Kornimate/medical-research-clean huggingface dataset:
precision application of clostridium butyricm of clinical research on osteoarthritis

Conditions: Osteoarthritis; Knee

Summary: osteoarthritis (oa) is a common joint disease worldwide. the main symptom is that the mechanical wear of the cartilage in the joint and leads to the abnormal proliferation of the surrounding bone and synovial tissue with the chronic inflammation and the narrowing of the joint cavity. the prevalence of oa is increasing due to population increasing and aging, and there are currently about 400 million oa patients in worldwide. the treatment methods of osteoarthritis are mainly divided into medicine and non-medicine therapy. the major function of medicine therapy is to reduce pain and the arthroscopic surgery (arthroscopy) is main treatment of non-medicine therapy. thus, in this project the investigators will mainly focus on the precise application of clostridium butyricum on oa and the investigators' previous study successfully demonstrated the therapeutic effects of clostridium butyricum on oa animal model. therefore, will test the clinical effects of oa patient with clostridium butyricum treatment, and whether it is also possible to improve the symptom of oa patients.


Eligibility criteria:
inclusion criteria: - a. patients aged 55 to 75 years old with degenerative arthritis, diagnosed by a physician as suitable for participation in this experiment. b. patients with early-stage degenerative arthritis symptoms, as interpreted by x-ray using the kellgren lawrence grading scale at grade 1 or 2, and determined by a physician to not require long-term treatment. c. patients with a high pain index when the knee is extended 40-70 mm. d. patients who feel knee pain, primarily those with a high western ontario and mcmaster universities osteoarthritis (womac) index score (pain scale score \>2.0 or total womac scale score \>12). exclusion criteria: - a. patients with a history of knee joint trauma or knee joint surgery (including arthroscopic surgery). b. patients who have taken steroid medication for the treatment of degenerative arthritis. c. patients with severe cardiovascular, cerebrovascular, rheumatic, or psychiatric diseases. d. patients with joint pain caused by other factors. e. patients with infectious diseases or acute infections (e.g., fever, localized inflammation, abscess). f. patients with systemic or metabolic diseases, or progressive bone degeneration caused by medication. g. cancer patients.

Keywords: clostridium butyricum osteoarthritis
surgical outcome of dorsolumbar intradural extramedullary spinal cord tumors

Conditions: Spinal Cord Tumor

Summary: primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (idem: 65%), and intramedullary the most commonly seen idem tumors are schwannomas, neurofibromas, and meningiomas. \[1\] the less frequently encountered idem tumors include ependymomas, lipomas, hemangiomas, metastatic deposits, paragangliomas, nerve sheath myxomas, and vascular tumors.\[2\] spinal cord tumors can cause different signs and symptoms, especially as tumors grow. the tumors may affect spinal cord or the nerve roots, blood vessels or bones of spine. signs and symptoms may include: pain at the site of the tumor due to tumor growth back pain, often radiating to other parts of body feeling less sensitive to pain, heat and cold loss of bowel or bladder function difficulty walking, muscle weakness . mri is the investigation of choice,however other investigation such ct or x ray are important to ensure stability of the vertebral column and the optimal management is gross total excision for symptomatic lesions.\[3,4\] over the years, there has been no significant change in the clinical symptoms and pathology of idem tumors. however, there have been dramatic improvements in the diagnosis and treatment with the advances of radiological and surgical techniques. despite advances in operative techniques and neuroimaging, the morbidity associated with the resection of idem tumors continues to be significant \[5,6\]. here, we examined the surgical outcomes of 20 patients with idem spinal cord tumors operated in neurosurgery department at sohag university hospital


Eligibility criteria:
inclusion criteria: * patients with intradural extramedullary lesion in dorsolumber region exclusion criteria: * previous history of spinal surgery * unfit medical patients * multiple level affection * associated cervical lesion * unstable segment
administration of graspa (suspension of erythrocytes encapsulating l-asparaginase)in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the interest in using l-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. interestingly, these studies suggest an additional effect of l-asparaginase associated to gemcitabine.graspa is a suspension of red blood cells encapsulating l-asparaginase. the aim of this phase i clinical trial is to evaluate the maximum tolerated dose (mtd) of graspa on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.


Eligibility criteria:
inclusion criteria: * exocrine pancreatic adenocarcinoma cytologically or histologically confirmed * locally advanced and non-resectable with invasion of the superior mesenteric artery (stage iii) or metastatic (stage iv) as defined by tnm (primary tumor, regional nodes, metastasis) 2002 classification (uicc 2002) * resistant to a first or second line chemotherapy with gemcitabine * patient aged between 18 to 70 years * signed informed consent form * life expectancy ≥ 12 weeks * accurate measurement of tumor volume by imagery (in at least one dimension) * presence of one or several tumor markers (carcinoembryonic antigen \[cea\] and cancer antigen \[ca\] 19.9) * eastern cooperative oncology group \[ecog\] prognostic score : 0, 1 or 2 * patient beneficiary of a social security insurance exclusion criteria: * patient with an endocrine or acinar pancreatic tumor * patient with known or suspected cerebro-meningeal metastases * haemoglobin level greater than 13 g/l * patient hypersensitive to l-asparaginase or have had prior exposure to any form of l-asparaginase * splenic vein thrombosis \< 3 months or under active treatment * anti-vitamin k treatment * hepatic insufficiency unrelated to pancreatic cancer * renal insufficiency unrelated to pancreatic cancer * pancreatitis or pancreatitis history unrelated to pancreatic cancer * insulin-dependant diabetes mellitus unrelated to pancreatic cancer * current or prior coagulopathy disorders unrelated to pancreatic cancer * ecog prognostic score 3 or 4 * history of grade 3 blood transfusion reaction (life threatening situation) * presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed red blood cells for the patient * patient already included in another clinical trial * pregnancy, breast-feeding or absence of secured contraception * unwillingness to sign the informed consent form

Keywords: pancreatic cancer asparaginase
effects of lycocomfort™ supplementation on symptoms associated with lower urinary tract symptoms (luts)

Conditions: BPH; Lower Urinary Tract Symptoms

Summary: this study will evaluate lycocomfort™ supplementation in alleviating symptoms associated with luts, bph, and general prostate concerns. inflammation, oxidative stress and androgenic activity in the prostate are proven catalysts of bph, ultimately leading to increased prostate cell proliferation. the once-daily supplement lycocomfort™, will be under investigation for symptom relief and will be taken by participants for a duration of 12 weeks.

lycocomfort™ is a dietary supplement containing tomato extract and phytosterols, ingredients that have been associated with relief of symptoms associated with general prostate discomfort and lower urinary tract symptoms (luts). the purpose of this study is to evaluate changes in these symptoms after taking this supplement daily for 12 weeks. although it was not until the latter part of the twenties century that investigators began to explore the importance of lycopene, the benefits of this natural carotenoid are well studied. a number of clinical trials have shown lycopene to be effectual for alleviating prostate discomfort, symptoms of bph and luts. the american urological association estimates that 90% of men between 45 and 80 years of age suffer some symptoms of luts. several pathophysiological mechanisms are believed to lead to luts and bph, including oxidative damage, inflammation and sympathetic nervous system issues. high blood lycopene concentrations have been suggested in epidemiological trials to be associated with decreases in oxidative stress and contributions to disease prevention overall. also, clinical trials have shown that higher levels of lycopene in the blood are associated with a reduced risk of prostate cancer, as well as other inflammatory conditions.

Eligibility criteria:
inclusion criteria: * males, age 40 and older * a score of 8 or greater on a self-administered i-pss test exclusion criteria: * acute or chronic prostatitis * acute urinary retention * allergy or sensitivity to any of the test product components (tomato \[lycopene\] or beta-sitosterol) * cancer of the prostate (pca) or other cancers, current or a history of pca * chronic diseases of the kidneys and/or liver * hematuria of unknown etiology * infection or malfunction of the urinary tract * inflammatory diseases of the urogenital tract * medication, herbal supplementation or other substance use for the treatment of urinary symptoms, bph/luts, or erectile dysfunction, including medications which may affect hormonal status within 30 days before screening. these may include, but are not limited to: sildenafil/viagra; tadalafil/cialis; vardenafil/levitra; "herbal viagra"; alpha-blockers; oral steroids, spironolactone or testosterone * previous radiotherapy of prostate * previous surgery of the prostate, bladder or urethra
long-term safety study of the gore® helex® septal occluder

Conditions: Septal Defect, Atrial

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of the gore® helex® septal occluder in the treatment of ostium secundum atrial septal defects (asds).

the gore® helex® septal occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (asds). the purpose of this study is to evaluate the long-term safety and efficacy of the gore® helex® septal occluder in the treatment of ostium secundum atrial septal defects (asds). this is an fda condition of approval study. all subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.

Eligibility criteria:
inclusion criteria: * asd less than or equal to 18 mm. exclusion criteria: * conditions that would confound treatment of asd or complicate distinguishing onset of adverse events. * unable to accommodate device delivery catheter.

