cyrilzakka/clinical-trials huggingface dataset:
Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome

Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and sucralose may not be as metabolically safe as they first appeared, and it has been proposed that their consumption may be linked to important disturbances in the gut microbiome. Some in vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg. steviol glycosides) can also influence intestinal homeostasis. However, it is not clear whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a positive action on intestinal health and gut microbiome, but this has yet to be experimentally tested in a rigorous study.

The main objective of this project is to evaluate whether steviol glycosides sweetened beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial, neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting impact of these NNSs on metabolic health.

As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic risk, this study will be the first to determine the metabolic impact of replacing SSBs by potentially "healthier alternatives" such as the increasingly popular stevia-based soft drinks and aspartame-based soft drinks. The investigators will further investigate whether these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a crucial concern since the importance of this unsuspected key "organ" has been ignored for too long and its important implication in many chronic societal diseases has just been discovered.

Results of this study could have a direct influence on health, nutrition and even agricultural policies as well as dietary guidelines around the world. This project is also critically important as an increasing amount of health professionals such as physicians, nurses and registered dietitians seek to provide evidenced-based guidance to individuals looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft drinks.


Eligibility Criteria:
Inclusion Criteria:

* Men and women in good health
* Soft drinks consumers (between 4 cans/week to 4 cans/day)

Exclusion Criteria:

* Metabolic disorders (hypertension, diabetes, hypercholesterolemia)
* Daily consumption of more than 4 cans of soft drinks
* Regular use of medication affecting study parameters
* Change of medication (type or dose) in the last year
* Use of antibiotics in the last 3 months
* Change in natural health product use in the last 3 months
* More than 2 alcohol drinks par day
* Weight change of more than 5% in the last 3 months
* Surgery in the last 3 months or planed during the study
* Allergy or intolerance for products contained in soft drinks
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
* Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
* Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
* Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
* Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
* Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
* Hemoglobin level greater than or equal to 10 g/dL

Exclusion Criteria:

* Has nephrotic range proteinuria
* Has liver disease or significant hepatic dysfunction
* Is taking Cytochrome P450 3A4 inhibitors or inducers
* Has adult history of kidney stones and dysphagia
* Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
* Currently on dialysis
* Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
Basiliximab Maintenance in Ulcerative Colitis

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population


Eligibility Criteria:
Inclusion Criteria:

1. Previously met eligibility criteria in the previous basiliximab UC study
2. Must have a total Mayo score at entry consistent with clinical response or clinical remission.
3. Signed a current IRB/IEC-approved informed consent form
4. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
5. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.

Exclusion Criteria:

1. Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:

   * Heart rate \> 90 beats/min at rest
   * Temperature \> 37.8 degrees C
   * Hemoglobin \< 10.5 g/dL
2. Subject is currently receiving a restricted/prohibited concomitant medication
3. Subject has undergone colectomy (total, or subtotal)
4. Subject is pregnant or breast-feeding
5. Prior noncompliance with previous study visit schedule and requirements
A Pharmacy-based Observational Study to Learn More About Iberogast Advance in the Real-world Setting

This is an observational study in which data from people with functional gastrointestinal disorders who decide on their own or by recommendation of their doctors or pharmacists to take Iberogast Advance are collected and studied. In observational studies, only observations are made without specified advice or interventions.

Functional stomach and bowel (or gastrointestinal) disorders are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis, is disturbed. Functional stomach and bowel disorders cause symptoms like heartburn, cramps and pain of the upper and middle part of the belly, also known as functional dyspepsia (FD) and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation.

Iberogast Advance is already available in German pharmacies without prescription for patients with gastrointestinal disorders such as FD and IBS. It contains herb extracts that work against inflammation, are calming, and protect the mucosa (innermost layer of the gastrointestinal tract). Earlier controlled studies with Iberogast Advance have shown how well it works and how it affects the body. Since Iberogast Advance is only available since October 2020, there is no information on its use in the real-world setting yet.

Therefore, the study researchers want to collect data on the use of Iberogast Advance in the real-world setting.

To do this, people with long-term and repeated functional gastrointestinal symptoms who purchase Iberogast Advance from participating pharmacies across Germany will be asked to fill out a questionnaire optionally covering 6 weeks of treatment. The participants will take Iberogast Advance as recommended in the product information.

The main purpose of this study is to see how well Iberogast Advance works and is perceived in the real-world setting. Participants will record how they experience a change of their gastrointestinal symptoms (assessed single-symptom-based) from start and during 6 weeks of treatment. Researchers will then compare the differences and analyze treatment effects.

The researchers will additionally collect information on usage behavior, characteristics of the patients, their symptoms, tolerability and their satisfaction with Iberogast Advance.

There will be no required tests or visits with a study doctor in this study. The researchers will collect the results of the patient questionnaires from Jun 2022 to January 2023.


Eligibility Criteria:
Inclusion Criteria:

* Adult female or male subject aged ≥ 18
* Decision to initiate treatment with Iberogast Advance was made as per pharmacist's routine recommendation practice/by the subject
* Subject purchases Iberogast Advance for his own use
* Not pregnant or lactating
* Not hypersensitive to any of the ingredients of Iberogast Advance

Exclusion Criteria:

* Patients with known hypersensitivity to any of the ingredients of Iberogast Advance
* Pregnant or lactating women
Study of the Nevisense Device to Assess Atypical Skin Lesions

The purpose of this study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma. Assessing particpants' moles with the Nevisense device may help improve screening methods for the early detection of melanoma in people with atypical mole syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 30 years of age) at the time of the initial study visit.
* Patients displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) \> 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study.
* Patients with at least three clinically stable nevi between 5 and 20 mm in diameter.
* Patients (or LAR) who are able to provide informed consent.
* Patients with previous total body photography images taken at least 3 years prior

Exclusion Criteria:

* Patients without at least three clinically stable nevi between 5 and 20 mm in diameter.
* Patients with any electronic implantable devices.
* Patients who are pregnant (verbally confirmed with the participant).
Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults

This study is to determine to see the effect of action observation therapy with otago exercise on Balance and Quality Of Life.

This study is designed to reduce the Fall and balance problems and increase the quality of life in older adults. Balance, which declines with aging, is a complex sensory-motor process in which the visual, vestibular, and musculoskeletal systems work cooperatively to produce postural stability and loss of balance control causes falls, resulting in severe injuries, such as fractures, causing longstanding pain, lower quality of life, disability, and even death.

Interventions include balance and postural control that can help older people to avoid falling, through tai chi methods, gait training, strengthening exercises, and balance training programs.

The Otago Exercise Program comprises muscle strength exercises, balance training, and walking. The Otago workout program is based on individual tolerance, consisting of strengthening, balance, walking, and aerobic activities, and can be done at home environment Action observation is a cognitive intervention training strategy that involves observing other people's performance in order to promote motor learning.

Participants were instructed to watch a video on a screen while comfortably seated in a chair with armrests. They were not allowed to follow along or engage in any movement while watching the video. After the watching video of each component of otago exercises the exercises performed by participant based on the content of the video.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Participant experience fall \> one time in last 6 months.
* Participants having Berg Balance score between 20 to 40

Exclusion Criteria:

* ●Abnormalities in visual, auditory, or vestibular system
* Limb defects
* History of recent fractures
* Participants with Cardiovascular, Cerebrovascular disease or traumatic brain injury and Epilepsy
MicroRNAs and Prognosis in Breast Cancer

Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients.

The potential role of miRNAs will be studied as a predictor of metastases development. miRNAs expression and miRNAs promoter methylation will be evaluated in surgically removed specimens obtained from breast cancer patients at diagnosis. Relevant miRNAs will be first identified by analysing a retrospective breast cancer cohort including at least and subsequently validated on a prospective cohort.

Eligibility Criteria:
Retrospective Cohort

Inclusion Criteria:

Tissue samples from breast cancer cases diagnosed from 2004 to 2014 for which informed consent for tumour banking and complete clinicopathological and follow up data were available.

Exclusion Criteria:

Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen.

Other cancers diagnosed in the last five years.

Prospective Cohort:

Inclusion Criteria:

Ability to provide written informed consent; Age greater than 18 years; Histological diagnosis of Breast disease; First diagnosis of Breast Cancer; Syncronous distant metastasis absent.

Exclusion Criteria:

Stage IV breast cancer; Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen; Other cancers diagnosed in the last five years; Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
Mobile-Based Intervention to Promote Physical Activity Among the Elderly

This study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention among elderly individuals with chronic diseases.

Promoting physical activity among elderly individuals is an increasingly critical public health priority. Regular exercise is essential for maintaining mobility, enhancing mental well-being, and reducing the risk of exacerbating chronic conditions. However, many elderly individuals encounter significant barriers, including physical limitations, lack of motivation, and restricted access to safe environments.

This mobile phone-based intervention seeks to address these challenges by offering accessible support through age-appropriate exercise routines, motivational prompts, and educational content delivered directly to participants' mobile devices. The intervention's primary objective is to reduce sedentary behavior, increase physical activity levels, and ultimately enhance the overall health and well-being of elderly individuals with chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥60 years and diagnosed with at least one chronic disease
2. Owns a smartphone and is proficient in using WeChat
3. Daily sedentary time ≥6 hours

Exclusion Criteria:

1. recent surgeries, injuries, or other conditions that would prevent simple physical activity
2. hearing, vision, or physical disabilities
Effects of TENS During the Performance of a Therapeutic Exercise Protocol in Individuals With Knee Osteoarthritis.

Research participants diagnosed with knee Osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. Therapeutic Exercises + Transcutaneous electrical nerve stimulation and 2. Therapeutic Exercises + placebo Transcutaneous electrical nerve stimulation.

Therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on scale 1 to 4).

Exclusion criteria are bilateral knee Osteoarthritis, hip Osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (Parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of unilateral osteoarthritis of the knee
* presenting knee pain for more than three months
* morning stiffness for less than 30 minutes
* crepitus, bone tenderness, and absence of palpable heat.

Exclusion Criteria:

* Bilateral knee osteoarthritis, hip osteoarthritis
* severe osteoporosis
* fibromyalgia
* medical history of tumors or cancer
* active inflammatory joint diseases (rheumatoid arthritis, gout),
* undergoing any lower extremity joint replacement
* neurological diseases (Parkinson's disease, Accident Cerebral Vascular, Multiple Sclerosis, muscular dystrophies, motor neuron disease, Alzheimer's disease)
* infected wounds or osteomyelitis in the knee region
* deep vein thrombosis or thrombophlebitis
* sensory changes in the lower limbs
* cognitive and cardiopulmonary impairment that may prevent or limit performing the exercises
* using a walking assistance device
* having a history of recent trauma to the knee,
* having undergone any form of treatment involving physiotherapy
* intra-articular corticosteroids, anti-inflammatories, or chondroprotective in the six months before the start of the interventions.
Brain-Shift Monitoring Using 3D Scanning

A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery.

The primary objective is to evaluate the performance of the scanner in determining the brain surface shape over multiple time points during craniotomies (surgical opening into the skull), and present those shapes in full color, with high resolution in all three coordinates of 3D space. A secondary objective is to use the measurements to determine brain shift as a function of time.

The scanner sterilization will largely follow procedures used currently for cameras and microscopes: the scanner will be draped in a disposable drape custom manufactured for the device by a leading instrument drape manufacturer (Medline). The drape will be windowed with a sterilized shatterproof plastic optical window. Standard hospital procedures will be followed for the disposal of instrument drapes. The drape will be sterile and wrapped in the conventional manner, and the drape itself will be disposable. Prior to surgery, the drape, window and frame will undergo the same sterilization procedure as other equipment. If window transparency is compromised during surgery, it can be cleaned with a cleaning agent.

The scanner will illuminate the craniotomy region with light for the duration of its use, which may be for the duration of the surgery. The scanner will be anywhere from 8 to 12 inches away from the patient, illuminating the subject's brain by the scanner light for 2 minutes at a time, or continuously, either with or without maximum overhead lighting.

For each patient, the duration of obtaining data will last for the duration of the clinical operation procedure. The 3D Scanner on and off time would add less than 5 minutes to the procedure, not including measurement time.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 6 years of age at Visit 1.
2. Clinically planned for craniotomy, including for malignant tumors, whether awake or under general anesthesia.
3. Able to provide written informed consent (and assent when applicable) - by subject or subject's legal representative - and agrees to comply with the requirements of the study.

Exclusion Criteria:

1. Language problems that would prevent from properly understanding instructions.
2. Requirement of an interpreter.
3. Patients who are excluded from consideration for the clinical operation are therefore excluded from the research study.
4. Special populations: pregnant women, prisoners.
Analysis and Improvising Working Practices in the ER

Analysis of electronic files of patients presenting to the emergency department to improve current practice

Overcrowding in the emergency department (ED) is a pressing healthcare issue globally and has been shown to negatively affect the quality of treatment, clinical outcomes and patient satisfaction.

In recent years, an increasing number of studies have tried to implement changes in the ED to increase efficiency and thereby reduce the length of stay (LOS). Examples to these efforts include physician triage, expanding the nursing scope of practice and patient-flow design (e.g., creating fast track units) in the ED. Importantly, not all intuitive changes in the ED resulted in the reduction of LOS Therefore, implementing changes in the ED must be done with caution and preceded with a cost-benefit analysis of the effects of the intervention using available retrospective data.

This research was conducted in the ED of Sheba Medical Center (SMC), a tertiary government-owned hospital in Israel with 1400 beds. This study is a retrospective medical record review of patients admitted to the adult primary SMC ED. The study sample comprises all the walk-in patients that visited the ED between January 2013 and December 2017. The data here does not include other EDs located elsewhere in SMC, (e.g., pediatric ED, gynecology ED, ophthalmology ED, and psychiatric ED). All admissions files in SMC ED are recorded in a computerized system with negligible exceptions (such as power outage and connection or server maintenance). The time and date of every change in the electronic files are also recorded in the system. Therefore, it is possible to track the waiting times as well as the full content of the admission file.

The aim of this study is to identify and analyze potential modifications in current ED practice which may improve outcomes such as LOS, missed diagnosis, leaving without being seen, patient satisfaction, etc.

Eligibility Criteria:
Inclusion Criteria:

* all the patients that visited the SMC - ED between August 2014 and December 2017

Exclusion Criteria:

* patients in which the electronic file is absent