Kornimate/medical-research-clean huggingface dataset:
semaglutide and physical activity for obesity and multimorbidity

Conditions: Obesity Morbid; Multimorbidity; Obesity

Summary: the aim of this observational study is to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity. this study is explorative and therefore does not include hypothesis testing.

this study is part of the project "semaglutide and physical activity for obesity and multimorbidity: co-designing healthy healthcare". while this observational quantitative study aims to provide a comprehensive description of changes in patients' health and wellbeing during and after participation in weight loss treatment, the project also includes a qualitative interview study with a subset of patients from the same population to supplement and expand upon the quantitative findings. additionally, a smaller subgroup of patients from the same population will eventually be invited to actively contribute to the collaborative development of a physical activity intervention in a co-design process, drawing on insights from the aforementioned studies. given its exploratory approach, the study is designed with a flat non-hierarchical outcome structure and multiple evenly valued outcomes measures. this will be reported evenly for all outputs of this research.

Eligibility criteria:
study participants are recruited from a particular interdisciplinary weight loss program based at copenhagen university hospital hvidovre. hence, the study uses the same set of inclusion criteria: inclusion criteria: * fulfilment of the danish criteria for bariatric surgery: * bmi ≥ 35 kg/m2 * aged ≥ 18 years * one or more obesity-related conditions (type ii diabetes, resistant hypertension, sleep apnea, severe osteoarthritis of the lower extremities) * one more comorbidities that prevent bariatric surgery exclusion criteria are: * unwillingness to participate in the study * inability to understand danish * cognitive impairments update 17.09.2024: after initiating patient recruitment for the study on 15.02.2024, the project group identified discrepancies between the eligibility criteria and description of the study population as originally reported in the trial registration and those actually applied in the study. as a result, we adjusted both the eligibility criteria and description of the study population in the trial registration on 17.09.2024. these adjustments do not represent a change in the actual patient population but rather offer a more accurate and consistent description of their characteristics.

Keywords: obesity multimorbidity semaglutide glucagon-like peptide-1 receptor agonist physical activity exercise co-design patient-centred cardiometabolic health health-related quality of life wegovy
feasibility aquatic physical exercise to reduce falls in institutionalized elderly

Conditions: Age Problems; Cognitive Impairment; Elderly; Postural Balance; Strength

Summary: this is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized old people. the secondary objectives are to study the applicability of the intervention in improving balance, function, gait mobility, muscle strength of the lower limbs and the perception of the intervention.

the participants will be randomized and divided into the hydrotherapy group or the control group. each participant will attend a total of 24 physical exercise sessions of 50 minutes of duration. the study outcomes will be measured before the intervention and in 3 posterior phases to evaluate its effects in the short, medium and long terms.

Eligibility criteria:
inclusion criteria: * be institutionalized in a care center * participate voluntarily and sign the informed consent * have a punctuation of 2 or more in the downton fall risk index exclusion criteria: * suffer from a condition that can be affected or hinder exercise * acute disease unresolved in 10 days * not controlled hypertension * contagious skin disorder * urinary or faecal incontinence

Keywords: physical therapy modalities accidental fall elderly hydrotherapy nursing home
evaluation of effectiveness and safety of xience skypoint stents in routine clinical practice

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate the effectiveness and safety of xience skypoint stents in comparison to other drug-eluting stents (des) in real-world practice.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 19 years old 2. patients receiving xience-skypoint™ stents. 3. the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: 1. patients with a mixture of other dess 2. terminal illness with life expectancy \<1 year 3. patients with cardiogenic shock

Keywords: drug eluting stent percutaneous coronary intervention
a double-blind, parallel group, comparative study of coadministration ad-4833 and syr-322

Conditions: Diabetes Mellitus

Summary: to evaluate the efficacy and safety of coadministration ad-4833 and syr-322 in patients with diabetes mellitus.