Keywords: atrial septal defect, septal occluder, helex
geodon (ziprasidone) for posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder; Post-Traumatic Stress Disorder; PTSD

Summary: atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of ptsd. the profile of the atypical antipsychotic, ziprasidone (geodon), suggests possible anxiolytic and antidepressant properties. this research will assess the potential effectiveness of geodon in civilian men and women who suffer from severe ptsd. response to ziprasidone or placebo will be measured by clinician administered ptsd scale (caps) and treatment outcomes ptsd scale (top-8).

ptsd is a common disorder with 10% lifetime prevalence among americans. the major causes of ptsd are sexual assault, accidents, disasters despite this public health burden, only two drugs, sertraline (zoloft) and paroxetine (paxil), are approved by the fda for the treatment of ptsd. new options for the treatment of ptsd are much needed. approximately half of patients with ptsd respond to zoloft and paxil. many patients experience psychotic symptoms with ptsd, which may not respond to treatment to zoloft and paxil. though classified as an anxiety disorder in the dsm-iv, ptsd is accompanied by psychotic symptoms in almost half of patients (butler et al 1996; hamner et al 1999, lindley et al 2000). also, ptsd has an extensive comorbidity with major depressive disorder (davis et al 2000). while geodon is approved by the fda in the united states for the treatment of psychosis, it has not been evaluated for the treatment of ptsd . a clinical trial of geodon in ptsd will help delineate the potential antidepressant spectrum of efficacy of geodon as well as its anxiolytic profile.

Eligibility criteria:
inclusion criteria: * men \& women with dsm-iv clinical diagnosis of ptsd who are able to attend weekly clinic appointments * age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control * a willingness and ability to provide competent signed informed consent * a level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken english) exclusion criteria: * any diagnosis of schizophrenia or bipolar i disorder, or active substance dependence * unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders. * subjects with prior non-response to geodon for the treatment of ptsd with an adequate trial * enrollment in any study drug within the last 30 days. current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days. * pregnancy or nursing * any subject judged clinically to be at serious suicidal risk in the opinion of the investigator

Keywords: posttraumatic stress disorder post-traumatic stress disorder ptsd geodon ziprasidone
dose escalation and dose expansion phase i study to assess the safety and clinical activity of multiple doses of nkr-2 administered concurrently with folfox in colorectal cancer with potentially resectable liver metastases

Conditions: Colon Cancer Liver Metastasis

Summary: shrink (standard chemotherapy regimen and immunotherapy with nkr-2) is an open-label phase i study to assess the safety and clinical activity of multiple administrations of autologous nkr-2 cells administered concurrently with a standard chemotherapy treatment (folfox) in potentially resectable liver metastases from colorectal cancer. the trial will test three dose levels. at each dose, the patients will receive three successive administrations, two weeks apart, nkr-2 cells. the study will enroll up to 36 patients (dose escalation and expansion phases).


Eligibility criteria:
inclusion criteria: 1. men or women ≥ 18 years old at the time of signing the icf 2. patients with histologically proven colorectal adenocarcinoma with potentially resectable liver metastases, 3. no previous chemotherapy for metastatic crc, 4. the patient is due to receive first-line metastatic chemotherapy regimen with folfox as a neoadjuvant 5. the patient must have an ecog performance status 0 or 1 6. the patient must have sufficient bone marrow reserve, hepatic and renal functions detailed disease specific criteria exist and can be discussed with contacts listed below exclusion criteria: 1. patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis 2. patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first nkr-2 administration 3. patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent, other than the treatment authorized per protocol 4. patients who underwent major surgery within 4 weeks before the planned day for the first treatment 5. patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder 6. patients who have received a live vaccine within 6 weeks prior to the planned day for the first nkr 2 administration 7. patients with a family history of congenital or hereditary immunodeficiency 8. patients with history of any autoimmune disease
long term cornea graft survival study

Conditions: Keratoconus; Fuchs' Endothelial Dystrophy

Summary: corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. published long term (10 years and up) graft survivals vary considerably from center to center. these variations may be explained by differences in case-mix and surgical techniques used. the investigators aim to better understand the factors associated with long term graft survival.


Eligibility criteria:
inclusion criteria: * all patients who underwent one or more keratoplasties since january 1983. * age 18 and older

Keywords: corneal transplantation
emboshield® and xact® post approval carotid stent trial (the exact study)

Conditions: Carotid Artery Disease; Carotid Stenosis; Stroke; Atherosclerosis

Summary: to collect clinical outcome and device performance data on the fda 510(k)-cleared emboshield® barewire™ rapid exchange embolic protection system and fda-approved xact® rapid exchange carotid stent system when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

this is a multi-center, observational, single arm, post-approval study enrolling the following study population: * subjects with neurological symptoms and \>= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate), or * subjects without neurological symptoms and \>= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate) * the endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (mi). * for the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and mi at 30 days and ipsilateral stroke at 12 months (31-365 days).

