Kornimate/medical-research-clean huggingface dataset:
a multicenter, open and observational real world study on the prognosis and treatment in young women with breast cancer

Conditions: Breast Cancer

Summary: this is a multicenter, open and observational real world study. the main purpose of this study is to map the genomic variation map of young breast cancer patients in china, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. the secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients. we expect to enroll 2000 young breast cancer patients (≤35 years old). all patients were detected by targeted next generation sequencing （ngs）(600+ gene panel). clinical diagnosis, treatment and prognosis information were collected. the stratification factors mainly include stage, molecular type and treatment method.

the study can only be formally carried out with the written approval of the ethics committee. we regularly submit annual research reports to the ethics committee. we will inform the ethics committee in writing when the study is discontinued and / or completed. all patients were required to sign informed consent before entering the group. all updated versions of informed consent and written information will be provided to the subjects during the participant's participation. in the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. employ statistical experts to calculate the sample size and data statistics, and participate in the design process. data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. they will ensure the authenticity, reliability and security of data throughout the process.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed as breast cancer. 2. the age of diagnosis was 18-35 years old. 3. ecog score was 0-2, and the expected survival time was more than 3 months. 4. no serious complications; no liver, kidney, hematopoiesis dysfunction. 5. informed consent, and patients willing to long-term follow-up. - exclusion criteria: 1. 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study. 2. having a clear history of neurological or mental disorders (including epilepsy or dementia). 3. patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders. 4. pregnant or lactating female patients. 5. hiv infected patients. 6. patients with other tumors. 7. after comprehensive evaluation, the researchers believe that patients are not suitable for this study.

Keywords: young women with breast cancer gene mutation characteristics prognosis
usability of pericardial flushing with the haermonics pure system after cardiac surgery

Conditions: Surgical Blood Loss; Surgical Complication

Summary: the goal of this clinical trial is to evaluate the usability of the haermonics pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass. all measurements and interventions are standard of care, except pericardial flushing with the haermonics pure system.

this is a prospective, single-arm, single-center clinical investigation of adult patients undergoing cardiac surgery. safety and efficacy of cppf, with and without the device, has been established in comparison with standard drainage. therefore, this study is designed primarily to establish the usability of the device and its accessories, not requiring randomization against a control group. because the haermonics pure system and its accessories are used directly after surgery for several hours up to several days until drain removal before being discharged from the hospital, it is sufficient to follow patients until discharge from the cardiac surgery department. for patients with a prolonged hospitalization because of postoperative complications, it is considered sufficient to follow patients for 2 weeks after surgery because the impact of a pericardial flushing and postoperative drainage on outcomes is critical within the immediate postoperative period but limited beyond the time that the drains are removed. for device-related adverse events, follow-up will continue until the event is considered resolved or the patient is discharged.

Eligibility criteria:
inclusion criteria: 1. adult patients (≥18yrs and weight ≥40kg) undergoing cardiothoracic surgery (cabg and/or valve surgery, elective aortic surgery, bentall procedure, ascending aorto/aortic arch replacement) with the use of cardiopulmonary bypass 2. patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation exclusion criteria: 1. euroscore ii \&gt; 20% 2. emergent procedures 3. complication during surgery which is life threatening and/or requires another surgical intervention 4. minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy) 5. thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity 6. participation in any study involving an investigational drug or device 7. patient is pregnant or nursing 8. inability to understand study information

Keywords: cardiac surgery therapeutic irrigation postoperative bleeding chest tubes haermonics pure system
efficacy, safety and immunogenicity study of recombinant human c1 inhibitor for the treatment of acute hae attacks

Conditions: Hereditary Angioedema

Summary: this study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human c1 inhibitor (rhc1inh) at a dose of 50 u/kg when used for the treatment of acute angioedema attacks in hereditary angioedema (hae) patients.

hae is characterized by recurrent localized angioedema caused by uncontrolled activation of the complement and contact systems due to a congenital deficiency of functional c1 inhibitor. rhc1inh has been developed to offer a more widely available therapeutic alternative to the existing plasma-derived c1inh (pdc1inh) products that have been used in the treatment of acute angioedema attacks patients with hae. patients who have qualified for enrollment in advance and who present to a study center within 5 hours of onset of an attack will be evaluated for eligibility. 75 eligible patients will be randomized (3:2) to receive an intravenous infusion of rhc1inh or saline in a double-blind fashion. open-label rhc1inh may be provided as rescue medication to patients who do not experience the beginning of relief within 4 hours or who experience life-threatening oropharyngeal-laryngeal angioedema symptoms. any patient having received a randomized treatment will be allowed to receive treatment with rhc1inh in an open-label fashion for subsequent eligible attacks.

