cyrilzakka/clinical-trials huggingface dataset:
Patients Judging Bowel Preparation by Using SMARTPHONE Application

High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of bowel preparation.

This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of SMARTPHONE application on the bowel cleansing was inspected.

A intervention patients take the picture of stool using SMARTPHONE camera application, and then assess the bowel cleansing result. If the result is "Pass", they stop the addition of bowel preparation agent. but the result is "Fail", so they have the additive bowel preparation agent and repeat using the SMARTPHONE application.

After the bowel preparation, Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale after procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera

Exclusion Criteria:

* known or suspected bowel obstruction known pregnancy, breast feeding known allergy to PEG presence of severe illness(renal failure, congestive heart failure, liver failure,), refusal of consent to participate in the study not available to use the SMARTPHONE application and SMARTPHONE camera
Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)

Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.

The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.

Exclusion Criteria:

* Schizophrenia
* Bipolar Disorder
* Obsessive Compulsive Disorder
* Head Injury with Loss of Consciousness for more than 30 minutes
* Active Alcohol/Substance Dependence in past 6 months
Advanced Glycation Products and Vascular Complications in Type 1 Diabetes

DIABAGE (Diabetes Advanced Glycation End products) study was conducted between 2015 and 2017. It included 196 type 1 diabetic patients with more than 10 years of diabetes. It revealed a significant association between the occurrence of vascular complications and tissular Advanced Glycation End products (AGEs) as well as with some circulating AGEs. This protocol is a continuation of that initial research.

The objective is to evaluate in patients included in the DIABAGE study the incident vascular events (micro and macroangiopathic) after at least 5 years of follow-up.

The secondary objectives are:

1. To assess the predictive value of the initial measurement of AGEs (Advanced Glycation End Products) on the occurrence of these complications.
2. To study the correlation between tissue AGEs measured after 5 years of evolution and HbA1c values between the first inclusion and this new evaluation.

Material and Methods:

Experimental design: monocentric observational study (Reims University Hospital).

Population/patients: patients included in the DIABAGE study are regularly followed in the Endocrinology, Diabetology, Nutrition department of the Reims University Hospital.

Investigation plan:

* All patients in the DIABAGE study will be invited to participate. The estimated participation rate is between 80 and 90%.
* The explorations will be carried out as part of their usual follow-up during a short hospitalization (day or week hospital, depending on the patient). A careful clinical examination will be conducted, as well as a biological check-up. If necessary, investigations for chronic complications will be carried out, including a fundus, systolic pressure indexes, an electrocardiogram and, if necessary, an evaluation of the Coronary Artery Calcium score. Skin auto-fluorescence will also be measured using the AGE-Reader (available at the University Hospital).

Judgement criteria:

Primary endpoint: measurement of the incidence of micro and macro angiopathic vascular complications occurring during the follow-up of type 1 diabetic patients in the DIABAGE cohort.

Secondary endpoints:

* Measurement of initial circulating and tissue AGEs.
* Measurement of tissue AGE delta, defined as the difference between AGE after at least 5 years and baseline AGE.
* Repeat measurements of HbA1c over the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion in initial DIABAGE study.
* Follow-up at Reims hospital.

Exclusion Criteria:

- Refusal to participate.
SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy

SSPC includes degree of Stenosis, Symptoms, Plaque stability and Compensation of the cerebral blood flow. SSPC, a comprehensive evaluation system on carotid artery stenosis, is established and advocated in this trial in order to make assessment on risk of carotid revascularization preoperatively and prediction of cerebral events postoperatively.

Although, cerebral perfusion and collaterals recruitment are crucial and integral to current treatment and stroke prevention paradigms, most consensus recommendations do not include assessments of cerebral hemodynamics in their management algorithms and arbitrarily focus on symptoms and degree of stenosis.

Based on four aspects of SSPC multidimensional assessment and grading, through clinical data, specimen collection, image technology of the multi-disciplinary cross research, we initially to propose a more scientific evaluation system for the perioperative period of carotid revascularization, to reveal the scientific mechanism of brain function changes after carotid revascularization, and to establish a method for the evaluation of brain function after carotid revascularization in accordance with the characteristics of Chinese lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
2. Unilateral or bilateral carotid artery stenosis diagnosed by ultrasound or CT angiography.
3. Complete revascularization followed by carotid endarterectomy or carotid artery stenting.

Exclusion Criteria:

1. Patients with carotid stenosis received best medicine therapy.
2. Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated.
3. Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
4. female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
5. Life expectancy of less than twelve months.
6. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
7. Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (\> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
8. Patient unwilling or unlikely to comply with Follow-Up schedule
Self Help for Fatigue in Multiple Sclerosis

The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).

Background: Fatigue is a common disabling symptom in patients with Multiple Sclerosis (MS). Cognitive behavioural therapy (CBT) has been shown to be effective in the reduction of fatigue in MS and CBT-based self-help has been shown to be effective as a low intensity intervention for anxiety and depression.

