Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of olmesartan associated with chlorthalidone versus benicar hct® in essential hypertension control

Conditions: Arterial Hypertension

Summary: the purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility criteria:
inclusion criteria: * signed consent of the patient; * participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the brazilian society of cardiology (2010), who are being treated with monotherapy. exclusion criteria: * patients with any clinically significant disease that in the investigator opinion can not participate in the study; * secondary hypertension diagnosis or blood pressure above 190x100 mmhg in the screening/randomization visit; * morbid obesity or immunocompromised patients; * participants with greater than 10 mmhg difference in the measurements of systolic or diastolic blood pressure between the two arms; * participants who do not have the two upper limbs; * participants with important electrocardiographic changes; * creatinine clearance - less than 60 ml / min; * history of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months; * microalbuminuria urine sample greater than 30 mg/g; * patients with history of hypersensitivity to any of the formula compounds; * pregnancy or risk of pregnancy and lactation patients; * participation in clinical trial in the year prior to this study;
study of cingal for the relief of knee osteoarthritis compared to triamcinolone hexacetonide at 39 weeks follow up

Conditions: Knee Osteoarthritis

Summary: extension study to cingal 16-02 to obtain 39-week safety and efficacy follow-up data

extension study to cingal 16-02: trial extension to 39 week follow up in the randomized, double-blind, active comparator controlled, multi-center study of a single injection cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (cingal) to provide symptomatic relief of osteoarthritis of the knee

Eligibility criteria:
inclusion criteria: 1. only subjects that were enrolled and met the inclusion criteria for the cingal 16-02 trial and signed the informed consent are eligible for cingal 17-02 trial. 2. subject is able to understand and comply with the requirements of cingal 17-02 and voluntarily provides consent. exclusion criteria: patients will not be rescreened at enrollment to cingal 17-02 as these patients met the inclusion / exclusion criteria for the cingal 16-02 clinical trial.

Keywords: osteoarthritis intra-articular injection hyaluronic acid triamcinolone hexacetonide
effect of mulligan mobilization with or without niel asher technique in patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: adhesive capsulitis is a prevalent condition characterized by pain and stiffness in shoulder joint and surrounding muscles shows decrease range and strength in patients with adhesive capsulitis. this study aims to determine the effect of mulligan mobilization with or without niel asher technique on pain, range of motion and disability in patients with adhesive capsulitis. this study will be a randomized controlled trial and will be conducted in ibne-siena hospital multan and multicare physiotherapy clinic. non-probability convenience sampling will be used to collect the data. sample size of subjects with age group between 40 to 60 years will be taken. data will be collected from the patients having present complaint of adhesive capsulitis. outcome measures used will be numeric pain rating scale (nprs) for shoulder pain and spadi for shoulder disability and universal goniometer (gu) for range of motion. an informed consent will be taken. subjects will be selected on the basis of inclusion and exclusion criteria. subjects will be divided into two groups by random number generator table. both the groups will receive heating pad, tens. group a will receive mulligan mobilizations and neil asher technique, and group b will receive mulligan mobilization and conventional treatment. outcome measures will be measured at baseline and after 4 weeks. data analysis will be done by spss version 26.


Eligibility criteria:
inclusion criteria: * age group 40-60 year * both gender male and female * stage 2 primary adhesive capsulitis with capsular pattern of restriction (rotation\>abduction\>flexion) * pain in shoulder should be ≤7 on nprs * patient is willing to perform. exclusion criteria: * • diabetes * malignancy * infection * arthoplasty * pregnancy * neurological disorders * fracture * thyroid diseases

Keywords: adhesive capsulitis frozen shoulder mannual therapy
immune monitoring of prevalent kidney transplant recipients using torque teno virus: a single-center, prospective cohort study

Conditions: Kidney Transplant Infection; Kidney Transplant Rejection; Kidney Transplant; Complications

