Kornimate/medical-research-clean huggingface dataset:
long-term outcomes of patients with rheumatoid arthritis in remission

Conditions: Rheumatoid Arthritis (RA)

Summary: the goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with ra in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources. the investigators will perform an extensive evaluation of all patients who participated in the arctic rewind study 10 and 15 years after they achieved sustained remission and received different treatment strategies.

rheumatoid arthritis (ra) is a chronic inflammatory disease that affects 0.5 to 1.0% of the population. in case of ineffective treatment, the inflammation can lead to joint destruction and reduced physical function, as well as affecting internal organs. ra is associated with an increased risk of cardiovascular disease and osteoporosis. the prognosis for ra has improved significantly over the past two decades, with effective treatment strategies and available drugs allowing a significant proportion of patients to achieve the treatment goal of remission (absence of signs of inflammation). ra has thus become a 'controllable' disease, and the large increase in the number of ra patients in remission leaves a need for improved understanding of how to best treat these patients. a total of 259 ra patients in sustained remission were included in the arctic rewind trial. they were randomized to either tapering of dmards, or to continue stable dmard medication, and followed for three years. the current study will provide a 10- and 15-year follow-up on the outcome of all these patients. the results from the project will add knowledge about the long-term consequences of achieving sustained remission, as well as of experiencing a disease activity flare regarding dmard use, joint damage progression, functional status and work productivity, and the study will provide novel data on cardiovascular health and other comorbidities in this patient group. further, the patient perspective on flare will be explored. such information will be valuable for patients and clinicians to improve shared decision on further treatment, and potentially allow more patients to reduce treatments in an evidence-based manner. results from the study could influence approaches to the management of ra in the future, as selecting patients who can be switched to remote care (reduce the number of visits the patient has to attend physically).

Eligibility criteria:
inclusion criteria: * participation in the arctic rewind trial * patients able and willing to give written informed consent and comply with the requirements of the study protocol exclusion criteria: * psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.

Keywords: remission tapering drug-free remission long-term outcomes
kinesio taping in sit to stand movement fo cerebral palsy

Conditions: Cerebral Palsy

Summary: children with cerebral palsy (cp) present limited performance of functional activities and activities of daily life. kinesio taping has been definied as a promising technique for children with cp ans has been extensively used in clinical practice. however, several studies have found a low level of evidence of its effectiveness in healthy individuals. we aim to evaluate the effects of the immediate application of kinesio taping on the activation of the rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in children with cp.


Eligibility criteria:
inclusion criteria: * diagnosed with spastic cp * aged from 5 to 18 years * gross motor function classification system levels i and ii * able to understand simple commands * able to perform the sit-to-stand movement without support exclusion criteria: * muscle shortening in hamstring, gastrocnemius and hip flexors * deformities in the lower limbs such as fixed hip and knee flexion that could compromise the sit-to-stand movement * surgical procedures in the lower limbs and trunk in the previous 12 months * botulinum toxin injection in the previous 6 months

Keywords: intervention children
military health and nutrition examination study

Conditions: Hypertension; Type 2 Diabetes; Dyslipidemias; Cardiovascular Diseases

Summary: the military health and nutrition examination study (mhanes) is a department of defense funded study conducted by pennington biomedical research center and the us army research institute of environmental medicine. this cross-sectional study will assess, in a large, diverse sample of army service members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. the proposed study is modeled after the national health and nutrition examination survey (nhanes) and customized for the army population.

background: comprehensive scientific data on dietary intake, nutritional status, cardiometabolic health, and performance of a representative sample of active-duty soldiers are not available. collecting such data will allow for assessment of disease prevalence and health status, provide novel descriptive information, and examine relationships between health and nutrition variables that are currently unavailable on the army active-duty population. study aim: to assess, in a large, diverse sample of army service members, dietary intake, nutritional status, cardiovascular health, body composition, metabolic biomarkers of nutritional state, and other measures of health status.

Eligibility criteria:
inclusion criteria: * u.s. army soldiers ≥ 18 years old * willing to have biological samples stored for future use * willing to have data linked to the soldier performance, health, and readiness (sphere) database exclusion criteria: * soldiers under the age of 18 years * soldiers with an inability to understand verbal or written instructions or testing materials in english * soldiers relocating or getting out of the army in the next 30 days * pregnant females * soldiers currently in basic training (bct) and/or one-station unit training (osut)

Keywords: diet quality healthy eating index body composition dietary supplements gut microbiome army combat fitness test
prospective cohort of patients with newly diagnosed glioblastoma: analysis of mmp2 and mmp9 expression and correlation to neuro-imaging features.

