Kornimate/medical-research-clean huggingface dataset:
first-in-human study of stx-721 in participants with locally advanced or metastatic non-small cell lung cancer harboring egfr exon 20 insertion mutations

Conditions: Non-Small Cell Lung Cancer; NSCLC; EGFR/HER2 Exon 20 Insertion Mutation

Summary: study stx-721-101 is an open label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (pk) exposure, and preliminary antitumor activity of stx-721 in participants with non-small cell lung cancer (nsclc) carrying egfr/her2 exon 20 insertion (ex20ins) mutations.


Eligibility criteria:
key inclusion criteria: 1. has histologically- or cytologically confirmed diagnosis of nsclc stage iiib/c or iv not eligible for curative intent surgery or chemoradiation 2. part 1: tumor tissue egfr or her2 exon 20 insertion mutations confirmed by qualified local laboratories. parts 2 and 3: egfr exon 20 insertion mutations confirmed by qualified local laboratories 3. part 1: has received all approved therapies for advanced or metastatic nsclc or is ineligible. part 2 and part 3: has received at least 1, but not more than 2, prior lines of treatment for advanced or metastatic nsclc, 1 of which must be platinum-based chemotherapy unless contraindicated 4. has documented tumor progression (based on radiological imaging) 5. has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling 6. has at least one measurable tumor lesion per recist v1.1 7. is ≥18 years of age at the time of signing the icf 8. has eastern cooperative oncology group (ecog) performance status score of 0 or 1 key exclusion criteria: 1. has a tumor that is known to harbor egfr ex20ins p.h773_v774insh variant, or any egfr kinase domain activating mutation concurrent with either a t790m and/or c797s resistance mutations 2. has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from nsclc 3. has symptomatic brain or spinal metastases 4. has toxicities from previous anticancer therapies that have not resolved to baseline levels or to ctcae grade ≤1, except for alopecia and peripheral neuropathy 5. has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments
wheelchair-bound senior elastic band (wseb) exercise program for the demented seniors

Conditions: Dementia

Summary: the goals of this three-year research project were: 1) to develop and evaluate the feasibility of the wheelchair-bound senior elastic band (wseb) for the demented, wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects of the instructor-led wseb on the functional fitness, daily life function, depression, and problem behaviors of this senior population, and 3) to test the feasibility, compliance, and effectiveness of the dvd-led wseb on this senior population.

a three-year, longitudinal, triangulation research method was applied. first year (phase i): a preliminary wseb, including hard copy descriptions and dvd demonstrations of each exercise, were sent to the 12 experts in the delphi advisory panel for their critique and evaluation. first year (phase ii): a quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the wseb on a group of 15-20 demented, wheelchair-bound seniors in long-term care facilities. second year: a quasi-experimental, pre-post tests, non-equivalent control group design was used to test the long-term effects of the instructor-led wseb on the functional fitness (cardiovascular-respiratory function, body flexibility, range of the joint's motion, and muscle strength and endurance), daily life function, depression, and problem behaviors of the demented, wheelchair-bound seniors in long-term care facilities. eight long-term care facilities with 150 demented, wheelchair-bound seniors from southern taiwan were recruited and randomly assigned based on the facilities to a wseb experimental group or a waiting-list control group. participants in the experimental group received the wseb lead by the pre-trained and certified instructors, three times per week, 40 minutes per practice for 24 weeks; participants in the waiting-list control group remained regular activities in the facilities. one pre-test and two post-tests, 12 weeks apart, were conducted. third year: using the same method as in the second year, participants from the second year were continued practicing the wseb, but guided by a dvd, for another 36 weeks. the feasibility, compliance, and effectiveness of the dvd-led wseb on the demented, wheelchair-bound seniors in long-term care facilities were tested, and another three post-tests, 12 weeks apart, were conducted on the same outcome measurements as in the second year.

Eligibility criteria:
inclusion criteria: * aged 65 and over * diagnosed with dementia by a physician or screened by the mini-mental state examination (mmse) as dementia * wheelchair-bound seniors * living in the long-term care facility for at least three months exclusion criteria: * having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses * suffering from spinal cord injury with no rehabilitation potential

Keywords: dementia wheelchair-bound seniors long-term care facilities elastic band exercise functional fitness daily life function depression problem behaviors
does amniotic fluid index affect the fetal cardiac performance?

Conditions: Oligohydramnios; Polyhydramnios

Summary: to evaluate and compare fetal cardiac performance by fetal echocardiography and delivery outcome between fetuses with isolated oligohydramnios, normal amniotic fluid and polyhydramnios.


Eligibility criteria:
inclusion criteria: * gestational age 24-42 weeks * singleton pregnancies exclusion criteria: * fetal anatomical or chromosomal abnormality * known fetal cardiac defect * suspected fetal infection * suspected iugr
clinical proof-of-concept study for the combination bay60-4552 / vardenafil for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with pde5 inhibitors

Conditions: Erectile Dysfunction

Summary: this study examines the efficacy and safety of the combination treatment bay60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with pde5 (phosphodiesterase 5) inhibitors. patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of pde5 inhibitor therapy given alone. patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. there is a 1 in 3 chance of receiving either the combination bay60-4552 plus vardenafil, or vardenafil alone, or placebo. neither patient nor the treating physician will know which treatment is given (double-blinded design).this part of the study will last four weeks patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.


Eligibility criteria:
inclusion criteria: * open-label run-in phase (first four weeks): * written informed consent signed before any study-specific procedure * history of ed (erectile dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ed has to be confirmed by a physician * stable, heterosexual relationship for at least 6 months prior to screening * aged 18 to 64 years (inclusive) at the first screening examination * history of previous use of at least 1 marketed pde5 (phosphodiesterase 5) inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose * double-blind treatment phase (last four weeks): * at least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse * iief ef (international index of erectile function - erectile function subscale) score \<17 * at least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful exclusion criteria: * contraindication to use of vardenafil * history of prostatectomy due to prostate cancer, including nerve-sparing techniques. * concomitant use of adrenergic blockers * history of spinal cord injury * resting hypotension, i.e. sbp (systolic blood pressure) \<100 mmhg at rest * moderate / severe hypertension, i.e. sbp \>170 mmhg or dbp \>110 mmhg at rest * symptomatic orthostatic hypotension with a decrease in sbp \>20 mmhg or in dbp (diastolic blood pressure) \>10 mmhg subsequent to change from the supine to standing position

Keywords: combination drug therapy phosphodiesterase inhibitors
comprehensive assessment of subclinical atherosclerosis in patients with rheumatoid arthritis

Conditions: Cardiovascular Diseases; Rheumatoid Arthritis; Atherosclerosis, Coronary

Summary: cardiovascular disease is a leading cause for morbidity and mortality in general population. the incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (ra). the risk of incident cvd is increased by 48% in patients with ra compared to the general population. ra is associated with 50% increase in the mortality in patients with cardiovascular disease (cvd). one reason is the more frequent cardiovascular risk factors in ra patients compared with the general population. patients with ra have a high risk of premature cardiovascular disease (cvd). the aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in ra patients.


Eligibility criteria:
inclusion criteria: 1. 18-70 years old (except for women till 75 years old) 2. absence of established cvd: * myocardial infarction p/h * pci with balloon and/or stent * intermittent claudication * pad / intervention * cas /intervention 3. signed informed consent form 4. documented diagnosis of rheumatoid arthritis exclusion criteria: 1. known cvd 2. pregnancy
a combined programme of exercise and dietary advice in men with castrate resistant prostate cancer

Conditions: Prostatic Neoplasms, Castration-Resistant; Prostate Cancer

Summary: the proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.the study will have 2 arms, with one set of participants randomized to resistance exercise training intervention plus dietary advice and the other arm will be standard of care plus exercise advice.

although there have been advances in recent years, therapeutic options remain limited for men with castrate resistant prostate cancer (crpc). there is an unmet clinical need for interventions which can improve quality of life, functional capacity and cancer related fatigue. adjunctive exercise therapy could be a potentially effective treatment for these men. a growing body of evidence has demonstrated numerous benefits in physiological and psychosocial outcomes in men with advanced prostate cancer. further, there is observational evidence linking physical activity with reduced disease specific mortality after a diagnosis of cancer. observational data also indicates that preserving skeletal muscle mass can improve responses to chemotherapy. the proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.

