Kornimate/medical-research-clean huggingface dataset:
a study evaluating veliparib as a single agent or in combination with chemotherapy in subjects with solid tumors

Conditions: Breast Cancer; Ovarian Cancer; Colon Cancer; Lung Cancer; Gastric Cancer; Solid Tumors

Summary: this is an extension study to evaluate the safety of veliparib monotherapy or in combination with carboplatin plus paclitaxel or modified folinic acid/fluorouracil/irinotecan (folfiri) in subjects with solid tumors.


Eligibility criteria:
inclusion criteria: * must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. * for veliparib monotherapy (must have tumor with defects in dna repair mechanisms (brca mutation or high grade ovarian cancer or solid tumors for combination therapy. * if the subject has known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (cns) disease progression as determined by comparing a computed tomography (ct) scan or magnetic resonance imaging (mri) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration). * subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range. exclusion criteria: * subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to: * uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months; * uncontrolled nausea/vomiting/diarrhea; * active uncontrolled infection; * symptomatic congestive heart failure; * unstable angina pectoris or cardiac arrhythmia; * psychiatric illness/social situation that would limit compliance with study requirements; * any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities. * subjects who have hypersensitivity to carboplatin, paclitaxel or cremophor should be excluded from arm b. * subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug. * subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug. * the subject has had another active malignancy within the past 3 years except for any cancer in situ that the principal investigator considers to be cured.

Keywords: gastric cancer lung cancer parp inhibitor ovarian cancer solid tumors breast cancer colon cancer
implementing hearts in guatemala

Conditions: Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Summary: the hearts technical package was developed by the world health organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. guatemala is a middle-income country that is currently implementing hearts. national authorities are interested in exploring how hypertension and diabetes management can be integrated in hearts implementation. the objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on hearts in the publicly funded primary care system in guatemala.

a single-arm pilot trial for 6 months will be carried out in 11 ministry of health primary care facilities starting in september 2023. a planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. the intervention will consist of hearts-aligned components: training health workers on healthy-lifestyle counseling and evidence-based treatment protocols; strengthening access to medications and diagnostics; training on risk-based cardiovascular disease management; team-based care and task sharing; and systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

Eligibility criteria:
patient participants inclusion criteria: * non-pregnant adults aged ≥18 years * diagnoses of type 2 diabetes or hypertension * present for routine care at participating moh primary health facilities exclusion criteria: * confirmed or suspected type 1 diabetes * pregnant * are not managed at moh health centers or health posts provider/other participants inclusion criteria: • participation in delivering hearts or on the technical advisory committee exclusion criteria: • none
measurement of the quality of life in patients operated with a total knee prosthesis (tka) from the fhk® range.

Conditions: Knee Disease

Summary: as part of medical devices ce marking regulatory process, an appropriate post-market clinical follow-up (pmcf) is required. this pmcf study is in the framework of ce mark renew of fhk® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use. this study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.

the primary objective of this study is to evaluate the quality of life in patients operated with a fhk® total knee prosthesis up to 2 years of follow-up. the secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.

Eligibility criteria:
inclusion criteria: * subject implanted with fhk® prosthesis in one of the following indication according to the instructions for use: knee disorders; aseptic condylar necrosis. * subject who received an information form and is willing to participate in the study. * adults subjects (≥18 years old). * access to an internet connection allowing to complete the questionnaires on the online platform exclusion criteria: * contraindications described in the instructions for use * subject who is not able to express his/her non-opposition

Keywords: knee arthroplasty replacement
collection of blood for gene expression study in individuals with chronic lung diseases

