cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis

A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement.

Extensive in vitro R\&D investigations in Kibow's laboratories

Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).

Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.

Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.

Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P\>95%) and improved quality of life (P\>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions.

Eligibility Criteria:
Inclusion Criteria:

* Currently on hemodialysis
* 18 to 75 years of age
* Willing to give informed consent
* Baseline serum creatinine \>2.5 mg/dL

Exclusion Criteria:

* Pregnant or nursing women
* Refusal to sign the informed consent form
* Documented to have HIV/AIDS/Liver disease
* Active dependency on drugs or alcohol
* Currently on anticoagulant therapy
Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma

Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.

Markers that can be identified in the EBC of patients with asthma include pH, hydrogen peroxide, nitrogen oxides, eicosanoids, isoprostanes, adenosine, certain cytokines, chemokines, and growth factors. Concentrations of these biomarkers are influenced by inflammation, oxidative stress, and can be modulated by therapeutic interventions. There is evidence that some markers in EBC differ between patients with asthma and controls, and some of them can correlate with asthma severity score, lung function. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. We will also evaluate the effect of antiasthmatic treatment applied out of dust season on the number of exacerbations in "asthma epidemic" in September. We will evaluate the effect of exposure to tobacco smoke on antiasthmatic treatment.

Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction (EIB) as another phenotype of asthma. At the first study vist patients with EIB underwent fractional exhaled nitric oxide measurement (FeNO) and baseline spirometry, performed exercise treadmill challenge (ETC) and EBC samples were obtained at the end of ETC.

Eligibility Criteria:
Inclusion Criteria:

* children with mild to moderate asthma allergic to house dust mite exposed/nonexposed to tobacco smoke
* healthy children

Exclusion Criteria:

* sensitization to allergens other than house dust mites
* other chronic diseases
* asthma exacerbation
* pregnancy
* oral corticosteroids for 4 weeks before the study
* montelukast sodium for 2 weeks before the study
ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients

the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.


Eligibility Criteria:
Inclusion Criteria:

* Expected ICU stay \> 48 hours
* All patients (immunocompromised or immunocompetent).

Exclusion Criteria:

* Patients aged \< 18 years
* Refusal to take part in the study
* ICU-stay \< 48 hours
* Non availability of initial MDR or subsequent screening
* Participation in another study that could interfere with the risk of ICU-acquired colonization and infection with MDR bacteria
RespirAq Humidifier Usability During Invasive Ventilation

This study aims to capture preliminary safety and effectiveness information on a near-final humidifier device design and to provide data for more extensive research, if required. This feasibility study will investigate the following: process, resources, management, and scientific aspects of delivering humidification by the RespirAq humidifier device in ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for coronary artery bypass surgery (CABG) will be recruited before their surgical procedure at the Waikato district health board during February, March, and April of 2021.

Exclusion Criteria:

* Age \<18 years
* Have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
* Patients admitted for emergency CABG surgery
* Unable to provide written informed consent before surgery
* Patients who would be contra-indicated to HME humidification devices
Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

This is an international, multicenter trial to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational GLP-2 analogue. The trial consists of an evaluation period of 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for this trial prior to any trial specific assessment.
* Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with \<200 cm from duodenojejunal flexure.
* Subject must require PS at least 2 days per week and be considered stable.
* No restorative surgery intended to change PS requirements in the trial period.
* Age ≥18 years at screening.

Exclusion Criteria:

* Pregnancy or lactation.
* Body mass index equal or higher than 30 kg/m2 at the time of screening.
* Major abdominal surgery in the last 6 months prior to screening.
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors

Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint

Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with cardio-vascular disease (CVD) and type 2 diabetes, and also with risk factors for these diseases like hypertension, dyslipidemia, insulin resistance, and endothelial dysfunction. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. Most of these studies were done in white, Western populations in subjects fairly vitamin D sufficient, and accordingly, no benefits were to be expected. Also, in many studies the doses of vitamin D have been too low, and the studies underpowered. To firmly establish the role of vitamin D regarding CVD risk factors we will in the present study include 600 subjects with vitamin D deficiency (serum 25-hydroxyvitamin D (25(OH)D) \< 30 nmol/L) and randomize to high dose vitamin D (3000 IU per day) versus placebo for four months. The subjects will be recruited based on 25(OH)D measurements in the forthcoming 7th survey in the Tromsø study where more than 20 000 subjects are expected to attend. If our hypotheses are correct and the vitamin D supplement has a positive effect, this will be of great importance not only in countries with low sun exposure, but particularly for subjects in developing countries where vitamin D deficiency is highly prevalent.

Eligibility Criteria:
Inclusion Criteria:

* participated in The 7th survey in The Tromsø study
* vitamin D deficiency

Exclusion Criteria:

* primary hyperparathyroidism
* granulomatous disease
* reduced kidney function
* systolic blood pressure \> 174 mmHg
* diastolic blood pressure \> 104 mmHg
* diabetes
* renal stones last 5 years
* use of solarium on regular basis
* planned holidays in tropical areas
* clinical depression
* clinical signs of vitamin D deficiency (muscle weakness)
* use of vitamin D supplements
* serious illness
The Role of Parents in Adolescent Weight Loss

The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.


Eligibility Criteria:
Inclusion Criteria:

* Between 30 and 90% overweight
* Parent or guardian willing to participate

Exclusion Criteria:

* Major psychiatric disorder
Effect of Dynamic Cupping & Myofascial Release on Pain, ROM and Performance in Athletes With Low Back Pain

Data will be collected at Pakistan Sports Board Lahore. Study design will be Randomized Clinical Trial. Sample size is 28. Population will be divided into two Groups by Convinient Sampling Technique. Group A willl be Treated with Dynamic Cupping And Group B will be Treated with Soft Tissue Myofascial Release. Inclinometer, Back Pain Functional Scale, Functional Mobility Scale and Numerc Pain Rating Scale will be used to generate the outcomes of study.

The objective of this study is to compare the Effects Of Dynamic Cupping Versus Myofascial Release on Pain, Range of motion and Function in athletes with non-specific low back pain.

Tools to be used in this study will be :

Inclinometer: An inclinometer is a sensor used to measure the magnitude of the inclination angle or deformation of any structure

. Back Pain Functional Scale: a subjective scale used to measure the patient's physical function after low back pain.

FMS: The Functional Mobility Scale (FMS) has been constructed to classify functional mobility.

Numeric PAIN Ratig Scale: The numeric rating scale (NRS) is a pain the screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

The study will be collected from Sports related persons at Pakistan Sports Board Lahore. First, a consent form will be filled the person and then the data will be recorded through our questionaire on day 1 and then after 6 weeks of treatment. Group A will be treated with Dynamic Cupping and Group B will be treated with Myofascial release. Group A: will be an interventional group and it will be treated by using dynamic cupping. Heating pad will be applied for 10 minutes as a base treatment then olive oil or petroleum jelly will be applied and cup will be placed,a vacuum will be created by using a vacuum pump then the cup will be moved to and fro or in figure of 8 for 5 minutes. Group B : Will be a control group and it will be treated by soft tissue myofascial release. Heating pad will be applied for 10 minutes as a base treatment, and petroleum jelly will be applied to the area followed by soft tissue myofascial release technique for 5 minutes either crisscross, along the fiber or in Figure of 8.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* 18-35years(1)
* low Backpain
* NPRS (3 to 10 cut of value)
* Must be a Sports related persons.

Exclusion Criteria:

* Systemic Illness. (Diabetes mellitus,Tuberculosis, Arthritis, Scoliosis)
* History of Fracture in last 6 months
* Stayed out of Sports from last 6 months
* History of Disc Buldge and another structural problem.
ASSESSMENT OF PAIN USING A PAIN DIAGNOSTIC SYSTEM THAT MEASURS FACIAL MOVEMENT USING

Pain is a subjectively difficult, abstract and comprehensive concept that is at the core of the whole study, emerging in relation to various advancements, and detailed description. For non-controlling, stress-free, stress-or-thickness training for thromboembolic, pulmonary and other organ modalities, re-admission from discharge, thromboembolic, pulmonary and other reasons.

The scales of use in the assessment of pain in the conscious surgical patient who cannot communicate verbally, into the pain, are physically subjective. Ekman and Friesen are planning the movements of their muscles to be performed by an Action Coding process that could be experienced in 1978. system; It has been applied in pain, in the evaluation of pain in the postoperative period and in children, in the new clinical practice, and in the new and clinical practice.

Health professionals may be biased in diagnosing pain, especially in intensive care patients, and may underestimate pain. In the literature, it is seen that the child who is made with pain in his patients in education in the field of medicine is not used in his experiences, similar to the pain that measures the tastes of the faces of the single scales. In this context, standardized, continuous, objective and scalable pain measures indicate the practice environment. The aim of these people is to evaluate the pain in our surgical patients who cannot communicate clearly and clearly with pain diagnosis that measures facial movement.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Those with intubation/tracheostomy,
* Conscious, unable to communicate verbally,
* Glaskow coma score 13-15,
* Patients who agreed to participate in the study

Exclusion Criteria:

* Those with any facial abnormality that may alter facial expression analysis (facial paralysis, Poland-mobius syndrome)
* Those with neurological and mental disorders,
* Having a history of chronic pain,
* Those who have a condition that requires them to be in the prone position all the time (Pilonidal Sinus, ARDS, etc.),
* Patients who cannot speak the same language as the healthcare professional
Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.


Eligibility Criteria:
Inclusion Criteria:

* elective flexible bronchoscopy

Exclusion Criteria:

* admitted in Neonatal intensive care
* previous respiratory support: oxygen any device, non invasive or invasive ventilation
* patient who may benefit with continuous positive pressure during procedure
Use of Text Messages to Improve Care For Children Following an ED Visit for Asthma

BACKGROUND Asthma is a prevalent and troublesome pediatric condition. In 2013, Emergency Department (ED) providers treated over 3,500 cases of asthma-related complaints at Children's Hospitals and Clinics of Minnesota. Pediatric ED visits for asthma exceeds billions of dollars annually when including direct cost and lost productivity. Many of these visits and resultant costs are avoidable. Patients with well-controlled asthma do not typically exhibit these patterns, while patients with poorly controlled asthma show patterns of increased utilization of healthcare resources and lower quality of life. Evidence suggests that a text message reminder and educational program might positively influence pediatric asthma care practices.

