cyrilzakka/clinical-trials huggingface dataset:
Acute Effects of Spirulina on Postprandial Glycemic Responses and Arterial Blood Pressure

This study investigated the effects of three doses of spirulina in glucose beverages on postprandial glycemic responses, arterial blood pressure, and subjective satiety.

This study aimed to determine the effects of three different doses (4, 6 and 8 g) of spirulina in glucose beverages on postprandial glycemic responses, blood pressure, and subjective appetite responses in healthy young adults.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smokers
* men and women
* body mass index between 18 and 24.9 kg/m2
* normal blood pressure (systolic blood pressure \<120 mmHg and diastolic blood pressure \<80 mmHg)
* normal fasting blood glucose concentrations (\<100 mg/dL)

Exclusion Criteria:

* Medical conditions (e.g., cardiovascular diseases, diabetes mellitus, kidney or liver conditions, severe clinical depression, gastrointestinal disorders)
* Under medications known to affect glycemia (glucocorticoids, metformin, thiazide diuretics)
* Allergy to spirulina
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency
Retrospective Review of Management of Infective Endocarditis

This is an analysis of the outcomes of patients having undergone surgical intervention for infective endocarditis.

This study will look at the presentations, epidemiology, risk factors, modalities of diagnosis; and the role of specific investigatory tools with surgical intervention and timimg of intervention in patients who underwent surgical treatment for infective endocarditis. Morbidity and Mortality post surgery and prognosis including long term outcome of our patients will be analyzed. Special attention will be made to those patients with pre-operative neurological deficit.

Eligibility Criteria:
Inclusion Criteria:

* Have undergone surgical treatment for infective endocarditis

Exclusion Criteria:

* Less than 18 years old
Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites

Evaluate a multi-faceted training program to improve short-term smoking cessation rates (\<14 days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114 enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in 26 community-based practices.

We utilize an effectiveness-implementation hybrid design, employing a cluster, randomized control trial of community-based NCORP sites to study the effectiveness of a multi-faceted intervention to improve smoking cessation among lung cancer screening patients, as well as dissemination and implementation (D\&I) science to optimize and accelerate translation of findings into clinical practice. We will: (1) Evaluate a multi-faceted training program to improve short-term smoking cessation rates (1-week post-visit) and sustained abstinence (6 months) among 1,114 enrolled smokers (557 in each trial arm) who present for LDCT lung cancer screening in community-based lung cancer screening practices; (2) Characterize the adoption and adaptation of the evidence-based tobacco cessation strategies in 26 community-based LDCT lung cancer screening programs; and (3) Develop and evaluate an implementation toolkit for integrating evidence-based tobacco cessation strategies in community-based LDCT lung cancer screening programs. Qualitative data will be collected from key informants at participating screening programs during and after intervention implementation. Quantitative survey data (baseline, \<14 days, 3 months, and 6 months) and saliva specimens (6 months only) will be collected from smoking patients receiving screening within these programs.

Eligibility Criteria:
Inclusion Criteria:

* Agrees to have NCORP research personnel serve as the study liaison and another person to serve as the cessation program champion.
* Agrees to participate in all aspects of the intervention, randomization, and evaluation.
* Agrees to participate in a confidential 1-on-1 semi-structured interview with the research team.
* Agrees to have the interview taped, transcribed and qualitatively analyzed.
* Age ≥18 years
* Potential participants will be screened using the following question: "Do you smoke cigarettes every day, some days, or not at all?" (BRFSS). A current smoker is anyone responds "every day" or "some days".

Exclusion Criteria:

* Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement
* Individuals who use e-cigarettes and who are not smoking cigarettes. Dual users (those who use both e-cigarettes and cigarettes) will still be included in the trial.
* The presence of a physical or cognitive impairment that would prevent a person from engaging in survey research (such as blindness, deafness, or dementia).
* Individual has already completed the intended LDCT lung cancer screening for this study.
* Non-English speaking participants.
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)

This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.

The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.

The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).


Eligibility Criteria:
Pre-inclusion criteria:

* Major patient with a colonoscopy scheduled in one of the participating hospitals (CHD Vendée and CHU Nantes).
* Patient who agreed to participate in the study and gave his express consent
* Patient affiliated with a social security system or beneficiary of a scheme

Inclusion Criteria:

* Patient with 1 or more polyps less than 20 mm observed during colonoscopy

Exclusion Criteria:

* Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms
* Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis
* Patient with familial adenomatous polyposis
* Pregnant or lactating woman
* Minor patient
* Major patient under tutorship, curatorship, or deprived of liberty
* Patient unable to understand protocol and / or give express consent
* Patient not affiliated with a social security system or beneficiary of such a scheme
* Patient hospitalized or treated without their consent
Markers of Atopy in Children With Presumed Early Exposure to Allergens, Unhygienic Conditions, and Infections

There are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. Main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. Primary Purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy.

There are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. Main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. Less exposition to microbes can lead to the disturbance in optimal balance between Th1 and Th2 lymphocytes, prevalence of Th2 cytokines and excessively high production of IgE. Decreased exposure to microbes has resulted in the loss of main source of immune provocation, and a consequent increase in pathogenic immune responses and their associated diseases. Molecular interactions between immunocytes and microbes are mediated largely by Toll-like receptors (TLRs) on host cells and a diversity of ligands produced by viruses, bacteria and fungi.

Many studies confirm the protective role of some viral, bacterial or parasite infections against atopy development.

The studied group consisted of 500 children, living in all the ten community foster homes in Lodz. The reference group consisted of 500 children, living with their parents at home, recruited from primary care centres.

Primary Purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy.

Secondary Purpose is the genotyping and cytometric study - to define risk and protective factors for the development of atopy.

Primary outcome measures: skin prick test results with 18 allergens, peripheral blood eosinophil count, level of total and specific IgE in children with positive skin-test results were secondary and point, spirometry, medical history and physical examination.

Secondary outcome measures: included symptoms of asthma and other allergic diseases, lung function, parental allergy only for children from reference group, family history including life conditions in very early childhood, and markers of allergy such as total IgE serum concentration and eosinophil blood count, expression of TLR2, TLR4, TLR7, TLR9, examining the serum samples for specific antibodies to Toxocara sp, Toxoplasma gondi, Ascaris lumbricoides, DNA.

Eligibility Criteria:
Inclusion Criteria:

* must be able to make spirometry

Exclusion Criteria:

* pregnancy
Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be a single-organ recipient (kidney only)
* Participants who are receiving their first living donor or deceased donor transplant

Exclusion Criteria:

* Participants who are recipients of HLA-identical living-donor renal transplants
* Participants with a PRA value \> 10% within 30 days prior to the transplant
* Participants who have received a multi-organ transplant
* Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV
* Participants who have received an investigational drug within 6 weeks of study entry
* Participants who have a previous history of, or who currently have, malignancies and/or lymphoma
* Participants who have received corticosteroids within three months of transplantation
* Participants who are 3rd transplant recipients
* Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study
The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy

This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women or men over 50 years old
2. Denosumab treatment for at least two years and less than three years (up to five doses).

Exclusion Criteria:

1. . Estimated glomerular filtration rate \<35 ml/min.
2. Malignancy
3. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
4. Secondary osteoporosis
5. Metabolic bone diseases
6. Contraindications to ZOL
7. Patients older than 80 years old
8. Hypocalcemia
Effect of Glucagon on Fasting Insulin Secretion and Glucose Metabolism in Subjects Without Type 2 Diabetes

Fasting hyperglycemia contributes disproportionately to nonenzymatic glycosylation and the microvascular complications of type 2 diabetes. However, little is known about the regulation of glucose concentrations in the fasting state relative to what is known about the postprandial state. The proposed experiment is part of a series of experiments designed to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.

The interaction between α-cell and β-cell function to regulate fasting glucose is incompletely understood. This is an important gap in our knowledge as fasting glucose contributes disproportionately to HbA1c and the microvascular complications of type 2 diabetes (T2DM). The regulation of fasting glucose in health and disease is relatively understudied.

Insulin and glucagon should regulate glucose reciprocally through direct interaction; insulin restrains α-cell secretion while glucagon directly stimulates β-cell secretion. In addition, there are indirect interactions via changes in glucose. Glucagon increases endogenous glucose production (EGP) increasing glucose (and insulin secretion). Conversely, insulin stimulates glucose disappearance (Rd) and suppresses EGP, lowering glucose (and stimulating glucagon).

However, this does not appear to occur uniformly in prediabetes. For example, in impaired fasting glucose (IFG), glucagon secretion rate (GSR) is inappropriate for the prevailing glucose. This is not accompanied by reciprocal changes in insulin secretion rate (ISR). Variability in the hepatic response to glucagon and to insulin further compound the dysregulation of fasting glucose. The net effect of these variables is unknown. This experiment is intended to test the hypothesis that impaired glucagon-induced insulin secretion contributes to fasting hyperglycemia in IFG.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with normal or impaired fasting glucose and normal or impaired glucose tolerance

Exclusion Criteria:

* HbA1c less than 6.5%
* Use of any glucose-lowering agents including metformin or sulfonylureas.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms.

Specific Aims

Specific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies.

Specific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

1. Current diagnosis of cancer.
2. Ages 18 and over.
3. Has access to a device (smart phone, computer, tablet) with internet access.
4. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. Females who are pregnant or lactating.
2. Other medical conditions or medications deemed exclusionary by the study investigators.
Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer

At all of the follow-ups, including the worst period (between four and ten weeks), the intervention group reported higher scores than the control group, suggesting in this RCT that adopting the person-centred-care concept was a promising way to improve function and wellbeing in patients with HNC.

Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its treatment may affect general domains of health-related quality of life (HRQoL) and provoke a variety of adverse symptoms and side effects, both during and after treatment. The objective of this study was to compare a person-centred care intervention in terms of HRQoL, disease-specific symptoms or problems, with traditional care as a control group for patients with HNC. Methods: The intervention and control groups comprised 54 and 42 patients, respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of treatment. The questionnaires' scores were compared between groups by using independent samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous variables. For categorical data, Fisher's exact test was used. Longitudinal data were analysed using repeated measures in covariance pattern models. Results: At baseline, the intervention and control groups were comparable in terms of medical and sociodemographic variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all the follow-up points, even during the worst period for the patients, the person-centred-care group consistently reported higher scores than the control group. The differences were numerically but not always statistically significant. When using repeated measures in covariance pattern models, statistically significant results were found for HNC-specific problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).

Eligibility Criteria:
Inclusion Criteria:

* Eligible for this study were patients diagnosed with HNC, older than 18 years and able to read and write Swedish and, in addition, suitable for outpatient treatment with chemo- and/or radiotherapy, either as primary treatment or in a postoperative setting.

Exclusion Criteria:

* Patients were excluded if they had a previous or concomitant malignancy or were diagnosed and treated for depression as stated in their medical record.
* In order to minimize the risk of bias, none of the patients were to be included if they were taking part in other research studies
A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects

A clinical study to evaluate the effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

* Japanese Males or females aged 20 years or older but less than 40 years at the time of informed consent
* those with a BMI of 18.5 in male (17.6 in female) or more and less than 25.0 and a body weight of 40.0 kg or more at screening test
* those whose pulse rate measured by standard 12-lead ECG is 50 beats/min or more but no more than 90 beats/min at screening test and at the time before administration of investigational drug in period 1
* those who are judged eligible to participate in the study by the principal investigator or sub-investigator based on the results of screening test and test conducted before administration of investigational drug in period 1. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator or subinvestigator.
* those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.

Exclusion Criteria:

* Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
* Subjects with a medical history considered inappropriate for participation in the study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrine, metabolic, hematological, immune, skin, neurological, and psychiatric diseases.
* Subjects with a history of drug allergy or food allergy.
* Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antimicrobials
* Subjects with risk factors or with a history of risk factors for aortic aneurysm, aortic dissection (such as Marfan syndrome)
* Subjects with significant allergic predisposition (such as asthma requiring medical treatment)
* Subjects with congenital disease, heart disease, or a history of heart disease
* Subjects with risk factors or with a history of risk factors for torsade de pointes (TdP) (heart failure, hypokalemia, family history of long QT syndrome, etc.)
* Subjects with a history of unconscious seizures suspected of involving TdP.
* Subjects with waveforms difficult to assess for QTc interval prolongation in standard 12-lead ECG at screening and the timing before administration of investigational product in period 1 (drift, electromyography contamination, T-wave geometry, marked sinus arrhythmia, frequent premature beats, etc.)
* Subjects with QTcF(Fridericia correction method) of at least 450 msec in men and at least 470 msec in women in standard-12-lead ECG at screening test and at the time before administration of investigational product in period 1.
* Subjects with suicidal ideation, suicide attempt on the Colombian Suicide Assessment Scale (C-SSRS) on Day-1 or a history of suicide attempt within the previous 5 years.
* Other protocol defined inclusion criteria could apply