Summary: kidney transplant recipients (ktrs) suffer from immunosuppression-related adverse events (iraes), such as infections and malignancy from chronic immunosuppression exposure but are also at risk of graft loss from rejection with under-immunosuppression. biomarkers that predict both iraes and rejection and allow individualisation of immunosuppression exposure are lacking. while plasma viral dna levels of torque teno virus (ttv), a widely prevalent, non-pathogenic virus, have been shown to predict both irae and rejection in incident ktrs within 1 year after transplant, its role for prevalent ktrs on stable immunosuppression is unclear. the investigators hypothesise that plasma ttv levels can predict iraes and rejection in ktrs on stable immunosuppression and propose a pilot study to pursue three specific aims: (1) to determine the ttv levels and its relationship with clinical factors affecting the 'net state of immunosuppression' in prevalent ktrs. (2) to analyse the prognostic value of ttv levels for iraes and rejection in prevalent ktrs. (3) to compare the prognostic performance of ttv levels to commonly available biomarkers and composite prognostic scores. the investigators seek pursue these aims by performing a single-centre, prospective, observational cohort study of 172 ktrs on stable immunosuppression for more than 3 months. ttv levels will be measured, using the ttv r-gene® kit, upon recruitment and when kidney allograft biopsies are performed. subjects will be monitored for iraes and rejection for at least 12 months. the study will provide data on the distribution of ttv levels in a prevalent cohort of ktrs and analyse its relationship with clinical factors and important clinical outcomes. if the study indicates that ttv may be predictive of iraes and rejection, the investigators aim to conduct further studies including interventional studies using ttv levels to guide immunosuppression. ultimately, the investigators aim to use ttv as a biomarker to optimise long-term immunosuppression exposure, reduce the risk of iraes without increase in rejection, and improve long-term outcomes for ktrs.


Eligibility criteria:
inclusion criteria: * kidney transplant recipients on follow up at singapore general hospital (sgh) * more than 21 years old * on stable doses of immunosuppression for more than 3 months exclusion criteria: * titration of immunosuppression (e.g. for rejection or infection) less than 3 months ago * active infection requiring treatment * less than 21 years old * unable to provide informed consent
biology and treatment strategy of aml in its subgroups: multicenter randomized trial by the german acute myeloid leukemia cooperative group (amlcg)

Conditions: Acute Myeloid Leukemia

Summary: the study in patients with primary and secondary aml and high-risk mds uses a risk-stratified, randomized design to evaluate the role of high-dose arac in induction, of g-csf priming, and of autologous stem cell transplantation.

the present study by the german aml cooperative group has been designed in order to investigate the effects of aml typical therapeutic strategies for aml and related diseases. thus, the entry criteria are age starting from 16 years with no upper age limit, de novo aml or aml secondary to chemotherapy or radiotherapy of another disease or myelodysplasia subtype raeb with bone marrow blasts greater than 10 %. all randomization is stratified according to karyotype favorable / intermediate / unfavorable. additional stratification is according to ldh \ = 700 u and age \ = 60 y. standard treatment is (a) double induction with tad and ham, consolidation with tad and maintenance treatment with monthly ad-at-ac-at -, rotatingly. experimental modifications to be compared with stan-dard treatment are (b) double induction with ham-ham, (c) multiple course g-csf before and during chemotherapy courses and (d) instead of maintenance treatment myeloablative consolidation with bu/cy and autologous blood stem cell transplantation. intent to treat conditions are guaranteed by randomization before induction treatment starts. in order to evaluate the effect of every single modification randomization to (c) is equally distributed to the patients in treatment arms (a) and (b) which is also true for the randomization to (d) (balanced randomization). similarly balanced between treatment arms are the patients according to diagnosis, age and risk factors like serum ldh and karyotype. in order to adapt treatment intensity to age patients of 60 years and older receive the second induction course only in case of 5 % or more residual bone marrow blasts. in addition, the arac dose in ham is reduced to 1 instead of 3 g/sqm in this age group. furthermore, there is no treatment arm including stem cell transplantation in patients of 60+ years. pri-mary endpoint to compare the therapeutic strategies is event-free survival from treatment start (a, b, c) and from achievement of remission (d), respectively. by this design the amlcg 2000 trial can contribute relevant experiences on optimum therapeutic strategies for the biological subgroups of de novo aml, secondary aml and mds. furthermore, new biological subgroups and their significance related to treatment strategies can be defined.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia (de-novo aml, secondary aml, high-risk mds) * age 16 - no upper age limit * written informed consent exclusion criteria: * severe comorbidity * presence of other malignancy * prior anti-leukemic treatment * pregnancy * severe psychiatric disorder or other circumstances which may compromise cooperation of the patients

Keywords: aml treatment, de-novo, secondary, high-risk mds, chemotherapy, autologous sct, adult
prospective study for endometrial carcinoma and hyperplasia in childbearing-age women

Conditions: Endometrial Cancer Stage I; Endometrial Hyperplasia

Summary: the goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions：when taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? what medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of pole-mutated, mismatch repair-deficient(mmrd), p53 wild type(p53wt), and p53-abnormal(p53abn). participants will: take drug membrane-inhibiting formula plus oral progestins every day visit the clinic once every 3 months for checkups, tests, and hysteroscopy keep a diary of examination results and pathology


Eligibility criteria:
inclusion criteria: * 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (mri) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and ct scan of the lungs exclusion criteria: * 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.any disease or symptom that may affect the implementation of the study or the interpretation of the results
virtual reality distraction during dental local anesthesia among children

Conditions: Dental Anxiety; Dental Fear

Summary: to evaluate the effect of virtual reality (vr) distraction on anxiety and pain during buccal infiltration anesthesia (bia) in pediatric patients.

design and participants: this randomized clinical trial was conducted including healthy, and cooperative 6-12-year-old children, with no known allergy and/or sensitivity to local anesthesia who are currently in need of nonemergency dental treatment under local anesthetic infiltration by one of the postgraduate or interns at the pediatric dentistry students, were eligible for the study. patients with history of epilepsy and anxiety disorder were excluded from the study methods and material: in the test group, subjects received bia while being distracted using vr goggles; in the control group, subjects watched a cartoon video on a regular screen. subjects' heart rate (hr) was measured at baseline and at four different timepoints during bia administration to assess anxiety. the face, legs, activity, cry, consolability (flacc) behavioral pain assessment scale was scored by two calibrated investigators to assess pain. after bia, subjects rated their pain using the arabic version of wong-baker faces pain rating scale.

Eligibility criteria:
inclusion criteria: * healthy * 6-12-year-old children * cooperative during dental treatments * in need of nonemergency dental treatment under local anesthetic infiltration exclusion criteria: * allergy and/or sensitivity to local anesthesia * epilepsy * anxiety disorder

Keywords: dental anxiety dental fear infiltration dental local anesthesia virtual reality dental pain
woodsmoke exposure, influenza infection, and nasal immunity

Conditions: Smoke Exposure; Influenza

Summary: this study will investigate the effects of woodsmoke (ws) exposure on human nasal mucosal immune responses to viral infection. the study tests the hypotheses that ws exposure modifies biomarkers of nasal mucosal immune function, increases in live attenuated influenza virus (laiv) -induced nasal symptoms, and reduces mucosal antibody production.

this study will investigate the effects of woodsmoke (ws) exposure on human nasal mucosal immune responses to viral infection. the study tests the hypotheses that ws exposure modifies biomarkers of nasal mucosal immune function, increases laiv-induced nasal symptoms, and reduces mucosal antibody production. healthy volunteers will be randomized for a 2-hr exposure to ws or placebo (filtered air) and then inoculated with either live attenuated influenza virus (laiv) or placebo. nasal mucosal samples, symptoms, and peripheral blood will be collected on days 1,2,3,7, and 21 post-exposure/laiv and assessed for a) mucosal antiviral responses using targeted and non-targeted analysis of the secretome and tissue-level gene expression; b) symptoms, virus quantity, differential cell count, and virus-specific antibody levels; and c) biomarker signatures associated with infection outcomes using computational modeling tools.

Eligibility criteria:
inclusion criteria: * normal lung function, * oxygen saturation of \>94%, * normal blood pressure, * no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing, * 18-49 years of age. exclusion criteria: * a history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension) * positive pregnancy test within 48 hours of the time of challenge * use of any inhaled substance (for medical or recreational purposes). * nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year. * history of allergy to eggs * acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks * unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental laiv infection, will be a basis for exclusion. * expected exposure of subject to immunocompromised individuals (who can be infected by laiv) for the 3 weeks following laiv inoculation. * use of immunosuppressive drugs within the past 6 months. * previous woodsmoke exposure \<3 weeks, which is considered to an appropriate washout period

Keywords: laiv flumist influenza wood smoke smoke fire
treatment of von hippel-lindau (vhl)-related hemangioblastoma with ptk787/zk 222584

Conditions: Von Hippel-Lindau Disease; CNS Hemangioblastoma; Retinal Hemangioblastoma

Summary: the purpose of this study is to determine whether ptk787/zk 222584 is effective in treating hemangioblastoma of the brain and/or retina in patients with von hippel-lindau disease. the study will also assess safety and tolerability of ptk787/zk 222584, and changes in markers of angiogenesis (new blood vessel growth).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of vhl disease * one or more measurable cns hemangioblastoma, if symptomatic, must be refractory or not amenable to standard therapy, if asymptomatic, must have had at least one prior neurosurgical treatment/ procedure; and/or: at least one untreatable or treatment-refractory retinal hemangioblastoma that is causing impaired visual function * karnofsky performance status \>=60 * life expectancy \> 3 months * able to sign informed consent * adequate hematologic status, liver and kidney function exclusion criteria: * patients with other vhl-related tumors requiring or amenable to standard treatment * severe or uncontrolled concurrent illnesses that could compromise participation in the study * total urinary protein in 24 hour collection \> 500 mg * pregnant or breast feeding females, adults of reproductive potential not using effective contraception (hormonal methods not considered effective due to possible decreased effectiveness secondary to drug interaction with ptk787). women of childbearing potential must have negative serum pregnancy test prior to initiation of treatment. * acute or chronic liver disease * diagnosis of hiv infection * gi function that may alter absorption of ptk787 * patients taking coumadin (warfarin sodium) * prior therapies (investigational drugs, chemotherapy) within 4 weeks prior to study entry * prior therapies (biologic, hormonal, immunotherapy, radiation therapy, surgery) within two weeks prior to study entry. * patients unwilling or unable to comply with protocol requirements * patients with concurrent, non vhl-related malignancies other than non-melanoma skin cancer * patients with contraindication to mri imaging

Keywords: von hippel-lindau disease, cns, hemangioblastoma, retinal
study of the benefit of exercise and aminoacid supplements in cirrhotic patients

Conditions: Cirrhosis

Summary: this is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. the hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. safety of physical exercise in cirrhotic patients will be strictly assessed.


Eligibility criteria:
inclusion criteria: * compensated liver cirrhosis. exclusion criteria: * hepatocellular carcinoma, * active alcoholism (less than 1 year), * decompensated cirrhosis, * variceal bleeding less than 3 months, * contraindication for exercise.

Keywords: cirrhosis exercise leucin glutamine synthetase
charm-copd program of care

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the investigators' goal for this project is to evaluate the feasibility, acceptability, and actual usage of a program of care for patients with copd recently discharged after an acute exacerbation. the program of care includes virtual pulmonary rehabilitation, integrated care, and remote clinical monitoring.

the investigators' goal for this project is to evaluate the feasibility, acceptability, and actual usage of a multimodal, individualized program of care for patients with copd recently discharged from hospital with an acute exacerbation. the program will combine elements of existing standards of care at two institutions, toronto grace health centre and university health network, with emerging technologies. the investigators want to determine whether the program is considered appropriate and useful to both patients and health care providers, and whether it is feasible to implement. the investigators also want to determine whether it is feasible to conduct a large-scale randomized control trial of the program. the investigators will also explore whether each intervention reduces re-admissions to hospital.

Eligibility criteria:
inclusion criteria: * referred to either virtual pulmonary rehabilitation or remote clinical monitoring at toronto grace health centre after discharge from uhn hospital with an aecopd as defined by the clinical team exclusion criteria: * pulmonary condition other than copd as the main respiratory disease such as bronchiectasis or asthma * projected life expectancy ≤ 2 months , as determined by the clinical team * significant cognitive impairment and absence/inability of a family caregiver to consent and to follow study processes

Keywords: remote clinical monitoring copd wearables digital health self-management
effect of dry needling on muscle mechanical properties and muscle contractility in latent trigger points

Conditions: Trigger Point Pain, Myofascial

Summary: the purpose of this study is to determine whether application of dry needling (dn) is effective for improved muscle mechanical properties and muscle contractility in latent trigger points point (ltrp) of upper trapezius. randomized controlled trial, in parallel with cross-control design. two groups with ltrp in upper trapezius, and will be randomly selected to dn group or sham-dn group.


Eligibility criteria:
inclusion criteria: * age between 18 and 30 years * the presence of ltrp in the middle third of the upper trapezius muscle on the dominant side * being able to provide written informed consent * being able to follow instructions and realize clinical tests exclusion criteria: * any pharmacological therapeutic * any medical treatment or physical therapies at cervical region during the 6-month before this study - any diagnosed health problem * any history of head and upper extremity surgery or trauma * any red flags to dn, (ie: metabolic diseases, pregnancy, kinesiophobia, infection, cancer) * absence of recurrent history of neck pain * no neck pain symptomatology the previous 6 months * cervical disk herniation

Keywords: latent trigger point dry needling myotonometer tensiomyography