Kornimate/medical-research-clean huggingface dataset:
pleural manometry in thoracocentesis

Conditions: Thoracocentesis of Pleural Effusion

Summary: the study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

this prospective controlled trial study will be performed between july 2019 and december 2020. the investigators will enroll patients with large volume pleural effusion referred to our cardiothoracic department, faculty of medicine, ain shams university to perform therapeutic thoracentesis. all the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis. the study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 85 years, 2. pleural effusion occupying at least one-third of the ipsilateral hemithorax in p-a chest radiograph (cxr) 3. no contraindications for therapeutic thoracentesis 4. general health condition allowing prolonged procedure of therapeutic thoracentesis. exclusion criteria: * patients with very small amounts of pleural effusion * patients on mechanical ventilation * patients using anticoagulant therapy * patients refusing to be subjected to thoracocentesis.
impact of a course on stress reduction

Conditions: Chronic Pain

Summary: this project seeks to measure the effectiveness of a course in self-management strategies (including yoga, mindfulness, and breathing exercises). the course will be provided by a certified yoga instructor to patients being followed at the pain management centre, hamilton health sciences (hhs).

the pain management centre at hamilton health sciences is organizing a course in stress reduction techniques for patients with chronic pain. the pain centre has arranged for a local certified yoga instructor to lead a 6-week course that she has developed for our specific patient population. the course will include self-management strategies for pain control, such as breathing exercises, yoga poses, and mindfulness meditation. standardized questionnaires and a semi-structured interview to record baseline and post-course outcomes. the study will involve the following questionnaires/surveys/interviews: 1) canadian occupational performance measure, 2) perceived stress scale, 3) burckhardt quality of life scale, 4) visual analog score, and 5) written questions concerning patient demographics, the patient's chronic pain condition, and their satisfaction with the course. the participants would be asked to fill out questionnaires at three different times: 1) baseline data collected within two weeks of starting course, 2) short-term outcome data within two weeks of completing course, and 3) long-term outcome data four to six months after the course.

Eligibility criteria:
inclusion criteria: * patients have a history of moderate to severe chronic pain exclusion criteria: * non-english speaking patients

Keywords: chronic pain mindfulness yoga quality of life stress
analgesic efficacy of ultrasound guided quadratus lumborum block during eswl

Conditions: Pain, Acute

Summary: extracorporeal shockwave lithotripsy (eswl) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation. lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream). the quadratus lumborum block was first described by blanco. ql block is performed as one of the perioperative pain management procedures for abdominal surgery. ql block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-ii patients undergoing extracorporeal shockwave lithotripsy exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases

Keywords: extracorporeal shockwave lithotripsy quadratus lumborum block bupivacaine lidocaine
pet scan to map the areas of the brain involved in planning

Conditions: Cognition Disorders

Summary: positron emission tomography (pet) is a technique used to investigate the functional activity of the brain. the pet technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. when a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). as the brain uses more fuel it produces more waste products, carbon dioxide and water. blood carries fuel to the brain and waste products away from the brain. as brain activity increases blood flow to and from the area of activity increases also. knowing these facts, researchers can use radioactive water (h215o) and pet scans to observe what areas of the brain are receiving more blood flow. this study will attempt to determine the areas of the brain activated by planning processes and decision making. researchers will ask patients to participate in tests and games (chess) that will stimulate the areas of the brain involved with decision making and planning while undergoing the water pet blood flow technique.

this protocol will attempt to determine the topographical distribution in the brain of the cognitive components of planning using the \[150\] water pet blood flow technique. we will administer perception, motor, simple decision, and planning tasks using the game of chess and the tower of hanoi test as paradigms. utilizing a "subtraction technique" we hope to identify those areas of cerebral cortex which are most activated by planning processes. it is predicted that the dorsolateral frontal areas will be most prominently activated. it is also predicted that the essential components of the planning process will be the same regardless of the type of plans being executed. the data we collect will be of value in determining 1) the neural representation of planning processes and 2) in guiding cognitive models of the planning system.

