Kornimate/medical-research-clean huggingface dataset:
cardiovascular morbidities and lung cancer treatment: a prospective registry

Conditions: Lung Neoplasm

Summary: therapeutic algorithms for lung cancer are mainly based on randomised controlled trials which excluded patients with severe co-morbidities. smoking, the main risk factor for lung cancer, is associated with cardiovascular events that may impact on the therapeutic decision. the aim of this registry is to determine if and how cardiovascular co-morbidities impact on the physicians' decision for anticancer treatment in lung cancer patients by comparing it to the european lung cancer working party (elcwp) guidelines


Eligibility criteria:
inclusion criteria: * histological diagnosis of lung cancer, either nsclc or sclc patients and carcinoid tumours * untreated lung cancer of any stage and any treatment (including palliative care only). * availability for participating in the detailed follow-up of the protocol. * signed informed consent. * age above 18 years. * presence of at least one co-morbidity: * any active or past cardiac ischemia * reduced left ventricular ejection fraction (\< 50%) * obstructive cardiomyopathy * valvular dysfunction (3 or 4/4; valvular replacement) * arrhythmia (atrial flutter or fibrillation, significant ventricular arrhythmia, 2nd-3rd degree auriculo-ventricular block, wolf-parkinson-white and other similar aberrant conduction, bifascicular block, arrhythmogenic right ventricular dysplasia) * uncontrolled hypertension (systolic blood pressure (bp) \> 160 millimeter of mercury (mmhg) or diastolic bp \> 100 mmhg on ≥ 1 hypotensive drug) or controlled hypertension on ≥ 2 concurrent hypotensive drugs * active or treated peripheral arteritis (grade 2 or more) * cerebrovascular events * pulmonary embolism and/or thrombophlebitis or patients at high risk of thrombophilia (homozygous leiden factor...) * aortic aneurism exclusion criteria: * thymoma and thymic malignancies, pleural mesothelioma. * patient previously treated for lung cancer. * tumours for which complete staging cannot be assessed. * history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval).

Keywords: lung neoplasms cardiovascular co-morbidity
efficacy of ciclesonide vs placebo administered as once daily or twice daily in patients not treated with inhaled corticosteroid.

Conditions: Asthma

Summary: to investigate the efficacy of ciclesonide mdi either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.


Eligibility criteria:
inclusion criteria: * males or females 12 years or older * history of persistent bronchial asthma for at least 6 months * documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening * at screening, fev1 60 to 90% of predicted. reversibility of fev1 by at least 12% post-bronchodilator * be able to use oral inhalers * non-smokers exclusion criteria: * history of life-threatening asthma * other pulmonary diseases * uri within 4 weeks before screening * use of systemic steroids within 6 months before screening. use of inhaled steroids within 30 days before screening. more than 2 in-patient hospitalizations or er visits due to asthma exacerbations in the prior year before screening * pregnant or breast-feeding females * females of child-bearing potential not using adequate means of birth control * clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease * abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results * history of drug or alcohol abuse * treatment with any investigational product within 30 days prior to study entry

Keywords: glucocorticosteroid. bronchospasm
a randomized, safety and efficacy study of taneasy 600mg granules and fluimucil 600mg granules in copd subjects

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Summary: to evaluate the safety and efficacy of taneasy 600mg granules and fluimucil 600mg granules administered twice daily for 14 days in treatment of copd disease.

the study will enroll 40\~60 patients and complete 40 patients.

Eligibility criteria:
inclusion criteria: * subjects aged older than 20\~75 years old. * able to sign informed consent prior to the study. * the appearance of sputum and the difficulty of expectoration are both at level 2 or above. exclusion criteria: * subjects with known hypersensitivity to acetylcysteine preparations. * subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.) * pregnancy or breast-feeding woman. * female subjects or their sexual partners do not use contraception during the trial. * joining any drug clinical trial within 3 months prior to dosing. * investigator considered to be inappropriate for enrollment.
a mobile intervention (txt4tki) for the improvement of tyrosine kinase inhibitor management in patients with chronic myeloid leukemia

Conditions: Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia

Summary: this trial studies the feasibility and acceptability of a mobile intervention called txt4tki for the improvement of tyrosine kinase inhibitor management in patients with chronic myeloid leukemia. tyrosine kinase inhibitors (tki) are associated with numerous potential side effects, including a decrease in bone marrow activity (myelosuppression), nausea, diarrhea, fatigue, and soft-tissue swelling (edema), especially in the face and lower legs, which are the primary reasons for patients to discontinue tki medication. using a mobile text messaging (txt) intervention that emphasizes the importance of tki compliance may improve tki adherence in patients with chronic myeloid leukemia.


Eligibility criteria:
inclusion criteria: * phase 1: patients diagnosed with chronic myeloid leukemia * phase 1: initiated tyrosine kinase inhibitors therapy for a year * phase 1: able to read and understand english * phase 1: able to provide informed consent * phase 1: have a mobile phone with txt capability * phase 1: know how to use txt * phase 2: patients diagnosed with chronic myeloid leukemia in the chronic phase * phase 2: starting tyrosine kinase inhibitors therapy or has been on tyrosine kinase inhibitors with anticipation of at least 6 month duration of use * phase 2: able to read and understand english * phase 2: able to provide informed consent * phase 2: have a mobile device with txt capability * phase 2: willing to use a wireless pill bottle during study for 6 months * phase 2: know or willing to learn how to use txt exclusion criteria: • cognitive impaired document in the electronic medical record (emr)
use of inhaled high-molecular weight hyaluronan in patients with severe covid19: feasibility and outcomes

Conditions: Covid19

Summary: to determine whether inhaled yabro protects against progression of covid19-induced respiratory failure preventing the passage to non-invasive ventilation (niv) and promotes recovery from covid19 lung disease in hospitalized patients.

all patients will be treated with state of the art covid19 treatment as per the treating clinician (remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). patients randomized to the active intervention group will also receive hmw-ha (yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily. due to increased risk for sars-cov-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. because covid19 may result in long-term o2 dependency, the study and treatment period will be limited to a maximum of 10 days. moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * diagnosis of covid19 by validated sars-cov-2 antigen, rt-pcr, or other molecular diagnostic assay, using an appropriate sample such as np, nasal, oropharyngeal \[op\], or saliva) and no alternative explanation for current clinical condition. * respiratory failure requiring oxygen therapy * has symptoms consistent with covid-19, and is in non-fibroproliferative stage of disease, as determined by investigator. exclusion criteria: * respiratory arrest or the need for immediate intubation; * upper airway obstruction; * facial trauma; * inability to cooperate (e.g. agitation or dementia) * inability to give informed consent * participation in another study for covid19 treatments * deterioration due to other reasons than progressive covid19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc. * palliative care or expectation that patient will not survive \> 72 hours post randomization per clinical judgment of the investigator.
68ga-psma-11 pet/ct for the diagnosis of bone metastases in patients with prostate cancer and biochemical progression during androgen deprivation therapy

Conditions: Biochemically Recurrent Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Summary: this phase ii trial studies how well 68ga-psma-11 positron emission tomography (pet)/computed tomography (ct) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased psa after treatment (biochemical recurrence) during androgen deprivation therapy. diagnostic procedures, such as 68ga-psma-11 pet/ct, may help find and diagnose prostate cancer and find out how far the disease has spread.

primary objective: i. to compare the per-patient detection rate of 68ga-psma-11 pet/ct versus bone scan (bs)/ct for m1b in patients treated with androgen deprivation therapy (adt) who are referred for the imaging evaluation of disease progression. secondary objectives: i. to compare the number of lesions rated as positive for bone metastases between the two imaging tests. ii. to compare the detection rate of 68ga-psma pet/ct versus bs/ct for all m1 disease (m1a or m1b or m1c). iii. to compare the positive predictive value (ppv) per-patient in patients with lesion validation (follow-up imaging or biopsy). outline: patients receive gallium ga 68 gozetotide intravenously (iv). after 50-100 minutes, patients undergo whole body pet/ct.

Eligibility criteria:
inclusion criteria: * patient with biochemical progression during adt or combination therapies including adt who are referred for imaging evaluation (prostate specific antigen \[psa\] level \>= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart) * patients with bone scan scheduled or performed * within 30 days of the psma pet, without any new prostate cancer (pca) therapy in between * bone scans performed at university of california, los angeles (ucla) and external institutions are eligible if digital imaging and communications in medicine (dicom) images can be obtained, imported, and anonymized * patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility * patients or their legal representatives must have the ability to read, understand and provide written informed consent exclusion criteria: * initiation of a new therapy between the psma pet/ct and the bone scans * inability to provide written informed consent * known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
characterizing breast cancer with al18f-nota-fapi-04 pet/ct (pfb-02)

Conditions: Breast Cancer

Summary: fibroblast activation protein (fap) is overexpressed in cancer-associated fibroblasts (cafs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. previous studies have demonstrated that fapi pet/ct performs well in cases of epithelial tumors, including breast cancer. this prospective study is going to investigate the performance and value of al18f-nota-fapi-04 pet/ct in patients with breast cancer.

breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18f-fluorodeoxyglucose (18f-fdg) pet/ct, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. cancer-associated fibroblasts (cafs) are a crucial component of the tumor stroma with diverse functions. fibroblast activation protein (fap), a type ii membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the cafs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. based on this characteristic, many small-molecule inhibitors of fap (fapis) labeled with radioactive tracers (68ga, 18f, or 177lu) have been synthesized as theranostic radiotracers for cancer. previous studies on fapi pet/ct tumor imaging have focused on the 68ga radionuclide rather than 18f. as 18f-labeled fapi has more favorable physical properties, high production capacity, and good imaging characteristics, it may be an ideal agent for pet imaging. therefore, this study aims to evaluate the performance and value of al18f-nota-fapi-04 pet/ct in patients with breast cancer.

Eligibility criteria:
inclusion criteria: * age 18-80 years old; * newly diagnosed bc confirmed by biopsy or with bi-rads category 4c or 5 lesions by us or mg; * bc clinical stagect1-3 cn0-3 m0; * no prior treatment for bc. exclusion criteria: * pregnancy; * breastfeeding; * patients who were unwilling to undergo pet/ct scans.
a study of ocrelizumab in participants with moderate to severe rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (iv) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe ra. part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab \[400, 1000, 1500, and 2000 milligrams (mg)\]. in part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in part 1.


Eligibility criteria:
inclusion criteria: * moderate to severe ra for at least 6 months * positive serum rheumatoid factor (\>/= 20 international units per milliliter) * current treatment with ra on an outpatient basis * treatment failure with one disease modifying anti-rheumatic drug (dmard) or biologic, but have not failed more than six of these agents including methotrexate * current treatment with methotrexate for at least 12 weeks, at a stable dose * use of highly effective contraception. exclusion criteria: * rheumatic autoimmune disease or inflammatory joint disease, other than ra * concurrent treatment with any disease-modifying anti-rheumatic drug (dmard) (other than methotrexate) or any anti-tumor necrosis factor (tnf) -alfa or other biologic therapy * treatment with any other investigational drug within 4 weeks of screening * previous treatment with cell-depleting therapies, iv gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening * previous treatment with rituximab or any other anti-cluster of differentiation 20 (cd20) agent * history of severe allergic or anaphylactic reactions to humanized monoclonal antibodies * known active bacterial, viral or fungal infections * history of active tuberculosis and primary or secondary immunodeficiency * history of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders * pregnancy or lactation.
symbicort onset of action 1

Conditions: Asthma

Summary: the purpose of this study is to compare the early onset of effect of symbicort compared to advair diskus and ventolin in adults with asthma


Eligibility criteria:
inclusion criteria: * diagnosis of asthma and baseline lung function test results as determined by protocol * required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol exclusion criteria: * severe asthma or asthma markedly affected by seasonal factors * has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Keywords: asthma bronchodilatation symbicort budesonide/formoterol advair diskus ventolin
the value of molecular residual disease monitoring based on ctdna in advanced or metastatic pancreatic cancer

