Kornimate/medical-research-clean huggingface dataset:
study to evaluate the performance of navigated tka with orthopilot® pheno4u tka level 1

Conditions: Osteoarthritis, Knee; Joint Diseases; Rheumatoid Arthritis of Knee; Posttraumatic Arthropathy

Summary: the purpose of this pmcf study is to demonstrate the accuracy of navigation using the new pheno4utka level 1 software for orthopilot elite® and to evaluate its safety and performance. patient-related outcome measures (prom) will be acquired to investigate functional outcome and patient satisfaction.


Eligibility criteria:
inclusion criteria: * indication for a tka with the orthopilot® navigation system with a aesculap total knee endo-prosthesis * written signed informed consent of patient * willingness and mental ability to participate at the long-term follow-up examinations exclusion criteria: * pregnancy * patients \ 80 years * patients unable to participate at the follow-up examination (physically, mentally) * previous joint replacement at the index knee * asa classification \> 3 ( asa i: a healthy patient without systemic diseases. asa ii: a patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). asa iii: a patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, copd). asa iv: a patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). asa v: a dying patient who is not expected to survive without the operation. asa vi: a deceased patient whose organs are being removed for donation.)

Keywords: navigation total knee arthroplasty orthopilot
amoxicillin-clavulanate in treating acute otitis media evaluated by daily tympanometry

Conditions: Otitis Media, Suppurative

Summary: the purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. the primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.


Eligibility criteria:
inclusion criteria: * children with acute otitis media exclusion criteria: * amoxicillin allergy * tympanic membrane perforation * tympanostomy tubes (current) * complication of acute otitis media such as mastoiditis

Keywords: middle ear effusion amoxicillin-clavulanate tympanometry
acute liver injury in patients with pneumonia

Conditions: Acute Liver Injury; Pneumonia

Summary: acute liver injury (ali) is defined as an acute derangement in liver function tests associated with liver-related coagulopathy, in the absence of underlying chronic liver disease. a subset progress to acute liver failure ,acute liver failure represent a more severe liver injury results in hepatic encephalopathy

acute liver injury is associated with a spectrum of haemostatic changes, including thrombocytopenia and reduced platelet function, reduced plasma levels of many coagulation factors such as factor (f)vii and increased levels of fviii . pneumonia is an acute inflammation of the lower respiratory tract. lower respiratory tract infection is a major cause of mortality worldwide .pneumonia is most common at the extremes of life. in adults, pneumonia can be broadly classified, on the basis of chest radiographic appearance, into lobar pneumonia, bronchopneumonia and pneumonia producing an interstitial pattern. there is lack of data regarding outcome and hospital stay in patients with pneumonia who develop acute liver injury.

Eligibility criteria:
inclusion criteria: 1. patients with pneumonia that developed acute liver injury 2. covid 19 pneumonia 3. patients with acute liver injury only. exclusion criteria: 1. cancer 2. immunocompromised patients i.e hiv patients and patients who take immunosuppressive medications. 3. patients who younger than 18 yrs old 4. pregnancy

Keywords: acute liver injury pneumonia covid19
effects of inspiratory muscle training in children with cerebral palsy

Conditions: Cerebral Palsy; Respiration; Decreased

Summary: even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. in literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. but, there is no study in literature that aims to increase respiratory muscle strength in these children. hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.

a convenience of children with hemiparetic and diplegia cp, 7-14 years, is going to recruited from gazi university, faculty of health science, department of physiotherapy and rehabilitation. patients will randomly allocate to either a treatment group or control group. the treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with pediatric evaluation of disability inventory (pedi), functional exercise capacity usin with six minute walk test (6mwt) and quality of life using with cerebral palsy quality of life questionnaire (cpqol).