Eligibility criteria:
normal controls: males and female subjects from two age ranges: 18-30 and 50-65 years of age. individuals with a history of neurological or psychiatric disorder will not be included nor will individuals currently taking psychoactive medication. patients: patients with outstanding problems in planning. patients must have a diagnosed cns disorder with lesion localization verified by mri scanning available from the referring physician or completed at the nih clinical center. patients with unilateral or bilateral lesions that meet the behavioral criteria for selection (planning disorder). patients will be medication free (or taking medication with no known central nervous system effects) and be able to understand instructions and task demands.

Keywords: blood flow chess play frontal lobe neurobehavioral deficits neuropsychology positron emission tomography prefrontal cortex
phase i study of hrs-4642 in patients with advanced solid tumors harboring kras g12d mutation

Conditions: Advanced KRAS G12D Mutant Solid Tumors

Summary: the study is being conducted to evaluate the safety and tolerability of hrs-4642 in patients with advanced solid tumors harboring kras g12d mutation.to estimate the maximum tolerated dose (mtd) and/or a biologically active dose (eg, recommended phase 2 dose \[rp2d\]) within investigated subject population groups


Eligibility criteria:
inclusion criteria: 1. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. male or female ≥ 18 years old. 3. histologically confirmed diagnosis of advanced solid tumor harbouring with kras g12d mutation 4. ecog performance status of 0-1. 5. with a life expectancy of ≥3 months. 6. have at least one measurable lesion. 7. adequate laboratory parameters during the screening period exclusion criteria: 1. previously received kras g12d inhibitors 2. priot radiotherapy within 28 days for non-thoracic radiation 3. prior anti-tumor chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration 4. any unresolved aes \> common terminology criteria for adverse events (ctcae) grade 1 or inclusion/exclusion criteria level (the investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ). 5. central nervous system (cns) metastases 6. major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study. 7. known history of hypersensitivity to any components of hrs-4642. 8. other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
identification of new biomarkers to promote personalized treatment of patients with inflammatory rheumatic diseases

Conditions: Arthritis, Rheumatoid; Psoriatic Arthritis; Axial Spondyloarthritis; Connective Tissue Diseases; Gout

Summary: introduction: the medical treatment of inflammatory rheumatic diseases has improved dramatically during the last decades primarily due to the introduction of biological disease modifying anti-rheumatic drugs (bdmards). however, bdmard treatment failure occurs in 30-40% of patients due to lack of effectiveness or side effects. the tools to predict treatment outcomes in the individual patient are currently limited. the objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1) diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and tolerability for the individual patient. methods and analysis: observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. patients contribute one cross-sectional blood sample (i.e. whole blood, serum, edta-plasma and -buffy coat, and blood in paxgene rna tubes) and/or are enrolled for longitudinal follow-up upon start of new dmard (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; dmard treatment and outcomes are collected repeatedly during follow-up. currently (june 2017) \>5,000 samples from ≈3,000 patients have been collected. data will be analysed using appropriate statistical analyses. ethics and dissemination: the protocol is approved by the danish ethics committee and the danish data protection agency. all participants give written informed consent. biomarkers will be evaluated and published according to remark, strobe and stard guidelines. results will be published in peer-reviewed medical journals and presented at international conferences.


Eligibility criteria:
inclusion criteria: * diagnosed with or suspected for the following diseases: rheumatoid arthritis (ra), psoriatic arthritis (psa), axial spondyloarthritis (axspa) or other inflammatory rheumatic diseases, connective tissue disorders or gout * aged 18 year or older * able to give informed consent exclusion criteria: * none

Keywords: inflammatory rheumatic diseases biomarkers tailored treatment personalised medicine danbio danish rheumatologic biobank clinical data
treatment pattern of oral anticoagulants (oac) in japan

Conditions: Atrial Fibrillation

Summary: 1. to understand the treatment patterns of oacs and baseline patient characteristics of japanese non-valvular atrial fibrillation (nvaf) patients 2. to determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates. 3. as an exploratory analysis, to assess mean duration of on-therapy follow-up time in database


