Kornimate/medical-research-clean huggingface dataset:
changes in health and functional status in patients with chronic obstructive pulmonary disease during therapy with spiolto® respimat® (aerial®)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this nis is to measure changes in health status including functional status using ccq scores in copd patients receiving treatment with spiolto® respimat® according to label after approximately 6 weeks in routine clinical practice.

the objective of this nis is to measure changes in health status including functional status using ccq scores in copd patients receiving treatment with spiolto® respimat® according to label after approximately 6 weeks in routine clinical practice. in visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. in visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.

Eligibility criteria:
inclusion criteria: patients can be included if all of the following criteria are met: * written informed consent prior to participation * female and male patients ≥40 years of age * patients diagnosed with copd and requiring a combination of two long-acting bronchodilators (lama + laba) according to approved smpc and gold copd guideline recommendation 2017 (gold copd groups b to d) * treatment with spiolto® respimat® acc. to smpc at the discretion of the physician. exclusion criteria: * patients with contraindications according to spiolto® respimat® smpc * patients already on a laba/lama combination (free and fixed dose) in the last 6 weeks before study entry * patients continuing laba-ics treatment should not be additionally treated with spiolto® respimat® in order to avoid a double dosing of long-acting beta-agonists * pregnancy and lactation * current participation in any clinical trial or any other non-interventional study of a drug or device.
resilience and quality of life in patients with gynaecological carcinomas and chronic gynaecological diseases

Conditions: Gynecologic Disease; Gynecologic Cancer

Summary: the intended pilot project aims at evaluating the feasibility and acceptability of questionnaires about resilience and quality of life in two different patient groups (either with a gynaecological carcinoma ora chronic gynaecological disease). the results provided by this pilot study will build the basis of an upcoming, larger project including these questionnaires and the main objective of assessing resilience. more precisely, the study aims at answering the following questions. how is the overall resilience and quality of life in the target population at one assessment point? are the instruments used in this pilot feasible for the target population when assessing resilience and quality of life?


Eligibility criteria:
inclusion criteria: * female, * \>18 years old, * german speaking exclusion criteria: - insufficient study language skills
an open-label, single arm, phase 2 study to evaluate abt-450/r/abt-267 and abt-333 with ribavirin (rbv) in adults with genotype 1 hcv infection taking methadone or buprenorphine

Conditions: Chronic Hepatitis C Infection; Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the safety and efficacy of abt-450/ritonavir/abt-267 (abt-450/r/abt-267; abt-450 also known as paritaprevir; abt-267 also known as ombitasvir) and abt-333 (also known as dasabuvir) coadministered with ribavirin (rbv) in hepatitis c virus (hcv) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.

this study consisted of 2 periods: a 12-week treatment period and a 48-week post-treatment period (for all participants who received study drugs). all participants who received at least 1 dose of study drug were to be followed for 48 weeks post-treatment to monitor for safety, hcv rna, the emergence and/or persistence of resistant viral variants, and assessment of patient-reported outcome (pro) instruments.

Eligibility criteria:
inclusion criteria: * females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile. * chronic hcv infection prior to study enrollment. * screening laboratory result indicating hcv genotype 1-infection. * subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced. * subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening. exclusion criteria: * positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) at screening. * prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir and boceprevir. * females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local rbv label) after their last dose of study drug. * any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a metavir score of \>3 or ishak score of \> 4.

Keywords: hcv genotype 1 hepatitis genotype 1 interferon free methadone hcv buprenorphine hepatitis c viekira pak paritaprevir viekira ombitasvir dasabuvir
randomized trial with trastuzumab versus observation in breast cancer patients

Conditions: Breast Cancer

Summary: epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood \[disseminated and circulating tumor cells, (dtcs) and (ctcs) respectively\] of otherwise metastases-free patients with early breast cancer. several studies have shown that the presence of these cells is an independent factor associated with an increased incidence of early disease relapse and disease-related death. in almost 50% of the patients, adjuvant chemotherapy cannot eliminate these occult tumor cells and this is also associated with a higher probability of early relapse and death. in 60-70% of the patients, dtcs and/or ctcs express the her2/c-neu molecule and one or two administrations of their monoclonal antibody trastuzumab (herceptin) could eliminate these cells for a period ranging from 3-12 months.

this pilot trial will compare the efficacy of the anti-her2/erb-b2 monoclonal antibody trastuzumab (herceptin) given after the completion of the standard adjuvant chemotherapy and radiotherapy versus observation in patients with stage i-iii operable breast cancer who have detectable cytokeratin-19 (ck-19) mrna-positive tumor cells in the bone marrow or the peripheral blood before and/or after the adjuvant treatment.

Eligibility criteria:
inclusion criteria: * age \>= 18 years. * performance status (world health organization \[who\]) \< 3 * adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * adequate liver (bilirubin \< 1.5 times upper limit of normal and sgot/sgpt \< 2 times upper limit of normal) and renal function ( creatinine \< 2 mg/dl) * adequate cardiac function (left ventricular ejection fraction \[lvef\] \> 50%). * informed consent * histologically or cytologically confirmed breast adenocarcinoma * prior surgical excision of the primary breast tumor * prior completion of standard adjuvant chemotherapy and/or radiotherapy * locally advanced disease after the completion of neo-adjuvant chemotherapy, surgical excision and radiotherapy provided that there was no evidence of local or metastatic disease * absence of any clinical or laboratory evidence of metastatic disease * detection of ctcs and/or dtcs (when it could be feasible) before the initiation and/or after the completion of adjuvant chemotherapy and/or radiotherapy * expression of her2/c-neu on the primary tumor is not mandatory exclusion criteria: * other invasive malignancy within the past 5 years except nonmelanoma skin cancer * other concurrent uncontrolled illness * psychiatric illness or social situation that would preclude study compliance * pregnant or nursing * positive pregnancy test * history of allergic reaction attributed to trastuzumab (herceptin)

Keywords: occult tumor cells micrometastatic cells cytokeratin-19 trastuzumab completion of adjuvant treatment
interferon alpha lozenges in the prevention of winter colds and flu

Conditions: Upper Respiratory Tract Infections

Summary: the aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. starting about 1 month before the expected start of the winter colds and flu season in perth, australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female * females of child-bearing potential must practice a medically accepted form of birth control exclusion criteria: * currently exhibiting an acute upper respiratory tract infection * history of chronic respiratory disease requiring regular therapy(i.e. copd, asthma, bronchitis, etc.) * any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy) * any condition requiring regular treatment with antihistamines, analgesics or antipyretics * known infection with hiv, hepatitis b virus or hepatitis c virus * any other serious, uncontrolled disease * any active infections requiring use of antibiotic or antiviral drugs * non-ambulatory status * suspected drug or alcohol abuse

Keywords: prophylaxis treatment symptoms winter colds and flu
efficacy and safety of argon plasma coagulation in the treatment of patients with hemoptysis caused by endobronchial malignancies

Conditions: Hemoptysis; Cancer

Summary: the aim of this study is to evaluate the efficacy, the safety and the main predictors of success of bronchoscopic argon plasma coagulation in patients with hemoptysis caused by endobronchial malignancies.

hemoptysis is a challenging symptom which may be frequently related to endobronchial malignancies. patients with central neoplasms and hemoptysis show a lower median survival than patients with no bleeding and endobronchial neoplasms and/or patients with hemoptysis and peripheral malignant lesions. hemoptysis control without recurrence at 48 hours after bronchoscopic interventions may improve survival in patients with mild bleeding and endobronchial malignancies. argon plasma coagulation is considered one of the most effective techniques for endobronchial management of hemoptysis in this subset of patients. nevertheless, few data are available in literature on its efficacy and safety, and the main predictors of success are still unclear. in this prospective, observational study, investigators aim to evaluate the efficacy (i.e. immediate bleeding cessation without recurrence during the following 48 hours) of endoscopic argon plasma coagulation in patients with hemoptysis caused by endobronchial neoplasms. investigators will also evaluate the safety of the procedure, the main variables associated to a successful intervention, the presence of hemoptysis relapses and patients overall survival to 3,5 months after the bronchoscopic intervention.

Eligibility criteria:
inclusion criteria: * adult patients with hemoptysis caused by endobronchial (i.e. identifiable with flexible bronchoscopy) malignancies, without coagulopathy or other medically correctable causes of bleeding, who need endoscopic intervention with argon plasma coagulation to stop bleeding * adult patients who are able to tolerate bronchoscopy * adult patients who are able to sign the written informed consent for the study participation exclusion criteria: * patients with hemoptysis caused by endobronchial malignancies with coagulopathy or other medically correctable causes of bleeding. * patients who are not able to tolerate bronchoscopy * patients with hemoptysis without identifiable endobronchial malignancies during flexible bronchoscopy * patients with pace-maker and/or automated implantable cardioverter- defibrillator(aicd) * patients who refuse/are not able to sign the informed consent for the study participation

Keywords: hemoptysis lung cancer
examining the immunological process of autoimmune patients

Conditions: Sjogren's Syndrome; Autoimmune Diseases; Dry Eyes; Dry Mouth

Summary: sjögren's syndrome (sjs) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. it can be systemic by affecting other organs including the gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. involvement of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia, lack of concentration, memory loss and various psychiatric disorders. like most autoimmune connective tissue diseases, sjs shows a sexual dimorphism with women affected 10-times more frequently than men, suggesting a role for sex hormones in disease susceptibility or progression. one common feature of sjs is it infiltration of mononuclear cells into the salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci (lf). critical to the studies proposed is the fact that a predominant cell population of lf is the pathogenic th17 cell that produces il-17 cytokine and autoreactive b cells reactive to m3r, ro, and la autoantigens. the goal of this study is characterize the change in receptor gene repertoires of autoreactive b and t cells at different time points during the disease process and examine the correlation with various disease parameters.

blood from patient and healthy controls will be collected once every 3-6 months. white blood cells from blood samples will be separated. tests will be done to see which substances these cells make. using sequencing techniques, the investigators will determine the genetic code of the receptors expressed on these cells. the investigators plan to test how these cells change over the period of at least 3 years at different visits. in addition, the investigators will check how these changes relate to patients' general medical history relevant to autoimmune disease, lab results and physical examinations and exams pertinent to the diagnosis of autoimmune disease, and psychosocial data.

Eligibility criteria:
inclusion criteria for sjogren's syndrome patients: * primary sjogren's syndrome patients: primary sjogren's syndrome patients who meet the revised criteria for sjs diagnosis by the american-european consensus group. * secondary sjogren's syndrome patients: secondary sjogren's syndrome patients who meet the criteria for primary sjogren's syndrome in association with other autoimmune diseases such as systemic lupus erythematosus , dermatomyositis, scleroderma, idiopathic arthritis, mixed connective tissue disease, etc. inclusion criteria for healthy controls: -subjects who does not have history of autoimmune diseases. exclusion criteria: * pregnant women. * patients with history of lymphoma or malignancy.
a global study of the petal consortium

Conditions: T-Cell and NK-Cell Neoplasm

Summary: the goal of this observational study is to correlate molecular alterations with outcomes including overall survival (os), progression-free survival (pfs), response rates for patients with a new diagnosis, primary refractory or relapse, of mature t-cell and nk-cell neoplasms (tnkl). we hypothesize that machine learning can be leveraged to uncover distinct genetic vulnerabilities that underlie treatment response and resistance for patients with tnkl, thus moving towards personalized treatment solutions.

this study is a prospective, longitudinal observational study of patients with newly diagnosed or relapsed/refractory t-cell and nk-cell neoplasms, conducted across multiple participating institutions globally. patients will be enrolled during their initial visit as new patients and will be followed for up to four years through the course of their clinical management. data for routine demographics, baseline clinical features, including pathology, molecular information related to the tumor, radiology, treatment characteristics and quality of life (qol) associated with their lymphoma care will be collected over the course of 4 years by clinical research teams at every participating institution. the de-identified data will be securely shared through a password protected redcap with other participating institutions under data usage agreements of the consortium. next generation sequencing (ngs) including but not limited to whole exome sequencing and bulk rna-sequencing will be performed on archived lymphoma specimens, mononuclear cells, cfdna and saliva (when feasible) for a comprehensive molecular characterization of the tumor. molecular data will be analyzed in correlation with patient outcomes. advanced deep learning algorithms will be applied to predict responses and survival across lymphoma subtypes, heterogeneous clinical scenarios and various potential therapeutic approaches that the patient has not been exposed to.

Eligibility criteria:
inclusion criteria: * untreated, relapsed, or refractory histologically confirmed mature t-cell or nk-cell neoplasm. * all subtypes of ptcl are eligible except for t-cell large granular lymphocytic leukemia, cutaneous t-cell lymphoma such as but not limited to mycosis fungoides and transformation, sézary syndrome, and primary cutaneous cd30+ disorders. exclusion criteria: * precursor t/nk neoplasms, t-cell large granular lymphocytic leukemia, cutaneous t-cell lymphoma such as but not limited to mycosis fungoides and transformation, sézary syndrome, and primary cutaneous cd30+ disorders. * adults who are unable to consent, individuals who are not yet adults such as infants, children and teenagers, pregnant women, and prisoners.
acceptability, usability and preliminary effectiveness of chatgpt in increasing seasonal influenza vaccination uptake among older adults in hong kong

Conditions: Behavior Change Interventions

Summary: in this project, we will train a chatgpt to provide real-time answers to questions related to the siv for older adults in hong kong. this study aims to evaluate the usability, acceptability, and preliminary effectiveness of the chatgpt among 50 community-living people aged 65 years and above in hong kong. the primary objectives are to evaluate the usability and acceptability (including the extent of usage and subjective experiences of behavioural, cognitive, and affective engagement) of the chatgpt at the end of the 4-week intervention period (t1). the secondary objectives are to evaluate the following conditions measured at t1, as compared to those measured at baseline (t0): 1. self-reported uptake of siv in the past month. 2. changes in behavioural intention to receive siv for the approaching flu season. 3. changes in knowledge and attitudes related to siv.


Eligibility criteria:
inclusion criteria: * aged ≥65 years; * possession of a hong kong id; * able to speak and comprehend cantonese; * have a smartphone with internet access; * have not taken siv for the approaching flu season. exclusion criteria: * with diagnosis of cognitive impairment or dementia; * either blindness or deafness; * with known contraindications to the siv as indicated by the hong kong centre for health protection
a multicomponent technology supported care delivery for older patients with hematologic malignancies (the m-tech study)

Conditions: Cancer

Summary: this is a randomized controlled trial to assess the feasibility and preliminary efficacy of a multicomponent technology-supported care delivery intervention trial in 110 older patients with hematologic malignancies \[acute myeloid leukemia (aml), myelodysplastic syndrome (mds), multiple myeloma (mm), and diffuse large b-cell lymphoma (dlbcl)\] receiving outpatient chemotherapy on treatment-related toxicities, patient-reported outcomes, healthcare utilization, and inflammatory and epigenetic markers.

compared to younger adults, older adults with cancer are more likely to have age-related vulnerabilities such as functional impairment and co-existing medical conditions. they are also often on many medications. as a result, older adults are more likely to experience treatment-related toxicities. these toxicities can lead to increased healthcare utilization (e.g., hospitalization, emergency room visits), decreased quality of life and functional status, and reduced survival. in addition, a disproportionate number of older adults live in rural areas which often limit access to healthcare. therefore, there is a need to better support older adults with hematologic malignancies during the course of their treatment to decrease treatment-related toxicities so they can continue to receive treatment. the proposed study will investigate whether digital health technologies can support older adults in various aspects of their cancer care.

Eligibility criteria:
inclusion criteria * age ≥60 years * have a new diagnosis of aml, mds, mm, and dlbcl * have a plan to receive outpatient chemotherapy for at least 4 months (patients may enroll within the first 2 weeks of chemotherapy initiation if they do not have grade 2 or higher non-hematologic adverse event) * no plan to or unlikely to proceed with autologous or allogeneic hematopoietic stem cell transplantation (sct) in the following 5 months (if sct is planned after 4 cycles of chemotherapy in the case of mds or myeloma, patients are allowed to enroll) * english speaking * eastern cooperative oncology group (ecog) performance status of 0-3 * no medical contraindications for exercise per oncologist * able to walk 4 meters as part of short physical performance battery measured walk (with or without the assistive device) * able to provide informed consent exclusion criteria: • none

Keywords: mobile health technology geriatrics
a phase i study of biib015 in relapsed/refractory solid tumors

Conditions: Solid Tumors

Summary: phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.


Eligibility criteria:
inclusion criteria * age 18 years or older at the time of informed consent. * solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists. * ecog performance status \</= 2. exclusion criteria * history of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease. * new york heart association (nyha) grade ii or greater congestive heart failure. * history of myocardial infarction within 6 months prior to day 1. * presence of \>/= grade 2 peripheral neuropathy. * known presence of central nervous system or brain metastases. * prior therapy with a conjugated or unconjugated maytansine derivative.

Keywords: relapsed refractory