Kornimate/medical-research-clean huggingface dataset:
phase iii trial of oral thalidomide in advanced hepatocellular carcinoma with poor liver reserve

Conditions: Carcinoma, Hepatocellular

Summary: to compare the overall survival of thalidomide- and placebo-treated advanced hcc patients.


Eligibility criteria:
inclusion criteria: 1. patients with measurable, metastatic or locally advanced hepatocellular carcinoma 2. the diagnosis of hcc should be established either by cyto/histology 3. patients must be \> 20 years of age. 4. ecog score \< 2. 5. signed informed consent. 6. female patients at child-bearing age must have negative pregnancy test. exclusion criteria: 1. patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible. 2. patients with advanced second primary malignancy are not eligible. 3. patients with active infection are not eligible. 4. patients with pregnancy or breast-feeding are not eligible. 5. patients with brain metastases are not eligible.

Keywords: phase iii hepatocellular carcinoma
personalized support for progress (psp) in a va women's wellness clinic

Conditions: Psychological Stress; Life Stress; Emotional Stress

Summary: the purpose of this study is to evaluate the personalized support for progress (psp) intervention in a veterans health administration (vha) women's wellness clinic. psp uses a peer support provider to help women identify their primary concern, develop a personalized plan to help address that concern, and provide practical and emotional support to implement the plan. the primary aim is to evaluate the feasibility, acceptability, and utility of psp and the research protocol.


Eligibility criteria:
inclusion criteria: * veteran status (non-veterans will not be enrolled in this trial) * enrollment in the syracuse va medical center women's wellness clinic * report high stress within the last month (perceived stress scale \[pss-10\] \> 18) * primary care provider approval for participation * ability to communicate in english including reading, writing, hearing, and speaking well enough to complete research and intervention tasks. exclusion criteria: * any veteran with "higher" suicide risk on the p4 or veterans with "lower" suicide risk on the p4 and evaluated by the pi or another clinician to be clinically unstable or at risk * homicidality (screened via adaptation of the p4 screener and evaluated on the same criteria above) * homelessness (including literally homeless, imminent risk of homelessness, or fleeing/attempting to flee domestic violence per va definitions) * veterans who are enrolled in or have had psychotherapy or changes to psychotropic medications in the last 12 weeks * veterans with impairment that would not allow them to engage in psp including active psychosis, cognitive deficits, severe substance use requiring detoxification (documented in cprs or reported by a pact member) * veterans who are not available for outpatient psp meetings (e.g., in a residential program) * veterans who have current va or non-va peer support engagement (an appointment within the last month and/or additional follow-up scheduled)

Keywords: peer support patient navigators
clinical performance of atypical contact lens powers on subjects with astigmatism

Conditions: Astigmatism

Summary: this study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by vistakon.


Eligibility criteria:
inclusion criteria: * able to wear study lenses in parameters available. * at least 18 * understand and sign informed consent * willing to follow the protocol * achieve at least 6/9 visual acuity (va), both eyes (ou) with study lenses * hyperopes: +2.00 to +4.00 with -0.75 d cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 d cylinder around 180 * oblique axis: -2.00 to -4.00 with -0.75 d cyl around 45 or 135, have worn soft contact lenses's within last 6 months exclusion criteria: * any ocular or systemic disorder which may contraindicate contact lens (cl) wear * any topical ocular medication * aphakic * corneal refractive surgery, * corneal distortion from hard cl wear or keratoconus * pregnant or lactating * grade 2 or worse slit lamp signs * infectious disease * previous clinical study within 2 weeks * don't agree to participate
upper gi outcomes following emr

Conditions: Adenoma, Villous

Summary: the purpose of this study is to evaluate the long-term outcomes of endoscopic resection (er) of superficial lesions of the upper gastrointestinal tract(ugit)

endoscopic resection (er) of superficial lesions of the upper gastrointestinal tract is a safe and effective surgery-sparing modality in experienced hands. it is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). westmead hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.the purpose of this study is to evaluate the long-term outcomes of er of superficial lesions of the ugit.

Eligibility criteria:
inclusion criteria: * ugit lesion \> 10mm * lesion limited to the mucosal and/or submucosal layer (t1 lesion) * aged 18 years or older exclusion criteria: * lesion less than 10mm * gastric lesion involves the muscularis propria (t2 lesion) on other staging modalities such as endoscopic ultrasonography (eus) * aged younger than 18 years
mcb vs eus-fna for preoperative pathological evaluation of gastric smt

Conditions: Gastrointestinal Stromal Tumor of Stomach; Submucosal Tumor of Stomach

Summary: gastrointestinal stromal tumors (gists) are the most common submucosal tumors (smts) of the stomach. the 2022 european society of oncology esmo diagnosis and treatment guidelines recommend that gists undergo biopsy with a clear pathological diagnosis and should be removed unless there are significant complications. but currently, the diagnostic rate of eus-fna for upper gastrointestinal subcutaneous lesions is less than 60%. in recent years, mucosal cutting biopsy (mcb) has become an effective method for diagnosing smts. regardless of whether the smts are large or small, the application of mcb technology can quickly obtain pathological tissue under direct visualization, and its immunohistochemical pathological diagnosis rate is relatively satisfactory. mcb technology has great potential in the biopsy of smts, but there is currently no comparison of results between two technologies in randomized controlled trials. the purpose of this study is to design a randomized controlled trial to compare the diagnostic rates of eus-fna and mcb techniques for tissue pathology (including immunohistochemistry) of smts, in order to improve the diagnostic accuracy of smts in our hospital and improve patient prognosis.


