Kornimate/medical-research-clean huggingface dataset:
glutamine plus l. reuteri prevents tki therapy-diarrhea in patients with nsclc

Conditions: Non-Small Cell Lung Cancer With EGFR Mutation

Summary: this open-label randomized clinical trial aims to evaluate the glutamine plus lactobacillus reuteri supplementation effect in a standard-of-care diet in egfr mutant patients with advanced non-small cell lung cancer (nsclc) under tyrosine kinase inhibitors (tkis) therapy. the main question it aims to answer is ¿what is the effect of glutamine plus l. reuteri added to an astringent diet in preventing diarrhea generated by tki therapy? patients will receive an astringent diet supplemented with 10 grams of glutamine and l. reuteri (100 million cfu). researchers will compare the glutamine plus l. reuteri diet with a standard astringent diet to see if tki therapy diarrhea is prevented.

patients in the experimental group will receive two sachets of glutapak-r every twelve hours for up to six weeks alongside treating physician-chosen egfr therapy. patients in the control group will receive a standard-of-care diet. all patients will receive nutritional counseling every two weeks.

Eligibility criteria:
inclusion criteria: * both sexes * ≥ 18 years old * pathologically confirmed diagnosis of nsclc * stage iiib - iv by the american joint committee of cancer version 8. * candidates to receive egfr-tki treatment (1st \& 2nd generation tki) * ecog score ≤ 2 * life expectancy \> eight weeks * signed written informed consent exclusion criteria: * patients who cannot attend the first protocol appointment. * treatment with other anti-cancer therapy * participating in other clinical trials in the former four weeks * any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results. * active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel. * active hiv infection. * breastfeeding.

Keywords: non-small cell lung cancer egfr mutation glutamine lactobacillus reuteri standard-care diet
double-bed spect/ct for bone scintigraphy in initial staging of cancer patients

Conditions: Bone Metastases

Summary: bone scintigraphy is currently a reference test in the initial staging of cancer. bone scintigraphy historically consists in a planar whole-body scintigraphy (wbs). spect/ct has been shown to dramatically reduce the proportion of inconclusive results and increase the specificity of bone scintigraphy. therefore, in most of nuclear médicine centers, the usual protocol for staging of bone metastases consists in a whole-body planar acquisition followed, if needed, by a targeted spect/ct to characterize suspicious or equivocal uptakes seen on wbs. the aim of this study is to assess the incremental diagnostic utility of a systematic double-bed spect/ct acquisition for bone scintigraphy in initial staging of cancer patients compared with the conventional "wbs plus single-bed targeted spect/ct" strategy.

images are interpreted by two nuclear medicine physicians in a 3-step procedure and by consensus. firstly,only wbs planar images are considered. secondly, a single-bed spect/ct chosen based on planar images is used if wbs demonstrated any equivocal or suspicious uptake. finally, wbs and double-bed spect/ct images are used for interpretation. a per-lesion, a per-anatomical region and a per-patient analysis is performed. at each step, lesions, regions and diagnostic conclusions are classified using a 3-level scale, as negative for malignancy, equivocal or suspicious for metastasis

Eligibility criteria:
inclusion criteria: * patients referred for bone scintigraphy for initial staging of biopsy proven malignancy. exclusion criteria: * monoclonal gammapathy * patients under 18 years of age * technical issues not allowing a double-bed spect/ct acquisition * double bed spect/ct acquisition not centered from the upper cervical spine to the proximal femora
family spirit strengths

Conditions: Depressive Symptoms; Anxiety Disorders and Symptoms; Substance Use; Mental Health Issue

Summary: this project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in american indian and alaska native communities. access to culturally competent and effective behavioral health services is limited in many of these communities. the investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, family spirit strengths (fss) that can be embedded within home visiting services. the fss program is a skills-based program that incorporates elements of evidence-based practice, the common elements treatment approach (ceta), and materials informed and developed based on an indigenous advisory group. the fss program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. the investigators will use a randomized controlled trial, whereby half of the participants will receive fss and the other half will receive an evidence-based nutrition education program. the investigators' study is grounded in participatory processes and led by a team of indigenous and allied researchers.


Eligibility criteria:
inclusion criteria: * self-identify as female; and * pregnant or be a primary caregiver of a child that is 24 months or younger; and * 14 years or older at time of enrollment; and * report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and * have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and * be part of the service population of one of the participating sites. exclusion criteria: * profound disability that limits the ability to participate in assessments or interventions; and * unlikely to be residing in or near the research service area for the next 6 months.
concurrent chemoradiotherapy followed by pd-1 inhibitor in advanced cervical cancer

Conditions: Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy

Summary: to explore the safety and efficacy of albumin-bound paclitaxel/platinum based concurrent chemoradiotherapy followed by pd-1 inhibitor (sintilimab) in locally advanced cervical cancer

patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly albumin-bound paclitaxel and cisplatin), followed by sintilimab 200mg q3w for 8 cycles.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75; 2. untreated patients with pathologically proven locally advanced cervical cancer; 3. eastern cooperative oncology group (ecog) performance status of 0-1 4. adequate hematological, renal and hepatic functions: 4.1 hemoglobin \> 8.0 g/dl 4.2 neutrophils \> 2000 cells/μl; leukocytes \> 4 × 109/l 4.3 platelets \> 100 × 109/lg. 4.4 serum urea nitrogen (bun) ≤ 1.5 × upper normal limit (unl) 4.5 serum creatinine (cr) ≤ 1.5 × upper normal limit (unl) 4.6 serum alt/ast ≤ 2.5× unl 4.7 serum total bilirubin ≤ 1.5× unl 5. life expectancy \> 6 months 6. eligible for concurrent chemoradiotherapy assessed by principle investigator; 7. no obvious active bleeding; 8. written informed consent must be available before study registration. exclusion criteria: 1. recurrent or distant metastatic disease; 2. prior malignancies (other than curable non-melanoma skin cancer) within 5 years; 3. active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; 4. patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; 5. vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; 6. previous organ transplantation or hiv patients; 7. allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; 8. active acute or chronic viral hepatitis b or c. hepatitis b virus (hbv) dna\> 2000iu/ml or 104 copies/ml; hepatitis c virus (hcv) rna\> 103 copies/ml.
building resilience against violence (brave)

Conditions: Post Traumatic Stress Disorder

Summary: the study has both quantitative and qualitative components. the objective of the quantitative study is: to evaluate the effectiveness of learning through play (ltp) plus culturally adapted trauma focused cognitive behavior therapy (tf-cbt) for post-traumatic stress symptoms in parents. the objective of the qualitative study is: to find out facilitators and barriers from the perspective of the participants and other stakeholders (e.g., clinicians, gps, people delivering the ltp plus tf cbt intervention etc)

despite the high prevalence of post-traumatic stress disorder in pakistan, research on psychosocial intervention is limited. we propose to investigate the acceptability, feasibility and effectiveness of manual assisted learning through play (ltp) plus culturally adapted trauma focused cognitive behavior therapy (tf-cbt) among parents experiencing post traumatic stress disorder (ptsd). ltp plus is proposed as a low cost intervention to improve parents' mental and physical health, and promote healthy child development. the ltp research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. this will be integrated with trauma focused cbt. purpose of this rct is to determine the effectiveness of ltp plus tf- cbt intervention. the study will be conducted in two cities of pakistan, karachi and peshawar.participants will be screened using impact of event scale-revised (ies-r) and eligibility checklist. those scoring 24 or above will be eligible for more in depth assessment. assessments will be done at baseline and after completion of intervention. outcome assessments will be done by independent research assistants blind to group allocations.

Eligibility criteria:
inclusion criteria: participants will be included in the study if they are: parents over the age of 16 years who are living with their children age 3-6 years. they meet the criteria for post-traumatic stress disorder (ptsd) and are able to give informed consent exclusion criteria: participants will be excluded from the study if they have: any diagnosed physical or learning disability which prevents them from attending the ltp+ group intervention, or suffering from psychosis or those who are actively suicidal. this will be assessed by the research team at screening stage. any disabilities or diagnosed mental illness. any parent who is on current use of anti-depressant medication. and a prior self-reported mental illness, including depression.

Keywords: parents young children trauma focused cognitive behavior therapy learning through play
effect of 7 days of grape seed extract supplementation on cold pressor test and muscle metaboreflex in individuals with elevated and stage 1 hypertension

Conditions: Prehypertension

Summary: this study aimed to assess the effect of the supplementation with grape seed extract (gse) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.

muscle metatoreflex (mmr) has been known to play an important role in adjusting hemodynamic responses during exercise. the reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. on the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive mmr in pathological conditions such as hypertension, diabetes, and congestive heart failure. excessive blood pressure (bp) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. previously, a study found that dietary supplementation with grape seed extract (gse) reduced bp response to dynamic exercise in individuals with elevated and stage 1 hypertension (es1h) and associated with peripheral vasodilation. however, mechanisms underlying this phenomenon are not clear. purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with gse can decrease bp responses to exercise and this observation is associated with reduced mmr. methods: 12 es1h males were studied. changes in cardiac output (q), mean arterial pressure (map) and total peripheral resistance (tpr) were compared between the gse and placebo supplementations during static handgrip exercise (she) and post exercise muscular ischemia (pemi). participants completed 3 min of she at 40% of mvc followed by 2 min of pemi.

Eligibility criteria:
inclusion criteria: * systolic blood pressure: 120-139 mmhg and/or a diastolic blood pressure: 80-89 mmhg exclusion criteria: * taking medications that could affect cardiovascular function or bp
rct for latina mental health using web-based apps

Conditions: Mental Health; Anxiety; Depression; Well-Being, Psychological

Summary: this study compares a choice-driven, interactive, evidence-informed storytelling web-based app intervention with links to resources and treatment (tx) recommendations (made by a character via her blog) and tx locator, to a web-based app with links to publicly available informational internet videos, mh resources, and a treatment locator for at least moderately anxious/depressed untreated english and spanish speaking latinas to determine if a story-based, character-driven approach is more effective for catalyzing mental health treatment initiation.


Eligibility criteria:
inclusion criteria: * latina (women who are from or have family ties to latin america) * currently resides in la or orange county * age 18 and older * able to speak, read, and write in english or spanish * score 10 or higher on gad-7 and/or phq-8 * access to the internet via smartphone, tablet, or computer * not currently receiving mental health therapy or pharmacotherapy * has not accessed mental health services during the previous 6 months exclusion criteria: * not latina or hispanic * under age 18

Keywords: latina women therapy
neo rehab for infants at risk of cerebral palsy

Conditions: Prematurity; Cerebral Palsy

Summary: premature infants are at increased risk of developing cerebral palsy (cp). early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. all infants demonstrate general movements (gms), which are reliable indicators of brain function and can be reproducibly evaluated using the general movement assessment (gma) tool. prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants. this pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal gma.

the study objective are 3-fold: 1. to determine the proportion of infants (\<32 weeks gestation and/or \<1500g) who have abnormal gms findings using the gma tool. 2. to determine the feasibility of nicu based rehabilitation program in 20 infants determined to be at high risk for cp using the gma tool. the intervention bundle will consist of a maternal-driven gestational age (ga)-appropriate intervention bundle that will include evidence-based interventions including vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage. patients will be compared to contemporary and ga-matched controls receiving standard of care with a 1:2 assignment. 3. to evaluate the short-term impact of a maternal-driven intervention bundle on the mother-infant dyad. maternal stress will be measured using the parental stress scale for nicu patients (pss: nicu) prior to the intervention and prior to the infant's nicu discharge. further, stress will be assessed by measuring maternal and infant salivary cortisol pre-and post-kangaroo care on 3 separate occasions (post enrollment in the study, mid-hospital stay, and prior to discharge). measures of maternal anxiety and depression will be evaluated prior to the intervention and prior to nicu discharge using the patient reported outcomes measurement information system (promis) instrument. the investigators hypothesize that the intervention will lead to positive and measurable outcomes for the mother-infant dyad.

Eligibility criteria:
inclusion criteria: * infant gestational age \<32 weeks and/or birth weight \<1500g exclusion criteria: * any clinical condition / diagnosis that would restrict the ability of the mother to do kangaroo care per the current uva kangaroo care guideline * non-english-speaking mother * mother is a prisoner * confirmed inability to return for follow-up appointment

Keywords: general movement assessment
dalpiciclib isethionate tablets combined with abiraterone acetate tablets (i) and prednisone tablets (aa-p) versus placebo combined with aa-p in treatment of high-volume, metastatic, hormone-sensitive prostate cancer (mhspc)

Conditions: High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Summary: this study was to evaluate the safety and efficacy of dalcilide tablets in combination with aa-p in the treatment of subjects with high tumor burden mhspc and to determine the second stage starting dose and progression-free survival（rpfs） based on bicr assessment


Eligibility criteria:
inclusion criteria: 1. age of ≥ 18 years old,male 2. ecog ps score of 0 or 1； 3. prostate adenocarcinoma confirmed by histological。 4. adt no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or psa progression 5. receiving or maintaining androgen deprivation therapy (adt) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (lhrha) (drug castration) or prior bilateral orchiectomy (surgical castration) 6. voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent exclusion criteria: 1. previous adt, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer 2. previous use of cdk4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as tak-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy 3. confirmed by imaging, there are brain tumor foci 4. history of severe lung disease such as interstitial pneumonia 5. plan to receive any other antitumor therapy during this trial 6. inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption
effects of a walking program on functional status of post-surgical lumbar spinal stenosis patients

Conditions: Lumbar Spinal Stenosis

Summary: overall objective: to evaluate the efficacy of an interventional walking program on the quality of life and functional status of patients with lumbar spinal stenosis, post-surgery, using subjective (vas, odi, rmdq, sf-36), and objective measures (triaxial accelerometry, step count, weight). design and methods: two groups of subjects will be examined; patients diagnosed with lumbar spinal stenosis (lss) that progress to surgical management, with one group of subjects staring on the walking program at 2 months postop, and the other group starting on the walking program at 3 months postop. subjects who agree to participate will be assessed (assessments listed below) after the diagnosis preoperatively and 2 months postoperatively. one half of the group will start the walking program at the 2 months postop visit and be assessed again at the end of the walking program, the other half will be assessed again at 3 months postop and start the walking program at that time and be assessed again at 4 months postop. all subjects will be contacted by phone during their walking program to allow for questions from the subjects and to offer support and encouragement. subjects will be given instructions and a daily diary to track steps taken each day (appendix a). subjects will be recruited from the referrals to the practices of the orthopedic and neurosurgery spine surgeons at the health sciences centre in winnipeg. this encompasses the majority of new and currently managed cases in the manitoba and northwestern ontario. subjects will be between the ages of 18 and 90. male and female subjects will be recruited into the study. all lss patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis. exclusion criteria will be any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program. subjects participating will be required to speak english.


Eligibility criteria:
inclusion criteria: * subjects will be between the ages of 18 and 90. * male and female subjects will be recruited into the study. * all lss patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis. exclusion criteria: * any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program. * subjects participating will be required to speak english.