Kornimate/medical-research-clean huggingface dataset:
pyrotinib combined with capecitabine in her-2 positive advanced breast cancer and brain metastases (post-permeate)

Conditions: Breast Cancer

Summary: this study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with her-2 positive advanced breast cancer with brain metastases.

this study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of her2-positive advanced breast cancer patients with brain metastases. efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases. the estimated sample size is 300 cases, and at least one group of cohort a, cohort b and cohort c is planned to exceed 100 cases; cohort a - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; cohort b- whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; cohort c - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。

Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed patients with her-2 expression-positive advanced breast cancer; note: positive her2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization \[fish\] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive; 2. brain metastases are diagnosed by mri/enhanced ct imaging, according to recist 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases; 3. pyrotinib combined with capecitabine in the treatment of brain metastases with non-pd evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments 4. for previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more; 5. there are traceable medical history data. exclusion criteria: 1. patients enrolled in the previous permeate study; 2. the research program is receiving other anti-tumor drug treatment at the same time; 3. the initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose; 4. pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients; 5. the investigator believes that the patient is not suitable to enter this study.

Keywords: her-2 positive advanced breast cancer pyrotinib capecitabine
dietary management of gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus in Pregnancy; Diet; Healthy

Summary: the goal of this clinical trial is to test effect of dietary management program based on the nudge strategy in gestational diabetes mellitus patients. the main questions it aims to answer is whether the dietary management program is effective for the diet management behavior of gestational diabetes mellitus patients. participants will receive a 12 week dietary management program. the intervention group will receive a diet management program based on the nudge strategy, and the control group will receive a routine dietary management program. researchers will compare two group's glycemic control and pregnancy outcomes and to see if effective for the diet management behavior.


Eligibility criteria:
inclusion criteria 1. meeting the diagnostic criteria related to gdm by oral glucose tolerance test (ogtt), etc. 2. singleton pregnancy 3. age ≥ 18 years 4. gestational weeks 24-28 5. informed consent for voluntary participation in this study exclusion criteria 1.patients with significant heart, liver, lung and other organ failure and malignancy 2.previous history of psychiatric disorders or existing psychiatric disorders 3.diabetes combined with other complications such as gestational hypertension dropout criteria 1. lost to the study due to unforeseen circumstances 2. voluntarily requested to withdraw from the study 3. did not take the intervention as required by the relevant requirements 4. condition was unstable and could not continue to cooperate.
delayed breast reconstruction by prepectoral implant after lipo-preparation (rm2prepec)

Conditions: Breast Cancer Female

Summary: breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes. the objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. it also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session. for a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. but the lipo-filling technique allowed to reconsider the management of these patients. the benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization). the objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.

60 women who have had a mastectomy and want a secondary breast reconstruction by implant at institut de cancérologie de l'ouest well be included in this study. patients will be recruited in consultation before the start of reconstruction and up to 18 months after radiation therapy. they will be followed for 24 months from the end of the breast reconstruction. the following data will be collected indirectly from the clinical medical record (letters, reports of examinations, consultations, surgical report, hospitalization) of the patient, supplemented if necessary by specific records (radiotherapy records, chemotherapy, physiotherapy management) : * clinical data * technique-related data * complication-related data : adverse events will be evaluated at 15 days, 3 months, 6 months, 12 months and 24 months after reconstruction * aesthetic results data : aesthetic result will be evaluated by patients and surgeons at 6 months, 12 months and 24 months after reconstruction * quality of life data : a questionnaire will be submitted prior to the intervention, at 12 months and 24 months after reconstruction clinicians at institut de cancérologie de l'ouest may be asked to complete the previous informations.

Eligibility criteria:
inclusion criteria: * woman aged over 18 * medical history of mastectomy +/- radiotherapy * woman requesting breast reconstruction by implant * patient treated for non-metastatic cancer exclusion criteria: * locally uncontrolled disease * metastatic disease * patient with major cutaneous atrophy allowing only flap reconstruction * patients under guardianship or trusteeship * patients who objected to the research

Keywords: reconstruction lipo-modelling breast cancer mastectomy prepectoral implant
telmisartan 80mg non-responder trial

Conditions: Hypertension

Summary: if a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly. in the japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (dbp) are equal or more than 95 mmhg, the dbp control rate (less than 90 mmhg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. there should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg. thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (fdc) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (t80/a5 mg), compared with telmisartan 80 mg (t80 mg) monotherapy in japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. in this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


Eligibility criteria:
inclusion criteria: * essential hypertensive patients * if already taking antihypertensive drugs, mean seated diastolic blood pressure (dbp) must be \>=90 and \>=114 mmhg * if not taking any antihypertensive drugs, mean seated dbp must be \>=95 and \>=114 mmhg * able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion. exclusion criteria: * patients taking 3 or more antihypertensive drugs at signing the informed consent form * patients with known or suspected secondary hypertension * patients with clinically relevant cardiac arrhythmia * congestive heart failure with new york heart association (nyha) functional class iii-iv * patients with recent cardiovascular events * patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form * patients with a history of sudden deterioration of renal function with angiotensin ii receptor blockers (arbs) or angiotensin converting enzyme (ace) inhibitors; or patients with post-renal transplant or post-nephrectomy * patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with arbs or ace inhibitors * patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs * patients with hepatic and/or renal dysfunction * pre-menopausal women who are nursing or pregnant
study to determine if azd0284 is effective and safe in treating plaque psoriasis

Conditions: Plaque Psoriasis Vulgaris

Summary: the sponsor is developing the study drug, azd0284, for the potential treatment of plaque psoriasis. psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. the severity of the disease varies, but in many cases it can have a major impact on their quality of life if not adequately treated. the purpose of the study is to determine the short term safety, pharmacodynamic and clinical effect of azd0284 in patients with psoriasis.

this is a randomised, double-blind, placebo-controlled, multi-centre, parallel group phase 1b study, designed to evaluate the pharmacodynamic effects, clinical efficacy and safety of azd0284 compared with placebo as measured by the relative change from baseline in psoriasis area severity index (pasi score), other disease assessments of involved body surface area (bsa), static physicians global assessment score (spga), pruritis and biomarkers associated with the mechanism of disease and azd0284. disease activity will be assessed throughout the study as will changes in skin biopsy biomarkers. the study population will be comprised of patients with moderate to severe plaque psoriasis as defined by pasi score, bsa and spga. following completion of screening assessments and meeting all eligibility criteria, patients will be randomised to receive azd0284 or placebo for 4 weeks of treatment followed by a 4 week follow up period

Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study specific procedures. * at least 6 months documented history with a diagnosis of moderate to severe plaque psoriasis as defined by the psoriasis area and severity index (pasi), psoriasis body surface area (bsa) and static physician global assessment (spga). exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study. * history and/or presence of tuberculosis, hepatitis, hiv. other opportunistic infections within 6 months of the study. * clinically significant laboratory abnormalities. * clinically important abnormalities in rhythm, conduction or morphology of the digital electrocardiogram (ecg) as considered by the investigator may interfere with the interpretation of study data. * current treatment or treatment for psoriasis with biological therapies within 6 months of study. * efficacy and safety failure of biologic therapies targeting the il-17 and il12/23 pathway at any time. * current treatment or history of treatment for psoriasis with non-biological systemic medications within 4 weeks of day 1

Keywords: plaque psoriasis pasi bsa spga p-vas il17a- ccl20 pk
emotional perception and production in facial palsy: respiratory, vocal and facial markers.

Conditions: Facial Palsy

Summary: respiratory function, phonation and facial expressivity are related to emotional reaction through neurophysiological process. specific emotional respiratory, vocal and facial patterns had been described in literature. respiratory cycles variation is modulated by stimulus arousal. furthermore, inspiratory-to-expiratory time ratio in abdominal area is modulated by emotional valence. inextricably linked to respiration, vocal production depends on emotional arousal and valence too. according to embodied cognition, the effector pattern of an emotion initiates the corresponding subjective activation. facial recognition is influenced by automatic mimicry and facial feedback. most facial feedback studies included patients with diplegia but few studies dealt with emotional perception in bell's palsy. the aim of the present study is to understand production and perception of emotion in bell's palsy with respiratory, vocal and facial markers. what impact lack of mimicry have on physiological emotional reaction in bell's palsy? to this end, prospective monocentric study will be conducted with 60 patients with bell's palsy from grade ii to grade vi of house \& brackmann's scale. during production and perception of vocal and facial expression, respiratory rate and thoraco-abdominal movements will be analyzed. the investigators hypothesize that severity of facial deficit is negatively correlated with variation of respiratory cycles, lower segmental and suprasegmental changes during vocal expression, and lower facial perception (congruency and arousal).


Eligibility criteria:
inclusion criteria: * patients affiliated to the health care system * patients must have been diagnosed with unilateral peripheral facial palsy stage iii to vi, according to house and brackmann international classification. * to be able to read, understand and sign a consent * to be able to understand french spoken and written exclusion criteria: * diplegia or facial graft * visual disorders, non corrected * respiratory or vocal disorders * psychiatric history * facial surgery

Keywords: emotions, respiratory rate, phonation
self-help forest bathing (shinrin-yoku) on depression, anxiety, and stress

