Kornimate/medical-research-clean huggingface dataset:
oxford/astrazeneca covid-19 vaccine effectiveness in england

Conditions: Covid-19 Infection

Summary: this is a retrospective cohort study to assess the real world effectiveness of the oxford/astrazeneca covid-19 vaccine in england. the study is using linkage of the english national databases on covid-19 vaccination, testing, medical records, hospitalization, and death.

the united kingdom (uk) is one of the first countries that introduced a mass vaccination campaign for covid-19 and vaccination of the adult population first focused on the oldest age groups, their carers and health care workers (jcvi, 2020). three covid-19 vaccines were licensed and are being used including the moderna, the biontech/pfizer, and the oxford/astrazeneca vaccines. vaccination with the biontech/pfizer vaccine started in december 2020 and the oxford/astrazeneca vaccine started in early january 2021. this study is to primarily assess the effectiveness of the oxford/astrazeneca covid-19 vaccine. given the known high efficacy of the mrna vaccines in randomized controlled trials (rcts) and real-world evidence studies, the study aims also to evaluate the vaccine effectiveness (ve) of other covid-19 vaccines as a validation of the study's methods. on 16 september 2021 it was announced that booster doses would be introduced in the uk to address vaccine waning and for groups with a suboptimal response. little is known about health care resource utilisation (hcru) and health care costs for those who have had covid-19 or by individual clinical risk group. the raven study is a retrospective cohort study to assess the real-world effectiveness of the oxford/astrazeneca covid-19 vaccine in england. the study is using linkage of the english national databases on covid-19 vaccination, testing, medical records, hospitalization, and death. analyses will examine the effectiveness of one and two doses, and booster or other additional doses if applicable. this study's extension (october 2021) adds a more detailed exploration of ve in risk groups and an evaluation of the hcru by people with covid-19 compared with those who are vaccinated.

Eligibility criteria:
inclusion criteria: * eligible for any covid-19 vaccination based on age at index date * have continuous data coverage for the covid-19 infection datasets * have continuous data coverage in other linked databases for a minimum of 12 months prior to the index date exclusion criteria: • people with a history of covid-19 infection (confirmed by reverse transcriptase polymerase chain reaction (rt-pcr) or not) prior index date
evaluation of stroke patient screening

Conditions: Stroke, Acute

Summary: background and rationale: traditionally, stroke rehabilitation studies have been performed in stroke patients beyond the first one to three months poststroke \[stinear et al. 2013; veerbeek et al. 2014\]. acknowledging that early stroke rehabilitation should be initiated soon after stroke onset to optimize stroke outcomes, it is has been stressed that stroke rehabilitation trials should be initiated within the first month \[stinear 2013\]. early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low enrollment rates \[avert 2015; winters 2015\]. explanations are for example priority given to (sub)acute medical interventions, highly dynamic situation at a stroke unit, and a more rapid change in patients' abilities when compared to patients in later stages poststroke. with the low enrollment rates (\~7%), the generalizability of study results is questionable. participant screening methods and procedures for research eligibility are part of the patient selection and recruitment process in clinical trials. however, no information is available regarding screening procedures and methods for these early initiated stroke rehabilitation trials, including reasons for not enrolling patients. this knowledge is essential to improve screening procedures and methods, in order to optimize patient enrollment and with that, increase the generalizability of study results. objective: the objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research. study design: observational study

objective: the objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research in the department of neurology, university hospital zurich. outcome: enrollment rates (defined as the number of patients enrolled per month of recruitment), reasons for non-enrollment, and estimated costs for screening for early stroke rehabilitation studies. study design: observational study

Eligibility criteria:
inclusion criteria: * first-ever unilateral ischemic stroke \<48 hours, confirmed by mri-dwi and/or ct * age 18 years or older * able to follow one-staged commands * nihss arm score ≥1 * informed consent after participants' information exclusion criteria: * modified rankin scale score \>2 before stroke * neurological or other diseases affecting the upper limb(s) before stroke * intravenous line in the upper limb(s) which limits assessment * contra-indications on ethical grounds * expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse

Keywords: rehabilitation screening enrollment
increasing treatment adherence in co-occurring psychiatric and drug use disorders

Conditions: Diagnosis, Dual (Psychiatry); Psychiatric Diagnosis; Drug Use Disorders