Eligibility criteria:
inclusion criteria: * patients aged \>18 year-old with confirmed diagnosis of nvaf (icd 10 code i48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other oacs for12 months prior to the index date (defined as the first prescription of oacs (the period is defined as baseline period)), and having an index date between 14 mar 2011 to 30 june 2016 exclusion criteria: * patients having less than 12 months of enrolment prior to the index date , being dialysis or kidney transplant recipients in baseline period, having either atrial flutter, valvular af, mechanical valve placement, rheumatic af, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism \< 6 months before atrial fibrillation (af) diagnosis in baseline period
a study to describe treatment patterns and disease control in participants with chl and salcl in routine clinical practice in the russian federation

Conditions: Hodgkin Disease; Lymphoma, Large-cell, Anaplastic

Summary: the purpose of this study is to describe patterns of treatment used for chl and salcl in real world setting.

this is a non-interventional, prospective and retrospective study of participants with chl and salcl. the study will collect information on therapy and outcome of chl and salcl in real-life clinical practice. the study will enroll approximately 2000 participants. based on the diagnosis of the disease, participants will be assigned to one of the following groups: * newly diagnosed and rr chl participants * newly diagnosed and rr salcl participants this multi-center trial will be conducted in russia. the retrospective data will be collected for the participants with rr chl or rr salcl at the time of enrollment and for participants with rr chl or rr salcl within 3 years prior to inclusion in the study at visit 1 (baseline). the prospective data will be collected for a period of 2 years from visit 1 (baseline) to visit 5 (month 24, final visit), both for newly diagnosed participants with chl or salcl and participants with rr chl or rr salcl at the time of enrolment, and participants with rr chl or rr salcl within 3 years prior to inclusion in the study.

Eligibility criteria:
inclusion criteria: 1. male and female participants 18 years or older by the time of enrollment. 2. histologically confirmed diagnosis of chl or salcl. 3. newly diagnosed participants, or participants with rr chl or rr salcl at the time of enrollment, or participants with rr chl or rr salcl within 3 years prior to inclusion in the study. exclusion criteria: 1. unconfirmed diagnosis of chl or salcl. 2. current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials. 3. participation in the non-interventional study chl-5001 "an international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical hodgkin lymphoma (b-holistic)" (sponsor is takeda pharmaceuticals international ag). 4. participants for whom the minimum study dataset was not available from their hospital medical records.

Keywords: drug therapy
additive effects of 4-7-8 breathing technique with standard management on dyspnea, pulmonary function and quality of life in patients with copd.

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Dyspnea

Summary: a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction. breathing exercises help to manage dyspnea and reduced pulmonary function often seen in copd patients. to handle respiratory complications copd patients are advised to practice breathing techniques in conjunction with their prescribed medications.

copd is a very common chronic respiratory disease with symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction. breathing exercises help to manage dyspnea associated with copd. in order to manage respiratory conditions copd patients are encouraged for nasal breathing techniques along with standard management. hence the objective of the study is to compare the effects of 4-7-8 breathing along with standard management versus standard management alone on dyspnea, pulmonary function, and quality of life in patients with copd.

Eligibility criteria:
inclusion criteria: * adults: aged (40-64 years) * gender: both males and females * grade1- grade 1-3 on modified mrc dyspnea scale * copd mild and moderate according to gold classification * mild: fev1 \> 80% predicted * moderate: fev1 \>50% predicted exclusion criteria: * severe and very severe stage of copd according to gold classification. * patients having acute exacerbation of copd. * patients diagnosed with acute infections. * patients unable to follow commands/ instructions.

Keywords: dyspnea pulmonary function quality of life
the diagnostic value of acupoint sensitization based on stable angina pectoris

Conditions: Stable Angina Pectoris; Acupoint Sensitization; Correlation Analysis; Diagnostic Value

Summary: investigators adopt cross-sectional study design to carry out the exemplary research in the aspects of disease diagnosis.this study is designed to confirm the hypothesis "acupoint sensitization is associated with a severity of angina pectoris, which may contribute to the diagnosis of stable angina pectoris". after the eligible participants recruited in group, the coronary artery lesions will be evaluated through coronary angiography and the canadian cardiovascular society(ccs) angina pectoris classification will also be evaluated at the same time. the degree of acupoint sensitization will be tested by the electronic von frey instrument by one professional acupuncturist with total 12 acupoints, including shenmen,yinxi, shaohao,jiquan,neiguan, ximen, quze, shanzhong, juque, jueyinyu, xinyu, duyu. analysis were conducted to explore relationships between the degree of acupoint sensitization, the degree of coronary artery stenosis and ccs angina pectoris classification. diagnostic value will be further analyzed in the final step.


