Kornimate/medical-research-clean huggingface dataset:
direct portal pressure measurement via endoscopic ultrasound in advanced chronic liver disease (evadipp)

Conditions: Portal Hypertension

Summary: a minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (eus-ppg) has become available and initial data have proved the technique to be safe. aims of our proposal are: (i) to assess performance of eus-ppg as compared to hvpg in evaluating hemodynamic response to non selective betablockers (nsbbs) in a large cohort of patients with csph;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of ppg measurement.

specific aim 1 to explore the correlation between endoscopic ultrasound (eus)-guided portal pressure gradient (ppg) and hepatic venous pressure gradient (hvpg) in evaluation of hemodynamic response to non-selective beta blockers (nsbbs) in patients with advanced chronic liver disease and high risk varices. the investigators will perform eus-ppg measurement and hvpg measurement at baseline and after nsbbs titration in enrolled patients. hemodynamic response to medical therapy is defined as either a decrease in hvpg by \>20% of the baseline value or an absolute value of hvpg \< 12 mmhg after dose titration. correlation between ppg/hvpg values and development of portal hypertension-related gastrointestinal bleeding or liver- related events (ascites, spontaneous bacterial peritonitis, and hepatic encephalopathy) will be clinically assessed during follow-up with outpatients visits every 2-3 months. specific aim 2 identification of other markers of hemodynamic response to non selective beta blockers (nsbbs), with focus on elastography modifications and gut microbiota composition. to identify predictors of hemodynamic response, splenic and hepatic elastography measurement will performed at baseline and after nsbbs titration. in the same way the investigators will evaluate the gut microbiota before and after the start of therapy with nsbbs. specific aim 3 identification of factors potentially affecting the accuracy of ppg measurement. it is well-known that deep sedation may cause inaccurate hvpg values, while mild sedation with low dose midazolam does not modify the hvpg. in a subgroup of enrolled patients the investigators will perform ppg measurement with deep and mild sedation in order to investigate influence of deep sedation on ppg measurement accuracy.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed esophago-gastric varices or with high suspicion of csph at non-invasive tests (porto- systemic collaterals at imaging, platelet count \ 13 cm in the largest axis, alteration of elastography parameters of the liver or spleen) * naïve to treatment with nsbbs, exclusion criteria: * child pugh \>a6 * hepatocellular carcinoma * portal vein thrombosis
an integrated care model for chronic patients

Conditions: Integrated Care

Summary: integrated care models aim to promote the coordination and communication between services. the present study aim to evaluate the effectiveness of a new integrated care model (salut+social model) which will promote the coordination and communication between social and healthcare services in southern catalonia (spain) for the improvement of quality of life of chronic patients, adherence to treatment, access to medical services and caregiver overload. also, we will evaluate the experience of health and social professionals with the new model implemented.

a clinical trial with mixed methodology will be carried out. the intervention consists of the promotion and coordination between the social and health sectors, for 6 months, through the use of information and communication technology (ict) tools that operate as an interface for the integrated care model. the study subjects are chronic patients with health and social conditions that are susceptible to be treated in a collaborative and coordinated way in the field of primary health care. a sample size of 141 patients was estimated. questionnaires will be used at baseline and at 6, 9 and 12 months after the beginning of the study for the evaluation of quality of life, treatment adherence, medical service and caregiver overload. the principal variable is the quality of life. for statistical analysis, comparisons of means and proportions at different time points will be performed. one discussion group will be performed with the aim of improving the care model according to professionals' opinions. a thematic content analysis will be carried out.

Eligibility criteria:
inclusion criteria: * adult patients with at least one health and one social condition, as below specified: 1. health condition, according to diagnosis of the electronic medical history: complex chronic patient; advanced chronic disease; patient in the home care program; dementia; neurodegenerative diseases; stroke; others chronic disease. 2. social condition, according to social service workstation from ribera d'ebre district: dependence grade; home social service assistance; teleassistance systems assigned by home support. * knowledgement of spanish or catalan. * accepting participation in the study (with informed consent signed by the patient or by the caregiver). exclusion criteria: * institutionalized patients. * users with difficulties filling out or respond a questionnaire.

