Kornimate/medical-research-clean huggingface dataset:
a randomized prospective trial of total knee arthroplasty options comparing standard knee cutting guides and mri generated patient specific custom cutting guides

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery: 1. standard knee cutting guides; 2. mri generated patient specific custom cutting guides. both types of cutting guides used in this study are registered with the u.s. food and drug administration (fda) and are routinely used for knee replacement surgery. however, it is unknown if one type of cutting guide has risks or benefits over the other.


Eligibility criteria:
inclusion criteria: * age 18 - 75 * diagnosis of osteoarthritis of the knee and qualify for surgery, as indicated by one of the following: * painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved; * correction of varus or valgus. * willing to participate and return for follow-up study visits. exclusion criteria: * infection * sepsis * osteomyelitis * uncooperative patient or patient with neurologic disorders who is incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction * marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency * muscular atrophy * neuromuscular disease * incomplete or deficient soft tissue surrounding the knee * previous osteotomy * diagnosis of rheumatoid arthritis * previous patella fracture or surgery * previous healed tibia or femur fractures * previous joint replacement surgery * cannot have an mri * patients receiving single-stage bilateral total knee arthroplasty (tka)
immuno-inflammatory profile and response to ischemic stroke reperfusion therapies (immunostroke)

Conditions: Stroke; Ischemic Stroke

Summary: immunostroke study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of aic management by reperfusion treatment and to monitor changes in these different parameters over time. post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-aic functional and cognitive disability.


Eligibility criteria:
inclusion criteria: * presenting an ischemic stroke for which reperfusion treatment is indicated according to european and north american recommendations (intraveinous thrombolysis or mechanical thrombectomy or a combination of both) exclusion criteria: * contraindication to performing a cerebral mri (claustrophobia, pacemaker or other implantable device contraindicating the performance of mri) * intracranial haemorrhage associated with aic on initial imaging * immunosuppressive treatment or corticosteroid therapy on admission of the patient * pre-existing neurological disability limiting the neurological assessment to 3 months (mrs\>2 on admission) * dementia known and diagnosed pre-existing at ischemic stroke * absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance \<15ml/min, pregnant or breastfeeding woman).
evaluation of tissue perfusion in peripheral arterial disease (evti-pad)

Conditions: Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Critical Limb Ischemia

Summary: in this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).

arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (pad). quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. not only in pad patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. digital subtraction angiography (dsa) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. however, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. in this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.

Eligibility criteria:
inclusion criteria: - patients with symptomatic peripheral arterial disease (rutherford categories 3-6) requiring revascularization. exclusion criteria: * patients younger than 18 years * patients unable to give consent without legal guardians * iodine allergy * hyperthyroidism * allergy to indocyanine green * glomerular filtration rate \<30ml/min/1.73m2

Keywords: tissue perfusion peripheral arterial disease critical limb threatening ischemia critical limb ischemia fluorescence angiography fluorescence imaging indocyanine green microcirculation
copd assessment test can predict depression

Conditions: Depression,; COPD

Summary: the frequency of depression in copd patients are substantial and early detection and prevention of depression is critical. recently, copd assessment test (cat) was developed and validated to assess the impact of copd on patients' quality of life. in this prospective study, we will investigate the predictive utility of cat for predicting depression in copd patients.

this study is aimed to investigate the association between the copd assessment test (cat) and depression in stable copd patients. stable copd patients will be enrolled from the tertiary hospitals. all patients will undergo lung function tests. the korean versions of the cat (copd assessment test) and patient health questionnaire-9 (phq-9) will be used to assess copd symptoms and depressive disorder, respectively. we will compare the depresssion frequency among gold classifications of airway limitation and among the four cat groups. and. we will also investigate which items of the cat are the strongest indicators of depression.

Eligibility criteria:
inclusion criteria: * copd patients who aged \> or = 40 years exclusion criteria: * acute exacerbation within 3 months * bronchial asthma or an increase in fev1 of more than 12% of the predicted value with the use of 400 µg of albuterol. * other lung diseases such as bronchiectasis, interstitial lung disease, and tuberculosis-destroyed lungs. * who denied to consent.
to compare positron emission tomography (pet) measurements of fibrillar amyloid burden

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to compare pet measurements of fibrillar amyloid burden using \[18f\]azd4694.