Summary: the investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (cod). the proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (codda) will be randomly assigned to one of the following brief, 8-week, manual-guided interventions following a 2-week "assessment only" baseline period: 1. adherence feedback (af); this condition will entail weekly, 20-25 minute sessions of af, which is a procedure that represents a technological advancement developed by cramer et al. (1989, 1995, and 1999) and is based on the use of adherence data from the microelectronic monitor in medication event monitoring system (mems) caps, 2. af + contingency management (af + cm); in this condition, participants will receive af, as described above, plus contingency management. cm is based on the behavioral learning theory, which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded, or 3. af + motivational enhancement therapy (af + met); in this condition, patients will receive af, as described above, plus motivational enhancement therapy. met is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence (i.e., reasons for and against changing/adhering), utilizing a series of strategies based on client-centered psychotherapy, self-efficacy theory, and social psychology. the study will allow the evaluation of three hypotheses: 1. af + met is superior to af + cm, 2. af + met is superior to af alone, and 3. af + cm is superior to af alone. primary outcome measures are: 1. rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or ssris), as measured by mems caps and self-report, 2. rates of counseling attendance, and 3. reductions in illicit drug use, including achievement of abstinence, as assessed by twice-weekly urine toxicology tests and self-report. secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization. the investigators will also evaluate the relationship between adherence and primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: * currently being treated with any class of psychotropic medication * have used illicit drugs or abused prescription drugs within the past year * are not adhering completely to their medication exclusion criteria: * current major depressive episode * active suicidal/homicidal ideation/intent * current manic episode * visiting nurse or living in a facility that distributed medications

Keywords: treatment adherence co-occurring disorders motivational enhancement therapy contingency management mems caps
vascular responses to sympathetic activation and altered shear rate: the impact of hypertension and sodium intake

Conditions: Hypertension

Summary: the aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.

sodium intake is a major contributor to the development of hypertension in the developed world. interestingly, it has been recently revealed that, in addition to the cardiovascular dysfunction associated with high sodium intake-induced hypertension, individuals who have unaltered blood pressure after chronic high sodium intake, termed salt resistant, report similar reductions in cardiovascular function when compared to salt sensitive individuals. while the extent to which this high sodium intake negatively alters cardiovascular structure as well as function is currently being explored, little is known about how high sodium intake impacts vascular function and blood flow regulation during exercise. therefore, this study will determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals. the investigators hypothesize that increases in sodium intake will reduce exercise-induced arterial dilation in response to shear and result in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise workloads. furthermore, the investigators hypothesize that these changes in blood flow regulation and exercise tolerance in young individuals will be reversed following antioxidant supplementation, implicating the role of oxidative stress in this dysfunction.

Eligibility criteria:
inclusion criteria: * normotensive blood pressure (systolic \<120 and diastolic \<80 * free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease * non-obese (bmi \<30 and/or body fat \< 25% for men, and \< 30% for women) * no tobacco use * no medications that could affect vascular function or oxidative stress * not sedentary exclusion criteria: * individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function * subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible * subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies * pregnant women, prisoners, and children will not be eligible for this study
integrated care for patients with high risk substance use and psychiatric disorder with chronic direct acting antiviral treatment

Conditions: Hepatitis C; Depression; PTSD; Substance Use Disorder; Fibrosis

Summary: to determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (svr) rates following initiation of direct acting antiviral therapies (daa) treatments in 2011.

background and aims: approval of direct acting antiviral (daa) therapies in 2011 initiated a new era of more effective treatments for hepatitis c (hcv). the impact of more effective therapies on patient access to treatment is unknown. integrated care (ic) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (sud). methods: prospective, randomized trial at a single medical center. patients with hcv at risk for active psychiatric and sud between jan 2012 and jan 2013 were recruited and randomized to ic or usual care (uc). a mid-level mental health practitioner was placed in the ic clinic and provided brief mental health care and case management.

Eligibility criteria:
inclusion criteria: * patients with hcv infection who were referred to the va hcv clinic and who received the usual initial evaluation in the clinic * all patients 18 and 75 years old with confirmed hcv infection * patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate * screening measures and cutoffs for inclusion were depression: * beck depression inventory: (bdi) \> 10 * alcohol use: alcohol use disorders identification test (audit-c) \> 4 * ptsd: va primary care ptsd screen = endorsement of three or more items or any single endorsement of item #3 * drug use: drug use questionnaire = self-reported drug/alcohol use within 6 months prior to screen exclusion criteria: * lacked a confirmed test of hcv rna * had hiv/hcv co-infection and received care at san diego or palo alto sites (these patients were treated in a separate clinic) * had hepatitis b (hbv) co-infection * had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or child-pugh class b or c * had other significant near term life-threatening diseases * were treatment non-responders with pegylated interferon plus ribavirin

Keywords: care integration hepatitis c substance use disorder ptsd
efficacy of external oblique intercostal block in laparoscopic bariatric surgery

Conditions: Bariatric Surgery Candidate; Pain, Postoperative; Narcotic Use; Analgesia

Summary: laparoscopic bariatric procedures nowadays are employed under eras protocol as an ambulatory surgery. pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (ponv), ileus, sedation and delayed hospital discharge. oblique subcostal transversus abdominis plane block (ostap) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively. the ultrasound-guided external oblique intercostal (eoi) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen. the aim of this study was to test the hypothesis that us-guided eoi blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal tap (ostap) block.


Eligibility criteria:
inclusion criteria: * age of 18 and 65; * american society of anesthesia (asa) class ii or iii * elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (t10 dermatome). exclusion criteria: * preoperative chronic use or contraindication to opioid or nsaid * allergy to bupivacaine * local skin infection at the injection site of eoi or ostap blocks * liver or renal insufficiency * psychiatric, or neurological disease * prior open abdominal surgery above t10 dermatome * patients converted to open surgery; and patients expected to be subjected to more tissue trauma.
safety and effectiveness of biotraceio 360 for planning, monitoring and assessment of liver tissue ablation procedures (panorama2)

Conditions: Hepatocellular Carcinoma; Metastatic Liver Cancer

Summary: pilot study planned to demonstrate the safety and effectiveness of the use of biotraceio 360 for planning, monitoring and assessment of liver tissue ablation procedures single-center prospective single-arm clinical investigation. sample size - 10 subjects.


Eligibility criteria:
inclusion criteria: * scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (hcc) or metastatic liver tumor(s) microwave (mw) energy. * patient must have at least one prior ct or cect scan (up to 6 months before enrollment). * tumor must be visualized on at least one diagnostic imaging modality (mri or contrast-enhanced ct). * single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones. * distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones. * at least 21 years of age. * able and willing to give informed consent. additional inclusion criteria for subgroup: - single ablation, using a single ablation needle, per tumor. exclusion criteria: * planned ablation includes adjunctive means other than mw energy (e.g., ethanol, hepatic artery embolization, etc.). * planned ablation includes the use of more than two ablation needles, per tumor * ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure. * pregnant or breastfeeding. * patient judged unsuitable for study participation by the physician for any other reason. * currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period. * unable or unwilling to give informed consent. additional exclusion criteria for subgroup: * liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion. * planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.
lundbeck toms orthostatic hypotension

Conditions: Orthostatic Hypotension; Idiopathic Parkinson Disease

Summary: orthostatic hypotension (oh), which consists in a significant reduction in blood pressure levels upon standing from a seated position, may affect approximately one in three patients with parkinson's disease (pd). it usually presents as dizziness, lightheadedness, feeling faint, or feeling like you might black out while standing. this can significantly impact the quality of life (qol) of pd patients, resulting in difficulties with balance, walking, and increased risk of falls. the main aim of this study is to evaluate whether the use of technological devices (a computerized system for analyzing abnormalities in walking in clinical settings and a wearable sensor to detect changes in postural unsteadiness in the home environment) may improve the detection of complications and the response to medical therapies for oh in patients with pd.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease, meeting uk brain bank criteria for at least 3 years * hoehn and yahr (h\&y) stage i-iii * age between 30 and 80 years old (both inclusive) * stable dosage of dopaminergic medications for at least 4 weeks * orthostatic hypotension, defined as a fall in systolic bp ≥ 20 mmhg or diastolic bp ≥ 10 mmhg within 3 minutes of standing * willingness and ability to comply with scheduled visits exclusion criteria: * diabetes mellitus or other diseases potentially associated with autonomic dysfunction * treatment with antihypertensive drugs or with alpha-adrenergic antagonists * cognitive impairment, defined as a score \< 24 at the montreal cognitive assessment (moca) * any atypical signs lowering the diagnostic certainty for pd * lack of postural reflex defined as a score \> 2 at the mds-updrs item 3.12 (recover at the pull test) * severe levodopa induced dyskinesia, defined as an mds-updrs item 4.2 \> 2 (functional impact of dyskinesia)
evaluation of dry eye disease's signs in patients who were administered intravitreal anti-vegf injections

Conditions: Dry Eye Syndromes

Summary: the goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of thealoz duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (hydrabak containing sodium chloride 0,9 g, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received intravitreal injections. the main questions it aims to answer are: * can ocular instillation of thealoz duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs? * can ocular instillation of thealoz duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision? each participant will be randomized into each of two arms: 1. treatment arm: patients who will receive the instillation of thealoz duo, 10 ml, 1 drop, 4 times/day; 2. control arm: patients who will receive the instillation of saline solution (hydrabak), 10 ml, 1 drop, 4 times /day; the decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement. in any case, the instillation of saline solution should not alter the ocular surface.


Eligibility criteria:
inclusion criteria: * patient with retinal disease who required anti-vegf therapy via intravitreal injections; * patient who has already received at least 2 anti-vegf therapy via intravitreal injections in the study eye during the last 6 months before the baseline; * capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * patient with naive retinal disease who has already received \< 2 anti-vegf therapy via intravitreal injections in the study eye; * subjects with autoimmune pathologies involving the ocular surface (e.g.sjögren's syndrome), dry eye syndrome, eyelid disease that can induce changes in ocular surface (e.g. entropion, ectropion, lagophthalmos, trichiasis, ptosis), with any other systemic disease that may confound the interpretation of study results.

Keywords: ocular surface discomfort