indacaterol maleate / glycopyrronium bromide in copd patients with moderate to severe airflow limitation

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.


Eligibility criteria:
inclusion criteria: * male and female patients that have signed informed consent and are \>/= 40 years of age. * patients with stable copd according to gold 2011. * patients with a post-bronchodilator fev1 of \>/= 30% and \< 80% predicted and a post-bronchodilator fev1/fvc \<0.70. * current or ex-smokers who have a smoking history of at least 10 pack years. * patients with an mmrc grade 2 or greater. exclusion criteria: * patients with type i or uncontrolled type ii diabetes - patients with a history of long qt syndrome or whose qtc measured at visit 101 (fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. (these patients should not be re-screened.) * patients who have a clinically significant ecg abnormality at visit 101 or visit 102. (these patients should not be re-screened.) * patients with a history of malignancy of any organ system, treated or untreated, within the last five years. * patients with narrow-angle glaucoma, bph or bladder-neck obstruction or moderate-severe renal impairment or urinary retention. * patients who had a copd exacerbation within 6 weeks prior to screening. * patients who have a respiratory tract infection within 4 weeks prior to screening. * patients requiring long term oxygen therapy prescribed for more than 12 hr per day. * patients with a history of asthma. 8. patients with an onset of respiratory symptoms, including copd diagnosis, prior to age 40 years. * patients with a blood eosinophil count of greater than 600 mm/3 during run-in. * patients with concomitant pulmonary disease. * patients with a diagnosis of alpha-1 anti-trypsin deficiency. * patients with active pulmonary tuberculosis. * patients in the active phase of a pulmonary rehabilitation programme. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd, qva149
impact of cancer on memory functioning: understanding disorders using approaches in neuropsychology and neuroimaging

Conditions: Breast Cancer; Healthy

Summary: the purpose of this study is to investigate memory problems in patients with cancer.


Eligibility criteria:
inclusion criteria for patients: * patients aged 45 and over * patients from grade 3 'end of primary schooling "minimum (scale barbizet) * non-metastatic breast cancer * adjuvant chemotherapy: fec, including docetaxel protocols * no major cognitive impairment * no previous neurological * lack of personality disorders and psychiatric disorders evolutionary * having signed the informed consent of study participation inclusion criteria for control group: * women from the general population aged 45 and over, and matched in age and cultural level in patients * topics of grade 3 'end of primary schooling "minimum (scale barbizet) * no prior cancer * no major cognitive impairment * no previous neurological * lack of personality disorders and psychiatric disorders evolutionary * participating in the imap protocol no. id-bcr: 2007-a00414-49 or imap+(n° id rcb 2011-a01493-38)(see how the study below) have signed forms no objection and consent to study participation exclusion criteria: traduction (français \> anglais) * metastatic * cancer of the breast other than primitive * patients with paraneoplastic syndrome * patients under 45 years * patients whose achievement is below level 3 'end of primary schooling "(scale barbizet) * patients with adjuvant chemotherapy is associated with targeted therapy * patients who have received other cancer treatments (chemotherapy or radiotherapy brain) * contraindication to the implementation of an mri (claustrophobia, metal objects in the body) * disorders of higher functions existing in the administration of chemotherapy * neurologic earlier * pathology psychiatric evolutionary * refusal of participation * patients unable to meet the cognitive tests * drug use * heavy drinking

Keywords: no metastatic breast cancer cognitive troubles adjuvant chemotherapy
family model dsme in fbos in the rmi

Conditions: Diabetes Mellitus, Type 2

Summary: health disparities in the republic of the marshall islands are striking, with extremely high rates of type 2 diabetes. documented prevalence of type 2 diabetes in the marshall islands ranges from 20%-50%.this is significantly higher than the global (8.5%) and united states (11%) prevalence. diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. diabetes self-management education and support is critical for persons with diabetes. this study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in marshallese by trained community health workers. the study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. the primary study outcome will be glycemic control as measured by hba1c. secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. the control arm of the study will have two pre-intervention data collections before beginning the intervention. data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.


