Kornimate/medical-research-clean huggingface dataset:
nimotuzumab plus s1 versus placebo plus s1 as maintenance treatment in patients with unresectable pancreatic cancer

Conditions: Unresectable Pancreatic Cancer

Summary: background: monotherapy with s-1, oral fluoropyrimidine, shows non-inferiority to gemcitabine in overall survival (os) with good tolerability for advanced pancreatic cancer in asian patients. it is also shown that nimotuzumab plus gemcitabine could improve os and progression free survival (pfs) in patients with unresectable pancreatic cancer. however, it is still unknown whether nimotuzumab plus s1 would improve more to os and pfs than single s-1. maintenance treatment, as a new treatment pattern, has also been tried in these patients after first line treatment to improve the os. thus, this study is designed to compare nimotuzumab plus s1 to placebo plus s1 as maintenance treatment in patients with locally advanced or metastatic pancreatic cancer who has benefited from the first-line treatment of gemcitabine combined with nimotuzumab and s1 (complete response+partial response+stable disease). patients and methods: 60 patients will be enrolled,and randomized in a 1:1 ratio to group nimotuzumab plus s1 and group placebo plus s1. nimotuzumab/placebo: 400 mg/w, intravenous infusion, infusion time ≥ 60 min, d1, once every two weeks. s1: oral, 40 mg (body surface area\ 1.5 m2), d1-d14, every three weeks for a cycle. treatment interventions will be stopped under the conditions of disease progression or intolerable toxic reaction or participants ask to quit. the primary endpoint is the time to disease progression since randomization (ttp), secondary points include os, 3 years overall survival rate (osr) and safety.


Eligibility criteria:
inclusion criteria: * 18-75 years; * karnofsky performance status≥ 60; * histologically proven locally advanced or metastatic pancreatic cancer,and unsuitable for radiotherapy or surgery resection; * benefited from the first line treatment of gemcitabine plus nimotuzumab and s1 (complete response+partial response+stable disease); * at least 4 weeks from the end of the first-line treatment; * with at least 1 measurable and evaluable lesion; * anticipated over survival≥12 weeks; * ast/alt≤2.5 uln (≤5 uln for patients with hepatic metastases); total bilirubin≤2 uln （≤3 uln for patients with hepatic metastases); neutrophil count≥1.5×109/l; platelet counts≥100×109/l; hemoglobin level≥90 g/l; creatinine clearance rate≥ 60 ml/min * written informed consent exclusion criteria: * previously received the following treatments: anticancer chemotherapy/molecularly targeted therapy as palliative treatment, or targeted chemotherapy and no progression, another interventional clinical trail within 4 weeks; * underwent major surgery within 4 weeks; * with brain or leptomeningeal metastases; * history of malignancy other than pancreatic cancer; * presented symptomatic abdominal fluid and needed treatment; * with other serious diseases such as diabetes,active infection; * known for allergy to anti epidermal growth factor receptor antibody

Keywords: pancreatic cancer unresectable maintenance treatment
open-label adjunctive zonisamide for bipolar disorder

Conditions: Bipolar Disorders

Summary: to study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar i or ii disorder.


Eligibility criteria:
* bipolar i/ii * average intelligence * taking at least one, but no more than two mood stabilizers

Keywords: zonisamide bipolar
vinorelbine/gemcitabine versus vinorelbine/carboplatin in advanced non-small cell lung cancer

Conditions: Advanced Non-Small Cell Lung Cancer

Summary: the purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer stage iiib or iv * not eligible for radical radiotherapy or surgery * who performance status 0-2 exclusion criteria: * pregnancy * other clinical active cancer disease * alat/alp more than 3 times upper normal limit, bilirubin \>1.5 upper limit * bowel disease that causes malabsorption

Keywords: lung cancer chemotherapy vinorelbine gemcitabine carboplatin advanced lung cancer non-small cell lung cancer
chemically assisted capsulectomy-a new clinical approach

Conditions: Implant Capsular Contracture

Summary: the purpose of this study is to make available an agent,mesna, which can assist the surgeon during the procedure of capsulectomy.

mesna is a fda approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. it has also been used in gynecologic surgery and ent. mesna is a drug that breaks down adhesions between tissue layers.

