Kornimate/medical-research-clean huggingface dataset:
research on the heterogeneity of taiwanese breast cancer patients by next generation sequencing (ngs) tools

Conditions: Next Generation Sequencing (NGS); Breast Cancer

Summary: the objectives of this study are: 1. to determine the difference in genetic profiling of subjects with breast cancer recurrence 2. to determine the comprehensive genetic profiling of subjects with late stage breast cancer 3. to determine the potential biomarkers for early detection and prognosis for breast cancer 4. to determine the genetic profiling of immune system in different subtypes of breast cancer by integrating and analyzing the data generated using the methods of ngs, these information can be used for: 1. understanding the genetic profiling of different subtypes of breast cancer in taiwan 2. assessing the efficacy of different treatments in breast cancer subjects 3. defining the molecular risk factors and predicting the potential risk of breast cancer recurrence 4. assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects 5. developing new strategies in treating patients with triple negative or late stage of breast cancer


Eligibility criteria:
inclusion criteria: * female subjects aged over 20 years old * subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer. however, subjects with breast cancer recurrence at screening will be enrolled if meet both the following conditions: 1. subjects had received surgery for primary breast cancer within 3 years prior to screening \[i.e. recurrence within 3 years after surgery (mastectomy or bcs)\]; 2. subjects diagnosed with stage iv breast cancer beyond 3 years after surgery (mastectomy or bcs) or who had received or are currently receiving treatments for breast cancer. and subjects with primary tumor ffpe tissues available and pass the rna quality check. * eastern cooperative oncology group (ecog) performance score ≤ 3 * life expectancy ≥ 3 months * subject agrees to provide the written informed consent. if a subject has breast cancer recurrence within 3 years prior to screening, she will be eligible if she agrees to provide the paired ffpe tissues (primary and recurrent tumors) exclusion criteria: * subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening
efficacy & safety study of vesicare® (solifenacin succinate) in patients wishing to switch from detrol la® for treatment of overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: to evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have oab syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes


Eligibility criteria:
inclusion criteria: * patients with oab who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes. * previous non-drug treatment of oab is allowed if it has been established at least 4 weeks prior to screening and is continued throughout the study. * at least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as oab syndrome. * prior to treatment with tolterodine tartrate extended release, patients must have had oab syndrome for 3 or more months. exclusion criteria: * previous treatment with darifenacin * treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study. * significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator. * evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones. * clinically significant outflow obstruction as determined by the investigator * uncontrolled narrow angle glaucoma, urinary or gastric retention. * all patients with severe renal or hepatic impairment will be excluded * patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

Keywords: urinary bladder, overactive urgency vesicare® solifenacin succinate
to study the influence of gcsf on natural history of acute on chronic liver failure after the acute phase

Conditions: Acute on Chronic Liver Failure

Summary: all consecutive aclf (acute on chronic liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. after performing baseline biochemical tests, patients will undergo transjugular liver biopsy (tjlb), hvpg (hepatic venous pressure gradient), circulating cd34 cells, bone marrow aspiration and biopsy (histopathological and immunohistochemical examination will be done).


Eligibility criteria:
inclusion criteria: * subjects aged 18-65 years * all patients who were known to have aclf and have survived 3 months of the onset of acute event * patients willing to participate in the study exclusion criteria: * presence of aki (acute kidney injury) * active sepsis (blood/ urine culture positive, sbp (spontaneous bacterial peritonitis, lrti (lower respiratory tract infection) * sickle cell anemia * hepatocellular carcinoma * hematological malignancies * multi organ failure * grade 3/ 4 he (hepatic encephalopathy) * hiv seropositivity * pregnancy * patients being taken up for transplant * refusal to participate in the study
surfaxin® treatment for prevention of bronchopulmonary dysplasia (bpd) in very low birth weight (vlbw) infants.

