Kornimate/medical-research-clean huggingface dataset:
combination of cryosurgey and nk immunotherapy for recurrent ovarian cancer

Conditions: Recurrent Ovarian Cancer

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to recurrent ovarian cancer.

by enrolling patients with recurrent ovarian cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (nk) cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: ovarian cancer cryosurgery nk immunotherapy
the effectiveness of a bacteriophobic coating on urinary catheters

Conditions: Urinary Tract Infections

Summary: to assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization

the purpose of the study is to provide pilot information on the characteristics of the biofilm formed on the coated catheter compared to a standard catheter. the two objectives are; 1. to evaluate the catheter's on-label performance in customary clinical use. 2. to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.

Eligibility criteria:
inclusion criteria: 1. all patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care. 2. patients aged 18-85 years will be eligible for the study. 3. able to give informed consent. exclusion criteria: 1. patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection. 2. pregnant patients. 3. patients with a potentially immunocompromised condition (steroids, hiv) 4. patients who are unable to give informed consent
phase 3 study of nimotuzumab and irinotecan as second line with advanced or recurrect gastric and gastroesophageal junction cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Cancer

Summary: this study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with egfr overexpressed advanced gastric or gastroesophageal junction cancer.

this randomized, open-label, japan, korea and taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with egfr overexpressed advanced gastric or gastroesophageal junction cancer. approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.

Eligibility criteria:
inclusion criteria: 1. advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma. 2. subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. the first line regimen must have contained a 5-fluorouracil based agent and platinum agent. 3. subjects with egfr overexpression (2+ or 3+ in ihc) exclusion criteria: 1. subjects who have received irinotecan 2. subjects who have received egfr-directed therapy 3. other active malignancy within the last 5 years

Keywords: epidermal growth factor receptor second line
optimal timing of br55 ceus of the ovaries

Conditions: Ovarian Cancer

Summary: this is an exploratory, single center, open label, prospective study of br55 to determine the optimal phase of the menstrual cycle for performing br55 contrast-enhanced ultrasonography (ceus) of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.


Eligibility criteria:
inclusion criteria: enroll a subject in this study if the subject meets the following inclusion criteria: * is a female subject of at least 18 years of age; * is premenopausal; * is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian cancer not earlier than 24 hours and not later than 5 days following the second br55 ceus examination; * provides written informed consent and is willing to comply with protocol requirements. exclusion criteria: exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed: * is a pregnant or lactating female. exclude the possibility of pregnancy: * by testing on site at the institution (serum βhcg) within 24 hours prior to the start of investigational product administration, * by surgical history (e.g., tubal ligation or hysterectomy), * has undergone prior systemic therapy for ovarian cancer; * has history of concurrent malignancy; * has history of any clinically unstable cardiac condition including class iii/iv congestive heart failure; * has had any severe cardiac rhythm disorders within 7 days prior to enrolment; * has severe pulmonary hypertension (pulmonary artery pressure \>90mmhg) or uncontrolled systemic hypertension and/or respiratory distress syndrome; * has open and/or non-healing wounds in the chest, abdomen and pelvis; * has other systemic vascular abnormalities associated with neovascularization that in the opinion of the investigator could significantly affect the ability to evaluate the effects of br55; * is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment; * has previously been enrolled in and completed this study; * has any known allergy to one or more of the ingredients of the investigational product or to any other contrast media; * is determined by the investigator that the subject is clinically unsuitable for the study; * has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment; * has history of surgery to the ovaries or pelvic inflammatory disease.
brain imaging of psychotherapy for depression

Conditions: Major Depressive Disorder

Summary: the goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fmri), and to compare results to those obtained from a nondepressed control group.


Eligibility criteria:
inclusion criteria: * for group 1: diagnosis of current depression and no other current axis i psychiatric disorder * for group 1: hamilton depression rating scale score of 15 or greater exclusion criteria: * a history of serious head injury or neurological disease or psychosis * current use of psychoactive medications * factors that could affect mri safety including current or planned pregnancy * for group 2: current axis i psychiatric disorder, as assessed by structured clinical interview

Keywords: control participants
get active study for at-risk youth

Conditions: Anhedonia; Depression and Suicide Ideation

Summary: the study will adapt and deploy a digital behavioral activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. the study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. this research will examine specifically whether an intervention involving an app called vira, combined with health coaching (get active) can improve enjoyment for teens coping with depression. research participants will be randomly assigned to one of two study intervention. one study intervention involves a) downloading an app called vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. the health coach will use the vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. the second study intervention involves downloading an app called ears and responding to a daily question.

aim 3 (randomized pilot): to examine implementation outcomes, initial effectiveness, and equity across outcomes in a pilot randomized trial (n=75, 2:1 randomization, 35% black, 10% hispanic) of get active vs. activity monitoring alone. h3a. the study will observe high get active feasibility (50% of eligible youth approached will enroll; completion \>50%; attrition \ 80%); acceptability (\>80%); and appropriateness (\>80%). h3b. youth who receive get active will show greater improvement in anhedonia (primary outcome) and h3c. depression severity and suicidal risk (secondary outcomes). h3d. outcomes will be equitable by race. h3e. exploratory (mechanistic): get active will lead to decreased depression and suicidal risk through increased activity and reward responsiveness.

