cyrilzakka/clinical-trials huggingface dataset:
Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation

Assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)

Clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle \< 5.4°, subjective global assessment B or C and/or handgrip strength \< 30 in men and \< 20 in women). The investigators make them body composition assessment (weight, height, body mass index \[BMI\], mean arm circumference \[MAC\], muscle arm area \[MAA\], tricipital skinfold, Dual X ray absorptiometry \[fat mass and fat free mass\]) and handgrip strength at beginning and after 30 days of nocturne supplementation with BCAA and standardized diet (35-40 Kcal, 55% carbohydrates, 25% lipids and 20% proteins).

Eligibility Criteria:
Inclusion Criteria:

* Patients on waiting list for liver transplantation.
* Diagnosis of undernutrition.

Exclusion Criteria:

* Hepatorrenal syndrome.
* Hepatopulmonar syndrome
* Diabetes
* Overweight
Digital Secondary Prevention After Atherosclerotic Cardiovascular Disease

Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of morbidity and mortality worldwide and in Norway. Approximately 50% of the patients admitted to hospitals with an acute ASCVD event has had a previous event. The high number of patients being readmitted to hospitals with new ASCVD events is to a large degree explained by poor control of established risk factors such as high LDL-cholesterol, high blood pressure (BP), diabetes, obesity, smoking, and lack of physical activity, as well as poor adherence to evidence-based medication. This pragmatic, open-label proof-of-concept study conducted at three secondary care hospitals will randomly assign patients hospitalized with an ASCVD event to either: (i) brief advice, tailored discharge information to general practitioners, and a nurse-led outpatient visit (control), or (ii) the same interventions as (i) plus a single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information/videos and an individualized treatment plan and follow-up plan. The primary end point will be between-group differences in the proportion who report having attended follow-up visits in primary (primary care physicians and community-based healthy life centres) and specialist (cardiac rehabilitation programs, hospital outpatient visits) healthcare after 8 weeks and 6 months follow-up. Secondary end points will be change in the SMART2 risk score and cardiovascular risk factors between baseline and 6 and 12 months follow-up. Exploratory end points will be changes in adherence to cardiovascular drugs, self-care behaviour, health literacy, patient activation, and quality of life.


Eligibility Criteria:
Inclusion criteria (all the following):

* Aged \>=18 years and signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
* Hospitalised with an planned or unplanned ASCVD event and/or established atherosclerosis
* Access to a smartphone or tablet

Exclusion criteria (any of the following):

-Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to: cognitive impairment, seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.

* Short life expectancy (\<12 months) due to end-organ (i.e COPD 4, CKD 4/5) or malignant diseases
* Clinically significant symptoms of anxiety and depression (HADS A and/or HADS-D score ≥8)
* Not being able to understand Norwegian.
Cardiopulmonary Effects of Intrathoracic Pressure Overshoot During Carbon Dioxide Insufflation in Thoracoscopic Surgery

Video-assisted thoracoscopic surgery (VATS) has become a standard technique for addressing all types of thoracic pathology. Insufflation of carbon dioxide (CO2) into the operated chest cavity could increase lung collapse and improve surgical field view. The actual thoracic pressure values may not be identical with the presetting on the insufflator display. This overshoot pressure during VATS may compromise cardiac and pulmonary function. The purpose of this study is to evaluate the effects of intrathoracic pressure overshoot during two-lung ventilation on the hemodynamic and respiratory function and clarify the relative safety of two different techniques of insufflation.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status Ⅰ,Ⅱ
* Patients with esophageal carcinoma
* Elective video-assisted thoracic surgery

Exclusion Criteria:

* Allergic to drugs used in the study
* Refusal of VAST
* Arrhythmia or treated with antiarrhythmic drug
* Surgery type were converted to thoracotomy,
* Massive intraoperative blood loss (\> 400ml)
Designing Multimedia Patient Education for Adolescent Idiopathic Scoliosis

The goal of this triple-masked three-armed feasibility randomised controlled trial is to compare patient education materials for participants with adolescent idiopathic scoliosis. The main question it aims to answer are:

* Are educational videos superior to usual care?
* Are educational videos formatted in line with literature advice on multimedia design superior to videos formatted as traditionally found on scoliosis advisory websites Participants in the video groups will be asked to do view six educational videos and respond to a quiz. Researchers will compare the informed video group and traditional video group to usual care to see if there are differences in engagement, quality of life, physical activity and health-related anxiety.

Multimedia patient education materials are increasingly used in healthcare. This triple-masked three-armed feasibility randomised controlled trial will examine participants aged 10-18 with radiographically confirmed adolescent idiopathic scoliosis and their response to usual care or to receive multimedia educational videos with or without evidence-informed design principles. Primary outcomes will be patient knowledge measured by online quiz and engagement measured by YouTube analytics. Participants will be masked in the two video intervention arms, as will the therapist sending the educational videos. The results will outline the number of participants recruited and randomised, the number analysed post-intervention and at week eight, and the outcomes for baseline, post-intervention and week 8, which will include the effect size and level of precision. Adverse events will also be reported.

This feasibility randomised controlled trial will offer insight into the effectiveness of implementing advice from the literature in designing multimedia patient education materials for a population with adolescent idiopathic scoliosis.

Eligibility Criteria:
Inclusion Criteria:

* aged 10-18 years
* parent/guardian consent for those under 18 years of age
* adolescent Idiopathic Scoliosis (AIS) as confirmed by Cobb angle ≥10deg on plain film radiographs
* able to watch and listen to online educational materials as well as read and complete online surveys

Exclusion Criteria:

- scoliosis due to non-AIS conditions
Evaluation of a School-Based Attention Training Programme for Improving Concentration

This study evaluates a school-based attention training programme for improving sustained attention in children.

Sustained attention is an elementary attentional function that is essential for effective learning and functioning in school. Poor sustained attention is a relatively common problem in childhood with as many as 24% of children exhibiting frequent inattention. Children with attentional difficulties are at increased risk for a variety of negative educational outcomes, including lower standardised grades, dropping out of school and repeating a year. This evidence highlights the need to develop interventions aimed at enhancing students' sustained attention capacity. Current school-based interventions for student attention problems include intervention strategies targeting behavioural, academic and self-regulation. However, none of these interventions aim to enhance attentional capacity. Attention network training (or attention training) has been identified as a potentially promising intervention for enhancing attentional capacity. This pilot study aimed to evaluate the preliminary efficacy of a theory-driven attention training programme, Keeping Score!, in improving students' capacity to sustain attention in a school setting. Training was based on sustained updating. Children engaged this process by mentally keeping score during an interactive face-to-face game without external aids. The study used a cluster randomised design. Students (N = 36) were assigned based on their class group to either the 6-week attention training programme (n = 18) or an active control (n = 18). Outcome measures were assessed at baseline, immediately after training and an approximate 6-week follow up.

Eligibility Criteria:
Inclusion Criteria:

* 4th and 5th class students
* aged 9 to 11 years
* parent consent and participant assent

Exclusion Criteria:

-
A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain

The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain below the neck present for a minimum of one year.
* Diagnosis of at least one of the following:

  * back pain with or without leg pain,
  * post-herpetic neuralgia,
  * complex regional pain syndrome (CRPS) 1 or 2,
  * diabetic neuropathy,
  * or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.
Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

* Polycystic Ovary Syndrome
* Age \>18 and \<35

Exclusion Criteria:

* Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).
Exercise in Patients Undergoing Urologic Surgery

Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.

Increases in physical activity and nutritional status are associated with improvements in a number of health conditions, including coronary artery disease, hypertension, stroke, insulin sensitivity, osteoporosis, and depression. Regretfully, despite the evidence supporting the benefits of physical activity, greater than half of adults in the United States do not get adequate activity and approximately one quarter do not get any activity. As such, many people, especially the elderly and those with comorbid diseases, have low levels of physical fitness. Additionally, up to 45% of community dwelling older adults are malnourished. Patients undergoing surgery with poor exercise tolerance and suboptimal nutritional status may be at an increased risk of perioperative complications. Thus, increasing physical activity and dietary intake quality prior to surgery is recommended, to hopefully decrease these risks. The primary objective is to determine if recommended physical activity or dietary intake results in an increase in patient physical function performance and if so, to what extent. The secondary goal is to examine if increased exercise or nutrition reduces perioperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for operative procedure with an inpatient postoperative stay are eligible for this study
* Patients willing and able to give blood sample as part of standard of care labs
* Patients willing and able to fill out questionnaire
* Patients who will fill out the step log daily
* Patients willing and able to sign informed consent

