Kornimate/medical-research-clean huggingface dataset:
sacubitril/valsartan treated adult patients with chronic heart failure

Conditions: Chronic Heart Failure

Summary: this study evaluated changes in healthcare resource utilization (hcru) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and medicare advantage (ma) lives in the u.s among adult patients with heart failure with reduced ejection fraction (hfref) (cohort 1) and adult patients with chronic heart failure (chf) (cohort 2).

this was a non-interventional, retrospective cohort study using secondary data sources from the optum clinformatics® data mart (cdm) and 100% files of the cms medicare rifs. two study cohorts were constructed to include adult heart failure with reduced ejection fraction (hfref) patients who newly initiated sacubitril/valsartan (cohort 1) and adult chronic heart failure (chf) patients who newly initiated sacubitril/valsartan (cohort 2). the date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. a 12-month washout period was employed to ascertain the "new user" status. the healthcare resource utilization (hcru) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.

Eligibility criteria:
inclusion criteria: cohort 1 - adult hfref patients * newly initiated sacubitril/valsartan during the cohort identification period; * presence of an international classification of diseases, tenth revision (icd-10) diagnosis code for systolic hf (i50.1x, i50.2x, i50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period; * that are ≥ 18 years old at index date; * that are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation; * that are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed. cohort 2 - adult chf patients * newly initiated sacubitril/valsartan during the cohort identification period; * presence of icd-10 diagnosis code for systolic hf or diastolic hf (i50.1x, i50.2x, i50.3x, i50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period; * that are ≥ 18 years old at index date; * that are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation; * that are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed. exclusion criteria: - patients who died during the post-index period will be excluded.

Keywords: heart failure, medicare advantage, commercial, hfref, chronic heart failure
focal therapy using hifu for localised prostate cancer

Conditions: Prostate Cancer

Summary: to evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (hifu) (ablatherm ®). evaluate the impact of the hifu treatment on continence, sexuality and quality of life at one year. evaluate the cost of hemi-ablation hifu treatment. a prospective single -centre phase ii, single arm, cohort study (therapeutic confirmatory) offering focal therapy using hifu (ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (psa ≤10ng/ml, gleason score ≤ 7 ,t1c or t2b ). precise mapping and characterisation of the disease will be established using multi-parametric (mp)-mri and prostate biopsies. only the lobe with disease will be treated.


Eligibility criteria:
inclusion criteria: * age≥ 50 years * clinical stage t1c (normal digital rectal examination) or t2a (one palpable nodule on digital rectal examination) * psa ≤10 ng / ml * presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex). * gleason score ≤ 7 (3+4) * flowmetry \> 12 ml / sec for a voided volume of 125 ml * pvr \<100 ml * patient with normal anal and rectal anatomy. * patient with a condition corresponding to a classification of asa 1 or 2. * patient signing icf and agreed for following monitoring exclusion criteria: * patient with an asa score 3. * patient in clinical stage t1a, t1b, t2b, t2c or t3. * patient with a tumor visible on mri: located at a distance less than 5 mm from the midline. located less than 6 mm from the apex real * metastatic lymph node or metastasis discovered by mri and bone scan. * patient previously treated for his prostate cancer by hormone therapy. * patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick * history of inflammatory bowel disease * rectal fistula. * history of pelvic radiotherapy. * history of bladder cancer. * history of bladder neck sclerosis or urethral stenosis. * patient with an implant located less than 1 cm from the treatment zone (stent, catheter). * urogenital infection. * latex allergy * contraindication to mri (pacemaker,metal prosthesis ...) * patient participated in another clinical study within 30 days. * illiterate patients * legally incapable patients

