Kornimate/medical-research-clean huggingface dataset:
does injection site matter? a randomized controlled trial to evaluate efficacy of knee intraarticular injections on improval of patient reported outcomes.

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. with the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. multiple studies have attempted to establish non-surgical criteria for knee arthritis and usage of resources to avoid major surgery. it has long been accepted as a treatment option for patients who have failed to respond to nsaids and other non-surgical therapies to receive intra-articular injections of steroid and anesthesia mixtures to hold off disease progression. various studies have compared different sites of injection and the accuracy rate of the injection being within the joint. recent studies report a 66% accuracy on palpation-guided injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the superolateral portal of the knee, and new studies show an improvement of up to 98% with use of ultrasound guiding software. however, in a health care system with limited resources, providing patients with us-guided injections represented an increased cost of $178.35 per patient as per 2010 medicare reports. therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral portals for knee injection and their clinical effect to monitor if in fact there is a difference in patient reported outcomes. as a secondary analysis, if no difference is found, a strong case for palpation-guided injections versus ultrasound-guided injections can be made. in this study we will prospectively enroll 60 patients to be divided into two 30 patient groups with primary knee osteoarthritis. patients that qualify as subjects will be treated with an intraarticular knee injection through an anterolateral portal or a suprapatellar portal as per group in which they are placed. scores will be given for pain of the injection and of the baseline illness and compared on a subsequent visit to assess self-reported functional outcomes.


Eligibility criteria:
inclusion criteria: * inclusion criteria include early osteoarthritis as per brandt grades, persistent joint pain warranting a clinic visit, no previous injections given, significant pain in visual analog scale, failure of exercise and oral analgesics. exclusion criteria: * exclusion criteria include advanced knee osteoarthritis, patients with bloody effusions, the use of warfarin or antiplatelet therapy, presence of any infection, patients with arthritis other than primary osteoarthritis, patients younger than age 25 due to low likelihood of primary arthritis, pregnant females, diabetics with poor glucose control, and patients that have previously been injected in knee(s).

Keywords: knee arthritis injections corticosteroids
breast cancer and sexuality treatment

Conditions: Sexual Dysfunction

Summary: the purpose of this project is to compare the effects of a group mindfulness treatment versus a group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (brca) survivors. participants will be randomly assigned to either 8 weekly sessions of a group mindfulness-based treatment or 8 weekly sessions of a sex education group. groups will consist of approximately 8 breast cancer survivors and will be led by 2 trained therapists. participants will complete four assessments (involving a clinician administered interview and standardized questions): pre-treatment, post- treatment, and 6 month follow up.


Eligibility criteria:
inclusion criteria: * women over the age of majority, with a history of breast cancer and who are at least 3 months following the end of their treatment * fluent in english * exceed the clinical cut-off for sexual distress (female sexual distress scale). * women who are, and who are not, in a relationship will be eligible as long as they have engaged in sexual activity either alone or with a sexual partner in the past 6 months, or as long as they indicate a willingness to engage in sexual activity (alone or with a sexual partner) during the time period of the study. exclusion criteria: * active cancer treatment (e.g. chemotherapy or radiation, not including endocrine or maintenance therapies provided they remain constant for the study duration), or scheduled breast reconstruction during the study period. * borderline personality disorder or other psychiatric or medical conditions that preclude the ability to fully participate in the group sessions, assessments, and homework. * in order to determine whether any changes in symptoms are a result of participation in the intervention, women must also agree to 1) not make changes to or commence vaginal interventions (e.g., topical hormone treatments, vaginal moisturizers, vaginal dilation) or 2) engage in other treatments for sexual difficulties (e.g., sex therapy), for 2 weeks prior to the baseline assessment until 2 weeks following the final intervention session.
hepa wash treatment of patients with hepatic dysfunction in intensive care units

Conditions: Liver Dysfunction; Critical Illness

Summary: patients with hepatic dysfunction are known to have a high mortality rate. hepa wash(r) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. the new system has shown a high detoxification capacity in in-vitro and preclinical studies. the aim of the study is to evaluate the safety and efficacy of the hepa wash system in patients with hepatic dysfunction in the intensive care unit.


