cyrilzakka/clinical-trials huggingface dataset:
The Effect of Active Breathing Exercises for Elderly People in the Community

The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

The investigators have designed a simple and user-friendly training method called "Active Breathing Exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery

The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.

There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.

This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.

Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.

Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.

Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Laparotomy for abdominal cancer surgery: urological, gynecological, digestive, abdominal sarcomas and melanomas, lymphomas and abdominal vascular.
* Informed consent form signed by the patient or legal guardian.

Exclusion Criteria:

* Reoperation within one year from the previous surgery. using previously parenteral nutrition.
* Participation in another research protocol.
The Role of Pro-angiogenic Immune Cells in Human Pregnancies

Identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders.


Eligibility Criteria:
Inclusion Criteria:

* Placentas that have been delivered in the Medical Center

Exclusion Criteria:

* None
Manage Your Workingnegative Thoughts Through Hypnosis

Medical doctor generally are exposed to several risks and pressures, it is not a case that several meta-analyses have shown high stress and anxiety level in these workers. Stress management represents a very important topic. Being a doctor means dealing with continous effort and arousal management to provide the best treatment through executive functions capacity. This is particularly true for younger medical trainees; that have also to learn how to deal with failure and the curve of learning. Hypnosis has been shown to be very effective at modulating executive functions and sympathovagal balance, with large effect in post traumatic stress disease (PTSD), anxiety and executive function modulation. Therefore, this study aim to investigate if hypnosis could be beneficial among medical trainees for managing negative thoughts related to work.

Stress and anxiety are very important issues in medical training. Several methods have been applied, from psychotherapy to biofeedback, but the physiological component usually have been dismissed. Training medical trainees to manage their physiological activity through hypnosis can probably transfer practical results, i.e. increased wellbeing, modulation of the working energy and the transfer from planning to properly execution. To obtain this results after a basal evaluation of physiological data (HR; Heart rate, HRV, Heart Rate Variability, EDA; Electrodermal activity, and SCr; Skin conductance responses) stress and of anxiety levels, , with PSS-10 scale, VAS stress, VAS anxiety and Tower of London test ( TOL-R), participants will recollect a negative memory for 3 minutes to monitor their response. After that a brief session of hypnosis will be performed with positive memories being recollected while all physiological data will be monitored. Then participants will be subjected again to the negative memory task end at the end of the session the same test of the basal evaluation will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old,
* being medical doctor or at first year of residency in Anesthesiology
* obtained written informed consent

Exclusion Criteria:

* Neurological issues affecting stress responses
* Diabetes
* Cardiovascular conditions (i.e., hypertension, orthostatic hypotension etc)
* Being under psychiatric medications
* Psychological or psychiatric diseases
Enhancing Quality of Life for Older Adults With and Without Mild Cognitive Impairment (MCI) Through Social Engagement Over Video Technology

The goal of this randomized controlled trial is to rigorously assess the efficacy of an 8-week social engagement OneClick intervention. A total of 120 older adults with and without mild cognitive impairment (60 per group) will be randomized after a baseline assessment to the social engagement OneClick intervention group or the waitlist control group. Participants assigned to the intervention group will receive the social engagement OneClick intervention for 8 weeks, and will complete a mid-assessment at week 4, and a post-assessment at week 8. Participants assigned to the waitlist control group will receive no intervention for the first 8 weeks and will complete assessments at week 4 and week 8. Subsequently, as an extension to this study, participants assigned to the waitlist control group will have an opportunity to participate in 8 weeks of social engagement OneClick intervention, with intervention effects assessed at week 4 and week 8.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+
* Fluent in English
* Adequate visual and auditory acuity
* Passing score on Telephone Interview for Cognitive Status - Modified (TICS-M) of 22 and above included
* Passing score on Montreal Cognitive Assessment (MoCA) of 20 and above included
* Geriatric Depression Scale (GDS) score of less than 9
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Access to and ability to use necessary resources for participating in technology-based intervention

Exclusion Criteria:

* Diagnosis of dementia
* Live in assisted living facility or skilled nursing facility
Validation of the Polish Version of the MPIIQM Questionnaire for Musicians

The aim of this study, originally named "Cross-Cultural Adaptation and Validation of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians of the Polish Population (MPIIQM-P)" is the enlargement of validation of the Polish questionnaire.

The aim is to determine the following psychometric properties: convergent and divergent validity, two-time reliability analysis, and exploratory factor analysis according to the recommended number of subjects of ≥45 subjects. In addition, the aim of the study is to assess the psychometric properties of the MPIIQM-P questionnaire in the online version and to compare these results with the results for the paper version obtained by Cygańska et al., 2021.

