cyrilzakka/clinical-trials huggingface dataset:
The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis

This pilot study aims to investigate whether 6 weeks of twice weekly High-intensity Interval Training (HIT) results in improvements in disease-specific measures, feelings of general well-being, physical fitness and cognitive function in patients with non-alcoholic fatty liver disease or non-alcoholic steatohepatitis.

The study aims to recruit up to 12 patients diagnosed with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) from the liver clinics at Ninewells Hospital, Dundee. Suitable patients who give informed consent will be assessed at baseline, again after 6 weeks of no intervention to act as a control period, and thirdly after 6 weeks of twice-weekly high-intensity interval training (HIT).

Assessments will be performed with the patient fasted overnight, and will involve body composition measurements, blood pressure, a venous blood sample for circulating triglycerides, fasting glucose, insulin, liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and platelets. An oral glucose tolerance test will be performed using fingerprick capillary samples. Cognitive function tests for episodic memory, executive function and semantic memory will be performed and a questionnaire (SF-36) will be used to assess general well-being. Physical fitness will be assessed through a 12-minute walk test on a treadmill, which will allow estimation of maximal oxygen uptake capacity (VO2 max), and a "get up and go" test will be used to assess physical function.

The exercise intervention will involve a 2 minute warm-up, cycling at 50 rpm before the participants will be asked to cycle at 100rpm and a weight will be added (7% body weight for men and 6% body weight for women) as resistance. The sprint will last 6 seconds and the participant will be asked to rest for at least 1 minute. This will be repeated for a total of 5 sprints in sessions 1-3, 6 sprints in session 4, 7 sprints in sessions 5\&6, 8 sprints in sessions 7\&8, 9 sprints in sessions 9\&10 and 10 sprints in sessions 11\&12. Exercise heart rate will be monitored and recorded.

At least 3 days after the last HIT session the pre-intervention testing assessment will be repeated for a third time.

Changes in measured variables will be analysed via repeated measures analysis of variance (ANOVA) with post-hoc testing of all variables.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
* attending a specialist liver clinic at Ninewells Hospital, Dundee

Exclusion Criteria:

* unstable cardiovascular disease
* uncontrolled arrhythmias
* structural cardiac abnormalities
* uncontrolled diabetes
* other uncontrolled metabolic abnormalities
* severe orthopaedic condition that would prohibit exercise
* severe pulmonary condition that would prohibit exercise
* any other poorly controlled medical condition.
* resting systolic blood pressure above 160 mm Hg
* resting diastolic blood pressure above 90 mm Hg
* symptomatic postural drop in blood pressure greater than 20 mm Hg
The Role of the Glymphatic System Avaluated Thourgh Mr Imaging in the Diagnosis and Management of NPH

The goal of this observational study is to evaluate the role of DTI-ALPS in the diagnostic and therapeutic management of NPH

The main questions it aims to answer are:

* Whether the glymphatic system (GS) is actually impaired in NPH
* Whether DTI-ALPS index can predict the positive response to tap test (TT) and to ventriculo-peritoneal shunt (VPS) surgery.

A healthy control group of patients (HC group) matched for age with the study group, will undergo MR with DTI-ALPS study

Enrolled patients followed a diagnostic-therapeutic pathway, consisting of the following steps:

* t0: MR with DTI-ALPS study;
* t1 (within 7 days from T0): clinical and neurosurgical assessment with NPH-specific rating scales (detailed below) before and after a lumbar TT, including measurements of opening pressure, drainage of 40-50 mL of CSF and collection of samples for neurodegenerative biomarkers (β-Amyloid 40, 42 total and P-Tau) quantification. An MR with DTI-ALPS study within 6 hours from TT;
* t2 (within 3 months from T1): patients with a positive TT response (included responders, IR group) underwent VPS surgery, with CSF samples collected for the same neurodegenerative biomarkers (β-Amyloid 40, 42 total and P-Tau);
* t3 (three months after surgery, IR group only): clinical and neurosurgical evaluation using NPH-specific rating scales to classify patients as improved, unchanged, or worsened compared to their preoperative condition; MR with DTI-ALPS study.

Eligibility Criteria:
Suspected NPH patients according to the following:

Inclusion Criteria:

* clinical and radiological diagnosis of probable NPH according to existing guidelines
* age of over 50 years

Exclusion Criteria:

* inability to undergo MR
* diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory
* previous neurosurgical interventions on the brain of any type.
* inability to undergo general anaesthesia
Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates

Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with invasive mechanical ventilation
* Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation.
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Mechanical ventilation started more than 36 hours before institution of enteral feeding
* Patients turned in the prone position at inclusion
* Abdominal surgery within 1 month before inclusion
* History of esophageal or gastric surgery
* EN via a gastrostomy or a jejunostomy
* Bleeding from esophagus, stomach or bowel
* Moribund patient
* Age less than 18 years
* Pregnancy.
* No informed consent.
A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity

The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.


Eligibility Criteria:
Inclusion Criteria:

* Subject must provide informed consent before any study-specific evaluation is performed.
* Subject is male and female aged 18 to 35 years, inclusive.
* Subject has a body mass index of 18 to 32 kg/m2, inclusive.
* Subject meets all inclusion criteria outlined in the Clinical Study Protocol.

Exclusion Criteria:

* Subject has a job (e.g., movers, construction workers) that requires regular lifting or involvement of the lower extremities.
* Subject has restless leg syndrome, a chronic pain condition, a history of intermittent claudication, or has taken any medication (e.g., analgesic medication, sleep medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months to treat a chronic pain condition, or has another painful physical condition in a lower extremity that, in the opinion of the investigator, may confound study assessments.
* Subject has received oral or topical analgesic medications within 14 days before the Screening Visit.
* Subject meet any other exclusion criteria outlined in the Clinical Study Protocol.
Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19

This randomized clinical on-line study examines whether whether a daily practice of meditation or Kundalini Yoga with anxiety reduction training leads to a greater reduction in anxiety than anxiety reduction training alone.

The individual and societal costs of the COVID-19 pandemic are wide-ranging. Based on past epidemics and on emerging data, anxiety and depression rates will increase, along with anger, grief, somatic complaints, and post-traumatic stress. Coping skills will be challenged, particularly as anxiety, uncertainty, and personal loss increase.

While anxiety is a healthy response to danger, excessive anxiety can be debilitating and impair our coping skills. Illness anxiety may also increase given concerns about infection risks to self and others.

This randomized on-line study is for individuals with anxiety and distress triggered by COVID-19 who have not yet been infected with the novel corona virus. .

The primary study goal is to examine the extent to which anxiety can be reduced through the use of on-line training programs. All participants will receive Anxiety Reduction Training using cognitive-behavioral methods known to be helpful in reducing stress, anxiety, depression, and insomnia. In addition, two-thirds of participants will be randomly assigned to receive training in either Kundalini Yoga (KY) or mindfulness meditation. The investigators will assess the degree to which each of these training programs lead to reduced stress, improved well-being, decreased multisystem symptoms, enhanced mood, and reduced cognitive complaints. Participants will complete self-report assessments at 2-week intervals during the 8 weeks of the acute phase of the study and then again 3- and 6-months later.

The current study may reveal that addressing emergent anxiety early through online self-guided treatment approaches can lead to improved short- and long-term outcome. Findings from this study may reveal that these inexpensive easily disseminated on-line programs can be helpful to enhance coping and improve mental health in the context of large-scale public health crises.

Eligibility Criteria:
Inclusion Criteria:

1. Heightened anxiety triggered or exacerbated by COVID-19
2. Anxiety it least mild-moderate in severity
3. English speaking and living in the United States
4. Access to a smart phone, tablet, or computer with internet
5. Able to read and understand English

Exclusion Criteria:

1. Individuals with severe depression or substance abuse
2. Individuals with a current or past history of psychosis, bipolar disorder, or PTSD.
3. Individuals with physical disability that might make study participation difficult.
4. Individuals with an unstable medical illness or a history of cardiac disease
5. Individuals with a current daily practice of meditation or Kundalini yoga
6. Individuals with confirmed or suspected COVID-19
7. Individuals who are currently pregnant or anticipate being pregnant during study
Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders

The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target individuals with psychiatric diagnoses such as mood disorders, and provide evidence either supporting the expansion of such groups and the development and testing of clinical procedures, or point toward reevaluation and development of alternative low-cost, community based approaches to promoting recovery among individuals suffering from these disorders.

Participants will include up to 200 participants from The Depression and Bipolar Support Alliance (DBSA) for Aim 1. Aim 1 will measure characteristics of current DBSA members through cross-sectional surveys of demographics, clinical use history, and involvement in DBSA. 60 new DBSA members who began attending in the past month will be enrolled for Aim 2. Aim 3 will consist of 100 matched controls of people who have never attended a DBSA meeting. Assessments will be completed at McLean Hospital, in which a study staff member will thoroughly explain the study to participants. If participants are eligible for Aim 2, study staff will receive written consent from the participant.

Eligibility Criteria:
Inclusion Criteria:

* Aim 1:
* 18 years of age or older
* Self-report a diagnosis of any type of mood disorder
* Attend DBSA meetings
* Aim 2:
* 18 years of age or older
* Self-report a diagnosis of any type of mood disorder
* Have attended their first meeting in the past month
* Aim 3:
* 18 years of age or older
* Self-report a diagnosis of any type of mood disorder
* Have never attended a DBSA meeting

Exclusion Criteria:

* Aim 1:
* Do not report a diagnosis of any type of mood disorder
* Have not attended a DBSA meeting
* Aim 2:
* Do not report a diagnosis of any type of mood disorder
* Have not attended a DBSA meeting
* Have attended their first meeting prior to a month before their assessment
* Aim 3:
* Do not report a diagnosis of any type of mood disorder
* Have attended a DBSA meeting
Monitored Effects of Physical Activity on Fetal Heart Rate by Using a Wireless Non-invasive Device

Effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.

The aim of the study is to evaluate in a preliminary step the validity of fetal heart rate measurement with the "Nemo Healthcare Monitoring System" - a wireless non-invasive CTG device. Furthermore, we will determine the reliability for CTG measurements (intraobserver and interobserver reliability) and for ultrasound (intraobserver reliability). The device is approved for use on pregnant women and is regularly used as a CTG device for monitoring fetal heart rate and contractions during childbirth. If in the preliminary step the heart rate measurements with the "Nemo Fetal Monitoring System" provide valid and fetal heart rate results compared to the standard Doppler ultrasound method and provide a reliable detection of fetal heart rate deceleration the effects of phys-ical activity on fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply rate will be investigated in the main part of the study in a larger study population.

It is hypothesized that CTG provides technically a valid and reliable continuous re-cording of fetal heart rate values, since fetal heart rate measurement under physical exertion has previously only been possible by intermittent but not continuous Dop-pler ultrasound. Furthermore, we will evaluate alterations in fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply according to the level of exertion.

Eligibility Criteria:
Inclusion Criteria:

* Presence of signed informed consent form
* healthy pregnant active female over the age of 18 years and below 45 years
* sporting activity \>4h/week on 2 or more weekdays
* single pregnancy, between 28+0 and 34+0 weeks of pregnancy

Exclusion Criteria:

* No signed informed consent form or revocation of consent
* pre-existing pregnancy complications
Protection Against Allergy: Study in Rural Environment - Part IV

PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133 children (farmers in about half of the children) to study the origins of asthma and atopy and to develop potential preventive strategies.

Previous results show a protective effect of farm exposure on allergic risk by livestock contacts and microbial exposures and by raw cow milk consumption in early age.

PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis) and to explain how early age exposures and particularly milk products consumption contribute in the process of allergic illness in childhood. A focus on the characterization of the protective biologically active components in raw milk and identification of immunological mechanisms are involved.


Eligibility Criteria:
Inclusion Criteria:

* PATURE IV is a birth cohort. All children enrolled at the beginning and who still agree to participate will be included at 10-year follow-up.

Exclusion Criteria:

-
Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction

This project is designed to test for the first time whether glucose metabolism is differentially impaired by sleep restriction with and without additional exposure to artificial light at night (ALAN).

Laboratory studies have shown that sleep restriction to 4-6h per night for durations varying from one to 14 days reduces glucose tolerance in otherwise healthy adults, but the mechanisms by which insufficient sleep impairs glucose metabolism are still unknown. Current theories are based on the premise that the adverse metabolic consequences are caused by reduction in the duration of sleep per se. However, sleep curtailment is typically accompanied by longer exposure to artificial light at night (ALAN), which is an environmental endocrine disrupter that profoundly disrupts circadian rhythms.

The investigators have previously reported that acute circadian misalignment induced hyperglycemia comparable to pre-diabetic states in a third of otherwise healthy participants. Since then, the investigators have shown that even when the circadian phase of participants was realigned, prior exposure to 2 ½ weeks of chronic sleep restriction combined with a history of recurrent circadian disruption induced even more deleterious effects on glucose metabolism, in which pancreatic beta cells failed to respond adequately to increased glucose levels. Moreover, both night and rotating shift work (which induce circadian disruption) are associated with increased risk for metabolic problems. Night shifts can lead to acute increases in glucose and insulin levels, although some studies report reduced insulin release in response to meals consumed during the night. Given that circadian disruption has been shown to independently adversely affect metabolism, and exposure to ALAN adversely impacts metabolism in animals, it is important to understand the extent to which circadian disruption contributes to the observed impact of sleep curtailment on metabolism. No previous studies of the metabolic impact of sleep restriction in humans have controlled for this additional exposure to ALAN, thus confounding the effects of sleep restriction with the effects of circadian disruption caused by extended exposure to ALAN.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with conventional and regular sleep-wake timing
* Non-smokers
* Completion of medical, psychological, and sleep screening tests
* Able to spend 33 consecutive days/nights in the laboratory
* Normal color vision

Exclusion Criteria:

* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Donating blood within past 8 weeks
* Worked night or rotating shift work within past 3 years
* Hearing impairment, visual impairment
* History of eye trauma or surgery
* Drug or alcohol dependency
Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment

In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment. Study participants will interact with a standardized patient educator (SP) wearing the Lactation Simulation Model and using two baby dolls in a randomized order.

Identifying signs of effective newborn positioning and attachment is an essential skill for maternal-child care providers. No study has evaluated the effectiveness of commonly used baby dolls for teaching this skill. In this comparison study, clinical lactation specialists will be randomly assigned two baby dolls to evaluate in two back-to-back video-based simulations (telesimulations) with a standardized patient wearing the LiquidGoldConcept Lactation Simulation Model. Participants will complete a novel competency assessment using 3-second video clips to show specific components of positioning and attachment and evaluating whether any correction is needed and why or why not.

Eligibility Criteria:
Inclusion Criteria:

* Received IBCLC, CLC, FABM, or similar certification in clinical lactation
* At least 2 years professional experience with breastfeeding patients
* Work with lactating patients/clients at least monthly
* Work with positioning and attachment at least weekly

Exclusion Criteria:

* n/a
Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)

Study Objective:

Primary

1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT).

Secondary

1. To determine the overall response rate.
2. To determine the locoregional and distant control rate
3. To determine the progression-free survival (PFS)
4. To determine the overall survival (OS)
5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.


Eligibility Criteria:
Inclusion criteria:

* Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end of last primary course of radiotherapy
* Age \> 18 to \< 70 years
* Performance status: \< 1 by ECOG System (Appendix I)
* Adequate bone marrow \& renal function
* Patients having Bilirubin =\< 1.5 x ULN, ASAT \& ALST=\< 1.5 x ULN, Serum creatinine=\< 1.25 x ULN and / or Creatinine clearance \>= 60ml/min
* Patients having WBC \>= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets \>= 100 x10e9/L,Hemoglobin \>=10g/dL
* Signed written informed consent
* Patients must have at least one measurable lesion

Exclusion Criteria:

* Use of investigational agent within the past 28 days
* Pre-treatment with an anti-EGFR drug
* Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
* History of severe pulmonary diseases
* Active infection or other systemic disease under poor control
* Uncontrolled chronic neuropathy
* Know grade 3 or 4 allergic reaction to any of the components of the treatment
* Estimated life expectancy is less than 3 months
* Pregnancy or breast feeding