Eligibility criteria:
inclusion criteria: 1. bilirubin ≥ 2 mg/dl and 2. sofa-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures and 3. patient is in the intensive care unit and 4. signed informed consent of the patient or legal representative and 5. patients are 18 years or older and 6. enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3). exclusion criteria: 1. patient with known history of chronic liver disease 2. untreatable extrahepatic cholestasis 3. patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the icu admission. 4. pao2/fio2 ≤ 100 mmhg 5. patients on kidney dialysis 6. patients with meld-score of 40 7. mean arterial pressure ≤ 50 mmhg despite conventional medical treatment 8. patient testament excludes the use of life-prolonging measures 9. post-operative patients whose liver failure is related to liver surgery 10. uncontrolled seizures 11. active or uncontrolled bleeding 12. weight ≥ 120 kg 13. pregnancy 14. patient diagnosed with creutzfeldt-jakob disease 15. participation in another clinical study

Keywords: liver failure hepatic insufficiency artificial liver albumin dialysis
referrals for clti: qualitative study

Conditions: Chronic Limb Threatening Ischemia

Summary: the goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (clti). the main questions it aims to answer are: * what are the perceptions and experiences of patients between first symptom of clti and vascular surgery assessment * what is important to patients during this process. participants will be interviewed and their words analysed using reflexive thematic analysis.

there are delays at every stage of the patient journey from developing chronic limb-threatening ischaemia (clti) to treatment, associated with poorer outcomes for patients. there is currently limited national and international guidance on how and when to refer patients with suspected clti to specialist vascular surgery services. the use of qualitative interviews will allow us explore perceptions and experiences of patients with clti being referred to vascular surgery services, and identify possible ways to improve the process via interviews. this study will provide novel information on patient experience, and together with other work provide a framework for improvement of the referral process for clti.

Eligibility criteria:
inclusion criteria: - clti diagnosed in the last year exclusion criteria: * lacking capacity to consent to interview * potential to be violent * cognitive impairment * non-english speaking
a non-invasive index of microciculatory resistance

Conditions: Coronary Microvascular Disease; Coronary Artery Disease

Summary: coronary artery microvascular disease (cmvd) lacks reliable and non-invasive quantitative diagnosis methods. improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. in this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (ct-imr) calculation method based on computational fluid method mechanics was established. at the same time, a phase i single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.


Eligibility criteria:
inclusion criteria: * subject must be older than 18 years * written informed consent available * subject is indicated for invasive coronary angiography * subject need to be taken within 30 days after enrolment exclusion criteria: * previous pci or cabg * subject is not eligible for measuring imr * complicated complex congenital heart disease * artificial pacemaker or internal defibrillator leads implanted * implanted artificial heart valve * severe arrhythmia including complete av block, ventricular arrhythmia * impaired chronic renal function (serum creatinine\>1.5uln) * allergic to iodine * pregnancy * body mass index \>35 kg/m2 * left ventricle is markedly thickened * needs for emergency procedures * severe distortion of in the blood vessel * unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic \< 90mmhg), severe congestive heart failure or pulmonary edema * life-threatening diseases (life expectancy \< 2 months) * tako tsubo syndrome (tts) * others who are inappropriate subject judged by clinician
pulmicort turbuhaler 100/200 specific clinical experience investigation

Conditions: Bronchial Asthma

Summary: the purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and \<15 years on bronchial asthma in daily clinical usage/effect on growth rate. effect on adrenal function. development of infection diseases by diseases type.