Eligibility criteria:
inclusion criteria: * adolescents age 12-18 * current moderate to severe depression (phq-9-m \> 11) * current clinically significant anhedonia, operationalized as phq-9-m anhedonia item score \> 1 * english language fluency and literacy level sufficient to engage in study protocol * willing to download the app on their smart phones exclusion criteria: * evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per electronic health record review and phone screen.

Keywords: behavioral activation health coach anhedonia minority youth suicide
molecular screening for lynch syndrome in denmark

Conditions: Colorectal Cancer; Lynch Syndrome; HNPCC

Summary: a clinically applicably strategy for molecular screening for lynch syndrome is being implemented in denmark. based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. these patients are offered genetic risk assessment and counselling. the study hypothesis is that molecular screening will identify more patients with lynch syndrome than the family history alone. prospective data collection is performed using established clinical databases.


Eligibility criteria:
inclusion criteria: * histological diagnosis of colorectal adenocarcinoma * diagnosed at one of the departments of pathology in denmark exclusion criteria: * none
dose-finding pilot study of acth in patients with idiopathic membranous nephropathy

Conditions: Idiopathic Membranous Nephropathy

Summary: this pilot study is aimed at demonstrating the effectiveness of acth (h.p. acthar gel) on the lipid profile and proteinuria in participants with mn. acth or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. the drug used in this study has been approved by the food and drug administration (fda) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic mn. however, the most adequate dose to use has not been adequately assessed. this is the reason for conducting this research study.


Eligibility criteria:
inclusion criteria: 1. idiopathic mn with diagnostic biopsy performed less than 36 months from the time of dose randomization. 2. age \> 18 years. 3. patients need to be treated with an acei and/or arb, for at least 3 months prior to acth treatment and have adequately controlled blood pressure 4. proteinuria of \>4.0 on a 24-hour urine collection. 5. estimated gfr \>40 ml/min/1.73m2 while taking acei/arb therapy. exclusion criteria: 1. age \<18 years. 2. estimated gfr \ 2.0 mg/dl. 3. renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy. 4. patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin a, tacrolimus) or mycophenolic mofetil for \>1 month, and alkylating agents or rituximab for \>6 months. 5. resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids. 6. patients with active infections or secondary causes of mn. 7. type 1 or 2 diabetes mellitus. 8. pregnancy or nursing. 9. acute renal vein thrombosis documented prior to entry by renal us or ct scan and requiring anticoagulation therapy.
incidence and echocardiographic predictors of hfpef in high-risk population afferent to italian echo-labs network

Conditions: Heart Failure; Heart Failure With Preserved Ejection Fraction

Summary: the evolving definitions of hf, the increasing attention of the medical community, and the aging of the population are some of the factors contributing to a still debated incidence and prevalence of hfpef across the general and specific populations. despite the current decline in new hf cases, hfpef shows stable incidence according to epidemiological studies. cardiovascular risk factors, such as a long history of hypertension, diabetes, obesity, and others seem to be associated with a higher hfpefincidence. nevertheless, the potential echocardiographic predictors of hfpef have not been defined yet. hypothesis in a population at high risk for hfpef, collected using a multicenter echo-lab network, the real incidence of hfpef cases and echocardiographic predictors can be identified. aim 1: to define the incidence of hfpef in a high-risk cohort of patients afferent to the italian echo-lab network. aim 2: to explore the standard (2d and doppler data) and advanced (lv and la strain) echocardiographic parameters associated with and potential predictors of hfpef. methods this is a multicenter, prospective, observational study involving an italian echo labs network. according to inclusion and exclusion criteria, patients will be enrolled during standard echocardiographic evaluation. after signing informed consent, clinical and echocardiographic data will be collected. thereafter, they will be followed up for major clinical events (cardiovascular death, hf requiring hospitalization, myocardial infarct, and atrial fibrillation) for a period of 12 months


Eligibility criteria:
inclusion criteria: * age \>65 years * echocardiographic lv ef \>50% * diastolic dysfunction at echocardiography of at least grade 1 * lv hypertrophy defined as: linear lv mass \>115 in men, \>95 g/m2 in women * left atrium (la) enlargement defined as la volume \> 34 ml/ m2 exclusion criteria: * severe chronic renal failure (gfr \<15) * severe chronic obstructive pulmonary disease (copd) (fev1 \<1) * more than moderate valve disease * previous cardiac surgery * previous lv ef \<40%

Keywords: echocardiographic predictors heart failure with preserved ejection fraction
assess the long-term effectiveness and safety of amevive (alefacept) in subjects with moderate to severe chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: the study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.

study includes a bio-marker sub-study to determine differences in responders vs. non-responders. additional consent is required for the sub-study.