Eligibility criteria:
inclusion criteria: * those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator. * those who can sign and date a written, informed consent form prior to the initiation of any study procedures. exclusion criteria: * those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc. * others who are assessed to be ineligible for the study by the investigator or subinvestigator.
a study to evaluate the pharmacokinetics and safety of k-808 (pemafibrate) in subjects with primary biliary cholangitis with compensated cirrhosis and without cirrhosis.

Conditions: Primary Biliary Cholangitis; Compensated Cirrhosis

Summary: a trial to investigate the pharmacokinetics (pk) effects and safety profile of k-808 (pemafibrate) in primary biliary cholangitis (pbc) subjects with and without cirrhosis.


Eligibility criteria:
inclusion criteria: * participant has a pbc diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria (lindor et al, 2019; hirschfield et al, 2017): 1. history of alp above uln for at least 6 months 2. history of positive antimitochondrial antibody (ama) titer or positive pbc-specific antinuclear antibody (ana) titers 3. historical liver biopsy consistent with pbc * has pbc with cirrhosis child-pugh grade a (well-compensated disease; score 5 to 6) at screening. group 2 (pbc w/ cirr cp-a) only * male or female participant is ≥18 years of age at consent. * able to understand and comply with study requirements and procedures and provide written informed consent. * meet all other inclusion criteria outlined in the clinical study protocol. exclusion criteria: * female subject of childbearing potential who is known to be pregnant, has a positive pregnancy test (serum test, or urine test that is confirmed by a positive serum pregnancy test), or is lactating and breastfeeding, or planning to become pregnant or breastfeed during the study. * subject has had ongoing conditions that may affect drug absorption such as gastroparesis, intestinal obstruction, severe gastritis, severe gastric reflux syndrome, conditions causing frequent vomiting and/or diarrhea. * subject who has participated in another investigational drug, biologic, or medical device study within five half-lives of the agent (or within 8 weeks when half-life is unknown) prior to the first dose of study drug, or prior participation in an investigational antibody drug study within 6 months prior to the first dose of study drug. participation in noninterventional studies (eg, observational studies, registries) is allowed. * meet any other exclusion criteria outlined in the clinical study protocol.
study of azd9829 in cd123+ hematological malignancies

Conditions: Hematological Malignancies

Summary: this is a modular, multicentre, open-label, phase i/ii, dose-setting study. azd9829 will be administered intravenously as monotherapy or in combination in participants with cd123 positive hematological malignancies.


Eligibility criteria:
inclusion criteria: * ≥18 years of age; * cd123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory; * r/r aml (except apl); * r/r hr-mds with ≥5% bone marrow blast at time of inclusion; * had at least 1 prior line of therapy at currents histology, and have no available treatment options; * ecog performance status of ≤ 2. the above is a summary, other inclusion criteria details may apply. exclusion criteria: * active cns leukemia; * previous treatment with any cd123 targeting therapy; * prior allogeneic hsct, within 90 or cell therapy within 60 of start of therapy; * active gvhd that requires immunosuppressive treatment within 4 weeks prior to start of azd9829; * history of other malignancy(with certain exceptions); * active and uncontrolled infections; * unresolved aes ≥2 grade, from prior therapies. the above is a summary, other exclusion criteria details may apply.

Keywords: azd9829 anti-cancer agents dose escalation
dna sequencing-based monitoring of minimal residual disease to predict clinical relapse in aggressive b-cell non-hodgkin lymphomas

Conditions: B-cell Non-Hodgkin Lymphoma; Aggressive

Summary: the purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive b-cell non-hodgkin lymphoma. the purpose of the study is to see if mrd in blood samples can potentially replace ct scans after completion of chemotherapy in the future.