Eligibility criteria:
inclusion criteria: * male or female, of any race or/ethnicity * ecg, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician exclusion criteria: * significant recent (within 6 months) history of neurological (including stroke) or psychiatric disorder or substance abuse * participated in a pet study within the last 12 months * pregnancy or lactation

Keywords: pet alzheimer's disease diagnostic
nalbuphine versus ketamine for prevention of emergence agitation after sevoflurane in children undergoing tonsillectomy

Conditions: Pediatric ALL; Pediatric Anesthesia

Summary: the effect of low dose nalbuphine or ketamine in the prevention of emergence agitation after sevoflurane anesthesia in children undergoing tonsillectomy with or without adenoidectomy. this randomized double-blind study was carried out at, ain shams university hospitals, from march 2021 to june 2021 on 90 patients after approval of the ethical committee.

emergence agitation (ea) in children is increased after sevoflurane anesthesia. nalbuphine and midazolam have been used for prophylactic treatment with controversial results. patients and methods:totally, 90 children between 4 and 10 years of age and of american society of anesthesiologists i-ii undergoing adenotonsillectomy under sevoflurane-based anesthesia were enrolled in the study. children were randomly allocated to one of the three groups: group n received nalbuphine 0.1 mg/kg, group k received ketamine 0.25 mg /kg and group s received the equivalent volume saline. the study medications was given after discontinuation of sevoflurane by the end of surgery. in the post anesthesia care unit emergence agitation was assessed with emergence agitation scale upon admission (t0), after 5 min (t5), 10 min (t10), 15 min (t15), 20 min (t20), 25 min (t25) and 30 min (t30).

Eligibility criteria:
inclusion criteria: pediatric patients undergoing tonsillectomy with or without adenoidectomy 1. age 4 - 10 years. 2. sex: both sexes 3. patients with asa classificaion i and ii. exclusion criteria: 1. declining to give written informed consent. 2. history of allergy to the medications used in the study. 3. psychiatric disorder. 4. asa classification iii-v. 5. fever ,cough , asthma or upper respiratory tract infection . 6. anticipated difficult airway . 7. hearing defect . 8. neurological disorder. 9. family history of malignant hyperthermia .

Keywords: emergence agitation ketamine nalbuphine sevoflurane.
domiciliary versus hospital management of pprom

Conditions: Preterm Premature Rupture of Membrane

Summary: this study is designed to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (pprom) on fetal, neonatal and maternal outcome.

background: pprom is encountered in 2.0% to 3.5% of pregnancies. domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. reliable discharge criteria have been mentioned by few studies for patients with pprom. studies had shown that domiciliary care management in a context of pprom did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. however, eligibility criteria for domiciliary care management were heterogeneous aim of the work: the aim of this study is to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (pprom) on fetal, neonatal and maternal outcome. patients \& methods: the current trial was conducted at ain shams university maternity hospital. a total of 3662 pregnant women were recruited from the outpatient clinic \& emergency room and included in the study. then, they were randomized into two groups; group (d) was counseled for home care management, while group (h) was hospitalized. take-home baby was assessed as a primary outcome and other maternal, fetal \& neonatal complications were recorded \& moreover latency period, mode of delivery \& preference of care were assessed

Eligibility criteria:
inclusion criteria include women with pprom ≥28 weeks \& \<37 weeks with no signs of intra-amniotic infection \& membranes rupture is confirmed by a sterile speculum examination and decrease amniotic fluid on ultrasound with singleton, viable, cephalic presenting fetus, morphologically normal fetus by ultrasound \& reactive fetal heart rate tracing with no evidence of meconium-stained liquor exclusion criteria: * query pprom: a history of pprom with no pooling of amniotic fluid from the cervix on a sterile speculum examination * maternal comorbidities (diabetes mellitus, hypertension, etc.) * patients with placenta previa * amniotic fluid pocket on ultrasound \< 2x2 cm * logistic problems interfering with follow-up * inability to check temperature every six hours, with parameters for notifying their clinician (temperature ≥38°c) * non-dependable transportation
oxygen portable concentrator during exercises in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (pocs) and liquid oxygen (los) portable units, pose a question if pocs are equally effective as los in reducing exercise-induced hypoxaemia. design: randomized, single-blind clinical trial.

our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with copd receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.