Keywords: prostate cancer hifu hemi-ablation prostate biopsies
role of hydroxychloroquine to improve endothelial dysfunction in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) increase cardiovascular risk and endothelial dysfunction. hydroxychloroquine (hcq) is expected to improve endothelial dysfunction through some metabolic effects. the investigators intend to find the role of hcq to improve endothelial dysfunction in ra patients. this study will also evaluate correlation homa-ir (homeostasis model assessment-estimated insulin resistance), ffa (free fatty acid) and ox-ldl (oxidized-ldl) level change, with endothelial dysfunction improvement.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis patients (2010 acr/eular criteria) * being or will be treated with methotrexate (monotherapy) * agree to join the study exclusion criteria: * autoimmune diseases other than ra * acute severe infection, acute coronary syndrome, heart failure, stroke * malignancy or chronic inflammatory diseases * eye disease involving the retina and visual field defects * g6pd (glucose 6-phosphate dehydrogenase) deficiency * history of smoking within last 5 years * lipid lowering, insulin resistance lowering, antidiabetic, insulin, ace(angiotensin converting enzyme)-inhibitor or arb(angiotensin receptor blocker) drugs
postoperative complications after appendectomy

Conditions: Appendicitis

Summary: the frequency of complications after appendectomy is about 9% . the predictive value of crp as an indicator of postoperative complications has been addressed in a small number of studies. the aim of the present retrospective analysis was to determine whether postoperative crp levels are a reliable predictor of postoperative complications.

background: acute appendicitis is a common emergency in general surgery. the frequency of complications after appendectomy is about 9% \[9\]. the predictive value of crp as an indicator of postoperative complications has been addressed in a small number of studies. the aim of the present retrospective analysis was to determine whether postoperative crp levels are a reliable predictor of postoperative complications. methods: this retrospective single-center cohort study comprised 744 patients who had undergone open or laparoscopic appendectomy for clinically suspected appendicitis between 1 january 2011 and 31 december 2015 at the department of general and visceral surgery, kepler university hospital in linz, austria. demographic data, the surgical technique, postoperative complications, histopathological findings, postoperative white blood counts, and c-reactive protein levels were evaluated.

Eligibility criteria:
inclusion criteria: * clinically suspected appendicitis between 1 january 2011 and 31 december 2015 exclusion criteria: * an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy
effectiveness of nmes on neck pain

Conditions: Chronic Neck Pain

Summary: the aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (nmes) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. the participants were randomly assigned to one group which in only five clinical pilates exercises were performed (group i) or the other group which nmes was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (group ii).

the aim of randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (nmes) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. this study, including adults with chronic neck pain aged between 18-65 years, was conducted in laboratory of xxx university from march 2021 to may 2021. the participants were randomly assigned to one group which in only five clinical pilates exercises were performed (group i) or the other group which nmes was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (group ii). both groups received 20 minutes of treatment session two days a week for the 8 weeks. the pain intensity, range of motion (rom), static endurance of cervical deep flexor muscles, fear of movement, and neck disability were assessed with visual analogue (vas), universal goniometer, the deep neck flexor (dnf) endurance test, tampa scale of kinesiophobia (tsk) and neck disability index (ndi), respectively. all the assessments were performed twice as before and end of the treatment.

Eligibility criteria:
inclusion criteria: * (1) being aged from 18 to 65 years old, * (2) having neck pain shows mechanical nature longer than 3 months, and * (3) getting a score of at least 10 from neck disability index. exclusion criteria: * (1) having a surgery on neck and shoulder regions, * (2) having a neurological symptom, and * (3) did not complete the process of the assessment and intervention of this study.

Keywords: cervical spine exercise neck pain neuromuscular electrical stimulation
h.e.r.o.s. study: an observational study of the cardiac safety of herceptin (trastuzumab) in patients with her2-positive breast cancer

Conditions: Breast Cancer

Summary: this observational study will assess the safety of herceptin (trastuzumab) in patients with her2-positive breast cancer in routine clinical practice. eligible patients will be followed for up to 4 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically confirmed her2-positive breast cancer * eligible to receive herceptin as per summary of product characteristics exclusion criteria: * contra-indications according to summary of product characteristics
understanding components of mind-body exercise for physical activity engagement in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the aim of this study is to assess the feasibility and acceptability (e.g., enrollment, adherence, retention, acceptability of procedures and interventions) of a pilot factorial study design that will help elucidate components of mind-body exercise interventions. the study involves completing a walking program, a mindful attention program, a walking program that includes mindful attention, or no program at all. a "pilot" study is a smaller study that helps researchers to understand whether the study design can be carried out and what participants think about the study.


