Kornimate/medical-research-clean huggingface dataset:
pegylated liposomal doxorubicin plus albumin-bound paclitaxel and trastuzumab in her-2 positive breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（pld）plus albumin-bound paclitaxel and trastuzumab as neoadjuvant therapy in her-2 positive breast cancer.

this is a single-center, prospective, single arm phase ii study. eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (pld)/albumin-bound paclitaxel/trastuzumab regimentation. this study consists of two phases, the first phase aims to determine the maximum tolerated dose (mtd) of pld, and the second phase will explore the efficacy and safety of the regimen.

Eligibility criteria:
inclusion criteria: 1. ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document; 2. female patients aged from 18 to 70 years old; 3. histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible; 4. clinical stageⅱ-ⅲ; 5. her-2 positive（defined by: ihc 3+ or ish positive）; 6. without previous treatment for this breast cancer; 7. patients must have at least one measurable disease according to recist 1.1; 8. ecog (eastern cooperative oncology group) performance score of 0-1 points; 9. lvef≥55%; 10. normal ecg; 11. bone marrow function:absolute neutrophil count (anc)≥2.0×109/l，platelets≥100×109/l，hemoglobin ≥90g/l。 12. hepatic function：alanine aminotransferase(alt) and aspartate aminotransferase(ast) ≤1.5×uln，serum total bilirubin≤ uln; 13. renal function：serum creatinine≤1.5×uln； coagulation function：the international standardized ratio (inr) ≤1.5×uln, prothrombin time (pt) or the activated partial thrombin time (aptt) ≤1.5×uln. exclusion criteria: 1. new york heart association (nyha) class ≥ⅱ heart failure. 2. known or suspected hypersusceptibility to any agents used in the treatment protocol. 3. need to concurrent treatment with any other anti-cancer therapy considered by the investigator. 4. participating in other clinical trials within 4 weeks before this study. 5. serious heart disease, including but not limited to: 1) significant ventricular arrhythmia or high degree atrioventricular block (mobitz ii or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) electrocardiogram shows transmural myocardial infarction; 5) uncontrolled hypertension. 6. uncontrolled diabetes. 7. severe or uncontrolled infection. 8. hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (hiv) antibody positive. 9. active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years. 9）women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation. 10）other conditions considered to be inappropriate to be enrolled by the investigator.
a pms on safety profile of pramipexole in chinese parkinson disease patients

Conditions: Parkinson Disease

Summary: this is an open-label, multicenter, non-interventional, prospective observational study. we collect the safety information of pramipexole over 12w treatment. parkinson disease patients with different severity who have already used pramipexole could be observed in this study. in the whole observation period, treatment decision was determined by physician and patient completely. the safety endpoint is ae(adverse event), sae(serious adverse event), patient withdraw, laboratory test.

purpose:

Eligibility criteria:
inclusion criteria: 1. diagnosed as idiopathic pd (parkinson' disease) according to uk brain bank criteria 2. age: from 30 to 75 years old 3. stage i-iv of revised hoehn-yahr standards 4. with current use of pramipexole 5. informed consent signed by every subject exclusion criteria: 1. diagnosis of parkinson¿s syndrome 2. current use of psychotolytic medications 3. allergic to pramipexole or any other ingredient of pramipexole 4. female patients in pregnancy and lactation 5. patients who were participating in other clinical studies by signing relevant informed consent or who received other investigational drugs within 30 days prior to the study
rheumatological evaluation of anastrozole and letrozole as adjuvant treatment in post-menopausal women with breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole

this is a multi-center prospective non-randomized single arm, open label trial in postmenopausal hr positive early breast cancer patients who experience grade 2-3 arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole. after a 2-3 week period without any aromatase inhibitor treatment, eligible patients will initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. if a patient has breast cancer recurrence or is intolerant to letrozole during the 24 week period, the drug will be discontinued.

Eligibility criteria:
inclusion criteria: 1. postmenopausal women with hr+ early stage breast cancer at the time of initial diagnosis. for study purposes, postmenopausal is defined as: * age ≥ 50 y and amenorrheic for 12 or more months. * age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy. * age \< 50 y and amenorrheic for 12 or more months. * prior bilateral oophorectomy. * prior hysterectomy and has postmenopausal levels of fsh, lh, and estradiol as per local institutional standards. * age \> 55 y and prior hysterectomy. 2. patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for hr+ early stage breast cancer due to grade 2-3 (nci-ctcae v3) arthralgia-myalgia. 3. hormone receptor-positive tumors as defined by institutional standards. 4. ecog performance status of 0, 1, or 2 5. consent to participate in the trial. - exclusion criteria: 1. postmenopausal women with hr+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease. 2. recent history of pain associated with non-traumatic bone fracture. 3. pain requiring chronic use of analgesics (due to any reason). 4. history of rheumatological disease except osteoarthritis. 5. prior hormonal therapy with ais other than anastrozole. 6. systemic hormone replacement therapy (hrt) less than 4 weeks before study entry other than estring®, vagifem® or low dose estrogen vaginal cream. 7. concomitant disease which significantly affects quality of life. 8. patient unable to complete self administered questionnaire. 9. patients unable to sign consent form. other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer adjuvant treatment in post menopausal women letrozole arthralgia-myalgia
functional outcome after treatment for oropharyngeal squamous cell carcinoma

Conditions: Oropharynx Cancer; Pain; Swallowing Disorder; Quality of Life; Saliva Altered; Human Papilloma Virus

Summary: to investigate the treatment related effects of transoral robotic surgery (tors) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

patients are enrolled prospectively at the department of otorhinolaryngology, head and neck surgery \& audiology at copenhagen university hospital, rigshospitalet. all eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included. outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

Eligibility criteria:
inclusion criteria: tors group: 1. who performance status 0-2 2. squamous cell carcinoma of the oropharynx 3. tnm: t1-2, n0-1 (without of evidence of extra capsular extent), m0. 4. no previous head and neck cancer 5. absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other. 6. signed written consent. 7. cancer eligible for surgery in the absence of significant trismus. oncological group: 1. who performance status 0-2 2. squamous cell carcinoma of the oropharynx 3. qualified for curative intended oncological treatment 4. signed written consent exclusion criteria: tors group: 1. serious co-morbidity 2. distant metastasis 3. previous radiotherapy to the head and neck region. 4. concurrent treatment eller investigations for another cancer, except carcinoma in situ. oncological group: 1. previous radiotherapy to the head and neck region. 2. concurrent treatment eller investigations for another cancer, except carcinoma in situ. 3. presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other. 4. presence of facors that inhibit the patient from completing the treatment. 5. previous head and neck cancer 6. distant metastasis
prospective cohort study on cognition and cardiovascular disease of sedentary behaviors in children

Conditions: Sedentary Behavior;Cognition;Cardiovascular-related Disease

Summary: the prospective cohort study is set up to address research questions dealing with sedentary lifestyle-related events mainly including cognition and cardiovascular-related disease in children .participants aged 7-12 years old from five primary schools in guangzhou,guangdong province will be recruited and followed up to evaluate the risk factors of cognition and cardiovascular-related disease. objective measurements combined with questionnaire-data-based information on a wide range of lifestyle factors and cognition were applied in this study.

there are three stages in this project.at first stage,information about socio-demographic, psychological status, physical activity,sleep and diet were collected by a multi-components questionnaire survey.the strengths and difficulties questionnaire(sdq) and behavior rating inventory of executive function(brief) were conducted at the same time. anthropometric measurement including height, weight, waist and hip circumferences, blood pressure and fat mass were conducted.besides,blood samples were collected to measure total cholesterol, triglycerides, high-density lipoprotein (hdl-c) and low-density lipoprotein (ldl-c). at second stage,participants were classified for 4 subgroups as follows: low active-high sedentary;low active-low sedentary; high active-high sedentary;high active-low sedentary by different sedentary status and physical activity levels according to the international standard. later cardiorespiratory fitness was assessed by the 20-m shuttle run test. accelerometer gt3x+ actigraph with physical activity log,combined raven's test, a series of psychometric paradigms were measured for further studies. at third stage,we will explore the related neuropsychological mechanism using the technology of event-related potentials (erps). about 1000 participants (7-12 years old) will be prospectively followed up. the associations between sedentary lifestyle and risks for cognition and cardiovascular-related disease will be evaluated.

Eligibility criteria:
inclusion criteria: * 7-12 years old * children with normal intelligence measured by raven good vision. * right hand. exclusion criteria: * children with mental health and behavioral problems in this study were found to have developmental behavior disorders, such as adhd, asd. * there are serious liver and kidney diseases, cardiovascular diseases, hematologic diseases or malignant tumors.
study of modified folfox6 plus or minus sorafenib in stage iv metastatic colorectal carcinoma (mcrc) subjects

Conditions: Metastatic Colorectal Cancer

Summary: to determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histological confirmation of adenocarcinoma of the colon or rectum * tumor tissue sample available for kras and braf assessment * measurable metastatic stage iv disease including at least one measurable lesion that has not previously been radiated * no prior chemotherapy for metastatic crc * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * life expectancy of at least 12 weeks * adequate bone marrow, liver, and renal function; adequate clotting parameters exclusion criteria: * prior treatment with sorafenib * clinical or radiographic evidence of brain metastasis * major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy * red blood cell (rbc), white blood cell (wbc), or platelet transfusions and/or growth factor use within 28 days before randomization * adjuvant therapy for crc (stage i, ii, or iii) completed within 12 months before randomization * serious, non-healing wound, ulcer, or bone fracture; grade 3 or 4 hemorrhage within 28 days before randomization * use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. the use of coumadin and related compounds is excluded.) * uncontrolled hypertension (systolic blood pressure \> 150 mmhg or diastolic pressure \> 100 mmhg on repeated measurement) despite optimal medical management * thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization * active cardiac disease including: * congestive heart failure * unstable angina or myocardial infarction within the 6 months before randomization * cardiac ventricular arrhythmias requiring antiarrhythmic treatment * peripheral neuropathy \> grade 1 (ctcae) * known hiv infection or chronic hepatitis b or c infection * any active infection \>/= grade 2 (ctcae) * any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results * use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization * subjects with metastatic crc who are currently candidates for surgery with curative intent

Keywords: colorectal cancer metastasis stage iv liver metastasis
safety and efficacy study of clindamycin/benzoyl peroxide/tazarotene cream in subjects with acne

Conditions: Acne Vulgaris

Summary: benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. the purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. you may be suitable to take part in this study because you have acne vulgaris on your face. acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

the study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks. study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. subjects will be assessed at every visit to determine how the study drug is working. safety will be assessed by evaluation of adverse events (aes), vital signs, physical examinations, and withdrawals from the study.

