Kornimate/medical-research-clean huggingface dataset:
rws of paclitaxel liposome combined with anti-her-2 monoclonal antibody

Conditions: Breast Cancer Stage IV

Summary: this is a retrospective, single-arm real-world study based on the national anticancer drug clinical application monitoring network database.the aim of this study is to evaluate the efficacy and safety of paclitaxel liposome combined with anti-her-2 monoclonal antibody as first-line salvage treatment for her-2 positive advanced breast cancer. it seeks to understand the application patterns, efficacy, and safety of paclitaxel liposome combined with anti-her-2 monoclonal antibody in real-world settings, providing patients with safer treatment options.

the national anticancer therapy data surveillance system (natdss) is the largest oncology diagnosis and treatment database in china to date, covering patient data from over 1400 oncology hospitals and integrated hospitals. it has collected data from approximately 15 million cancer patients since 2013, including mortality information obtained from the cdc death registration database. paclitaxel liposome was introduced to the market in 2004 as a formulation of paclitaxel. it utilizes nanotechnology to encapsulate the poorly water-soluble paclitaxel within a lipid bilayer of liposomes, solving the issue of paclitaxel\& low solubility in water. paclitaxel liposome no longer employs polyoxyethylated castor oil as a solvent. while ensuring efficacy, it reduces the risk of associated adverse drug reactions (such as severe allergic reactions), thereby enhancing the tolerance of cancer patients. although paclitaxel liposome is widely used in her-2 positive advanced breast cancer, there is currently no research on the efficacy and safety of combining paclitaxel liposome with anti-her-2 monoclonal antibodies as first-line salvage treatment of her-2 positive advanced breast cancer. this study aims to conduct a real-world study on the efficacy and safety of combining paclitaxel liposome with anti-her-2 monoclonal antibodies as first-line salvage treatment of her-2 positive advanced breast cancer based on the natdss

Eligibility criteria:
inclusion criteria: 1. patients with unresectable or metastatic her-2 positive breast cancer (immunohistochemistry 3+ or fish positive) have received at least 2 cycles of salvage treatment with paclitaxel liposome in combination with anti-her-2 therapy (monotherapy or dual-targeted therapy) ± other chemotherapy drugs (such as capecitabine, carboplatin, gemcitabine) as first-line treatment. 2. patients with no visceral metastases, but only have bone metastases or multiple lymph node metastases are eligible for inclusion. 3. eastern cooperative oncology group (ecog) performance status score of 0-2. expected survival of at least 3 months. exclusion criteria： 1. accompanied by other secondary malignant tumors. 2. male breast cancer or bilateral breast cancer. 3. brain metastasis
vitamin k and cognition in coronary heart disease (nutricog)

Conditions: Coronary Heart Disease

Summary: the purpose of this pilot study is to obtain a preliminary assessment of the effect of vk supplementation on cognitive performance and vascular function in adults with stable coronary heart disease (chd)

the overall goal of this study is to obtain a preliminary assessment of the effect of a vk1 (phylloquinone) supplementation on cognitive performance (primary outcome) and vascular function (secondary outcome) in adults with stable chd. specifically, the investigators will conduct a double-blind, 2-armed, parallel-group intervention study in which 40 men and women aged 60 years and over with stable chd will be randomly assigned to 0.5 mg phylloquinone per day or matching placebo for a period of 3 months. all participants will have signed a written consent form before taking part in the study

Eligibility criteria:
inclusion criteria: * men and women * age 60 years and older * medically documented stable coronary heart disease (chd) * daily dietary intakes of phylloquinone \<150 mcg * non-consumption of vitamin k supplements (i.e. k1 or k2, singly or in combination with other nutrients), or other cognitive aids * good french or english understanding * physical exercise not exceeding 2.5 hours/week of moderate to vigorous aerobic activity * capacity and willingness to sign informed consent exclusion criteria: * recent acute coronary syndrome (\<3 months) or recent coronary revascularization (bypass surgery or percutaneous coronary intervention, \<3 months) * known left ventricular dysfunction (lvef \< 40%) or chronic heart failure * recent modification of medication (\<2 weeks) * warfarin (coumadin) use * cognitive impairment (based on telephone version of the mini-mental state examination test, score \<19/23) * diagnosis of depression or uncontrolled anxiety * malabsorption disorder (advanced liver disease, crohn's disease) * patient with auditory or vision impairments not properly corrected by glasses or hearing aids * unable to read the informed consent form or unable to understand the oral explanations provided by the assessor