Conditions: Brain Tumor

Summary: glioblastoma is the most frequent and aggressive primary brain tumor in adults. a team recently showed that baseline plasma levels of matrix metalloproteinase-2 (mmp2) and matrix metalloproteinase-9 (mmp9) were correlated to bevacizumab activity in patients with recurrent glioblastoma. to date, the biological rationale of this results remains unknown but mmp2 could be involved in classical angiogenesis while mmp9 could promote vasculogenesis. the objectives are to correlate the plasma levels of mmp2 and mmp9 to their ribonucleic acid (rna) and protein tissue expression, activity and to patient neuro-imaging features. to analyze the changes of mmp2 and mmp9 plasma levels during peri-operative period and after radio-chemotherapy. methods: plasmatic levels of mmp2, mmp9, vascular endothelial growth factor-a (vegfa), vascular endothelial growth factor-r2 (vegfr2), stromal cell-derived factor 1 (sdf1) and chemokine receptor-4 (cxcr4) will be analyzed by enzyme-linked immunosorbent assay (elisa) in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma. rna expression of these factors will be analyzed by reverse transcription-polymerase chain reaction (rt-qpcr) on frozen tumor samples, whereas protein expression will be analyzed by elisa and immunohistochemistry. enzymatic activity of mmp2 and mmp9 will be analyzed by zymography. tumor volume, infiltration and perfusion degrees will be analyzed on magnetic resonance imaging (mri) performed before and after surgery and before adjuvant temozolomide. neuro-imaging characteristics will be correlated to plasma and tissue expressions of these factors. the expected results are to better define the expression profile of mmp2, mmp9 and the change in their plasma level during treatment, a prerequisite for their clinical use.


Eligibility criteria:
inclusion criteria: * patient, male or female, aged 18 years or over * imaging suggestive of glioblastoma * patient eligible for excision surgery (partial, subtotal or macroscopically complete) * candidate for concomitant and adjuvant radiotherapy chemotherapy (stupp protocol) * patient having signed an informed consent * patient having undergone a preoperative mri exclusion criteria: * existence of a contraindication to the mri * nonoperable lesion * history of radiotherapy and / or chemotherapy for this lesion * scalability of a low grade lesion * person in emergency situation, a legal person of legal age (guardianship, guardianship or legal guardianship), or unable to express his or her consent * no affiliation to a social security scheme (beneficiary or beneficiary) * pregnant or lactating woman
trial comparing the effect of a paravertebral block on pain post percutaneous nephrolithotomy

Conditions: Nephrolithiasis

Summary: this is a randomized control trial (meaning the selection is random as when flipping a coin) to assess the benefit of paravertebral blockade (pvb) in percutaneous nephrolithotomy/nephrolithotripsy (pcnl) surgery.

percutaneous nephrolithotomy/nephrolithotripsy (pcnl) is an effective treatment that offers maximal physical removal of large kidney stones. however, despite the minimally invasive nature of the procedure, postoperative pain still remains a significant concern. general anaesthetic (solution given to put the patient to sleep) for the procedure is routinely given, along with a local anaesthetic injection at the operative site (injection of anaesthetic solution to the incision area to reduce the pain after the procedure) and pain pills to reduce the pain even further after surgery. paravertebral nerve blockade (pvb) is a technique for inserting anesthetic solution into an area near the vertebrae (bony segments that form the spinal column of humans or backbone), and is an effective method for reducing pain in the post operative period from a variety of surgeries. the investigators expect that the pvb can decrease side effects from opioids (pain medication) and other analgesics used post-operatively. opioid side effects include nausea, vomiting, urinary retention, constipation, and drowsiness. other side effects associated with anaesthetic use include peptic ulcer disease and acute renal failure. the investigators also expect that pvb will result in decreased post-operative pain.

Eligibility criteria:
inclusion criteria: * 19 or older, able to give consent * asa 1, 2 or 3 patients * patients to undergo pcnl exclusion criteria: * complex stone with anticipation of requiring \>1 access sites * prior diagnosis of chronic pain requiring daily opioid analgesia for \> 1 month prior to diagnosis of nephrolithiasis * allergy to local anesthetic * local infection at site of regional anesthesia * back or other msk deformity that contributes to inaccuracy of paravertebral block placement * severe cardiopulmonary disease * fibromyalgia * anticoagulation * patient with language barrier or inability to communicate

Keywords: paravertebral nerve blockade percutaneous nephrolithotomy/nephrolithotripsy opioids pain
clinical application of an automated liquid biopsy platform for early detection of colorectal cancer

Conditions: Colo-rectal Cancer

Summary: colorectal cancer (crc) is among the most preventable cancers when precancerous lesions are detected at an early stage. current screening methods for crc require bowel prep or stool-based testing that are inconvenient, resulting in low compliance. stool based tests have limited sensitivity for the detection of precancerous lesions. the cmx platform has been showed to be able to the detection of circulating tumor cells (ctcs) in high sensitivity and specificity. in published studies, circulating tumor cells (ctcs) are captured and quantified in advanced-stages of colorectal cancer. in order to detect early and pre-cancer circulating tumor cells, we have developed an automated liquid biopsy platform that improves the detection of ctcs in early cancer stages. therefore, this study goals are: 1) to establish a standard detection process utilizing the automated liquid biopsy platform. 2) parallel comparison of laboratory manual operation and automated liquid biopsy platform. 3) verify the feasibility of use of an automated liquid biopsy platform in the clinical setting.

1. selection of patients: a. the disease group includes 300 patients diagnosed with stages 0-4 colorectal cancer not previously treated. b. the control group includes 450 control subjects who will undergo a colonoscopy procedure. 2. study stages stage i: the laboratory manually analyzes circulating tumor cells to establish a standard detection process for automated liquid biopsy system stage ii: comparison analysis between manual and automated liquid biopsy platform, establishing the procedural and analytical models for the automated liquid biopsy platform stage iii: verification of the feasibility of use of an automated liquid biopsy platform in the clinical setting. 3. methods i. ctc isolation peripheral blood drawn from subjects will be processed using the cmx platform or the automated liquid biopsy system for detection and capture. ii. characterization of isolated ctc using immunofluorescence staining iii. crc-related gene expression the serum and circulating tumor cells isolated from the blood will be used to extract rna, and then be analyzed with the expression of different genes by real-time quantitative polymerase chain reaction (real-time pcr).

Eligibility criteria:
inclusion criteria: * 1. the disease group is diagnosed with colorectal cancer 0-4 and has not been treated. * 2. the control group will receive colonoscopy * 3. above 20 years old exclusion criteria: * 1. refuse to sign the informed consent form * 2. received surgery within one month * 3. previous cancer history * 4. autoimmune diseases * 5. chronic inflammatory diseases * 6. acute inflammatory or infectious diseases in three months * 7. myelodysplastic syndromes and myeloproliferative disorder * 8. other diseases decided by pi

Keywords: colorectal cancer crc circulating tumor cells ctcs early detection automated
bone, inflammation, gut and renal biomarkers in antiretroviral naïve hiv-1 positive subjects

Conditions: HIV Positive

Summary: co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (ckd) are frequent in people living with hiv, and may be driven by ongoing inflammation and immune activation. initiation of art reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.


Eligibility criteria:
inclusion criteria: * hiv-1 positive * age 18-64 years * able to give informed consent * not previously treated for chronic hiv-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago * due to commence antiretroviral therapy by treating clinician exclusion criteria: * - previous major intestinal surgery/inflammatory bowel conditions * infective diarrhoea in the last 3 months * bmi\<18.5 * currently pregnant or planning to conceive during the study period * previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago * use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months
improving voice production for adults with age-related dysphonia

Conditions: Presbylarynx; Age-Related Dysphonia

Summary: the objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. the central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.