Eligibility criteria:
inclusion criteria: * self-reported marshallese * 18 years of age or older * have type 2 diabetes (defined as having hba1c equal to or greater than 6.5%) * have at least one family member willing to take part in the study exclusion criteria: * has received diabetes self-management education in the past five years * has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder * plans to move out of the geographic region
beginning a randomized evaluation of the age breaker alagebrium in diastolic heart failure (break-dhf-i)

Conditions: Diastolic Heart Failure

Summary: this study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. the primary assessment for effectiveness is the assessment of exercise tolerance.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes or hypertension requiring therapy * ef \>/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of e/e'\>/= 12 determined by echo within 1 year * previous hospitalization for heart failure or previous bnp \>100 pg/ml. exclusion criteria: * clinically significant valvular disease * history of stroke/tia or reversible ischemic neurological defect w/i 6 mths * history of acute mi within 6 months * severe copd * active or treated malignancies (except basal cell carcinoma) * significant systemic illnesses that would prohibit completion of the study or compliance

Keywords: diastolic heart failure
short-term clinical outcome of cortical bone trajectory compared with the traditional "open" and minimal invasive posterior lumbar interbody fusion

Conditions: Degenerative Spondylolisthesis; Spondylolytic Spondylolisthesis

Summary: a combined prospective cohort study and retrospective analysis of previously collected data. three different techniques for posterior lumbar interbody fusion (plif) are compared: cbt-plif, mi-plif and open plif. a total of 180 patients are included, who will be followed up to 6 weeks postoperatively.

a combined prospective cohort study for cbt-plif and retrospective analysis of prospectively collected data from the misos study, regarding traditional open plif and mi-plif. a total of 180 patients will be included in the study: 60 prospective cbt-plif patients, 60 retrospective open plif patients and 60 retrospective mi-plif patients. the new data will be collected prospectively by means of questionnaires. no biomaterial will be collected. the included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. in addition, vas scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery. inclusion criteria: patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months. exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade iii or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the dutch language and morbid obesity (body mass index \>40). main research question: does the cbt-plif provide less low back pain in the short term than the traditional open plif and the mi-plif? primary outcome measure * low back pain measured with the visual analogue scale (vas) 2 weeks after surgery secondary outcomes * low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery * leg pain * oswestry disability index * quality of life (eq-5d-5l) * observed patient recovery * other parameters such as complications, surgical parameters (intraoperative blood loss, duration of surgery), length of stay in hospital and return to work

Eligibility criteria:
inclusion criteria: * 18-75 years * degenerative or spondylolytic spondylolisthesis * neurogenic claudication and/or radicular leg pain * low grade (meyerding grade l and ll) * persistent complaints for over 3 months exclusion criteria: * previous spine fusion surgery at the same level * osteoporosis * active infection or prior infection at the surgical site * active cancer * spondylolisthesis grade lll or greater * more than one symptomatic level that needs fusion * pregnancy * contraindication for surgery * severe mental or psychiatric disorder * substance abuse * inadequate knowledge of dutch language * morbid obesity (body mass index \>40)
impact of the comprehensive geriatric assessment on the quality of life of elderly patients

Conditions: Hematologic Malignancies; Solid Tumor; Elderly Patients

Summary: impact of the comprehensive geriatric assessment on the quality of life of elderly onco-hematologic patients' candidates for complex antitumoral therapies: clinical and biological correlatives