Eligibility criteria:
inclusion criteria: * subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept exclusion criteria: * subjects with a contraindication to alefacept * subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions) * subjects with any active cancer, including skin cancer * subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept. * subjects known to be infected with the aids virus

Keywords: plaque psoriasis psoriasis alefacept amevive
beta blockers for the treatment of asthma

Conditions: Asthma

Summary: current asthma medicines include inhalers. a common inhaler used in asthma is called a beta-agonist (for example salbutamol). they improve asthma symptoms by stimulating areas in the human airway resulting in widening of the human airway. although these drugs are useful after the first dose, longterm use can cause worsening asthma symptoms. beta-blockers are the complete opposite type of medication. just now they are avoided in patients with asthma as after the first dose they can cause airway narrowing and cause an asthma attack. new research has suggested that long term use of beta-blockers can reduce airway inflammation which can improve asthma control and improve symptoms. this research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. what the investigators want to do is see if the same benefit of beta-blocker use is asthma can be seen in people who take inhaled steroids.


Eligibility criteria:
inclusion criteria: * male and female volunteers with stable mild intermittent or mild persistent asthma. * stable defined as: fev1 (forced expiratory volume in 1second) \>80% predicted with diurnal fev1 variation \<30% when laba (long acting beta agonist) washed out. * methacholine pc20 \<4mg/ml. * ability to perform spirometry, ios (impulse oscillometry), bronchial challenge and all domiciliary measurements. * ability to obtain informed consent. * mild to moderate asthmatics taking ≤1000μg bdp (beclomethasone diproprionate) per day or equivalent. * withhold labas for 1 week prior to study. exclusion criteria: * uncontrolled symptoms of asthma. * resting bp (blood pressure) \<110 systolic or hr (heart rate)\<60. * pregnancy or lactation. * known or suspected sensitivity to the imp (investigational medicinal product)(s). * inability to comply with protocol. * any degree of heart block. * rate limiting medication including β blockers, rate limiting calcium - channel blockers and amiodarone. * any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol. * an asthma exacerbation within the last 6 months.
duration of skin numbing effect created by the s-caine™ peel

Conditions: Pain

Summary: s-caine™ peel (lidocaine 7% and tetracaine 7% cream) is a new skin numbing cream made of lidocaine and tetracaine. the purpose of this study is to evaluate and measure the length of time the s-caine peel numbs the skin, when applied for 30 and 60 minutes.

this was a single center, randomized, double-blind, placebo controlled, paired study that evaluated the duration of anesthetic effect produced by s-caine peel when applied for 30 or 60 minutes in 40 adult volunteers. a pinprick test was used to determine duration of anesthetic effect. at the procedure visit, subjects were to be assigned the lowest available sequential subject number. treatment was randomized according to a computer-generated randomization schedule provided by the sponsor. the randomization to application time of 30 or 60 minutes was to be 1:1 and un-blinded. the randomization of study drug to treatment area (concurrent applications of either s caine peel applied to the anterior surface of the right thigh with placebo applied to the anterior surface of the left thigh, or placebo applied to the anterior surface of the right thigh and s-caine peel applied to the anterior surface of the left thigh) was 1:1 and double-blind. instructions for implementing the randomization (ie, the correct application time and treatment area) appeared on the study drug labels assigned to each subject number. subjects were administered both s-caine peel and placebo on separate thighs for either 30 or 60 minutes. the study drugs were applied concurrently to the anterior surfaces of the right and left thigh (one application per thigh, with study drug applied to the right thigh first, followed immediately by application of the alternate study drug to the left thigh). each study drug was dispensed to cover a 200 cm² treatment area with a uniform thickness of approximately 1 mm

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older. * meet pinprick test requirements. exclusion criteria: * subject is pregnant or breastfeeding. * subject has participated in a clinical trial of an unapproved drug within the previous 30 days.
qiastat-dx® meningitis/encephalitis panel performance evaluation study

Conditions: Meningitis/Encephalitis

Summary: study for performance evaluation of the qiastat-dx® meningitis/encephalitis panel in comparison with other chosen comparator methods.

this multicenter study aims to evaluate the performance of qiastat-dx meningitis/encephalitis (me) panel with another validated comparator method.

Eligibility criteria:
inclusion criteria: * residual specimens (minimum 500μl) of csf obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing specimen that have not undergone more than 3 freeze/thaw cycles. exclusion criteria: * specimens not fitting criteria outlined above. * csf obtained from an external ventricular drain or shunt source. * lack of clear subject identification or label on residual banked csf specimen. * specimen has been centrifuged. * obvious physical damage of banked residual specimen. * repeat specimens from the same subject.
study of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery

Conditions: Cataract

Summary: the purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.


Eligibility criteria:
inclusion criteria: * male and female * can read and sign informed consent form； * clinical diagnosis of cataract * cataract density grade ii-iii according to the emery-little system classification system exclusion criteria: * sensitivity to adrenalin； * sensitivity to topical mydriatics； * any other ocular surgeries； * iris abnormalities

Keywords: cataract