Eligibility criteria:
inclusion criteria: * aged 7-14 years * diagnosed to spastic cerebral palsy * gross motor function classification system levels i or ii. * have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type a in the 6 month prior to baseline assessments * child are able to demonstrate sufficient co-operation and cognitive understanding participating exclusion criteria: * active medical condition impairment (pneumonia etc.) * do not accommodate the study * do not want to attempt the study

Keywords: cerebral palsy inspiratory muscle training
vaccination against influenza h1n1 in rheumatic diseases

Conditions: Influenza; Rheumatic Diseases

Summary: the spread of influenza h1n1 has prompted the development of vaccines against this virus. immunocompromised patients are at increased risk of developing complications of influenza h1n1. the efficacy and safety of h1n1 vaccination have not been evaluated in this population of patients.

100 patients with rheumatoid arthritis (ra), 50 patients with systemic lupus erythematosus (sle), 50 patients with spondyloarthropathies (psoriatic arthritis (psa) and ankylosing spondylitis (as) and 200 healthy subjects will participate in the study. all the subjects will be vaccinated with focetria (novartis) and will be evaluated the day of vaccination and 4 weeks later. the evaluation will include: efficacy of the vaccine: blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against a/california17/2009/h1n1 by hemagglutination inhibition test. safety of the vaccine: * records of adverse event * assessment of disease activity : ra - disease activity score (das 28), sle - sledai, psa - das 28 and pasi, as- basdai, esr, crp

Eligibility criteria:
inclusion criteria: * patients suffering from: rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis * able to firm an informed consent * aged - 18-65 * candidates to receive vaccination against h1n1, according to the recommendation of the ministry of health exclusion criteria: * allergy to eggs * known allergy to seasonal influenza vaccine * pregnant women

Keywords: rheumatoid sle psoriatic arthritis ankylosing influenza h1n1 vaccine vaccination against h1n1 in rheumatic diseases
clinical evaluation of shengdi dahuang decoction in the treatment of acute hemorrhagic stroke

Conditions: Hemorrhagic Stroke

Summary: the purpose of this study is to assess the efficacy and safety of shengdi dahuang decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.

the main purpose of the study is to observe the clinical efficacy and safety of shengdi dahuang decoction in the treatment of acute hemorrhagic stroke. this project is funded by science and technology commission of shanghai municipality and will be carried out in 5 hospitals. investigators will recruit 464 participants who meet the inclusion criteria and agree to participate in the research. participants will be randomly assigned into experimental or placebo group. granules of shengdi decoction is the therapeutic drug used in the experimental group. each pack of the test drug contains 15 grams of rehmannia and 5 grams of rhubarb. while for the placebo group, each pack contains 2% rehmannia and rhubarb. participants will receive a follow-up observation in the following 90 days. modified rankin scale score (mrs), the mortality rate on day 7 and day 90 after treatment, national institute of health stroke scale (nihss), expansion rate of hematoma, the degree of edema and the expressions of inflammatory indicators will be detected to evaluate the clinical efficacy of shengdi dahuang decoction.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of acute intracerebral hemorrhage； 2. ct scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is \<80ml; 3. the time from onset to confirmed diagnosis by ct scan is within 4 hours; 4. enrolled and receive treatment within 12 hours from onset; 5. age ≥18 years old; 6. obtain approval from the patient or family members. exclusion criteria: 1. the time from onset to confirmed diagnosis by ct scan is over 4 hours; 2. ct scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one); 3. the volume of hematoma is above 80ml; 4. glasgow coma scale (gcs) is ≤ 5 points; 5. the time from onset to confirmed diagnosis is over 12 hours; 6. have a surgical treatment planning within 24 hours; 7. cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons; 8. patients with disabilities before onset (modified mrs score \> 2); 9. patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system; 10. patients who have participated in other clinical trials within the past 1 month; 11. pregnant or nursing women; 12. allergic constitution (allergic to more than two kinds of food or medications).

Keywords: acute hemorrhagic stroke shengdi dahuang decoction
the acute cardiovascular effects of nicotine in e-cigarettes (ace) study

Conditions: Cigarette Smoking Toxicity; Nicotine; Acute Cardiovascular Disease

Summary: the goal of this project is to evaluate the nicotine induced acute cardiovascular changes in e-cigarette users and also study the mechanism involved particularly with vascular impairment.

we will recruit 30 experienced e-cigarette users (those using e-cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.the participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit. measurements will be taken at each study visit before and after e-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. these measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.