Eligibility criteria:
inclusion criteria: * inclusion criteria: subjects must be males or females 12 to 45 years of age. * subjects must have acne on their face. * female subjects of childbearing potential must have a negative pregnancy test. if sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit. * subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. * subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements). * subjects must be able to complete the study and to comply with study instructions. exclusion criteria: * subjects who are pregnant, trying to become pregnant, or breast-feeding. * subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination * history of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products * subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months. * subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study. * other exclusion criteria may apply.

Keywords: acne acne vulgaris pimples
clinical study to evaluate the pharmacokinetics, safety and tolerability of da-2803 in healthy subjects

Conditions: Hepatitis B

Summary: this study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of da-2803 in healthy subjects

to healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. reference drug: vemlidy tab. / test drug: da-2803 tab. pharmacokinetic blood samples are collected up to 72hrs. the pharmacokinetic characteristics and safety are assessed.

Eligibility criteria:
inclusion criteria: * healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening. * calculated body mass index (bmi) of ≥ 18.0 and ≤ 28.0 kg/m2 * bmi = weight(kg)/ height(m)2 * individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study * individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial exclusion criteria: * history or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder. * any medical history that may affect drug absorption, distribution, metabolism and excretion. * individuals who had history of hypersensitivity to investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) * any clinically significant chronic medical illness. * any genetic disease including galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. * individuals with one of the following laboratory test results in screening. * ast, alt \> unl (upper normal limit) x 1.5 * creatinine clearance ≤ 60 ml/min * positive test results at hbs ag, anti-hcv ab, anti-hiv ab, vdrl. * use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration. * individuals who cannot eat standard meal provided from clinical trial center. * donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first ip administration. * individuals who had received a blood transfusion within 60 days prior to study drug administration. * exposure to any investigational drug within 6 months prior to the first ip administration. * individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first ip administration. * individuals who had drinking (alcohol \> 21unit/week) within 14 days prior to screening. * heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening. * subjects having been deemed inappropriate for the trial as determined by the investigator.
a study of rapamycin combined with intravesical bcg in patients with non-muscle invasive bladder cancer

Conditions: Bladder Cancer

Summary: this study is looking at the effects of sirolimus (rapamycin) on bcg-specific immunity during treatment of non-muscle invasive bladder cancer (nmibc) with maintenance bcg.

this study will evaluate change from baseline in gamma-delta t cell numbers and function and ag85 peptide-specific t cell responses following treatment.

Eligibility criteria:
inclusion criteria: * pathologically (histologically) proven diagnosis of non-muscle invasive (ta, tis or t1) bladder cancer * in their treating physician's opinion is a good candidate for bcg therapy * be able to give informed consent * be age 18 or older * not be in an immunosuppressed state (e.g. hiv, use of chronic steroids) * not have active, uncontrolled infections * not be on agents known to alter rapamycin metabolism significantly * not have a reported history of liver disease (e.g. cirrhosis) * not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin. * not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy. exclusion criteria: * have muscle-invasive (≥t2) bladder cancer * unable to give informed consent * age \< 18 * immunosuppressed state (e.g. hiv, use of chronic steroids) * active, uncontrolled infections * on agents known to alter rapamycin metabolism significantly * another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) * patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy. * individuals with a reported history of liver disease (e.g. cirrhosis) * individuals who are not a good candidate for bcg in their treating physician's opinion

Keywords: bcg rapamycin
preventing chemotherapy-induced peripheral neuropathy using presiona exercise program

Conditions: Breast Neoplasm

Summary: the aim of this study is to determinate if therapeutic exercise with blood flow restriction (bfr) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (cipn) comparing to usual care.

cipn is a side effect of cancer therapies that nowadays has no solution, so our intention is to carry out a preventive therapy against the onset of cipn. the nature of the studies that try to prevent is very diverse, but one of the wide tools is therapeutic exercise. in this case we intend to combine therapeutic exercise with bfr to obtain a pre-conditioning effect that protects intraepidermal fibers from exposure to the chemotherapy.

Eligibility criteria:
inclusion criteria: * 18 years or older * her2+ breast cancer diagnosis * on the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy) exclusion criteria: * previous diagnosis of cancer * pregnant * cardiac pathology * no symptoms or pathology that could be confused with neuropathy or related to diabetes * no recommendation from oncologist for therapeutic exercise practice

Keywords: breast neoplasm breast cancer therapeutic exercise small fiber neuropathy