Conditions: Pulmonary Diseases

Summary: this protocol is designed to gather a small amount of blood from patients seen in the new york presbyterian hospital-weill cornell medical center pulmonary, critical care unit, and 5 west floor (pulmonary floor) for clinical care associated with chronic lung disease. this protocol will also survey medical records of patients with chronic lung disease, in order to study the clinical characteristics of these individuals. investigators aim to understand the genetics of chronic lung diseases, and will use the serum and dna from this blood to perform various genotyping studies such as such as genomic/gene expression studies of individuals with chronic lung diseases

this protocol is designed to gather a small amount of blood from patients seen in the new york presbyterian hospital-weill cornell medical center pulmonary, critical care unit, and 5 west floor (pulmonary floor) for clinical care associated with chronic lung disease. this protocol will also survey medical records of patients with chronic lung disease, in order to study the clinical characteristics of these individuals. investigators aim to understand the genetics of chronic lung diseases, and will use the serum and dna from this blood to perform various genotyping studies such as such as genomic/gene expression studies of individuals with chronic lung diseases. general admission criteria for this project will require at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest x-ray consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) patients with diseases of organs with known association with lung disease. the following studies will be conducted on blood specimens: genomic dna will be extracted; promoter sequences for antioxidant-related genes will be obtained by pcr and sequenced. the goal is to find single nucleotide polymorphisms (snp) to see if they correlate with lung disease. dna samples and blood specimens will be coded. samples could potentially be traced back to the patient. however, every effort will be made to keep the patient's identity confidential per hipaa regulations. the study does not aim to create a blood bank. rather, the blood samples will be used for dna extraction only. serum will be stored for future studies, to look at levels of proteins.

Eligibility criteria:
inclusion criteria: * must provide informed consent * males and females, age 18 years and older * lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest x-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease exclusion criteria: * drug and/or alcohol abuse within the past six months * females who are pregnant or nursing

Keywords: chronic lung disease
exercise in lessening fatigue caused by cancer in patients undergoing chemotherapy

Conditions: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: physical activity may help lessen fatigue caused by cancer in patients receiving chemotherapy. it is not yet known whether a home-based walking and resistance-band exercise program is effective in lessening fatigue. purpose: this randomized phase iii trial is studying how well exercise works in lessening fatigue caused by cancer in patients undergoing chemotherapy.

objectives: primary * determine the efficacy of a home-based walking and progressive-resistance exercise program in reducing cancer-related fatigue (crf) in patients undergoing chemotherapy. outline: this is a multicenter study. patients are stratified according to participating site, chemotherapy course length (2 weeks vs 3 weeks), gender, and degree of fatigue reported on the study assessment questionnaire (≤ 5 vs \> 5). patients are randomized to 1 of 2 intervention arms. * arm i: patients receive standard chemotherapy. * arm ii: patients receive a home-based walking kit comprising an exercise for cancer patients manual, a pedometer, and therapeutic resistance bands. patients undergo moderately intense aerobic exercise (walking) monitored by a pedometer, and low to moderately intense progressive-resistance exercise using therapeutic resistance bands for 6 weeks. patients also receive standard chemotherapy. patients in both arms undergo assessment of their aerobic capacity and strength by the 6-minute walk test and handgrip dynamometry at baseline and at day 41. they also have a fasting blood draw and wear an actigraph for one week at baseline and week 6. patients complete functional assessment of chronic illness therapy-fatigue and -cognitive subscales, brief fatigue inventory, multidimensional fatigue symptom inventory, center for epidemiological studies-depression scale state trait anxiety inventory, pittsburgh sleep quality inventory, profile of mood states, aerobic center longitudinal study physical activity, and symptom inventory questionnaires at baseline and at day 41 and keep a daily exercise diary during study intervention.

Eligibility criteria:
inclusion criteria: * primary diagnosis of cancer other than leukemia, with no distant metastasis * chemotherapy naïve * starting chemotherapy treatments for cancer and scheduled for at least 6 weeks of treatments with treatment cycles of either 2, 3 or 4 weeks. oral chemotherapy (e.g., xeloda) is acceptable * karnofsky performance level of 70 or greater * able to read english exclusion criteria: * diagnosis of leukemia * metastatic disease * receiving concurrent radiation therapy * physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance program * identified as in the active or maintenance stage of exercise behavior as assessed by the exercise stages of change short form

