Kornimate/medical-research-clean huggingface dataset:
exercise and nutritional intervention for deconditioned older adults

Conditions: Muscle Weakness

Summary: in this study we will evaluate whether the addition of a formal lower extremity resistance exercise training program and/or a nutritional supplement will improve the functional recovery of older adult veterans participating in a geriatric rehabilitation program for deconditioning. specifically, subjects admitted to a geriatric inpatient rehabilitation program with a diagnosis of deconditioning will be randomly assigned to one of four groups; 1) control/standard rehabilitation program, 2) standard rehabilitation plus resistance exercise twice per week, 3) standard rehabilitation plus a daily nutritional supplement, 4) standard rehabilitation plus the resistance exercise and the nutritional supplement. subjects will participate in each program for 12 weeks. at the beginning and end of the study we will measure lower extremity strength, walking speed, and overall function (using the standardized functional independence measure), and compare the changes in each group.


Eligibility criteria:
inclusion criteria: * veteran admitted to gem rehabilitation unit * primary problem: deconditioning/generalized weakness * age 65-90 * self reported ability to report to the cavhs grecc twice per week after discharge from the gem unit. * living in the community prior to recent acute care hospitalization * decision making capacity to be able to consent to the study as documented in the gem attending or gem apn's admission note exclusion criteria: * conditions that are exclusionary criteria for gem admission including the following: direct transfer from any icu, end-stage chronic medical/surgical disorder with no rehabilitation potential, terminal diagnosis /hospice/respite care, hemodialysis, active radiation therapy. also, type i diabetes mellitus * any other condition considered exclusionary by the pi / study physician. prior to group assignment, subjects will be evaluated for contraindications to exercise training per the american college of sports medicine (acsm)guidelines including the following: * myocardial infarction documented in the past 3 months * unstable angina (at rest in past 3 months, or increased angina pattern in past month) * uncorrected left main coronary obstruction \> 50%; * congestive heart failure exacerbation in past 3 months (symptoms at rest or worsening symptoms requiring change in baseline diuretic dose) * severe valvular heart disease (aortic or mitral stenosis with valve area \ 50 mmhg\], or lv enlargement \[lvesd 40 mm, or lvedd \> 55 mm\]) * active pericarditis / myocarditis * malignant or unstable arrhythmias, third degree av block without pacemaker * elevated resting blood pressure (systolic \> 200 mmhg, diastolic \> 110 mmhg) * known large (\> 4 cm) aortic aneurysm * known cerebral aneurysm or intracranial bleed in past 1 year * terminal cancer * acute retinal hemorrhage or ophthalmologic surgery within 3 months
a study of a probiotic in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the aim of this study was to assess the clinical effect of lactobacillus sakei supplementation in children with atopic dermatitis.

probiotics were also shown to reduce severity of aeds when administered to infants with early onset aeds. in contrast, only a few studies have evaluated the therapeutic effectiveness of probiotics on the groups of older children with established aeds. in these studies, administration of lactobacillus strains to unselected children aged 1 year and over was associated with improvement in the clinical severity of eczema. the purpose of this study was to evaluate the clinical efficacy in aeds of a newly identified probiotic strain, lactobacillus sakei kctc 10755bp, which showed the most potent inhibitory activity against s aureus growth among lactobacillus species in our preliminary experiment. we administered l sakei to an unselected group of children aged 2 to 10 years with moderate and severe aeds and evaluated the clinical outcome at the end of the intervention. in addition, we also measured levels of serum chemokines as activity markers for aeds to provide a more objective evidence for the beneficial role of this probiotic.

Eligibility criteria:
inclusion criteria: * patients with atopic dermatitis present for at least 6 months before inclusion * a total scorad score above 25 * a change in a total scorad score of not more than 10% within 2 weeks exclusion criteria: * patients who had been treated with cyclosporine, systemic steroid, topical calcineurin inhibitor, or chinese herbal medicine during the preceding 3 months

Keywords: atopic dermatitis chemokines probiotics
developing an integrated psychotherapy with cognitive-behavioral therapy and biofeedback therapy for somatic symptom disorder

