Kornimate/medical-research-clean huggingface dataset:
assessment of cardiorespiratory fitness using the pacer in patients with juvenile idiopathic arthritis and familial mediterranean fever

Conditions: Juvenile Idiopathic Arthritis; Familial Mediterranean Fever; Healty Controls

Summary: juvenile idiopathic arthritis (jia) and familial mediterranean fever (fmf) are the most common autoimmune and autoinflammatory rheumatic diseases in childhood. symptoms such as reduced muscle strength, joint pain, fatigue, and limited activity, which are common in childhood rheumatic diseases, often lead to impaired physical function. cardiorespiratory fitness, which is an important indicator of physical function, plays a critical role in health-related outcomes in children and adolescents with rheumatic disease. maximum oxygen consumption (vo2 peak) is considered the fundamental criterion for evaluating cardiorespiratory fitness. the need for extensive equipment and trained personnel, accompanied with the inability to assess large numbers of children at one-time makes the objective assessment of cardiorespiratory fitness in a clinic setting unmanageable. therefore, there is a need to assess their cardiorespiratory fitness utilizing an easily administered test that has minimal measurement errors in patients with jia and fmf. the progressive aerobic cardiovascular endurance run (pacer) has become a routine cardiorespiratory fitness assessment for predicting vo2peak in children. a review of the literature revealed that no studies have evaluated crf using pacer in childhood rheumatic diseases. the aim of this study was to compare the fitnessgram vo2 max values of children and adolescents diagnosed with jia and fmf with those of their healthy peers and to examine the relationship with body composition.


Eligibility criteria:
inclusion criteria: * did not have any chronic disease other than rheumatic disease * diagnosed with rheumatic disease at least 6 months ago * had stable medical treatment * being between the ages of 12 and 18 * volunteering to participate in the study exclusion criteria: * have experienced trauma or surgery affecting the musculoskeletal system within the last 6 months * have acute pain for any reason, have visual or hearing problems * have cognitive impairment * not volunteering to participate in the study

Keywords: cardiorespiratory fitness progressive aerobic cardiovascular endurance run body composition maximum oxygen consumption juvenile idiopathic arthritis familial mediterranean fever
study of sars-cov2 virus (covid-19) seroprevalence among lyon-bron military health schools personnel

Conditions: SARS-CoV Infection; Covid19

Summary: emerging in china in december 2019, covid-19, whose pathogen is sars-cov-2, was declared a global pandemic in march 2020. the clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. transmission is by droplet route, with an r0 of approximately 3. rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions. health care institutions are places at risk of covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. in order to protect personnel, hygiene measures were immediately recalled and reinforced. during the period of containment, the majority of students from the lyon-bron military medical schools were sent as reinforcement in army training hospitals and in the military reanimation unit (mulhouse). some students developed symptomatic forms of sars-cov-2 infection, documented by positive pcr, during operation resilience or on their return from the mission. the lyon-bron military medical schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * personnel of the military health schools of lyon-bron * working at the military health schools of lyon-bron during the covid-19 crisis exclusion criteria: * under 18 * contraindication to blood sampling
loveyourbrain yoga for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of the study is to assess the feasibility of a 6-week yoga and meditation intervention for people with multiple sclerosis (ms). the study will evaluate the impact of the program on fatigue, anxiety, depression, positive affect, and other measures. a sub-study will collect brain images using mri on 2 subjects before and after the intervention to identify potential biological markers of ms related-fatigue.

this study will recruit 20 subjects with multiple sclerosis (ms) to participate in a 6-week yoga/meditation program. subjects will be randomly assigned to one of two groups. the first group will complete the yoga/meditation classes, followed by a waiting period. the second group will go through a waiting period, followed by yoga/meditation classes. two subjects assigned to classes during the first session will be selected to participate in an mri sub-study to look for biomarkers of ms-associated fatigue. all subjects will complete questionnaires and assessments during 3 clinic visits - at baseline, in between the class sessions, and at the end of the study. questionnaires will also be mailed to subjects 6 weeks after the last study visit.

