Kornimate/medical-research-clean huggingface dataset:
plant protein blend and milk protein supplements in older individuals

Conditions: Sarcopenia; Skeletal Muscle Atrophy; Protein Malnutrition

Summary: background protein intake is important for skeletal muscle mass maintenance with aging and the ingestion of specifically-timed protein supplements could increase overall protein intake and thereby contribute to skeletal muscle mass maintenance. recently, more attention has been given to the ingestion of plant-based protein blends as a more sustainable high-quality alternative to milk protein, as a means to increase muscle protein build-up and, as such, support muscle maintenance, especially when consuming suboptimal amounts of protein in the regular diet. objective to assess the benefit of daily protein supplementation with either a plant-based protein blend or a milk protein on top of a standard diet to stimulate integrated muscle protein synthesis rates in healthy older individuals with and without exercise. hypotheses it is hypothesized that both the plant protein blend and the milk protein supplement will result in greater muscle protein build-up when compared with a standard diet control condition. it is also hypothesized that exercise will result in greater muscle protein build-up when compared to the resting leg in all conditions, with similar effects of the protein supplements vs the control diet as in the non-exercised leg. this study will show the potential benefit of protein supplementation with alternative protein sources to support skeletal muscle maintenance in older individuals.


Eligibility criteria:
inclusion criteria: * male or female sex * aged between 60 and 80 y inclusive * bmi between 18.5 and 30 kg/m2 exclusion criteria: * following a self-reported vegetarian and vegan diet the 6 months prior to the study. * intolerant to milk products * corn allergy * pea allergy * participating currently or in the 3 months prior to the study in a structured (progressive) exercise program. * smoking regularly (i.e. \>5 cigarettes/week) * history of cardiovascular, respiratory, gastrointestinal, urogenital, neurological, psychiatric, dermatologic, musculoskeletal, metabolic, endocrine, haematological, immunologic disorders, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol, interfere with the execution of the experiment, or potential influence the study outcomes (to be decided by the principal investigator and responsible physician) * diagnosed with phenylketonuria (pku) * uncontrolled hypertension (blood pressure above 160/100 mmhg) * donated blood 3 months prior to test day * use of any medications that interferes with study participation and/or outcomes (i.e. corticosteroids, non-steroidal anti-inflammatories, gastric acid suppressing medication) as assessed by the responsible medical doctor. * use of doac, vitamin-k-antagonist, or multiple anticoagulants * pregnancy

Keywords: muscle protein synthesis
group vs. traditional diabetes prenatal care

Conditions: Pregnancy; Diabetes

Summary: this study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. the group care model will be compared to a control group, a traditional, individual care model.


Eligibility criteria:
inclusion criteria: * clinically confirmed viable pregnancy at the time of enrollment. * able to provide consent for participation. * diabetes diagnosed prior to 12 weeks gestation. * initiation of care by 20 weeks gestation. * age 18 years or older. exclusion criteria: * not planning to deliver at unitypoint health- meriter hospital.
study of npc-08 is to treat for newly-diagnosed malignant glioma and recurrent glioblastoma multiforme

Conditions: Malignant Glioma

Summary: the purpose of this study is to evaluate whether npc-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 and 65 years; * radiographic evidence on cranial mri of a single contrast-enhancing unilateral supratentorial cerebral tumor; * karnofsky performance score of 60 or higher; * willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery; exclusion criteria: * more than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial mri scan; * prior radiotherapy to the brain; * prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents; * known hypersensitivity to nitrosoureas; * participation in any other investigational protocol in the previous 6 months for any type of malignancy;

Keywords: npc-08 carmustine nitrosourea safety
isolation of volatile organic compounds (vocs) related to the olfactory signature of breast cancer.

Conditions: Breast Cancer; Surgery

Summary: to ascertain the possibilities to isolate the breast cancer olfactive signature

patient recruitment during the first surgery consultation in curie institute. odor sampling (non-invasive) with an odor-sensing polymer (sorbstar® polymer developed especially for the trace level analysis), on: * the hands, before and after surgical excision of the tumor (friction of the hands) * the diseased breast, before and after surgical excision of the tumor (via a compress positioned on the breast for 1 night) * the tumor, during the surgical procedure (odor collection over a tumor sample). each patient will be her own witness, before and after surgical excision, in an attempt to isolate the chemical signature tracks of breast cancer. the samples after surgery will be made after healing and before implementation of a treatment (chemotherapy and / or radiotherapy).