Eligibility criteria:
inclusion criteria: * copd with respiratory failure and indication for oxygen supplementation at rest and/or during exercice. exclusion criteria: * evolutive heart disease. * unability to understand or realize the tests. * acute exacerbation during the last month.

Keywords: copd patients with respiratory failure
robotic laparoscopic radical prostatectomy

Conditions: Prostate Cancer

Summary: this is a pilot study to evaluate the role of ralrp in the management of localized prostate cancer.

to establish a robotic-assisted laparoscopic radical prostatectomy programme at the university of western ontario/london health sciences centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.

Eligibility criteria:
inclusion criteria: 1. informed consent 2. locally confined, stage t1a, t2a or t2b prostate cancer 3. aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy. 4. serum prostate specific antigen equal to or less than 10mg/ml 5. histologically confirmed adenocarcinoma of the prostate 6. gleason score equal to or less than 7 7. life expectancy of greater than 10 years. 8. prostate size on trus measurement less than 40 grams exclusion criteria: 1. patients who have undergone prior hormone therapy. 2. patients with a previous transurethral resectioning of the prostate (turp) 3. history of other cancers other than basal cell carcinoma. 4. patients with any prior abdominal surgery. 5. any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions) 6. patients with a large median lobe of the prostate. - exclusion criteria: -
phase i/iia clinical evaluation of allert vs placebo in subjects allergic to birch pollen

Conditions: Allergic Rhinitis; Allergy

Summary: birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (sit) or ultra-rush immunotherapy. such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. the aim of this study is to test the new product allert expected to show widely reduced side effects. allert will be injected via two different routes, subcutaneous versus intradermal. the primary endpoint of the study is the local and systemic safety of repeated injections of the product. since allert should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (npt) with birch pollen

in addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (april 2009) and to obtain blood samples for evaluation of immunology markers igg4 and ige after the season 2010 (july 2010) and after the season 2012 (july 2012),

Eligibility criteria:
inclusion criteria: * allergic rhinitis symptoms during the pollen season preceding the study, confirmed by spt (prick tests) and/or a positive specific ige cap test for birch pollen (class i minimum) * positive spt to bet v 1 (prick tests), negative spt to allert exclusion criteria: * received immunotherapy against any allergen within 3 years before the start of the study. * symptomatic to perennial allergens or active seasonal allergy during the trial. * non controlled asthma (peak flow lower than 30% of predicted value). * history of any severe medical condition able to influence the course of the study * any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (hiv) infection and asplenia. * subjects under immunosuppressive medication. * pregnant or lactating women or women willing or intending to become pregnant during the study. * any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study

Keywords: allergy birch pollen immunotherapy
the effect of fatigue on static and dynamic balance in healthy young male athletes

Conditions: Fatigue

Summary: participants were randomized into control and experimental groups. they were examined on static and dynamic balance (pre- \& post-tests). then, the experimental group went through a fatigue protocol, in which speed and incline increase one unit each minute passing, and stopped when rate of perceived exertion level reached ≥ 18, and the plasma lactate level differed from the baseline by ≥ 4mmol/l.


Eligibility criteria:
inclusion criteria: * male and aged between 18-24 years old, * physically active (i.e. exercised ≥ 3 times weekly during the past three months). exclusion criteria: * reported a minor injury in the past two months, * major injury in the past 12 months, and/or underwent a major primary surgery in their lower limb.