Eligibility criteria:
inclusion criteria: * 18 years of age at time of signing informed consent * histology-confirmed aggressive b-cell non-hodgkin lymphoma * de novo diffuse large b-cell lymphoma (including all subtypes such as primary mediastinal b-cell lymphoma and t-cell rich b-cell lymphoma). according to the 2008 who classification of hematopoietic and lymphoid tumors. these would include double or triple-hit diffuse large b-cell lymphomas with myc/bcl2 and/or bcl6 gene rearrangements. these cases may be classified as high grade b-cell lymphomas according to the 2017 revision of the who classification of hematopoietic and lymphoid tumors. * recipient of frontline multi-agent chemotherapy (for example, rchop, dose adjusted-repoch, rchop/rice, rchop+investigational agent, etc). eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). a frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation. * required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype. * ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and mrd test specimen collection at specified time points. exclusion criteria: * patients receiving 2nd or greater line of therapy. * stage i or ii disease. * primary mediastinal b-cell lymphoma. * transformation from antecedent or coincident indolent b-cell non-hodgkin lymphoma.

Keywords: dna sequencing 15-180
effects of prehabilitation and early mobilization for patients undergoing pancreas surgery.

Conditions: Pancreas Cancer

Summary: open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. after upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. there is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery. this study's aim is to evaluate the effect of prehabilitation and extra early mobilization. the study includes two substudies: 1. a prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. primary outcome is postoperative complications. 2. a randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. the intervention group will be mobilized to bedside, standing or sitting in armchair \<6 hours after surgery, ie 3-4 hours after arrival at the postoperative department (piva). the control group will be mobilized according to routine i.e. the morning after surgery. primary outcome is pao2.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo pancreatic surgery exclusion criteria in substudy b: * preoperative injury or disease making it impossible to perform the intervention

Keywords: prehabilitation recovery complications
early visual functions in patients at risk of developing cerebral visual impairment. a pilot study

Conditions: Visual Impairment

Summary: the aim of the study is to assess visual function from neonatal age to 36 months of age in infants at risk of visual impairment due to brain lesion or ocular pathology


Eligibility criteria:
inclusion criteria: * age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age * genetic syndroms * hypoxic hischemic encephalopathy * brain malformation * metabolic diseases * ocular pathologies exclusion criteria: * patients at low risk of developing neurological outcomes * refusal of informed consent
clinical and microbiological effects of an essential oils solution used as an adjunct to daily oral hygiene practices in chronic periodontitis patients in supportive care

Conditions: Chronic Periodontitis

Summary: chronic periodontitis is a common infectious disease characterized by progressive attachment loss and alveolar bone resorption eventually resulting in tooth loss. the ultimate goal of periodontal therapy is to prevent this endpoint. at least when a strict supportive care program is implemented following active therapy, subsequent tooth loss is limited to a mean of about 0.1 per patient per year. in contrast, three to six times as many teeth may be lost if the disease is left untreated. the objective of supportive care is to prevent disease recurrence, which is accomplished by strict home care and professional plaque control at regular intervals depending on the patient's needs. evidently, not all patients are optimally compliant in terms of plaque control. therefore, chemical aids could be administered to supplement mechanical plaque removal. essential oils solutions containing menthol, thymol, methyl salicylate and eucalyptol as active agents may be more appropriate to supplement daily home care. clinical studies have shown an additional anti-plaque and anti-gingivitis effect over mechanical plaque control without relevant side effects in healthy subjects and gingivitis patients. recently, significant reductions of periodontopathogens in the subgingival biofilm have been shown in periodontitis patients following subgingival irrigation using an essential oils solution. in addition, mouthrinsing on a daily basis seemed to substantially alter the subgingival microflora towards a less pathogenic one in gingivitis and periodontitis patients. even though these are interesting findings, they should be considered exploratory since they relate to a small number of patients observed for only two weeks. the goal of the present study was to thoroughly document the clinical and microbiological effects of an essential oils solution used on a daily basis for 3 months as an adjunct to mechanical plaque control measures in a large number of chronic periodontitis patients in supportive care.