Eligibility Criteria:
Inclusion Criteria:

* permanent musician in an orchestra
* Polish as a native language

Exclusion Criteria:

• freelance musician
Losartan and HCTZ and Amlodipine vs Atenolol and Amlodipine (0954A-309)(COMPLETED)

A study to evaluate the effects of combination losartan versus combination atenolol in patients with ambulatory systolic hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age who have ambulatory systolic hypertension.
Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation

The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation for at least 24 hours before the first weaning test
* difficult weaning of mechanical ventilation defined as failure to the first weaning test
* patients aged at least of 18 years

Exclusion Criteria:

* peripheral or central nervous system pathology
* known psychiatric pathology or agitation
* clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale \< 8, PaO2/FiO2 ratio \< 150 with respiratory distress signs)
* pregnant or breastfeeding women
* patient under legal guardianship or protection
* patient with no health insurance coverage
* age \< 18 years
From Known to New Genes in Dyslipidemia

The mechanism of the majority of the dyslipidemia is multifactorial at the molecular level and remains elusive in more than 50% of the patients in many clinical conditions. Next generation sequencing, a booming strategy, improves the molecular diagnosis efficiency in both monogenic and polygenic dyslipidemia.

In order to decipher the mechanisms involved in the occurrence of dyslipidemia, in addition to the exploration of known candidate genes and Single Nucleotide Polymorphisms (SNP) involved in polygenic modulation, new genes involved in the regulation of lipoprotein metabolism or associated with lipids concentrations need to be sequenced in large groups of dyslipidemic patients.

The goal of this project is to gain new insight into genotype/phenotype correlation.


Eligibility Criteria:
Inclusion Criteria:

* patients with a family documented history of primary hypercholesterolemia, hypertriglyceridemia, hypobetalipoproteinemia, combined hypolipidemia and combined hyperlipidemia according to the European Atherosclerosis Society and/or published data.
* patients with major secondary dyslipidemia.

Exclusion Criteria:

* inability to provide written informed consent
* lack of legal representative
Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty

The purpose of this study is:

* To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty.
* To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.


Eligibility Criteria:
Inclusion Criteria:

* Give written informed consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, must use contraception
* Undergoing elective, primary unilateral total knee arthroplasty

Exclusion Criteria:

* Body weight \<50 kg
* Patients at increased risk of bleeding. History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year.
* History of excessive intra- or direct post operative bleeding or a traumatic spinal or epidural anesthesia
* Brain, spinal, or ophthalmologic surgery within the past 3 months
* History of clinically significant liver disease in the past year
* Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values

  * aPTT or PT or INR \>ULN
  * Factor IX activity \<LLN
  * Factor VIII activity, vWF antigen or Ristocetin cofactor activity \<0.5 U/mL
  * FXI activity \<0.3 U/mL
  * Urine protein or blood persistently positive by dipstick. In the event of positive test results, eligibility may be confirmed with urine microscopy or 24 hour urine protein measurement as applicable
  * ALT or AST \>1.5 x ULN
  * Total bilirubin \>ULN
  * Platelet count \<150,000 (or history of thrombocytopenia)
* Hypersensitivity to enoxaparin
* Anticipated concomitant use of anticoagulants/antiplatelet agents or the NSAID nimesulide that may affect study outcome or any other drug influencing coagulation (except low dose aspirin and short acting NSAIDs with a half-life \<20 hours) at least 7 days before surgery or during treatment with ISIS Rx.
* Anticipated use of indwelling intrathecal or epidural catheters
* Anemia at Screening
* Have any other conditions which could interfere with the patient participating in or completing the study
Relationships Between Exercise and Emotion Regulation on Physical Activity in Frail Older Adults

Frailty in older adults is a consequence of physical inactivity, which leads to poor physical function, disability and poor health outcomes. Nearly 60% of older adults report inactivity. Emotion regulation strategies have affective, cognitive and social consequences. Positive emotions are significantly associated with a higher ability to perform activities of daily living. There is a gap in the understanding of how exercise influences the selection of emotion regulation strategies (avoidant vs. adaptive) in frail older adults. The investigators propose to examine the interactions between regular exercise, selection of emotional regulation strategies, and daily physical activity in frail sedentary older adults.

1. Determine the choice of emotion regulation strategies used by frail sedentary older adults (60+ years; n=24). Frailty will be defined as a gait speed \<0.8 m/sec.

   Hypothesis: Frail sedentary older adults will choose avoidant emotion regulation strategies.
2. Examine whether a peer-led, community-based, group-exercise program lasting 12-weeks improves the selection of emotion regulation strategies in frail sedentary older adults as compared to those receiving support services (12/group).

   Hypothesis: Exercise will result in higher use of adaptive emotion regulation strategies than support services.
3. Examine if improved selection of emotional regulation strategies with exercise translates into increased daily physical activity and reduced sedentary behavior by frail older adults as compared to those receiving support services.

   Hypothesis: Exercise will significantly increase daily physical activity and decrease sedentary behavior than support services.
4. Determine if improvements in emotional regulation strategy selection and daily physical activity levels positively influence health and well-being (i.e. health status, physical function, mood, depressive symptoms, anxiety, and sense of loneliness and isolation).

Hypothesis: Exercise-induced improvements in emotion regulation and increased daily physical activity will be associated with improved overall health and well-being as compared to support services.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults 60+ years of age
* Men and women
* Frail older adults with impaired mobility (gait speed \< 0.8 m/sec)
* Sedentary older adults

Exclusion Criteria:

* Unable to give consent
* Unable to exercise
* Unable to travel to the community site
* Unstable chronic conditions
Confident Birthing: What Influences Women's Confidence for Birth?