Conditions: Pancreatic Cancer; Advanced Cancer; Metastatic Cancer

Summary: the goal of this clinical trial is to explore the value of molecular residual disease (mrd) monitoring based on ctdna in advanced or metastatic pancreatic cancer. the main questions it aims to answer are: * prognostic value of baseline mrd; * the role of mrd dynamic changes after treatment in guiding treatment. peripheral blood derived from participants will be obtained for mrd test before first-line chemotherapy initiation and at the first imaging assessment after chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed unresectable advanced or metastatic pancreatic cancer; * both sexes, age ≥18 years old; * ecog performance status score ≤2; * the expected survival time was ≥3 months. exclusion criteria: * a known diagnosis of pancreatic cancer other than ductal adenocarcinoma; * treated with any systemic antitumor treatment before first-line chemotherapy onset; * died or lost to follow-up within one month after the initiation of first-line chemotherpay; * combined with other primary malignances.
efficacy of a herbal formula for bone metastases

Conditions: Bone Metastases

Summary: rationale: nearly 50% of patients with bone metastases develop one or more complications collectively termed skeletal-related events (sres). the study herbal medicine might reduce the morbidities due to "skeletal-related events" (sres), and extend survival time. purpose: the study is to explore the effects of the 4 herbs formula on the reduction of "skeletal-related events" (sres), and survival time.

objectives: primary primary efficacy end points are sre, general state and biomarkers. secondary survival rate and survival time time to first sre (since randomization) biochemical markers quality of life: eq5-d pain control (brief pain inventory) outline: patients will be randomized to receive either 4 herbs formula plus zometa or zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone * confirmed diagnosis of metastatic breast cancer * radiographic proof of metastatic bone disease * informed consent obtained exclusion criteria: * known history of primary bone tumors (benign and/or malignant) * prior use of bone modifying agents, including but not limited to zoledronic acid or denosumab within 12 months of study entry * active anti-cancer therapies in the form of cytotoxics or targeted therapies. \[patients who are currently on hormonal therapies, including but not limited to tamoxifen, aromatase inhibitors and lhrh agonists/antagonists are allowed for study entry. clarifications shall be sought from investigators if in doubt\]. * significant drug hypersensitivity * no informed consent signed
self neuro-modulation therapy for major depressive disorder (mdd) with anhedonia

Conditions: Depressive Disorder, Major

Summary: the purpose of this research is to learn more about a new treatment for individuals with major depressive disorder (mdd) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). the treatment is called prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting. during this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (mri) and electroencephalography (eeg).

the study is comprised of the screening visit, baseline assessment, pre-training visit, 20 nf training visits (two training visits per week over 10 weeks), two booster nf training visits (week 16, and week 20, and the 3-month follow-up assessment visit (week 24). participants will receive 20 nf sessions. the study will test the following hypothesis: * h0: m(anhedonic)rs-efp = m(anhedonic)sham-efp * h1: m(anhedonic)rs-efp ≠ m(anhedonic)sham-efp where: m(anhedonic)rs-efp and m(anhedonic)sham-efp are the mean changes from baseline hdrs-17 score in the active and sham arms of the anhedonic mdd participants. \*hdrs-21 is administered for cluster analysis

Eligibility criteria:
inclusion criteria: 1. primary diagnosis of mdd with anhedonia, established according to the diagnostic and statistical manual of mental disorders, fifth edition text revision (dsm5tr) - hdrs-17 score of ≥20, shaps-c score of ≥25. 2. fluency in written and spoken english. 3. able intellectually to understand the instructions 4. ability to give signed, informed consent either written or electronic (via redcap econsent). 5. normal or corrected-to-normal vision and hearing. 6. ability to adhere to the study schedule. 7. completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the atrq. exclusion criteria: 1. contraindications to mri (e.g., metal in the body, claustrophobia). 2. any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using columbia -suicide severity rating scale (c-ssrs) prior to screening and during the screening period. 3. diagnosis for current moderate or severe substance or alcohol use disorder (sud/aud) within the past month (as defined in dsm-5-substance use disorder). 4. any unstable medical condition, as per the clinical judgement of the investigator. 5. any change in, or initiation of, fluoxetine within the past 8 weeks or of other ssris/snris antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks. 6. recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted. 7. enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.

Keywords: major depressive disorder (mdd) anhedonia depression