Eligibility criteria:
inclusion criteria: * men with castrate resistant prostate cancer * men with histologically confirmed pca on long-term adt with either * psa\>2ng/ml above nadir or psa level that has risen serially on at least two occasions (each at least 4 weeks apart) in the presence of castrate levels of testosterone or; * evidence of symptomatic disease progression whilst undergoing first line androgen deprivation therapy (adt) in the presence of castrate levels of testosterone or; * radiographic disease progression whilst undergoing first line adt in the presence of castrate levels of testosterone exclusion criteria: * • participation in other trials which might bias the evaluation of the primary objectives of the present study. * current participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 90 minutes per week for at least six months). * unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers. * uncontrolled painful or unstable bony metastatic lesions. * within two months of invasive surgical treatment (transurethral surgery allowed). * any physical, neurological or psychiatric impairment or disease or other condition that would limit the ability to understand and complete the study assessments and complete the required questionnaires, recall and record of dietary information would be excluded.
xarelto on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation in china: a non-interventional study

Conditions: Stroke

Summary: this non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-cns systemic embolism in patients with non-valvular atrial fibrillation in china.

3000 patients will be provided with free drug.it is planned to have an interim analysis(ia) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). to end or continue enrolling patients will be decided based on the ia result and the evaluation comments from cfda.

Eligibility criteria:
inclusion criteria: * female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation * patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-cns systemic embolism was made as per investigator's routine treatment practice exclusion criteria: * na

Keywords: rivaroxaban, non-interventional, atrial fibrillation, stroke prevention,
clinical trial to evaluate the safety and tolerability of hydrogen in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage parkinson's disease. the medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.

this study will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage parkinson's disease. subjects will be sequentially randomized in a 1:1 ratio to receive hydrogen-enriched water or the corresponding placebo twice a day, in addition to all standard-of-care treatments. enrollment goal is 70 subjects. duration of therapy is 52 weeks. the primary outcome measures are safety and tolerability of hydrogen-enriched water. secondary outcome measures include: progression of motor symptoms, health-related quality of life, progression of cognitive decline, and progression of symptom burden.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * modified hoehn \& yahr stage \< iii * diagnosis of parkinson's disease made within past 3 years• * ability to complete questionnaires * willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments exclusion criteria: * other major diseases of the central nervous system * history of stroke * use of antipsychotic neuroleptic medication within the last 6 months * symptomatic (secondary) parkinsonism * atypical parkinsonian variants * unstable medical or psychiatric illness * known kidney disease * history of stereotactic brain surgery * significant cognitive impairment * inability to safely tolerate 8 ounces of water twice daily associated with the study medication * unable to avoid regular use of medications containing magnesium * treatment with another investigational drug within the last 30 days that may interfere with the study medication * pregnancy or nursing
web based patient tutorial on prolonged grief

Conditions: Prolonged Grief Disorder

Summary: the goal of this clinical trial is to learn about usefulness of the online patient grief tutorial in bereaved adults with prolonged grief disorder who are receiving psychotherapy treatment for it. the main question it aims to answer is how helpful the tutorial was and how much therapists and clients liked it. participants will be given access to the online tutorial for use during their talk therapy treatment. participants will be asked to complete surveys before starting the treatment and after its completion to provide information about their symptoms and feedback about the tutorial.