This is a grounded theory study aiming to understand women's perception of what influences their confidence for birth during labour and birth. Data is being collected using interviews and social media sources.

This study aims to help women have a better birth experience, by trying to understand what a 'confident birth' means to women during pregnancy and labour. Results from a recent service evaluation at a local NHS Trust, exploring a new programme designed to enhance women's birth experience, highlighted the importance of understanding women's confidence for birth. A significant number of pregnant women that attended the course (19.5%) felt 'not at all confident' for birth. The service evaluation results also suggested that confidence for birth is an important influence of enhancing birth experience.

There is some research that suggests that if women's confidence for birth can be improved, then she may be less fearful of birth and have experience less labour pain. However, very little is known about what women consider to be a 'confident birth' and who or what they feel influences their confidence. If maternity services are able to understand this, this could possibly lead to the development of tools and strategies to help women to feel more confident for giving birth.

This is a qualitative study that involves two methods of data collection: interviews and social media. Women that are pregnant or have recently given birth will be interviewed to explore who or what they feel has influenced their confidence for birth. The interviews will last for about one and a half hours. The location for interview is flexible and women can be interviewed in their own home. In addition to this, approximately 500 messages posted on a large UK parenting website about confidence for birth will also be analysed.

Eligibility Criteria:
Inclusion Criteria:

* given birth within the last two years or are pregnant
* consider themselves well enough to take part in the study
* have received maternity care from specific NHS Trust

Exclusion Criteria:

* under 18 years old
* have not received maternity care from specific NHS Trust
Study on Cardiac Output Evaluation Based on Wearable Monitoring Data

Based on the monitoring data of wearable devices, with cardiac output (CO) as the gold standard, this study intends to develop a non-invasive evaluation model of CO based on wearable data, and optimize the parameters to realize the cardiac capacity detection function in resting and exercise states on the wearable device.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) \< 50%(200 subjects)
* Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) ≥50% (100 subjects)
* Able to use smart phones and operate wearable devices such as wristbands/watches

Exclusion Criteria:

* Patients with pacemaker implantation
* No smartphone
* Currently participating in other clinical trials
* Lactating women
* Pregnant Women
* Unable to run and ride due to personal physical and external reasons (subjects participating in the exercise state cardiac output model study)
* Physical examination results in the past year have clear cardiovascular, metabolic, bone and joint related diseases that have exercise risk, or have diseases and related potential health risks confirmed by the self-examination form of physical status before exercise (participants in the exercise state cardiac output model study)
* No informed consent was obtained
Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion

This study will provide feasibility data regarding the conduct of a clinical trail evaluating the use of early aggressive inpatient intravenous rehydration in children with Shiga Toxin producing E. coli infection.

Background: Shiga toxin-producing Escherichia coli (STEC) cause a spectrum of disease, ranging from asymptomatic carriage to bloody diarrhea and the hemolytic uremic syndrome (HUS). HUS is caused by a toxin that destroys red blood cells, consumes platelets and impairs kidney function. HUS results in morbidity and even death in otherwise healthy children. Over the last 30 years however, there has been extremely limited progress in preventing acute and long-term complications in children with STEC infection. However, it is believed that Shiga toxins generate clots or blockages in the kidneys that damage it much the way strokes cause brain damage. There is emerging evidence that if children with STEC infection are recognized early, then the interval between diarrhea onset and the presence of HUS could be exploited to preserve kidney function through the use of intravenous rehydration.

Study Design: The investigators propose to conduct the first randomized clinical trial of volume expansion therapy in children with STEC infection. Employing Alberta's unique province-wide microbiology network and its only two pediatric tertiary care centres, the investigators will conduct a proof of principal feasibility study that evaluates novel technologies to identify STEC infected children and those at risk for HUS.

Objectives: The primary outcome will be process: number of children recruited. Secondary outcomes will include: 1) resources: retention; refusal; compliance; eligibility criteria; questionnaires; data collection tools; and time requirements; 2) management: capacity and impact on clinical services; 3) scientific: utility of point-of-care STEC diagnostics; use of urine biomarkers to identify high risk children, monitoring of kidney injury and response to therapy; and safety.

Significance: This pilot will provide the necessary data to integrate novel technologies into the design and conduct of a multicentre, multinational, clinical trial that will reduce morbidity and mortality from STEC infection.

Eligibility Criteria:
Inclusion Criteria:

1. Age \<18.0 years;
2. STEC infection \[positive culture OR antigen OR polymerase chain reaction test for Stx/gene\];
3. Day of illness 1-10: Children who develop HUS will do so by day #14 of illness;8 restricting enrolment to the first 10 days will ensure all participants are at risk of HUS.

Exclusion Criteria:

1. Evidence of evolving HUS: A) Hematocrit \<30% OR B) Platelet count \<150 x 109/L;
2. Responsible physician desires patient admission (therefore unable to randomize);
3. Unable to contact family within 48 hours of positive stool test;
4. Patient with history of atypical HUS;
5. Chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)