cyrilzakka/clinical-trials huggingface dataset:
Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

Patients with or without diabetes may have high blood sugar levels due to stress response of the body during heart surgery. This study is being done to determine if maintaining normal blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney failure, stroke and prolonged time on the breathing machine (artificial ventilation) within 30 days after surgery.

Rigorous intraoperative glycemic control may be of paramount importance in affecting outcomes after cardiac surgery. There is evidence that strict control of glucose levels postoperatively results in improved outcomes in patients undergoing cardiac surgery. There is currently no consensus on optimal management of hyperglycemia intraoperatively. The aim of this prospective randomized controlled clinical trial is to determine whether normalization of intraoperative glucose levels with insulin improves outcomes. The comparison group will be treated with current standard practice to control hyperglycemia during surgery. The primary outcome is a composite of mortality, sternal wound infections, prolonged pulmonary ventilation, cardiac arrhythmias (new-onset atrial fibrillation, heart block requiring permanent pacemaker, cardiac arrest), stroke and acute or worsening renal failure within 30 days after surgery. Secondary outcome measures are length of intensive care unit and hospital stay as well as safety and efficacy of the study insulin infusion protocol.

Eligibility Criteria:
Inclusion Criteria

All subjects accepted for this study must be:

1. \>=18 years of age
2. Undergoing an elective cardiac surgical procedure

Exclusion Criteria

Subjects who have one or more of the following will be excluded from the study:

1. Undergoing surgery not utilizing cardiopulmonary bypass
2. Unable to grant informed consent or comply with study procedure
3. Undergoing emergency open heart-surgery

3. Are allergic to any of the excipients in insulin
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle

Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.

The author wants to see the effect of short needle in patients undergoing retinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing pars plana vitrectomy under local anesthesia

Exclusion Criteria:

* Patients allergic to local anesthetic solutions
* With local sepsis
* Serious impairment of coagulation
* Orbital abnormalities
* Unable to cooperate in maintaining a relatively motionless supine position
* Who refused the anesthetic technique
Defining the Skin and Blood Biomarkers of Ichthyosis

Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper understanding of this disease is required to develop better treatments. There are different types of cells and cell-produced signals (biomarkers) that are being studied in order to help find these new treatments. Looking at biomarkers has been successful in helping us to understand other skin disorders better. The purpose of this study is to determine which blood and skin biomarkers characterize ichthyosis.

Hypothesis: We predict that the biomarkers correlating with disease activity in Netherton syndrome will be different than the biomarkers found to correlate with the lamellar and other ichthyosis phenotype.

Objectives:

1. To define a panel of skin and blood biomarkers associated with disease activity and pruritus in Netherton syndrome, lamellar ichthyosis, and other ichthyosis subtypes.
2. To determine if blood samples can serve as surrogates for skin immune activation and will correlate with disease severity.
3. To determine FLG, SPINK5, TGM1, or other mutation via buccal/saliva samples in ichthyosis subjects
4. To determine differences in alterations of epidermal lipids and proteins in the outer stratum corneum of epidermis collected from tape strips in patients with ichthyosis compared to the general population. There will also be a difference detected in epidermal lipids from blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Control and ichthyosis subjects may be of either sex and must be between 1-60 years of age at the time of enrollment
* Ichthyosis subjects include individuals with a diagnosis Netherton syndrome, lamellar ichthyosis, or other ichthyosis subtypes
* Ichthyosis subjects should not have administered systemic immunosuppressant therapy in the month before the study
* Ichthyosis subjects should not use topical immunosuppressants in the week before the study
* Ichthyosis subjects should not have applied emollients to the planned biopsy sites within 12 hours before biopsy, but can be applied elsewhere
* Controls may have no inflammatory disease, atopy, or obvious xerosis (urticaria, food allergy, allergic rhinitis or conjunctivitis, asthma)
* Controls for skin sampling may have no observable abnormality in the sampled skin and, to further assure the normality of the "normal" skin edges, must not have evidence of inflammation or epidermal change in the lesion to be surgically removed
* Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol

Exclusion Criteria:

* Subjects who are unable to give informed consent or assent
* Subjects who administered anti-inflammatory systemic and topical therapy or emollients that do not comply with inclusion criteria prior to blood and biopsy sampling
* Subjects whose main diagnosis is deemed unsafe by the study investigator for study participation
Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength

Gluteus maximus transfer following THA does not improve abductor strength - a case-control gait analysis study of 15 patients with gluteus medius disruption

The investigators have compared 15 gluteus maximus transferred patients with the use of a gait analysis system based on reflective markers and force plates to objectively evaluate the gait performance pre- and postoperatively.

The gluteus maximus flap transfer (GMT) is a surgical technique to improve gait kinematics and kinetics as well as reduce pain and ameliorate functional outcome in patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA). The investigators used a gait analysis system based on reflective markers and force plates to objectively evaluate gait performance pre- and postoperatively.

Methods Gait analysis was performed in 15 patients who underwent GMT and were examined with an optical tracking system before and at a minimum of 13 months after the operation. Mean age was 69 years (SD=11), all were females. Median follow-up time was 24 (13-60) months. The primary outcome was hip abduction moment (Nm/kg) during gait. The control group consisted of 66 subjects without any gait pathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)

Exclusion Criteria:

* THA prior to the muscle transfer
A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures, be able and willing to provide a written informed consent.
2. 18-55 years of age at the time of signing informed consent.
3. SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
4. Subjects with good general health, no clinically significant abnormalities.

Exclusion Criteria:

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
3. Abnormal and clinically significant blood pressure at screening.
4. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
5. Participation in other clinical trials.
6. Presence of any clinically significant results in examination at screening visit.
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
8. Presence of - clinically significant ECG results.
9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
10. Addiction to tobacco and alcohol.
11. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Exercise Study Including Patients With Hypertrophic Cardiomyopathy

The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 - 80 years old.
2. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) \> 13 mm in any wall segment.
3. Exercise £ 30 minutes, 1 day per week for the previous 3 months.
4. Agreement to be a participant in the study protocol and willing/able to return for follow-up.

Exclusion Criteria:

1. History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
2. Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
3. Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
4. Hypotensive response to exercise (\> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
5. Pregnancy.
6. ICD placement in last 3 months or scheduled.
7. Life expectancy less than 12 months.
8. Inability to exercise due to orthopedic or other non-cardiovascular limitations.
Optimizing the Patient Experience Through Provider Coaching or Communication Intervention

Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction.

Aims, purpose, or objectives:

To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction.

Eligibility Criteria:
Inclusion Criteria:

• Clinicians of Primary Care Mayo Clinic

Exclusion Criteria:

* Not clinicians of Primary Care Mayo Clinic or Residents within Rochester Primary Care Clinicians from Family Medicine, or Clinicians from Community Internal Medicine Geriatrics, Palliative Medicine, and Community Pediatrics and Adolescent Medicine
Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients

Preoperative anxiety is a common occurrence for many patients undergoing all types of surgery. Patients with a high level of anxiety before surgery have been shown to have numerous negative outcomes both intra-operatively and post-operatively. Many studies have shown that preoperative psychological interventions that aim to reduce anxiety also result in improved post-operative behavioral and clinical recovery. Currently, the most common method to treat preoperative anxiety is the administration of a prescription benzodiazepine. However, there is limited clinical evidence that supports the use of sedative premedication, such as with a benzodiazepine, before surgery. Complementary integrative medical therapies including music, massage, guided imagery, and deep breathing have been proposed to minimize stress and pain in surgical patients. These therapies are thought to be effective by evoking the relaxation response through stimulation of the parasympathetic nervous system and engagement of the patient in the healing process. Relaxation and deep breathing, particularly, have been shown to reduce pain, anxiety, and "tension-anxiety" in hospitalized patients. Based on this evidence, a guided paced deep breathing module has been proposed to reduce preoperative anxiety in patients undergoing gynecological surgery at Mayo Clinic Rochester Methodist Hospital. In this study, patients' anxiety will be assessed pre-intervention on a 0-10 numeric rating scale, as well as post-intervention and a paired t-test will be used to assess effectiveness. Additionally, qualitative questions will be administered via a questionnaire post-intervention to gain more insight on the effectiveness of the intervention. The feasibility of the intervention in the busy preoperative setting will be evaluated by assessing how many times a patient is interrupted while participating in the paced deep breathing module. If this module is found to be effective in reducing patients' anxiety, it will be implemented into practice so that every patient undergoing gynecological surgery, at the institution, will be offered the module preoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Women
* aged 18 years or older
* undergoing gynecological surgery at Rochester Methodist Hospital
* roomed in pre-operative area on Eisenberg 1-4
* English-speaking
* Able to complete pre- and post-intervention questionnaires
* Able to read and understand informed consent form

Exclusion Criteria:

* Non-English speaking women
* first-case of the day gynecological surgery patients
Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.

This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.

Patients will be co-enrolled in this study and an ancillary study for administration of Bendroflumethiazide. Administration of bendroflumethiazide will take place under an ancillary protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic clinical diagnosis of HF with a documented ejection fraction \<40%.
2. Use of beta blocker, ACE, ARB or neprilysin inhibitor (sacubitril/valsartan), aldosterone antagonist, and SGLT2 inhibitor at ≥50% guideline directed doses for 30 days with no plan for titration/change during the study period.
3. Chronic stable use of ≥80mg furosemide equivalents per day for ≥ 30 days
4. Peak FENa \< 5% following 10mg IV bumetanide challenge at the screening visit
5. Absence of hospitalizations in the previous 3 months.
6. At optimal volume status by symptoms, exam, and dry weight.
7. Serum potassium ≤ 5.0 mmol/L
8. Serum sodium ≥ 130 mEq/L
9. Age \> 18 years

Exclusion Criteria:

1. GFR \<20 ml/min/1.73m2
2. Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg)
3. History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy
4. Hemoglobin \< 8 g/dL
5. Pregnant or breastfeeding
6. Inability to give written informed consent or comply with study protocol or follow-up visits
Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.

