cyrilzakka/clinical-trials huggingface dataset:
Effect of Lubricity of Food Gels on Satiation and Satiety

The main aim of the study is to elucidate the influence of fibre-based hydrogels differing in their mechanical properties (characterized both instrumentally and sensorially) in terms of low/ high lubricity on satiety, satiation and salivary biomarkers.

An acute, randomized cross-over study that compares two types of fibre-based hydrogels differing in their lubrication properties, resulting in different pastiness and instrumental mechanical properties (lubricity). The gels are prepared using dietary fibres (kappa carrageenan, alginate). Both hydrogels contain added watermelon flavor, food grade color and sweetener. Water acts as a control and has the same flavor, color and sweetness to match the hydrogels.

Participants are asked come to the laboratory on three occasions. Before participating, each participant is screened for eligibility criteria using an online health screening questionnaire and Three Factors Eating Questionnaire. Participants are offered one of the three products (water or either of the two gels), the order of which is randomized and counterbalanced.

Participants are instructed to fast for 11 hours and to restrict from drinking alcohol for 24 hours before each session. In the first session, weight and height are measured. Participants then provide baseline (- 5 minutes) appetite ratings on a 100 mm visual analogue scale (VAS). After that they are given a standardized breakfast (females - 250kcal, males - 350 kcal). Then, participants are asked to rate their appetite on a 100-mm VAS in every 30 minutes for the next 2.5 hours. After that, they are given the preload - either hydrogels differing in their structure complexity or water. After consuming the preload, appetite ratings are recorded by the participants on three time points on 100-mm VAS. Ad libitum food is offered as lunch after 30 minutes after ingesting the preload and the last VAS is taken. Food intake is measured. Saliva is taken three times during each session after breakfast, before and after preload consumption to measure protein, mucin content, amylase activity, and salivary lubricity (tribology).

Eligibility Criteria:
Inclusion Criteria:

* With a normal weight (BMI=18.5 - 24.99 kg/m²)
* Generally healthy

Exclusion Criteria:

* A smoker
* Having oral infections/diseases/problems in chewing and swallowing
* Anyone with a chronic or acute health condition that may affect the ability to sense, eat, digest or absorb food
* Anyone currently using prescribed or non-prescribed medication that may interfere with the ability to sense, eat, digest or absorb food
* Anyone who is pregnant or lactating
* Anyone with a food allergy or intolerance
* Anyone who are on a special diet or are taking protein/fiber supplements
* Anyone who cannot tolerate food gels
* Underweight (BMI \<18.5 kg/m²) or overweight (25 - 29.99 kg/m²) or obese (BMI=\>29.99 kg/m²)
* Suffer from any blood borne disease e.g. HIV, Hep B
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.


Eligibility Criteria:
Inclusion Criteria:

* male and females 40 to 80 years of age (inclusive)
* COPD diagnosis
* Current or previous smokers with a cigarette smoking history of at least 10 pack-
* Post-albuterol FEV1/FVC of 0.70 or less
* Post-albuterol FEV1 of 35% to 80% (inclusive)

Exclusion Criteria:

* Pregnant or lactating females
* current diagnosis of asthma
* respiratory disorders other than COPD
* clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
* clinically significant sleep apnea
* previous lung resection surgery
* clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
* hospitalization for COPD within 3 months of screening
* use of antibiotics for lower respiratory tract infection within 6 months of screening
* abnormal and clinically significant 12-lead ECG findings
* current malignancy in remission for less that 5 years
* medical conditions that would contraindicate the use of anticholinergics
* positive hepatitis B or C test
* history of alcohol or drug abuse
* unable to withhold albuterol for 6 or more hours
* use of long term oxygen therapy
* conditions that would limit the validity of informed consent
* use of GW642444 or GSK233705 in previous studies
* use of an investigation drug with 30 days of screening
* use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
* hypersensitivity to beta-agonists
* concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.
GastroIntestinal Cancer in Children and Adolescents

The goal of this observational population-based cohort study is to investigate the clinical characteristics and outcomes of children and adolescents with primary gastrointestinal malignancies registered in the publicly available Surveillance, Epidemiology, and End Results (SEER) 17 database during 2000-2019.

The investigators aim to describe the patient and tumor characteristics, treatments, and outcomes of children and adolescents diagnosed with primary gastrointestinal malignancies, and to analyze these data for trends over time. In addition, the investigators want to explore independent prognostic factors for overall survival. Finally, the investigators want to describe subsequent primary malignancies diagnosed among patients from the study cohort, as well as to calculate their risk of developing a second primary cancer relative to the general population. Data on children (aged 0-17 years at diagnosis) and young people aged 18-24 years at diagnosis are analyzed separately. Special focus is laid on patients with primary carcinomas of the gastrointestinal tract; particularly colorectal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age at primary gastrointestinal cancer diagnosis \<25 years
* Diagnosis of a primary gastrointestinal malignancy as an individual's first primary malignancy

Exclusion Criteria:

* None
CHILD (Child Health and Infection With Low Density) Malaria

This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania

This is a 3-arm open-label randomized control trial of 600 children aged 6 months to 10 years in Tanzania, where transmission is low and a high proportion of infections are low-density. Standard of care based on passive case detection (PCD) using rapid diagnostic test (control arm) will be compared to two different approaches to detect and treat P. falciparum LMI: active case detection using molecular testing (ACDm) and PCD using molecular testing (PCDm). Aims are:

1. To assess the impact of standard PCD plus ACDm vs standard PCD on long-term child health
2. To assess the impact of PCDm vs standard PCD on long-term child health
3. To evaluate the cost-effectiveness of ACDm and PCDm

Eligibility Criteria:
Inclusion Criteria:

1. 6 months to 10 years of age of age at enrollment
2. Primary residence in the study area during the study period
3. Agree to come to study clinic for any illness
4. Agree to avoid medications outside the study, even herbal medication

Exclusion Criteria:

1. Another child from household already randomly selected for recruitment
2. Not able or does not provide informed consent
3. Need for emergency intervention
4. Known history of chronic illness requiring regular specialty care including diabetes mellitus, cancer, or Stage 3 or 4 HIV/AIDS
5. Contraindications to artemether-lumefantrine (AL) including history of allergic reaction, weight under 5 kg
6. Participation in another active/ongoing intervention trial
The PROSECCA Study, Answering New Questions in Prostate Cancer

Nearly half of all cancer patients receive radiotherapy as part of their treatment and although it is effective at destroying cancerous lesions deep within the body, this comes at the cost of damaging healthy, or normal, tissues. With 50% of cancer patients surviving for 10 years or more, these patients can be left with life-changing side effects from their radiotherapy. It is clear that more must be done to limit damage to normal healthy tissue without compromising annihilation of the tumour and curing patients. The key to this is personalising an individual's radiotherapy treatment, in other words rather than assuming that all tumours respond similarly to radiotherapy, the treatment is optimised for an individual. To date, approaches to do this have been restricted to small numbers of carefully selected patients, are inordinately expensive, and not suitable for rolling out into everyday practice across the NHS. There is however another way, namely using Artificial Intelligence (AI) combined with an individual's healthcare record. By linking together large numbers of healthcare records at a national level, combined with the power of AI, the PROSECCA project will transform radiotherapy and cancer care.

As an example of how this technology is beginning to emerge, proof of concept data from the team has shown that using AI it is possible to identify patients at increased risk of damage from radiotherapy long before they receive any radiation as part of their treatment. However, to move these AI-based approaches from the research domain into the clinic requires significant effort, which is the aim of PROSECCA study.

The project will use AI to analyse healthcare records from up to 15,000 prostate cancer patients who underwent radiotherapy in Scotland. Through linkage of data obtained specifically for radiotherapy and data held within each patient's unique healthcare history it will be possible to establish new relationships between a patient's medical history and how well a patient responds to radiotherapy. By establishing what factors or information in a patient's complex healthcare record indicate that an individual may have a poor response to treatment, or an increased risk of side effects from radiation, it will be possible to identify these patients earlier than is currently possible and adapt treatment accordingly. Furthermore, identifying these important factors would improve radiotherapy treatment for prostate cancer patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* External beam radiotherapy delivered by a linear accelerator
* Prostate Specific Antigen (PSA) recorded at regular intervals after radiotherapy
* Minimum of 10 year survival post-radiotherapy
* Diagnostic Computerised Tomography (CT) acquired
* Radiotherapy planning CT acquired
* Radiotherapy treatment planning data available
* Corresponding healthcare data available to infer toxicity events (ref previous work by Lemanska et al)

Exclusion Criteria:

* Incomplete course of radiotherapy
* No PSA data
* No follow-up corresponding healthcare data available
* No imaging data available
A New Adaptive Physical Activity Technology in Older Adults

The purpose of this study is to explore the feasibility and acceptability of a new physical activity technology (Jintronix) based on TV screen, virtual games and motion sensing cameras among pre-disabled older adults.

A total of 12 older adults will be recruited in the Oak Hammock residential community to participate in a physical activity program using a new technology called Jintronix. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity. The exercises will be performed by each participant autonomously in the living room of the residential community following a specific schedule. The duration of the exercise program will be of 30 minutes for two days a week for a total of four weeks. The participants will be trained prior the beginning of the program in order to enter autonomously in the Jintronix platform and perform the exercises.

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years and older
* Pre-disabled status evidenced by: 6 ≤ score ≤ 9 on the Short Physical Performance Battery test.
* Willingness to participate in all study procedures.

Exclusion Criteria:

* Failure to provide informed consent
* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
* Significant cognitive impairment, defined as a known diagnosis of dementia or a short portable mental status questionnaire score \> 2 errors
* Unable to communicate because of severe hearing loss or speech disorder
* Severe visual impairment, which would preclude completion of the assessments and/or exercise program
* Other significant co-morbid diseases that would prevent participation in exercise
* Planning to move out of the area during the study timeframe
Cardiovascular Risk Evaluation in Clinical Practice in Metabolic Syndrome Patients

Metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. Its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in Italy is 34.1% if diagnosed using WHO criteria and 17.8% if diagnosed using the NCEP-ATPIII criteria.

On the basis of the above considerations, the aim of this study is to promote the use of the SCORE algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients with metabolic syndrome after the implementation of a multifactorial preventive strategy, with particular reference to the correction of lifestyle, hypertension and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aged 40-65 years.
* A diagnosis of metabolic syndrome formulated on the basis of the criteria proposed by the NCEP - Adult Panel III: i.e. the presence of at least three of the following conditions:

  1. Waist circumference \>102 cm in men and \>88 cm in women
  2. Triglyceridemia 150 mg/dl
  3. HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women
  4. Sitting arterial pressure 130/85 mmHg
  5. Fasting glycemia 110 mg/dl
* A risk of cardiovascular death of \>5% at the current age of the patient or \>5% if projected to an age of 60 years, as calculated by means of the SCORE algorithm using the table based on the total/HDL cholesterol ratio relating to low-risk populations and appropriate for Italy.
* Written informed consent.

Exclusion Criteria:

* Women who have not been in menopause for at least one year or are not surgically sterile, and do not use an effective contraceptive method, such as spermicidal barrier methods or intrauterine devices. The use of oral contraceptives is not allowed.
* Known or suspected hypersensitivity to valsartan and/or fluvastatin, or other contraindications to their use;
* A positive history of ischemic heart disease, peripheral artery disease or cerebral vasculopathy;
* Patients with an SBP of 180 mmHg and/or DBP of 110 mmHg.
* Patients with severe medical conditions which, in the judgement of the Investigator, contraindicate trial participation or significantly limit life expectancy;
* Treatment with drugs able to modify the lipid profile (ongoing or in the three months preceding trial entry);
* Patients unable to follow the planned protocol procedures or sign the informed consent form.
Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing

The aim of this study is to identify effective methodologies to help people to improve their awareness of change, motivation, self-confidence and self-efficacy, compliance in behavioral change and psychological well-being.

Subjects involved will have the opportunity to partecipate in a two-weeks course: two SDT (Self Determination Theory) psychological interviews are scheduled (1 per week) to help the participant increase his motivation and awareness about the problem reported during the counseling session.

For this purpose, the use of an APP with a CA (Conversational Agent) will be implemented as a support to help people to identify one's thoughts and emotional states as well as increase their awareness about themselves.

Test will be administered at the beginning (T1) and at the end of the meetings (T2).

Participants will be randomly divided into one of two groups to understand whether APP and CA has a significant impact in increasing motivation and awareness of the need for a pathway with a professional.

Eligibility Criteria:
Inclusion Criteria:

* whitecollar
* a sufficient level of education to understand study procedures and be able to communicate with site personnel
* 50 to 70 years old

Exclusion Criteria:

- current use of narcotics or other substances
Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
2. Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
3. Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required.
4. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
5. Patients must be between the ages of 18 and 50 years inclusive
6. Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy
7. Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
8. Patients must be relapse-free and off corticosteroids between the screening and baseline visits
9. Patients must be willing and able to give written informed consent

Exclusion Criteria:

1. Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
2. Previous treatment with glatiramer acetate (injectable)
3. Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years
4. Previous total body irradiation or total lymphoid irradiation
5. Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
6. Pregnancy or breastfeeding
7. Life-threatening or other clinically significant disease
8. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
9. A known sensitivity to gadolinium (gadolinium acid)
10. A known history of sensitivity to mannitol
11. Inability to successfully undergo MRI scanning
5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes

Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Uveal Melanoma
* Patients whose physician deems them appropriate for DecisionDx-UM testing
* Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data

Exclusion Criteria:

* Patients with any other form of cancer
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients on stable metformin
* 18-70 years old
* Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria:

* Type 2 diabetes patients on any other antidiabetic treatment
* Patients listed in other trials
* Patients with significant diabetic organ disease or complications.

Other protocol-defined inclusion/exclusion criteria may apply
Improving the Self-Efficacy of African American Parents in Infant Supine Sleep

This is a research study of African American parents/caregivers of newborns. The purpose of this research study is to learn what type of educational materials about infant safety and safe infant sleep are most effective and acceptable to parents and caregivers. The investigators will compare the responses of parents who receive enhanced materials to the responses of parents who receive the ordinary materials that are currently in use.

The goal of the proposed research is to determine whether a tailored multi-media mailed intervention is superior to standard non-tailored print brochures along with a generic DVD in increasing the prevalence of African American infant supine sleep during the first six months of life.

Eligibility Criteria:
Inclusion Criteria:-

- Self-identified AA adult parents and primary caregivers (≥ 18 years of age) of newborns ≤ four weeks old at the time of the infant's first office visit to the pediatrician.

Exclusion Criteria:

* Foster parents and temporary guardians:
* Prior study participants:
* Parents without a reliable phone number:
* Parents without ready access to a DVD player: an ownership of a DVD player,