Keywords: static balance athletes dynamic balance lactate
efficacy of manuel pressure and local cold spray in reducing injection pain in pregnant women

Conditions: Pain, Acute; Alloimmunisation in Pregnancy; Injection Site; Injection Fear

Summary: a randomized controlled study was planned to determine the effect of manual pressure and local cold spray application on the intensity of pain, fear, hemodynamic parameters, and satisfaction related to the pain reduction of human anti-d immunoglobulin injection administered to pregnant women.

injections are a commonly used treatment method that can induce fear, tension and anxiety in individuals despite their frequent use. the use of long needles, especially for intramuscular injections, to reach the target area through an injection can disrupt tissue integrity and cause discomfort. therefore, injection pain is a widespread problem. depending on the severity of perceived pain, it can affect an individual's hemodynamic parameters. pain-related factors such as high heart rate, blood pressure, low oxygen saturation, and hyperventilation can develop. primary caregivers, such as nurses, attempt to minimize pain by using pharmacological methods (local anesthesia, adjuvant analgesia, non-steroidal anti-inflammatory drugs (nsaid), opioids, paracetamol) and non-pharmacological interventions (manual pressure, cold application, helfer skin tap, shotblocker, massage, internal rotation, buzzy). human anti-d immunoglobulin injection, like all other injections, causes pain, negatively affecting the quality of life and treatment experiences of individuals. in our study, we aim to evaluate the effectiveness of pre-injection manual pressure and local cold spray application, create data in the clinical field and reduce injection pain in pregnant women to have a positive impact on injection satisfaction and hemodynamic parameters.

Eligibility criteria:
inclusion criteria: * ability to understand, speak, read and understand turkish * volunteering to participate in the study * being pregnant (gestational week 20 and above) * being between the ages of 18-45 * has not had an im injection in the last week * there are no complications related to im injections such as pain, abscess, infection, tissue necrosis, hematoma at the im injection site. * not taking any analgesics before the procedure * no chronic disease * those who do not have visual or cognitive impairments that prevent them from marking measurement tools exclusion criteria: * not volunteering to participate in the study * having chronic pain disorders

Keywords: human anti-d immunglobulin red blood cell alloimmunization injection pain local cold therapy manuel pressure pregnancy
the united kingdom multiple sclerosis register covid-19 substudy

Conditions: Multiple Sclerosis; COVID-19

Summary: the aim of the study is to understand the impact of covid-19 on people with multiple sclerosis in the united kingdom.

study objectives 1. to identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of covid-19 infection, respiratory tract infections suggestive of covid-19, and covid-19 confirmed by laboratory testing among the uk ms population 2. to establish if some dmds increase the risk of covid-19 infection 3. to determine the incidence and effectiveness of self-isolation in the ms population. to examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the ms register. 4. to determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of covid-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death. 5. to determine the longer-term impact of covid-19 on ms, using routinely collected ms outcomes in the ms register, including impact on disability, relapses and changes in dmds as assessed at 3 monthly intervals. 6. to determine where people are obtaining their health information during the covid-19 outbreak. 7. to establish changes in dmds prior to and as a result of symptoms related and unrelated to covid-19

Eligibility criteria:
inclusion criteria: * \>18 and confirmed diagnosis of ms, enrolled on uk ms register exclusion criteria: * none of the above
upper extremity elevation and lungfunction after open heart surgery

Conditions: Heart Diseases; Heart Diseases, Ischemic; Heart Disease, Valvular

Summary: the purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.

this single center, interventional crossover study will involve patients day 2, 3 or 4 after open heart surgery. patients who meet the eligibility requirements will be informed about the study and potential risks, given a written informed consent they will be included for intervention being held later on the same day. randomization will be given to the investigator in a sealed envelope and being opened after base line measurements. data will then be collected for the randomized intervention and after a wash out period (several minutes) again for the crossover intervention.

Eligibility criteria:
inclusion criteria: * open heart surgery at university hospital in örebro exclusion criteria: * not able to communicate in swedish * difficulties in cooperating during measurements * cognitive impairement * prolonged stay at icu (still at icu on the day of investigation) * ongoing oxygen treatment with more than 5 liter/minut (fio \> 40 %)