cyrilzakka/clinical-trials huggingface dataset:
Kettlebell-classroom Training

Physical fitness is a crucial health marker, predicting both cardiovascular and all-cause mortality. Muscular strength, an essential component of physical fitness, underpins physical and psychological well-being, particularly from childhood. Increasing sedentary behavior has led to rising obesity and cardiovascular disease rates in children, exacerbated by the COVID-19 pandemic and the emergence of pediatric dynapenia. Muscular fitness positively affects body composition, bone health, psychological health, and academic performance, and is necessary for fundamental motor skills.

In Basel, a ten-year trend shows declining physical fitness and rising obesity among primary school children, especially those from lower socio-economic backgrounds with less access to sports. This presents an opportunity to promote physical activity in schools. The "Kettlebell Classroom" project aims to introduce daily, playful resistance training with kettlebells over seven weeks in various schools, focusing on culturally and socially less integrated children.

Evidence supports the benefits of resistance training (RT) for children, including increased joint stability, improved motor skills, reduced injury risks, and increased spontaneous physical activity. Despite WHO recommendations for muscle and bone-strengthening activities three times a week, these guidelines are often unmet. This project aims to demonstrate the effectiveness of short, intensive exercise sessions for children, with the goal of expanding the initiative across Basel to improve health outcomes for all children.

Study intervention The intervention emphasizes full-body exercises which are performed with the own body weight and kettlebells. On every weekday, the intervention classes will receive 15 min of supervised training over 7 weeks. This results in a total number of training sessions of 35 sessions. The movements and exercises in all phases are based on functional, multi-joint movements. The focus will be on age-appropriate whole-body strength and motor skill development. It will be designed with different, varying exercises, which can be individually tailored and adapted to the children's ability. Tailored to the group, the sessions will also include parts which engage social cooperation and teamwork, so that the children will experience a sense of competence, self-determination and enjoyment of exercise while enhancing motor skills and athletic ability.

Eligibility Criteria:
Inclusion Criteria:

* all of the selected second-graders who can participate in physical education lessons will be included in the study

Exclusion Criteria:

* Children with a medical certificate, that prohibits physical activity, will be excluded from performance testing and training intervention.
Varenicline Pregnancy Cohort Study

A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.

Sampling will not be employed. The data sources record nearly all (\>98.6%) births in Denmark and Sweden.

Eligibility Criteria:
Inclusion Criteria:

All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.

Exclusion Criteria:

Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.
Impact of Radiation Therapy on Breast Conservation in DCIS

Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead.

Patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. Quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient.

Although the incidence of DCIS has risen dramatically (1), there exists considerable debate about optimal treatment. In general, people with DCIS have high rates of recurrence-free survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) In addition, radiation usually necessitates mastectomy should a new cancer or DCIS develop in the same breast at any point during the patient's lifetime. Patients also have a small chance of experiencing long-term toxicity. Previous radiation can also complicate reconstructive options following mastectomy. The tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making.

Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if they have a second breast event in the same breast. One study suggests that some women choose not to have radiation after DCIS because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of DCIS. We sought to study whether regional intensity of radiation use for DCIS treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial DCIS diagnosis. (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July 21, 2016.)

Eligibility Criteria:
This study used data from SEER and SEER-Medicare.
Soda and Milk Study

Much attention has been directed at the unhealthy effects of sugar-sweetened beverages (SSBs), as an increase in their consumption has paralleled the rise obesity rates. In adults, SSBs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. Replacement of soda with milk had the added benefit of also reducing systolic blood pressure. While several studies have investigated the effects of SSBs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of SSBs. The main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. The investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of SSBs. Participants will consume energy equivalent amounts of SSB (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. Anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. Plasma measurements will include LDL peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, LDL, and HDL-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity C-reactive protein; uric acid; and liver enzymes.


Eligibility Criteria:
Inclusion Criteria:

* Males, age 13-18
* Tanner stage ≥ 2
* Self reported sugar sweetened beverage intake 24oz to 60oz per day
* Self reported milk intake ≤16 oz. per day
* BMI 85-99 percentile for age
* Tolerant to milk

Exclusion Criteria:

* History or diagnosis of hypertension or taking blood pressure lowering medication
* History or diagnosis of diabetes, HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl
* Fasting triglyceride \> 300 mg/dl
* On lipid lowering or diabetes medication
Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

The aim of present study is to analyze and compare the effect of two exercise programs - psychomotor exercise program vs exercise combined program (psychomotor + whole body vibration) - on risk factors for falls of community-dwelling older adults who are fallers or are "at high risk of falling".

This experimental study is a randomized controlled trial. The program will run for 24 weeks (3 sessions / week of 75 minutes), followed by 12 weeks of follow-up without intervention. Participants of the groups will be assessed 1) at baseline, 2) at 12 weeks, 3) at 24 weeks, and 4) after the follow-up. Participants will be randomly allocated to three groups: experimental group 1 (psychomotor program); experimental group 2 (combined program) and control group.

Aging is associated with a decline in executive functions, negatively influencing the motor, social and emotional capacities of older adults. (1) These losses will contribute to increase the risk of falling, so much that most falls occur during the performance of a dual-task (DT) (2).

The lack of balance, strength and poor body composition are seen as causes of falls, and should therefore be considered in the prevention programs of these events in older adults. (3-5) A psychomotor exercise program uses the body and movement as mediators, relying on the prevention of cognitive, sensory, perceptive, emotional and affective deterioration, exploring the neuroplasticity. (6,7) Therefore, this sensorimotor and neurocognitive program may prevent falls, but it is important to analyze its real impact in reducing either falls or the risk factors for falls in the older adults. No studies focusing on this subject were found.

The intervention through the whole body vibration (WBV) is referred in the literature as promoting the improvement of balance, mobility and agility, and preventing falls in the older adults.(8,9) WBV will have long-term therapeutic effects promoting the increase of muscle strength and increased bone mineral density. (10) Being two intervention methods with potential good results on falls prevention, it is not known whether there will be additional benefits in an intervention that combines both methods.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged ≥65 years;
* Community-dwelling older adults;
* Older adults who have fallen in the last 6 months or who are at high risk of falling (scoring ≤25 points on Fullerton Advanced Balance Scale);
* Participation agreement;

Exclusion Criteria:

* Presence of severe cognitive decline (patients with a Mini-Mental State Examination ≤9);
* Fracture in one or both lower limbs for less than 4 months;
* Diagnosed of health conditions compromising the program participation, such as: severe osteoporosis (T ≤ 2.5, with the occurrence of one or more associated osteoporotic fractures); hip or knee prostheses; incapacitating cardiovascular conditions; epilepsy; cancer or metastases;
* Do not wish to participate in the study;
Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses

The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.

In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.

Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult males

Exclusion Criteria:

* past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)
Blood Conservation in Cardiac Surgery

The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based transfusion triggers in patients post cardiac surgery.

Nearly 20% of blood transfusions in the United States are given to in patients undergoing cardiac surgery. Despite the many blood conservation techniques that are available, safe, and efficacious for patients, many of these operations continue to be associated with significant amounts of blood usage. We believe that transfusion protocols which employ specific guidelines for transfusion can decrease blood product usage and improve outcomes for patients undergoing cardiac surgery. Our goal is to demonstrate that a carefully chosen trigger can achieve better outcomes.

Our hypothesis is that a transfusion trigger of Hgb 7.5 g/dl will lead to decreased utilization of blood transfusions and will have many positive effects on the patients post cardiac surgery in addition to substantial cost savings. We will use an evidence based approach to observe the relative safety of a conservative transfusion trigger (7.5 g/dl) as compared to a more liberal trigger (9.0 g/dl). We will also study the effect of blood conservation on the incidence of transfusion-related complications such as transfusion related lung injury (TRALI) and infectious complications as well as length of hospital stay, cost and ventilator time.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria will be considered for inclusion in this study:

1. Subjects scheduled to undergo any of the following cardiac surgeries as part of their routine medical care:

   * CABG
   * AVR
   * MVR
   * MV Repair
   * CABG/AVR
   * CABG/MVR
   * CABG/MV Repair
   * Thoracic Aneurysm Repair ± any concomitant cardiac procedure (valve, CABG, etc.)
2. Subjects must be \> 18 years of age
3. No prior history of cardiac surgery.
4. Able and willing to give informed consent

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in this study:

1. Prior history of cardiac surgery
2. Patients who do not have sufficient time prior to surgery to give proper informed consent (i.e.: immediate, emergency surgery)
3. Patients who are younger than 18 years of age
4. Prior history of

   * bleeding disorders
   * symptomatic anemia (i.e. persistent tachycardia, orthostatic hypotension, persistent pressor requirement)
   * hereditary/acquired coagulopathy
   * platelet defects (e.g.: disseminated intravascular coagulation (DIC), hemophilia, Henoch-Schönlein purpura, hereditary hemorrhagic telangiectasia, thrombocytopenia (ITP, TTP), thrombophilia, Von Willebrand's disease)
5. History of leukemia or any other blood related malignancy
6. History of liver failure
7. Current, or history of, pre-existing medical condition other than current cardiac condition, which in the opinion of the investigator, would place the subject at risk or have the potential to confound interpretation of the study results
8. Participation in another clinical trial
9. Lack of capacity to give informed consent.
Predicting Favorable Outcomes in Hospitalized Covid-19 Patients

Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours

To assess if display of low risk of adverse event in EPIC can safely reduce length of stay and plan for discharge.

Eligibility Criteria:
Inclusion Criteria: Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a threshold at 90% PPV, with at least one low risk during their admission who are discharged alive and have not been in the ICU

Exclusion Criteria: Age \< 18 years not hospitalized for COVID19+.
Correlation of X-ray and Pathology With Needle Biopsy of Lung Tumors

The purpose of this study is to compare the features that the pathologist sees, when examining a lung tumor under the microscope, to the way that the tumor appears on the computed tomography (CT) scan. Features of the tumor may include abnormal blood vessels and areas in which tumor cells are dying. The samples that are taken during the needle biopsy contain information from one small part of the tumor. The investigators believe that they can show where in the tumor the samples came from, based on the CT scans during the biopsy procedure. If the investigators can accurately determine where in the tumor their samples came from, they can compare the features of that part of the tumor, as seen on the CT images, to the features of that part of the tumor as seen under the microscope. This research study also will give the investigators an idea of how much the biopsy samples are distorted in the process of preparing them for examination under the microscope.

Newer cross-sectional imaging methods allow improved visualization of anatomic detail-for example, high-resolution CT has a spatial resolution of less than 1 mm in all 3 dimensions. These imaging methods also provide a limited amount of physiologic information-for example, tumor perfusion as demonstrated by enhancement with intravenous contrast agents. Radiologic-pathologic correlation in the current era gives us the opportunity to work on a finer spatial scale and to take advantage of the additional physiologic information. Pathologic assessment of tissue has evolved at the same time. Tissue can be stained in the traditional way for microscopic evaluation but newer tools such as immunohistochemistry and, most recently, methods of molecular biology can be applied as well.

We are interested in radiologic-pathologic correlation in lung tumors. Tumors are known to be heterogeneous; we want to develop an approach that will allow us to explore their spatial organization. We cannot rely on surgical resection to provide tissue for pathologic evaluation, because the majority of lung lesions never come to resection. For example, only \~15% of lung cancer patients are surgical candidates. The remainder would be lost to the classical approach that depends on surgery. Percutaneous needle biopsy provides an alternative means of tissue sampling. This is a safe, effective and commonly used way to obtain samples of tissue ("core samples") from any given lung mass. The pathologist can process these core samples in the same way as a surgical specimen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a lung tumor that is likely to be malignant
* Subjects who have been referred for percutaneous needle biopsy
* The target lesion must be at least 10 mm in short-axis dimension.
* Subjects must have intravenous access.
* No history of significant allergy to intravenous contrast.
* Subjects must have sufficient renal function to receive intravenous contrast for enhancement of the CT images.

Exclusion Criteria:

* Vulnerable populations will be excluded.
* Subjects who lack the capacity to provide consent
* Subjects who are pregnant
S-ICD® System IDE Clinical Study

This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.

This clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the United States, Europe, and New Zealand.

Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure.

Eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study.

The safety endpoint will be evaluated through the use of a 180-day S-ICD System complication-free rate. The effectiveness endpoint will be evaluated using an induced ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD System.

Eligibility Criteria:
Inclusion Criteria:

* For patients without an existing transvenous device

  • Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment
* For patients with an existing transvenous device

  • Patient requires replacement or revision of an existing implanted transvenous ICD system
* Age is ≥ 18 years
* An appropriate pre-operative ECG per template provided

Exclusion Criteria:

* Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
* Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study.
* Participation in any other investigational study without prior written consent from the study sponsor.
* Patients with a serious medical condition and life expectancy of less than one year.
* Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous ICD system.
* Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
* Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
* Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.