Conditions: Respiratory Distress Syndrome, Newborn; Premature Birth; Bronchopulmonary Dysplasia

Summary: surfaxin® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (bpd), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (rds).

determine the safety and tolerability of surfaxin administration in the first weeks of life as a therapeutic approach for prevention of bpd. determine whether treatment with surfaxin during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or bpd in vlbw infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Eligibility criteria:
inclusion criteria: * premature infants between 600 and 900 grams birth weight * intubated and on mechanical ventilation * sustained (\>= 30 minutes) fraction of inspired oxygen (fio₂) \>= 0.30 within 8 hours prior to randomization exclusion criteria: * mother has prolonged rupture of membranes ≥ 2 weeks * culture-proven sepsis * high grade intraventricular hemorrhage (ivh) * congenital heart disease * congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints * fio₂≥ 0.80 and mean airway pressure (map) ≥ 12 cmh2o at day of life (dol) 3 * fio₂\< 0.25 at any time between meeting the entry criteria to immediately prior to randomization * concomitant use of any other surfactant within the first 48 hours of life * prior use of nitric oxide * prior use of steroids * current participation in any other clinical trial or has received an experimental drug or used an experimental device

Keywords: double-blind low birth weight surfactant placebo-controlled premature birth
open, non-comparative study of intravenous and oral fluconazole in the treatment of acute cryptococcal meningitis

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in aids and non-aids patients. both newly diagnosed and relapsed patients are eligible. the effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in aids patients will also be evaluated.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antivirals such as zidovudine. prophylaxis for pneumocystis carinii pneumonia. aerosolized pentamidine. concurrent treatment: allowed: * radiation therapy for mucocutaneous kaposi's sarcoma. written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. * patient's treatment status must be one of the following: * no prior systemic antifungal therapy for cryptococcosis. * relapse after prior therapy. the success of prior therapy must have been documented by negative csf culture at the end of therapy. following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin b in the 4 weeks before entry into the study. prior medication: allowed: * antivirals such as zidovudine (azt). prophylaxis for pneumocystis carinii pneumonia. aerosolized pentamidine. exclusion criteria co-existing condition: patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * a history of allergy to or intolerance of imidazoles or azoles. * moderate or severe liver disease defined by specified lab values. * life expectancy of \< 2 weeks. concurrent medication: excluded: * coumarin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine. concurrent treatment: excluded: * lymphocyte replacement. patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * a history of allergy to or intolerance of imidazoles or azoles. * moderate or severe liver disease defined by specified lab values. * life expectancy of \< 2 weeks. prior medication: excluded: * coumarin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine. prior treatment: excluded: * lymphocyte replacement.

Keywords: aids-related opportunistic infections meningitis injections, intravenous cryptococcosis fluconazole administration, oral acquired immunodeficiency syndrome
neuromuscular ultrasound in correlation to neurophysiological findings

Conditions: Carpal Tunnel Syndrome; Diabetic Neuropathies; Guillain-Barre Syndrome

Summary: 1. study the neuromuscular ultrasound findings in different types of neuropathies 2. correlation between ultrasound and neurophysiological findings in peripheral nerve diseases 3. correlation between clinical pain scale and severity of neuropathy

ultrasonography is a diagnostic tool that is increasingly used in the work-up of peripheral nerve disease. as many peripheral nerves run a superficial course, especially in the arms. this is a big advantage over magnetic resonance imaging that is relatively expensive, time consuming and not readily available everywhere. nerve cross-sectional area (csa) can be determined at multiple sites along the nerve. csa can be measured at entrapment sites but also at nonentrapment sites. vascularization, echogenicity, fascicular pattern and endoneurial thickness can be investigated as well. all those modalities can give critical insight in the origin and development of various peripheral neuropathies1,2,3 major peripheral nerves in the extremities, such as the median,ulnar thick enough to reflect the sound beam, resulting in hyperechoic on the us scan 4. the correlation between nerve conduction study parameters and csa in ultrasound ultrasound of the peripheral nervous system is an additional useful diagnostic tool in neuromuscular disorders..5,6,7,8,9 in the longitudinal plane, nerves present as long, slim structures with a mixture of parallel hypoechoic and hyperechoic lines. nerves must be distinguished from other nearby structures to ensure correct identification muscles are hypoechoic and interspersed with small hyperechoic foci which easily distinguishes muscles from nerves. tendons, which are sometimes adjacent to nerves, move proportionately with joint movement. us has higher specificity than sensitivity in differentiating myopathic and neuropathic changes the most sensitive diagnostic marker for symptomatic carpal tunnel syndrome patients is an enlarged crosssectional area of the median nerve 10,11,12