Conditions: Somatic Symptom Disorder

Summary: this research program is aimed to develop a integrative psychotherapy (including cbt and biofeedback therapy) and to examine its efficacy on treatment of somatic symptom disorder. the study design is a randomized controlled trial with waiting list control. scores of patient health questionniare-15 and health anxiety questionnaire are the primary endpoints.

somatic symptom disorder (ssd) is a psychiatric disorder featured with somatic distress and related psychological phenomena. in the past several years, our research team has investigated several aspects of ssd, including psychopathology, epidemiology, mechanism, and diagnostic biomarkers. but the aspect about treatment on ssd has not been comprehensively explored. in literature, the treatment of ssd can be separated into physical and psychological approaches. the physical approach includes pharmacotherapy and magnetic/electrical neuromodulation. among several types of psychotherapies, cognitive behavioral therapy (cbt) has the most evidence. previous studies have disclosed ssd patients to have following cognitive or behavioral features: selective attention on somatic distress; memory bias on the severe health conditions; all-or-none cognition about health; organic attribution style; catastrophizing cognitive pattern about health; high motivation of concerning issues about health; inadequate reassurance-seeking behavior; the assumption about the connection between rest and somatic distress, etc. biofeedback therapy works by measuring several biological signals related with stress and relaxation (such as heart rate, skin conductance, electromyography, electroencephalography, and finger temperature); feedback of these signals to the subjects can help them more clearly understand the association between their behavior/cognition and relaxation. biofeedback therapy has been extensively applied in the psychosomatic field. this research program is aimed to develop a integrative psychotherapy (including cbt and biofeedback therapy) and to examine its efficacy. the study design is a randomized controlled trial with waiting list control. scores of patient health questionniare-15 (phq-15) and health anxiety questionnaire (haq) are the primary endpoints; the changes of other psychological and biological measurements are viewed as secondary endpoints.

Eligibility criteria:
inclusion criteria: * patient with somatic symptom disorder (confirmed by psychiatrists) exclusion criteria: * the age is younger than 20 or older than 70 years * having psychotic symptoms or cognitive impairment * having a potentially lethal illness * cannot read the questionnaires by oneself

Keywords: somatic symptom disorder cognitive behavioral therapy biofeedback therapy somatic distress health anxiety
the effect of whey protein and dietary fibers on risk markers of the metabolic syndrome and bone health

Conditions: Abdominal Obesity; Metabolic Syndrome; Type 2 Diabetes; Cardiovascular Disease

Summary: the prevalence of overweight and lifestyle related diseases such as cardiovascular disease (cvd) and type 2 diabetes (t2d) is increasing world wide. the metabolic syndrome (mes) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. mes is associated with an increased risk of developing cvd and t2d. dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. whey protein is furthermore seen to show positive effects on bone turnover. the purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of mes and bone turnover in abdominally obese subjects. a total of 80 people with abdominal obesity will be included. the design is a randomized, double blinded, controlled dietary intervention trial. subjects are assigned to one of four experimental groups. each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. the subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability. the primary outcome is postprandial lipaemia (ppl) - an independent risk factor of developing cvd. ppl is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. the authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in ppl.

please refer to summary

Eligibility criteria:
inclusion criteria: * waist circumference ≥ 80 cm (women)/94 cm (men) * age ≥40 years exclusion criteria: * significant cardiovascular, renal or endocrine disease * history of diabetes * ≥ 3 kg of weight gain or loss within the last 3 months * any change in medication within the last month * treatment with steroids * pregnancy, breastfeeding or planned pregnancy * psychiatric history * alcohol or drug addiction * dietary fiber supplement within the last month

Keywords: whey protein dietary fibers wheat bran arabinoxylan postprandial lipaemia body composition blood pressure metabolic rate insulin sensitivity metabolic syndrome
an eighteen month efficacy and safety study in obese patients (0364-020)(completed)

Conditions: Obesity and Obesity-related Medical Conditions

Summary: a study to determine the safety and efficacy of an investigational drug in patients with obesity.