This is an international multi-center study. Chest radiographs (CXR) from different participating centers will be collected to develop an AI algorithm to detect COVID-19 pneumonia. This will be tested on external hold out datasets from different centers using SARS-CoV-2 by Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Assay as ground truth.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients \>18 years of age
* Attended any of the participating institutes between February 1, 2020 until September, 2020
* Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection
* frontal CXR of patients pre-covid pandemic

Exclusion Criteria:

* Unavailability of patient demographics and clinical data
* Inconclusive RT-PCR results
* CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site
* CXR not in a retrievable or processable format for AI inference
COVID-19, Obesity and Lifestyle in Children

This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.

The threat of the severe acute respiratory syndrome coronavirus (SARS-CoV-2, from here onward mentioned as COVID-19) and the national measures to restrict transmission of COVID-19 in the Dutch population have caused a radical change in the daily life of Dutch citizens. Closing of schools and public locations, even as the public order for social distancing and self-isolation, is affecting the daily structure and lifestyle habits of Dutch children greatly. These radical changes in the current situation could yield important information regarding the health behaviour of children and their families. Knowledge of these changes and their effects on the health behaviour of these children and their families could influence future interventions and regulations regarding health behaviour. Current (preliminary) prevalence figures show that up to 80% of patients infected with COVID-19 are overweight or obese, indicating that being overweight or obese could be a potential adverse predisposition in the course of a COVID-19 infection. In the light of this (and possible future) pandemic, it is important to investigate the effects of the COVID-19 pandemic on the health behaviour i.e. lifestyle of children (aged between 4 and 18 years) and their families and especially the effects on possible weight gain during the COVID-19 pandemic. Earlier studies demonstrated that in particular children with overweight/obesity gain weight in situations when schools close such as during summer holidays and also during (economic) crisis. It is of importance to investigate the effects of the Corona-crisis in particular in these children with a high health risk.

This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in lean children and children with overweight and obesity. It evaluates differences in subgroups, e.a. lean/overweight children, socio-economic status, gender and age.

Study design is a mixed-methods study. Children and/or parents will receive online questionnaires regarding lifestyle during governemantal measures due to the Covid-19 pandemic, such as closure of schools and sportclubs.

In addition, several children and parents will be interviewed about the changes in lifestyle, and their needs for working on lifestyle, during the pandemic, for in-depth qualitative information.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 - 18 years.
* Living in The Netherlands.

Exclusion Criteria:

* No signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older)
Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS

This was a prospective double blind study conducted on 200 polytrauma patients admitted to King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in surgical ICU. All patients were having severe chest trauma, contused lungs either with or without severe head trauma.

Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week, while patients of Group B received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes. • Temperature was measured every 3 hours for 2 weeks. • ABG was done every 8 hours for 2 weeks. • CBC including white cell count was done daily and for 2 weeks. • Complete renal functions daily (urea and creatinine serum level) for 2 weeks. Any patient showing rise in the creatinine level was recorded and excluded from the study. • Chest X-ray for all the patients was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. • All patients received anti-stress (Omeprazole 20 mg IV every 12 hours). • Oro-gastric tubes were inserted to all patients and feeding was started within 24 hours.Daily evaluation for conscious level and need for sedation and ventilation were done for all patients. • Tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative culture for 2 weeks. • Blood culture was also taken 2 times per week for 2 weeks. • The planned duration of the study is two weeks from diagnosis of VAP and starting the antibiotics so any patients who failed to be weaned within this period were considered morbidity and recorded.

Eligibility Criteria:
Inclusion Criteria

patients with respiratory failure diagnosed by ABG,chest Xray, and clinical by Arterial oxygen low saturation.

Exclusion Criteria:

* Any other types of respiratory failure rather than trauma
Effect of Non-Invasive Ventilation in Cystic Fibrosis Patient With Chronic Respiratory Failure.

There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients.

The effects of long term mechanical ventilation for the treatment of respiratory failure in patients with neuromuscular diseases is well established.

Long term non-invasive ventilation is commonly used in the treatment of Cystic Fibrosis patients with respiratory failure. However, the benefits of this treatment have never been studied in randomized control trials and are unknown.

The goal of this multicenter study is to evaluate the effects of the addition of non-invasive ventilation to the standard therapy in stable Cystic Fibrosis patients with chronic hypercapnia.

Two groups of patients will be followed: The first group will receive standard treatment for advanced Cystic Fibrosis according to international guidelines, the second group will receive the same treatment plus non-invasive ventilation (4H/day). The follow up time will be one year for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Cystic fibrosis
* Chronic hypercapnia on room air in stable condition (PaCO2 between 45 and 55mmHg in two occasions separated by more than 4 weeks)
* Informed consent

Exclusion Criteria:

* Current treatment with non-invasive ventilation
* PaCO2 more than 55 mmHg
* Recent pneumothorax (within past 3 months)