Kornimate/medical-research-clean huggingface dataset:
biological therapy in treating women with breast cancer that has spread to the liver

Conditions: Breast Cancer; Metastatic Cancer

Summary: rationale: biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.

direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (adv.rsv-hil12, also termed adv-hil-12). objectives: * study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer. * determine tumor responses produced by this regimen. * determine immune responses induced by this regimen.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed\* breast adenocarcinoma metastatic to the liver * solitary or multiple hepatic metastases * no malignant involvement of \> 40% of the estimated liver volume note: \*must be from the hepatic tumor designated for study injection * metastatic liver tumors must be measurable in ≥ 2 dimensions on ct scan or mri * at least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance * extrahepatic metastasis allowed * no solitary hepatic metastasis eligible for liver resection * no clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy) * hormone-receptor status not specified patient characteristics: * female * menopausal status not specified * granulocyte count ≥ 1,500/mm\^3 * hemoglobin ≥ 9.0 g/dl * platelet count ≥ 100,000/mm\^3 * pt ≤ 14.5 sec * creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 45 ml/min * bilirubin ≤ 2 times upper limit of normal (uln) * transaminases ≤ 2.5 times uln * karnofsky performance status ≥ 70% * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 2 months after completion of study treatment * no active infection or serious intercurrent medical illness * no hiv infection * life expectancy ≥ 16 weeks * no other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer * at highest dose level, patient must weigh ≥ 30 kg prior concurrent therapy: * no systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry * not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment * no chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)

Keywords: stage iv breast cancer liver metastases
registry-based stroke in tunisia

Conditions: Stroke, Ischemic; Strokes Thrombotic; Stroke

Summary: study the prevalence of strokes in the emergency department (ed) and their possible eligibility for thrombolysis.

the diagnosis and management of strokes represent a great emergency that requires multidisciplinary teams and an organization of the care chain from the collection of patients at the site of the stroke to follow-up care. that is why it is necessary to identify the prevalence of stroke in the ed in tunisia and to evaluate their eligibility for thrombolysis.

Eligibility criteria:
inclusion criteria: * all patients with stroke symptoms. exclusion criteria: * refusal of inclusion

Keywords: stroke thrombolysis tunisia
exercise tolerance in patients with implanted left ventricular assist device

Conditions: Left Ventricular Assist Device

Summary: to evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.

left ventricular assist devices (lvad) are becoming a destination therapy in patients with end-stage left ventricular dysfunction. current generation pumps operate with a fixed rotation speed without the capability of automated speed adjustment. it was shown that acceleration of the pump speed during stress test increases the maximum exercise tolerance. periodic aortic valve opening (avo) is used to set up an optimal resting pump speed. the study aimed to evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of avo during the cardiopulmonary exercise test (cpet). patients with implanted third-generation lvads with hydrodynamic bearing (hvad, medtronic, mn, usa) are prospectively enrolled. two cpets are performed after resting speed optimization. the first one with maintained baseline pump speed settings, and the second one with gradually increased speed depending on live echocardiographic imaging. the sequence of tests is random.

Eligibility criteria:
inclusion criteria: * patients with implanted cardioverter-defibrillator and third-generation centrifugal cf-lvad with hydrodynamic bearing (hvad, medtronic, minnesota, united states), at least three months after surgery. exclusion criteria: * hemodynamic instability. * non-therapeutic anticoagulation. * device or intracardiac thrombus. * inflammation. * active bleeding.

Keywords: left ventricular assist device cardiopulmonary exercise test stress echocardiography heart failure mechanical circulatory support peak vo2
supracondylar pinning antibiotic stewardship (spas) trial

Conditions: Supracondylar Humerus Fracture; Infection

Summary: prospective, multi-center, randomized controlled trial studying infection rate with or without prophylactic antibiotics at the time of closed reduction and percutaneous pinning of pediatric supracondylar humerus fractures.

the goal of the spas trial will be to determine the role of prophylactic antibiotics in closed reduction and percutaneous fixation of pediatric supracondylar humerus fractures. the study will be designed as a prospective, double-blinded, two-arm, non-inferiority trial. the control arm will receive standard of care preoperative prophylactic antibiotics. the intervention group will receive a preoperative saline placebo. the primary outcome of the study will be the development of a surgical site infection, including all infections both superficial and deep. secondary outcomes will include rate and type of post-operative complications in either group, to account for any drug-related adverse outcomes. the hypothesis is that this surgery is safe to perform without prophylactic antibiotics, and the investigators anticipate finding no difference in infection rates between the two groups. inclusion criteria will consist of an isolated, closed, displaced supracondylar humerus fracture treated with closed reduction and temporary percutaneous pinning. immunocompromised patients, pathological fractures, open fractures, polytrauma, skeletally mature patients, and those treated primarily with open reduction or those converted to open reduction will be excluded. because of the low infection rate observed in this type of surgery, the sample size for the study is estimated at 600 patients per arm for adequate power. with a multicenter design, the expectation will be enrollment over the course of 1-2 years with a follow up of approximately 3 months post-surgical intervention per participant.