Eligibility criteria:
inclusion criteria: * metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 12 months at the time of medical record review: (a) bmi ≥ 25; (b) fasting glucose ≥ 100 \[5.6 mmol/l\] or a1c ≥ 5.7 or medications; (c) blood pressure ≥ 130 systolic or ≥ 85 diastolic or medications; (d) triglycerides ≥ 150 or 1.7 mmol/l or medications; (e) or hdl \< 40mg/ dl for men and 50mg/dl for women or medications; * insufficiently active, defined as a score ≤ 23 (moderate-to-strenuous units) on godin-shepard leisure-time physical activity questionnaire; * age 18-70 years; * given medical clearance for moderate-intensity exercise and exercise stress testing by their primary care physician (pcp); * access to a device with internet and videoconferencing capabilities exclusion criteria: * current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure) in which exercise would be contraindicated or that would preclude hrv analyses (e.g., some arrhythmias); (b) any diabetes; (c) chronic obstructive pulmonary disease or other severe lung dysfunction (e.g., severe asthma); (d) severe cognitive impairment * \>2 self-reported classes or self-guided mindfulness or mindful movement sessions per week in past 3 months * self-reported inability to speak and read in english * current beta blocker or calcium channel blocker medication * uncontrolled hypertension, defined as resting blood pressure ≥ 150 systolic or ≥ 90 diastolic in the last 6 months * self- or physician-reported contraindications for exercise (e.g., severe balance impairment, musculoskeletal restrictions)
brain connectivity in attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: this study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with attention deficit hyperactivity disorder (adhd).

there is a pressing need in psychiatry to offer more individualised treatments, and to improve outcomes from clinical trials. this 'individualised medicine' approach requires the development of biomarkers of treatment response. 60 adults with adhd are recruited from the adult adhd clinic at the maudsley hospital, london, united kingdom. the study is developed over three sessions, two at baseline (day 1 and day 2) and one after two months of treatment (follow-up). the first two sessions are conceived as a single-blind non-randomised placebo-controlled cross-over experiment. the first 30 participants enrolled in the study receive a placebo tablet (ascorbic acid 50 mgs) on day 1 before the behavioural assessment and magnetic resonance imaging (mri) scan. the behavioural assessment and the functional mri measurements are repeated two days after (day 2), under a clinically effective dose (20 mgs) of short-acting methylphenidate (mph). the order of the tablets is reverted for the remaining 30 participants to balance any potential expectation and practice effect between the two conditions. placebo and medication are over-encapsulated with the same red opaque capsules by the pharmacy team. also, the protocol followed during the two sessions is absolutely identical in respect of timing and tests administered in order to keep the participants blind to the drug condition (medication or placebo). after the scanning sessions, all the participants receive the same prescription of a long-acting formulation of mph, according to the clinical guidelines adopted by the maudsley hospital. treatment response is evaluated clinically and behaviourally after 2 months of treatment (follow-up). pre-treatment brain characteristics are tested as potential predictors (biomarkers) of treatment response.

Eligibility criteria:
inclusion criteria: * males * aged 18-45 years old * intelligent quotient (iq) \> 70 (as measured by wasi) * diagnosis of adhd confirmed through clinical assessment (adult adhd clinic) * non-medicated (stimulant medication-naive or not taking stimulant medication for at least 4 weeks) exclusion criteria: * no other brain disorders other than adhd * no condition precluding mri scanning (e.g., metallic implants, claustrophobia)

Keywords: longitudinal study magnetic resonance imaging (mri) brain connectivity biomarker treatment response methylphenidate stimulant medication
norwegian randomized trial on indocyanine green cholangiography utility for laparoscopic cholecystectomy, prestudy

Conditions: Gall Stone; Cholecystitis

Summary: the purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. the study is randomized.


Eligibility criteria:
inclusion criteria: * indication for laparoscopic cholecystectomy * signed informed consent exclusion criteria: * allergy to indocyanine green or iodine * pregnancy or breast feeding

Keywords: cholecystectomy flourescent cholangiography
extending contingency management's benefits with progressively increasing variable interval prize reinforcement

Conditions: Exercise; Addictive Behaviors

Summary: contingency management (cm) is highly effective in promoting recovery from substance use disorders, but benefits tend to attenuate over time when cm is discontinued. identifying modifications of cm delivery that can extend its benefits is an important goal. the goal of this study is to evaluate the use of reinforcements to increase physical activity, specifically walking. the study provides a standard cm intervention to promote walking for three weeks. after three weeks, a progressively increasing variable interval schedule of reinforcement will be evaluated for increasing the durability of effects of the initial cm intervention. we hypothesize that variable interval prize contingency management will result in greater adherence to a walking goal of 10,000 steps per day at week 15 and week 24 compared to the control condition.


Eligibility criteria:
inclusion criteria: * age \> 18 years * currently not physically active * physically able and willing to walk 10,000 steps per day exclusion criteria: * psychiatric or physical illness that could interfere with participation
detection and characterization of anti-sars-cov-2 salivary antibodies after covid-19 booster vaccines

Conditions: Anti-SARS-CoV-2 Antibody Response

Summary: the investigators aim to evaluate the ability of a covid-19 (coronavirus disease) booster vaccine to induce a salivary antibody response and investigate a possible correlation with the serum antibody response and the cellular response. the investigators will conduct a prospective single center cohort study including fully vaccinated probands.

the investigators will conduct a prospective single center cohort study including fully vaccinated probands.. the study will take place at the medical university of graz. blood and saliva samples will be obtained before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination. the total duration of the study is 15 months, starting in november 2021 with a recruiting period until june 2022 and termination of all scheduled visits until january 2023. in order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (biobank informed consent and study specific informed consent).scheduled vaccination for the booster vaccination with comirnaty or spikevax will allow recruitment. at visit 1, after informed consent, inclusion and exclusion criteria will be checked to include or exclude the subject in the trial. clinical history will be assessed and blood (32ml - serology, t cell immunity) and saliva (1.5ml) will be taken. at visit 2, 3-8 weeks after after 3rd vaccination, vaccination reactions and clinical history will be assessed. blood (32ml - serology, t cell immunity) and saliva (1.5ml) will be taken. at vist 3,6 month (±3 weeks) after 3rd vaccination, clinical history will be assessed. blood (8ml - serology) and saliva (1.5ml) will be taken. antibody tests and t cell assays will be performed according to protocol.

Eligibility criteria:
inclusion criteria: 1. healthy individuals who received full vaccination with any authorized covid-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines. - exclusion criteria: 1. presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination. 2. any contraindications to the vaccine planned to receive as listed in the product characteristics. 3. lack of willingness to undergo serial blood draws and attend follow-up appointments. 4. having already received a third (booster) vaccination with any covid-19 vaccine. 5. women who are pregnant or breastfeeding. 6. persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent) -

Keywords: vaccination
botulinum toxin a in the treatment of hemifacial spasm

Conditions: Hemifacial Spasm

Summary: hemifacial spasm patients who received botulinum toxin a injection were divided into two groups. group a received unilateral injection while group b received bilateral injection. patients completed follow-up a researcher record facial videos and analyzed facial symmetry and completed 3 scales.

hemifacial spasm patients who received botulinum toxin a injection were divided into two groups.patients of unilateral group were injected to the affected side and the dose of botulinum toxin a was 2.5-3.75 units/per site. patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site. 3 scales for measurement were used.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hemifacial spasm * scott grading iii to iv * hemifacial spasm duration of half or more years * last botulinum toxin a application at least 3 months before the start of the study exclusion criteria: * history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression * bilateral hemifacial spasm * allergies to botulinum toxin a or to any component of the drug * previous treatment with botulinum toxin a fewer than 3 months * the use of drugs that could interfere with neuromuscular transmission or spasm

Keywords: botulinum toxin a