Eligibility criteria:
inclusion criteria: * adults in age range who volunteer * can understand and complete directions presented in english * people with voice disorder associated with advancing age will be included, including bowing, incomplete closure, mild edema, erythema, signs of laryngopharyngeal reflux. exclusion criteria: * laryngeal differences not related to aging (e.g., vocal fold paralysis, moderate-severe edema, lesions, leukoplakia, dysplasia, parkinson disease) * known history of stroke, brain injury, or other neurological disorder
microbiome analysis of skin and airway samples and effect of face masks

Conditions: Healthy

Summary: the goal of this study is to optimize two methods for microbiome analysis of skin and upper airway samples (16s amplicon sequencing and shotgun sequencing). in addition, the researchers will investigate whether there is an effect of wearing a face mask on the microbial communities of the skin and upper airways. the volunteers will self-collect swabs of the skin and upper airways (nose and/or throat). bacterial dna and/or total rna will be isolated and the microbial communities will be investigated with 16s amplicon sequencing and shotgun metagenomic sequencing.


Eligibility criteria:
inclusion criteria: * adult age 18 at the start of the study exclusion criteria: * pregnant women

Keywords: skin microbiome 16s amplicon sequencing face masks upper airway microbiome shotgun sequencing
trial of vitamin c as add on therapy for children with idiopathic epilepsy

Conditions: Idiopathic Epilepsy

Summary: there are no solid treatment guidelines for idiopathic intractable epilepsy in children. the investigators propose that vitamin c being an antioxidant will improve seizure frequency and eeg in children with idiopathic intractable epilepsy.

is vitamin c; being an antioxidant based on the hypothesis of oxidative stress as a provocation factor for idiopathic epilepsy low in those with idiopathic epilepsy, and is it lower in those with refractory than those with newly diagnosed? will vitamin c supplementation for 1 month be efficient to raise the vitamin c level and will it improve seizures and eeg findings in those with idiopathic epilepsy?

Eligibility criteria:
inclusion criteria: * normal neuroimaging exclusion criteria: * developmental delay. * suspected metabolic problems.

Keywords: vitamin c convulsions status eeg children
exercise with individual dosage against the best current practice in lower limb tendinopathy (malaga trial)

Conditions: Tendinopathy

Summary: this study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. half of the participants will receive the experimental intervention, while the other half will receive the best current practice.

the current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by cook and purdam (cook \& purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (mellor et al., 2018). however, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities. therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.

Eligibility criteria:
inclusion criteria: 1. people between 18 and 65 years with a clinical diagnosis of mid-portion achilles, patellar, or gluteal tendinopathy; 2. pain duration for at least one month. exclusion criteria: 1. corticosteroid injection in the studied tendon in the last 12 months; 2. other injuries in the affected lower limb in the last 12 months; 3. previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months; 4. tendinous rupture history in the affected lower limb; 5. systemic diseases such as rheumatic arthritis or diabetes mellitus.

Keywords: tendinopathy exercise dosage physiotherapy
study of intravenous bcx-1777 in relapsed or refractory aggressive t-cell leukemias or lymphomas

Conditions: Leukemia, Lymphocytic; Lymphoma

Summary: the purpose of this study is to determine if intravenous bcx-1777 can be given safely to improve relapsed or refractory aggressive t-cell leukemias and lymphomas.

despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive t-cell malignancies, the prognosis with relapsed or refractory t-cell leukemias or lymphomas is poor. bcx-1777 is a purine nucleoside phosphorylase (pnp) inhibitor and a potential t-cell target therapy. the purpose of the phase i portion of the study is to determine the maximum tolerated dose (mtd) of bcx-1777 and the dose to be studied in the phase ii portion of the study. the purpose of the phase ii portion of the study is to determine the safety and efficacy of bcx-1777 in patients with relapsed or refractory aggressive t-cell malignancies. patients who respond to bcx-1777 or have stable disease may be eligible to receive an additional course of treatment.

Eligibility criteria:
inclusion criteria: * previously treated, relapsed or refractory aggressive t-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease. * capable of only limited self-care, confined to bed or chair more than 50% of waking hours. * all ages are eligible. pediatric patients (\<15 years of age) are eligible to be treated at a dose level previously tested in adults. * adequate liver and renal function. * patients with prior history of stem cell transplant if they meet all other eligibility requirements. * negative pregnancy test within 72 hours of study treatment in females of childbearing potential. * life expectancy of at least 2 months. exclusion: * active serious infection not controlled by oral or intravenous antibiotics. * treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. * concurrent treatment with other anti-cancer agents. * known cns leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. lumbar puncture not required in asymptomatic patients. * pregnant and/or lactating women; or fertile men or women not willing to use contraception.

Keywords: leukemia, lymphoma, t-cell