Eligibility criteria:
inclusion criteria: * closed, isolated extension type supracondylar humerus fracture, gartland type 2, 3, or 4 exclusion criteria: * inability to secure consent * open fractures * polytrauma * pathologic fractures * flexion type fracture * associated compartment syndrome * allergy to cefazolin which precludes its use * skeletally mature patients or patients greater than 18 years of age * medical comorbidities including immunocompromised state, active infection, and any associated bone, endocrine, or neoplastic conditions contributing to local or generalized abnormal bone mineralization. * inability to attain satisfactory reduction and fixation via closed manipulation, resulting in conversion to open reduction

Keywords: antibiotic stewardship post operative infection pediatric cefazolin
cadonilimab plus regorafenib and gem-cis chemotherapy in advanced biliary tract cancer

Conditions: Advanced Biliary Tract Cancer

Summary: to evaluate the efficacy and safety of cadonilimab in combination with regorafenib and gem-cis chemotherapy in advanced biliary tract cancer


Eligibility criteria:
main inclusion criteria: 1. subjects with a histopathological or cytologically diagnosis of btc 2. the participants must be required to sign an informed consent 3. at least one measurable lesion (recist 1.1) 4. no previous systematic treatment for btc 5. child-pugh score, class a 6. ecog performance status 0 or 1 7. adequate organ function 8. life expectancy of at least 3 months exclusion criteria: 1. diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma 2. known history of serious allergy to any monoclonal antibody 3. known central nervous system metastases and/or leptomeningeal disease prior to treatment 4. portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment 5. any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 6. any active malignancy prior to the start of treatment 7. active or history of autoimmune disease 8. other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 9. pregnant or lactating women
the effect of final exam preparation on anxiety level, self-perception, ocular symptoms, accommodation and vergence in myopia

Conditions: Myopia

Summary: to evaluate the effects of exam preparation on anxiety level, self perception, ocular symptoms and oculomotor responses in myopes

twenty two first year optometry students were evaluated towards the end of their first academic year on a battery of oculomotor and survey tests. this occurred during two sessions, one low stress session and one high stress session. sessions were separated by one month. low stress session (ls), no exams or minor exams high stress session (hs), final exam preparation week battery of surveys: adult manifest anxiety scale for college students (amas-c): 36 items which probe 4 types of anxiety * worry/oversensitivity * test anxiety * physiological anxiety (somatic responses to anxiety) * social concerns self perception profile (spp): 45 items which probe 9 domains * scholastic competence * social acceptance * athletic competence * physical appearance * job competence * romantic appeal * behavioral conduct * close friendship * global self-worth ci symptom survey (ciss-15): 15 items which probe ocular and aesthenopic signs and symptoms students also reported hours of daily near work (nwhrs). battery of oculomotor tests: (20/30 etdrs target used for all) vergence tests * phorias near and far (neutralized alternate cover test) * vergence ranges near and far (prism bar) * vergence facility near and far (3bi/12bo) * near point of convergence objective accommodative tests (srw-5000autorefractor) monocular accommodative responses to: * near target (33cm) * minus lens (-3d) while viewing distant (6m) target subjective accommodative tests: monocular accommodative responses to: * donder's push up amplitude test * near accommodative facility (+/-2.00, five practice trials) * distant accommodative facility (plano/-2.00, five practice trials)

Eligibility criteria:
inclusion criteria: * any first year optometry student exclusion criteria: * previous refractive surgery, amblyopia, strabismus, rgp wearer

Keywords: stress anxiety myopia progression accommodation vergence
validation of korean version of iciq-sf

Conditions: Urinary Incontinence

Summary: 1. validation of the korean version of the iciq-ui sf for pregnant and postpartum women 2. evaluation the effect of urinary incontinence in pregnant and postpartum women.


Eligibility criteria:
inclusion criteria: * being pregnant or postpartum ≤ 3 weeks * able to read and understand korean * at least 18 years of age exclusion criteria: * refuse to participate in the study * pelvic inflammatory disease * psychiatric disease * needed to be treated in the 7 days

Keywords: urinary incontinence validation study pregnant women postpartum period
phase ii study evaluating the efficacy and safety of kx-826

Conditions: Androgenetic Alopecia (AGA)

Summary: this is a multi-center, randomized, double-blind, placebo-controlled phase ii clinical study of kx-826 in chinese adult male patients with aga.

based on the results of the phase i studies of kx-826 in androgenetic alopecia and the pre-clinical pd studies, the investigational product will be administered at 2.5 mg bid (0.25%), 5 mg qd (0.5%), and 5 mg bid (0.5%) in treatment groups a, b, and c, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo qd group (10) and placebo bid group (20). the investigational product will be administered in the evening once daily for all qd dose groups, and once in the morning and once in the evening for the bid dose groups.

