cyrilzakka/clinical-trials huggingface dataset:
Immune Response to Influenza Vaccine in ESRD Patients

On-line hemodiafiltration (HDF) clears more azotaemic toxins compared to high-flux hemodialysis (HD). The response to vaccination is impaired in dialysis patients. We aimed to study the immune responses to influenza vaccine in dialysis patients treated by HDF vs. HD.


Eligibility Criteria:
Inclusion Criteria:

- ESRD patients aged 18 years or older, who had been treated for more than one month of either thrice weekly on-line hemodiafiltration (HDF) or conventional high flux hemodialysis (HD), with a session dialyzer urea clearance (Kt/V urea) of 1.2 and greater, with a convection volume target of 20 L/session for the HDF group

Exclusion Criteria:

* Had received any vaccination within the previous four weeks, or influenza vaccination within six months
* Patient who reported upper respiratory tract symptoms within three days prior to the study vaccination
* A history of allergy to influenza vaccine or egg
* Thrombocytopenia
* In receipt of immunosuppressant medications, chemotherapy, or had immunodeficiency
Clinical Trial of L. Reuteri in Infantile Colic 2017

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21

Eligibility Criteria:
Inclusion Criteria:

* Younger than 10 weeks of age
* Full term infant (37-42 weeks gestational age)
* Birth weight ≥ 2,500g
* Apgar score ≥ 7 at 5 minutes
* Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment)
* Parental motivation to postpone changes in the infant feeding mode, unless necessary
* Stated availability throughout the study period
* Parent(s) willingness and ability to fill out charts and questionnaires
* Signed informed consent

Exclusion Criteria:

* Failure to thrive
* Chronic illness or major medical problem
* Gastrointestinal disease
* Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial
* Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1
* Use of proton pump inhibitors in the week (7 days) prior to enrolment
* If breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period
* Use of infant formula with hydrolysed protein
* Infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
* Change of feeding mode planned by parents during the study period
Post Intensive Care Optimization Through Lifestyle Intervention

The quality of the intensive care unit (ICU) has been steadily improving over the years. Although improvements in the acute treatment of critically ill patients have been made, a large number of ICU survivors suffer from severe physical, cognitive and mental health problems persisting months to years after leaving the ICU. Physical impairments occur the most and can be very severe, greatly affecting activities in daily life and subsequently the perceived quality of life of ICU survivors. Although there is an increased awareness of long-term complaints following ICU stay, there is currently a knowledge gap on how to enhance the recovery of ICU survivors 6 to 12 months post-ICU discharge. The overall objective of the current study is to establish the extent of health and functional improvements that can be obtained with an optimized, combined exercise and nutritional intervention in ICU survivors 6 to 12 months post-ICU discharge.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Minimum ICU length of stay of 5 days and/or mechanically ventilated for a minimum of 2 days
* Persistent physical complaints
* Community-dwelling, living independently (non-assisted)
* Mentally competent with a Mini-Mental State Examination (MMSE) score of ≥24
* Willing to participate in a 20-week multimodal lifestyle intervention

Exclusion Criteria:

* Any medical condition that may interfere with the safety of the subjects during exercise or any condition that interferes with assessment of the outcome parameters, in the investigators' judgement in consultation with the responsible physician or treating physician/specialist. In case of a contra-indication for MRI (e.g., a pacemaker), subjects will be excluded from this measurement but not necessarily from the study.
* Any medical condition or circumstance where supplementation with the nutritional supplement is potentially contra-indicated.
* Known allergy to any of the ingredients present in the nutritional supplement.
* Simultaneous use of other nutritional supplements during the study period (i.e., unwillingness to stop for the duration of the study).
* Current participation in other scientific research that conflicts with this study (e.g. intervention studies or weight management studies).
* No permission to request information from the general practitioner/treating specialist(s) about medical history, medication use.
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure

In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of TRV120027. The results of this study will help choose the proper range of TRV120027 doses to use in future research studies involving patients with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congestive heart failure made at least 3 months prior to screening
* NYHA Class III or IV heart failure, ejection fraction \</= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated.
* Baseline mean PCWP \>/= 20 mmHg
* Systolic blood pressure at screening must be \>/= 100 mmHg. Heart rate at screening must be \</= 90 bpm.