Keywords: coronary heart disease (chd) cognition cerebral vasoreactivity nutrition heart disease cardiovascular disease vitamins micronutrients vitamin k vitamin k1
extraction socket management using connective tissue graft versus mucograft®

Conditions: Tooth Lost

Summary: this study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas: * 3d radiographic evaluation (ct scan) was performed post extraction and 3 months after at the time of implant placement. (outcomes 1: hard tissues analyses ) * impressions, models and 3d analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (outcomes 2: soft tissues analyses )


Eligibility criteria:
inclusion criteria: * patients needing an extraction in the aesthetic area to be replace with an implant (incisive, canine or premolar) * good general health (asa 1, 2) * controlled periodontitis * no age restriction exclusion criteria: * extraction socket with buccal bone defect / buccal bone wall dehiscence * smokers \> 10 cigarettes per day * immune system disease * bone disease or treatment by medicines interfering with bone metabolism
intraperitoneal paclitaxel with xelox in gastric cancer with peritoneal metastasis

Conditions: Stomach Neoplasms; Paclitaxel; Peritoneal Metastases

Summary: ipxelox will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis. study hypotheses: intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.


Eligibility criteria:
1. inclusion criteria: * ecog(eastern cooperative oncology group) performance status 0 or 1 * pathologically proven primary gastric adenocarcinoma * peritoneal metastasis confirmed by laparoscopy or diagnostic imaging * written informed consent * adequate function of important organs (within 14 days before registration) absolute neutrophil count ≥1.5 x 10\^9/l, platelet \>=100,000/mm3, hemoglobin \>=8.0g/dl, total bilirubin \<= ≤ 2.0mg/dl or uln(upper limit of normal) x 1.5, ast(aspartate aminotransferase) \<=100iu/l(international unit/liter), alt(alanine transaminase) \<=100iu/l, creatinine clearance ≥ 50ml/min (milliliter/minute), 2. exclusion criteria: * other active concomitant malignancies * her2(human epidermal growth factor receptor 2) positive (immunohistochemistry 3+ or 2+ with in situ hybridization positive) * no investigational anticancer therapy within 30 days prior to the first dose of study treatment * recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease * uncontrolled acute or chronic disease * uncontrolled infection or inflammation * uncontrolled psychiatric disorder or central neurologic disease * not fully recovered from previous surgery * prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months * intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome * fertile males and females who are unwilling to use effective contraceptive methods. * pregnancy, breast feeding or intention to become pregnant * interstitial pneumonia or pulmonary fibrosis * peripheral neuropathy with functional impairment * hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or cremophor el. * concomitant therapy with any substrate or inhibitor of cytochrome p450 2c8 or 3a4 * concomitant therapy with sorivudine or brivudine * dihydropyrimidine dehydrogenase (dpd) deficiency. * current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium

Keywords: oxaliplatin capecitabine xelox
prevention of asthma relapse after discharge from emergency

Conditions: Asthma

Summary: the purpose of this study is to compare the symbicort® turbuhaler® to both pulmicort® turbuhaler® and bricanyl® turbuhaler® for the treatment of asthma after discharge from the emergency room


Eligibility criteria:
inclusion criteria: * 18 - 65 years of age * presenting at a study emergency department with an asthma exacerbation exclusion criteria: * admission to hospital * patients receiving more than 2000 µg/day of beclomethasone equivalent inhaled corticosteroids (1000 µg/day fluticasone or 1600 µg/day budesonide)

Keywords: asthma reoccurrence acute asthma patient discharge emergency service, hospital asthma exacerbation asthma relapse
a study of gk activator (2) in patients with type 2 diabetes mellitus treated with a stable dose of metformin

Conditions: Diabetes Mellitus Type 2

Summary: this study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of gk activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. patients will continue on their stable dose of metformin and will be randomized to receive either gk activator (2) or placebo. the anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 30-75 years of age; * type 2 diabetes mellitus; * individual maximal tolerated daily dose of metformin monotherapy for \>=3 months prior to screening. exclusion criteria: * type 1 diabetes mellitus; * any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
cord blood transplantation in severe aplastic anemia

