cyrilzakka/clinical-trials huggingface dataset:
Quality of Life and Nutritional Improvements in Cirrhotic Patients

The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction with the use of nutritional concepts is effective in improving morbidity and quality of life in cirrhotic patients suffering from hepatic encephalopathy (HE).

Prevention of portal hypertension complications should be at the forefront. In doing so, the end result will be an improvement in the multitude of morbidity and mortality issues. The proposed prospective trial will compare patients with similar demographics and medical and clinical settings utilizing standard of care therapy. Study subjects will be randomly assigned into two treatment groups. Group one will receive Lactulose 30ml three times a day as SOC and Rifaximin Placebo 550mg twice a day with nutritional supervision and group two will receive Rifaximin 550mg twice per day as SOC and Lactulose placebo 30ml three times per day with nutritional supervision.

Eligibility Criteria:
Inclusion Criteria:

* Male and female gender of Age 18 years or older
* Liver cirrhosis defined as one or more of the following: Radio-graphically proven portal hypertension (CT with nodular appearance) or Liver biopsy with cirrhosis
* Model for End Stage Liver Disease (MELD) score \< 20
* Willingness to provide written informed consent, and participate in all study requirements
* Sodium greater than 130 meq/L
* Conn Score \< 2

Exclusion Criteria:

* Active alcohol consumption
* Serum total bilirubin level \> 5 mg/dl
* History of hepatocellular carcinoma (HCC) and malignancies other than basal cell carcinoma of the skin
* Pregnant or breastfeeding women
* Subject has renal insufficiency requiring routine dialysis
* Poorly controlled diabetes as defined by HgA1C \> 10
* Narcotic/psychotropic usage other than a stable dose of antidepressant and/or methadone. Neurontin (gabapentin) and Lyrica (pregabalin) are permitted if the subject has been on a stable dose for at least 2 months prior to the screening visit and no change of dosing is expected throughout the length of the trial
* Any of the following diagnoses:
* HIV
* Evidence of severe concomitant illness or any condition that makes them unsuitable for the study in the opinion of the investigator(s)
* Subject has received an investigational drug within 30 days prior to enrollment
Effect of Pyridorin in Patients With Diabetic Nephropathy

The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
* Sitting blood pressure of \<=170/100 mm Hg at weeks -2 and -1
* Hemoglobin A1C \<=12% at week -2
* Patients with diagnosis of diabetic nephropathy as defined by

  1. Serum Creatinine \<=2.0 mg/dL at weeks -2 and -1
  2. Urinary albumin excretion \>=300 mg/24 hours at week -2
  3. Diagnosis of diabetic retinopathy
* Creatinine clearance \>=40 mL/min at weeks -2 and -1
* Voluntary written consent to participate in this study

Exclusion Criteria:

* History of allergic or adverse response to any B vitamin
* History of major cardiovascular or cerebrovascular events
* History of cancer except adequately treated basal or squamous cell carcinoma of the skin
* History of diabetic ketoacidosis
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Tiral in Healthy Male Volunteers

The safety and tolerability of single and multiple administration of DWP212525

The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult male volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 55 years, Caucasian
2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
3. Received a sufficient explanation on this study
4. Eligible as subjects in the study

Exclusion Criteria:

1. History of diseases such as clinically significant disease of hepatobiliary
2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
3. Hemato-oncologic diseases, including malignant tumor diagnosis
4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test
Reduction of Cardiovascular Risk in Severe Mental Illness

Background:

Patients with severe mental illness (SMI) have a higher prevalence of cardiovascular risk factors (CVRF) than the general population and a control of these risk factors poorer. Serious mental illness often causes health teams to focus interventions in mental illness and put aside the CVRF.

Objectives:

This project aims to assess the CVRF, stratify the cardiovascular risk, adequate drug treatment to reduce this risk and evaluate the effectiveness of an intervention by professional community nurses in patients with SMI.

Materials and Methods:

Prospective study of a cohort of patients over 18 years with a diagnosis of SMI with two cross sections to evaluate the cardiovascular risk and adequacy of drug treatment. The investigators calculate the risk to the cardiovascular risk tables with the SCORE (Systematic Coronary Risk Evaluation) for countries of low cardiovascular risk and the of Framingham REGICOR (Heart registry of Girona, Spain). The adequacy of pharmacotherapy will be assessed contrasting it with the recommendations of the Program of Preventive Activities and Health Promotion of Family medical association. The intervention will be conducted by professional nurses and consist of an initial psycho-educational intervention, and two more reinforcement throughout twelve months, of duration less than 30 minutes that will be addressed in an integrated manner the clinical situation with regard to cardiovascular risk. If necessary, pharmacological treatment will be prescribed. Twelve months after the first intervention, a second evaluation on cardiovascular risk and the effectiveness of the intervention will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a severe mental illness as schizophrenia, bipolar disorder, affective disorder, schizoaffective disorder or personality disorder and others who receive clinical follow-up in Osona (a county) mental health center.
* Inclusion will be delayed in patients with acute psychiatric symptoms.