Eligibility criteria:
inclusion criteria: * above 18 years old * males or females * diabetic complaining of neuropathy or not * carpal tunnel syndrome * guillain-barré syndrome exclusion criteria: * patient refuse to participate * the anatomy is altered due to sever trauma,tumor,or surgery * severe spasticity preventing examination
integrated mental healthcare plan for management of depression and self-harm in pakistan

Conditions: Depression; Self Harm

Summary: aims: 1. to describe the process of developing a feasible district mental healthcare plan (mhcp) for depression, self-harm and suicide prevention, and 2. to describe its enabling intervention packages and components to be delivered at the basic health units in thatta district. the proposed study will be a pilot implementation with nested qualitative component. the study will also involve situational analysis for proposed study site and theory of change workshops with key stakeholders. this study is a replication of the methods used in the development of a district mental healthcare plan in uganda (kigozi et al., 2016).

mental neurological and substance use (mns) disorders contribute significantly to global burden of disease. the who mental health action programme (mhgap) taking a life course approach has developed an intervention guide to scale up services in low and middle income countries (lmics) focusing on priority mental health conditions in adults and older adults. the gap between the individuals in need of mental health interventions and those who actually receive such care remains very large. to reduce the treatment gap, the who mental health action plan (who, 2017) strongly recommended assessment, diagnosis and treatment of mns in community settings and primary healthcare (phc). central to this agenda is the who mental health gap action programme (mhgap) and intervention guide (ig) (who, 2010) which is an evidence based tool. the proposed project aims to integrate the adapted who-mhgap-ig for depression, self-harm and suicide prevention into the community and primary settings in thatta (situated in the province of sindh, pakistan). depression and self-harm are selected priority conditions for the proposed study. in order to collect information and detailed cross-sectional data on health and factors that can influence health of thatta district, a situational analysis tool will be used. both one to one in-depth interviews as well as focus groups will be conducted with stakeholders to explore possible barriers and facilitators of testing the feasibility of adapted mhgap-ig for depression and self-harm in thatta. pilot study will be conducted using the mhgap-intervention guide (mhgap-ig) (two modules: depression, self harm and suicide prevention)

Eligibility criteria:
inclusion criteria: * all patients aged 18 and above presenting to recruiting health facilities will be assessed by the research team for depression (positive) and/or history of self-harm (positive exclusion criteria: * patients below 18 years of age, * patients taking medication for/ having a diagnosis of substance abuse, severe mental/physical disability/ comorbidity, whereby they are unable to participate in the interview.

Keywords: treatment gap mental health primary care task shifting mhgap pakistan
effect of hict and liit on functional strength and weight efficacy in overweight and obese females

Conditions: Overweight and Obesity

Summary: this study is aimed at determining the effects of high-intensity circuit training versus low-intensity circuit training on functional strength and weight efficacy in overweight and obese females.

a high-intensity circuit promotes muscle mass and as a result, potentially reduces the incidence of cardiovascular disease and reduces the risk of death in the young population. low-intensity interval training increases muscle circulation and improving the uptake of oxygen. both high-intensity circuit training and low-intensity interval training enhance body composition, quality of life, functional fitness and decrease body mass index. these trainings also motivate participants to continue their exercise. this study will help us determine whether high intensity or low-intensity training is more helpful in improving the functional strength and weight efficacy in overweight and obese females. as obesity is on the rise in modern society, our results will help improve the quality of life of obese and overweight females.

Eligibility criteria:
inclusion criteria: * females with bmi \>25 kg/m2. * females not engaged in routine exercise programs in last 6 months exclusion criteria: * females who are using weight loss products. * females having uncontrolled diabetes, thyroid disease, arthritis, cardiac diseases, asthma, hypertension, and recent trauma would not be included in the study. * females who are pregnant would not be included in the study.

Keywords: female quality of life overweight obesity exercise
adults nutrition as a protective or health-risk factor

Conditions: Nutritional Status; Nutrient Deficiency; Micronutrient Deficiency; Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Iron-deficiency; Thyroid Diseases; Diet

Summary: to obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the eu menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the consumption of foods and enabling the assessment of energy and macronutrient intakes. participating subjects will be invited to nutrihealth study for assessment for micronutrient status (focusing into vitamin d, folic acid, vitamin b12, and iron) and medical examination, in which thyroid size will be aslo measured, to investigated thyroid epidemiology in slovenia.


Eligibility criteria:
inclusion criteria: * resident of republic of slovenia (included to the register of residents) * finished eu menu slovenia study exclusion criteria: * not willing to give blood\&urine sample * long-term disease * living in institutions with controled diet, such as such as in elderly care, hospital, prison, etc.

Keywords: dietary intake nutritional status micronutrients thyroid health
adolescent responses to varying environments in virtual reality simulations

Conditions: Residential Characteristics; Emotions; Stress, Psychological; Stress, Physiological

Summary: the objective of this study, named thrive (the research in virtual environments study), is to test hypotheses for how neighborhood environments influence stress and emotion, as a mechanism by which they may influence health. neighborhood environments may have both acute influences on stress-related processes, but also may have lifespan effects due to the chronic, cumulative effects of repeated exposures and the long-term toll of adapting to adverse neighborhood environments. however, assessing neighborhood influences on stress and emotion is methodologically challenging. this study develops such a novel, alternative approach to address these questions by deploying a virtual reality (vr) based model of neighborhood disadvantage and affluence that creates an immersive experience approximating the experience of being in different neighborhoods. in this study, this model will be applied to understand neighborhood effects in a diverse sample of adolescents (n = 130) from a range of disadvantaged and affluent neighborhoods. the proposed study will employ a randomized experiment (n = 65 per condition), with online questionnaires and a single study session, to determine (a) if virtual exposure to neighborhood disadvantage elicits differences in emotion and stress reactivity; (2) if growing up in a disadvantaged neighborhood results in habituation or sensitization to different neighborhood characteristics; and (3) if chronic stress results in habituation or sensitization to different neighborhood characteristics. this research will develop an innovative methodology that will help establish the role that neighborhoods may play in eliciting stress as well as the processes of adaptation to chronic stress and chronic neighborhood exposures. in addition, it will help establish a method that can be utilized more broadly to study contextual and social environmental influences on psychological and biological risk in adolescence.


Eligibility criteria:
inclusion criteria: * english speaking * are able to use a dominant hand for joystick manipulation and a non- dominant hand for physiological measurements, * are in good physical and mental health, with no self-reported history of hypertension, cardiovascular disease (cvd) or cvd treatment (with associated medication list indicative of treatments that result in exclusion), * have hair at least 1cm in length based on self-report to be able to provide a hair sample. exclusion criteria: * pregnant, by self-report

Keywords: neighborhoods poverty areas adolescent development
observational safety study of menactra® administered under standard health care practice in the russian federation

Conditions: Meningitis; Meningococcal Meningitis; Meningococcal Infections

Summary: the aim of this study is to generate local data on the safety of menactra® in individuals 2 to 55 years of age in the russian federation. primary objective: * to describe the safety profile after 1 dose of menactra® administered in individuals 2-55 years of age under standard health care practices.

participants will be enrolled after receipt of one dose of menactra® during a routine health care visit. they will be monitored for safety throughout the study.

Eligibility criteria:
inclusion criteria: * aged 2 through 55 years on the day of enrollment "2 through 55 years" means from the day of the 2nd birthday to the day before the 56th birthday * for adults (18-55 years old) informed consent form has been signed and dated by the participant. * for minors: informed consent form has been signed and dated by the parent. in addition, in accordance with the institution ethics committee/institution review board requirements and as appropriate for the age of the participant: * participants aged 14 to 17 years are required to sign and date the informed consent form, * participants aged 10 to 13 years are required to sign and date the assent form, * for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding * receipt of one dose of menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert. exclusion criteria: * participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.

Keywords: meningitis meningococcal meningitis meningococcal infections menactra® meningococcal vaccine