Kornimate/medical-research-clean huggingface dataset:
prediction of response to intra-articular injections of hyaluronic acid for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate whether the investigators can develop a computer algorithm to predict which individual patients will respond to injections of hyaluronic acid (ha) products for knee osteoarthritis.

background osteoarthritis (oa) of the knee is a debilitating condition that affects an estimated 21 million americans. this number is expected to rise steadily as the population ages. the medical expenditures associated with arthritis and other rheumatic conditions in the united states have increased from $50 billion in 1997 to $86 billion in 2003. in 2003, almost 420,000 total knee replacements were performed, primarily for arthritis. injections of hyaluronic acid (ha) have been shown to provide symptom relief for many oa patients who have failed to respond to conservative interventions. many other patients, however, experience only slight or no improvement. the results from this study will allow physicians to identify whether a patient is likely or not likely to respond well to ha therapy leading to improved treatment success rates. goals this study has two related goals: 1) to identify patient and treatment factors that predict response to intra-articular injections of hyaluronic acid for knee osteoarthritis using multivariable analysis and 2) develop mathematical and statistical models that will predict individual patient response to ha for knee oa. it is anticipated that the investigators will develop computer software in this study that can support clinical decision making related to viscosupplementation in the treatment of knee oa. if this project yields successful patient predictive models, physicians who are considering a trial of ha for a patient will have some empirical basis for treatment selection. eventually a physician would be able to assess a relatively small number of variables for a patient and then be provided with predictions regarding treatment response. \*\*please note that the study site at the naval medical center in portsmouth, virginia can only enroll patients who are eligible to be treated at a military facility.

Eligibility criteria:
inclusion criteria: * symptomatic knee osteoarthritis presenting to physician's office * radiographic evidence of knee osteoarthritis * age 18 years or older * failed minimum of 3 months of non-operative treatment, including, but not limited to, tylenol, anti-inflammatory medication, cortisone injection, physical therapy, bracing, and/or heel wedge * symptoms for at least 3 months exclusion criteria: * associated ligamentous instability * history of deep knee infection * candidate for total knee arthroplasty or arthroscopy * peripheral neuropathy. * x-rays that are completely negative and only mri evidence or arthroscopic evidence (from previous arthroscopy) of oa. * prior ha injections at any point in the past * chondrocalcinosis * patients with precautions or contraindications for viscosupplementation use * cortisone injection within past 3 months
effect of yoga vs. stretching on chronic back pain

Conditions: Chronic Non-specific Low Back Pain

Summary: this study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.it will also for physical, psychological and physiological factors associated with improvement in back pain.


Eligibility criteria:
inclusion criteria: * group health cooperative enrollee * uncomplicated low back pain * at least moderate pain levels exclusion criteria: * sciatica persisting 3 or more months after physician visit * history of cancer (other than nonmelanoma skin cancer) * severe disk problems * unstable medical conditions * back surgery within past 3 years * physically unable to do the yoga or exercise classes and homework * unable to attend classes * currently doing yoga * taken yoga or exercise class for back pain within past year * currently in litigation for back pain * seeking other treatment for back pain

Keywords: chronic low back pain yoga
non-interventional study of novoseven® used in patients with haemophilia a and b with inhibitors when undergoing surgery

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this study is conducted in japan. the aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (novoseven®) when undergoing surgery under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * patients with haemophilia a and b with inhibitors who received eptacog alpha (novoseven®) as treatment when undergoing surgery exclusion criteria: * patients who was not deemed to be appropriate to the treatment of eptacog alpha (novoseven®)
neutrophil phenotypic profiling and organ injury assessment in patients with sepsis

Conditions: Sepsis

Summary: in this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. sepsis is a severe type of infection, affecting various parts of the body. neutrophils are a type of white blood cell that are part of the body's immune system. even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in organs in patients with sepsis. neutrophils can change their character in sepsis. because of this, it is important for doctors to know what kind of neutrophils are in the blood of children with sepsis so that they can work to develop therapies to prevent these cells from being harmful.


Eligibility criteria:
inclusion criteria patients will be eligible for enrollment as septic patients if they * are \< 18 years old * meet the definition of sepsis described in the study design section above. patients will be eligible for enrollment as control patients if they * are \< 18 years old * are scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure. exclusion criteria patients will be ineligible for enrollment in either control or sepsis group if any of the followings is present or anticipated * congenital cardiac disease * on chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases
epidemiologic and genetic study on familial prostate cancer

Conditions: Prostate Cancer

Summary: the aims of the study are: * to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment, * to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

the impact of genetic factors on the natural history of prostate cancer (pc) is shown schematically at two levels: 1. first, at the constitutional level with germline alterations. family history is found in 20% of pc patients. different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy). 2. secondly, pc is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). these changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance). the purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples: * for men with known prostate cancer. * for men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer. the registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

Eligibility criteria:
inclusion criteria: * patient with a histological confirmed prostate cancer * member of a hereditary prostate cancer family * healthy control men without prostate cancer exclusion criteria: * absence of signed informed consent * refusal to participate in the study