Eligibility criteria:
inclusion criteria: 1. patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection 2. of-age female patient (over 18 years old) 3. life expectancy \> to 1 year at the inclusion 4. ecog performance status: 0 or 1 or 2 5. patient benefiting from the social security 6. signature informed consent of the study exclusion criteria: 1. neoplasia in progress or neoplasia history of cancer other than breast to be treated. 2. wound presence on breasts 3. male subjects 4. pregnant or lactating women 5. specified metastatic breast cancer 6. concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics) 7. persons under guardianship or deprived of liberty 8. impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
effectiveness of flipped learning on nurses' knowledge, attitude, and self-efficacy in pressure injury prevention

Conditions: Educational Problems

Summary: the occurrence of pressure injuries mainly comes from disabled patients who are bedridden for a long time. according to a report from the ministry of health and welfare, about one-tenth of chronic patients need to be bedridden for a long time, and pressure injuries account for the most in the comorbidities of bedridden for a long time. the main cause of pressure injury is the natural aging of the patient's body and long-term bed rest so that it is difficult to detect physical stress and cannot change the posture within an effective time to reduce the pressure, which is prone to pressure injury. the prevalence rates of stress injuries in various countries are 13-23% in the netherlands, 10-15% in the united states, and 8-23% in europe. in addition, studies have also shown that the prevalence of stress injuries in the elderly in the uk is 0.31-0.70%. the incidence rate is 0.18-3.36% and these two indicators are increasing year by year; in taiwan, related surveys show that the prevalence rate of pressure injury in hospitalized patients is 7.53%, and the incidence rate of pressure injury in bedridden patients is 36.8%. according to a national pressure ulcer advisory panel (npuap) survey, the prevalence rate of stress injuries in acute wards ranges from 0.1% to 17%, and the incidence rate is 0.4% to 38%. the prevalence of intensive care units the prevalence rate is higher than 41%, the incidence rate is higher than 33%, the prevalence rate of long-term care is 2.3% -28%, the prevalence rate is 2.2%-23.9%, the prevalence rate of nursing homes is 0% -29%, and the prevalence rate is 0%- 17%. in addition, npuap estimates in 1989 show that the average medical cost for each stress injury case ranges from 2,000 to 30,000 us dollars, while the medical cost for each stress injury patient in taiwan is about nt 7,000 to 80,000. if the knowledge of stress injury prevention can be improved, the number of outpatient visits will be reduced, and the occurrence of stress injury will also be reduced. in summary, under the trend of aging development, stress injury management and care are important issues of medical quality.

the purpose of this research is to integrate the past education that affects nursing staff to receive care for stress injuries and to explore the intervention of different education measures, including conventional education methods and digital flipped education methods, to measure nursing staff effectiveness in learning about the knowledge, attitude, self-awareness and self-efficacy of pressure injury management.

Eligibility criteria:
inclusion criteria: 1. full-time or part-time nursing staff registered in the research site and engaged in front-line clinical care or nursing-related administrative services; 2. those who agree to participate in the research and provide informed consent. exclusion criteria: nursing student

Keywords: knowledge attitude self-efficacy
a post marketing surveillance study to assess the safety and efficacy of cetuximab plus radiotherapy in locally advanced squamous cell carcinoma of the head and neck

Conditions: Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck; LA SCCHN

Summary: this prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with locally advanced squamous cell carcinoma of the head and neck (la scchn) treated with cetuximab and radiotherapy (rt) based on the locally approved label.

this is a prospective, non-randomized, observational, single arm, cohort study, wherein 200 patients of unresectable la scchn will be enrolled. the eligibility of the patients will be decided by the investigators based on the locally approved label. the patients will be treated with cetuximab in combination with rt for a duration of 8 weeks and then followed up for 3 years. the objectives of this study are to record safety and efficacy information on the treatment combination in the general population.

Eligibility criteria:
inclusion criteria: * inclusion criteria as per the product label for la scchn approved by india health authority * unresectable locally advanced squamous cell carcinoma of the head and neck * patient willing and able to give written informed consent * patient capable of complying with study data collection procedures exclusion criteria: * exclusion criteria as per the product label for la scchn approved by india health authority

Keywords: la scchn cetuximab rt pms
fentanyl matrix in lung cancer pain

Conditions: Lung Cancer; Pain

Summary: the purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).

this study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed lung cancer, who complain of cancer pain * patients who are taking ultracet, tramadol, or codeine (or codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the numeric rating scale (nrs) during the past 24 hours: ultracet 3 tablets/day, tramadol 150 mg/day, codeine 200 mg /day, or codeine combination less than 3 capsules/day * patients who are able to communicate with the investigator about his/her pain * patients who use proper contraceptives during the study period if they are women of childbearing potential * patients whose life expectancy is 3 months or longer * patients who have signed an informed consent form exclusion criteria: * patients participating in other clinical trials * patients with a history of hypersensitivity to opioid analgesics * patients with a history of drug abuse * patients who are unable to use a transdermal product due to skin disease * patient with a history of co2 retention (e.g. chronic obstructive pulmonary disease) * patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study * patient who are pregnant or are of childbearing potential and not using contraceptives

Keywords: fentanyl matrix
comparing fares method with spaso method for reduction of anterior shoulder dislocation: a prospective randomized trial

Conditions: Shoulder Anterior Dislocation

Summary: shoulder anterior dislocation is a major disease entity in emergency department. there are more than 10 reduction methods that have been reported. traditional reduction methods require sedatives, which could cause adverse effects on the patients such as respiratory suppression and allergy. there are some reduction maneuvers reported recently which do not need sedatives prior to performing reduction, including fares method and spaso method. so far, there are no well-designed study to compare these two methods. besides, in clinical experience, we found that combining these two methods could even get higher successful reduction rate. this study is aimed to compare these two methods as a prospective randomized design, and furthermore, to show that combining these two methods could get higher successful reduction rate.


Eligibility criteria:
inclusion criteria: * shoulder anterior dislocation * conscious clear * communicable exclusion criteria: * unconscious * non-communicable * humeral neck fracture * dislocation time \> 24 hours * neurovascular compromise
clinical performance of the vesto® vascular stent for treatment of iliac peripheral obstructive arterial disease

Conditions: Peripheral Arterial Disease

Summary: this study will validate the efficacy and safety of the vesto® vascular stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial

multicenter study aimed at collecting post-market clinical data on the vesto® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. the objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older; 2. tasc-ii aortoiliac lesion classification of modified class a, b, c, or d; 3. rutherford classification score of 2 to 5; 4. access site compatibility with the device delivery system; 5. compliance with the device's instructions for use (ifu); 6. patient availability for appropriate follow-up times for the duration of the study; 7. patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form. exclusion criteria: 1. known hypersensitivity to heparin, contrast media, or stent components; 2. patient with blood dyscrasia; 3. pregnant or breastfeeding women; 4. patient currently participating in an investigational drug or device study; 5. patient undergoing chemotherapy or radiation therapy; 6. patient with a stent or graft located in the target limb; 7. patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study; 8. patient with a life expectancy of less than 12 months; 9. inability to undergo dual antiplatelet therapy (dapt)
evaluation of oral anticoagulation with vitamin k antagonists - the thrombeval study programme

Conditions: Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use; Atrial Fibrillation; Venous Thromboembolism

Summary: since decades, oral anticoagulation (oac) with vitamin k antagonists (vka) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine. increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an increasing complexity of medical therapy. however, data on quality and management of vka therapy with phenprocoumon in current medical care are limited. our aim was to investigate the quality of oac with vka in current health care and to evaluate the potential for improvements. the investigator-initiated thrombeval study program comprises two cohorts of patients treated with vitamin k antagonists for oral anticoagulation therapy in real-life settings: a multicentre cohort of patients in regular medical care and a multi-local, single centre cohort of patients in a telemedicine-based coagulation service. the study program is expected to enrol a total number of approximately 2,000 to 2,500 patients. both cohorts build on a detailed clinical assessment of participants and anticoagulation therapy at study enrolment. subsequently active and passive follow-up investigations are carried out to document and validate complications of the treatment. primary short-term outcome is the distribution of time in therapeutic range; the primary long-term outcome comprises the composite of stroke, systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.


Eligibility criteria:
inclusion criteria 1. age ≥ 18 years of age at study inclusion 2. written informed consent by patient or legal guardian, if appointed 3. cohort a: pretreatment with oral anticoagulation therapy with vitamin k antagonists (vka) for at least 4 months in regular medical care including patients with self-management of oral anticoagulation therapy 4. cohort b: indication for oral anticoagulation therapy with vka for at least 3 months (both drug-naive and -experienced patients) at enrolment including patients with self-management of oral anticoagulation therapy. exclusion criteria 1. contraindication to vka treatment, e.g. pregnancy or known hypersensitivity 2. participation in other clinical trial

Keywords: oral anticoagulation regular medical care coagulation service vitamin-k antagonists quality of therapy atrial fibrillation venous thromboembolism bypass surgery prosthetic heart valve
a pilot evaluation of a digital peer support intervention for suicidal adolescents

Conditions: Suicide

Summary: suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. to address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in the bronx, ny. in collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. a smartphone ecological momentary assessment app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.

this is a single-arm investigation of a novel suicide prevention intervention, called "supporting wellbeing with everyday experiences of peers" (sweep). in a preliminary phase of the study, suicide recovery narratives: short first-person stories about lived experience with and recovery from bronx adolescents will be collected. the investigator team will then evaluate evaluate the anti-suicidal benefits of this intervention in a single-arm trial. adolescent participants (n=46) will be provided with the sweep intervention, which involves reading or listening to one suicide recovery narrative each day during the 14-day trial. the narratives will be provided, in audio and text formats via a smartphone app. that same smartphone app will also collect real-time (ecological momentary) assessments of suicidal thoughts, the primary outcome of the study, five times per day. this app will also collect secondary and additional outcomes. the investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial.

Eligibility criteria:
inclusion criteria: * past-month history of suicidal thoughts * past-month history of major depressive disorder * possession of apple or android smartphone with data plan exclusion criteria: * inability to read/write in english * active mania * active psychosis * autism spectrum disorder

Keywords: digital intervention community participation ecological momentary assessment