Eligibility criteria:
inclusion criteria: * patients treated with pulmicort turbuhaler for the first time due to bronchial asthma and children of \>= 5 years and \< 15 years old age at the start of study treatment exclusion criteria: -none

Keywords: bronchial asthma, pulmicort, long term use, pediatrics
errector spinae plane block for postoperative pain management in cardiac surgery: a randomized controlled trial

Conditions: Erector Spinae Plane Block; Cardiac Surgery

Summary: the purpose of this study is to assess efficacy of erector spinae plane block (esp) for postoperative pain management in cardiac surgery patients.

after being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. all patients will be evaluate during 48 hours for postoperative pain.

Eligibility criteria:
inclusion criteria: * must be asa score i-iii * must be 18-75 years old * must undergo cardiac surgery exclusion criteria: * emergency surgery, * bleeding diathesis, * presence of contraindications to la agents used in this study, * use of chronic opioids, * psychiatric disorders. * prolonged extubation * presence of infection at the injection site. * cardiovascular conditions (ef\<40, lmca obstruction)
safety and pharmacodynamic study of abt-436 in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a multiple-dose study to assess the safety and pharmacology of abt-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. efficacy for treatment of depressive symptoms is not a goal of this study.

this is a multiple-dose study to assess the safety and pharmacology of abt-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. efficacy for treatment of depressive symptoms is not a goal of this study. fifty subjects will receive study drug for seven days. thirty subjects will receive abt-436 and twenty subjects will receive placebo. blood, urine and saliva samples will be obtained, both before and during study drug administration, to measure abt-436 pharmacology. safety will be assessed throughout the study, including at two follow-up visits after completion of study drug administration.

Eligibility criteria:
inclusion criteria 1. age between 18 to 55 years, inclusive. 2. body mass index is 20 to 35 kg/m2, inclusive. 3. a primary diagnostic and statistical manual of mental disorders - fourth edition, text revision (dsm-iv-tr) diagnosis of major depressive disorder. 4. mild-to-moderate depressive symptoms at screening. 5. a condition of general good physical health. exclusion criteria 1. pregnant or breast-feeding female. 2. use of any medication within 4 weeks prior to day -2, unless the dose has been stable for 4 weeks, no dose change is anticipated during the study, and the medication is specifically allowed for this study, or prior as needed (prn) use of the medication is specifically allowed for this study. 3. use of fluoxetine or aripiprazole within 8 weeks prior to day -2. 4. positive screen for drugs of abuse/alcohol, recent history of drug/alcohol abuse or smoking. 5. a current or past history of major depressive disorder with psychotic features, bipolar disorder, schizophrenia or other psychotic disorder, mental retardation, or mental disorder due to a general medical condition.

Keywords: depression
study of safety in hemolytic paroxysmal nocturnal hemoglobinuria (pnh) patients treated with eculizumab

Conditions: Hemoglobinuria, Paroxysmal

Summary: the primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic pnh


Eligibility criteria:
inclusion criteria: * pnh \> 6 months * type iii pnh red blood cell (rbc) clone by flow cytometry \>10% * at least one transfusion in the past 2 years but no more than 3 transfusions in the past 12 months; or personal beliefs that preclude the use of transfusion with severe hemolytic pnh * lactate dehydrogenase (ldh) \>1.5 x upper limit of normal * must avoid conception * willing and able to give written informed consent exclusion criteria: * platelet count of \<30,000/mm3 * absolute neutrophil count \<500/ul * active bacterial infection * hereditary complement deficiency * history of bone marrow transplantation * participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days * pregnant, breast-feeding, or intending to conceive * history of meningococcal disease
validation of artificial intelligence as decision support system in via (prescrip-tec)

