cyrilzakka/clinical-trials huggingface dataset:
Breaking up Sitting With a Treadmill Desk in Office Workers

Sitting for long uninterrupted periods of time can increase risk of heart disease, diabetes and early death, even if you take part in the United Kingdom government guidelines for physical activity of 21/2 hours per week of exercise. Effective interventions to reduce the risk of these diseases are therefore needed. The aim of this study is to examine the effects of regularly breaking up sitting time with light intensity treadmill desk walking among office workers on health markers, sitting time and physical activity. If using a treadmill desk leads to benefits in these disease risk markers then this could be an effective strategy to improve employee health in the workplace.

Participants will be randomly assigned to the intervention group or the control group. After baseline activity and health measures, they will take part in the study for 4 weeks.

Intervention group: Participants will have a treadmill desk placed in their office or a nearby location and will be asked to walk while working on the treadmill desk continuously for 20 minutes at a self-selected slow pace each hour for a minimum of 6 hours per shift. There will be one treadmill desk between 2-3 people.

Control group: Participants will be asked to work as usual at their regular workstation with no changes in their physical activity and dietary habits.

Sitting time and physical activity will be measured at baseline and during the last week f the intervention. A range of health and psychological measures will be taken at baseline and post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 18-65 years who work for shifts lasting ≥ 6 h and spend ≥ 75% of this time sitting at their desk
* work a minimum of 3 days per week

Exclusion Criteria:

* the presence of any known blood borne disease
* self-reported diagnosed diabetes
* physical activity contraindications
* pregnancy
* any major injury or illness, tobacco use, or any other health issue that my limit the participant in carrying out the required activity bouts.
* any planned absence from their office for more than one week during the 4 week study period.
A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.


Eligibility Criteria:
Inclusion Criteria:

Adult Cohort: 18 to 49 years and in good health

* Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.

Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Exclusion Criteria:

Adult cohort: Prior administration of any pneumococcal vaccine

* History of invasive pneumococcal disease
* Known hypersensitivity to any vaccine component
* Known or suspected impairment of immune function
* Coagulation disorder contraindicating intramuscular vaccination
* Received a blood transfusion or blood products within 6 months
* Participated in another clinical study of an investigational product within 2 months
* Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
* Known hypersensitivity to any vaccine component
* Known or suspected impairment of immune function
* History of congenital or acquired immunodeficiency
* Has or mother has documented Human Immunodeficiency virus (HIV) infection
* Has or mother has documented hepatitis B surface antigen positive result
* Functional or anatomic asplenia
* History of failure to thrive
* Coagulation disorder contraindicating intramuscular vaccination
* History of autoimmune disease or autoimmune disorder
* Known neurologic or cognitive behavioral disorder
* Received systemic corticosteroids within 14 days
* Received other licensed non-live vaccine within 14 days
* Received other licensed live virus vaccine within 30 days
* Received a blood transfusion or blood products
* Participated in another clinical study of an investigational product
* History of invasive pneumococcal disease
A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B

This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
* Anemia at Screening Visit

Exclusion Criteria:

* Transfusion of red blood cells within 2 months of study drug
* Treatment-resistant hypertension
* Acute or chronic bleeding (requiring therapy) within 3 months of study drug
A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.

The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* weight 5-50 kg
* age 3 months-11 years

Exclusion Criteria:

* ASA class IV, V Emergency procedures
* active respiratory infection
* known history of difficult mask ventilation
* a diagnosis of a congenital syndrome associated with difficult airway management
* airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
* active gastrointestinal reflux
* coagulopathy
* clinically significant pulmonary disease(s)
Community Acquired Pneumonia in Older Adults

This study will utilize diagnostic imaging and salivary biomarkers to estimate the prevalence of aspiration in older adults with suspected community-acquired bacterial pneumonia (CABP). 150 participants over the age of 60 diagnosed with pneumonia will be recruited into this study. 62 of these participants will be enrolled in a supplemental study.

Pneumonia is the most common infectious cause of mortality in older adults. Standard practice for older adults with pneumonia involves hospitalization and antibiotics. However, recent studies suggest that a significant portion of suspected community-acquired bacterial pneumonia (CABP) cases may actually be due to distinct, dysphagia-related aspiration syndromes (e.g. aspiration pneumonia, pneumonitis).