Eligibility criteria:
inclusion criteria: 1. agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (icf) in writing; 2. male, aged ≥ 18 years, in good general health; 3. clinical diagnosis of aga; 4. stage iiiv, iv and v according to hamilton-norwood scale. exclusion criteria: 1. patients who have used external topical drugs for alopecia sites within 3 months prior to screening; 2. patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening; 3. minoxidil use within 6 months prior to screening; 4. treatment with finasteride or dutasteride within 12 months prior to screening; scalp radiation and/or laser or surgical therapy within 12 months prior to screening; history of malignancy; 5. other conditions that may affect compliance or ineligibility for participation of the study.

Keywords: kx-826 aga
stip: statin trial for influenza patients

Conditions: Acute Respiratory Distress Syndrome; Influenza; H1N1 Influenza

Summary: to assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (icu) admission due to respiratory distress.

hypothesis: rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.

Eligibility criteria:
inclusion criteria: 1. patients with suspected or confirmed influenza (appendix a) 2. requirement for icu (or icu step-down) admission due to respiratory distress defined as: * sao2/fio2 \< 315 or pao2/fio2 \< 300 * multiply by pb/760 (when altitude exceeds 51000 ft) * for fio2 for non-intubated patients see appendix b participants must receive the first dose of study drug within 48 hours following icu admission for confirmed or suspected influenza or be excluded from participation in the study. exclusion criteria: 1. no consent/inability to obtain consent 2. age less than 13 years 3. weight less than 40 kg 4. unable to receive or unlikely to absorb enteral study drug (e.g. patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome) 5. allergy or intolerance to statins\* 6. pregnancy or breast feeding 7. receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir. 8. existing clinically significant myositis or myopathy or has a measured ck greater than 5,000 u/l 9. requiring statin for underlying disease as determined by the patients attending physician team\*\*. 10. severe chronic liver disease (child-pugh score 11-15) 11. previous myocardial infarction or thrombotic stroke within the past 6 months 11.12. any significant funding in the patient's medical history or physical or psychiatric exam prior to randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol

Keywords: ards h1n1 influenza statin
diabetes education and care for deaf populations

Conditions: Diabetes

Summary: this study will assess the feasibility and preliminary efficacy of a 10-week intervention called "deaf diabetes can together".


Eligibility criteria:
inclusion criteria: * identify as deaf/hard of hearing * living with diabetes (any type) * speak and understand english or american sign language * have access to internet * willing to participate in the intervention exclusion criteria: * participating in another diabetes study * have significant cognitive impairment * are pregnant or planning to become pregnant in the next year * have life expectancy of \<6 months
comparison of enteral products for tube fed patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: to compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * diagnosis of type 2 diabetes * hba1c between 7.0 and 9.0% * 18 - 75 years of age * currently receiving a standard enteral product * anticipated duration on tube feeding at least one month * 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support * anticipated life expectancy is more than or equal to 6 months * free of infections * no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose exclusion criteria: * composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products * composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions * significant cardiovascular event less than or equal to 2 weeks prior to study entry * major surgery less than or equal to 2 weeks prior to study entry * pre-planned surgery during the study period * active malignancy, including melanoma and excluding cutaneous malignancies * severe dementia * known allergies to medical grade adhesives and/or skin disinfectants * taking octreotide * chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv * participation in a concomitant trial
managing childhood abdominal pain

Conditions: Pediatric Abdominal Pain

Summary: functional abdominal pain (fap) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. the study will test a treatment approach which, if successful, would substantially change the treatment for fap and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. the study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.

functional abdominal pain (fap) affects 10 to 15% of children and has significant social, emotional, and financial costs, but no known organic cause and no accepted medical or behavioral treatment. the researchers have conducted studies that provide support for a theoretical model in which cognitive-behavioral and social learning processes (modeling and/or potentially reinforcing responses by parents) may contribute to the maintenance of illness behaviors and functional disability in children with fap. the researchers subsequently tested a social learning and cognitive-behavioral intervention for parent-child dyads which focused on changing these parent behaviors as well as teaching coping skills to children. results support the effectiveness of the intervention and the explanatory value of the theory, demonstrating that parental change is a key element in reducing children's symptoms. the proposed study will build on these findings by evaluating a parent-only intervention. furthermore, our experience and that of other investigators indicates that alternative intervention models are needed for wider accessibility to the intervention for families in need. while a parent-only format is expected to increase accessibility, we will also evaluate the use of a remote telephone intervention.

Eligibility criteria:
inclusion criteria: * the child is 7 to 12 years old * the child experienced at least three episodes of unexplained abdominal pain over a three month period which affected the child's activities * the child lived with the primary caregiver for at least the last 3 months * the child and the parent agree to the conditions of study participation, including randomization, participation in intervention and follow-up evaluations * the parent and child comprehend and speak english without assistance exclusion criteria: * the child has positive physical or laboratory findings which would explain the abdominal pain * the child has a chronic disease (e.g. crohn's, ulcerative colitis, pancreatitis, diabetes, epilepsy, etc.) * the child is lactose intolerant * the child had major surgery in the past year * the parent or child has developmental disabilities that require full-time special education or that impair ability to respond to assessment measures

Keywords: fap rap abdominal pain ibs