Exclusion Criteria:

* Renal or hepatic failure, metabolic or endocrine disorder
* Patients who do not accept to participate
Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players

The objective of this clinical study is to investigate the effects of applying Kinesio Taping to female soccer players with PD and comparing this application with a placebo group.

Women's football has grown in the last decade, but there is still a need to study how the menstrual cycle affects players' performance. Primary Dysmenorrhea (PD), a common menstrual pain, impacts between 50% and 90% of women, reducing their participation in sporting activities. Many players notice that their performance is affected during the cycle, and the use of anti-inflammatories is not always effective. Therefore, it is important to implement simple measures that improve the quality of life and performance of players. Alternatives such as physical therapy and Kinesio Taping (KT) can help alleviate symptoms. The literature shows that KT is a technique with the potential to produce tactile sensory impulses on the skin, which can block or reduce the arrival of painful sensations to the brain, and could therefore be interesting in the treatment of PD. Therefore, the present study aims to investigate the effects of applying Kinesio Taping to female soccer players with PD and comparing this application with a placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Women practicing football from the Mulheres em Campo project
* Primary dysmenorrhea
* Aged between 15 and 17 years
* Regular menstrual cycle (28 ± 7 days)
* Nulliparous
* Not having an intrauterine contraceptive device or using oral contraceptives
* DP will be defined according to the Visual Analogue Scale from 5 points.

Exclusion Criteria:

* Women who do not play football in the Mulheres em Campo project
* Secondary dysmenorrhea
* Diagnosed with serious comorbidity
* Skin lesions in the abdominal region
* Allergy to adhesive tapes.
Pediatric Distal Radius US Study

The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient with a wrist injury.

Exclusion Criteria:

* Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery
Total Knee Arthroplasty: Functional and Clinical Outcomes

The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring primary total knee replacement
2. Patients willing and able to comply with the follow-up visits and evaluations
3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

1. Patients with inflammatory arthritis
2. Patients with diabetic neuropathy
3. Patients unable to ambulate without the use of an assistive device prior to surgery
4. Patients unable to stand in single limb stance on each foot prior to surgery.
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the correction or maintenance treatment in participants with anemia secondary to chronic kidney disease who have recently initiated dialysis treatment for end-stage renal disease.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
* Mean Screening hemoglobin between 8.0 and \<11.0 grams per deciliter (g/dL) (inclusive)
* Serum ferritin ≥100 nanograms per deciliter (ng/mL) and TSAT ≥20% during Screening

Exclusion Criteria:

* Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
* Red blood cells transfusion within 8 weeks prior to randomization
* Anticipated to recover adequate kidney function to no longer require dialysis
* Uncontrolled hypertension
* Severe heart failure at Screening (New York Heart Association Class IV)
* Acute coronary syndrome (hospitalization for unstable angina, myocardial infarction); surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity); surgical or percutaneous valvular replacement or repair; sustained ventricular tachycardia; hospitalization for congestive heart failure; or stroke within 12 weeks prior to or during Screening.
* Participants meeting the criteria of erythropoiesis-stimulating agent resistance within 8 weeks prior to or during Screening defined as follows

  1. epoetin: \> 7700 units/dose three times per week or \>23,000 units per week
  2. Darbepoetin alfa: \>100 micrograms per week (mcg/week)
  3. methoxy polyethylene glycol-epoetin beta: \>100 micrograms (mcg) every other week or \>200 mcg/month
* Hypersensitivity to Vadadustat, Darbepoetin alfa or any of their excipients
Liquorice and Salivary Cortisol

Salivary cortisol is used as a diagnostic analysis in the investigation of suspected Cushings' syndrome. This study evaluates if liqourice intake increases salivary cortisol in healthy individuals. Late night salivary cortisol and cortisone is analysed before, during and after 7 days of liqourice intake in three different doses.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-65 years.

Exclusion Criteria:

* Known pituitary or adrenal disease
* Medication with glucocorticoids (incl. inhalation, nasal, dermal)
* Known hypertension or blood pressure \>140/90 at screening
* tobacco use
* Subjective problems in oral mucosa or saliva
* Abnormal diurnal rhythm (awake 03:00 - 05:30)
* Difficulties taking liqourice for 3 weeks or refraining from liqourice during 4 weeks
A Case Series of VPIA Using Remifentanil for Labour and Delivery

This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.

This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. This system will study the parturient's pattern of analgesic use in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.

The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached.

Eligibility Criteria:
Inclusion Criteria:

* Patients who choose to use parenteral opioid for pain relief with informed consent
* Patients who refuse labour epidural analgesia
* Patients with contraindication to epidural analgesia (eg. Thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)

Exclusion Criteria:

* Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
* Patients with difficulty in communication due to language differences
* Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogs
* Patients with severe respiratory disease
* Patients with history of drug dependence of recreational drug abuse
* Patients with unmanaged foetal bradycardia
Incidence of Adductor Canal Catheter Dislodgment

The goal of this observational study is to determine the incidence of dislodgement for adductor canal catheters after total knee arthroplasty on post-operative day 1. We will also attempt to identify factors associated with secondary catheter failure.