Eligibility criteria:
inclusion criteria: * patients meet the diagnostic criteria of acc/aha angina pectoris of coronary heart disease * the frequency of angina attacks were greater or equal to twice a week over the previous 3 months * patients agree to do coronary angiography examination and sign the informed consent. exclusion criteria: * people with mental disabilities and intelligent obstacle * patients who can't accomplish the detection of acupoint sensitization * patients with allergic condition, especially the contrast media * patients with acute myocardial infarction, unstable angina, during arrhythmia and serious diseases which can affect the blood supply of myocardial * patients with skin or peripheral nerve paresthesia, pain or the detect area of skin ulcerate * pregnant or lactating women * patients who undergoing other clinical trials

Keywords: stable angina pectoris acupoint sensitization correlation analysis diagnostic value
china evera mri® study

Conditions: Arrhythmias, Cardiac

Summary: the study is a prospective, single arm, non-blinded, multi-site study conducted in mainland china.

the purpose of the china evera mri® study is to confirm safety of the evera mri icd system in the clinical mri (magnetic resonance imaging) environment when subjects receive mri scans up to 2w/kg specific absorption rate (sar) without positioning restrictions (mri scans may occur anywhere on the body). long-term device effects, such as long-term lead integrity, will not be assessed in the china evera mri® study.

Eligibility criteria:
inclusion criteria: * subjects who are indicated for implantation of an icd at the time of study enrollment. * subjects who are able to undergo a pectoral implant. * subjects who are able and willing to undergo elective mri scanning without sedation , . * subjects who are geographically stable and available for follow-up at the study site for the length of the study. * subjects who are at least 18 years of age (or older, if required by local law). exclusion criteria: * subjects with a history of significant tricuspid valvular disease that precludes the ability to place the rv lead. . * subjects who may be contraindicated to the dexamethasone sodium phosphate and/or dexamethasone acetate. * subjects who require a legally authorized representative to obtain informed consent. * subjects with abandoned or capped leads. * subjects who require an indicated mri scan, other than those specifically described in the china evera mri® study, before the one-month post-mri follow-up (approximately 4 months post-implant). * subjects with a non-mri compatible device (such as neurostimulators) or material implant (e.g., non-mri compatible sternal wires, neurostimulators, biostimulators, metals or alloys). * subjects with medical conditions that preclude the testing required by the cip or limit study participation. * subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the china evera mri® study. co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the medtronic study manager. * female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant * subjects with exclusion criteria required by local law (e.g., age, breastfeeding). * subjects who are diagnosed with terminal disease with life expectancy less than 4 months.
gene therapy(ft-003) for wet amd

Conditions: Neovascular Age-related Macular Degeneration

Summary: the goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of ft-003 in subjects with neovascular age-related macular degeneration (namd). the study was divided into two phases, phase 1 dose escalation and phase ii dose expansion.

ft-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (namd). neovascular amd is the main cause of blindness among elderly individuals. the available therapies for treating namd require life-long intravitreal (ivt) injections every 4-12 weeks to maintain efficacy. administration of ft-003 has the potential to treat namd by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. ft-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with namd receiving anti-vegf therapy in clinical practice.

Eligibility criteria:
inclusion criteria: * subjects that are willing and able to follow study procedures; * female or male patients 50-80 years old at the time of signing the icf; * clinically diagnosed with namd; * presence of active cnv * the best corrected visual acuity (bcva) of the studied eye is 24-73 letters; exclusion criteria: * •presence of any other intraocular diseases other than namd in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Keywords: ft-003 namd