Conditions: Hereditary Diseases; Acquired Aplastic Anemia; Relapse; Absence of an HLA Identical Donor

Summary: this is a prospective phase ii study to evaluate cord blood transplantation in inherited or acquired severe aplastic anemia refractory or in relapse after immunosuppressive therapy in the absence of an hla identical donor;

this is a prospective phase ii study to evaluate cord blood transplantation in inherited or acquired severe aplastic anemia refractory or in relapse after immunosuppressive therapy in the absence of an human leucocyte antigen (hla) identical donor; 26 patients will be recruited, according to a one step fleming design

Eligibility criteria:
inclusion criteria: * age: 3-55 years old * inherited aplastic anemia (with severe aplastic anemia criteria) or acquired aplastic anemia in relapse or treatment failure after immunosuppressive therapy without clonal evolution * karnovsky index \>= 60% * informed consent exclusion criteria: * hla identical donor

Keywords: severe aplastic anemia cord blood transplantation
study of remission in patients treated for generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. the study will also assess patient functioning and compare functioning in patients who do and do not achieve remission.

the aim of the study is to assess the remission rates in patients treated for generalized anxiety disorder in primary and specialized care. factors that may influence remission such as disease history and severity of the anxiety disorder, the type of treatment, the presence of co-morbid depression or anxiety disorder as well as socio-demographic factors will also be evaluated. the study will also assess patient functioning and compare functioning in patients who do and do not achieve remission. the objectives of the study are: primary: to determine the prevalence of remission in patients treated for generalized anxiety disorder in primary care and specialized care. secondary: to determine patient functioning and work loss days and compare these in patients who do or do not achieve remission. to determine the effect of disease factors on remission rate such as disease history, duration, severity, co-morbidity with depression or other anxiety disorders. to determine the effect of treatment factors on remission rate such as setting, type of treatment, duration and adherence. to determine the effect of socio-demographic factors on remission rate such as gender, age, region (language), marital status, educational level and employment status. this will be a cross-sectional observational study looking at the point prevalence of remission in treated patients with generalized anxiety disorder in general practice and specialized care in belgium. general practitioners and psychiatrists will assess remission rates in patients treated for generalized anxiety disorder during 1 routine visit of these patients. the participating physicians will have 3 months to evaluate remission at a routine visit in 5 to 10 patients that have been treated for generalized anxiety disorder since at least 3 months

Eligibility criteria:
inclusion criteria: to be eligible the patient must meet all of the following: 1. being treated for generalized anxiety disorder for approximately 3 months and not more than 12 months 2. be at least 18 years of age; 3. written informed consent 4. out-patient

Keywords: remission generalized anxiety disorder
caelyx plus carboplatin versus paclitaxel plus carboplatin in patients with epithelial ovarian cancer in late relapse

Conditions: Ovarian Cancer; Fallopian Tube Cancer

Summary: this is a study of the efficacy and safety of caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (\> 6 months).

the main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. and it is hoped that substituting paclitaxel with caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.

Eligibility criteria:
inclusion criteria: * patients aged \> 18 * histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors * measurable disease (response evaluation criteria in solid tumor \[recist\] criteria) or cancer antigen (ca) 125 assessable disease (gynecologic cancer intergroup \[gcig\] criteria) or with histologically proven diagnosis of relapse * disease in progression \> 6 months after a first or second platinum-based line. patients should have previously received a taxane derivative. * ecog performance status \< 2 * life expectancy of at least 12 weeks * adequate bone marrow, renal, and hepatic function exclusion criteria: * ovarian tumors of low malignant potential * non-epithelial ovarian or mixed epithelial/non-epithelial tumors * previous radiotherapy * prior diagnosis of malignancy * bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases * pre-existing motor or sensory neurologic pathology or symptoms national cancer institute (nci) - common terminology criteria for adverse events (ctcae) grade \> 1 * history of congestive heart failure (new york heart association \[nyha\] classification \> 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias * severe active infection * severe hypersensitivity to products containing cremophor el and/or to compounds chemically related to paclitaxel, carboplatin or caelyx * fertile women not using adequate contraceptive methods * pregnant or breast feeding women