The main study will will assess whether salivary biomarkers (viscoelasticity, substance P) and swallowing function tests can be used to help differentiate CABP from aspiration-related syndromes. The following aims will be completed:

* Aim 1: Compare salivary properties and health outcomes among older adults with aspiration related pneumonia mimics and those with infectious pneumonia
* Aim 2: Compare appearance of lung ultrasound findings among older adults with aspiration related pneumonia mimics and those with infectious pneumonia.
* Aim 3: Describe dysphagia screening results, patient reported swallowing function, salivary properties, oral/nasopharyngeal microbiome profiles, in older adults with pneumonia presenting to the ED.
* Aim 4: Assess the potential impact of the MeMed BV® test's result on patient management decision making, including antibiotic prescribing and disposition.

A supplemental study will be the first to utilize diagnostic imaging (videofluoroscopic evaluation of swallowing and radionuclide salivagram) to estimate the prevalence of aspiration in older adults with suspected CABP.

* Aim 1: Determine the prevalence of dysphagia-related aspiration among older adults with pneumonia.

Eligibility Criteria:
Emergency Department (ED) Recruitment

Inclusion Criteria:

* 60 years of age or older
* Patient has clinical criteria for pneumonia or is being treated for pneumonia as defined by abnormal chest imaging or receiving antibiotics for a chest infection or the provider thinks the patient has pneumonia or is planning to treat the patient for pneumonia.
* Patient is clinically stable and able to safely drink water, per the emergency department provider
* Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient

Exclusion Criteria:

* Prisoner
* Non-English speaking
* Respiratory symptoms for 7 days or more

Phone Recruitment

Inclusion Criteria:

* 60 years of age and older
* Patient was diagnosed with or treated for pneumonia at UW Health in the past 6 months
* Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient

Exclusion Criteria:

* Prisoner
* Non-English speaking
Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa

The goal of this clinical trial is to test the effectiveness of a mental health prevention and promotion programme delivered to children (ages 8 to 13) living in under-resourced communities in South Africa.

The main question it aims to answer is:

Does the programme increase resilience and improve psychological well-being?

Participants will be asked to attend the programme twice a week after school for a period of six weeks and complete a series of questionnaires.

Researchers will compare children who attended the programme to those who did not to see if the programme resulted in better social/emotional functioning and resilience.

Although the well-being of vulnerable South African children is a significant public health concern, few studies have evaluated the effectiveness of mental health prevention and promotion interventions in low- and middle- income countries. Little Lions Child Coaching is a South African youth-led, community-based non-governmental organisation (NGO) that aims to normalise mental health conversations and empower the next generation to tap into their emotional resilience by providing accessible mental health support to children in under-resourced communities surrounding Cape Town.

The aim of this effectiveness study is to measure how a mental health prevention and promotion programme, designed and implemented by Little Lions Child Coaching, impacts the resilience and social/emotional functioning of children (ages 8 to 13) living in townships surrounding Cape Town.

Participants in the intervention condition will receive the programme twice a week after school for a period of six weeks to boost their emotional awareness, confidence, coping skills and resilience. Resilience scores will be compared to a control group.

Eligibility Criteria:
Inclusion Criteria:

* Between 8 and 13 years old
* Fluent in Xhosa and/or English
* Lives in one of the following communities in Cape Town, South Africa: Khayelitsha, Langa, or Mfuleni

Exclusion Criteria:

* Younger than 8 years old or older than 13 years old
* Do not have a strong understanding of the language of instruction (i.e., Xhosa/English)
* Lives in an area outside of Khayelitsha, Langa, or Mfuleni
Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial

Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion

Sinus conversion by electrical cardioversion increase cardiac output and systemic perfusion. According to recent reports, maintenance of sinus rhythm increase systemic perfusion which leads to improve renal function. Therefore, we hypothesized that sinus conversion of patients with atrial fibrillation will increase systemic perfusion which might improve the erectile dysfunction and cognitive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to electrical cardioversion

Exclusion Criteria:

* Patients have taken any medication for erectile dysfunction or who have got any operation already or are scheduled to do.
* More than moderate degree of cognitive dysfunction
Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

Takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries in the body, such as the aorta. In order to ensure proper treatment, measuring disease activity is critical. The purpose of this study is to establish new biological markers (biomarkers) to assess the severity of disease in people with Takayasu's arteritis.