Eligibility criteria:
inclusion criteria: * endoscopic evaluation considers gastric submucosal tumors (smts) with a diameter of ≥ 15mm exclusion criteria: * endoscopic non bulging lesions. * the upper gastrointestinal lesions measured by endoscopic ultrasonography(eus) are less than 15 mm. * lesions that do not require tissue collection (such as lipomas, varicose veins) * patients with cystic lesions * the patient has uncorrectable coagulation dysfunction (international normalized ratio (inr)\>1.5 or platelet count\<50x109) * patients with portal hypertension * patients with a history of upper gastrointestinal surgery * pregnant women * patients who refuse to participate in this clinical trial
lycopene in treating patients with prostate cancer or benign prostatic hyperplasia

Conditions: Nonmalignant Neoplasm; Prostate Cancer

Summary: rationale: chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.

objectives: * assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia. * determine whether the steady state level of dna oxidation in blood and prostate tissue is responsive to lycopene dosing. * investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum. * assess the importance of measuring multiple dna oxidation products as biomarkers of oxidative stress and its chemoprevention. * determine the significance of dna oxidation products in blood as an indicator of oxidative stress in the prostate. * measure prostate and blood uptake of the chemoprevention agent lycopene. outline: this is a randomized, double-blind, placebo-controlled study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral lycopene once daily for 3 weeks. * arm ii: patients receive oral placebo once daily for 3 weeks. in both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy. blood samples are collected at baseline and before surgery for biomarker/laboratory studies. projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of 1 of the following: * prostate cancer * benign prostate hyperplasia * high blood levels of prostate-specific antigen * enlarged prostate patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: benign prostatic hyperplasia stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer
ologen collagen matrix safety and effective comparison with mitomycin-c(mmc) in glaucoma surgery

Conditions: Open Angle Glaucoma

Summary: to compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and mitomycin-c(mmc) in glaucoma surgery.

to compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and mitomycin-c(mmc) for glaucoma surgery. the surgery is performed by the gold standard of trabeculectomy. mitomycin-c(mmc) is applied for those who not collagen matrix implanted.

Eligibility criteria:
inclusion criteria: * open angle glaucoma * maxima anti-glaucoma medication failed * age\>18 * able to complete the follow up exclusion criteria: * topical eye inflammation * angle closure glaucoma * deformity glaucoma * one eye glaucoma * previous conjunctiva opened * allergy to collagen

Keywords: ologen collagen matrix glaucoma trabeculectomy mitomycin-c
trigeminal nerve stimulation (tns) in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: to the investigators knowledge there are no studies of trigeminal nerve stimulation (tns) for fibromyalgia. tns may modify overlapping mood and fibromyalgia pain regulation circuitry. the investigators hypothesized that patients with fibromyalgia might experience a clinically significant reduction in daily pain if investigators were to administer tns in a manner similar to experimental antidepressant protocols.


Eligibility criteria:
inclusion criteria: * we will adopt the following inclusion criteria: (1) patients between 18 and 69 years; (2) patients with a diagnosis of fibromyalgia according to a trained phisycian; (3) score greater than or equal to 5 on the vas for pain; (4) agreement to participate in the study as recommended in the ic. exclusion criteria: * exclusion criteria we cite: (1) patients with psychiatric hospitalization indicated; (2) patients with psychiatric comorbidity; (3) patients with a diagnosis of personality disorder; (4) presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic decompensated.

Keywords: pain fibromyagia tns
r3470-3471-3479 (regn-eb3) expanded access protocol (eap) for treatment of ebola virus disease

Conditions: Ebola Virus Disease

Summary: provide access to regn-eb3 for the treatment of patients with ebola virus disease (evd).


Eligibility criteria:
key inclusion criteria: * males or females in an ebola endemic region with documented positive polymerase chain reaction (pcr) for ebola virus infection who are symptomatic * ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations * regn-eb3 can be administered to pregnant women infected with zaire ebolavirus, as defined in the protocol * children of any age will be eligible for enrollment, as defined in the protocol * neonates born to an infected mother who has not yet cleared the ebola virus are eligible for enrollment, as defined in the protocol key exclusion criteria: * negative ebov diagnostic test result * a patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol * any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions * eligible for an ongoing randomized clinical trial with regn-eb3 note: other protocol defined inclusion / exclusion criteria apply

Keywords: positive ebola virus (ebov) diagnostic test symptomatic
transpulmonary pressures in mechanical ventilated patients with morbid obesity

Conditions: Mechanical Ventilation Complication; Respiratory Insufficiency

Summary: the study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation. * both gender * only adults * medical intensive care patients.

we are studying adult patients with morbid obesity with respiratory failure requiring mechanical ventilation. we are measuring transesophageal presssures to estimate ideal peep and evaluate hemodynamic parameters.