Keywords: integrated care health and social care chronic disease primary health care quality of life
hydrogen-oxygen mixed gas in the treatment of insomnia

Conditions: Insomnia

Summary: the purpose of this study is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas inhalation in the treatment of insomnia.

this ia a randomized, double-blind, crossover, placebo-controlled study. the purpose is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas(h2-o2) inhalation in the treatment of insomnia, and explore the possible mechanism by detecting the changes of serum inflammatory factors (crp, il-6, il-1β, tnf-α) levels, so as to seek an effective therapy for insomnia.

Eligibility criteria:
inclusion criteria: 1. diagnosed of insomnia according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5). 2. no use of sleep medications within the preceding 2 weeks, or a stable dose of only one sedative hypnotic medicine for at least 1 month before the enrollment and remain unchanged throughout the course of the study. 3. signed informed consent form (icf). exclusion criteria: 1. complicated with other sleep disorders (sleep apnea syndrome, narcolepsy, restless legs syndrome, nocturia, etc.); 2. complicated with serious heart, lung, liver or renal diseases or malignant tumor; 3. history of mental illness; 4. drugs or substances abuse; 5. pregnant women, breast-feeding women or those with recent birth plans; 6. participants in other clinical trials within 1 month before the study.

Keywords: insomnia hydrogen-oxygen mixed gas
digitally prompted parenting: a text message parent-based alcohol intervention for incoming college students

Conditions: Underage Drinking

Summary: this pilot randomized controlled trial (rct) will evaluate both the feasibility and efficacy of digitally prompted parenting (dpp), a text-message based parent intervention (tm-pbi) designed to prevent and reduce alcohol use among first-year college students. in this study, parents of incoming first-year students will receive risk-reducing text messages during the first 10 weeks of the fall semester, which they can forward to their students. the trial uses a longitudinal design to compare drinking outcomes between students whose parents receive the dpp messages and those whose parents receive an established alcohol pbi (the active control condition). the investigators hypothesize that students in the dpp group will report lower levels of alcohol use and fewer alcohol-related consequences after the intervention compared to those in the active control group.


Eligibility criteria:
inclusion criteria: * student is 17-20 years of age * student is an lmu incoming first-year college student * student has access to a cellular device capable of receiving text messages * student's parent or legal guardian has an email address on file at lmu * student's parent or legal guardian has a cellular device capable of receiving text messages * student's parent or legal guardian received an invitation from the research team to participate * student's parent or legal guardian signed up to access the assigned intervention * student's parent or legal guardian is a resident of the united states * informed consent (or assent, as applicable) is provided exclusion criteria: * student is not 17-20 years of age * student is not an lmu incoming first-year college student * student does not have access to a cellular device capable of receiving text messages * student's parent or legal guardian does not have an email address on file at lmu * student's parent or legal guardian does not have a cellular device capable of receiving text messages * student's parent or legal guardian did not receive an invitation from the research team to participate * student's parent or legal guardian did not sign up to access the assigned intervention * student's parent or legal guardian is not a resident of the united states * informed consent (or assent, as applicable) is not provided
a chronological study of the formation of hiv cellular reservoirs through the expression of surface markers on cd4 + t lymphocytes, including cd32a

Conditions: HIV Infections

Summary: to analyze the hiv viral sequences present in the cd32 + cd4a + t lymphocytes of the patients who have participated in the anrs 139 trio trial, always followed and in virological success, and carrying multi-resistant viruses archived in the hiv cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

objectives principal objective to analyze the hiv viral sequences present in the cd32 + cd4a + t lymphocytes of the patients who have participated in the anrs 139 trio trial, always followed and in virological success, and carrying multi-resistant viruses archived in the hiv cell reservoir, in order to reconstruct the chronology of the installation of this reservoir. secondary objectives to analyze the hiv viral sequences present in the cd4 + lymphocytes with other membrane hiv reservoir markers, currently being identified, in these same patients methodology pathophysiological study, in patients infected by multi drug-resistant viruses estimated enrollment 21 participants (total and per group) intervention 167ml blood sample in edta tube: * 160ml (16 tubes of 10ml): for igh (institute of human genetics-montpellier) * 7ml (1tube of 7ml): to measure hiv-rna in centers estimated planning or study / trial timetable study start date: september 2017 enrollment period: 12 months total study duration: 24 months (analyses included) estimated study/trial completion date: september 2019 (one year after enrollment of the last patient) study design cross-sectional survey, 167ml of blood in edta tube will be obtained on a research visit, after signature of written informed consent