Takayasu's arteritis is a chronic inflammatory condition that affects the aorta, the largest blood vessel in the body, and its branches. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. Symptoms may include arm pain with use, decreased or absent pulses, lightheadedness or dizziness, headaches, and visual disturbances. Many individuals with Takayasu' arteritis, however, have no apparent symptoms despite disease activity. Additionally, current tests used to measure vessel inflammation are considered unreliable and inconsistent. It is therefore very difficult to determine the extent of disease activity in a person with Takayasu's arteritis. This study will use novel scientific methods to establish new biomarkers that can be used to monitor disease activity in individuals with Takayasu's arteritis. These biomarkers may be used to help direct clinical care and assist in future drug development.

Study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical examination, disease assessment, and review of medications will occur every 3 months; participants may also be asked to complete various questionnaires. Diagnostic testing, which may include chest radiograph, echocardiogram, magnetic resonance imaging, or angiography, will occur every 6 months. Tobacco, alcohol, and drug use will be assessed on a yearly basis. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of arteriogram abnormalities compatible with Takayasu's arteritis (includes conventional dye angiography, magnetic resonance angiography, or computed tomography angiography)
* Evidence of one of the following criteria:

  1. Age at disease onset of 50 years or younger
  2. Claudication of the arms or legs
  3. Decreased brachial artery pulse (one or both arteries)
  4. Blood pressure difference between the arms of at least 10 mm Hg
  5. Bruit over the subclavian arteries or aorta
* Parental consent for children under the age of 18

Exclusion Criteria:

* Arteriographic lesions that could be entirely due to atherosclerosis
* Fibromuscular dysplasia
* Cogan's syndrome
* Behcet's disease
* Sarcoidosis
* Kawasaki disease
* Giant cell arteritis (large vessel vasculitis and at least 50 years old)
* Syphilis or other infectious forms of large vessel vasculitis
Magnesium Sulphate in Premature Rupture of Membranes

To assess the outcome of using magnesium sulphate on fetus and women with preterm premature rupture of membranes

Preterm premature rupture of membranes (PPROM) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. Approximately 1% to 5% of pregnancies are complicated by PPROM . PPROM contributes to perinatal morbidity and mortality, secondary to premature birth, and maternal morbidity. Overall, PPROM accounts for about one-third of all preterm births . In order to reduce the effects of prematurity, early PPROM (24 to 33 weeks) is best served with conservative management in the absence of labor, infection, or fetal distress . The conservative management of PPROM consists of the use of antibiotic treatment and antenatal steroid to enhance fetal lung maturity . With or without the presence of labor, it is unclear whether tocolysis of women with PPROM would be efficacious in reducing the consequences of prematurity .The use of tocolytics in women with PPROM is still controversial. Many physicians use tocolytic therapy as a prophylactic measure and others initiate tocolysis only with the onset of contractions. There is also a variety of options for tocolysis: betamimetics, calcium channel blockers, cyclo-oxygenase (COX) inhibitors, oxytocin receptor antagonists and magnesium sulphate . As betamimetis is not available and isn't used in our country and magnesium sulphate is available magnesium sulphate is used widly. The loading dose of magnesium sulphate is IV 4 gm over 20 minutes followed by 1gm/hour for 6 hours The potential benefit from increased latency due to tocolysis must be weighed against the potential harm in increased maternal and perinatal infection, the latter of which can possibly lead to long-term sequelae for the child, including cerebral palsy

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with gastational age between 28 weeks and 36 weeks and 6 days who are diagnosed with preterm prelabour rupture of membranes

Exclusion Criteria:

* clinical suspicion of chorioamnionitis
* Patients refusal to participate in clinical research.
* significant vaginal bleeding
* previous tocolysis use after rupture of membranes
* nonreassuring fetal heart tracing
* fetal anomalies
* significant maternal medical complications, and maternal or fetal indication for delivery
Screw Lengths in Radius Volar Plates

Background Fractures of the distal radius are among the most common. Major complications, including irritation and rupture of the extensor tendons, may occur if epiphyseal screws of inappropriate length are used.