Eligibility criteria:
inclusion criteria: * both gender * morbid obesity * hemodynamically stable exclusion criteria: * pregnant patients * cirrhotic patients with esophageal varicose

Keywords: transpulmonary pressure - morbid obesity
slipped capital femoral epiphysis treatment

Conditions: SCFE

Summary: slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children. the primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. loder described a classification for slipped capital femoral epiphysis based on ability of the child to walk or not(walking=stable, non-walking=unstable).

in slipped capital femoral epiphyses (scfe), the severity of slippage correlates with poor long-term clinical outcome scores and radiographic evidence of osteoarthritis . in situ fixation of higher-grade scfe has a low surgical risk and has been advocated by authors who believe the deformed hip has the potential to remodel with some restoration of the disturbed anatomic axes ; however, the remodeling potential remains controversial . despite remodeling, the head-neck offset will remain abnormal . this is the cause of potential impingement of the femoral neck with the acetabular cartilage . impingement in scfe has been associated with damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after scfe . ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip osteotomy and anterior capsulotomy preserving the blood supply to femoral head. the technique is based on extensive study of blood supply to the proximal femur. this technique allows us to completely dislocate the joint which allows complete access to intra articular pathology and allow reduction of the slipped capital femoral epiphysis .

Eligibility criteria:
inclusion criteria: * 1- patients with moderate slipped capital femoral epiphysis 2- patients with severe slipped capital femoral epiphysis exclusion criteria: * patients with mild slipped capital femoral epiphysis
interleukin-38 levels in individuals with periodontitis

Conditions: Periodontitis; Gingivitis; Healthy

Summary: interleukin (il)-38 is the newest member of the il-1 family. it can bind to receptors through various pathways and regulate the formation and function of inflammatory cytokines. periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. the aim of this study is to compare the il-38, il-1β and il-10 levels of healthy and periodontitis individuals.

periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. more than any other cytokine family, the interleukin (il)-1 family (il-1α, il-1β, il-18, il-33, il-36α, il-36β, il-36γ, il-1ra, il-36ra, il-37, il-38) includes key signaling molecules that trigger and perpetuate periodontal inflammation. interleukine -1β ( il-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. interleukine-10 (il-10) has been reported to decrease periodontal disease progression rate. gingival crevicular fluid shows the cellular response in the periodontium. the most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies. in recent studies, il-38 expression has been reported to be abnormal (abnormal) in chronic inflammatory diseases, especially in rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis, psoriasis, and inflammatory bowel disease. therefore, this relationship of this inflammatory cytokine with chronic inflammatory diseases draws attention to the regulatory effect of il-38 in these diseases. the aim of this study is to compare the il-38, il-1β and il-10 levels of healthy and periodontitis individuals.

Eligibility criteria:
inclusion criteria: * systemically healthy individuals who does not have a disease under treatment, * individuals without regular systemic medication exclusion criteria: * smoking * receiving periodontal treatment in the last 6 months * pregnancy * lactation

Keywords: periodontal disease il-38
immunogenicity and safety study of a glaxosmithkline biologicals' candidate influenza vaccine in healthy children

Conditions: Influenza

Summary: the purpose of the present study is to assess the immunogenicity and safety of vaccine gsk2321138a in children.


Eligibility criteria:
inclusion criteria: for all subjects: * subjects who the investigator believes that they and/or their legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol. * written informed consent obtained from the subject/from the lar(s). for unprimed subjects: * a male or female child aged 18 to 47 months at the time of the first vaccination. * children who did not have influenza vaccine in a previous season. for primed subjects from study nct00764790: • children who received fluarix™ in the 111751 study nct00764790. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * history of hypersensitivity to any vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s). * acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * acute disease at the time of enrolment. * history of guillain barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination inhaled and topical steroids are allowed. * administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Keywords: vaccine influenza
diameter changes of retinal vessels during hypoxia

Conditions: Diabetes Mellitus Type 1; Diabetic Maculopathy

Summary: the primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. diameter changes are studied using the dynamic vessel analyzer.


Eligibility criteria:
inclusion criteria: * diabetes type 1 without retinopathy * diabetic retinopathy exclusion criteria: * cardio-vascular disease * lung disease * pregnancy * previous ocular disease other than retinal branch vein occlusion * previous treatment with medications influencing on the intraocular pressure or the metabolism of nitric oxide or prostaglandins