Kornimate/medical-research-clean huggingface dataset:
project adapt: an adaptive physiotherapy intervention augmented with a healthy mind training program for people with chronic low back pain

Conditions: Back Pain Lower Back Chronic; Disability Physical

Summary: in the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (pt) vs. pt augmented with a self-guided, app-based healthy minds innovation wellbeing program (pt+hmi) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (clbp).

the overall objective is to primarily elucidate differential changes in clbp patients administered pt or pt+hmi across physical health domains (back disability, pain interference, actigraphy, gait performance). secondarily, we will elucidate changes in patient-reported physical health outcomes for early non-responders who go on to receive an adaptive intervention that provides augmented treatment pathways. our central hypothesis is that improvements in disability (primary outcome), i.e., responders to pt and pt+well will be differentially associated with changes in physical activity levels, gait kinematics, psychological flexibility, and fear-avoidance. we further predict that initial non-responders who progress to augmented care will show improvements in the primary outcomes. we will conduct a two-armed rct with 20 clbp participants who will receive pt or pt+hmi and test our hypotheses in 3 specific aims. in aim 1, we will use patient-reported measures of disability and pain interference to elucidate subjective physical health outcomes. in aim 2, we will use actigraphy to measure physical activity levels, 3d trunk kinematic measures during gait, and a lifting task to reveal movement-based responders. in aim 3, we will use patient-reported measures for indices of psychological flexibility and healthy emotionality to elucidate mental health processes that correlate with physical health outcomes.

Eligibility criteria:
inclusion criteria: * a minimum age of at least 18 years; the ability to read and speak english; have visited a health care professional for back pain during the past 90 days with a physician referral for pt; have experienced back pain for at least 3 months duration and for at least ½ days in the past 6 months; and currently experiencing at least moderate back-related disability, which was operationalized as a score of ≥24% (12 out of 50 points) on the oswestry disability index (odi). participants needed to have smart device access to engage with the hmi app. exclusion criteria: * having undergone lumbar surgery within the past year; an ongoing disability or worker's compensation, or legal claim; informed by their physician the presence of a serious pathology causing their lbp; pregnancy or planning to become pregnant; and having previously received pt for lbp during the prior 6 months.
osteosclerotic changes on ct predict survival in prostate cancer

Conditions: Prostate Cancer (Adenocarcinoma); Prostate Cancer Metastatic Disease

Summary: the study specifically investigated pc patients with bone metastasis and conducted a comprehensive analysis of the correlation between ocs and patient survival outcomes.


Eligibility criteria:
inclusion criteria: * 1）histopathological confirmation of prostate adenocarcinoma * 2）radiologically verified bone metastasis, assessed through bone scintigraphy and ct imaging from the initiation of systemic therapy until disease progression. exclusion criteria: * 1）lacking of complete clinical profiles.

Keywords: bone metastasis computed tomography osteosclerotic change prostate cancer
biosimilarity study of subcutaneous pegfilgrastim in healthy volunteers

Conditions: Neutropenia

Summary: this study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by megalabs (test product) and neulastim® (reference product) amgen.


Eligibility criteria:
inclusion criteria: * healthy eligible participants able to read, understand and sign the latest version of the informed consent form (icf) approved by the research ethics committee (cep) * males aged between 18 and 55 years * be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ecg), * not indicating any evidence of disease * body weight between 60-100 kg; * body mass index (bmi) ≥ 18.5 and ≤ 29.9 kg / m2; * negative test for coronavirus exclusion criteria: * present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° c), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods); * direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods); * living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods). * participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma; * participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis; * participants with chronic diseases and, therefore, who regularly use medications; * being a smoker or quitting less than 6 months ago; * participants who consume more than 5 cups of tea or coffee a day and who cannot abstain during the trial period; * history of alcohol and illicit drug abuse * electrocardiogram (ecg) findings that, at the investigator's discretion, may compromise participation in the trial; * history or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug; * use of lithium 2 weeks before and / or after medication administration; * participants who are hypersensitive or contraindicated to use any of the components of the formulation; * research participants who have participated in clinical trial protocols in the last 12 (twelve) months (resolution cns 251, of august 7, 1997, item iii, subitem j); * have donated blood (\> 500 ml) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form; * have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form;
efficacy and safety of advate standard prophylaxis to hemophilia a

Conditions: Hemophilia A

Summary: hemophilia a is an x-linked recessive, congenital bleeding disorder caused by deficient or defective coagulation factor viii (fviii). prophylaxis is recommended as the standard of care for boys with severe haemophilia by who and world federation of hemophilia (wfh). the efficacy and safety of prophylaxis in preventing bleeds and arthropathy in patients with hemophilia has been confirmed in well-designed clinical studies.to keep the factor level above 1%, the standard dosage for patients with severe hemophilia a is 20-40 units /kg/infusion (average 30 units /kg) every other day or three times a week. this dosage has a very high consumption of factor, up to 5000-6000 international unit (iu)/kg/year. the high consumption of factor and cost present a major barrier to use the standard prophylaxis in many countries particularly in the developing world. in china the majority of boys with severe hemophilia a can only pay for on-demand treatment or low-dose prophylaxis. ao after the affordability of patients was solved and many patients will get more chance to receive standard prophylaxis. this study is designed to evaluate the annual bleeding rate (abr), joint health outcomes and qol outcomes in subjects using advate(recombinant human coagulation factor viii for injection) standard prophylaxis under the conditions of routine practice.


Eligibility criteria:
inclusion criteria: 1. subject has hemophilia a with fviii≤2 %. 2. previously treated patients (ptps). 3. age from 2 to 18 years. exclusion criteria: 1. subject has known hypersensitivity to the active substance or any of the excipients. 2. subject has known allergic reaction to mouse or hamster proteins. 3. subject has participated in another clinical study involving an investigational product (ip) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving another fviii concentrate or device during the course of this study. 4. subject is planned, or likely to have surgery during the study period. 5. subject has end-stage renal failure or evidence of a severe or uncontrolled systemic disease as judged by the investigator. 6. subject has full-blown acquired immuno deficiency syndrome (aids),determined by cluster determinant 4+(cd4+) and clinical presentation. 7. subject has active hepatic disease (alanine aminotransferase (alt) and aspartate aminotransferase (ast) levels \> 5 times the upper limit of normal). 8. subject has clinical or laboratory evidence of severe liver impairment including (but not limited to) a recent and persistent international normalized ratio (inr)\> 1.4, and/or the presence of splenomegaly and/or significant spider angioma on physical exam, and/or a history of esophageal hemorrhage or documented esophageal varices. 9. the subject in the opinion of the investigator is unable or unwilling to comply with study protocol 10. subject is a family member of the investigator or site staff

Keywords: hemophilia a standard prophylaxis recombinant human coagulation factor viii for injection advate pediatric
dry needling and pain education in the treatment of chronic neck pain

Conditions: Pain, Neck

Summary: to compare the effects on pain, disability and psychological factors of the combination of mtrp dry needling and pain neuroscience education to mtrps dry needing alone and control electrotherapy usual care in patients with chronic neck pain.


Eligibility criteria:
inclusion criteria: * mechanical neck pain for at least 12 weeks * 10% or higher on the neck disability index questionnaire * 20mm or higher on the visual analogue scale (vas) of neck pain * presence of at least one active myofascial trigger point exclusion criteria: * neck pain associated with whiplash injuries * medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis) * neck pain with cervical radiculopathy * neck pain associated with externalized cervical disc herniation * fibromyalgia syndrome * previous neck surgery * neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches
empiric quinidine for asymptomatic brugada syndrome

Conditions: Arrhythmia

Summary: the purpose of this study is to determine if quinidine therapy (not guided by the results of electrophysiologic studies) will reduce the long-term risk of arrhythmic events in asymptomatic brugada syndrome.


Eligibility criteria:
inclusion criteria: 1. patients with asymptomatic brugada syndrome. * "brugada syndrome" is defined as the presence of a type-i brugada electrocardiogram \[coved st-segment elevation ≥2 mm (0.2 mv) in v1, v2 or v3\] either spontaneously (at rest, in the baseline state or during a febrile episode) or following a standard drug-challenge test (with flecainide, ajmaline, procainamide, or pilsicainide) and recorded either with standard electrode position or with the precordial electrodes placed on the second or third intercostal space. negative t waves in the precordial leads are not required to define a type i electrocardiogram. * "asymptomatic patients" will be defined as patients without a history of cardiac arrest, a history of "arrhythmic syncope" or a history of "suspected arrhythmic syncope." arrhythmic syncope" is a syncope occurring during documented ventricular tachyarrhythmias. "suspected arrhythmic syncope" is syncope without documented arrhythmias believed to be caused by a tachyarrhythmia based on clinical judgment. in other words, patients with typical vagal syncope will be counted as "asymptomatic" and will be accepted to the registry whereas patients with a clinical history suggesting "syncope other than vagal syncope" will not be accepted to this registry. * genetic confirmation (identification of a disease-causing mutation) will not be required for establishing the diagnosis of brugada syndrome but will be recorded when present. 2. patients with questionable brugada syndrome who are asymptomatic. * patients with "questionable brugada syndrome" are defined as patients with type ii or iii electrocardiogram who have an inconclusive result during a drug challenge with a sodium channel blocker. "asymptomatic" is defined as above. * genetic testing will not be required. however, patients with "questionable brugada" based on electrocardiographic criteria will be defined as "patients with brugada syndrome" if a disease-causing mutation is identified. exclusion criteria: 1. a history of cardiac arrest, "arrhythmic syncope" or "suspected arrhythmic syncope" (as defined above). 2. evidence of organic heart disease. the evaluation considered mandatory for excluding heart disease will consist of electrocardiogram, echocardiogram and exercise stress testing. additional tests will be performed only if clinically indicated. 3. evidence of non-cardiac disease likely to affect 5-year survival.

Keywords: brugada syndrome quinidine asymptomatic brugada syndrome
a study of amphotericin b in the treatment of fungal infections of the mouth in hiv-infected patients who have not had success with fluconazole

Conditions: Candidiasis, Oral; HIV Infections

Summary: to assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin b oral suspension. experience with amphotericin b oral suspension for drug-sensitive thrush in hiv-infected patients is limited but encouraging.

experience with amphotericin b oral suspension for drug-sensitive thrush in hiv-infected patients is limited but encouraging. patients swish and swallow amphotericin b oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. failures discontinue the study. responders after 28 days of induction are placed on maintenance. after successful completion of initial induction, patients remain on study for 6 months.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection or diagnosis of aids. * diffuse oral candidiasis, symptomatic or asymptomatic, that is resistant to fluconazole. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * current symptoms of esophageal candidiasis unless there are negative endoscopic visualization and biopsy for candida or related yeasts. * perioral lesions only (e.g., angular stomatitis, perleche). * inability to swish and swallow oral solution. * inability to tolerate further oral therapy for thrush. concurrent medication: excluded: * fluconazole. * itraconazole. * ketoconazole. * flucytosine. * intravenous amphotericin or other non-study formulations. * nystatin. * clotrimazole. * other investigational antifungal agents. * systemic cytotoxic chemotherapy for malignancy. concurrent treatment: excluded: * radiation therapy to the mouth, neck, or chest. patients with the following prior conditions are excluded: * esophageal candidiasis, proven or presumptive, occurring since fluconazole failure. * successful treatment of thrush with fluconazole at \<= 200 mg/day after original treatment failure. * history of oral candidiasis that recurred or persisted despite iv amphotericin b given once or more weekly. * history of anaphylaxis to amphotericin b. * history of hypersensitivity to components in amphotericin b oral suspension. prior medication: excluded within 6 weeks prior to study entry: * cytotoxic therapy for malignancy. * corticosteroids at higher than replacement doses.

Keywords: administration, oral acquired immunodeficiency syndrome amphotericin b aids-related complex candidiasis, oral suspensions
use of ebus tbna for cell culture as an aid to diagnose lung cancer and lymphoma

Conditions: Lung Cancer; Lymphoma; Non-small Cell Lung Cancer; Non-Hodgkin Lymphoma; Mediastinal Lymphadenopathy

Summary: participants who are scheduled to have an endo bronchial ultrasound (ebus) trans bronchial needle aspiration (tbna) will provide additional samples. these samples will then be sent to imperial college london to see whether a cell line can be grown. if growth is successful then the samples will be returned to our pathology department to see if grading is possible and then to compare these results with the previous diagnostic samples. the cell line samples will not be used for patient diagnosis.

obtaining adequate pathological specimen is essential in the diagnosis of cancer. ultrasound guided sampling through endo bronchial ultrasound (ebus) trans bronchial needle aspiration (tbna) has emerged as a safe and accurate technique in the diagnosis and staging of lung cancer but subtyping and/or genotyping of tbna samples obtained by convex probe ebus has long been considered to be limited by the lack of tissue architecture in these small tissue samples. the performance of small tissue samples in non-small cell lung cancer (nsclc) subtyping has been proven to be accurate in modern pathology practice adopting cell blocks and immunohistochemistry (ihc), reducing the nsclc not otherwise specified rate for needle aspiration samples to 8-23%. it has also shown recently a promising result in work up of mediastinal lymphadenopathy when lymphoma is suspected. it is thought that at times ebus tbna sample is still inadequate for further essential testing for diagnostic and therapeutic purpose and enhancing the yield is possibly by cell culture will not only be useful for diagnosing lung cancer and lymphoma but also will provide material for future research study. we have therefore developed a research proposal in collaboration with scientists at the biomedical research laboratory at imperial college london, who have excellent record in basic scientific research and currently involved in similar research on cell culture for other type of diseases.

Eligibility criteria:
inclusion criteria 1. male or females aged \>18 years 2. completed chest ct 3. written informed consent exclusion criteria 1. patients with active tuberculosis (tb) 2. pregnancy 3. patients with significant psychiatric and or neurological comorbidity

Keywords: endo bronchial ultrasound trans bronchial needle aspiration cell line lung cancer
apparatus and method for moving patients

Conditions: Respiratory Failure; Covid19

Summary: a novel device and process to move patients has been developed, particularly useful for patients with severe respiratory failure (ie covid 19) who require prone ventilation (moving from their back onto the stomach and then onto back for a 16 hour cycle, usually for several days). this study will assess staff impressions of the feasibility of the use of this device/ process to prone patients as well as their impressions of the use of this device, compared to repositioning sheets, for the general care of the icu patient. an economic analysis of the use of the ammp for proning compared to movement without assists will be done

movement of non ambulatory patients is typically a physically demanding, resource intensive intervention that places the healthcare team members at risk of injury. a quantitative survey of healthcare team members perspectives on the challenges associated with patient movement will be distributed. this is particularly true for caregivers responsible for severely ill respiratory failure patients (ie covid 19) who are moved into prone position (flipped on to their stomach) and back to supine over a 16 hour cycle, typically repeated for several days, as part of their therapy. (proning) a method of wrapping the patient in a secure "cocoon" which is coupled to a mechanical lift system through a designed strapping system and support bar will be tested for proning on healthy volunteers and then in the clinical environment ( intensive care unit (icu) . healthcare team members will complete surveys to assess ease of use, efficiency, safety and physical demands of this process relative to traditional (control) manual methods of patient reorientation, without the use of assists for proning. critically ill nonambulatory patients require assistance to move. the ammp can be used to assist and impressions of this device. comparing the impressions of healthcare team members of the use of the ammp, repositioning sheets, and to care without the use of a movement assistance device will be undertaken using quantitative surveys an economic analysis of the use of the ammp to prone patients, focused on personnel time and personal protective equipment use, compared to proning without assistance, will be completed

Eligibility criteria:
inclusion criteria:any adult icu patient is eligible for enrolment in assessment of health care team members impressions of the use of repositioning sheets for general care ( movement up or down the bed or in to lateral position) adult icu patients admitted to the icu with severe respiratory failure (pao2/fio2 ratio \<150) are candidates for use of the ammp for prone positioning unless exclusion criteria are present adult icu patients requiring general care are candidates for use of the ammp for general care unless exclusion criteria are present - exclusion criteria:discretion of icu attending, unable to obtain consent, unstable spine fracture, chest tube drainage in place, open abdomen, \>140 kg -

Keywords: prone ventilation patient movement
reducing cognitive impairment in glioma with repetitive transcranial magnetic stimulation and cognitive strategy training

Conditions: Cognitive Impairment; Glioma

Summary: the true-grit study will assess the feasibility of a study protocol investigating the efficacy of a combination therapy consisting of cognitive strategy training (cst) and repetitive transcranial magnetic stimulation (rtms) to reduce cognitive impairment in adult glioma patients. this study is part of the grip-project, a project aimed at investigating interventions for improving quality of life in brain tumor patients.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * histological diagnosis of diffuse glioma (who grade 2,3, or 4) * subjective cognitive impairment, defined as cfq-score ≥ 44 * being able to give informed consent and undergo treatment and measurements based on researchers insight * stable disease, i.e. no oncological treatment for ≤ 2 months prior to inclusion; no radiological progression on the most recent mri, not older than 6 months, and no clinical progression at inclusion * stable dosage (for at least 8 weeks) of anti-epileptic medication exclusion criteria: * current pregnancy or have given birth less than three months ago * current other treatment for cognitive complaints * karnofsky performance score \<70 * a tumor located in the parietal cortex * tms exclusion: implanted medical devices (e.g. pacemaker, deep brain stimulator, cochlear implants, medical infusion device, etc.); metal in the body; sleep deprivation * mri exclusion: extreme claustrophobia or metallic objects in or on the body

Keywords: repetitive transcranial magnetic stimulation (rtms) cognitive strategy training (cst) cognitive impairment