Eligibility criteria:
inclusion criteria: 1. participant will be currently healthy individuals, between 18 and 40 years of age. 2. e-cigarette users using e-cigarette for at least 1 month and smoke ≤ 1 tobacco cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their lifetime and are not active nicotine/tobacco or related product users 3. participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study. 4. do not meet any of the exclusion criteria. exclusion criteria: 1. unwilling or unable to provide informed consent. 2. participant that have: diabetes, hypertension hiv, hepatitis, liver disease (including fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ transplant, renal replacement therapy, kidney disease or insufficiency, dialysis, active cancer of any type, and untreated thyroid disease, major injury or trauma. 3. body weight less than 100 pounds or bmi \>40. 4. participants that are taking the following medications: estrogen, testosterone, anti tnf agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, isoniazid, rifampicin certain biologics, or procrit 5. participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device 6. pregnant or lactating women. 7. prisoners and other vulnerable populations. 8. anyone that pi thinks is unsafe to participate in the study.

Keywords: electronic cigarette endothelial function
tdcs and lower limb performance in stroke

Conditions: Stroke

Summary: lower limb rehabilitation is especially important, as the simple act of regaining the ability to walk has subsequent effects on the ability to engage in activities of daily living .so, this study will contribute in describing the management of lower limb motor recovery along with the therapeutic intervention (mrp) with tdcs (anodal stimulation). this study aims to address some of the drawbacks observed in previous studies like allocation concealment, small sample size due to drop outs, short term effects of tdcs and experimental designs as well.

transcranial direct current stimulation (tdcs) appears to be an intriguing adjuvant for stroke neurorehabilitation, though there are many other methods available. depending on the polarity used, tdcs alters cortical excitability when electrodes applied over the motor cortex area (m1) to be stimulated, and the cathode above the contralateral eye (orbital area), tdcs (thus termed anodal) increases cortical excitability. it is easy to use, safe and has minimal side effects like a sensation of itching, post-stimulation headache and sometimes mild nausea may experience. numerous research indicates that cortical activity rises in conjunction with gait. according to a number of studies, corticospinal neuron activity either parallels or possibly even partially regulates the activity of spinal motor neurons during walking. there exist various techniques for implementing transcranial direct current stimulation in conjunction with multiple supplementary therapies.

Eligibility criteria:
inclusion criteria: * stroke for more than 6 months. * national institutes of health stroke scale (nihss) for severity level (mild (1-4), moderate (5-15), moderate to severe (16-20), severe (21-42) exclusion criteria: * epilepsy * scalp injury/ skin lesion e.g. psoriasis or eczema etc. * patient with lower limb amputation or any msk/neurological disorder that limit the le function * implanted medical devices including intracranial electrodes, surgical clips, shrapnel or a pacemaker

Keywords: stroke lower limb transcranial direct current stimulation
open-label, flexible-dose study of vortioxetine in patients with depression in india

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in india


Eligibility criteria:
inclusion criteria: * the patient has a major depressive episode (mde), is diagnosed with major depressive disorder (mdd) according to dsm-5® and would benefit from pharmacological treatment with vortioxetine. the current mde should be confirmed using the mini international neuropsychiatric interview (mini). * the patient has a cgi-s ≥4 at screening. exclusion criteria: * the patient has a significant risk of suicide according to investigator's clinical judgment or has made an actual suicide attempt in the period of 6 months prior to screening. * the patient previously received vortioxetine. other in- and exclusion criteria may apply.
the efficiency of fascial plane blocks in bariatric surgery

Conditions: Regional Anesthesia Morbidity; Post Operative Pain; Bariatric Surgery Candidate

Summary: bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery \[1\]. opioids remain the first choice for multimodal analgesia in the treatment of postoperative pain. providing analgesia after bariatric surgery might be challenging due to a high prevalence of obstructive sleep apnea syndrome and the increased sensitivity to respiratory depression triggered by opioid overuse after surgerythe most common plane block techniques utilized during laparoscopic bariatric surgery are transversus abdominis plane block (tap), rectus sheath block (rb), the erector spinae plane block (espb) and the external oblique intercostal block (eoi). in this study, we have evaluated the auxiliary benefit of these various techniques in reduction of the postoperative in bariatric surgery. patients who had laparoscopic bariatric surgery at vkv american hospital between january 2019 and december 2021 were reviewed retrospectively.