Eligibility criteria:
inclusion criteria: * all females undergoing capsulectomy exclusion criteria: * all pregnant women and nursing mothers will be exclued

Keywords: capsular contracture capsulectomy mesna capsular contracture after breast implant placement
randomized, double-blind, placebo-controlled study of pregabalin in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * acr criteria for fibromyalgia * a score of more or equal to 40 mm on the pain vas * an average score more or equal to 4 on 4 daily pain diaries exclusion criteria: * patients with other severe pain conditions * patients with severe depression * patients taking excluded medications * patients with suicidality
pilot placebo controlled study with lovaza in cardiovascular disease

Conditions: HIV Infections; Heart Disease

Summary: several studies have shown that there is an increased risk of heart disease in people with hiv. in this study the investigators are looking at the effect of lovaza (omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. the investigators will also be doing studies to analyze coagulation and inflammation markers.


Eligibility criteria:
inclusion criteria: * hiv+ * ages 18-70 * hiv-1 rna \<400 copies/ml. * on stable art (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative art before study entry of 12 mos. exclusion criteria: * active infection * inflammation or malignancy * uncontrolled diabetes or hypothyroidism * ldl (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750 * framingham risk score \<6.

Keywords: omega-3 fatty acids hiv heart disease treatment experienced
efficacy and safety of ibi110 in combination with sintilimab versus sintilimab alone in neoadjuvant and adjuvant therapy of radically resectable non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the main purpose of this study is to evaluate the neoadjuvant therapy efficacy of ibi110 in combination with sintilimab versus sintilimab alone based on pathologic complete response (pcr) rate in stage iib (primary tumor \> 4 cm ) to iiib (n2 only) subjects with radically resectable nsclc.


Eligibility criteria:
inclusion criteria: 1. have nsclc that has been classified as stage iib (primary tumor \> 4 cm), iiia, or iiib (n2 only) per the 8th edition of tnm staging system of international association for the study of lung cancer (iaslc) and the american joint committee on cancer (ajcc). 2. subjects with non-squamous nsclc should undergo genetic testing to confirm the absence of epidermal growth factor receptor (egfr) sensitizing mutations or anaplastic lymphoma kinase (alk) rearrangements; 3. eligible for radical resection (r0 resection) at the thoracic surgeon's discretion, and the lung function meets the criteria for planned surgery; 4. have at least one measurable lesion per recist v1.1 criteria; 5. have a performance scale of 0 or 1 on the eastern cooperative oncology group performance status (ecog ps) exclusion criteria: 1. have pathological evidence for small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelial rumen carcinoma, salivary gland tumor, or mesenchymal tumor from the biopsy. 2. have been previously exposed to immune-mediated therapies, including but not limited to lag-3 antibody drugs, anti-cytotoxic t lymphocyte antigen-4 (ctla-4), anti-pd-1, anti-pd-l1, and anti-pd-l2 antibodies.
retrospective review of xen gel stent implantation with open vs. closed conjunctiva approach

Conditions: Glaucoma, Open-Angle

Summary: to measure surgical success of open vs closed conjunctiva with xen implantation.

this retrospective, single-arm multicenter study included \>100 eyes (\>100 patients) with glaucoma refractory to medical therapy. all surgeries were performed by two groups of surgeons at johns hopkins university and the sub-investigator group at new york university. group 1: xen with open conjunctiva for positioning and application of mitomycin. the xen was placed through the sclera either ab-interno or ab-externa. group 2 had xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-c. success rates will be determined based on need for re-intervention and intraocular pressure control.

Eligibility criteria:
inclusion criteria: * require surgery for uncontrolled glaucoma exclusion criteria: * none

Keywords: glaucoma surgery xen gel stent
an observational study of participants with type 3 von willebrand disease on prophylactic standard-of-care treatment

Conditions: Von Willebrand Disease, Type 3

Summary: this non-interventional study (nis) is designed to collect information on the effectiveness and safety of treatment received in routine clinical care, as well as measure the health-related quality of life (hrqol) of participants with type 3 von willebrand disease (vwd) receiving prophylactic therapy per local standard of care (soc) over an observation period of at least 24 weeks.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type 3 von willebrand disease (vwd), based on medical records * adequate hematologic, hepatic, and renal function * documented and confirmed previous use of soc prophylactic therapy for vwd (1-3 times weekly, as per prescribed dose) and anticipation to remain on the same regimen during the study * for participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements exclusion criteria: * inherited or acquired bleeding disorder other than congenital type 3 vwd * history of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia * history of intracranial hemorrhage * previous or current treatment for thromboembolic disease or signs of thromboembolic disease * other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis * history of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection * use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
pharmacological regulation of fat transport in metabolic syndrome

Conditions: Obesity; Lipid Disorders; Hypertriglyceridemia; Cardiovascular Disease

Summary: the purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.

insulin resistance is a heterogeneous metabolic disorder of complex etiology. it underpins dyslipoproteinemia, a key feature of the metabolic syndrome (mets) that independently predicts cardiovascular disease (cvd). hypertriglyceridemia, the most consistent lipid disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of overproduction and delayed clearance of triglyceride-rich lipoproteins (trls). although the precise mechanisms involved are incompletely understood, experimental and clinical evidence suggests that elevated apolipoprotein (apo) c-iii may play a crucial role in the dysregulation of trl metabolism. investigating the effects of these agents on vldl-apoc-iii kinetics. in this study, we aimed to examine the effect of two lipid-regulating agents, atorvastatin and fenofibrate on vldl-apoc-iii transport. we hypothesized that atorvastatin and fenofibrate would have similar effects on apoc-iii transport by decreasing the production and increasing the catabolism of vldl-apoc-iii.

Eligibility criteria:
inclusion criteria: any three of the followings * waist circumference \>102cm * triglycerides \>1.7 mmol/l * hdl-cholesterol \<1.05 mmol/l * blood glucose \>6.1 mmol/l * blood pressure \>130/85mmhg exclusion criteria: * plasma cholesterol \>7mmo/l * triglycerides \>4.5mmo/l * diabetes mellitus (defined by oral glucose tolerance test) * cvd * consumption of \>30g alcohol/day * use of agents affecting lipid metabolism * apoe2/e2 genotype, macroproteinuria * creatinaemia (\>120umol/l) * hypothyroidism * abnormal liver and muscle enzymes.
nursing study of skin lesions related to health care protection in novel nursing study of skin lesions related to health care protection in novel coronavirus epidemic

Conditions: Associated Skin Lesions

Summary: in the fight against the epidemic, medical personnel need to wear protective equipment, such as n95 mask, face screen, goggles, latex gloves, waterproof isolation clothing, and have special requirements. protection-related skin lesions after the use of protective equipment will affect the health and comfort of medical workers. in this study, a retrospective study was conducted on the front-line medical workers in the fight against covid-19 using questionnaires, so as to understand the incidence, location and clinical manifestations of skin lesions caused by the use of protective equipment by medical workers. and analyze the causes of these skin damage, so as to develop the corresponding prevention and treatment countermeasures, select 170 cases that meet the research conditions, a randomized controlled experiment, divided into control group and experimental group: the control group is on the basis of three-level protection, did not use any preventive measures of health care workers. in the experimental group, skin related prevention was carried out on the basis of three-level protection. the specific interventions are as follows :(1) focus on protecting exposed skin and making it locally dry. (2) do a good job of facial moisturizing before work (at least 1 hour before wearing the mask), use moisturizing ointment, longer lasting and non-irritating cream or emulsion, such as vitamin e cream, vaseline, avoid direct contact with the skin of the mask, choose the appropriate type of protective device; reduce friction by sticking foam paste, hydrocolloid accessories, ampute and so on on good hair parts. however, it should be noted that it must be confirmed that the airtightness is good, and the primary purpose of the medical staff is to ensure the protective effect. (4) after work, avoid using irritant (such as hot water, exfoliating cream, etc.) to clean the face, and massage local skin with skin moisturizer; (5) in case of severe skin damage, treat as prescribed by the doctor; (6) after finishing the front-line work, "questionnaire star" was used to collect data, and all data were input into the statistical software for analysis to compare the index differences between the two groups.


Eligibility criteria:
inclusion criteria: 1. job post: fever clinic, covid-19 throat swab sampling site, isolation ward 2. health care workers who have worked for 30 days or more 3. the continuous working time of tertiary protection shall be more than or equal to 4 hours 4. signed the informed consent and volunteered to participate in the study. exclusion criteria: 1. existing long-term skin damage 2. the skin damage related to protection is too heavy to be studied
liver cancer registry platform

Conditions: Hepatocellular Carcinoma (HCC); Cholangiocarcinoma

Summary: the purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hepatocellular carcinoma (hcc) or cholangiocarcinoma (ccc) in germany.

jade is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of hcc or ccc in germany. the registry will follow patients for up to three years. it will identify common therapeutic sequences and changes in the treatment of the disease. at inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. during the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. health-related quality of life in patients with hcc / ccc will be evaluated for up to three years.