Total knee arthroplasty (TKA) is a common procedure for indications including osteoarthritis and malignancy involving the knee, with over 55,285 knee replacements performed between 2020-2021 in Canada. Ultrasound guided continuous adductor canal block (cACB) is the standard of care for postoperative analgesia for this procedure. The catheter is not always as effective at providing analgesia as would be expected - which could be due to displacement of the catheter. This displacement is most likely to occur peri-operatively or during physiotherapy post-operatively and as such, post-operative assessments can provide useful insight into causes of secondary failure. This prospective observational study aims to estimate the cACB dislodgment on POD 1 rate at a high volume, tertiary care referral centre, and identify factors associated with dislodgement and clinical sequelae. As this is an observational/QI study of the current standard of care at Sunnybrook Health Sciences Centre, anesthesiologists are free to use the cross sectional versus parallel insertion of the cACB per their discretion.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for Total Knee Arthroplasty
* Older than 50 years

Exclusion Criteria:

* Body Mass Index greater than 40
* Chronic opioid consumption (greater than 30mg oral morphine equivalent daily)
* Contraindication to Adductor Canal Catheter
Prevalence of Cervical Extension of the Thymus in Children

This prospective, observational study included all pediatric patients who were referred to the radiology department for neck ultrasonography between August-October 2018. A high-frequency probe was implemented and 220 patients were examined.

This prospective single-centered study was approved by the Institutional Review Board for Ethical Issues in Clinical Research and is compatible with the Declaration of Helsinki. The patients referred to the radiology department for the neck US with various clinical indications between August-October 2018 were included in the study. The informed consent was taken from the parents of the patients. The patients who had any systemic illness, were treated for malignancy or had any history of lower neck or chest surgery, were excluded.

The neck US was performed by two radiologists. The length of the extended thymus, from the upper margin of the manubrium to the superior edge of the thymic tissue on the transverse plane, was measured in millimeters and recorded.

al analysis of the data was performed in SPSS, Version 24 program (IBM, Armonk, New York). Pearson Chi-Square Test was used in comparing categorical data between groups.

Eligibility Criteria:
Inclusion Criteria:

* The patients referred to the radiology department for the neck US with various clinical indications between August-October 2018 were included in the study.

Exclusion Criteria:

* The patients who had any systemic illness, were treated for malignancy, or had any history of lower neck or chest surgery, were excluded.
Evaluation of Treatments to Improve Smoking Cessation Medication Adherence

Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.

Nonadherent use of smoking cessation medications is very common and highly associated with cessation failure. However, little is presently known about how to improve adherence and whether improved adherence will actually boost cessation success (i.e., its causal role is unknown). This research represents groundbreaking integration of 1) basic theory and data on tobacco dependence, adherence, and intervention mechanisms with 2) the state-of-the-art Intervention Optimization Cycle methodology. This methodology uses factorial designs to efficiently engineer and evaluate intervention components, and to develop an optimal comprehensive treatment package. Participants in Project 3 will be smokers (N = 544) visiting primary care clinics for a regular outpatient visit who, when asked, express an interest in quitting and agree to participate in a smoking cessation research study. The experiment will comprise five experimental factors (2X2X2X2X2), and participants will have a 50% chance of being assigned one of the levels of each factor. The five factors include one medication factor (medication duration: 8 vs. 26 weeks), one counseling factor (maintenance counseling vs. no maintenance counseling), and three adherence factors: 1) Cognitive Medication Adherence Counseling (C-MAC); C-MAC vs. no C-MAC; 2) electronic medication monitoring device (the Helping Hand) + Feedback vs. the medication monitoring device alone; and 3) automated adherence prompting phone calls vs. no prompting.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Report smoking at least 5 cigarettes per day for the previous 6 months;
* Able to read and write English;
* Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
* Plans to remain in the intervention catchment area for at least 12 months;
* Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
* All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.

Exclusion Criteria:

* Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
* Study candidate is pregnant, trying to get pregnant, or nursing.
* A history of psychosis or bipolar disorder
* A history of skin or allergic reactions while using a nicotine patch.
* Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
Generalized Anxiety Disorder Adjunct Study

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo


Eligibility Criteria:
Inclusion Criteria:

Provision of Informed Consent

* Documented diagnosis of Generalized Anxiety Disorder
* Female patients must not be pregnant and be willing to use a reliable method of birth control
* Be able to understand and comply with study requirements

Exclusion Criteria:

Other psychiatric disorders that could confound the study results, as judged by the study doctor

* Moderate to severe depression
* Other clinically relevant diseases, as judged by the study doctor
* Medication that you are taking, as judged by the study doctor