cyrilzakka/clinical-trials huggingface dataset:
Near-Infrared Laser Stimulation for Various Neurological Conditions

The study will evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, neurodegenerative disease, and traumatic brain injury.

The present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., Alzheimer's), and traumatic brain injury. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. The present study can be easily implemented because instruments have been in routine clinical deployment providing for a high degree of availability and reliability. Quality assurance is tightly controlled. The study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of subjects is not a limiting factor.

Eligibility Criteria:
Inclusion Criteria (depression):

* Diagnosis of Major Depressive Disorder
* Score greater than 13 on the Beck Depression Inventory
* Failure to remit with 3 antidepressants
* At least 18 years of age

Inclusion Criteria (anxiety):

* Diagnosis of Generalized or Acute Anxiety Disorder
* Score greater than 22 on the Beck Anxiety Inventory
* Failure to remit with 3 anxiolytics
* At least 18 years of age

Inclusion Criteria (neurodegenerative dementia):

* Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia (CDR stage 2)
* Lumbar puncture for Abeta 42 and Tau proteins evincing clinical correlation of neurodegenerative disease pathology
* Advanced MRI of the brain including volume measurement of the hippocampus, blood-oxygen level dependent imaging, and arterial spin labeling perfusion scans. On entry, patients will have CDR stage of at least 0.5 and at least one abnormal imaging biomarker.

Inclusion criteria (TBI/CTE):

* Diagnosis of Traumatic Brain Injury or Chronic Traumatic Encephalopathy
* At least 18 years of age

Exclusion Criteria:

* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disorder
* Myeloproliferative disorder
* Sickle cell disease
* Primary pulmonary hypertension
* Immunocompromising conditions and/or immunosuppressive therapies
* Any other neoplastic illness or illness characterized by neovascularity
* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding
Intestinal Organoids

Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

The project aims to generate a biocollection of 3D intestinal models from digestive biopsies with associated health data and to characterize them before using them for the screening of potential therapeutic molecules.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 75 years
* Subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples
* Subject having signed a free and informed consent in writing

Exclusion Criteria:

* Subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty.
* Anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)
A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer

This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value \[SUV\]) of less than (\<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram \[mg/kg\]) and docetaxel (100 milligrams per square meter \[mg/m\^2\]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (\>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participants with early stage HER2-positive breast cancer
* Scheduled to receive neoadjuvant therapy with the objective of conservative surgery
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Exclusion Criteria:

* Participants with partial or total lobular carcinoma
* Participants with inflammatory breast cancer
* Previous treatment with chemotherapy, radiation therapy or hormonal therapy for breast cancer
* Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5 years before study entry or in situ contralateral breast carcinoma
Improving Diabetes Equity and Advancing Care Study

The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.

Sinai Health System is Illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large Medicaid-eligible populations in Chicago. In response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, Sinai designed the Center for Diabetes and Endocrinology (the Center) which launched in 2020. The Center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. This study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the Center to define the ideal sequence for improving patient outcomes. Grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (SMART), we propose evaluating the appropriateness of novel intervention components (Aim 1); measuring fidelity of new intervention components (Aim 2); comparing the effectiveness and determine optimization of intervention components (Aim 3). We will evaluate Aim 1 via key stakeholder interviews and focus groups. We will analyze Aims 2 \& 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. We will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of type 1 or type 2 diabetes
* 18+ years of age
* Able to provide consent
* Identify as African American/Black or Latinx
* most recent HbA1c \> 7%,
* Have a smartphone compatible with the Glooko application
* Have completed at least one Center appointment (i.e. current patient)
* Completed at least 3 months of their assigned study condition

Exclusion Criteria:

* Already an active user of RGM
* Actively working with a CHW
* Diagnosis of gestational diabetes (without type 1 or type 2)
* Has a Power of Attorney
* Be suffering from Stage-V renal disease or undergoing dialysis.
* Be suffering from a severe form of cardiovascular disease (NYHA Class III and IV)
Effect of Sesame Oil in Preventing Phlebitis

Background: To determine the effect of sesame oil in preventing phlebitis that may occur during intravenous therapy in patients undergoing cardiac surgery.

Material and Method: A randomized controlled interventional study will be conducted with patients treated in the coronary intensive care unit of a university hospital. The population of the study will be the patients hospitalized in the intensive care unit after cardiac surgery and administered parenteral amiodarone infusion. The power analysis was carried out by taking the study by. The sample size was determined as 44 patients. Personal Information Form and Visual Infusion Phlebitis Scale will be used to collect data. Sesame oil will be applied to the patients in the intervention group as 10 drops, 10 cm around the cannula, for 10 minutes. This administration will be repeated every eight hours during the 24-hour amiodarone infusion. No application will be made by the researcher to the patients in the control group. At the end of each 24 hours, patients in both groups will be evaluated by the investigator on the Visual Infusion Phlebitis Scale. Descriptive statistics, chi square, independent t test and Fisher's exact test will be used to evaluate the data.

No application was made to the patients assigned to the control group. Sesame oil was applied by the researcher to the patients assigned to the intervention group. Sesame oil was applied to the 10 cm circumference of the cannula by applying 10 drops and 10 minutes. This application was repeated every eight hours during the 24-hour amiodarone infusion. The area where the intravenous line is located is covered with a standard transparent dressing (Tegaderm) so that it can be observed. Patients in the intervention and control groups were evaluated for phlebitis at the end of every 24 hours (1st day, 2nd day, 3rd day) according to the VIP scale. The highest of the phlebitis stages obtained as a result of the evaluation was accepted as the final evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone cardiac surgery,
* were over 18 years old,
* were conscious, could communicate,
* were not allergic to sesame,
* were administered prophylactic rhythm regulator
* amiodarone as a treatment were included in the study.

Exclusion Criteria:

* who was with cancer,
* who was with diabetes mellitus,
* who was with hypertension
* who was with peripheral vascular disease
* Patients who had myocardial infarction during the procedure,
* Received immunosuppressive therapy,
* underwent resuscitation and could not use an intravenous catheter for any reason
Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial

Heat-sensitive moxibustion is considered to be effective for primary hypertension in hospital setting. This study aims to investigate whether heat-sensitive moxibustion self-administration is effective for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting using a multicenter, prospective, non-randomized study design

Primary hypertension is a global health issue with high incidence; it affected approximately 1.13 billion people worldwide and directly or indirectly causing an 10.4 million of death yearly. The routine drugs for primary hypertension are limited by adverse effects and expensive costs. Therefore, complementary and alternative medicine with good efficacy and safety and low expenditure is still needed for primary hypertension, especially in poverty-stricken areas.

Heat-sensitive moxibustion is an innovative therapy developed on the basis of traditional moxibustion. Compared with traditional moxibustion, heat-sensitive moxibustion advocates finding heat-sensitive acupoints where patients have special reactions to moxibustion heat, including diathermy, heat transfer, soreness, etc. The application of moxibustion on heat-sensitive acupoints (i.e., heat-sensitive moxibustion) has been shown to be more effective to traditional moxibustion for many diseases, including primary hypertension. Moreover, compared with acupuncture, heat-sensitive moxibustion has a main advantage that moxibustion does not require professional qualifications and patients can self-administer moxibustion after professional training. However, the current evidence is generated only from hospital settings. Therefore, this study is specifically designed to investigate whether heat-sensitive moxibustion self-administration is an effective intervention for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of primary hypertension
2. 18 to 70 years old
3. Sign the informed consent

Exclusion Criteria:

1. Secondary hypertension caused by kidney disease, macrovascular disease, pregnancy, endocrine disease, brain disease, drug-induced factors, etc.
2. Allergic to moxibustion equipment, moxa smoke or moxa
3. Pregnancy or lactation
4. A history of serious cardiovascular and cerebrovascular events such as cerebrovascular accidents and myocardial infarction
5. Complicated by liver and kidney dysfunction indicated by total bilirubin, alanine aminotransferase, aspartate aminotransferase, or blood creatinine are more than 2 times upper limit of normal value
6. Complicated by malignant tumors
7. Complicated by major mental disorders
Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome

In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. Patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) for 24 weeks. Clinical assessment will be done at screen/baseline, 4 weeks, 12 weeks, and 24 weeks. The specific aims are to compare the metformin group versus controls on 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms.

In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. Patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) . Clinical assessment will be done at screen/baseline, 4 week, 12 week and 24 week. The specific aims are to compare the metformin group versus controls on: 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms. Clinical symptoms will be measured by the Positive and Negative Syndrome Scale and Calgary Depression Scale for Schizophrenia (Chinese version). Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery.

The investigators hypothesize that 1) metformin may improve the cognitive impairment of schizophrenia patients; 2) metformin may alter oxidative stress indexes or inflammatory biomarkers thus influencing the oxidative and inflammatory mechanism, and the structure and function of the hippocampus that may be significantly associated with cognitive function.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
2. Duration of illness less than 5 years with current symptoms exacerbation;
3. Male and female aged 18 to 65 years;
4. PANSS total score \< 60 and CDSS-C total score \< 6;
5. Signed the study consent for participation;
6. Patients with higher risk factors for MetS, or patients who gained weight \> 10% of their pre-drug weight within the first year after antipsychotic medication.

Exclusion Criteria:

1. Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
2. Having a history of traumatic brain injury, seizures, or other known neurological or organic diseases of the central nervous system;
3. Taking antidepressants, stimulants, mood stabilizers or accepting electricity shock treatment;
4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting;
5. The routine blood tests showing abnormal renal, and liver function;
6. Pregnant or lactating women.
VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-45 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²
* Normal blood pressure
* Normal laboratory tests

Exclusion Criteria:

* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
* History of drug allergy
* Abnormal ECG or history of clinically significant abnormal rhythm disorder
* Positive alcohol, drug, or tobacco use/test
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration

Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed neovascular age-related macular degeneration.

Exclusion Criteria:

* Chronic gastrointestinal disorders
Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in Establishment Hosting For the Dependant Elderly (EHPAD) (Old-people's Home)

In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.

For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.

Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie


Eligibility Criteria:
Inclusion Criteria:

* people older than 65 years
* persons living in EHPAD-type old people's homes or living at home and using a meals-on-wheels service
* persons without known heart disease or arterial hypertension
* persons who have given oral consent

Exclusion Criteria:

* Persons suffering from a serious illness during the trial
* Persons with life expectancy of less than 6 months
* Persons with proven anosmia (total loss of olfaction), from birth or because of physical trauma (head injury) or disease (acute rhinitis)
* Persons with an allergy or an aversion for any of the foods used
* Persons with a strict prescribed diet
Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice

The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages.

Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin glulisine associated with a telemedicine system to teach CHO counting (DID) with the same insulin regimen administered according to usual practice.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 1 diabetes as defined by the criteria of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (29)
* Males and females
* Age equal or more than 18 years
* Patients not habitually using CHO (carbohydrates) counting
* Self monitoring blood glucose (SMBG) at least 3 times a day
* Four basal-bolus daily injections of short-acting and long-acting insulin analogues
* HbA1c equal or more than 7.5%
* Female patients have to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or IUD);
* A full study-specific informed consent must be obtained in writing for all subjects

Exclusion Criteria:

* Multiple daily injections of NPH insulin or soluble rapid insulin or Continuous Subcutaneous Insulin Infusion (CSII) therapy
* Mental conditions, depression, or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Eating disorders
* Pregnancy / lactation.
* Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases making implementation of the protocol or interpretation of the study results difficult
* Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
* Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures.