Kornimate/medical-research-clean huggingface dataset:
locally ablative therapy for oligoprogressive lung and thoracic malignancies (obliterate)

Conditions: Non-small Cell Lung Cancer; Oligoprogressive; Small-cell Lung Cancer

Summary: this is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. the primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

this is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. the primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. participants will be assigned stereotactic ablative radiotherapy (sabr) or interventional radiology (ir) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility criteria:
inclusion criteria: 1. must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. cohort a: non-small cell cancer 2. cohort b: small cell cancer 2. provision of signed and dated informed consent form. 3. stated willingness to comply with all study procedures and availability for the duration of the study. 4. age ≥18 years at time of consent. 5. currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy. 6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[clinical benefit: treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\] 7. ≤ 5 progressing or new metastatic lesions. 8. all progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist. exclusion criteria: 1. medical comorbidities precluding locally ablative therapies. 2. history of treatment related toxicities that limit or prohibit application of locally ablative therapies. 3. progressing intracranial lesions.
dilapan-s osmotic dilator in pre-induction of labor

Conditions: Uterine Cervical Incompetence

Summary: non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of dilapan-s in the indication of labor pre-induction in women with/without a history of caesarean section. the evaluation will be based on prospective data collection in at least four obstetrics centers in the czech republic.

nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. dilapan-s is a hygroscopic uterine neck dilator. its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of dilapan-s sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. although dilapan-s is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Eligibility criteria:
inclusion criteria: * single pregnancy * pregnancy more than 36 weeks * vertex presentation of the fetus * cervix score less than 4 points exclusion criteria: * contraindication to vaginal delivery * pathological fetal station * states after uterine body surgery - except for caesarean section * clinical signs of uterine, vaginal or vulvar infection * fetus hypoxia (ktg recording evaluated as pathological prior to pre-induction initiation)

Keywords: cervical ripening
biological variation of cardiac biomarkers in aortic valve stenosis

Conditions: Aortic Valve Stenosis

Summary: calcified aortic valve stenosis (cavs) is a progressive disease and nowadays, the cornerstone in diagnostics and follow-up is echocardiography. cardiac biomarkers (such as cardiac troponins t and i and nt-pro-bnp) hold promise to fulfil a role in early recognition of complications concerning the aortic valve and decompensation. for this purpose, it is important to assess the normal biological variation (bv) of cardiac biomarkers in cavs. the assessment of biological variation will contribute to a better understanding of fluctuation of cardiac biomarkers in subjects with stable cavs. these data will improve monitoring of cavs using cardiac biomarkers.


Eligibility criteria:
inclusion criteria: * clinically stable moderate aortic valve stenosis * no evidence of acute cardiovascular disease exclusion criteria: * acute myocardial infarction in the last six months * pulmonary embolism in the last six months * hospitalisation for heart failure in the last six months * chronic kidney disease

Keywords: cardiac biomarkers
topical agents containing magnesium sulfate & wound healing in the rat model

Conditions: Wound Heal

Summary: an experimental study examining wound healing in 5 different groups on 30 rats.

magnesium topically increases collagen synthesis and angiogenesis, providing faster and higher quality wound healing. in addition, with its analgesic effect, it will also eliminate the pain sensation caused by the wound and increase the quality of life of the patient whose skin integrity is impaired.

Eligibility criteria:
inclusion criteria: * healthy rats between ages of 8- 12 weeks exclusion criteria: * weight loss of more than 15% of body weight

Keywords: magnesium sulphate wound healing rat model hydroxyproline
the effect of education provided to family members caring for colorectal cancer patients on caregiving reactions and healthy lifestyle behaviors: a prospective quasi-experimental study.

Conditions: Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients

Summary: the effect of education provided to family members caring for colorectal cancer patients on caregiving reactions and healthy lifestyle behaviors: a prospective quasi-experimental study

the study was conducted as a pre-test-post-test, control group and quasi-experimental intervention research design in order to evaluate the effects of education applied to family members who provide care for patients with colorectal cancer on their healthy lifestyle behaviors and reactions towards caregiving. the study population consisted of 100 caregiver who provide primary care to patients with colorectal cancer. the study data were collected using the "socio-demographic characteristics data collection form", "healthy lifestyle behaviors scale ii (hplp-ii)" and the "caregiver reaction assessment (cra)". the pre-test was applied to the experimental and control groups at the first interview. the preferred interview format was a booklet. three times face to-face individual educational sessions were provided to the experimental group, accompanied by a education booklet. after the third educational session the post-test was applied to the caregivers in the experimental and control groups.

Eligibility criteria:
inclusion criteria: * caregivers who committed to providing care to their patients diagnosed with stage ii/iii crc and agreed to participate in the study, and who were suitable to respond to the forms in terms of cognitive and mental health were included in the study. exclusion criteria: * caregivers whose patients had previously received chemotherapy for crc or had colostomy in their patients and who had previously been education on the subject were excluded from the study

Keywords: caregiver caregiving reactions colorectal cancer family member educational program
national health and nutrition examination survey 24-hour urine collection feasibility study, 2013

Conditions: Hypertension

Summary: a 24-hour urine pilot study was conducted as part of the 2013 nhanes to test the feasibility of implementing a 24-hour urine collection as part of nhanes in 2014.

the 24-hour urine pilot study was conducted march - june 2013 in three nhanes locations. a random half-sample of non-pregnant us adults, aged 20-69 who were examined in the nhanes mobile examination center were selected. participants received instructions, started and ended the urine collection in a urine study mobile examination center (umec), and answered questions about collection. a random half of participants who collected a complete 24-h urine were asked to collect a second 24-h urine. urinary sodium, potassium, chloride, and creatinine excretion were analyzed. participation rates in two other post-examination components, the physical activity monitor and the dietary recall, were monitored to determine whether collecting a 24-hour urine had an effect on response rates for the two components.

Eligibility criteria:
inclusion criteria: * 20-69 year old adults examined in the nhanes mobile examination center exclusion criteria: * pregnant, unable to respond for themselves
effect of supplementary dietary protein (21g per day) on lean mass and strength in sedentary, adult vegetarians

Conditions: Muscle Weakness

Summary: it is possible that the lower protein intake in vegetarians and vegans may relate to a decrease in grip strength. furthermore, there is limited research examining the effects of plant-based protein intake on strength and lbm independent of an exercise training component. the present study was designed to examine relationships between strength, protein intake, and lbm in underactive vegetarian and vegan adults, as well as the impact of protein supplementation (18 g mung bean protein daily) on these indices.

the american dietetic association states that based off of evidence, it is possible for a vegetarian to obtain the recommended amount of nutrients with a properly planned diet. by mixing various sources of plant proteins throughout the day, a person can obtain all the amino acids needed for growth and tissue maintenance and repair. yet, many vegetarians struggle to eat a substantial diet, especially when it comes to protein. this is because plant protein has protein bioavailability that is 10-30% lower than animal protein. as a result, current research suggests that there needs to be a separate protein dietary reference intake (dri) for vegetarians and it needs to be larger than the protein dri for omnivores. whenever considering protein bioavailability, the quality must be assessed by analyzing the digestibility, chemical integrity, and freedom from interference in metabolism of the amino acid. this is a major concern because inadequate protein intake can affect bone health and alter muscle mass. importantly, research has shown as a result of inadequate protein intake, vegetarians tend to have less lean body mass and less muscle strength than omnivores. currently, all research available on this topic included strength training as a variable for increasing lean muscle mass, and no research has been reported that analyzed the impact of increased dietary protein on lean body mass without a training component. this parallel arm study will examine the effect of supplemental plant protein on strength and lean body mass in adult, non-athletic vegetarians in the phoenix area.

Eligibility criteria:
inclusion criteria: * vegetarian or vegan for at least one year * healthy by self-report exclusion criteria: * supplement use such as protein powder or creatine * previous diagnosis of heart disease, cancer, stroke, diabetes, autoimmune disorders, or thyroid condition * competition in any athletic event in the past year * moderate to strenuous exercise exceeding 150 minutes per week * pregnant or planning to become pregnant.

Keywords: vegetarian vegan plant-based protein strength
randomized study with midazolam for sedation in flexible bronchoscopy

Conditions: Sedation; Tolerance; Anxiety; Satisfaction

Summary: the flexible bronchoscopy (fb) is a diagnostic and therapeutic procedure which is not usually tolerated by the patient. this makes the examination more difficult and a repetition of the examination, if necessary, resulting in a lower diagnostic performance. furthermore, there is nowadays little information with a highly obvious level about the relationship between sedation and the patient´s satisfaction with the fb. midazolam is one of the most commonly used sedatives at the beginning for its rapid onset property and brief duration of action with sedatives, anxiolytics and amnesia properties. the principal aim of our study is to analyse if the use of a local anaesthetic with midazolam whilst performing an fb improves the quality of examination in terms of tolerance for the patient. it would also be of interest to know if there is an improvement in the acceptance of a second or further fb and if this improves the satisfaction of the bronchoscopist as far as the examination performed is concerned.

patients and methods: a randomized, prospective study has been carried out; double blind and controlled with placebo to be treated with midazolam. this included 152 patients, randomized into two groups: group a - 79(51.9%) patients which received midazolam before the fb, and group b - (49.1%) patients which received placebo. the patients were given a questionaire of 13 questions about different aspects of perception of the procedure after the respiratory endoscopy and another was given to the bronchoscopist. results: both groups started off with a similar assessment of fear and nervousness before the fb. nevertheless, group a gave a much higher score than group b referring to variables related to symptoms and feeling. the patients´ cooperation was assessed by the bronchoscopist in a similar way in both groups, although the length of the procedure and difficulty was higher in the group treated with placebo (group b).

Eligibility criteria:
inclusion criteria: * patients referred for diagnostic flexible bronchoscopy * american society of anaesthesiology (asa) class of risk i to iii exclusion criteria: * patients undergoing flexible bronchoscopy procedures such advanced techniques (autofluorescence, nbi, endobronchial ultrasound (ebus)...) * psychological disorders * hypersensitivity to benzodiazepine * severe chronic obstructive pulmonary disease (fev1 \< 50% predicted value, requirement for oxygen therapy * unstable haemodynamic status (defined as a heart rate \ 120 and/or a systolic blood pressure \ 180 mmhg) * sings of systemic or pulmonary infection

Keywords: sedation midazolam flexible bronchoscopy tolerance
hispanics with metabolic syndrome and non-ischemic heart failure

Conditions: Metabolic Syndrome; Heart Failure

Summary: the investigators aim to examine how medical conditions that indicate high cardiometabolic risk, such as increased body weight, high cholesterol levels and high blood pressure, affect heart structure and function among individuals with known hf. furthermore, this study is being undertaken to identify potential differences in these effects between non-hispanics whites and mexican americans.

while it is known that mexican americans are inordinately affected by metabolic syndrome (mets), it is unclear how metabolic risk factors impact left ventricular structure and function in mexican americans with hf. there is also a gap in the knowledge of the principal etiology of hf in this ethnic group. the overall objective of this pilot study is to define the association between mets and and non-ischemic hf in mexican americans. our central hypothesis is that there is a positive graded association between an increasing number of metabolic risk factors (ie. individual components of mets) and increasingly compromised lv structure and function in this population, independent of blood pressure and cad. additionally, we hypothesize that this association is more pronounced than that seen in non-hispanic whites suggesting a predominant role of mets on hf among mexican americans. the rationale that underlies the proposed research is that, once the association between metabolic risk factors and hf in this ethnic group is defined, future research on the impact of management of these metabolic risk factors on hf outcomes, both among mexican americans and in the larger population, will be advanced.

Eligibility criteria:
inclusion criteria: 1. age 18-59 years 2. known diagnosis of hf 3. complete 2-dimensional and doppler echocardiogram within the last 12 months. exclusion criteria: 1. history of cad determined by recorded or self-reported history of cad and/or revascularization 2. recent history (previous 6 months) of decompensated hf 3. heart transplant 4. diagnosis of diabetes (rationale: diabetes independently predicts hf) 5. race/ethnicity other than mexican american or non-hispanic white.

Keywords: metabolic syndrome heart failure mexican americans ethnic differences echocardiography
comprehensive segmental revision system

Conditions: Degenerative Disease; Oncology; Revision Surgery; Trauma; Rheumatoid Arthritis

Summary: clinical data evaluation to document the performance and clinical outcomes of the comprehensive segmental revision system.

the purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the comprehensive segmental revision system. the data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of zimmer biomets post market surveillance. the comprehensive segmental revision system consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler). patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. specifically, the quickdash will be used for all cases enrolled in the study. in addition, the constant and murley score may be used for shoulder applications, the liverpool elbow score may be used for elbow applications and the msts score may be used for tumor cases. the study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. the study will last for at least ten (10) years from the time of surgery.

Eligibility criteria:
inclusion criteria: * non inflammatory degenerative joint disease, including osteoarthritis, and avascular necrosis * rheumatoid arthritis * revision where other devices or treatments have failed * correction of functional deformity * oncology applications including bone loss due to tumour resection exclusion criteria: * sepsis ( active) * infection ( active) * osteomyelitis (active)

Keywords: non inflammatory degenerative joint disease rheumatoid arthritis revision where other devices have failed correction of functional deformity oncology applications treatment of acute or chronic fractures
safety study of mt-4666 in subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the objective of this study is to evaluate the safety and efficacy of 2 fixed dose of mt-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (acheis), in patients with mild to moderate alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * probable alzheimer's disease consistent with the national institute on aging and the alzheimer's association criteria for diagnosis of alzheimer's disease (mckhann et al. 2011). * mmse score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline. * modified hachinski ischemic score (mhis) ≤ 4 at the screening * appropriate caregiver available * subject living at home or in facilities who do not require continuous (24-hour) nursing care. exclusion criteria: * diagnosis of any other disease which may cause dementia * diagnosis of major depressive disorder as defined by diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) within last five years * history of or current diagnosis of any psychosis * history of myocardial infarction or unstable angina within six months before screening * history of cerebrovascular disorder within 18 months before screening * complication of hepatic disorder or renal dysfunction

Keywords: mt-4666 α7 nicotinic acetylcholine receptor agonist alzheimer's disease cognitive function dementia central nervous system agents
a feasibility randomised controlled trial of an online exercise programme for adults with cerebral palsy

Conditions: Cerebral Palsy; Exercise; Adults; Fitness

Summary: adults with cerebral palsy (cp) often face challenges in accessing exercise programmes that are appropriate for their needs. barriers such as limited mobility, a lack of tailored options, and restricted access to physiotherapy services can make participation difficult. exercise is important for improving physical health, mental well-being, and overall quality of life. however, many adults with cp do not have regular opportunities to take part in structured physical activity. this study aims to investigate whether an online exercise programme can serve as an effective and accessible alternative. the main aim of the study is to assess the feasibility of delivering an online exercise programme for adults with cp. key areas of focus will include demand, implementation, practicality, adaptability, acceptability, and potential benefits to physical, mental, and social well-being. a total of 60 adults with cp will be recruited and randomly assigned to one of two groups (30 participants per group). one group will complete an 8-week online exercise and education programme. the second group will receive the same educational materials during the study and will be provided with information about the home exercise programme after the 8-week intervention period. data will be collected on attendance, completion rates, engagement with exercises, and any reported adverse events. health-related surveys will be completed before and after the programme to assess any changes. in addition, a selected group of participants from the intervention group will take part in interviews to provide feedback on their experiences. findings from this study may support the development of accessible, effective, and person-centred online exercise programmes for adults with cp. results may help improve future programme design and contribute to better care and support for adults with cp in ireland.


Eligibility criteria:
inclusion criteria: * adults aged 18 and over with cerebral palsy (cp) residing on the island of ireland. * individuals of any gross motor function classification system (gmfcs) level. * individuals with other associated impairments. * people with mild-to-moderate intellectual disability who can access the online platform and follow study instructions, with or without support. exclusion criteria: * individuals with severe intellectual disability where sufficient adaptations cannot be made. * adults with unstable medical conditions.

Keywords: adults with cerebral palsy online exercise programme physiotherapy