Eligibility criteria:
inclusion criteria: * patients who participated to anrs139 trio trial, and still followed in centers * who remained in virological success since the participation at the trial: 90% of hiv-1 rna level less than 50 copies/ml : one or more blips less than 1000 copies/ml are tolerated * genotypic resistance profiles available at baseline and before trial * age ≥ 18 years * affiliate or beneficiary of a social security system (the state medical aid or ame is not a social security system). * written informed consent signed by the person and the investigator before any exam performed in the study. exclusion criteria: * hiv-1 rna level ≥ 1000 copies/ml at least once since the end of the 139 trio trial * patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit. * person under legal guardianship or deprived of liberty by a judicial or administrative decision.

Keywords: hiv cell reservoir
coronally advanced flap with alloderm versus coronally advanced flap with micro-needling on rt1 gingival recession

Conditions: Gingival Recession; Recession, Gingival; Thin-gingiva

Summary: this study aims to assess the effect of micro-needling together with coronally advanced flap procedure on the gain of gingival thickness (gt) and keratinized tissue width (ktw) and compare it to alloderm with coronally advanced flap procedure in the management of thin periodontal phenotype associated with recession type 1 (rt1)

gingival or periodontal diseases were found to occur more likely in patients with a thin gingival biotype. the periodontal phenotype was also found to show stronger correlation with gingival thickness rather than keratinized tissue width and papilla height. moreover, the thin gingiva was usually found to be associated with thin bony plate with potential for dehiscence and fenestration and hence was thought to be at risk for recession after trauma. several techniques have been recommended for the treatment of gingival recession. one of the most predictable outcome is associated with the use of a coronally advanced flap and acellular dermal matrix graft. treatment of thin periodontal phenotype through the conjunction of i-prf and micro-needling may be a first move of the non-surgical approach for improving the gingival thickness. micro-needling was proved to be generally an effective and safe therapeutic option for numerous dermatologic conditions as clinical improvement of scars, striae, and rhytids with appropriate recovery and limited side effects. the controlled dermal wounding and stimulation of the wound healing cascade through micro-needling was found to enhance collagen production and thus was responsible for the clinical results obtained. therefore, this study will be aiming to compare the effect of micro-needling on the gingival thickness in root coverage procedures. it will also provide an insight of its effect on the patient related factors and the root coverage parameters.

Eligibility criteria:
inclusion criteria: * patient consulting in the outpatient clinic. * able to tolerate the study procedures. * patient ready to perform oral hygiene instructions. * compliance with the maintenance program. * provide informed consent. * accepts the 6 months follow-up period * mature permanent tooth. * full-mouth plaque index (pi) and full-mouth bleeding on probing (bop) score of ≤ 15%. * presence of identifiable cemento-enamel junction. * rt1 facial recession defect of ≥3 mm. * clinical indication and/or patient request for recession coverage exclusion criteria: * medically compromised patients. * use of any drugs that might lead to gingival enlargement * pregnant or nursing women. * uncooperative patients. * smokers. * teeth with malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth. * cairo recession type 3 (rt3) recession defects. * teeth with active orthodontic treatment. * previous periodontal surgery.

Keywords: rt1 recession micro-needling micro-needles coronally advanced flap alloderm
efficacy of local anesthetic and ozone injection in patients with myofascial pain syndrome

Conditions: Myofascial Pain Syndrome; Ozone

Summary: in this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome.

the investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (mas) (according to travell-simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic. age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. patients will be randomly divided into three groups. a total of 3 consecutive weeks of treatment were planned.