Eligibility criteria:
inclusion criteria: 1. diagnosis of multiple sclerosis with edss score equal to or less than 6 (within last year) 2. 18 years of age or older 3. ability to ambulate without assistance from a device or person 4. subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline 5. able to read, write, and speak english 6. willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment 7. willing and able to give informed consent exclusion criteria: 1. participation in yoga and/or meditation more than twice within 8 weeks prior to baseline. 2. ms symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study. 3. any other reason that, in the investigator's opinion, would exclude the subject from participation in the study. 4. contraindication to scanning, including but not limited to ferromagnetic metal in the body, claustrophobia, inability to lie still or otherwise tolerate being in the scanner. 5. pregnant women must be excluded from the imaging component of the study due to unknown but possible risk of fetal exposure to the scanner. women of child-bearing potential will take a confidential pregnancy test immediately prior to each scan session.

Keywords: multiple sclerosis fatigue anxiety depression
exercise and pain in ccs

Conditions: Childhood Cancer Survivors

Summary: the purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.


Eligibility criteria:
inclusion criteria: 1. male and female ccs diagnosed with any type of cancer 2. ccs who have completed all standard/planned cancer treatment and are stable at the time of recruitment 3. ccs are \< 1-year post cancer therapy 4. ccs who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer) 5. ccs who are age between 10 and 17 years old at the time of enrollment 6. ccs who are and who are not non-ambulatory/wheelchair bound. 7. ccs and parent/legal guardian must be able to speak, read and understand the english language 8. ccs's parent or legal guardian must be able to provide and understand informed consent 9. ccs must be able to provide and understand assent 10. ccs must be able to attend three visits (baseline, 8 and 16-week follow-up) at the penn state health children's hospital 11. ccs and parent/legal guardian must have access to a computer, smartphone or tablet note: the agreement of the attending oncologist will be required for the participation of ccs eligible for this study. exclusion criteria: 1. ccs who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment 2. ccs who are \> 1-year post cancer therapy 3. ccs who are \ 17 years old at the time of enrollment 4. ccs who have evidence in their medical record of an absolute contraindication to complete any of the physical assessments in their medical record. this exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. the oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments. 5. ccs who have history of refractory or recurrent cancer 6. ccs or their parent/legal guardian who are unable to speak, read, and understand the english language 7. ccs who are unable to access and complete online questionnaires
an additional analysis of data from the paradigm exploratory study (nct02394834) in patients with advanced/recurrent colorectal cancer

Conditions: Colorectal Cancer

Summary: the main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from paradigm exploratory study, which is conducted for people with advanced/recurrent colorectal cancer. in the paradigm exploratory study (nct02394834), the drug being tested in this study is called panitumumab and the main aim of this study is to check side effect from the study treatment (mfolfox6 + bevacizumab versus mfolfox6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.

this is a non-interventional study to do additional exploratory analysis of biomarkers from the paradigm exploratory study (nct02394834), which is conducted for participants with advanced/recurrent colorectal cancer. 757 patients have enrolled in the paradigm exploratory study.