Exclusion Criteria:

* None
Comparison of Outcomes Between Hemodialysis and Peritoneal Dialysis Patients in a Multi-Ethnic Asian Population

End-stage renal disease (ESRD) presents a heavy burden on a patient's psychological and social life, as well as overall quality of life (QoL). Health-related quality of life (HRQoL) in dialysis patients measures the physical, social or emotional well-being that is affected by ESRD and/or its treatment, and has been increasingly used as an outcome measure in interventional studies. Additionally, associations between social support and QoL have been observed, indicating that improved social support could improve HRQoL, morbidity and mortality in ESRD patients. However, it is not clear if hemodialysis (HD) and peritoneal dialysis (PD) have different impacts on HRQoL. Furthermore, comparisons of HRQoL and social support between HD and PD patients in the multiethnic society of Singapore have not been evaluated. As such, the investigators propose to conduct this cross-sectional study in the investigators local multiethnic ESRD patient population to evaluate and compare patient-reported outcomes (HRQoL and social support), economic and clinical laboratory outcomes in HD and PD patients.

All chronic HD and PD patients seen in NUH outpatient renal or PD clinic will be included in this cross-sectional, observational study. Information on patient demographics, medical/medication histories, dialysis vintage, clinical laboratory data and associated medical costs will be obtained from clinic notes, electronic medical records and hospital databases. Patient-reported outcomes will be determined from scores of the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale, Multidimensional Scale of Perceived Social Support, Kessler Psychological Distress Scale and Health Services Utilization questionnaires (for indirect costs), and compared between HD and PD patients.

Results from this study will provide important HRQoL information to assist renal physicians and patients to make treatment decisions. Furthermore, intervention programs could be developed to improve social support based on patients' needs. These could in turn improve patients' HRQoL, morbidity and mortality outcomes with minimal risks involved.


Eligibility Criteria:
Inclusion Criteria:

* All chronic HD and PD patients who are on regular follow-up with nephrologists in the NUH outpatient renal or PD clinic, and who meet the following criteria will be included in the study: male or female 21 years of age or older, with stage 5 CKD (eGFR \<15 ml/min/1.73m2) and have been receiving HD or PD for at least 3 months.

Exclusion Criteria:

* Transient dialysis patients, those have poor cognitive function or are not able to complete the questionnaires or give informed consent.
Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)

Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways

Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.

1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.

1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.

1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.

1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.

1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 years old
* Asthma diagnosis by physician
* Current treatment with an inhaled corticosteroid medication

Exclusion criteria:

* Bronchiectasis
* Cystic Fibrosis
* Chronic Obstructive Pulmonary Disease
A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \< 35 kg/m2
* AHI between 15 to 65 events/hour documented by a PSG during the screening phase.
* Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.

Exclusion Criteria:

* Night shift worker
* Significant comorbidities that contraindicates surgery
* Life expectancy \< 12 months
* Participation in another clinical study (excluding registries) during the study period (3 years).
Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.

Aim of study:

To investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP).

Hypothesis:

The efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 to 65 years
* at least 2 years of T2DM
* a BMI between 28 to 42 kg/m2
* a HbA1c level above 7% despite multiple oral medications (\> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months
* no active cardiovascular diseases, and
* a ASA grade II or below
* a fasting C-peptide \< 0.6ug/L

Exclusion Criteria:

* significant anaesthetic risk ASA grade III or above
* history of diabetic ketoacidosis
* uncontrolled DM with HbA1c \> 12%
* malignancy diagnosed within 5 years
* chronic renal failure requiring dialysis
* previous upper abdominal surgery affecting gastroduodenal configuration
* major psychiatric illness including major depression and substance abuse
* pregnancy or ongoing breast-feeding
* inmates
Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy

Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.


Eligibility Criteria:
Inclusion Criteria:

* - children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:

  1. documented tachypnoea (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y, \>40 bpm for 2-4 y, and \>30 bpm for \>4 y);
  2. cough on exam or by history;
  3. increased work of breathing on exam; or
  4. auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Exclusion Criteria:

* Children will be excluded if: antibiotics have been discontinued; they received \>3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.