Eligibility criteria:
inclusion criteria: * confirmed hepatocellular carcinoma (hcc) or cholangiocarcinoma (ccc) als early, intermediate or advanced/metastatic stage * age ≥ 18 years * signed and dated informed consent (ic): * for participation in the pro module: before primary locoregional therapy or start of first systemic treatment * for no participation in the pro module: no later than 8 weeks after primary locoregional therapy or start of first systemic treatment exclusion criteria: patients treated with best supportive care (bsc) only (i.e. no surgery, no radiotherapy, no ablative procedures, no systemic anti-tumoral therapies)
comparison of two exercise programmes in patients undergoing hemodialysis

Conditions: End Stage Renal Disease

Summary: although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy. this is often related to financial cost and/or staffing limitations. home-based programs could be an alternative means of providing exercise benefits without associated implementation costs the aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.


Eligibility criteria:
inclusion criteria: * people under hemodialysis treatment at least 3 months * be medicable stable * complete all the physical tests exclusion criteria: * heart stroke in the previous 6 weeks of the study * inferior limb amputation without artificial aids * cerebral vascular disease (ictus, ischemic) * disability to complete functional tests
change in mindfulness in borderline personality disorder

Conditions: Mindfulness; Borderline Personality Disorder

Summary: the current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with borderline personality disorder. a treatment group will be compared to a waitlist control group.

participants will be recruited from the dialectical-behavioral-therapy (dbt) unit. dbt is a treatment approach that has been shown to be effective in the treatment of borderline personality disorder. dbt integrates different psychotherapeutic interventions as well as mindfulness meditation exercises. mindfulness is a meditation practice that can improve present moment awareness. when applied as therapeutic intervention mindfulness meditation can help patients to stay with their attention in the present moment, to be aware what is happening in the here and now, and to better identify and regulate upcoming emotions. the current observational study investigates changes in symptom severity and mindfulness skills during dbt treatment. a treatment group will be compared to a waitlist control group. the two groups are predefined by routine medical care. symptom severity and mindfulness skills will be assessed at baseline (before treatment or when accepted for the waitlist) and after 12-weeks. a within and between group analyses will be performed.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of borderline personality disorder * on the waitlist for dbt treatment or actually treated with dbt * not previously treated with dbt. exclusion criteria: * severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
a multi-center trial to study acute liver failure in adults

Conditions: Acute Liver Failure; Fulminant Hepatic Failure; Acute Liver Injury

Summary: the purpose of this study is to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and dna samples on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy.

although alf is truly an orphan disease affecting only about 2,000 persons per year, its severity, its frequency among young adults, and its high resource utilization justifies the attention paid to it. in addition, alf has captured the interest and attention of researchers because of its unique pathogenesis and extreme severity, encouraging us to understand the processes underlying all forms of liver injury, by focusing on this most lethal manifestation. the etiologies associated with alf have continued to change further over the years with an apparent decline in viral hepatitis, and a remarkable increase in acetaminophen toxicity to its current level of \~44-50% of cases. a further problem in studying alf is that the number of cases of a specific etiology observed at any one institution are vanishingly small. the earliest goals of the alf study then were to more carefully define the etiologies of alf on a national scale, and to finally allow in-depth study of specific alf causes such as autoimmune alf, viral hepatitis and wilson disease (wd). a second group of patients worthy of study are those with acute liver injury.it would be of value to study patients destined to possibly have alf earlier in their illness for several reasons: first, we might be able to better predict who will progress to full liver failure; second, the current definition requiring encephalopathy limits the number of patients available for study at any site; finally, therapeutic trials might have greater efficacy if begun at earlier disease stages. patients who are enrolled are referred to alfsg clinical sites by gastroenterologist/hepatologist and fellows. detailed clinical data and bio-specimen (sera, urine, plasma, dna and tissue if available) are collected. subjects are followed long-term at 6 months and 12 months. detailed clinical data and sera are collected.

Eligibility criteria:
alf inclusion criteria: * written informed consent from patient's next of kin * altered mentation of any degree (encephalopathy) * evidence of moderately severe coagulopathy (inr ≥ 1.5) * a presumed acute illness onset of less than 26 weeks * the nih guidelines on the inclusion of women and minorities as subjects in clinical research will be observed alf exclusion criteria: * cirrhosis patients * alcohol induced liver failure * known pre-existing chronic liver disease ali inclusion criteria: acetaminophen (apap) etiology: acute illness \< 2 wks * inr ≥ 2.0, alt ≥ 10x uln non-acetaminophen etiology: acute illness \< 26 wks * inr≥ 2.0, alt≥ 10x uln, tbili ≥ 3 mg/dl ali exclusion criteria: • altered mentation of any degree (encephalopathy)

Keywords: liver disease liver injury