cyrilzakka/clinical-trials huggingface dataset:
Community-designed Food Is Medicine for Adults With Diabetes

The goal of this clinical trial is to learn if an educational intervention can affect clinical outcomes in adults with diabetes. The main question it aims to answer is:

Can a Food Is Medicine intervention affect obesity and/or diabetes markers in adults?

Researchers will compare a Food Is Medicine arm to a control arm to answer the research question.

Participants will provide biometrics and questionnaire responses at three time points. Those in the Food Is Medicine arm will receive regular free meal kits combined with cooking and nutritional education.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years, weight 100+ pounds, HbA1c \>7% in 2020

Exclusion Criteria:

-
Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation

The purpose of this research is to estimate the frequency of postoperative lasting muscle weakness in patients receiving Sugammadex after undergoing liver transplant surgery by using electromyographic device (EMG), such as TetraGraph.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing primary liver transplantation.

Exclusion Criteria:

* Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with a known history of cerebrovascular accident (CVA).
* Patients undergoing repeat liver transplantation or concomitant pancreas/kidney transplantation at the time of liver transplantation.
* Patients admitted to the intensive care unit prior to liver transplantation.
Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants

Primary Objective:

To assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants.

Secondary Objective:

To assess the tolerability and safety of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants

The duration of the study for a participant will be up to approximately 7 weeks and include:

* Screening period: up to 4 weeks (Day -28 to Day -2).
* Institutionalization period at each period of treatment: 4 days (Day -1 to Day 3, single SAR443820 administration on Day 1).
* Wash-out period: at least 5 days between each dosing.
* End-of-study visit: Period 3/ Day 6±1 day.

Eligibility Criteria:
Inclusion Criteria:

East Asian (Chinese and Japanese) male and/or female participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent.

Chinese or Japanese ethnicity, according to the following criteria:

Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China.

Japanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.

Body weight within 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, and body mass index (BMI) within the range 18.0 and 30.0 kg/m2, inclusive.

Exclusion Criteria:

Medical history of any seizure.

Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any live attenuated vaccine given within 3 months or any non-live vaccine given within 2 weeks before inclusion, and any biologics (antibody or its derivatives) given within 4 months before inclusion.

Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test.

Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or a lifetime suicide attempt. A "yes" response to questions 4 or 5 on the Suicidal Ideation section, or a score of 4 or 5 on the Intensity of Ideation section of the baseline/screening version of the C-SSRS at screening, or on the Since Last Visit version of the C-SSRS at baseline.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform.

Parents of healthy infants as well as parents of infants with early onset eczema:

* user experience of reading and understanding the microbiome and eating pattern analysis reports
* user experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime

Eligibility Criteria:
Inclusion Criteria:

1. Infants diagnosed with early onset eczema (\<12 months of age) and healthy infants (\<6 months of age, before weaning).
2. Parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
3. Parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
4. Parents of children should stay in Singapore and remain contactable.

Exclusion Criteria:

1. Children born prematurely.
2. Children with a chronic illness.
3. Children with congenital malformations, surgeries in the neonatal period or genetic syndromes.
4. Incapability of the parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
5. Any other family member is enrolled in the study.
6. Incapability of the parents of children to comply with study protocol or investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.
Pilot Trial to Test a Nutrition Application for Making Smart and Healthy Choices

An innovative nutritional application (App) entitled "MyNutriCart" was developed to create a list of foods and beverages to help individuals make smart and healthy choices when purchasing foods at grocery stores based on the Dietary Guidelines for Americans. This App was tested in a pilot trial to evaluate its feasibility, usability, and acceptability for making smart and healthy choices when purchasing food in grocery stores and test its effectiveness in improving food selection, dietary patterns, and weight status compared with the traditional nutritional counseling.

An innovative nutritional application (App) entitled "MyNutriCart" was developed to create a list of foods and beverages to help individuals make smart and healthy choices when purchasing foods at grocery stores based on the Dietary Guidelines for Americans. A pilot randomized clinical trial was done to test the effectiveness of this App on food selection and purchase, dietary patterns, and weight loss during two months of intervention. We also assessed feasibility, usability, satisfaction and acceptability of the App. A total of 138 overweight and obese adults aged 21-45 years old who own a Smartphone were invited to participate in this study. Participants were randomized into two groups; (1) the intervention group used the App, which generated a healthy grocery list to use when purchasing foods in in the supermarket; (2) the control group had a traditional intervention with a nutritionist. To assess the impact of the intervention on dietary patterns, participants completed three 24-hour dietary recalls, a short food frequency questionnaire (FFQ) and provided grocery receipts at baseline and at the end of the study (8 weeks later). Weight and height were also performed before and after the intervention. Feasibility, usability, satisfaction, and acceptability of the nutrition App were assessed at the end of the study using a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* overweight/obese adults
* aged 21-45 years
* main household shopper (responsible for \>50% of the household grocery shopping)
* shopping at a grocery store at least once a week
* owner of a smartphone (iPhone or Android) with internet access
* willingness to be randomized into one of the two groups.

Exclusion Criteria:

* Use of other apps
* Participating in weight loss programs
* Pregnant women
* Individuals with chronic health conditions
* Individuals with reported food allergies
BSCU1 and Immune Function

The current study aims to explore a range of possible pathways by which BSCU1 could beneficially modulate the immune system, in three target populations representing the general population.

This exploratory study is designed as a single-arm study with repeated measures, involving three different populations, in which each subject serves as its own control. The duration of the intervention is 4 weeks, with biomarker assessments at baseline, after 2 weeks, and after 4 weeks intervention.

Eligibility Criteria:
Inclusion Criteria:

Adults

* 30 ≤ age ≤ 49 years
* BMI ≥ 18.5 and ≤ 25 kg/m2
* In good health as assessed during screening (by questionnaire), and the medical investigator's professional judgment
* Non-smoking

Elderly

* 65 ≤ age ≤ 79 years
* BMI ≥ 22.0 and ≤ 28.0 kg/m2
* Generally healthy as assessed during screening (by questionnaire), and the medical investigator's professional judgment
* Non-smoking

Children

* 3 ≤ age ≤ 6 years
* Healthy BMI, cut-off points will be used as indicated by JGZ
* Generally healthy as assessed during screening (by parental anamnesis), and the study physician's professional judgment

Exclusion Criteria:

Adults and elderly

* Chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease),
* Acute infection in the past month
* Gastrointestinal disorders (e.g., inflammatory bowel disease),
* Acute gastroenteritis in the past 2 months
* Any vaccination in the past month or any scheduled vaccination during the study period
* Treatment with antibiotics within 2 months before the start of the study and during the study period
* Regular use of laxative agents
* Immunodeficiency disorder
* Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies)
* Unexplained weight loss or weight gain of \> 3 kg in the 3 months prior to pre-study screening
* Regular consumption of probiotics within 1 month before start of the study
* Evidence of current excessive alcohol consumption (\>4 consumptions/day or \>20 consumptions/week) or drug (ab)use
* Mental status that is incompatible with the proper conduct of the study

Children

* Acute respiratory or gastrointestinal infection in the past month
* Chronic illness (e.g. chronic infections, systemic or metabolic disease)
* Gastrointestinal disorders (e.g., inflammatory bowel disease),
* Acute gastroenteritis in the past 2 months
* Any vaccination in the past month or any scheduled vaccination during the study period
* Treatment with antibiotics within 2 months before the start of the study and during the study period
* Immunodeficiency disorder
* Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic corticosteroids, antibodies)
* Regular use of laxative agents
* Regular consumption of probiotics within 1 month before start of the study
Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation

Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to conservative treatment. Success rates range from 70 to 80%, and good long-term results are reported. The working mechanism of SNM is not completely understood, and the only prognostic factor for good response to this treatment is a successful test stimulation period. There is no consensus on the duration of this test stimulation period. The experience in our clinic during test stimulation period is that for responders it takes up to one week to achieve maximal effect, after the system is turned 'on'. On the other hand the investigators notice that after turning the neuromodulation system 'off', it will take a few hours for symptoms to return to the baseline situation. The fact is: no information concerning the so called "time of onset" and "time of offset" (or popular called: wash-in / wash-out) of sacral neuromodulation is available in current literature.


Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients should have been diagnosed with overactive bladder syndrome and should be put on the waiting list for scheduling treatment with sacral neuromodulation.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* patients receiving neurological or psychiatric medication without being diagnosed with a neurological or psychiatric disease
* patients who have been treated by means of bladder wall botulin toxin injections in the previous year
* patients with evident subsequent complaints of bladder pain syndrome or other pelvic pain
Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network

The evolving definitions of HF, the increasing attention of the medical community, and the aging of the population are some of the factors contributing to a still debated incidence and prevalence of HFpEF across the general and specific populations. Despite the current decline in new HF cases, HFpEF shows stable incidence according to epidemiological studies. Cardiovascular risk factors, such as a long history of hypertension, diabetes, obesity, and others seem to be associated with a higher HFpEFincidence. Nevertheless, the potential echocardiographic predictors of HFpEF have not been defined yet.

Hypothesis In a population at high risk for HFpEF, collected using a multicenter echo-lab network, the real incidence of HFpEF cases and echocardiographic predictors can be identified.

Aim 1: to define the incidence of HFpEF in a high-risk cohort of patients afferent to the Italian echo-lab network.

Aim 2: to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potential predictors of HFpEF.

Methods This is a multicenter, prospective, observational study involving an Italian echo labs network. According to inclusion and exclusion criteria, patients will be enrolled during standard echocardiographic evaluation. After signing informed consent, clinical and echocardiographic data will be collected. Thereafter, they will be followed up for major clinical events (cardiovascular death, HF requiring hospitalization, myocardial infarct, and atrial fibrillation) for a period of 12 months


Eligibility Criteria:
Inclusion Criteria:

* Age \>65 years
* Echocardiographic LV EF \>50%
* Diastolic dysfunction at echocardiography of at least grade 1
* LV hypertrophy defined as: linear LV mass \>115 in men, \>95 g/m2 in women
* Left atrium (LA) enlargement defined as LA volume \> 34 mL/ m2

Exclusion Criteria:

* Severe chronic renal failure (GFR \<15)
* Severe chronic obstructive pulmonary disease (COPD) (FEV1 \<1)
* More than moderate valve disease
* Previous cardiac surgery
* Previous LV EF \<40%
Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia

Postprandial glycemic control is essential for diabetes compensation. Insulin pump therapy control blood glucose released in response to both high and low glycemic index carbohydrates in a mixed diet using normal, square and dual-wave boluses. The investigators hypothesize a mixture of rapid insulin analogue and human insulin has the same effect.

This pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by combined prandial application of insulin aspart and human insulin. Mixed-meals with high, both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios of analogue to human insulin mixture. Subjects are followed by continuous glucose monitor for six days (Phase One), changing between the experimental or their standard protocol for insulin injection on consecutive days. The outcome was measured by comparing average glycemia and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable salad. The next three-to-four week period of therapy was evaluated by glycated hemoglobin before and after the intervention (Phase Two).

Expected outcomes are postprandial and complex improvement of diabetes control, similarly to the insulin pump therapy.


Eligibility Criteria:
Inclusion criteria

* pubertal children, adolescents, young adults able to follow instructions, regardless of their long-time compliance
* willing to undertake a prandial application of two kinds of insulin using two standard insulin applicators.
* willing to complete detailed meal, insulin and/or combination insulin and hypoglycemia diary throughout the study.

Exclusion criteria:

* acute illness and celiac disease, but not euthyroid autoimmune thyroiditis, defined as thyroid stimulating hormone (TSH)\<4 mIU/l.
Probiotics in Cystic Fibrosis

Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and environmental factors. Children with CF may harbor an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). The investigators have previously demonstrated that intestinal inflammation is highly frequent in CF children, being a major feature of intestinal involvement. In addition, specific probiotics significantly improved airway and GI inflammation in a preliminary trial. The investigators aim to characterize intestinal and respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG) supplementation on both GI and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. The investigators aim is to eventually improve the quality of life of CF patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.


Eligibility Criteria:
Inclusion Criteria:

1. A confirmed diagnosis of CF documented by sweat chloride test over 60 mmol/L and confirmed by genotype analysis with the presence of F508del/F508del or F508del/other
2. Boys and girls between 2 and 16 years of age
3. Clinical stability at enrolment, defined as no clinical evidence of acute exacerbation, no modifications in the therapeutic regimen and no hospitalization in the last 2 weeks
4. Pancreatic insufficiency
5. Basal Forced Expiratory Volume 1 second above 50% of predicted value

Exclusion Criteria:

1. Colonization of respiratory tract with Burkholderia cepacia spp.
2. Steroid therapy within one month before enrolment
3. Pregnancy and fertile women taking oral contraceptives
4. Parenteral or oral antibiotics therapy within 2 weeks before enrolment
5. Regular assumption of probiotics
6. Regular assumption of azythromycin
Fugal Infection in COVID-19 Patients

Screening early detection of invasive fungal sinusitis in COVID-19 positive patients

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2); the causative organism of Coronavirus disease 2019 (Covid-19); infects primarily the lungs leading to more than 100 million COVID-19 cases around the world, resulting in almost three million deaths. Covid-19 spectrum of symptoms expanded from upper respiratory tract infection to extensive viral pneumonia and respiratory failure. Covid-19 patients are highly susceptible to superimposed secondary infection especially fungal infections.

Acute invasive fungal sinusitis (AIFS) is one of the most aggressive forms of sinusitis that is commonly present in immunocompromised patients and frequently leads to significant mortality and morbidity. Mucormycosis a life threatening AIFS characterized by hyphal invasion and massive destruction of maxillofacial structures. Histological characters include mycotic infiltration of vessels with propensity to tissue infarction. In addition to other fungi such as Acinetobacter, Klebsiella, Enterobacter, Aspergillus and Candida that frequently lead to secondary fungal infection in Covid-19 patients.

The co-existence of Covid-19 and AIFS is due to immune dysregulation in Covid-19 patients as both CD4+ and CD8+ T lymphocytes are suppressed thus impair patients' innate immunity. In addition to the extensive use of steroids, broad spectrum antibiotics and monoclonal antibodies may contribute in fungal infection. Covid-19 patients with pre-existing conditions such as untreated HIV, organ transplantation, un controlled diabetes and malignancies are more susceptible to AIFS on the contrary Covid-19 patients with underlying chronic disease such as hypertension, chronic kidney and chronic heart disease usually are not associated with more risk of AIFS.

Taking in consideration raised incidence of morbidity and mortality associated with AIFS and on the other hand limited studies available especially in middle east region raised the importance of studying the incidence and the behaviour of AIFS in Covid-19 patients. This study aims to To assess the occurrence of AIFS superinfections in patients with Covid-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2.

Exclusion Criteria:

* - Patients who received antifungal therapy within three days prior to sample collection.
* Patients refused to participate in the study.
A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded
* At least 1 line of prior taxane-based chemotherapy
* At least 1 line of prior androgen receptor (AR) targeted therapy
* Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of lesser than or equal to \[\<=\]1

Exclusion Criteria:

* Known brain metastases or history of seizure
* Prior treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor
* Prior platinum-based chemotherapy for the treatment of prostate cancer
* Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Severe or unstable cardiovascular disease or uncontrolled hypertension
* Left ventricular ejection fraction (LVEF) of lesser than \[\<\] 50 percent (%) as determined by multiple uptake gated acquisition (MUGA) or echocardiography during screening