RESEARCH QUESTION Does a targeted ED based text message intervention program improve outpatient follow-up and routine preventive care in pediatric asthma patients?

METHODS Study subjects will be block randomized based on age and insurance group. The experimental group will receive text messages with guidance towards follow-up care with their PCP and the importance of the flu vaccine for children with asthma. The control group will receive a series of educational self-care and health based text messages unrelated to asthma or the flu vaccine. Some self-report of behaviors will be captured via text message response.

ANALYSIS Primary outcomes for the educational versus targeted text message groups will be compared use Chi-square tests. Additional adjustments may be applied for missing data or if, despite randomization, there is substantial imbalance between group in key covariates (eg race/ethnicity, insurance type or asthma severity.)


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of patients aged 4 - 17 years (inclusive) will be eligible for study participation if they meet the following criteria:

  1. Presentation to the ED with a chief complaint related to an asthma exacerbation such as shortness of breath, respiratory distress, wheezing, etc...
  2. Receive an albuterol treatment in the ED
  3. Previous history of asthma as represented in the medical record or by parental report
  4. Have a cell phone that is able to receive text messages
  5. Able to communicate and provide consent in English or Spanish

Exclusion Criteria:

* Caregivers of patients will be excluded from this study for the following reasons:

  1. First episode of wheezing
  2. Admitted to the hospital
  3. Co-morbid respiratory disease:

     1. Cystic fibrosis
     2. Bronchiectasis
     3. Pulmonary hypertension
     4. Other chronic lung disease
  4. Current cancer diagnosis
  5. Previous cardiovascular surgery
  6. Inflammatory bowel disease
  7. Sickle Cell disease
The Use of Sugammadex in the Critically Ill

Moderate and Deep neuromuscular blockade (rocuronium administered to a train of four count 0 and post-tetanic count of 1-2) in critically ill patients needing intubation or procedures can be reversed immediately and effectively by sugammadex avoiding unnecessary paralysis in an already weakened population

The Critically ill is a special population needing immediate and aggressive treatments and interventions. Neuromuscular blockade is frequently used to secure an airway, optimize ventilation/oxygenation in ARDS, aid in maintaining hypothermia in patients post-cardiac arrest. Muscle relaxants can also contribute to neuromuscular weakness in the critically ill which can be a devastating condition. Appropriate depth of neuromuscular blockade is important but unnecessary paralysis need to be avoided. Rocuronium is one of the most popular neuromuscular blockade agents used in the critically ill (1). Sugammadex is a modified γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular blocking agents rocuronium and vecuronium (2). Sugammadex results in rapid, predictable recovery from moderate and deep neuromuscular blockade. Sugammadex has been mostly studied and used in the surgical population but its use outside the operating room is still very relevant. The investigators set up to evaluate the potential benefit that may result from the reversal of NMB with sugammadex compared to neostigmine.

Objectives

In critically ill patients undergoing intubation receiving appropriate depth of NMB (moderate and deep blockade) the investigators will assess:

Primary objective:

1. To determine if choice of reversal agent affects time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio \>0.9

Secondary objectives:

1. To document the ability of 1.0 mg/kg rocuronium (maximum 100 mg) to achieve satisfactory intubation conditions in the ICU, based on measurement of the number of intubation attempts and intubation grades in the entire cohort
2. To document General adverse effects: Hemodynamic instability, need for vasopressors etc

Eligibility Criteria:
Inclusion Criteria:

* Adult patients requiring intubation in the intensive care unit

Exclusion Criteria:

* Patients younger than 18 yr, to have known or suspected neuromuscular disease, allergies to medications to be used during intubation, a (family) history of malignant hyperthermia or severe renal insufficiency (glomerular filtration rate \<30 ml/h) will not be eligible.
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation

The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. The purpose of the study is to determine the ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in children which occur in response to Dexmedetomidine sedation. The investigators postulate that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX) sedation in children the investigators can delineate changes in cardiac output, stroke volume, and systemic vascular resistance associated with observed changes in heart rate and blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients (1 month to 18 years of age)
* Eligible for Radiology Sedation Service for CT scan and Nuclear Medicine
* Scan procedure

Exclusion Criteria:

* Pacemakers and Vagus Nerve Stimulator
* Mitral or Aorta Valve Dysfunction
* Dextrocardia
* Second or Third degree heart block
* Current diagnosis of Cardiac, Pulmonary, Hepatic or Renal Failure
* Current diagnosis of pulmonary masses/tumor/pleural effusions/pneumonia/edema
* Pericardial effusion
* Concomitant use of hypertension medications including ACE inhibitors, beta receptor and calcium channel blockers.
* Large Implanted Metallic Devices (including orthodontic braces, spine rods, plates and screws)
* Allergy to device electrodes