Keywords: fatigue unspecified adult solid tumor, protocol specific
assessing frailty in older adults with functional mental illness

Conditions: Frailty; Mental Illness

Summary: the purpose of this study is the development of, and two stages of pilot testing of, a tool designed to assess frailty in older adults with a diagnosis of a functional mental illness. during the tool's development stage, participants' input, ideas and feedback will be sought to inform the tool's design. in the first pilot test the comprehensibility, acceptability and feasibility of the tool will be established. the tool will be amended based on information gained in the first pilot test. in the second pilot test the comprehensibility, acceptability and feasibility of the revised tool will be established. reliability of the tool will be explored and preliminary examinations of both the interpretability and construct validity of the tool will be completed.


Eligibility criteria:
inclusion criteria: * aged ≥65 years * diagnosis of one of the following functional mental illnesses; depression, anxiety, bipolar affective disorder, schizophrenia. * currently in receipt of mental health services under the care programme approach (cpa). * presence of ≥2 of the following frailty indicators: aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. in receipt of weekly support for activities of daily living (adl) tasks, in receipt of daily support for instrumental activities of daily living (iadl) tasks, ≥2 chronic physical health conditions. * fluent in english language. * able to provide informed consent to engage in the study. * able to tolerate the mental and physical demands of the study exclusion criteria: * a diagnosis of a neurodegenerative condition (e.g. mild cognitive impairment or dementia), neurological condition (e.g. stroke, parkinson's disease) or head injury (where a loss of consciousness greater than 10 minutes is reported/recorded). * the presence of a severe sensory impairment (e.g. registered blind or deaf). * presence of a developmental intellectual disability. * current alcohol/substance abuse or dependence.

Keywords: frailty, assessement
an open-label extension trial of hznp-hzn-825-301 in adult participants with diffuse cutaneous systemic sclerosis (diffuse cutaneous ssc)

Conditions: Diffuse Cutaneous Systemic Sclerosis; Sclerosis, Systemic

Summary: primary objectives: 1. the primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with hzn-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (fvc %) predicted. 2. the primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with hzn-825, inclusive of, but not limited to, adverse events (aes), serious aes (saes) and the adverse event of special interest (aesi), from day 1 to 4 weeks after last dose.

this is an open-label, repeat-dose, multicenter extension trial of hznp-hzn-825-301. participants who complete the double-blind treatment period (week 52) in trial hznp-hzn-825-301 will be eligible to enter this 52-week extension trial. participants entering this extension trial will complete the week 52 visit activities in hznp-hzn-825-301 and will not complete the safety follow-up visit 4 weeks after the last dose of trial drug in hznp-hzn-825-301. acquired from horizon in 2024.

Eligibility criteria:
key inclusion criteria: 1. completed the double-blind treatment period (week 52) in trial hznp-hzn-825-301; participants prematurely discontinued from trial drug in trial hznp-hzn-825-301 for reasons other than safety or toxicity can be included at the discretion of the investigator after completing trial hznp-hzn-825-301 scheduled visits, including week 52 assessments. key exclusion criteria: 1. anticipated use of another investigational agent for any condition during the course of the trial. 2. new diagnosis of malignant condition after enrolling in trial hznp-hzn-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 3. women of childbearing potential (wocbp) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol. 4. any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of trial hznp-hzn-825-301 that, in the opinion of the investigator, would potentially put the subject at unacceptable risk. 5. pregnant or lactating women. 6. participants will be ineligible if, in the opinion of the investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.

Keywords: scleroderma forced vital capacity
aging and gastrointestinal barrier function

Conditions: Aging; Hyperthermia

Summary: the purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.

heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. although gastrointestinal barrier dysfunction is a primary cause of heat related illness, little is known about the effects of aging on gastrointestinal barrier function during hyperthermia. the central hypothesis of this work is that the elderly exhibit greater gastrointestinal barrier dysfunction during hyperthermia. participants will complete a control trial where gastrointestinal permeability (without heating) will be assessed in young and older adults. in the experimental trial, controlled hyperthermia will be achieved using a water perfused, tube lined suit. core body temperature will be raised to a maximum of 2 degrees celsius above the baseline value, or an absolute temperature of 39.5 degrees celsius. core temperature will not be collected during the control trial. comprehensive assessments of gastrointestinal barrier function and systemic inflammation will be assessed in young and older adults. the expected outcome of this work will re-shape our understanding of the consequences of aging on gastrointestinal barrier function during heat waves.

Eligibility criteria:
inclusion criteria: * healthy male and female individuals * 18-35 years or 65+ years of age * free of any underlying moderate to serious medical conditions exclusion criteria: * known heart disease * any chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolled hypercholestrolmia etc; * abnormality detected on routine screening suggestive of provocable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram. * current smokers, as well as individuals who regularly smoked within the past 3 years * subject with a body mass index ≥35 kg/m2 * pregnant * use of immunosuppressant drugs within last 4 weeks prior to screening * use of antibiotics or antimicrobial medication in last month * any previous abdominal surgery * use of steroids in last 6 weeks * regular use of probiotics in last month * use of laxatives or anti-diarrhetic in last month
crizotinib in alk rearranged non-small-cell lung cancer

Conditions: Non Small Cell Lung Cancer; Advanced Cancer; Metastatic Cancer

Summary: this is a multicenter, observational, retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in alk positive nsclc treated in real life setting.

primary efficacy objective: to assess the efficacy of crizotinib in real life setting secondary objectives: 1. to evaluate the therapeutic response to crizotinib-based treatment 2. to identify additional biomarkers selectively present in the alk positive population 3. to assess the safety of crizotinib (250 mg/bid) in the treatment of nsclc in real life setting non-small-cell lung cancer (nsclc) remains the leading cause of cancer death in western countries. identification of anaplastic lymphoma kinase (alk) gene rearrangements reinforced the role of targeted therapies in lung cancer. the eml4-alk fusion gene is detected in 3-7% of patients with adenocarcinomas of the lung and is associated with specific clinical pathological features, including young age, absent or minimal smoking history and adenocarcinoma histology. however, such clinical features do not properly select patients for alk inhibitors (alk-is) and, consequently, molecular testing is mandatory. indeed, current guidelines recommend to test alk rearrangements at diagnosis all patients with advanced lung adenocarcinoma, due to immediate therapeutic implications.

Eligibility criteria:
inclusion criteria: * 1. males and females aged 18 years with diagnosis of advanced or metastatic nsclc * 2. former participation in the italian npu program between december 2010 - april 2013 or receiving crizotinib according to 648 legislative decrete from april 2013 to february 2015 and thereafter in clinical practice up to december 31st, 2017. * 3. ascertained compliance to the crizotinib therapy as prescribed by the relevant physician * 4. alk rearrangement report including details of method and cutoff used for alk testing * 5. data on prior therapies * 6. data on toxicity * 7. data on crizotinib therapy efficacy including response to the therapy and survival * 8. data on site of metastases * 9. availability of archival tissue (not mandatory) * 10. signed informed consent for alive and contactable patients exclusion criteria: * 1. lack of clinical data * 2. no evidence of alk rearrangemement * 3. early death defined as fatal outcome within 30 days since the first crizotinib dose * 4. absence of any radiological assessment * 5. no data on crizotinib efficacy including survival

Keywords: crizotinib non small cell lung cancer metastatic cancer advanced cancer nsclc alk positive
pulses, satiation, food intake and blood glucose

Conditions: Metabolic Syndrome

Summary: pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. however, the role of individual pulses incorporated into a mixed meal on regulation of food intake, satiety and glycaemic control remains unclear. therefore, the objective of our study was to determine the effects of ad libitum consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.


Eligibility criteria:
inclusion criteria: * healthy young males with bmi of 20-24.9 kg/m2 exclusion criteria: * females * smokers * breakfast skippers * individuals with diabetes or other metabolic diseases * those scoring ≥ 11 on an eating habit questionnaire