the center for prolonged grief at columbia university will send announcements to therapists who have done training in prolonged grief disorder treatment (pgdt) inviting them to participate in the study and directing them to a study information page in qualtrics. after reviewing the information sheet, therapists will give their consent for participation and then complete a demographics and professional experience questionnaire. the study coordinator will monitor qualtrics for new responses and email eligible therapist-participants instructions for accessing the tutorial in moodle. participating therapists will then recruit their patients to take part in the study and direct them to the study information page in qualtrics to provide consent. therapists will conduct a clinical assessment to determine that the client is an appropriate candidate for the study. then therapists will provide the clients with a brief introduction to the patient tutorial and log-in credentials, before starting prolonged grief disorder treatment. client-participants will have access to the tutorial for 6 months. the patient tutorial will supplement a course of prolonged grief disorder treatment (aka complicated grief treatment or cgt) provided by participating therapists in their practices. typical course of pgdt takes about 4 months of weekly meetings. therapists are licensed professionals who will monitor their patients, as usual in practice, and can recommend to stop the study treatment at any point or switch to alternative treatment, as indicated. frequency, duration and pattern of use of the patient online tutorial will be monitored. patients will also complete online questionnaires about their grief symptoms before and after treatment and overall experience with the tutorial.

Eligibility criteria:
licensed mental health professionals trained in prolonged grief disorder treatment and their clients in treatment for prolonged grief. inclusion criteria to participate in step 2 of the study are: 1. a clinical diagnosis of prolonged grief disorder according to dsm-5 criteria, 2. a judgment that grief is the primary problem, 3. a score of at least 30 on the inventory for complicated grief (icg), and 4. at least 1 year has passed after the death of their loved one (part of dsm-5 criteria). exclusion criteria: 1) active suicidal ideation or suicidal intent, current or past psychotic disorder, or active substance use disorder.

Keywords: grief therapy training
a study to investigate the analgesic efficacy of azd2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy

Conditions: Neuropathic Pain

Summary: a study to investigate the analgesic efficacy of azd2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent form * males and female of non-child bearing potential patients aged 18 to 80 years * patients with neuropathic pain due to painful diabetic polyneuropathy. exclusion criteria: * other pain that may confound assessment of neuropathic pain * history of treatment failure with more than three adequate trials of medication for neuropathic pain * central neuropathic pain conditions (caused by central nervous system injury/disease, eg. stroke)

Keywords: analgesic effect
hearing loss, vestibular loss and cognitive performance

Conditions: Vestibular Disorder

Summary: hearing loss is an established independent risk factor for dementia. likewise, recent research demonstrated cognitive deficits in subjects with vestibular loss. however, in these studies data have not been adjusted for the hearing status of the enrolled study subjects. as hearing loss prevalence is high in patients with vestibular loss, this could be a major confounder. therefore, in this study the investigators investigate cognition in patients with bilateral vestibulopathy with and without hearing loss. the investigators adjust data for the hearing status of the patients to explore the link between hearing loss, vestibular loss and cognition.


Eligibility criteria:
inclusion criteria for bvp patients were: 1. bilaterally reduced vestibular function, as defined by the bárány criteria for bvp (michael strupp 2017): * horizontal angular vor gain \< 0.6 measured by the vhit, and/or * reduced caloric response (sum of bithermal, 30° and 44°, max. peak slow phase velocity (spv) on each side \< 6°/sec), and/or * reduced horizontal angular vor gain \< 0.1 upon sinusoidal stimulation on a rotatory chair. at our clinic rotatory chair tests are performed using sinusoidal rotation (0.05 hertz) with a peak velocity of 60°/sec (van der stappen a 2000). 2. disease duration of bvp \> 6 months. healthy controls (hc). only subjects with no history of vertigo, scores \<5 on the dizziness handicap inventory (dhi) and normal hearing thresholds at 0.25 - 8 khz, based on age and sex (defined by the bs 6951:1988, en 27029:1991 and iso 7029-1984 standards), were enrolled in the study. for both bvp patients and hc the following additional inclusion criteria were applied: 1) age ≥ 18 years; 2) fluency in dutch; 3) no history of neurological diseases (e.g. dementia, parkinson's disease, cerebrovascular accident, etc.); 4) absence of clinical signs indicating dementia or mild cognitive impairment.