Conditions: HPV Infection; Cervix Cancer; Cervical Dysplasia

Summary: the research project is a component of another research project that applies the protocol of the world health organization for screening of cervical cancer, with testing of high-risk human papilloma virus (hrhpv) as first screening. in the screen, triage and treat approach women who tested positive for hrhpv are undergoing visual inspection of the cervix with acetic acid (via). this procedure is applied in uganda, india and bangladesh. however the quality of via by lower-trained staff is variable because low and middle income countries face limited numbers of qualified health care professionals. artificial intelligence (ai) might be a solution to improve consistency of via assessment. this research validates an ai decision support system (ai-dss) under field conditions.

this research project aims to validate an image processing algorithm in order to study if the ai can function as decision support system (dss) for healthcare workers, who perform via. the ai-dss has been designed by the manipal academy of higher education in india and has shown a sensitivity of 99.05% and specificity of 97.16% for detection of aceto-white lesions. the first step of the validation process is a dry run using a database of via pictures with pathology confirmation. the accuracy, sensitivity and specificity of healthcare workers, an expert team and the ai will be analysed, based on the ground truth of database pictures. thereafter, the ai-dss will be validated under field conditions. women who are hrhpv-positive in uganda, india and bangladesh will undergo a via. the ai is incorporated in a device, that can take pictures of the cervix and provide and instant report (positive = needs further investigation or negative = no lesions found). the user experience of the device will be evaluated. the ai-dss will be validated by comparing the via assessment by health workers, the ai with assessment by the expert panel. accuracy, sensitivity and specificity of the ai algorithm will be assessed.

Eligibility criteria:
inclusion criteria: * female in eligible age group * women who tested hpv positive and are eligible for via * ability to give informed consent and participate in study exclusion criteria: * clinical signs of cervical carcinoma * menstruation or other vaginal blood loss * hpv negative women

Keywords: visual inspection cervix artificial intelligence screening cervical cancer decision support system
a study of 2-hydroxyflutamide (liproca depot), injected into the prostate in patients with localized prostate cancer

Conditions: Prostate Cancer

Summary: the primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (mri) following a single injection of liproca depot in patients with localized prostate cancer.

the primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (mri) following a single injection of liproca depot in patients with localized prostate cancer. the secondary aims ere to evaluate efficacy and safety of a single injection of liproca depot, and to follow the pharmacokinetic profile.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50 years, ≤ 75 years 2. histologically confirmed localized (stage t1c, t2a-t2c) prostate cancer that is judged relevant for prostatectomy. 3. psa value \< 20 ng/ml within 6 weeks before enrolment. 4. gleason score ≤ 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci). 5. adequate renal function: creatinine \< 1.5 times upper limit of normal. 6. adequate hepatic function: aspartate transaminase (asat), alanine transaminase (alat) and alkalase phosphatase (alp) \< 1.5 times upper limit of normal. 7. negative dipstick for bacteriuria. 8. patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit. 9. patients that has been scheduled for prostatectomy exclusion criteria: 1. ongoing or previous hormone therapy for prostate cancer. 2. on-going or previous therapy within 12 month of finasteride or dutasteride. 3. on-going or previous invasive therapy for benign prostate hyperplasia (turp, tumt). 4. use of pace maker or other electronic devices 5. symptoms or signs of acute prostatitis. 6. symptoms or signs of ulcered proctitis 7. severe micturation symptoms 8. on-going therapy with anticoagulant (e.g warfarin. other anticoagulant should be withdrawn 1 week before injection). 9. concomitant systemic treatment with corticosteroids, or immune modulating agents. 10. known immunosuppressive disease (e.g. hiv, diabetes). 11. simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.
a feasibility and safety study of the use of a dedicated ballooned intercostal drain

Conditions: Pleural Effusion

Summary: drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in chest medicine. a common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. this often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. one suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. these would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required. the investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.


Eligibility criteria:
inclusion criteria: * age \>16 years * able to give written informed consent * requiring intercostal tube drainage of a pleural effusion for clinical reasons exclusion criteria: * requiring intercostal tube drainage for chest trauma * requiring blunt dissection for drain insertion

Keywords: ballooned intercostal drain pleural effusion