Eligibility criteria:
inclusion criteria: * with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of mps exclusion criteria: * presence of any cervical radiculopathy or a history of degenerative conditions * presence of any cervical surgery or trauma in the past year, * history of injection for the treatment of mas in the last 6 months, * cognitive disorder, * rheumatological disease, fibromyalgia, * history of metabolic diseases such as hypothyroidism and diabetes mellitus

Keywords: ozone pain
perfusion ct in the foxfire trial to study blood flow to liver metastases

Conditions: Metastatic Colorectal Cancer

Summary: the perform study is a pilot study investigating the feasibility and usefulness of performing a novel ct (computed tomography)scanning technique called perfusion ct(ctp) as an addition to normal ct scanning in patients recruited to the foxfire trial. all patients recruited to foxfire at the oxford radcliffe hospitals and university hospitals of leicester will be invited to take part. foxfire is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(sir-spheres) to the liver via its own blood supply (radioembolisation). in the foxfire study a normal ct scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. perfusion ct gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal ct scans. all patients consenting to participate in the perform study will undergo four perfusion ct scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. the aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion ct and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. this research is funded by the national institute for health research biomedical research centre in oxford and oxfordshire health services research committee.


Eligibility criteria:
inclusion criteria: * patients who have given written informed consent to participate in the foxfire clinical trial and have not yet started chemotherapy treatment in the trial. * serum creatinine and calculated glomerular filtration rate are less than the upper limit of normal (uln) in blood tests performed up to 29 days before entry into the foxfire clinical trial. * liver metastasis 1.0 to4.0 cm in cranio-caudal diameter on imaging performed up to 29 days before entry into the foxfire clinical trial exclusion criteria: * true allergy to intravenous iodinated ct contrast * active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this pilot study, at the discretion of the investigator

Keywords: imaging study perfusion computerised tomography
osteopathic treatment in patients with low back pain: stabilometry

Conditions: Lower Back Pain

Summary: determine the improvement in nonspecific low back pain patients with osteopathic techniques (body adjustment protocol) and know changes in stabilometric measures analyzed with a stabilometric platform (footscan®).

fifty patients participate in this study (25 experimental group with body adjustment protocol of osteopathy and 25 control group). for a first objective of this study, all the patients determine if the osteopathic approach to the body adjustment approach will improve low back pain (oswestry questionnaire). for the second aim, the investigators want to know if there are changes in the distribution of body weight in lower limbs in group experimental and control group, analyzed with a stabilometric platform (footscan®). the experimental group is treated with osteopathy, three sessions (20 minutes/session) and a frequency one session/week. the treatment osteopathic is the body adjustment protocol. in the other hand, the control group made 2 stretching global postures once a week (10 minutes for each posture) for three weeks: the first was for the anterior muscular chain and the second posture to stretch the posterior muscle chain. before treatment, immediately after the last session and a month later, are measured stabilometric parameters, height and oswestry. the analysis will be made with statistical package for the social sciences (spss statistics) 22.0

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years. * patients with non-specific low back pain. * patients with alteration in the distribution of loads in a podiatric platform. exclusion criteria: * specific low back pain diagnosed. * pregnancy. * recent surgery in the last year. * acute musculoskeletal disorders out of the lumbar region. * patients with vestibular and instability problems. * meniere syndrome. * oncologic patients. * patients with manual therapy treatment during the study.

Keywords: non specific low back pain osteopathy foot pressure platform postural balance
cap7.1 for the treatment of advanced stage, therapy refractory lung and biliary tract tumors

Conditions: Advanced Endstage Solid Carcinomas in Adults

Summary: to assess the anti-tumor activity of cap7.1 based on the observed objective response rate and rate of disease stabilization, as defined by the below primary and secondary endpoints, in patients with non-small cell lung carcinoma (nsclc), sclc or biliary cancer who have progressed despite one or more previous chemotherapy line.

a phase ii evaluation will be performed in adult patients in parallel studies in 3 tumor types: nsclc, sclc and biliary tract cancer. all patients will have advanced or metastatic disease with primary or secondary resistance to standard therapy. in each tumor type the patients will be randomized to receive either therapy with cap7.1 or best supportive care according to institution standards. patient in the control group who progress may cross over to cap7.1, however these patients will be analyzed separately from the patients randomized to cap7.1.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically-confirmed, advanced disease with documented progression (recist1.1.) after one or several chemotherapy line * patients may also have received molecular targeted therapy and progressed while on therapy or after completion * must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy exclusion criteria: * serious concurrent medical condition, which could affect compliance with the protocol or interpretation of results. * patients with uncontrolled infection and patients known to be infected with the human immunodeficiency virus (hiv) or hepatitis infection are not eligible for the study * pregnancy or breast-feeding

Keywords: therapy refractory endstage solid tumours