Eligibility criteria:
inclusion criteria: * patients undergoing elective bariatric surgery exclusion criteria: * patients with a history of cerebrovascular events * alzheimer's and dementia * inadequate cognitive functions * history of chronic pain * long-term opioid therapy
mind-body intervention in glioma couples

Conditions: Glioblastoma; Low Grade Glioma; Malignant Glioma; Metastatic Malignant Neoplasm in the Brain; Partner; WHO Grade III Glioma

Summary: this trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or low grade glioma or tumors that have spread to the brain and their partners. a couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.

primary objectives: i. examine the feasibility of the couple-based mind-body (cbmb) program in patients with high grade glioma (hgg) and their partners. ii. establish the initial efficacy of the cbmb program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (qol) (secondary) outcomes relative to a waitlist control (wlc) group. exploratory objectives: i. explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention. outline: patients are randomized to 1 of 2 groups. group i (cbmb program): patients undergo cbmb program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life. group ii (waitlist control): patients complete questionnaires as in group i. patients may undergo cbmb program after completion of study. after completion of study, patients are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * patient only: patients with a diagnosis of hgg or low grade glioma (lgg), based on radiographic or pathologic diagnosis of grade iii or iv listed in the medical records, or patients with a malignancy that has metastasized to the brain * patient only: patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy) * patient only: karnofsky performance status (kps) of 80 or above * patient only: having a spouse/romantic partner (including same-sex) and who is willing to participate * patient \& partner: able to read and speak english * patient \& partner: able to provide informed consent * patient \& partner: have access to internet connectivity exclusion criteria: * patient only: regularly (self-defined) participation in psychotherapy or a formal cancer support group * patient only: cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
assessing the patient experience in cancer care

Conditions: Brain Neoplasm; Breast Neoplasm; Endocrine Gland Neoplasm; Gastrointestinal Neoplasm; Genitourinary Neoplasm; Gynecological Neoplasm; Head and Neck Neoplasm; Lung Neoplasm; Melanoma; Sarcoma

Summary: communication is an important component of comprehensive cancer care impacting patient satisfaction, adherence, and quality of life. the wide array of issues addressed in cancer clinical interactions makes communicating about a broad range of topics (including quality of life, communication, symptom control, complementary/alternative therapies, costs, treatment burden, prognosis, anxiety, side-effects, sexual function, palliative care options, etc.) especially interesting and potentially challenging. some of these topics may not be routinely addressed in the clinical interaction or may require consultative support from other members of the comprehensive cancer care team. one frequently overlooked critical element in research on communication between cancer clinicians, their patients, and their primary care clinicians is describing real-time consultations between patients and their clinicians. these interactions provide rich material for assessing key psycho-social dynamics and identifying issues that patients find important in their care. in order to devise systems of care that optimize the patient experience, it is critical that clinicians and researchers understand, appreciate, and systematically characterize the richness and complexity of the decision-making process in routine cancer consultations between cancer patients and their treating clinicians. this study seeks to assess the patient experience in cancer care by observing patients and their physicians in their clinical interactions and following them for several months to see how their care went. by describing in-depth the conversations and experiences of patients in these clinical interactions, this study will lay the foundation for practice-based interventions to optimize patients' interactions with their cancer care teams.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * histological confirmation of: brain, breast, endocrine, gastrointestinal, genitourinary, gynecological, head/neck, lung, melanoma, or sarcoma malignancies. * speak english or spanish * not enrolled in hospice * in any of the following phases of the cancer control continuum: initial diagnosis, initial treatment, early survivorship, or recurrence. * provide written informed consent exclusion criteria: