cyrilzakka/clinical-trials huggingface dataset:
6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Chronicle Obstructive Pulmonary Disease

The purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 ans ;
* Chronicle obstructive pulmonary disease stage I/II (FEV1 ≥ 50%) ;
* Chronicle obstructive pulmonary disease stage III/IV (FEV1 \< 50%) from may 2019 (ethical approvement granted)
* Weight ≤ 90kg ;
* Eligible for pulmonary rehabilitation.

Exclusion Criteria:

* Pregnant woman or likely to be ;
* Patient under guardianship ;
* Contraindication to cardiopulmonary exercise testing ;
* Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
* Patient treated with pacemaker or defibrillator ;
* History of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).
C Tracker, Hepatitis C, Care & Collaboration - Patient Reported Outcomes Survey Study

Today's mobile devices (especially smartphones) are powerful ways to communicate new information to medical researchers. For this study, researchers at Boston Children's Hospital are asking people with hepatitis C to make use of their smartphones to help report information about themselves that may improve how hepatitis C is treated. This study uses a free app called C Tracker that can be installed from the Apple App Store onto the participants iPhone. The main goal of this research study is to use this app to report hepatitis C related health information to the researchers who are conducting this study. The investigators will ask participants about their health,activities, medications, and ways in which hepatitis C has impacted you. This information will be reported anonymously, which means that the researchers doing the study won't know who the participants are.

Specific Aims/Objectives

Aim 1. Develop a free iPhone app ("C TRACKER") designed to anonymously record and report Hepatitis C related health data to study investigators via periodic patient-reported surveys.

Aim 2. Examine the feasibility of enrolling a large cohort of geographically dispersed cohort of subjects with hepatitis C who download and install the C TRACKER app, provide informed consent using the app, and complete study surveys using the app. The app will be made available to the public via the Apple App Store at no cost.

Aim 3. Pilot usage of the app to track and analyze longitudinal measures of hepatitis C related health concerns, physical function, and physical activity via selected disease-specific as well as more broadly applicable patient-reported instruments, including regarding work productivity (WPAI-Hepatitis C), physical functioning (subsets/subscales of the MOS SF-36), physical activity (collected through Apple HealthKit), and prescribed medications.

Eligibility Criteria:
Inclusion Criteria:

* Self-report a diagnosis of Hepatitis C
* English speaking individuals
* 18 years or older
* Must have access to an iPhone that operates on iOS version 8 or higher
* Be able to download apps from the U.S. Apple iPhone Store, and enter data themselves or via a proxy on their behalf

Exclusion Criteria:

• Individuals not meeting inclusion criteria will be excluded.
Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery

The purpose of this study is to determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers.

For now, intraoperative analgesia remains hard to assess in the absence of reliable and validated analgesia monitor. The analysis of pupillary reflex is a new tool to assess analgesia during the intraoperative and postoperative period.

During laparoscopic surgery, carbon dioxide insufflation that produce pneumoperitoneum may induce hemodynamics events such as tachycardia or hypertension. These events may be misleading or confusing. Actually, these events are mainly considered as insufficient analgesia. Thus, anesthesiologists deepen analgesia and/or anesthesia by increasing concentration of anesthetics or opioids. These inappropriate actions may induce hypotension and/or bradycardia especially in elderly patients. On the contrary, insufficient analgesia may exist in hypovolemic patients or in patients with neuromuscular blocking agents.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists status 1 to 4
* Scheduled laparoscopic surgery
* Standardized anesthesia (TCI)
* Social security affiliation

Exclusion Criteria:

* Age \< 18 yrs old
* Emergency
* BMI ≥ 35 kg.m-2
* Refusal of consent
* History of ocular pathology
* Intake of: metoclopramide, droperidol, opioids or substitutive therapies
* Patient with chronic pain
* Neurologic impairments
* Neuropathic pain
* Drug or alcohol abuse
Training Church Leaders in Mental Health First Aid

The purpose of this study is to train Church Leaders and other community members in Mental Health First Aid (MHFA), which is an evidence-based public mental health education program. MHFA has been found to improve people's recognition of emotional and mental health challenges and to increase people's confidence in providing help to others. Information about MHFA can be accessed at http://www.mentalhealthfirstaid.org.

MHFA consists an 8-hour training program in which participants will be provided a manual, learn the signs and symptoms of common mental health problems, and learn a 5-step action plan to help someone in an emotional crisis.

Participants ware recruited from faith-based organizations (i.e., churches), health care organizations (i.e., hospitals), and other community based organizations. There will be no treatment directly provided as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Able to provide signed formed consent

Exclusion Criteria:

* Any circumstances limiting participant's ability to complete the 8-hour training
* Inability to provide informed consent
GTA-Glyceryltriacetate for Canavan Disease

The purpose of this study is to determine whether oral supplementation of glyceryl triacetate improves the clinical prognosis of Canavan Disease.

Canavan Disease is caused by a deficiency in the enzyme named Aspartoacylase (ASPA). This disease is a devastating, progressive disease with no available treatment. As a result of the ASPA deficiency, there are high levels of N-acetylaspartate (NAA) and low levels of L-aspartate and acetate.

We hypothesize that one of the functions of ASPA is to provide sufficient levels of acetate for CNS myelinization. For this reason, we offer to supplement acetate levels by the oral administration of glyceryl triacetate (GTA). Such treatment must be offered to patients before the age of 18 months, prior to the termination of CNS myelinization.

1. Two patients, aged less than 15 months, will receive daily doses of oral GTA
2. The daily dose will be increased incrementally until the maintenance dose is reached. This will be done under close monitoring of the patients, including periodic blood gas sampling.
3. GTA has not been shown to cause any known toxicity, according to the Cosmetic Ingredient Review Expert Panel (Fiume, 2003).

Eligibility Criteria:
Inclusion Criteria:

* Age below 15 months
* Biochemically diagnosed with Canavan Disease

Exclusion Criteria:

* None
Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease

In people living with coronary heart disease (CHD), V̇O2 peak predicts all-cause mortality. V̇O2 peak increases with regular exercise training. Thus, in exercise-based cardiovascular rehabilitation programmes, V̇O2 peak is a useful marker of how effective the exercise training has been.

Maximal cardiopulmonary exercise testing (CPET) is the gold standard method of measuring V̇O2 peak. However, maximal CPET is expensive and requires trained staff to conduct the test and interpret the results. Furthermore, CPET is not routinely available in United Kingdom (UK) cardiovascular rehabilitation programmes. Field exercise tests, such as incremental cycle ergometer tests, are used in conjunction with predictive equations to estimate V̇O2 peak. However, this group has shown that estimating changes in V̇O2 peak in this way is inaccurate. Alternative solutions are required.

VentriJect Seismofit® uses a technique called seismocardiography (SCG); the measurement of vibrations in the chest wall, caused by each heartbeat, using accelerometers. SCG can be used to estimate V̇O2 peak from a SCG measurement taken at rest. This study will explore the validity of VentriJect Seismofit for estimating V̇O2 peak in people with CHD.


Eligibility Criteria:
Inclusion Criteria:

* Stable coronary heart disease
* Able to lay fully supine for five minutes
* Capable of performing a maximum effort CPET on a stationary cycle ergometer
* Currently enrolled in a Phase IV cardiac rehabilitation programme
* A minimum of 12 weeks after a cardiac event

Exclusion Criteria:

* Awaiting any significant medical investigations relating to CPET absolute contraindications
* Hospitalisation within the last 4 weeks relating to CPET absolute contraindications
* Implantable cardiac devices e.g. pacemaker or implantable cardioverter defibrillator
* Unstable angina
* Unstable diabetes
* Left main coronary stenosis or its equivalent
* Known third degree heart block
* Unstable heart failure/New York Heart Association (NYHA) III or IV Heart Failure
* Acute aortic dissection, myocarditis, or pericarditis/endocarditis
* Suspected or known dissecting aneurysm
* Symptomatic severe aortic stenosis
* Acute deep vein thrombosis, pulmonary embolism or pulmonary infection
* Uncontrolled asthma
* Pulmonary oedema
* Respiratory failure
* Ambient O2 desaturation at rest \<85%
* Resting tachycardia (\>100bpm)
* Currently in atrial fibrillation
* Uncontrolled arrhythmia
* Resting systolic blood pressure \>180 mmHg
* Resting diastolic blood pressure \>100 mmHg
* Other conditions that prevent participants from completing study investigations (e.g. recent (last \~6 months) cardiac arrest)
4-question "RACY" Delirium Screening Tool Validation Study

Delirium is a serious medical condition associated with increased mortality, longer hospital stay, increased rates of institutionalisation, and declines in post-admission functionality. Despite the prognostic utility of diagnosing delirium and its utility as an important indicator of health quality in elderly patients in developed countries, it is not routinely screened for in many busy general medical in-patient settings, especially in developing countries. Unpublished data from a recent study of general medical in-patients in Groote Schuur Hospital, Cape Town, South Africa, found that no patients admitted during an 8-week period received any formal cognitive testing or had documentation of the presence/absence of delirium in routine clinical notes. This under-recognition is largely the result of the length and complexity of available delirium diagnostic tools e.g. Mini-mental state exam (MMSE), although the perceived lack of clinical importance and conflicting results about specific treatment modalities also contribute.

The investigators recently developed the simple 4-question "RACY" delirium screening tool for use in general medical in-patients. Preliminary data show the test to be simple and effective with a sensitivity and specificity of 78% and 85% respectively using a ROC-selected cut-point of RACY≤2. The investigators hypothesis that the RACY screening tool has the potential to be a simple and effective bedside delirium diagnostic instrument for use in non-geriatric, busy general medical in-patient settings. This study is a two-centre validation study to evaluate the diagnostic accuracy of this tool.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
* \>18 years and willing to give informed consent

Exclusion Criteria:

* Patient admitted directly to intensive care unit
* Patient refusing consent or \<18 years old
* Patients unable to undergo delirium testing due to: i) Glasgow coma scale ≤ 12/15, ii) Aphasia
Nagasaki and Tokushima

we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers, cytokines, and periodontitis through community-based study held in the Goto city, Japan.


Eligibility Criteria:
Inclusion Criteria:

more than 15 teeth

Exclusion Criteria:

less than 15 teeth
Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients.


Eligibility Criteria:
Inclusion Criteria:

Lower Back Pain Cohort

* Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain
* Age ≥ 18 years

Bertolotti's Syndrome Cohort

* Positive diagnosis of Bertolotti's Syndrome
* Age ≥ 18 years
* Positive imaging for Bertolotti's Syndrome
* Previous analgesic injection results

Exclusion Criteria:

Lower Back Pain Cohort

* History of spinal deformity, previous spinal surgeries, spinal infections
* Pregnant women

Bertolotti's Syndrome Cohort

* History of spinal deformity, previous spinal surgeries, spinal infections
* Pregnant women
Comparative Study Menaquinone-7

The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.

In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and postmenopausal women between 45 and 65 years old
* Subjects with body weight and height according to BMI between 20 and 30 kg/m2
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with hypertension
* Subjects with hypercholesterolemia
* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects with (a history) of diabetes mellitus
* Abuse of drugs and/or alcohol
* Subjects receiving corticosteroid treatment
* Subjects using oral anticoagulants and subjects with clotting disorders
* Subjects using blood pressure-lowering medication
* Subjects using cholesterol-lowering medication
* Subjects using multivitamins or vitamin K supplements
* Subjects consuming high amounts of vitamin K-containing food products
* Subjects with cow's milk allergy and lactose intolerance
Humoral and Cellular Response in Shift Workers

The purpose of this study is to access whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment.

Sleep regulates immune functions. In this sense, we asked whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment. Men (18 to 55 years) will be recruited through different forms of media (electronic, newspapers, radio and magazines). The shift workers sleep pattern will be recorded polysomnographically. Subsequently, the volunteers will be underwent vaccination against hepatitis A (2 doses) and after 30, 60 and 90 days, blood samples will be collected to assess the humoral response in the experimental groups. The hormones prolactin, growth hormone, cortisol, adrenaline and noradrenaline will also be evaluated. Indeed, stimulations in culture will be conducted to assess the cellular response profile against the vaccination through the production assessment of IL-4, IFN-γ, IL-2 and TNF-α.

Eligibility Criteria:
Inclusion Criteria:

* shift workers
* naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL

Exclusion Criteria:

* smokers
* individuals with complaints and/or sleep disorders
* acute or chronic disease
* use of medication during the study period.
* acute illnesses
Enhanced Internet Behavior Therapy for Treating Obesity

The purpose of this study is to compare two Internet-based behavioral weight loss programs.

Given the increasing prevalence of obesity and fact that many adults have a strong preference to lose weight without attending weekly treatment meetings, there is need to develop effective alternatives to behavioral lifestyle interventions requiring less face-to-face contact. The Internet offers exciting opportunities to deliver behavior change interventions that minimize face-to-face interaction. We have recently developed and tested an Internet behavioral weight loss program compared with an Internet educational program in a randomized trial and found the behavioral program produced significantly better weight losses (4.1 kg) at 6 months. Our study clearly establishes the potential for using the Internet to deliver alternative treatment programs; however, treatment efficacy research is needed to further develop an Internet approach that will promote longer-term weight loss. The objectives of the proposed study are I) to enhance our Internet program to develop a state of the art Internet Cognitive-Behavior Therapy (I-CBT) program for obesity treatment; and 2) to conduct a randomized trial comparing the enhanced program with a Minimal CBT program also delivered via the Internet. We propose to recruit 100 overweight adults and randomly assign them to Enhanced Internet CBT or Minimal Internet CBT programs. The Minimal I-CBT condition will be given links to weight loss websites, weekly structured cognitive-behavioral lessons for weight loss, weekly prompting, and an on-line bulletin board. The Enhanced I-CBT program will have these same features plus weekly on-line group therapy sessions, computer-aided self-monitoring diaries, and weekly individual e-mail feedback from a therapist. The primary outcome is weight loss from 0-12 months. Secondary outcomes will examine patterns of weight change and changes in waist, diet, physical activity, and social support. The proposed research has significant implications for expanding the audience served by obesity treatment program by using the Internet. This study utilizes an innovative approach and extends our programmatic research on the development of a cognitive-behavioral Internet treatment for obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25 to 40

Exclusion Criteria:

* heart attack, stroke, cancer in the last 5 years, angina, diabetes that is treated with oral agents or insulin (people with type 2 diabetes whose disease is controlled through diet and exercise alone will be considered eligible), orthopedic or joint problems that would prohibit exercise;
* major psychiatric diagnoses and organic brain syndromes;
* pregnant, lactating, less than 6 months post-partum, or plan to become pregnant w/in 12 mos.
* currently taking weight loss medications or lost \> 5% of body weight during the past 6 months;
* intend to move to another city within the 12 month study duration;
* have another family member living in the household enrolled in the study
* heart problems, frequent chest pains, or faintness or dizziness
Effects of Inspiratory and Expiratory Pressure Training Methods in Patients With Chronic Obstructive Pulmonary Disease

The study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.

We will study 60 patients diagnosed of chronic obstructive pulmonary disease.The monitoring will be done for 8 weeks. Pressure-threshold respiratory trainers were calibrated to provide different loads according to the patients against inspiration (IMST) or expiration (EMST). Those chronic obstructive pulmonary disease clinically stable patients stratified from mild to very severe GOLD stages, were blinded to randomly divided into 3 different groups: a)control group:without any training;b) inspiratory and expiratory pressure threshold training group: trained with the pressure threshold trainer twice time daily with 15minutes' duration;c)inspiratory pressure threshold training group:trained with the pressure threshold trainer twice time daily with 15 minutes' duration,different from the b group,the expiratory pressure threshold is calibrated at 0.

Eligibility Criteria:
Inclusion Criteria:

Clinically stable COPD with diagnosis of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) \< 70%

Exclusion Criteria:

Cancer Unstable heart disease Neuromusculoskeletal disorder mental disorder Active smokers
Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism

In this study, the subconscious memory extinction therapy based on very brief exposure is used to intervene to reduce the alcohol craving of alcohol-dependent patients, prevent relapse, and observe the psychological craving, heart rate, skin conductance, and pupil diameter changes of the patients during the brief exposure extinction. The main questions it aims to answer are:

1. Whether subconscious extinction intervention would reduce psychological craving and alcohol relapse?
2. What is the mechanism of subconscious extinction intervention in alcohol dependence?

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. patients who meet the eligibility requirements will be randomized in very brief extinction, clearly visible extinction, or very brief neutral extinction. This study will recruit alcohol-dependent participants aged 18-60 in the ward, observe reported subjective scores during the extinction, and record the heart rate, skin conductance, pupil diameter, and ERP changes.

Eligibility Criteria:
Inclusion Criteria:

1. Adopt DSM-IV alcohol dependence diagnostic criteria;
2. Complete detoxification treatment without obvious withdrawal symptoms;
3. Informed consent, voluntary participation.

Exclusion criteria:

1. Acute alcohol dependence withdrawal period;
2. Patients who meet the DSM-Ⅳ diagnosis of psychoactive substances or non-psychoactive substances other than alcohol (except nicotine);
3. Previous acceptance experienced similar exposure therapy;