Eligibility criteria:
inclusion criteria: * obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (bmi between 27 kg/m2 and 43kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia and sleep apnea). exclusion criteria: * patients with serious or unstable current or past medical conditions.
evaluation of a blood biomarker to try and distinguish between the presence or absence of aggressive prostate cancer

Conditions: Prostate Cancer

Summary: a laboratory study to evaluate urine and blood biomarkers that can distinguish between the presence or absence of aggressive prostate cancer

the over-arching goal of this study is to evaluate if biomarkers within the blood or urine of men with localized prostate cancer can distinguish between those with indolent cancer, defined as gleason grade groups 1 and 2 and those with more aggressive disease (gleason grade groups 3, 4, and 5).

Eligibility criteria:
inclusion criteria: 1. patient has been diagnosed with prostate cancer and is planning on having a radical prostatectomy performed at the global robotics institute. 2. diagnostic psa ≤ 20 ng/ml. 3. pathology report from most recent positive biopsy, prior to radical prostatectomy, is available. 4. ability to read and understand the informed consent form. 5. patient must have signed informed consent form exclusion criteria: 1. any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or hifu. 2. diagnostic psa \> 20 ng/ml or missing psa. 3. patients who are unable or unwilling to provide informed consent.

Keywords: active surveillance radical prostatectomy
retrospective record-review study in patients who had diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: the purpose of the study is to evaluate the medical cost of illness for dfus on the patients who had used on101 or aquacel® in the on101clct02 trial.


Eligibility criteria:
no additional inclusion or exclusion criteria will be applied.
effectiveness of a combined mhealth-cbt psychological intervention to improve psychological well-being in young patients with t1d

Conditions: Diabetes Mellitus, Type 1

Summary: type 1 diabetes (t1d) can lead to psychological adjustments that impact the acceptance and management of this health condition, as well as the overall quality of life of patients, especially among the young. therefore, there is a need for psychological interventions aimed at enhancing the psychological well-being of children and adolescents with t1d. the goal of this non-randomized controlled trial is to evaluate whether a combined intervention comprising mhealth (using an app) and face-to-face psychological sessions based on barlow's protocol and cognitive-behavioral therapy techniques (cbt) is effective in enhancing psychological well-being in children and adolescents with t1d. the main hypotheses are: * h1: the primary results expected to be obtained are a significant increase in psychological well-being, which means a decreased diabetes distress (dds) (h1a) an increased subjective well-being (panas) (h1b) and a better self-efficacy for managing their emotions (rese) (h1c). * h2: as secondary outcomes, it is also expected that the combined mhealth-cbt intervention would increase the level of positivity (p-scale) (h2a), the self-esteem (rses) (h2b) and the satisfaction with life (swls) (h2c).


Eligibility criteria:
inclusion criteria: * girls and boys with a diagnosis of t1d 6 - 18 * having a smartphone compatible with the app created used for the mhealth intervention and daily access to internet * having the required digital skills to follow the mhealth intervention * not currently participating in another clinical trial involving a psychological intervention exclusion criteria: * girls and boys with a diagnosis of t1d \>18 years * not having a smartphone compatible with the app created used for the mhealth intervention and daily access to internet * currently participating in another clinical trial involving a psychological intervention

Keywords: type 1 diabetes cognitive-behavioral therapy mhealth interventions psychological well-being
smoking cessation in head and neck cancer patients receiving curative radiation therapy

Conditions: Head and Neck Neoplasms

Summary: to propose a feasibility study of introducing a smoking cessation program in head and neck cancer patients with planned radiotherapy. the study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation.

smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute and late complications but also poor clinical tumor response, poor local control, and poor overall survival. however, smoking cessation has not been included into the standard intervention in treating head and neck cancer patients in taiwan. we propose a prospective study of introducing a smoking cessation program in head and neck cancer patients receiving radiotherapy. the study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation. the primary outcome is to test the feasibility of the smoking cessation intervention, and the secondary outcome is to test the efficacy of the intervention during radiotherapy on acute and late rt toxicities, tumor response, patterns of relapse, and overall survival.

Eligibility criteria:
inclusion criteria: * age 18 to 70 years * head and neck malignancy stage i-ivb without distant metastasis * receiving five weeks or more of external beam radiotherapy * report smoking one or more cigarettes in the past 30 days or self-identify as a smoker * kps 70-100 exclusion criteria: * serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorders, as assessed by the study-site physician * a current diagnosis of major depressive episode or a history of psychosis, bipolar disorder, or seizure disorder * pregnancy or lactation

Keywords: radiation therapy,smoking pattern,head and neck cancer
sequencing to identify gene variants in familial colorectal cancer

Conditions: Colorectal Cancer

Summary: the project will use exome sequencing to search for genetic predispositions for familial colorectal cancer (crc). except for certain syndromes there is today no good method for identifying individuals with a hereditary high risk for crc (about 25% of the cases). there is currently no routine screening of the population in norway for crc today. coloscopy, which is the most reliable method, is demanding with respect to resources, it can be painful, and may have complications. this project will attempt to find genetic determinants for identification of individuals with increased risk for familial crc. such methods will reduce unnecessary medical examination of unaffected family members, and will make it easier to focus health services on individuals with increased risk. this will represent a significant contribution towards improved health reduced death rate caused by crc. the project includes research on the ethical aspects, in particular challenges related to how feedback to donors is handled.

participants will be from a specific family, and will be selected by invitation to volunteer.

Eligibility criteria:
inclusion criteria: * member of a specific family with increased risk of crc, including individuals both with and without crc exclusion criteria: * young age

Keywords: gene sequencing familial risk factors
phase 1, open-label, dose escalation study of trc093, in patients with locally advanced or metastatic solid tumors

Conditions: Cancer; Neoplasm Metastasis

Summary: this study is being performed to evaluate the safety and tolerability of the trc093 antibody.

in addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-trc093 antibody formation.

Eligibility criteria:
inclusion criteria: a patient will be eligible for study participation only if all of the following criteria apply: 1. the patient has given informed consent. 2. the patient is willing and able to abide by the protocol. 3. the patient is at least 18 years old. 4. the patient has advanced cancer and is not eligible for treatment or no effective treatment exists. 5. significant toxicities resulting from prior therapy must have recovered. 6. if the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception. 7. if the patient is a female, she has had a negative serum pregnancy test within the past 30 days. 8. the patient has adequate ability to perform activities of daily living. 9. the patient has adequate organ function as assessed by laboratory tests exclusion criteria: a patient will not be eligible for study participation if any of the following criteria apply: 1. the patient weighs more than 264 lbs. 2. the patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study. 3. the patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days. 4. the patient has known brain tumors. 5. the patient experienced blood clots within six months prior to study start. 6. the patient has a non-healing wound, ulcer or bone fracture. 7. the patient received recent thrombolytic or anticoagulant therapy. 8. the patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study. 9. the patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product. 10. the patient is receiving, or plans to receive, an anti-cancer therapy during the study with the exception of patients receiving chronic luteinizing hormone-releasing hormone (lhrh) agonists.

Keywords: phase 1 trc093 denatured collagen solid tumor antibody tracon locally advanced solid tumors metastatic solid tumors
one-step application of artificial dermis

Conditions: Wounds and Injuries

Summary: the goal of this observational study is to study the effectiveness of one-step application of lando® artificial dermal regeneration matrix for burn and plastic wound repair. the main question it aims to answer is: the effectiveness of one-step application of lando® artificial dermal regeneration matrix, including the take rate of skin graft and the appearance recovery of the wound. participants will be treated with artificial dermis that perfomed with stsg simultaneously. according to the routine clinical practice, the take rate of split-thickness skin graft at about 2-3 weeks and the appearance recovery of the wound at 3 months and 6 months after the implantation were measured.


Eligibility criteria:
inclusion criteria: 1. age ≤ 70 years old. 2. patients with non-infectious wounds of deep burns, full-thickness traumatic skin defects or plastic surgery that need to be repaired and reconstructed by artificial dermis. 3. patients who voluntarily participate in this clinical trial and sign the informed consent form. when the subjects are under 18 years old or they have no capacity or limited capacity, they should have the consent and signature of the guardian or legal representative. exclusion criteria: 1. patients who need to participate in other clinical researchers within 30 days before or during the period of joining the group. 2. patients with poor control of diabetes (those with fasting blood glucose ≥ 7.0mmol/l or glycosylated hemoglobin hba1c ≥ 12% after drug control, transaminase \> 1.5 times and other diabetic complications). 3. other cases that researchers believe not suitable for the participants of the trial.