Questions/Purposes The main objective of the present study was to determine whether the optimal epiphyseal screw length can be determined by reference to the diaphyseal screw length.

Methods Forty CT scans were semi-automatically segmented. A 3D model of the volar plate was affixed to each distal radius with simulation. The maximum lengths of the diaphyseal screws, as well as the four distal epiphyseal screws, were measured. Linear regression analysis was performed.


Eligibility Criteria:
Inclusion Criteria:

* All CT-scans available in our database

Exclusion Criteria:

* Any pathology that could affect the radius morphology
* Refuse to participate
Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.


Eligibility Criteria:
Inclusion Criteria:

* Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling.
* Infant delivered at, or greater than 37 weeks gestation.
* Singleton birth.
* Speaks and understands English.
* Access to telephone.

Exclusion Criteria:

* Infant not expected to be discharged home with mother.
* Infant with congenital abnormalities that would impair breastfeeding.
* Maternal allergy to lanolin.
* Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff.
Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES)

This study evaluates correlation in changes of HVPG-pressure values and stiffness values (ARFI) for spleen and liver and flow-volume values in Portal vein in patients with liver cirrhosis/Portal Hypertension, respectively, after new-admission of beta-blocker therapy.

Portal Hypertension is the most important risk factor for development of liver cirrhosis-linked complications (e.g. ascites, variceal bleeding, hepatocellular carcinoma, etc.). The invasive HVPG-technique is the standard-of-care Investigation for Evaluation of Portal Hypertension. Administration of Beta-Blocker-therapy results in dropping of the elevated Portal vein pressure values so Overall-survival rate and incidence of liver-cirrhosis-linked complications can be ameliorated. Ultrasound-based Investigation of liver and Spleen-stiffness and of portal-vein-flow-volume, respectively, are the non-invasive methods for Evaluation of Portal Hypertension. But the cut-off values for detection of significant Portal Hypertension by the ultrasound investigation strongly vary depending on the study performed. This study evaluates the changes in ARFI-assisted elastography measurements of liver and spleen and in portal vein flow values, respectively, compared with the recorded Delta in invasive hepatic vein pressure gradient (HVPG)-values for patients with portal hypertension and new administered beta-blocker-therapy. The aim of this study is to evaluate value drop in liver- and Spleen-stiffness and portal-vein-flow required in corelation to a significant drop in HVPG-pressure after new-administered beta-blocker therapy.

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* portal hypertension
* indication to beta-blocker-therapy

Exclusion Criteria:

* contraindication to beta-blocker-therapy
* HVPG-measurement not feasible
* portal vein thrombosis
* hematologic underlying disease as the source for enlarged/stiff spleen or liver
Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay

A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary bypass increases not only cost of patient care but also morbidity and mortality of patients. The ability to predict which patient has the tendency to have a prolonged ICU stay would help in patient and resource management of the hospital. There are many predictive models aiming at identifying patient at risk of prolonged ICU stay after cardiac surgery with cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this study was to re-validate the performance of OHIR score in the recent context.

This will be a retrospective, observational, analytical study. The study protocol was approved by the Human Research Ethics Committee, Khon Kaen University (HE581287).

The investigators will review all eligible medical records at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University during January 2013 and December 2014. The extracted data consist of patient's clinical data and all risk factors in the OHIR score. The investigators will apply the OHIR scoring to the data to assess its performance. The investigators will use the same criteria for a prolonged ICU stay as in the previous study, i.e. a stay longer that the median.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-75 undergoing cardiac surgery, both CABG and valvular surgery, with the use of cardiopulmonary bypass.

Exclusion Criteria:

* patients having emergency surgery; receiving special devices such as intra-aortic balloon pump or extracorporeal membrane oxygenation.