Eligibility criteria:
inclusion criteria: * subjects who agree to participate in this study and have signed the irb approved informed consent form. * subjects who are willing to have the emboshield and/or the xact inserted into the their vasculature. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: carotid stenting carotid endarterectomy carotid artery disease with severe narrowing of the artery stroke prevention cerebral infarction
a phase ib study of tqb2450 combined with anlotinib in patients with limited stage small cell lung cancer after first-line radiotherapy and chemotherapy

Conditions: Limited Stage Small Cell Lung Cancer; Not Progressed After First-line Chemoradiotherapy

Summary: to assess the efficacy and safety of tqb2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who do not progress after first-line chemoradiotherapy. based on the incidence and severity of benign and serious adverse events, as well as abnormal laboratory


Eligibility criteria:
inclusion criteria: * the subject voluntarily joins the study, signs the informed consent form, and has good compliance; * age: 18\~75 years old (when signing the informed consent form); ecog ps score: 0-1 points; expected survival beyond 6 months; body weight\> 40 kg; * patients with pathologically confirmed limited-stage small cell lung cancer (according to the veterans administration lung study group (valg stage); * through the neck, chest, abdomen, pelvic enhanced ct and brain plain scan + enhanced mri examination with diagnostic quality, there is no evidence of metastatic disease (pet-ct examination is recommended before starting radiotherapy and chemotherapy, if not performed before radiotherapy and chemotherapy pet-ct examination, bone scan examination should be performed; pet-ct examination must be performed during the screening period after chemoradiotherapy to exclude metastasis); * it is expected that no tumor resection will be required during the study (patients who are not suitable for surgery or those who are unwilling to undergo surgery are acceptable); * radiotherapy technology adopts three-dimensional conformal radiotherapy, conformal intensity-modulated radiotherapy, tomographic radiation therapy and other precision radiotherapy technologies; * patients must achieve cr, pr or sd after receiving radical platinum-based crt and cannot develop disease progression; * patients with at least one measurable lesion confirmed according to recist 1.1 criteria prior to chemoradiotherapy; exclusion criteria: * complex small cell lung cancer confirmed by histopathology or cytopathology; * subjects with known central nervous system metastasis and/or cancerous meningitis; * malignant pleural effusion and pericardial effusion; * imaging shows that the tumor has invaded important blood vessels, or the researcher has determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies; * within 2 weeks before the start of the study treatment, he has received the treatment of traditional chinese patent medicines and simple preparations with anti-tumor indications specified in the nmpa approved drug manual; * patients who have received immunomodulatory drugs within 30 days before starting treatment; * previously received anti pd-1, anti pd-l1, or anti pd-l2 drugs or medication targeting another stimulating or co inhibitory t cell receptor; * previous use of antivascular survival drugs（ bevacizumab, arotinib, apatinib ,ect);
the effects of supplementation of conjugated linoleic acid on body fat reduction

Conditions: Obesity; Adiposity

Summary: this is a double-blinded randomized controlled trial, to evaluate the effectiveness of daily supplementation of 3.2 g cla on body fat reduction and lipid profile in overweight or obese chinese adults, during a lifestyle counselling-based weight loss.

this will be a parallel randomized, double-blinded, placebo-controlled trial. sixty-six overweight or obese men and women aged from 18 to 45 years with elevated body fat percentage, who also meet our inclusion and exclusion criteria, will be randomly assigned to: the treatment group, daily supplementation of 3.2 g cla (cis-9, trans-11 isomers and trans-10, cis-12 isomers) plus lifestyle counselling weight loss program; or the control group, daily supplementation of sunflower oil. the intervention will include a 3-day run-in phase and 12-week interventional phase. at baseline and the end of the intervention, physical examination including questionnaires, anthropometric measurement, body composition by dual energy x-ray absorptiometry (dxa), biological sample collection will be undertaken. during the invention, regular lifestyle counselling sessions will be delivered, and detailed record will be tracked for all participants to monitor and improve the adherence and safety.

Eligibility criteria:
inclusion criteria: 1) body fat percentage ≥ 20% for men, body fat percentage ≥ 30% for women ; 2) aged from 18 to 45 years old. exclusion criteria: 1. pregnancy or lactation; 2. abnormal liver or kidney function indicated by physical examination within 6 months; 3. gastrointestinal problems that affect the complying with the procedure; 4. sever cardiovascular disease; 5. active cancer; 6. mental diseases, epilepsy or using anti-depression drugs; 7. using medicine that affect body weight; 8. participating in other scientific studies within 3 months before the study.