cyrilzakka/clinical-trials huggingface dataset:
Exercise is Medicine: a Cohort Study

6,000 patients with HT and/or DM will be recruited to participate a 12-week EIM exercise intervention, which also involve consistent feedback and reminders using information technology (IT). The primary outcome will be improvement of blood pressure at 1-year. Other clinical outcomes will be obtained on recruitment (baseline), 12-week (immediately after EIM classes) and 1-year after recruitment


Eligibility Criteria:
Inclusion Criteria:

* have a clinical diagnosis of primary HT and/or type II DM from clinical medical record
* having less than 150 minutes of moderate intensity exercise per week OR having less than 75 minutes of intensive intensity exercise per week (this is set according to latest World Health Organization guideline)
* who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)

Exclusion Criteria:

* patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months)
* Patients on 3 or more anti-hypertensive medications (on maximum or maximal tolerable doses) are excluded because these patients have resistant HT and may represent another spectrum of disease.
* Patients with spinal cord compression, radiculopathy with active pain, or osteoarthritis of hips and knees that are on the waiting list for joint replacement surgery are excluded for safety reasons.
* acute myocardial infarction in last 6 months
* ongoing angina
* uncontrolled cardiac arrhythmia
* acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
* known aortic stenosis
* known heart failure
* known obstructive left main coronary artery stenosis
* uncontrolled ventricular rates
* complete heart block
* known hypertrophic obstructive cardiomyopathy
* mental impairment that limit co-operation
* resting blood pressure with systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg
* known anaemia with haemoglobin level less than 11gm/dL
* known uncorrected electrolyte imbalance
* known uncontrolled hyperthyroidism.
* For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months)
Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19

Based on Chinese studies, cardiac injury occurs in 20-30% of hospitalized patients and contributes to 40% of deaths. There are many possible mechanisms of cardiac injury in COVID-19 patients and increased myocardial oxygen demand and decreased myocardial oxygen supply are likely contributors to increased risk of myocardial infarction and heart failure. Interventions reducing the risk of cardiac injury are needed.

Ketone bodies, such as 3-hydroxybutyrate and acetoacetate, can maintain ATP production in the heart and brain during starvation. It has been suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced. In addition, the reduction in hospitalizations due to heart failure observed in type 2 diabetes patients treated with sodium-glucose cotransporter 2 inhibitors, is suggested to be partly attributable to increased levels of 3-hydroxybutyrate. Infusion with 3-hydroxybutyrate reaching a plasma level of approximately 3 mM had acute beneficial hemodynamic effects in patients with heart failure and in healthy controls in a study by Nielsen et al. Improved haemodynamics and reduced systemic oxygen consumption might be of great benefit in patients with COVID-19.

The primary endpoint is left ventricular ejection fraction. Secondary endpoints are conventional echocardiography parameters, peripheral blood oxygen saturation, venous blood oxygen saturation and urine creatinine clearance.

The study population are twelve previously hospitalized patients with COVID-19

The study design is a randomized placebo-controlled double-blinded crossed-over acute intervention study.


Eligibility Criteria:
Inclusion Criteria:

- Patients previously hospitalized at hospitals of greater Copenhagen and the Zealand region with a laboratory confirmed diagnosis of COVID-19 \> 18 years of age.

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"
* Diagnosis with chronic obstructive pulmonary disease
* Diagnosis with asthma
* Active treatment with sodium-glucose transporter 2 inhibitors
* eGFR \< 15 ml/min/1.73m2
* insulin-dependent diabetes
Peripheral Microvascular Resistance as a Predictor for Limb Salvage

Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. It is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. However, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography.

In the coronary circulation, coronary flow reserve (CFR) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. Studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. The study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.


Eligibility Criteria:
Inclusion Criteria:

* Chronic critical limb ischemia (Rutherford 4-6).
* Age ≥18 years
* Ability and willingness to sign the IRB approved Informed Consent form

Exclusion Criteria:

* Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible.
* Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients).
* Inability to understand the study or a history of non-compliance with medical advice;
* History of any cognitive or mental health status that would interfere with study participation;
* Currently enrolled in any pre-approval investigational study.
* Female subjects who are pregnant or nursing or planning to become pregnant within the study period;
* Known sensitivity to contrast media, which can't be adequately pre-medicated;
* Expected life span less than 6 months.
* Unable to read/understand/sign the English Language consent form
Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease

To determine if prasugrel is superior to clopidogrel in providing adequate antiplatelet effect in a high risk population that requires concomitant use of a Proton Pump Inhibitor (PPI).

To evaluate if simultaneous treatment with the PPI omeprazole and a P2Y12 receptor antagonist will influence the effect of either clopidogrel and/or prasugrel on platelet reactivity in patients with Coronary Artery Disease (CAD) or Peripheral Arterial Disease (PAD).

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 75 years of age
* Known or documented history of CAD or PAD prior to enrollment (a diagnosis of CAD may be based upon a positive stress test, prior documented acute coronary event, or angiographic demonstration of CAD; a diagnosis of PAD may be based upon an ankle-brachial index less than 0.9, or angiographic demonstration of PAD)
* Have not had thienopyridine therapy for at least 15 days before the study
* Have not had treatment with a PPI for at least 15 days before the study
* Are taking aspirin (75 to 325 mg/day) for at least one week prior to randomization

Exclusion Criteria:

* Have New York Heart association (NYHA) Class III and IV congestive heart failure
* Have any form of coronary revascularization (PCI or coronary artery bypass grafting \[CABG\]) planned to occur during the study
* Have undergone PCI or CABG within 30 days of entry to the study
* Have received a drug eluting endovascular stents in the past year
* Have any of the following:

  1. Prior history of hemorrhagic stroke or transient ischemic attack (TIA)
  2. Intracranial neoplasm, arteriovenous malformation, or aneurysm
  3. A body weight less than 60 kg
* Have prior history of GI ulcer disease or bleeding
* Have symptoms of dyspepsia or gastroesophageal reflux disease
* Have active internal bleeding or history of bleeding diathesis
* Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
* Have an International Normalized Ratio (INR) known to be \>1.5 at the time of evaluation
* Have a platelet count of \<100,000/mm3 at the time of screening, if known
* Have anemia (hemoglobin \[Hgb\] \<10 gm/dL) at the time of screening, if known
* Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin) that cannot be safely discontinued for the duration of the study
* Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or require daily treatment with NSAIDs during the study.
* Are receiving corticosteroid therapy
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care

ADHD is the most prevalent mental health disorder of childhood. The majority of children with ADHD receive their care in primary care settings. While the American Academy of Pediatrics (AAP) issued evidence-based guidelines and recommendations for pediatricians, most pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in evidence-based ADHD care and the likely effects on child outcomes, the development and testing of interventions aimed at improving ADHD care in primary care settings is necessary. Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines. This intervention model has been used to train over 200 physicians at 55 practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold increases in the use of evidence-based ADHD-related practice behaviors in participating physicians. To date, the intervention has been implemented as a quality improvement project with few experimental controls. The primary goal of the proposed study is to conduct an experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention. Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD patients will be included in the study. Chart reviews, parental interviews, and parent and teacher rating scales will be collected. Between- and within-group hierarchical linear modeling analyses will examine whether the intervention produces significant improvements in pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative intervention over typical care will be established by computing incremental cost-effectiveness ratios using cost and effect size estimates.


Eligibility Criteria:
Inclusion Criteria:

* Practice must have a minimum of two pediatricians who agree to participate.
* Practice must have an electronic billing system.
* Practice must have internet access at office.
* Practice must not have an on-site mental health professional.
* Practice must have a member of practice staff willing to be trained in human subjects certification and willing to consent families.
* Children must be in Grade 1-5.
* Children must be newly diagnosed with ADHD.

Exclusion Criteria:

-
Hospital for Special Surgery Shoulder Arthroplasty Cohort

Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes.

HSS is a world leader in total joint replacement including total shoulder arthroplasty. However, there is no systematic follow-up or evaluation of patients who have their shoulders replaced here.

The purpose of this study is to establish a prospective cohort of HSS total shoulder arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing evaluation of the results of our patients over time.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older and undergoing total shoulder arthroplasty at HSS

Exclusion Criteria:

* No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.
Facilitated Tucking Position's Effect on Comfort and Breastfeeding

This study investigated the effect of facilitated tucking in the early postpartum period on preterm neonate comfort and breastfeeding performance.

Individualized Developmental Care (IDC) offered by NICUs yields positive outcomes in preterm neonates and neonates. Those positions should be comfortable and safe to promote physiological stability and optimal neuromotor development. The facilitated tucking position is the position of the baby in its mother's womb. It calms the neonate and helps it feel safe and maintain body control. It also improves sleep quality, stabilizes physiological parameters, gives a sense of security, supports motor development, and optimizes energy use. The facilitated tucking position makes it easier for preterm neonates to undergo invasive procedures (heel blood collection, aspiration etc.). However, there is no published research examining the effect of the facilitated tucking position in the early postpartum period on physiological parameters, comfort, and breastfeeding performance in preterm neonates.

Eligibility Criteria:
Inclusion Criteria:

* Born at 35-37 weeks of gestation,
* Appropriate weight for the week of gestation,
* 1-min and 5-min Apgar score of ≥ 8,
* No oxygen therapy,
* No anatomical and physiological problems,
* Showing no signs of illness,
* No congenital disorder,
* No breastfeeding problems

Exclusion Criteria:

* No parental consent
* Medical intervention other than the follow-up
Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management. A Double Blind, Randomised Controlled Clinical Trial.

The purpose of this study is to determine the effectiveness of aerosolized pain medication (.5% bupivicaine) delivered into the peritoneal cavity after laparoscopic gastric bypass surgery. This double blind study will include 50 patients. 25 will receive the aerosolized pain medication and 25 will receive a placebo (normal saline). All 50 patients will receive routine/typical methods of post-operative pain management. Post operative pain scores of the patients will be examined to determine the effect of aerosolization.

Surgical Technique

1. 30 mls of 0.5% bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity.
2. All the patients will be under a consistent intra-abdominal pressure using CO2 and the laparoscopy will be carried out using the same, routine / typical surgical instruments.

A. Control Group (n=25): Aerosolized normal saline will be introduced at the end of the procedure, using a specially designed sterile catheter. The catheter will be inserted via trocar port under direct vision. The other end of the catheter will be connected to a 72" Edwards Lifesciences pressure tubing (Ref: 50P172), which will be connected to a B\&D 20cc syringe filled with 15 ml of normal saline and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent. The total dose of patient delivered normal saline will be 10 ml, with 5 ml remaining contained and undelivered within the catheter and 72" pressure tubing. Routine/Typical methods of post-operative pain management will be employed.

B. Aerosolized anesthetic (n=25): at the end of the procedure, the aerosolized local anesthetic will be introduced using a specially designed sterile catheter. The catheter will be inserted via trocar port under direct vision. The other end of the catheter will be connected to a 72" Edwards Lifesciences pressure tubing (Ref: 50P172), which will be connected to a B\&D 20cc syringe filled with 15 ml of anesthetic agent and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent. The total dose of patient delivered anesthetic will be 10 ml, with 5 ml remaining contained and undelivered within the catheter and 72" pressure tubing. Routine/Typical methods of post-operative pain management will be employed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between the ages of 18-65
2. Patients in general good health requiring elective surgery

Exclusion Criteria:

1. Female patients that are pregnant
2. Patients allergic to bupivicaine
3. Patients who have used narcotic drugs within 30 days of the surgical procedure.
LLLT to Reduce Low Back Pain

The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain.

Patients will be administered one of 4 treatment options using the Trident LLLT. The treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. All patients will receive two self-help patient education manuals. Low Back Pain will be compared among all 4 options at the end of week 6.

Eligibility Criteria:
Inclusion Criteria:

* Reporting a primary pain point in lower back.
* Pain intensity reported at baseline must be 4 and above on the Visual Analogue scale (PROMIS Numeric Rating Scale).
* Individual able to participate fully in all aspects of the study and have understood and signed study informed consent.

Exclusion Criteria:

* Have used pain medications or participated in a pain treatment within three days of study enrollment.
* Have an implanted device (including lap band) in the targeted area of Low Level Laser Treatment.
* Have used an investigational drug within 30 days of study enrollment.
* Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low level laser treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms of contraception include: Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD); Total hysterectomy or tubal ligation; Abstinence (no sex).
* Have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
* Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled diabetes type 2), active cancer, actively receiving l treatment for cancer or within 1 year of cancer remission.
* Surgical intervention for pain within 1 month prior to enrollment.
* Active infection, wound or other external trauma to the areas to be treated with the laser
* Known photosensitivity disorder.
* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma

Soft tissue sarcomas are rare malignant tumors. Liposarcoma constitute the most frequent histological subtype of retroperitoneal sarcoma. The prognosis of soft tissue sarcomas depend on clinical and histologic characteristics. Objective: Evaluate variables that may be related to overall survival and local recurrence free survival in patients with retroperitoneal liposarcoma. Methods: retrospective analysis of medical records of 60 patients attended from 1997 to 2017, who underwent surgical resection of retroperitoneal liposarcoma.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent surgical resection of retroperitoneal liposarcoma

Exclusion Criteria:

* Unresectable disease (upper mesenteric artery or vein involvement) or metastatic disease (sarcomatosis or distant disease)
Lower Urinary Tract Symptoms and School Functioning in Children

Children in primary school often suffer from lower urinary tract symptoms (LUTS), which may negatively impact their overall well-being. Co-occurring neurodevelopmental disorders (NDDs) can adversely affect children as well and can cause restrictions in their daily life, especially in their school-environment.

The goal of this observational study is to identify the prevalence of LUTS in Flemish primary school children.The main questions it aims to answer are:

* How prevalent are LUTS in regular primary education?
* Is there a relation with well-being in school environment?
* Is there an influence of co-occuring NDDs? Children, parents and teachers will be asked to fill in questionnaires related to this research question.


Eligibility Criteria:
Inclusion Criteria:

* Children in 4th-6th grade
* Parents whose children are in grades 1-6
* Teachers responsible for teaching children in grades 1-6
* Children who attend regular primary education
* Capable of speaking \& comprehending Dutch

Exclusion Criteria:

* High school students
* home-schooled children
* children who attend special needs education
* Language barrier to understanding Dutch
Psychological Effects of Implant Loss

Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Biological women
* Age \>18 years
* Have lost an implant after a mastectomy and immediate breast reconstruction

Exclusion Criteria:

* Inability to give informed consent
* inability to speak and understand Swedish
* relapse of breast cancer after the reconstruction
* metastatic disease
* psychiatric co-morbidity.