Eligibility criteria:
inclusion criteria: 1. participants enrolled in the paradigm exploratory study (nct02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent. 2. participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (ihc, if and/or ish, etc.) analysis. exclusion criteria: participants who are considered inappropriate for participation in this study by the research institution.
an expanded access, open-label study of obinutuzumab (ga101) plus chlorambucil in patients with previously untreated chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated chronic lymphocytic leukemia (cll) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. this study will enroll patients with previously untreated cd20-positive cll requiring treatment according to the iwcll guidelines (hallek et al 2008), as assessed by the investigator.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cd20-positive cll (per iwcll guidelines, hallek et al 2008) * previously untreated cll requiring treatment according to the iwcll guidelines (hallek et al 2008), as assessed by the investigator * adequate baseline bone marrow function unless it due to underlying cll disease no previous treatment for cll by chemotherapy, radiotherapy, or immunotherapy * patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator * life expectancy of \> 6 months exclusion criteria: * treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of cycle 1 * transformation of cll to aggressive b-cell malignancy history of severe allergic or anaphylactic reactions to monoclonal antibody therapy * known hypersensitivity to chlorambucil or any of its excipients * history of other malignancy that could affect compliance with the protocol or interpretation of results known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with iv antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of cycle 1 * major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis * known infection with human immunodeficiency virus (hiv) or human t-cell leukemia virus 1 (htlv-1) seropositive status * positive hepatitis serology * women who are pregnant or lactating * fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly * effective contraception is required while receiving obinutuzumab. for women, effective contraception is required to continue for \>= 12 months after the last dose of obinutuzumab. for men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment. * vaccination with a live vaccine a minimum of 28 days prior to the start of cycle 1
a study to evaluate the safety, efficacy, and pharmacokinetics of argx-113 in patients with itp

Conditions: Primary Immune Thrombocytopenia

Summary: the purpose of the study is to determine safety, efficacy, tolerability and pharmacokinetics of argx-113 in patients with primary immune thrombocytopenia.

this is a randomized, double-blind, placebo-controlled phase ii study in which approximately 36 patients will be randomized in a 1:1:1 ratio to receive either argx-113 dose a, or argx-113 dose b body weight or placebo in 4 infusions administered 1-week apart in addition to standard-of-care (soc) treatment. patients aged 18 to 85 years (inclusive) with confirmed primary immune thrombocytopenia (itp) who have a platelet count ˂ 30 × 109/l and who are receiving oral corticosteroids and/or permitted oral immunosuppressants and/or thrombopoietin receptor (tpo-r) agonist as soc which must be maintained on a stable dose and frequency for at least 4 weeks prior to screening. the study will include a 2-week screening, a 3-week treatment period, and an 21-week follow-up (fu) period. the study is followed by an open label period where patients will be given the option to be treated with argx-113 dose a in cycles of 4 weekly infusions with a minimum of 4 weeks apart. patients may receive rescue therapy during the study at the discretion the investigator when deemed medically necessary.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥ 18 to ≤ 85 years. 2. must receive soc treatment for itp that has been stable in dose and frequency for at least 4 weeks prior to screening. soc may include oral corticosteroids and/or permitted oral immunosuppressants and/or tpo-r agonist. 3. confirmed diagnosis of itp with blood platelet counts \< 30 × 109/l and who have not experienced major bleeding in the last 4 weeks prior to screening. exclusion criteria: 1. use of anticoagulants, or any drug with antiplatelet effect within 3 weeks prior to screening. 2. patients who have received any blood support or transfusion within 4 weeks prior to screening. 3. use of intravenous immunoglobulin g (ivig) or anti-d immunoglobulin treatment within 4 weeks prior to screening. 4. use of recombinant thrombopoietin at any time. 5. use of rituximab within 6 months prior to screening. use of any anti-cd20 other than rituximab at any time is not permitted. 6. use of immunosuppressants is not permitted within 4 weeks prior to screening, with the exception of the following oral immunosuppressants: azathioprine, danazol, mycophenolate mofetil, mycophenolate sodium which must have been stable for at least 4 weeks prior to screening. 7. use of any other biological therapy or investigational drug than those previously indicated within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening. 8. received vaccinations within 4 weeks prior to screening or planned during the study. 9. at screening, have clinically significant laboratory abnormalities 10. history of any thrombotic or embolic event within 12 months prior to screening. 11. known auto-immune disease other than itp.
evaluation of safety of candidate gd vaccine, with or without mpl in healthy herpes simplex virus-positive adults

Conditions: Herpes Simplex

Summary: the purpose of the study is to evaluate the safety and reactogenicity of candidate gd vaccine, with or without mpl, in hsv-seropositive subjects. the immune response elicited in these subjects will also be evaluated.

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 40 years of age * seropositive for antibodies against hsv * female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study. * good physical condition as established by physical examination and history taking at the time of entry exclusion criteria: * any abnormal laboratory value among the tests performed at screening. * history of persistent hepatic, renal, cardiac or respiratory diseases * clinical signs of acute illness at the time of entry into the study. * previous history of asthma or hypersensitivity to drugs. * seropositive for antibodies against the human immunodeficiency virus * pregnancy and lactation. * treatment with corticosteroids or immunomodulating drugs. * simultaneous participation in another clinical trial. * administration of any other vaccine or immunoglobulins during the study period

Keywords: herpes simplex herpes simplex candidate (gd) vaccine
ultrasound-guided cervical medial branch blocks

Conditions: Neck Pain; Cervical Spondylosis

Summary: in this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.

while several clinical trials have found that ultrasound guidance provides similar accuracy to fluoroscopy and reduces performance times for cervical medial branch blocks, larger studies documenting safety-related outcomes are lacking. in addition, although cervical medial branch blocks are an accepted tool to diagnose neck pain originating from the cervical facets, there are reports of long-lasting analgesic effects in a subset of patients, suggesting that these blocks may have long-term benefits. we therefore propose to prospectively examine the incidence of adverse events, as well as the clinical long-term effects of ultrasound-guided cervical medial branch blocks, in a cohort of pain clinic patients undergoing these procedures as part of their usual care.

Eligibility criteria:
inclusion criteria: * consenting patients over 18 years of age undergoing cervical medial branch blocks as part of their usual care and who have a pain intensity of at least 5/10 (at rest or on movement) and a pain duration of at least 4 months. exclusion criteria: * inability to communicate or complete follow up questionnaires * known bleeding disorder or coagulopathy * patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, at iii agents) * inability to visualize targeted structures on ultrasound * presence of acute radiculopathy of new onset neurological symptoms in the upper extremities * patients with bilateral neck pain if only one side is treated
a study to evaluate safety, tolerability, and immunogenicity of an investigational zoster vaccine in subjects with a history of varicella (chickenpox)(v211-010)(completed)

Conditions: Herpes Zoster

Summary: the purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

the duration of treatment is 4 weeks.

Eligibility criteria:
inclusion criteria: * individuals who are at least 50 years of age or older with a history of varicella (chicken pox) exclusion criteria: * prior history of herpes zoster (shingles) * prior receipt of varicella or zoster vaccine * immunosuppressed
effect of different heparinization schemes on prognosis of intracranial aneurysm

Conditions: Intracranial Aneurysm

Summary: the goal of this clinical trial is to compare intracranial aneurysm patients. the main question it aims to answer are: which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. participants will be randomized to different intraoperative heparinization regimens: (i) 50 u/kg intravenous (iv) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 70 u/kg iv at 1-h intervals reduced by half to a minimum of 1000 u/h. mri will be performed within 72 h after surgery, and the dwi sequence of mri will be analyzed. if there is a comparison group: researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.


Eligibility criteria:
inclusion criteria: 1. greater than 18 years old, less than 75 years old 2. patients with unruptured intracranial aneurysm were confirmed by dsa. 3. coagulation function should be normal in the enrolled patients. exclusion criteria: 1. dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation. 2. previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).

Keywords: intracranial aneurysm
safety and surgical performance study of aurosleek surgical blades

Conditions: Cataract

Summary: to evaluate the safety and surgical effectiveness of surgical blades (aurosleek) made by aurolab.

cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. one of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. the surgeon repeatedly and reliably needs to create similar tunnels of the proper length. aurolab is producing surgical blades (aurosleek) intended for making incision in cataract surgeries.

Eligibility criteria:
inclusion criteria: * senile cataract * willing to give written informed consent * ability to follow study instructions and likely to complete required visits. exclusion criteria: * intraoperative complication including posterior capsular rent and zonular dialysis * traumatic cataract * uveitis and complicated cataract * one eyed patients

Keywords: patients having cataract