Conditions: Depression, Anxiety; Stress

Summary: the objective of this pilot randomized controlled trial is to evaluate the efficacy and acceptability of self-help forest bathing on depression, anxiety, and stress in the hong kong adult population. prior to all study procedures, eligible participants will be required to complete an online informed consent form (with telephone support). around 80 eligible participants aged between 18 to 65 years old with at least a mild level of depression, anxiety, or stress symptoms will be randomly assigned to either the self-help forest bathing intervention group (fb group) or the waitlist control group (wl group) in a ratio of 1:1. participants in the fb group will receive forest bathing guidance via an in-house smartphone app. the wl group will be asked to maintain their typical activity in week 1-7. this group will receive the guide upon trial completion in week 8. the outcomes of the interest will include generalized anxiety symptoms, depressive symptoms, insomnia symptoms, wellbeing, health-related quality of life, functional impairment at baseline (week 0), immediate (week 7), and 1-month post-intervention assessments (week 10). treatment credibility and acceptability will be collected at baseline and immediately after the intervention.


Eligibility criteria:
inclusion criteria: 1. hong kong residents; 2. aged between 18 to 65 years; 3. meet the threshold for mild depression (score of \>5 on the patient health questionnaire 9 \[phq-9\], anxiety (\>5 generalized anxiety disorder 7 \[gad-7\]), or stress (\>15 on the depression, anxiety, and stress scale \[dass-21\] stress subscale, after multiplying score by 2); 4. able to read and understand chinese and type in chinese or english 5. have an internet-enabled mobile device (ios or android operating system) 6. willing to provide informed consent and comply with the trial protocol exclusion criteria: 1. received psychotherapy for depression, anxiety and stress in the past 6 months; 2. a change in psychotropic drugs or over-the-counter medications that target depression, anxiety, and stress within 2 weeks before the baseline assessment. 3. patient health questionnaire-9 (phq-9) item 9 score \> 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided); 4. currently participating in another intervention study that may potentially affect mental health; 5. self-disclosure of having unsafe health conditions for which physical activity was contraindicated by physicians; 6. self-disclosure of any psychiatric, medical, or neurocognitive disorder(s) that makes participation unfeasible; 7. pregnancy; 8. hospitalization.

Keywords: lifestyle medicine randomised controlled trial depression stress anxiety
a smartphone-based application post-myocardial infarction to manage cardiovascular disease risk

Conditions: Percutaneous Coronary Intervention

Summary: the investigators aim to evaluate wellframe, a patient engagement platform that includes a mobile phone application for patients, for its impact on supporting patients who have undergone a percutaneous coronary intervention. the patient mobile app has articles about cardiovascular disease and other health related topics, patient-reported outcomes surveys, physical activity tracking, reminders for medications and upcoming appointments, and two-way communication with a wellframe health advocate. the wellframe health advocate encourages patients to achieve their health goals and stay engaged in their health. the feasibility of onboarding patients to the app and the clinical efficacy of the platform will be evaluated.


Eligibility criteria:
inclusion criteria: english-speaking pci: balloon angioplasty, bare-metal stent, or drug-eluting stent at mgh smartphone or tablet (ios or android) exclusion criteria: recent (within 1mo) illicit substance use or alcohol abuse in-hospital ami known pregnancy dementia or cognitive disability incarceration
a study of sustained virological response in relation to il28-b expression in treatment-naïve patients with chronic hepatitis c genotype 1 on combination treatment with pegasys (peginterferon alfa-2a) and copegus (ribavirin)

Conditions: Hepatitis C, Chronic

Summary: this multi-center, open-label study will evaluate the efficacy and safety of pegasys (peginterferon alfa-2a) and copegus (ribavirin) in relation to il28-b gene expression in treatment-naïve patients with chronic hepatitis c genotype 1. patients will receive pegasys (180 mcg sc weekly) and copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 and \<70 years of age at initiation of treatment * body weight between 50 kg and 125 kg at baseline * chronic hepatitis c, genotype 1 * chronic liver disease consistent with hcv infection * compensated liver disease (child-pugh grade a) exclusion criteria: * pregnant or lactating women, and male partners of pregnant women * chronic hepatitis c, genotype 2, 3, 4, 5 or 6 * previous treatment with interferon or ribavirin * positive for hepatitis a, hepatitis b or hiv infection * history or evidence of a medical condition associated with liver disease other than chronic hepatitis c * decompensated liver disease and/or liver disease child-pugh classification \>6 * hepatocellular carcinoma * history or evidence of esophageal bleeding * hemoglobinopathy, or any other cause for possible hemolysis * hb \<11 g/dl in women, \<12 g/l in males
response to rsd1235 compared to placebo in subjects with atrial arrhythmia after heart surgery

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: the purpose of this study is to demonstrate the safety and efficacy of rsd1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

this multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of rsd1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (cabg) surgery.

Eligibility criteria:
inclusion criteria: * documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery exclusion criteria: * unstable class iv heart failure

Keywords: treatment