Eligibility criteria:
inclusion criteria: * aged at least 13 years * signed written informed consent * clear clinical and laboratory diagnosis of hae with baseline plasma level of functional c1inh of less than 50% of normal * willingness and ability to comply with all protocol procedures * clinical symptoms of an eligible hae attack with onset less than 5 hours before the time of initial evaluation exclusion criteria: * medical history of allergy to rabbits or rabbit-derived products (including rhc1inh), or positive anti-rabbit dander ige test (cut off \>0.35 ku/l; immunocap® assay; phadia or equivalent). * a diagnosis of acquired c1inh deficiency (aae) * pregnancy, or breastfeeding, or current intention to become pregnant * treatment with any investigational drug in the past 30 days * known or suspected addiction to drug and/or alcohol abuse * suspicion for an alternate explanation of the symptoms other than acute hae attack

Keywords: hereditary angioedema hae angioedema recombinant c1 inhibitor rhc1inh
insulin resistance and blood pressure regulation in blacks

Conditions: Cardiovascular Diseases; Hypertension; Heart Diseases; Insulin Resistance

Summary: to determine the role of insulin resistance in peripheral vascular dynamics, sodium sensitivity, and blood pressure regulation in a young representative black population and in a group of young blacks at high risk for hypertension.

background: epidemiologic studies have demonstrated a greater prevalence of essential hypertension in blacks with a disproportionately greater hypertension related mortality in blacks. similar vascular consequences occur with diabetes and obesity. these three diseases not only share a common outcome, but also overlap in occurrence with blacks having greater prevalence rates in the three disorders. insulin resistance has been documented in all three disorders and may contribute significantly to the vascular disease. this project originated in response to a request for applications on biobehavioral factors affecting hypertension in blacks issued in december 1982. the original project was supported by the rfa for three years. the first three years of the study focussed on the hypothesis that sodium loading would augment cardiovascular responses of psychogenic stress in blacks at high risk for hypertension. the first phase of the study examined and compared 80 blacks and whites, 18-22 years of age. the second phase involved an additional 40 black borderline hypertensives who were exposed to the same set of studies designed to examine possible interactions between neurogenic and renal controlled volume mechanisms in essential hypertension. the project was renewed as a regular research grant in 1986 and was designed to investigated biobehavioral factors in blood pressure control. in 1988, the study on insulin resistance was funded and continued through 1990. design narrative: subjects in this project consisted of blacks who were enrolled in the collaborative perinatal project (cpp) at birth and who had been studied longitudinally in adolescence and young adulthood. each subject brought to the study data on blood pressure, growth, and maturation from birth through late adolescence. peripheral vascular structure was studied using measures of forearm blood flow and forearm vascular resistance. measurements of peripheral vascular structure were compared to data on sodium sensitivity and potassium sensitivity in the population. insulin resistance was studied using the euglycemic hyperinsulinemic clamp technique. variations in the activity of the sodium-potassium pump and sodium-hydrogen exchange in red cells were correlated with insulin resistance to determine if hyperinsulinemia alters cation transport rates. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
brief video interventions for depression

Conditions: Depressive Symptoms

Summary: in this study, we test brief video interventions for those with elevated depressive symptoms. we randomize participants to one of three conditions. (1) an entrée condition involving in-depth coverage a set of cognitive behavioral therapy (cbt) skills. (2) a sampler condition which introduces three sets of cbt skills. (3) a control condition involving no skills. among those in the entrée condition, participants are further randomized to one of three cbt skills. we plan on two sets of primary comparisons. first, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. second, we will compare the entrée and sampler conditions. we will recruit participants from amazon's mechanical turk program (mturk). in the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. they will also be asked to practice skills introduced in the videos in the week following the intervention. in the control condition, participants will not watch videos. one week after the intervention, all participants will respond to a follow-up assessment.

access to the study will be provided via the mturk website. study measures and interventions will be provided via qualtrics. to determine eligibility, participants will be asked to fill out a pre-screening measure of depressive symptoms, the personal health questionnaire-9 (phq-9). those who score 10 or higher will be eligible. after consenting to participate, participants will fill out baseline measures, be randomly assigned to a condition, participate in any condition related procedures, and then respond to a follow-up assessment one week later. each brief intervention consists of watching a series of videos. after each video, participants in the intervention conditions will be prompted to answer a series of questions to practice the skills explained in the videos. for the entrée and sampler conditions, watching all videos and filling out any worksheets that are part of the initial intervention is expected to take approximately 30 minutes. participants in the entrée and sampler conditions will be asked to work on a coping skills worksheet over the next seven days (estimated to involve about 10 minutes of work). participants will receive an email seven days after participating in the brief intervention, asking them to take part in the following portion of the study. before beginning the follow-up activity, participants in the intervention conditions will be asked to upload the coping skills worksheet they worked on. all participants will be asked to respond to follow-up assessment measures at this point.

Eligibility criteria:
inclusion criteria: * score above 10 on the patient health questionnaire-9 * are 18 years of age or older

Keywords: depression video intervention cognitive behavioral skills
comparative effects of perioperative and adjuvant chemotherapy on outcomes of operable gastric cancer: experience from a cancer care center

Conditions: Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy

Summary: * patients with gastric adenocarcinoma * comparison: perioperative chemotherapy vs. adjuvant therapy. * sample size differences between the two groups. * kaplan meier survival analysis, overall survival and disease free survival


Eligibility criteria:
inclusion criteria: * we included histologically proven gastric adenocarcinoma patient with operable disease and the patients who completed their prescribed perioperative or adjuvant chemotherapy cycles exclusion criteria: * patients were excluded if they had tis or t1, n0 disease, inoperable disease, metastatic. in addition, all those who did not undergo adequate lymphadenectomy (\< d2) or had r1 margins following surgery were excluded
gluteus maximus strengthening exercises augmented by high-intensity laser therapy in patients with plantar fasciopathy

Conditions: Plantar Fascia

Summary: plantar heel pain is one of the most commonly encountered problems of the feet in adults \[1\]. it accounts for nearly 11%-15% of all foot symptoms, the purpose of this study was to investigate the effectiveness of high intensity laser therapy combined with gluteus maximus strengthening exercise on pain, thickness of plantar fascia, and function of the foot.


Eligibility criteria:
inclusion criteria: * unilateral plantar heel pain with or without calcaneal spur for more than 3 months. * tenderness at the insertion of the plantar fascia * bmi index will be from 25 up to 30 * patient will wear silicone insole . * diagnosis of pf based on orthopedic referral exclusion criteria: * patients with presence of foot deformity, * systemic inflammatory arthritis disease, * foot surgery, or * plantar heel pain due to trauma, * wound, or infection in the foot, * received oral corticosteroids

Keywords: plantar heel pain obese laser therapy
vr-based avatar therapy for treatment of auditory hallucinations

Conditions: Hallucinations, Auditory; Schizophrenia Spectrum and Other Psychotic Disorders

Summary: the primary aim of this study is to evaluate the safety and efficacy of avatar therapy, developed to address residual auditory hallucinations persisting despite medication in schizophrenia spectrum disorder. the intervention aims to reduce the intensity and frequency of these symptoms, as well as alleviate associated depressive and anxiety symptoms, using a virtual reality (vr)-assisted intervention developed for this purpose by the danish company heka vr. the study will be a pre-post non-invasive, waiting list-controlled study, enrolling 30 patients from three clinical sites (hungary, spain, poland). the study centers around administering therapy based on vr over a 12-week period, comprising a total of 7 sessions. these sessions are conducted individually and last 50 minutes each. the psychotherapist leading the sessions adheres to a strict protocol defined by the method's developers. during the intervention, vr technology is used to simulate the source of distressing auditory hallucinations. the therapist facilitates coping with these experiences externalized in this way through simulated conversations, supporting the development of more adaptive responses. patients undergo a comprehensive cross-sectional evaluation of their condition before and after the intervention, including assessments of symptom severity, quality of life, and their experience with the method. the intervention is conducted with constant monitoring for possible adverse effects.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia spectrum disorder according to dsm-5, * age 18 or older, * the fluent use of the spoken language at the site (hungarian/spanish/polish), * informed consent provided by the patient or their caregiver after being informed about the research procedure * stable medication dosage for at least 4 weeks prior to recruitment, * regular psychiatric follow-up, * experience of auditory hallucinations for at least three months (panss hallucination score of at least 3 points), * meeting the remission criteria described by andreasen, except for the score related to auditory hallucinations exclusion criteria: * inability to identify a single dominant voice that is the subject of the intervention, * lack of cooperation, * intellectual disability based on medical history, * regular substance abuse * central nervous system injury or neurological disease that affects cognitive performance, * suicidal risk * aversion to virtual reality, * severe visual impairment

Keywords: virtual reality avatar therapy auditory verbal hallucation schizophrenia spectrum disorder
randomized trial of fluticasone in bronchial premalignancy

Conditions: Bronchogenic Carcinoma

Summary: the purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers

bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. in rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. the purpose of this study is to assess the efficacy of fluticasone on premalignant lesions in volunteers with a smoking history of \>10 pack-years and patients cured of head and neck cancer or lung cancer. participants are screened for premalignant lesions by bronchoscopy and if these are present randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. after 6 months, biopsies are taken from the same locations. efficacy of treatment is assessed by reversal of metaplasia/dysplasia; secondary end-points are reversal of increased p53 immunoreactivity and htert expression.

Eligibility criteria:
inclusion criteria: * signed informed consent * age over 18 * metaplasia index \> 15% * over 25 pack years smoking history or history of lung- or head\&neck cancer * male/female of non-childbearing potential or using approved contraception exclusion criteria: * use of inhaled/systemic corticosteroid drugs in the preceding 12 months * contraindications for bronchoscopy/use of fluticasone * major illness * baseline fev1\<1000ml * previous participation in clinical study * nodules \> 1cm on ct

Keywords: bronchial squamous metaplasia bronchial squamous dysplasia
effectiveness of extended treatment for drug dependence (etdd) in the city study

Conditions: Cocaine Dependence

Summary: this protocol (a supplement to 805466) is to test whether our telephone continuing care model can be implemented successfully by "real world" publicly funded programs. participants will be recruited from philadelphia's department of behavioral health - run drug programs. the investigators will train city telephone care managers to deliver our telephone continuing care intervention to patients in this program. the investigators will randomize 200 to receive this intervention or usual care and follow them for 12 months.


Eligibility criteria:
inclusion criteria: * (1) qualify for a dsm-iv diagnosis of cocaine dependence, with cocaine use in the 6 months prior to entrance into the city of philadelphia department of behavioral health facilities or controlled environment; * (2) 18 to 75 years of age; * (3) no current psychotic disorder (as assessed with the psychotic screen from the scid) or evidence of dementia severe enough to prevent participation in outpatient treatment; * (4) no acute medical problem requiring immediate inpatient treatment; * (5) no current participation in methadone or other modes of drug and alcohol treatment, other than an intensive outpatient program; * (6) willingness to be randomized and participate in research. * (7) finally, because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least two contacts who can provide locating information on the patient during follow-up. we will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria. exclusion criteria: * current dependence on opiates is an exclusion as those participants may be better served as part of a methadone program rather than a telephone based therapy protocol. also, if patients are court-ordered to treatment, or otherwise considered prisoners, they will not be included in the study.
sepsis 3 critera for risk stratification in emergency patients

Conditions: Sepsis; Emergency

Summary: investigators aim to evaluate the sepsis 3 criterion for "sepsis" and "septic shock" in a prospective manner. investigators will evaluate qsofa performances and other sepsis 3 criterion in a population of emergency patients with infection


Eligibility criteria:
inclusion criteria: * adult that present to the emergency department * diagnosis of infection by the treating emergency physician exclusion criteria: * refuse to participate * pregnancy * prisoner * low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)