Exclusion Criteria:

* Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests.
* Significant valve disease
* Current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (ACS) or coronary revascularization in the past 3 months.
* Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery

The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

The post operative period, wich is a critically ill condition, and history of cancer are related to a high risk of venous thrombosis. Catheter is one of the most common complication of parenteral nutrition and is also related to thrombosis.

The combination of theses conditions increases the risk of venous catheter thrombosis. , Since, there is no data evaluating this risk nowadays, the objective of this study is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in surgical intensive care in the immediate post-operative period
* surgery for cancer
* central venous catheter placement for parenteral nutrition
* written consent dated and signed before doppler examination

Exclusion Criteria:

* patient \< 18 years old
* pregnancy
* surgery with no indication for parenteral nutrition on central venous access
Observational and Prospective Study of Hepatic Steatosis and Related Risk Factors Using Ultrasound and Artificial Intelligence

Fatty liver is the most frequent chronic liver disease worldwide and ultrasonography is widely employed for diagnosis. The accuracy of this technique, however, is strongly operator-dependent. Few information is available, so far, on the possible use of algorithms based on Artificial Intelligence (AI) to ameliorate the diagnostic accuracy of ultrasonography in diagnosing fatty liver. This study showed that the use of AI is able to improve the diagnostic accuracy of ultrasonography in the diagnosis of fatty liver

In recent years, ultrasound has taken on a predominant role in the evaluation of liver steatosis, as it is a non-invasive, non-irradiating method that is easily reproducible and inexpensive. Of particular effectiveness is the use of the hepatorenal index, evaluated as the intensity ratio (echogenicity) between the hepatic parenchyma and the renal cortical parenchyma. The main limitations of detecting the hepato-renal index during abdominal ultrasound, however, are operator dependence and the use of a relatively long time span to complete the sequence of operations and calculations required to determine the index itself. The use of Artificial Intelligence (AI) techniques for image analysis in the medical field is yielding excellent results. AI-based algorithms are increasingly a powerful tool that allows the physician to improve their performance in terms of speed and accuracy of clinical evaluations. Today, there is already evidence of the effectiveness of using AI on ultrasound images for clinical evaluations. The use of AI as an aid in diagnosing liver diseases through ultrasound is still under-researched. The hypothesis to be tested is the utility that AI can have in the evaluation, its general and specific uses in reducing calculation times of the hepatorenal index.

In this study, 134 patients were enrolled with no clinical suspicion of liver steatosis. All patients underwent abdominal ultrasonography (US) and magnetic resonance imaging fat fraction (MRI-PDFF), assumed as reference technique to evaluate the grade of steatosis. The hepatorenal index (US) was manually calculated (HRIM) by 4 skilled operators. An automatic hepatorenal index calculation (HRIA) was also obtained by an algorithm. The accuracy of HRIA to discriminate different grades of fatty liver was evaluated by Receiver operating characteristic (ROC) analysis using MRI-PDFF cut-offs.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years
* MRI regardless of clinical indications,
* written informed consent

Exclusion Criteria:

* cirrhosis
* hepatocellular carcinoma or any liver tumours,
* absence of the right kidney
* previous liver transplantation
* large liver cysts or kidney cysts
Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes

Glycemic variability will be assessed using continuous glucose monitor(CGM) in type 2 diabetic patients who receive dulaglutide 1.5 mg/qw injection for 4 weeks.

Glycemic fluctuation is a major problem in glucose control in diabetic patients. It is interesting to know that whether weekly GLP-1RA can improve glycemic variability in diabetic patients. The present study aims to assess the effect of dulaglutide on glycemic variability using continuous glucose monitor(CGM) (Libra, Abbott) in type 2 diabetic patients with 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
* Meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
* 18 ≤ age ≤ 70 years old, male or female;

Exclusion Criteria:

* Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)
* Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).
* History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones).
* History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function.
* Fasting triglyceride level more than 750 mg/dL at screening.
* Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/minute/1.73 meter\^2 (calculated using the Schwartz equation) at screening.
* ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening.
* Use of a GLP-1receptor agonist at study entry and during the study.
The Influence of Vision on Balance, Gait and Falls

Falls are the most serious and frequent home accident amongst elderly. Most falls occur during walking. Vision is reduced with ageing and visual impairments affect balance. Uncorrected visual deficits and balance problems are reported to be risk factors for falls and fall related fractures. The present project uses a longitudinal design and aims at assessing the impact of cataract surgery on balance and gait as risk factors for falls.

A longitudinal design is used, where subjects referred to the Cataract Unit are tested 1-3 weeks in advance of the surgery, and 4-6 weeks and 12 months after the surgery. Outcome measures are visual function, falls, balance and gait. Secondary outcome is quality of life, fear of falling and daily life functioning

Eligibility Criteria:
Inclusion Criteria:

* \>70 years of age
* referred to cataract surgery on one or both eyes
* able to walk unassisted at least 10 m

Exclusion Criteria:

* terminal illness
* have undergone orthopedic surgery in the lower limbs the last 12 months
* Have had a stroke last 12 months
* dementia (measured by MMSE \<20
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)

A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA) before and after treatment.

The Purpose of the Research: The purpose of this study is to test the effectiveness of Emotional Freedom Technique (EFT) versus Diaphragmatic Breathing in Reducing Post Traumatic Stress Disorders.

The Scientific or Scholarly Rationale: Clinical experience and anecdotal reports have demonstrated EFT to be effective for a wide range of behavioral disorders, including PTSD. However with the exception of several studies demonstrating the efficacy of EFT for the treatment of simple phobias, there have been no formal research studies in this area. It is the intention of this study to extend the phobia studies to the area of PTSD, and to determine what other conditions EFT might be effective in treating. Another intention of this study is to see whether, and to what degree, changes in psychological functioning (as measure by the PAI and TSI) are reflected in physiological markers such as HRV (Heart Rate Variability) and levels of cortisol and DHEA.

The Procedures to be Performed: Approximately 8 to 10 subjects would be randomly designated to either the experimental or Diaphragmatic Breathing control groups. There will be 4-5 subjects in the EFT experimental group and 4-5 subjects in the control Diaphragmatic Breathing group.

Eligibility Criteria:
Inclusion Criteria:

* PTSD
* Recent Service in Afghanistan or Iraq
* Good Health History

Exclusion Criteria:

* Illegal Drug Use
* Recent Physical Trauma
* Head injuries, concussions, amputees
* Mental health issues prior to entering military service
Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.

In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy

Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% .

The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC

Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests.

This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB.

The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features.

Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.
* Subject provides informed consent.
* A negative pregnancy test in women of child-bearing potential.
* Subject is mentally capable of understanding study procedures.
* 18 years and older.

Exclusion Criteria:

* Study subject has any disease or condition that interferes with safe completion of the study including:
* Platelet count \< 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) \> 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.
* Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) \< 0.8, or radiographically as diffuse bullous disease
* Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
* Hypoxemia with pulse oximetry values \<88% or partial pressure of oxygen in arterial blood (PaO2) \< 60 on baseline oxygen requirements
* Concurrent participation in another study involving investigational drugs or investigational medical devices
* Inability to read and understand the necessary study documents
The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation

The purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Null hypothesis (H0): There is no significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Alternative hypothesis (H1): There is significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.

The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world, and it is expected to rise over the next 30 years. In Taiwan, COPD is estimated as the seventh leading cause of death in 2016, and has been gradually increasing in the past decades. COPD has been long considered to be a disease state characterized by airflow limitation that are not fully reversible, leading to abnormalities in control of breathing, worsening of respiratory mechanics and pulmonary function. However, COPD is no longer considered to affect only the lungs and airways, but also the rest of the body including decreases in respiratory and limb-muscle mass and function. When acute exacerbation occurs, lung function decreases rapidly. According to the previous studies, inspiratory muscle training (IMT), can improve the strength and endurance of the diaphragm, reduce dyspnea and breathing pattern, thus increasing the capacity of activities tolerance in patients with COPD. Although more and more studies are focus on diaphragm weakness and the effect of IMT in patients with COPD, the efficacy and intensity of IMT in patients with COPD is still controversial and the clinical use is limited. Whether increases intensity during IMT would lead to improvements in contraction pattern of respiratory muscle remained unclear. Therefore, the purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years old
* has been diagnosis of chronic obstructive pulmonary disease and experienced at least 2 times of acute exacerbation in recent 6 months
* can cooperate with the measurements of this study

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* participated in inspiratory muscle training program in the previous three months
* any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study