cyrilzakka/clinical-trials huggingface dataset:
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days.

The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Diagnosed with diabetes, all types except gestational diabetes
* Skin phototype 1-4
* Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days
* Subject has a wireless internet connection at home to be used in the study

Exclusion Criteria:

* For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female subjects: Breastfeeding
* Subject currently participating in another study
* Subject not able to understand and read the local language
* In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
* Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
* Subject diagnosed with cardiovascular diseases
* Reduced circulation in right hand evaluated by Allen's test
* Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity
* Radiotherapy for the past six months
* Extensive skin changes, tattoos or diseases on right hand thenar (probe application site)
* Known allergy to medical grade alcohol used to clean the skin
* Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
* Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff
Optimizing Weight Loss Outcomes Through Body Image Enhancement

The study will examine if a standard group-delivered cognitive behavioral lifestyle intervention for weight loss can be improved via the incorporation of a novel body image intervention designed to address body image and improve weight loss outcomes in a sample of women with overweight/obesity.

Weight loss is associated with improved morbidity and mortality in people with overweight/obesity. Lifestyle-focused interventions reliably produce modest weight loss. While some comprehensive multidisciplinary weight management interventions include behavioral and psychosocial aspects of behavior change, including brief body image education, few have focused substantially on body image as a potentially salient influence on motivation and/or successful outcomes. Body image is an individual's perception of their physical self. A common psychosocial correlate of obesity is body dissatisfaction, and research has shown that individuals with obesity are more often dissatisfied with their bodies than individuals without obesity. Multiple studies suggest that improving body image might enhance eating self-regulation during weight management interventions and engagement in physical activity. Additionally, negative body image has been associated with detrimental health outcomes, such as emotional eating and avoidance of physical activity. Although body image has been addressed in the context of obesity and weight management, it is often done in a cursory manner. To date, no weight loss programs have attempted to develop a novel body image intervention that specifically targets the necessary dichotomy between body acceptance and expectable desire for body changes in a weight loss program. As such, the investigators will examine if a standard group-delivered cognitive behavioral lifestyle intervention for weight loss can be improved via the incorporation of a novel body image intervention designed to address body image and improve weight loss outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 and older
* Sex: Female
* BMI of 25 kg/m2 or greater

Exclusion Criteria:

* Participants unable or unwilling to provide informed consent
* Participants who are pregnant or planning to become pregnant over the next 4 months
* Participants who are breastfeeding or planning to breastfeed over the next 4 months
* Participants who have received a diagnosis of diabetes (type I or II)
* Participants who been told NOT to lose weight or exercise for any reason by a healthcare provider
* Participants who currently have psychiatric illnesses (e.g., Psychosis, schizophrenia, bipolar disorder or severe depression/anxiety)
* Participants who currently have persistent suicidal thoughts or have attempted suicide in the last year
* Participants with a history of diagnosed eating disorders such as bulimia nervosa or anorexia nervosa.
Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* french language
* effective contraception for women during the study
* informed consent
* no alcohol intake the day before the exam
* for patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology or degenerative disease with cognitive deficit

Exclusion Criteria:

* for healthy volunteers: previous neurological history (except non complicated migraine), previous psychiatric history (except depression with good evolution or anxiety with maximum one anxiolytic treatment), or severe cranial traumatism
* for patients: vigilance disorders, severe depression or anxiety.
* for both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for MRI, participation in another trial or former involvement in another trial within one month
Regenerative Cellular Therapies, Physiology, Pathology and Developmental Biology

This study aims to use tissue from deceased organ donors to investigate organ physiology, developmental biology, as well as the development of future regenerative cellular therapies. It will investigate function and immune response to stem cells as well as their generation from adult cells and generation of induced pluripotent stem cells (iPSCs).

The purpose of this study is to use tissue from deceased organ donors to address questions that are of importance for the development of regenerative cellular therapies for better understanding of organ physiology and developmental biology. This study aims to maximise the clinically available data as well as patient benefit that can be generated from donated tissue. It also aims to reduce number of consent forms given to patients by consolidating and coordinating a number of related investigations.

The study aims are:

* To examine function and the immune response to stem cells and their differentiated progeny as well as development of immunomodulatory approaches to prevent their rejection.
* Generation of induced pluripotent stem cells (iPSCs) and their subsequent differentiation into functional cells as potential therapies.
* Generation of differentiated cells from native adult stem cells as cellular therapies.
* Investigation of organ physiology.