the screenings for the next 2 decades indicate an exponential increase in the incidence of neoplastic diseases in the elderly population. in order to successfully balance effectiveness and low toxicity of immunochemotherapy, a treatment personalisation based on an objective evaluation of fitness is therefore needed. the use of geriatric screening is a first step to rationalize decisions in this regard, the g8 tool has demonstrated the ability to identify patients and mostly to objectively separate elderly fragile patients from those who are fit. in that consideration, the individualization of the anticancer treatment based on a comprehensive geriatric assessment (cga) is desirable in elderly fragile patients with solid or haematological malignancy. cancer mortality is constantly increasing after 65 years and the consequent increase in life expectancy favour the processes of cellular senescence. in this context g8 fragility assessment will take place in the screening test and by using the eortc qlq-c30c questionnaire to assess quality of life (qol). the evaluation of senescent cells will be done by real-time pcr. our aims are i) to evaluate the impact of the cga on the qol of elderly onco-haematological patients, candidates for complex therapies, that resulted as fragile at the g8 geriatric screening and ii) to evaluate the senescent cells in the peripheral blood of the patients enrolled in the study. the study is expected to contribute to precision medicine management of elderly patients and refine the therapeutic stratifications.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 65 years * diagnosis of solid or hematologic cancer * patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy * patient with g8 scores ≤ 14/17 exclusion criteria: * patients aged less than 65 years * patients who have received or currently in treatment for solid or hematologic cancer * patient with g8 scores more than 14/17

Keywords: onco-hematologic diseases comprehensive geriatric assessment (cga) screening tool g8 geriatric medicine precision medicine senescence
a study of kk4277 in healthy volunteers and patients with systemic lupus erythematosus and cutaneous lupus erythematosus

Conditions: Healthy Volunteers; Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)

Summary: part 1 : to evaluate the safety and tolerability of a single intravenous (iv) or subcutaneous (sc) dose of kk4277 in healthy japanese or non-asian adult males. part 2 : to evaluate the safety and tolerability of repeated iv or sc administration of kk4277 in patients with systemic lupus erythematosus (sle) or cutaneous lupus erythematosus (cle).


Eligibility criteria:
inclusion criteria: part 1 * voluntary written informed consent to participate in the study * japanese or non-asian healthy men 18 to \< 50 years at the time of informed consent * bmi 18.5 to \< 30.0 at screening inclusion criteria: part 2 * voluntary written informed consent to participate in the study * age 18 years to \< 75 years at the time of informed consent * weight over 40 kg and bmi 18.5 to \< 35.0 at screening * patients who meet any of the following criteria 1. patients who meet the eular/acr 2019 sle classification criteria and have a diagnosis of sle by screening 2. patients with cle diagnosed by skin biopsy exclusion criteria: part 1 * current illness requiring treatment * history of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or cancer. * history or of current drug allergy exclusion criteria:part2 * complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (\>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria \>0.5 g/24 h, pyuria (\>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.) * patients with serious complications that are judged by the investigator or sub-investigator to affect the conduct and evaluation of the study. * patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent * patients with an infectious disease requiring hospitalization or iv administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent
incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain

Conditions: Geriatric Patients With Neck Pain

Summary: cross sectional study to detect the incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain. patients will fill out quality of life questionnaire and headache disability index. we will take information from the patients about: * the frequency of headache occurrence. * visual analogue scale of chronic neck pain. main measures: chronic neck pain will be assessed by visual analogue scale. patients will fill out quality of life questionnaire and headache disability index.


Eligibility criteria:
inclusion criteria: - geriatric patient with neck pain from 1moth ago exclusion criteria: * patient with the following conditions autoimmune disease neurological disease have previous cervical surgery
a study to evaluate the safety, pharmacokinetics, and activity of ro7759065 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors

Conditions: Solid Tumour

Summary: this is a first-in-human phase ia/ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of ro7759065 as a single agent (phase ia) or in combination with atezolizumab (phase ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. several key aspects of the study design and study population are summarized below.


Eligibility criteria:
inclusion criteria: * life expectancy at least 12 weeks * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic and end-organ function * measurable disease according to response evaluation criteria in solid tumors (recist) version 1.1 * histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * availability of representative tumor specimens required for patients in select cohorts. exclusion criteria: * women who are pregnant or breastfeeding * any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment * active hepatitis b or c or tuberculosis * positive test for human immunodeficiency virus (hiv) infection * acute or chronic active epstein-barr virus (ebv) infection at screening * administration of a live, attenuated vaccine (e.g., flumist) within 4 weeks before first ro7759065 infusion * primary, untreated, or active central nervous system (cns) metastases * active or history of autoimmune disease or immune deficiency * prior allogeneic stem cell or organ transplantation * any history of a grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent * any history of a grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.