Keywords: prostate cancer genetic epidemiology susceptibility
a study to patients with relapsed/refractory follicular lymphoma treated with liso-cel (lisocabtagene maraleucel) in the post marketing setting

Conditions: Follicular Lymphoma

Summary: the purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (fl) indication, and will be part of post-marketing liso-cel pharmacovigilance activities


Eligibility criteria:
inclusion criteria: • participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (r/r) follicular lymphoma (fl), including fl grade 1, grade 2 and grade 3a, within the fda-approved indication and dosage per the united states prescribing information (uspi) and product specifications approved for commercial release in the usa exclusion criteria: * participants known to be participating in investigational studies at the time of liso-cel, infusion * participants treated with liso-cel for the treatment of r/r fl grade 3b * participants treated with non-conforming chimeric antigen receptor (car) t-cell product

Keywords: follicular lymphoma
mri effects of pegvorhyaluronidase alfa (pegph20) in pancreatic ductal adenocarcinoma

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: this research study is being conducted to determine the effects of pegph20 plus chemotherapy treatment on the mri characteristics of locally advanced pancreatic cancer patient tumors. subjects will received gemcitabine, abraxane and pegph20.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. capable of giving informed consent. 3. ability and willingness to comply with the protocol including all scheduled mri studies and paired tumor biopsies 4. aged ≥ 18 years. 5. borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease. 6. ecog ps of 0 or 1 7. must have adequate organ and hematopoietic function 8. female and males must use an approved contraceptive method exclusion criteria: 1. received prior therapy for pancreatic adenocarcinoma 2. history of deep vein thrombosis (dvt) or pulmonary embolism (pe) 3. contraindication to therapeutic anticoagulation or heparin 4. intolerance to dexamethasone 5. contraindication to mri or unwillingness to undergo all scheduled mri exams 6. known or suspected brain metastasis 7. significant cardiovascular disease such as current new york heart associate class iii/iv heart failure, myocardial infarction or stroke within 6 months prior to enrollment 8. a second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results 9. any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint 10. active bacterial or fungal infection requiring iv therapy at the start of protocol treatment 11. subjects may not receive concomitant anticancer agents or radiation. 12. female subjects who are pregnant or nursing 13. pre-existing peripheral neuropathy \> ctcae grade 2. 14. known allergy to hyaluronidase 15. current use of megestrol acetate (use within 10 days of day 1) 16. inability to comply with study and follow-up procedures as judged by the investigator
timing of orthodontic therapy and regenerative periodontal surgery in advanced periodontitis patients with pathologic tooth migration

Conditions: Periodontitis; Tooth Migration; Intrabony Periodontal Defect

Summary: pathologic tooth migration (ptm) is a common complication of advanced periodontitis and often motivation for patients to seek orthodontic therapy. an interdisciplinary approach is required to control the periodontal infection, reconstruct the defects and realign the migrated teeth. the optimal timing of active orthodontics after regenerative therapy is a topic of ongoing debate. there are no data available from rcts that have compared the effect of the timing of orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal surgery in these patients. it is the aim of the present randomized clinical multicenter trial to compare 2 different treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced periodontitis patients with intrabony defects and pathologic tooth migration in order to establish whether one treatment modality is superior to the other with regard to clinical outcomes. a total of 46 patients will be enrolled and randomized into 2 treatment groups that differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6 months following regenerative periodontal surgery). primary outcome measure will be the change in clinical attachment level (cal gain) at 12 months after regenerative therapy. secondary outcomes will include changes in probing depth bop, gingival recession, radiographic bone height and patient-centered outcomes.


Eligibility criteria:
inclusion criteria: * advanced periodontitis * presence of intrabony defects at a minimum of 2 and a maximum of 7 adjacent teeth (positions 15-25 or 35-45) in either the maxilla or the mandible with ppd of ≥6 mm at a minimum on one site * pathologic tooth migration * full mouth plaque index (pi) \<25% at baseline (after initial non-surgical periodontal therapy) * full mouth bleeding on probing (fmbp) \<25% at baseline (i.e., following initial non-surgical periodontal therapy) * committed to the study and the required follow-up visits exclusion criteria: any contraindications for oral surgical procedures * uncontrolled diabetes or other uncontrolled systemic diseases * disorders or treatments that compromise wound healing * medical conditions requiring chronic high dose steroid therapy * bone metabolic diseases * radiation or other immuno-suppressive therapy * infections or vascular impairment at the surgical site * presence of oral lesions (such as ulceration, malignancy) or mucosal diseases * history of malignant disease in the oral cavity or previous radiotherapy to the head * inadequate oral hygiene or unmotivated for adequate home care * current smokers \> 6cig

Keywords: pathological tooth migration periodontal regenerative surgery vertical infrabony defects xenogeneic bone graft orthodontic therapy
acute medium chain triglycerides (mct) intake in young and older participants

Conditions: Ketonemia

Summary: compare plasma metabolites following different conditions paired with a dietary mct beverage over an 8-hour metabolic day protocol in young and older participants.


Eligibility criteria:
inclusion criteria: * 10 health young (20-40 y old) and 10 health older (\> 60 y old) participants * men and women exclusion criteria: * smoking * diabetes (fasting glucose \>7.0 mmol/l and glycated hemoglobin \>6.9%) * strenuous aerobic exercise more than three times a week * untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function * under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)

Keywords: ketones medium chain triglycerides glucose insulin free fatty acids
prevalence survey of plasmodium falciparum antimalarial drug resistance markers

Conditions: Plasmodium Falciparum

Summary: this study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at komé, doba, republic of chad.

this is a cross-sectional, observational study using dried blood samples collected from p. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin act partner drugs. a maximum of 200 participants will be enrolled at each participating site per year. study duration is 2 years. therefore total participant is up to 400. prospective participants will have blood collected for dried blood spot (dbs) study sample after providing informed consent. individuals with confirmed p. falciparum infection will have dbs samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.

Eligibility criteria:
inclusion criteria: participants must meet all of the inclusion criteria to participate in the study. * patients (6 months - 75 years) with confirmed uncomplicated p. falciparum infection * written informed consent obtained exclusion criteria: * patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.

Keywords: antimalarial drug resistance republic of chard
siewert type i-ii: ct, pet-ct, eus sensitivity/specificity for the assessment of lymph node metastases

Conditions: Siewert Type I-II Adenocarcinoma of the Esophagus

Summary: in siewert type i/ii eac, sensitivity/specificity of ct, pet-ct, eus for assessment of n descriptor in defined groups of lymph nodes were investigated.

esophageal adenocarcinoma (eac) is a disease with poor overall prognosis and rising incidence in western countries. in patients without organ metastases, therapy is currently based on surgery with or without neoadjuvant therapy; indication for primary surgery is reserved to clinical tnm stages 0-iia, whereas a multimodality approach is more suitable for clinical tnm stages iib-iii. the operation comprises the resection of distal esophagus and proximal or total gastrectomy. two field lymphadenectomy is generally recommended, but the extent of lymphadenectomy is among the controversial issues, as extensive removal of nodes may cause significant morbidity and its effect on survival in addition to neoadjuvant therapy is not clear. current guidelines are based on the 7th edition of ajcc \& uicc tnm classification, which stages lymph node status (n) according to the number of metastatic nodes, but do not consider the specific anatomic stations of regional nodes. eac subtypes are known to demonstrate different metastatic nodal patterns of spread. they may be classified with the siewert's classification according to the position of the tumor with respect to the esophago-gastric junction (egj), or according to histologic parameters like the presence/absence of intestinal metaplasia in the esophagus and stomach. siewert type i eac, which fairly corresponds to the barret's like type according to the presence absence of intestinal metaplasia, spreads more likely to the thoracic nodal stations, while siewert type ii and the pyloric like type, do spread more frequently to the perigastric and celiac stations. therefore, an increasing interest is emerging for preoperative mapping of lymph nodes metastases in order to tailor surgery according to metastatic patterns. the majority of studies aiming to assess the accuracy of n staging with clinical methods generally refer to the global evaluation of regional nodes according to the 7th edition of staging descriptors. studies reporting specific data on the clinical staging assessment of specific thoracic and abdominal lymph nodal stations are few, diagnostic tests and results are not uniform, interpretation and comparison of data within reports is not immediate.

Eligibility criteria:
inclusion criteria: * siewert type i-ii adenocarcinoma \> 18 year submitted to primary surgery exclusion criteria: * siewert type i-ii adenocarcinoma submitted to neoadjuvant therapy. * siewert type iii adenocarcinoma squamous carcinoma

Keywords: esophageal adenocarcinoma staging ct pet-ct eus
dose finding study of krn125 (pegfilgrastim) for treatment of neutropenic patients

Conditions: Neutropenia

Summary: to assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of krn125 or multiple daily injections of filgrastim.


Eligibility criteria:
inclusion criteria: * patients diagnosed as malignant lymphoma * patients who were refractory to anthracycline or anthraquinone containing chemotherapy * patients who are going to receive eshap or chase treatment regimen * ecog performance status =\< 2 * patients who have appropriate bone marrow, hepatic and renal functions * written informed consent exclusion criteria: * double cancer * history of bone marrow transplantation or pbsct * more than 2 prior chemotherapy regimens * primary hematologic disease such as myelodysplastic syndrome * previous radiotherapy within 4 weeks of enrollment * woman of childbearing potential who were either pregnant, breast feeding * patients who participated in other clinical trials within the last 4 weeks of enrollment

Keywords: pegfilgrastim neutropenia cancer patients lymphoma
a pilot evaluation exploring new adhesive materials and their ability to adhere to abdominal and peristomal skin

Conditions: Skin Abnormalities

Summary: the study investigates different adhesive materials on healthy and peristomal skin


Eligibility criteria:
inclusion criteria: * has given written consent * be at least 18 years of age and have full legal capacity * have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) have suitable peristomal skin area (assessed by investigator) (for stoma patients) exclusion criteria: * currently receiving or have within the past 2 months received radio- and/or chemotherapy * currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment * are pregnant or breastfeeding * having dermatological problems in the abdominal area (assessed by investigator) * participate in other clinical investigations. exception: participation in other coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol