Kornimate/medical-research-clean huggingface dataset:
novosyn® chd vs polyglactin 910 suture to close wounds after emergency or elective laparotomy or laparoscopic surgery

Conditions: Surgical Site Infection

Summary: the aim of the study is to elucidate, if the colonization of bacteria is lower on the novosyn® chd suture compared to uncoated polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (ssi: a1 and a2). the results of this registry will generate further clinical evidence for the use and the benefit of a chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. the benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.


Eligibility criteria:
inclusion criteria: * patients undergoing an emergency or elective laparotomy or laparoscopic surgery. * written informed consent * age≥ 18 years * not incapacitated patient exclusion criteria: * no exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine

Keywords: chlorhexidine coated suture emergency laparoscopic surgery emergency laparotomy surgery elective laparoscopic surgery elective laparotomy surgery novosyn® polyglactin 910
research for predictive biologic parameters of cutaneous hypersensitivity after brachytherapy in breast cancer

Conditions: Breast Cancer

Summary: 25 patients, treated by brachytherapy in a phase ii study "mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy. during this consultation, a blood sample will be taken for analysis ( rate of cd8 t-lymphocyte apoptosis)

this is an interventional study for the french law

Eligibility criteria:
inclusion criteria: * all patient treated by exclusive per-operative brachytherapy in the prior study mammosite for breast cancer * patient with social security exclusion criteria: * not applicable

Keywords: brachytherapy, late cutaneous toxicity
resource allocation for alcohol

Conditions: Alcohol Drinking

Summary: a total of 150 young adults (ages 21-29) will be randomized to receive a brief alcohol intervention (intended to reduce alcohol-related resource allocation (e.g., time and money spent on alcohol), alcohol consumption, and alcohol related consequences) or an assessment only control condition. all participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains, alcohol use, personal goals, and money spent on alcohol and substance-free activities. those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation. all participants will complete a 1 and 3 month follow up survey. participants can earn up to $126 for completing all study components.


Eligibility criteria:
inclusion criteria: * 1)21-29 years old, 2) reside within wa state, 3) report drinking 2+ days per week, on average, in the last six months, 4) report 4+ heavy drinking episodes (4+/5+ for women/men) in the past month, exclusion criteria: * 1) currently enrolled in a 4-year college, 2) currently in or seeking treatment for alcohol use
study of ipatasertib or apitolisib with abiraterone acetate versus abiraterone acetate in participants with castration-resistant prostate cancer previously treated with docetaxel chemotherapy

Conditions: Prostate Cancer

Summary: this multicenter, international, phase ib/ii trial consists of three stages: a phase ib, open-label stage in which the recommended phase ii dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a phase ii, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort) * two rising psa levels greater than or equal to (\>/=) 2 ng/ml measured \>/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone * eastern cooperative oncology group (ecog) performance status of 0 or 1 at screening * adequate hematologic and organ function * documented willingness to use an effective means of contraception * safety cohort only: agreement to use cgm for first cycle of treatment exclusion criteria: * history of type i or type ii diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible * new york heart association class iii or iv heart failure or left ventricular ejection fraction \< 50% or ventricular arrhythmia requiring medication * significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to day 1, or cerebrovascular accident within 6 months prior to day 1 * active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy * clinically significant history of liver disease * history of adrenal insufficiency or hyperaldosteronism * phase ii only: previous therapy for prostate cancer with 17 alpha-hydroxylase/c17,20-lyase inhibitors, including abiraterone * phase ii only: previous treatment for prostate cancer with protein kinase b phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors * need for chronic corticosteroid therapy of \>/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
cardiox shunt detection technology study

Conditions: Patent Foramen Ovale

Summary: the cardiox flow detection system is designed to detect the presence of indocyanine green (icg) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (rtls). the cardiox system will be compared against transesophageal echocardiography (tee) for sensitivity and specificity, as well as transcranial doppler (tcd) for positive percent agreement and negative percent agreement.


Eligibility criteria:
inclusion criteria: * eighteen (18) years of age or older * informed consent documentation understood and signed * planned or completed tee study within the last 12 months exclusion criteria: * subjects with a known allergy or sensitivity to indocyanine green dye (icg) or to iodide contrast dye or iodides * pregnant women or nursing mothers * subject unable or unwilling to understand and sign the informed consent * subject scheduled for radioactive iodine uptake test (thyroid test) within 7 days of post screening * subjects that have poor renal function such as subjects on dialysis, subjects with a recent history of creatinine \> 2.0 or subjects currently being followed by a nephrologist

Keywords: right to left cardiac shunt finding
valopicitabine alone and together with pegylated interferon in patients with chronic hepatitis c who have failed to respond to standard therapy

Conditions: Chronic Hepatitis C

Summary: this study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (nm283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis c treatment failure patients. these results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis c viral infection.


Eligibility criteria:
inclusion criteria: * documented clinical history compatible with chronic hepatitis c and compensated liver disease * failed response to previous hepatitis c therapy of pegylated interferon/ribavirin other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breastfeeding * patient is co-infected with hepatitis b or hiv other protocol-defined exclusion criteria may apply.

Keywords: genotype-1 previously failed treatment
activity for diabetic polyneuropathy

Conditions: Diabetic Neuropathy

Summary: the proposed study will randomize participants with diabetic peripheral neuropathy into two groups. one group of participants will receive standard-of-care counseling while the other group will undergo supervised exercise and counseling to increase physical activity.

type 2 diabetes (t2d) affects over 8% of americans, and half will develop peripheral neuropathy, a progressive injury to the very longest nerves of the body. our previous research has found that neuropathy can be detected early in its course and followed by examining nerves that reach to the skin using a small punch biopsy. these cutaneous nerves can be injured by high blood glucose, obesity and high triglycerides, but have the potential to regrow in response to treatments that improve these metabolic conditions. the proposed study will randomize participants with mild to moderate diabetic peripheral neuropathy to receive either generic annual counseling or an integrated program of moderate supervised exercise and actigraphy based anti sedentariness counseling.

Eligibility criteria:
inclusion criteria: 1. t2d defined by ada criteria. 2. peripheral neuropathy based on the toronto diabetic neuropathy expert group consensus criteria for "confirmed diabetic sensorimotor peripheral neuropathy". 3. moderate dpn severity with a uens of 2-18. 4. age between 30 and 75. 5. under the care of an identified primary care physician (pcp). exclusion criteria: 1. any alternative cause for peripheral neuropathy. the following tests must have been found normal within the last 12 months or will be performed pre-randomization: vitamin b12, serum protein electrophoresis and immunofixation. ana and tsh may be obtained if clinically indicated and not available from clinical records. 2. family history of a non-diabetic neuropathy in a first-degree relative. 3. severe or longstanding neuropathy: uens \> 18 or history of foot ulceration or amputation. 4. participants taking coumadin or oral factor x or thrombin inhibitor therapy will be considered on an individual basis by the site investigator. 5. severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy. 6. a serious medical condition that might shorten life span or prevent exercise. 7. subjects with obesity or hypertension considered in a dangerous range (bmi\> 45, systolic bp \>170, or diastolic bp \>110) and those who fail a medically supervised graded maximal stress test will be excluded from the study for safety reasons. 8. an inability to understand or cooperate with the procedures of the study 9. females who are pregnant at screening or actively plan to become pregnant during the study period, because of the marked changes in metabolism anticipated during pregnancy. 10. if ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition.
online psychological care program for women who attend a breast clinic.

Conditions: Breast Cancer

Summary: the objective of this study is to evaluate the effectiveness of an online psychological care program to reduce anxiety, depression and negative psychological consequences and to increase a sense of coherence in the process of diagnostic evaluation and/or screening of mammary glands in women who attend a breast clinic. there will be an experimental group and a control group. the experimental group will receive the psychological intervention through a virtual platform and the control group will be given visual material with the information. this platform will be designed based on the principles of user experience (ux).

it has been shown that women who undergo diagnostic tests or screening of their mammary glands present symptoms associated with anxiety, concerns regarding a possible positive result for malignancy, as well as emotional distress. it is important to generate psychological programs aimed at reducing the psychological consequences of the diagnostic evaluation and/or screening of mammary glands because there are few approaches on the subject. in mexico there are breast clinics of the mexican social security institute, designed to perform screening tests and diagnostic evaluation of mammary glands, with the aim of identifying cases of breast cancer in early stages. however, few psychological interventions have been reported during the diagnostic process, so it is important to know the psychological affectations presented by women who undergo these tests. given this, this intervention has the objective of evaluating the effectiveness of an online psychological care program to reduce psychological distress and increase the sense of coherence in the process of diagnostic evaluation of mammary glands in women who attend a breast clinic. in the intervention there will be two groups: a) experimental group and b) control group. the experimental group will receive online psychological care through the virtual platform and the patients in the control group will be given visual material with the information. all participants will be invited to attend the breast clinic and undergo screening studies and/or diagnostic evaluation. for the assignment of the experimental and control group, it will be carried out through a randomization process through the excel program.

Eligibility criteria:
inclusion criteria: * patients of legal age who attend a health institution for screening studies and/or diagnostic evaluation of breast cancer. * patients who can use an electronic device (smart phone, computer, laptop, tablet) to access the virtual platform. * patients who give their informed consent to participate in the study. exclusion criteria: * patients with suicidal ideation and/or attempt.

Keywords: cancer screening tests anxiety depression sense of coherence psychological intervention internet-based intervention
a clinical study of car-t cells treatment for children with cd19+/cd22+ r/r all and lymphoma

Conditions: Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood; Refractory B-cell Acute Lymphoblastic Leukemia, Childhood; Relapsed/Refractory B-cell Lymphoma, Childhood

Summary: this is a single arm, open-label, uni-center, phase i study . in this study, children withcd19+/cd22+ r/r b-cell acute lymphoblastic leukemia or lymphoma will be treated with car-t19/car-t22 immunotherapy to determine the safety and efficacy of treatment.


Eligibility criteria:
inclusion criteria: * male and female subjects with cd19+/cd22+ b cell malignancies who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled. 1. no available curative treatment options (such as autologous or allogeneic sct) 2. if patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of b cells recovered. 3. patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no gvhd and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the cart reinfusion; 4. patients must be willing to sign an informed consent. 5. age:≤18 years. 6. survival\>12 weeks 7. flow cytometry or ihc showed positive expression of cd19/ cd22 in tumor cells within two months. 8. routine blood test:hemoglobin\>=90 g/l; platelet\>=50×10\^9/l. 9. liver function: alt and ast≤2.5 (uln) times the upper limits of normal (if abnormal liver function is mainly caused by tumor infiltration, it can ≤5 uln), bilirubin \<2.0 mg/dl. 10. renal function:bun: 9-20mg / dl; serum creatinine\ =50 ml/min 11. negative serum antibody for ebv, cmv, hiv , syphilis, hbva nd hcv. 12. cardiac function: stable hemodynamic and left ventricular ejection fraction (lvef)\>=55%. 13. ecog score ≤2。 14. adequate venous access for apheresis, and no other contraindications for leukapheresis exclusion criteria: 1. ecog \>= 3. 2. patients with history of t cell tumors . 3. organ failure:heart failure ⅲ and ⅳ;the liver reached grade c of child-turcotte .renal failure and uremia;respiratory failure;people with impaired consciousness. 4. acute or chronic gvhd after allogeneic hematopoiesis. hormone or immunosuppressant was used within 30 days. 5. steroid hormoneswere used before and after blood collection and infusion. 6. hiv infection or active hepatitis b or hepatitis c infection. 7. uncontrolled active infection. 8. enrolled to other clinical study in the last 4 weeks. 9. subjects with systemic auto-immune disease or immunodeficiency. 10. allergic to cytokines. 11. definite neuropathic or psychotic patients, including authors of dementia or seizures, history of psychotropic substance abuse and unable to quit, or other substantial lesions that may increase central neurotoxicity. 12. patients with malignant tumors of the central nervous system. 13. lung, brain or intestinal tumor infiltrates. 14. the second tumor was found. 15. allergic to cytokine antagonists. 16. other patients that researchers considered unsuitable for inclusion.
effect of stopping risedronate after long term treatment on bone turnover

Conditions: Postmenopausal Women With Osteoporosis

Summary: the effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on bmd (bone mineral density) and btms (bone turnover markers) will be summarized.


Eligibility criteria:
inclusion criteria: * post-menopausal women who sequentially completed studies rve009093, rve1996077, rve1998080 exclusion criteria: * less than 60% compliant between drug start and month 21 * using bisphosphonates, glucocorticoids, anabolic steroids, vitamin d supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection \>10,000 iu vitamin d, investigational drug

Keywords: postmenopausal women osteoporosis
to study the use of humanized cd25 in preventing the relapse of psoriasis vulgaris

Conditions: Psoriasis

Summary: this study is designed to study disease relapse after nbuvb and how the administration of daclizumab/placebo alters disease relapse.

the first part of the study involves nb-uvb light treatment, a well-established treatment to treat psoriasis. in the second part, we are testing a drug known as humanized cd25 monoclonal antibody (anti-tac) or placebo to prevent disease relapse. anti-tac is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.

Eligibility criteria:
inclusion criteria 1. male or female patients with chronic psoriasis vulgaris (disease stable or worsening for \> 6 months). patients age 16 - 21 will be considered on a case to case basis. for those patients under the age of 18, parental consent will be obtained. 2. extensive skin involvement. 3. scale, thickness, and erythema in individual psoriasis lesions of at least moderate intensity. 4. psoriasis treated with emollients only for 2 weeks prior to treatment 5. patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface. 6. patients that are appropriate for treatment with uvb. exclusion criteria: 1. positive serology for hiv, hepatitis b, or hepatitis c. 2. positive β-hcg titer. for women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-hcg. 3. guttate psoriasis, pustular psoriasis, or whole body erythroderma. 4. active infection or persistent fever of unknown origin. 5. major concurrent illness, which could worsen following treatment with anti-tac.

Keywords: psoriasis cyclosporine daclizamub anti-tac dermatology skin lesions
calm psychotherapy in patients with metastatic cancer in chile

Conditions: Metastatic Cancer

Summary: patients with metastatic cancer experience multidimensional challenges that increase the risk of emotional distress, which must be addressed by the health team. chile lacks evidence on effective therapeutic interventions in this population. calm is a brief, individual (with the presence of a caregiver in one or more sessions) and evidence-based psychotherapy developed at the princess margaret cancer center. it consists of an intervention of 3 to 6 psychotherapy sessions over a period of 3 to 6 months. the global calm program aims to expand calm research around the world, a program to which falp has subscribed. objective: to evaluate the preliminary efficacy of calm in a sample of patients with metastatic cancer in chile. phase 2 study of preliminary, pseudo-experimental efficacy, without a control group. the study will be carried out in falp and corporación valientes.

patients with metastatic cancer experience multidimensional challenges that increase the risk of emotional distress, which must be addressed by the health team. chile lacks evidence on effective therapeutic interventions in this population. calm is a brief, individual (with the presence of a caregiver in one or more sessions) and evidence-based psychotherapy developed at the princess margaret cancer center. it consists of an intervention of 3 to 6 psychotherapy sessions over a period of 3 to 6 months. the global calm program aims to expand calm research around the world, a program to which falp has subscribed. objective: to evaluate the preliminary efficacy of calm in a sample of patients with metastatic cancer in chile. phase 2 study of preliminary, pseudo-experimental efficacy, without a control group. the study will be carried out in falp and corporación valientes. sample size 34 participants. sessions will be online, 45 to 50 minutes long. sessions can be recorded for supervision and training purposes.

Eligibility criteria:
inclusion criteria: * be ≥18 years of age; * be fluent in spanish; * be able to give informed consent; and * have received a diagnosis of advanced or metastatic solid tumor cancer with a reduced life expectancy but greater than six months. exclusion criteria: * significant verbal communication difficulties; * cognitive impairment indicated by the clinical team or in the patient's file. * patients currently in psychotherapy. * active suicidal ideation

Keywords: psychotherapy palliative care
efficacy of dietary education and education on phosphate binder use in hemodialysis patients

Conditions: Hyperphosphatemia; End-stage Renal Disease

Summary: hyperphosphatemia is an independent risk factor for mortality among dialysis patients. and most phosphate in human is derived from the food. the purpose of this study is to evaluate the efficacy of nutritional consultation and education on phosphate binder among dialysis patients.

hyperphosphatemia is an independent risk factor for mortality among dialysis patients. hyperphosphatemia is associated with increased incidence of cardiovascular diseases, and is a mediator to the development of hyperparathyroidism and mineral bone disorder. phosphate is usually obtained by food intake, and it can be removed by hemodialysis. however, the efficacy of removal is limited, so that dietary education and proper intake of phosphate binder is essential.

Eligibility criteria:
inclusion criteria: * end-stage renal disease patients whose dialysis vintage is more than 3 months exclusion criteria: * patients with liver cirrhosis * pregnant patients * patients with alimentary tract malabsorption diseases * history of recent alcohol or drug abuse * patients receiving chemotherapy for solid organ tumor * history of mental illness (major depressive disorder, bipolar disorder, schizophrenia, etc.) * patients having difficulty communicating with our medical team (dementia, mental retardation, etc.)

Keywords: end-stage renal disease phosphate binders hyperphosphatemia dietary education