Objectives: To evaluate the effectiveness of a CBT based self-help workbook at reducing perceived impact of fatigue in a clinical sample of MS patients.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be aged 18 or over
* Will have a recognised diagnosis of relapsing remitting or primary progressive relapsing remitting Multiple Sclerosis from a neurologist
* Cognitively able to give informed consent as deemed by referring clinician in the Fife Rehabilitation Service
* Willing to consent to randomised control trial
* Fatigue as a primary symptom

Exclusion Criteria:

* Patients with severe anxiety or depression (assessed by cut off on HADS)
* Patients with psychosis or personality disorders (assessed by referring clinician)
* Patients currently receiving input from psychological services for fatigue management
* Patients with suicidal ideation or plans (assessed by referring clinician)
* Patients who are unable to read the workbook or standardised questionnaires due to literacy levels or cognitive abilities will be excluded from the analysis, although if patients have literacy or cognitive problems, referral to a more suitable 1-to-1 type of therapy will be made.
Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years of age, male or female patients.
2. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).
3. BMI\<16.
4. Long-term pharmacotherapy resistance.
5. Written informed consent.
6. normal intelligence and compliance

Exclusion Criteria:

1. Surgical contradiction（implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS）or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions； History of brain trauma；
2. History of severe neuropsychiatric disease；
3. Epilepsy；
4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
5. Severe diabetes ,severe cardiovascular and cerebrovascular disease；
6. Malignant tumor；
7. Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female；
8. Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher
Oral Mucosal Absorption of ICI176,334-1

The purpose of this study is to investigate the presence or absence of oral mucosal absorption of ICI176,334-1

Oral mucosal absorption of ICI176,334-1 in Japanese healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Japanese healthy male subjects aged 20 to 45 years
* Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
* Have a body mass index (BMI) between 17 and 27 kg/m2
* Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

Exclusion Criteria:

* Presence of any disease under medical treatment
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
* Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
* Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
Methodology Study of Novel Outcome Measures to Assess Progression of ALS

The primary objectives of the study are to estimate and rank-order the longitudinal standardized mean changes over 6 months and over 12 months, for a set of outcome measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to identify measures that are more sensitive to disease progression than Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study are: To evaluate the test-retest reproducibility of each outcome measure; To determine correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in ALSFRS-R and survival; To assess correlations between/among the various measures; To obtain biological samples in order to identify molecular correlates to the clinical measures and to further characterize previously identified and novel molecular biomarkers of disease progression for incorporation into future clinical studies.


Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of sporadic or familial ALS
* ALS onset within ≤5 years
* Must be 16 to 85 years of age, inclusive, for sites in the United States and 18 to 85 years of age, inclusive, for all sites outside of the United States

Key Exclusion Criteria:

* History of or positive test result at Screening for human immunodeficiency virus (HIV)
* History of or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus (HBV)
* Possibility of neuromuscular weakness other than ALS
* Unspecified reasons that, in the opinion of the site Investigator, make the subject unsuitable for enrollment or unlikely to be able to complete, at a minimum, the Month 6 Visit

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply
Cardiac Arrest in Residential Areas With Mobile First-responder Activation

The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.

Survival decreases by 10% for every minute that passes after a cardiac arrest until defibrillation. Despite an increasing number of available AEDs, survival and defibrillation rates in residential areas remain poor. Efforts to increase bystander defibrillation has the potential to improve survival. Through the strategic deployment of AEDs, training, and recruitment of residents as citizen responders, we aim to improve proportions of bystander defibrillation and 30-day survival in densely populated residential areas with a high density of cardiac arrests.

Eligibility Criteria:
Inclusion Criteria:

* All witnessed cardiac arrests recognized registered in the Danish Cardiac Arrest Registry occurring within the study sites. This excludes non witnessed cardiac arrests.
* Witnessed cardiac arrest
* Non-traumatic etiology, this excludes intoxication, drowning or suicide.

Exclusion Criteria:

* Cardiac arrest occurring in a nursing home
* Cardiac arrest not treated by the EMS due to ethical reasons or obvious signs of death
* Not true cardiac arrest (suspected, but not verified)
* Cardiac arrests witnessed by the emergency medical personnel
Experiential Avoidance as Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress

This study hopes to explore whether experiential avoidance could be a mediator between mindfulness-based interventions and emotional distress.

The improvement of emotional distress by mindfulness intervention has been supported by a large number of empirical studies. For example, the meta-analysis of the effect of MBSR on people with chronic diseases shows that both anxiety (Hedges' g = 0.47) and depression (Hedges' g = 0.26) in mindfulness intervention group are reduced. Mindfulness-based interventions also have good intervention effect on anxiety (Hedges' g = 0.67) and depression (Hedges' g = 0.48) in the general population. Unfortunately, few studies have used the correct methods to test the mechanism of mindfulness-based interventions in mediation analysis or experiments.

Experiential avoidance refers to the unwillingness to keep in touch with specific personal experiences (such as physical feelings, emotions, thinking, memory, and behavioral tendencies), and to take measures to change the form or frequency of these experiences, as well as the situations that trigger these experiences. Experiential avoidance often has only a short-term effect, but it has no effect in the long run, and may even be unfavorable. The paradox of experiential avoidance is that trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences, and will enhance the feeling that they are unreal or out of touch with themselves. In addition, long-term experiential avoidance will interfere with the fun of being completely immersed in any activity, leading to the reduction of the frequency of positive events and the suppression of positive emotions.

Some reviews believe that experiential avoidance is one of the mechanisms of beneficial effects brought by mindfulness. Some cross-sectional studies show that the reduction of empirical avoidance is an important intermediary factor in the path of mindfulness to psychopathology . However, no research has directly tested the mediating role of experiential avoidance in mindfulness-based intervention to alleviate emotional distress, which is also the problem that this study wants to explore. According to Kazdin(2007), in order to prove the timeline principle, that is, the change of experiential avoidance is before the change of emotional distress, we will measure the above variables every week during the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

Exclusion Criteria:

* Subjects who could not access the Internet;
* Subjects with insufficient Chinese ability;
* Subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week;
* Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection

The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.

Postoperative pulmonary complications (PPC) are the most common adverse events following lung resection, with a reported incidence of over 20-30% in some series. The objective of this study is to demonstrate that inspiratory muscle training (IMT) with daily use of an incentive spirometer (IS) for at least 14 days prior to lung surgery will reduce the risk of PPCs compared to the usual care, consisting of no formal preoperative IMT. The hypothesis is that preoperative inspiratory spirometer breathing (ISB) is a feasible and cost-effective intervention that can significantly reduce PPCs after lung resection. It is also hypothesized that patient compliance with the intervention will be high because of its simplicity, convenience, low cost and no potential for adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status score 2 or less
* Undergoing elective lung resection (includes wedge resection, lobectomy, bi-lobectomy, pneumonectomy, sleeve resection) via minimally invasive (VATS or robotic) approach or thoracotomy
* Chest wall resection if performed concurrently with lung resection

Exclusion Criteria:

* ECOG performance status score greater than 2
* Significant cognitive impairment preventing informed consent
* Non-English speaking
* Wedge biopsy for interstitial lung disease
* Bullectomy for bullous emphysema
* Pre-existing tracheostomy
* Emergent or urgent surgery
* Preoperative home oxygen use
* History of neuromuscular disease
* Prisoners
A Study on the Effect of Position on Walking Labour Epidural Efficacy

This study is being done to better understand how patient positioning can affect pain relief after an epidural. In addition to pain, the investigators will assess how position affects epidural spread, and its effects on maternal blood pressure and fetal heart rate.

Epidurals will be placed with parturients in the standard sitting position. An epidural catheter will be placed to a depth of 5 cm into the epidural space. After placement, parturients will be randomized to one of the four position groups (left uterine displacement, left lateral, right lateral, or seated upright). After successful positioning, a series of 5 cc bolus doses of 0.08% ropivacaine with 2 mcg per cc of fentanyl will be injected through the epidural catheter in 5 minute intervals for a total volume of 20 cc. After the initial loading dose of epidural solution has been injected in the first 20 minutes post-insertion, the patient will be able to return to whatever position they are most comfortable with. The parturient will be asked to rate their pain on a verbal pain scale of between 0 and 10 at the peak of their contraction at three time intervals. The spread of the blockade will be assessed with ice applied along both the left and right mid-clavicular lines. Maternal blood pressure will be measured on the upper arm in all patients as per nursing protocol. Fetal heart rate will be monitored intermittently with Doppler ultrasound as per nursing protocol.

Eligibility Criteria:
Inclusion Criteria:

* Active labour or admitted for induction of labour
* Requesting an epidural for labour analgesia
* Contractions occurring greater than once every 5 minutes

Exclusion Criteria:

* Coagulation disorder
* High risk pregnancy as per obstetrics
* Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)
Post-SOPHrology Cancer Patients' anxieTY Report

Cancer is pathology with a high impact on patients and relatives quality of life. Most of the time, it is a stressful trial. Professionals have often resort to pharmaceutical solutions, but sometimes, it is not sufficient. So, patients resort to alternative and complementary medicines, as sophrology. In Lucien Neuwirth Cancer Institute, patients can benefit from sophrology.

Anxiety levels have never been reported before and after sessions. Indeed, the present study wants to report anxiety levels before, after, and one and three weeks after session. Levels of satisfaction will also be reported.

Cancer is pathology with a high impact on patients and relatives quality of life. Most of the time, it is a stressful trial. Professionals have often resort to pharmaceutical solutions, but sometimes, it is not sufficient. So, patients resort to alternative and complementary medicines, as sophrology. In Lucien Neuwirth Cancer Institute, patients can benefit from sophrology.

Anxiety levels have never been reported before and after sessions. Indeed, the present study wants to report anxiety levels before, after, and one and three weeks after session. Levels of satisfaction will also be reported.

Eligibility Criteria:
Inclusion Criteria:

- Patient performing at least one session of sophrology in the Lucien Neuwirth Cancer Institute

Exclusion Criteria:

* Protected patient (according to the law),
* Patient with incapacity to complete questionnaires,
* Patient with incapacity to perform sophrologic movements.