Eligibility criteria:
inclusion criteria: * presence of at least one 4 mm pocket per quadrant * patient in maintenance care for at least one year exclusion criteria: * presence of 7 mm pockets or more * use of antibiotics within 3 months prior to the study * patients undergoing orthodontic therapy * patients wearing removable partial dentures

Keywords: chronic periodontitis
temporal variation in exhaled volatile organic compounds in esophageal cancer patients

Conditions: Esophageal Cancer

Summary: the purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.

esophageal cancer ("eg cancer") affects over half a millions people worldwide every year. early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. as a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. as a consequence, 7 out of 10 new cases of eg cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. better ways of diagnosing esophageal cancer earlier are therefore needed. an ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective. the investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. in this study that is being conducted in collaboration with researchers in the united kingdom (uk), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. by studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease. the investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. the investigators will also attempt to measure different bacteria

Eligibility criteria:
inclusion criteria: * aged 18-90 years * newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer * planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection exclusion criteria: * pregnant females * without malignant esophageal disease * malignancy at a secondary site other than the esophagus * undergoing palliative treatment for esophageal cancer * not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer * inability or unwillingness to provide written informed consent
efficacy and safety study of ozanimod (rpc1063) in relapsing multiple sclerosis patients

Conditions: Relapsing Multiple Sclerosis

Summary: this study is a two-part trial consisting of part a (presented in this record) and part b (see nct02047734). the primary objective in part a of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (gde) lesions from week 12 to week 24 in patients with relapsing multiple sclerosis (rms).


Eligibility criteria:
inclusion criteria: * multiple sclerosis as diagnosed by the revised 2010 mcdonald criteria * expanded disability status scale (edss) score between 0 and 5.0 at baseline exclusion criteria: * secondary or primary progressive multiple sclerosis
comparison of the frequency of subclinic synovitis in the distal interphalangeal joints of the hand in psoriasis patients

Conditions: Psoriasis; Synovitis

Summary: in this cross-sectional study, it was planned to compare the frequency of subclinical synovitis in the distal interphalangeal joints of the hands in psoriasis patients. 28 patients followed up by the dermatology department with a diagnosis of psoriasis and referred to us and 28 healthy volunteers were included in the study. participants' age, gender, body mass index (bmi), year of psoriasis diagnosis, treatments they received, and comorbid diseases were recorded as demographic information. psoriasis area and severity index (pasi) and nail psoriasis severity index (napsi) were calculated by a dermatologist. tenderness in the distal interphalangeal joints of both hands was evaluated by palpation. subsequently, the presence of ultrasonographic synovitis findings of the participants was examined by a physician who was experienced in musculoskeletal ultrasonography and was blind to clinical evaluations. scoring was done with the eular gs / pd joint scoring system and eular-omeract composite scoring system. the scores of the most affected joint were used in statistical analysis. comparisons were made between psoriasis and control groups in terms of scores. relationships between variables in the psoriasis group were examined.


Eligibility criteria:
inclusion criteria: for patient group 1. being over the age of 18 2. being followed up by the dermatology department with a diagnosis of psoriasis and receiving topical or systemic treatment for this 3. absence of clinically detected signs of arthritis 4. absence of serious trauma, surgical intervention or injection in the joint areas to be evaluated. 5. absence of any known inflammatory rheumatic disease for control group 1.\> 18 years old 2. absence of clinically detected signs of arthritis 3.lack of clinical signs suggestive of psoriasis exclusion criteria: for patient group 1. to be \<18 years old 2. clinically detected evidence of arthritis 3. history of serious trauma, surgical intervention or injection in the joint areas to be evaluated 4. having a known inflammatory rheumatic disease for control group 1. to be \<18 years old 2. having clinical signs suggestive of psoriasis 3. having clinically detectable signs of arthritis 4. history of known inflammatory disease, severe trauma in the joint areas to be evaluated, surgical intervention, injection -