Eligibility Criteria:
Inclusion Criteria:

* All deceased organ donors with informed consent from the donor family

Exclusion Criteria:

* Donors aged \<16
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-75 years
* Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
* Failed in the previous standard therapy;
* ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
* The estimated survival period is ≥3 months;
* Rehabilitate from previous therapy;
* Adequate organ functions;
* Patient's written informed consent;

Exclusion Criteria:

* Tumor emergencies;
* Abnormal coagulation function;
* Contagious diseases, such as HIV, HBV, HCV infection;
* Mental disorders;
* Concomitant tumors;
* Immunological co-morbidities
Efficacy of Subfascial Approach in Thyroidectomy to Quality of Life in Thyroid Disease Patients

Subfascial approach method in thyroidectomy maybe result in better quality of life than conventional approach method in thyroid disease patients


Eligibility Criteria:
Inclusion Criteria:

* micropapillary thyroid cancer

Exclusion Criteria:

* lateral neck lymph node metastasis
* severe thyroiditis
* goiter
* reoperation
* extrathyroidal extension
A Randomized Controlled Trial of the Efficacy of the Lighthouse Parenting Programme in Addressing Parenting Difficulties in China

The study will be conducted in three phases: assessments, group intervention and individual intervention. All participants will engage in the full program over a period of five weeks, divided into ten sessions. The 5 group interventions will occur once a week for 1.5 hours. During this time, the psychotherapist will disseminate psychological knowledge and skills pertinent to parenting, after which the group members will engage in practice exercises and discourse. Subsequently, one individual session will be conducted each week for one hour. The test group (Group A) will be assessed once at recruitment and after the last individual session. The control group (Group B) will undergo the same intervention as the test group after the test group completes the intervention and posttest, and will be assessed one additional time for pre-intervention status.


Eligibility Criteria:
Inclusion Criteria:

* Parents with children aged 2-14 years who exhibited parenting that were identified as being problematic (Parenting Stress Indicator PSI ≥ 86 (critical high level)).

Exclusion Criteria:

* Parents in the family with either parent and child who have a serious medical condition (e.g., cancer, heart disease, etc.), an acute psychotic episode, or difficulty engaging in group interventions may be excluded from participation.
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.

Fibromyalgia (FM) is a chronic disorder that involves chronic widespread musculoskeletal pain typically accompanied by fatigue, disordered sleep, cognitive complaints, psychological distress, and impairments in functioning. Treatments to date have been only partially effective and typically of modest benefit. Many persons with FM remain persistently dysfunctional and often disabled. This has given greater impetus for patients to seek complementary and alternative medicine (CAM) therapies. In this study, a variant of electroencephalograph (EEG) biofeedback known as Low Energy Neurofeedback System (LENS) will be used to reduce FM symptoms.

Participants in this study will be randomly assigned to receive either LENS or placebo for several sessions. The Fibromyalgia Impact Questionnaire will be used to assess participants at the end of the study and at the 3- and 6- month follow-up visits.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of fibromyalgia with symptoms for at least 1 year
* Self-report of having attention/concentration, memory, multi-tasking or other thinking difficulties
* Able to read and understand English
* Able to attend treatment sessions weekly and return for planned follow-ups
* Appropriate balance of average delta (\<4 Hertz) EEG waveband and alpha (approximately 4-8 Hertz) EEG waveband amplitude on LENS screening (to be determined by study personnel);

Exclusion criteria:

* Other chronic pain condition of major significance
* Current chronic viral infection
* Current other unstable medical condition
* History of spinal, including neck, surgery
* Psychological screening indicates psychotic, suicidal, homicidal, and/or substance abusing
* Use of long-acting opioid medication taken on a continuous 24-hour dosing schedule
* Current involved in litigation regarding pain condition or seeking disability
* History of electroconvulsive therapy
The Burden of Pediatric Surgical Conditions in Rural Kenya

PURPOSE OF THE STUDY

The main purpose of this study is to find out what is the true burden of surgical conditions in pediatric population in a well defined geographical rural area in western Kenya.

MATERIAL This research will be conducted in the Homa Bay county in western Kenya in previously selected locations around the county in rural area. An estimated 800 children and youth under the age of 18 will be selected for this study. This study will take place between October and November 2015. The investigators hypothesis, based on prior survey studies done in Sub-Saharan Africa, is that roughly 6% of the people under 18 are suffering from a surgical condition. In a sample size of 800 people the margin of error is 1,65%.

People who are currently being treated in a hospital will be excluded from the study. Also the people who decline from the study will be excluded. The number of declinations will be recorded.

METHODS The people will receive a written and a verbal information regarding the study and its purposes from the primary research assistant. If they decide to participate in the study they or their parent/guardian will be asked to sign an informed consent. Local interpreter will be available to help with possible questions.

The primary research assistant will conduct a short interview. Prior medical history will be taken. The participants will be asked their age. If age is not known the primary research assistant will estimate it. The height, weight and sex will be registered. A full physical examination will then be conducted. In this examination the participants will be assessed for visible deformations i.e. masses, scars, limb deformities. It will be determined whether the deformation is congenital or acquired. If the deformity is acquired the cause will be asked from the subject. The range of major joints will be registered. In case of palpable masses the possible diagnosis will be figured out using basic clinical skills. A structured survey sheet will be used collect the information. No other forms of diagnostic measures will be used. No blood or microbial culture samples will be collected and no x-ray imaging will be done.

If a surgical condition is diagnosed the participant will be informed about the nature and possible cause of this condition. No treatment procedures will be done on site.

Eligibility Criteria:
Inclusion Criteria:

* Age under 18

Exclusion Criteria:

* Not meeting the age criteria.
* Declining to participate in the study.
* Patients who meet the criteria but are currently being treated in a hospital.
Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke

The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.

This study aims to detect the impact of probiotics administration during the process of ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria1.

the time from paroxysm to admission ≤2weeks.

Exclusion Criteria:

* Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing vision and reading Illiteracy Have recognitive disorder before stroke (recorded in medical records) Treated with antibiotics probiotics or prebiotics in1month before admission
Effect of Exercise and Education After Pneumonia

The mortality rate and quality of life is effected in patients with pneumonia, especially in the older population.

The end point of this study is to improve quality of life by and interventional exercise and education. Patients will be randomized at admission and enrolled into the study. They will be assessed with various performance and quality of life indicators before, during and after the study, and exercise tolerance will be assessed throughout and after.

The purpose of this research study is to assess improvement in functional status and quality of life of patients 40 years of age and older patients hospitalized for community acquired pneumonia and healthcare associated pneumonia with a multi-disciplinary program of exercise, education and psychological support. This study will use a randomized, controlled clinical trial design. The total number of patients enrolled will be 120, divided into two groups of 60 patients each. One group will have patients age 40 to 60 and second group will have patients age 60 and above. Stratified randomization will be done to divide these into two (control group and intervention group) equal groups with 30 patients each. The primary endpoint is improvement in quality of life indices. Secondary endpoints are improvement in functional status, change in 6 minute walk test, exercise intolerance, immunization, occult desaturation and change in body weight of patients hospitalized for community acquired pneumonia with a multi-disciplinary program of exercise, education and, psychological support. Eligibility includes age 40 and above at the time of admission, diagnosis of CAP and HCAP via radiographic and PNA symptoms, discharge to home, ability to read and sign informed consent to participate, ability to perform procedures/exercises involved in the study and ability to comprehend educational component of program.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CAP or HCAP via radiographic imaging and symptoms of pneumonia Age 40 and above.
2. Discharge to home.
3. Ability to read and sign consent.
4. Ability to perform in procedures/exercise.
5. Ability to understand educational component of the program.
6. Antibiotic administration for pneumonia within 12 hours of admission.

Exclusion Criteria:

1. Severe lung diseases like ILD(Interstitial Lung disease), ARDS (Adult Respiratory Distress Syndrome.)
2. Ventilator dependent patients.
3. Discharge to nursing home.
4. Comorbidity that could limit exercise training.
5. Dementia, Schizophrenia or any active severe psychiatric disorder.
6. Any Active Malignancy or diagnosis of Lung malignancy.
7. Inability to attend program two times per week.
8. Recent myocardial infarction within two months.
9. Unstable angina, Heart failure (NYHA class III and IV.)
10. Patients with pneumonia who did not receive antibiotics within 12 hours of admission.
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye

The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Have provided written informed consent;
* Have a history of dry eye for at least 6 months prior to enrollment;
* Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;
* Demonstrate a response when exposed to the CAE.

Exclusion Criteria:

* Have an on-going ocular infection, or active ocular inflammation
* Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;
* Have contact lens-induced dry eye;
* Have previously had laser in situ keratomileusis (LASIK) surgery;
* Be using or have anticipated use of temporary punctual plugs during the study;
* Have best corrected visual acuity \> +0.7 in both eyes;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Have a known allergy and/or sensitivity to the test article or its components;
* Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days
Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.


Eligibility Criteria:
Inclusion Criteria:

1. Left Ventricular Ejection Fraction \<40%
2. Patients aged \>18 years
3. Able to provide written consent

Exclusion Criteria:

1. Known acquired or congenital structural heart disease such as severe valve disease, ventricular/atrial septal defects
2. Haemodynamic Instability
3. Severe disease in major proximal coronary arteries or planned percutaneous coronary intervention during the index procedure