Keywords: extra-ovarian papillary serous tumors relapse over 6 months previously received taxane derivative
an open-label, multicenter, prospective study of irreversible electroporation (nano knife) combined with radiotherapy and chemotherapy in patients with locally advanced pancreatic cancer

Conditions: Pancreatic Cancer; Locally Advanced Pancreatic Caner

Summary: this is an open-label, multicenter, prospective study of irreversible electroporation (nano knife) combined with radiotherapy and chemotherapy in patients with locally advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, no gender limitation; 2. patients with locally advanced pancreatic cancer diagnosed by cell / histopathology, either initially diagnosed or previously treated; 3. the target lesion is not suitable for surgical resection, or the target lesion is suitable for surgical resection but the patient gives up the surgical treatment and chooses nano-knife combined with radiotherapy and chemotherapy 4. ecog score is 0 \~ 2; 5. expected survival ≥ 3 months; 6. women of childbearing age must undergo a pregnancy test within 14 days prior to enrollment, and those who have a negative result are eligible for enrollment. men and women of childbearing age and their sexual partners agreed to use reliable methods of contraception before, during, and at least 90 days after the end of the study. 7. full informed consent and signed informed consent. exclusion criteria: 1. patients suffering from active infection; high blood pressure (≥160 / 100mmhg) that cannot be controlled by drugs; angina pectoris and unstable angina pectoris that have begun in the last 3 months. myocardial infarction and cardiac insufficiency occurred within 1 year before enrollment ≥ nyha class ii), schizophrenia, or history of psychotropic substance abuse; 2. patients with severe heart and lung insufficiency or intolerance to general anesthesia; 3. those who are allergic to ct and mri contrast agents and unable to perform preoperative three-phase dynamic enhanced scanning; 4. ascites due to clinical symptoms, after 2 weeks of conservative medical treatment (excluding drainage of ascites), the ascites still increases gradually; 5. pregnant or lactating women; 6. hbv dna ≥ 104 copies or ≥ 2000 iu / ml, antiviral liver protection treatment is required before hbv-dna \<104 copies (2000 iu / ml) before enrollment, and continue to take antiviral drugs and monitor liver function and hepatitis b virus load; hcv antibody positive or hcv-rna positive; hiv-infected patients; 7. patients that the investigator considers unsuitable for enrollment.

Keywords: irreversible electroporation, nano knife, pancreatic cancer.
stromal vascular fraction (svf) injection in the treatment of patellar tendinopathy

Conditions: Patellar Tendinitis; Tendinopathy; Patellar Tendinopathy

Summary: the aim of the study is the evaluation of clinical and radiological results after the treatment of patellar tendinopathy through the injection of autologous ultrasound-guided, intra- and peri-tendon stromal vascular fraction.

after being informed about the study and potential risks, all patients giving written informed consent will be treated according to the study protocol. every patients will undergo to a single peri- and intra- tendon injection with autologous stromal vascula fraction (svf). at baseline and at every follow-ups patients will be evaluated clinically and radiologically. in particular, clinical evaluation and questionnaires will be performed at baseline, 1, 3, 6, 12 and 24 months visits, ultrasound will be performed at baseline, 6 and 12 months visits. mri will be performed at baseline and 6 months visits.

Eligibility criteria:
inclusion criteria: * ultrasound or mri signs of patellar tendon pathology exclusion criteria: * bmi \> 30 * patients suffering from: rheumatic diseases, diabetes, infectious processes, epilepsy, severe osteoporosis * patients undergoing intra-tendon infiltration of another substance within the previous 6 months; * patients who had patellar tendon surgery within the previous 12 months; * immunodepression * on going systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications).

Keywords: stromal vascular fraction patellar tendinopathy injection
study of vortioxetine (lu aa21004) in major depressive disorder in asian countries

Conditions: Major Depressive Disorder

Summary: this study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day vortioxetine in asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).


Eligibility criteria:
inclusion criteria: * the patient suffers from recurrent mdd as the primary diagnosis according to dsm-ivtr™ criteria. the current major depressive episode (mde) should be confirmed using the mini international neuropsychiatric interview (mini) * the patient has a madrs total score ≥26 * the patient has a cgi-s score ≥4 * the reported duration of the current mde is ≥3 months. other inclusion criteria may apply. exclusion criteria: - the patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.

Keywords: mdd