cyrilzakka/clinical-trials huggingface dataset:
Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study

This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.

All patients who respond to inclusion/exclusion criteria at baseline will be considered valuable for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines.
* Patients eligible to anti-TNF therapy
* Patients naïve to anti-TNFa drugs
* Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method \[Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989\] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form

Exclusion Criteria:

* Patients with tumors
* Patients already included in clinical trials
Effect of Daily Consumption of a Novel Biscuit Enriched With Edible Mushrooms, on Intestinal Health-related Parameters

The purpose of the study is to assess the effect of dietary intervention that includes the daily consumption of a novel biscuit (enriched with the selected mushrooms rich in β-glucans) on gut health related parameters of healthy subjects over 60 years old.

After having been informed about the study and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry (inclusion criteria). At baseline, the participants will provide biological samples and they will be randomly assigned in a double-blind manner (investigator and participant) to one of the intervention groups, i.e. consumption of the novel biscuit (biscuit enriched with mushroom powder containing 3g of β-glucans) or consumption of the placebo biscuit for 3 months,. After a washout period of 2 months, the subjects will consume the novel biscuit or the placebo biscuit in a cross-over design for 3 more months. Throughout the interventional period subjects' dietary intake, anthropometrical data and gastrointestinal symptoms will be monitored. Meanwhile at baseline and at the end of each trimester physical activity, mental health and sleep habits will be evaluated with the use of questionnaires and biological samples will be provided for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals aged 60-80 years old, of both sexes/genders

Exclusion Criteria:

* no recent weight loss and extreme dietary behaviors;
* no history of gastrointestinal disease, chronic constipation, chronic/acute diarrhea, autoimmune disease, coronary disease, liver and/or kidney malfunction;
* no consumption of antibiotics two months prior to the initiation of the intervention;
* no consumption of probiotics and/or prebiotics and/or dietary fiber supplements two weeks prior to the initiation of the intervention.
Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits

The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in psychiatric populations. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for emotion regulatory deficits.


Eligibility Criteria:
Inclusion Criteria:

* current anxiety or depression symptoms
* internet access

Exclusion Criteria:

* lifetime psychotic disorder, past-year substance dependence
Enteral Nutrition in Cancer Patients

CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM.

METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Eligibility Criteria:
Inclusion Criteria:

* Were on chemotherapy;
* Age above one year;
* Malnutrition;
* A z-score of weight for height (zW/H) \< -1.0 to -2.0 in children and ≥ 5th to \< 15th of body mass index (BMI) in adolescents were considered as mild malnutrition;
* A zW/H \< -2.0 in children and \< 5th of BMI in adolescents as severe, respectively;
* In adults, the World Health Organization (WHO) cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition.

Exclusion Criteria:

* Were on corticosteroid or hormonal therapy;
* Had swallowing abnormalities;
* Had parenteral or tube feeding therapy;
* Had palliative care;
* Presence of non cancer-related diseases.
Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management

The primary purpose of the study is to identify clinical, radiological and genetic diagnostic criteria for Primary Failure of Eruption (PFE).

The secondary purposes are to highlight the genotype-phenotype correlations in the PTHR1 and non-PTHR1 forms and analyze the therapeutic failures.


Eligibility Criteria:
Inclusion criteria:

* people over 6 years old
* people with Primary Failure Eruption

Exclusion criteria:

* children under 6 years old
* endocrine pathology that may interfere with dental eruption
* rickets
* chemotherapy / radiotherapy
* bisphosphonate treatment
Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis

Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy
* Fractionated courses including at least 30 fractions (treatments)
* Minimum of 18 completed radiation treatments
* Radiation dose: \> 50 Gy
* Radiation technique: IMRT
* Radiation equipment: TrueBeam or Tomotherapy

Exclusion Criteria:

* Prior radiation to the treatment area
* Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
* Patients undergoing SBRT
* Patients with existing rashes or wounds in the target region or radiation therapy at RT start
* Patients receiving hypofractionation
* Patient receiving bolus
Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.

Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin.

The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.

Developing an IF with A2 β-casein, high proportion of alpha-lactoalbumin and less protein that commercial IF, similar to breast milk (1g/100 mL), could be and important strategy to decrease the risk of diseases. This infant formula was compared with breast milk and two other IF with different protein composition. The three formulas were packed in the same presentation and identified by a number. Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn. the present study

Infants' mothers were recruited from six health centers from the Health Ministry in Querétaro, México. Directors of each health center authorized the protocol study. The field workers were read and explained the informed consent letter, the objectives, procedures, risks and benefits of the study in detail.

Eligibility Criteria:
Inclusion Criteria:

* Full-term newborn (≥37 weeks of gestation)
* Birth weight ≥2500 g and ≤4000 g
* Apgar score \> 8
* Infants from birth to 40 days of age at the time of enrollment
* Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn.

Exclusion Criteria:

* Infants with congenital heart defect, congenital illness or malformations, severe gastrointestinal disease, kidney, liver, central nervous system, or metabolic disease, or born from mothers with gestational diabetes.
Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy

The goal is to optimize peer coaching in order to optimize engagement and outcomes in digital therapy. The unmet mental health needs of community college students are staggering and a growing body of research demonstrates that therapy provided digitally with the assistance of trained community members without advanced degrees in mental health is an effective and scalable way to address these needs. Despite being effective for improving symptoms and functioning in those who engage in it, uptake and engagement in digital therapy is generally quite low. Recent research suggests that this is especially true of Latinx individuals, who tend to have unique and significant unmet mental health needs. To address these issues, Project 2 will examine treatment engagement, treatment satisfaction, symptoms and functioning outcomes among Latinx students at East Los Angeles College (ELAC) receiving digital therapy with peer coaching in the STAND program.

A sample of 240 students who identify as Latinx will be recruited. A 2x2 design will randomize students to 1 of 4 peer coaching conditions (n = 60 per condition): 1) demographic matching + standard supervision, 2) demographic matching + reduced supervision, 3) no demographic matching + standard supervision, and 4) no demographic matching + reduced supervision. Students in the demographic matching condition will be assigned to peer coaches who also identify as Latinx, whereas those in the no demographic matching condition will be assigned to peer coaches who do not identify as Latinx. Supervision will either involve individual session review and personalized feedback or not. Students will participate in this project for 24 weeks and will complete brief weekly assessment batteries and longer assessment batteries at baseline and at weeks 8, 16 and 24. Explanatory/intervening variables that are hypothesized to explain treatment effects will also be explored. In addition to the quantitative data collected from the randomized controlled trial, we will collect and analyze qualitative data from the peer coaches via annual focus groups and will evaluate cost-effectiveness specifically focused on costs related to supervision. These data will inform the iterative refinements made to Tier II in the Signature Project.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in the East Los Angeles College
* Either uninsured or covered by California Medicaid
* Own or have private access to internet to complete the assessments and online prevention and therapy programs
* Self-identify as Latinx.

Exclusion Criteria:

* Unable to fully comprehend the consent form, respond adequately to screening questions, or maintain focus or to sit still during assessment
* Diagnosed with disorders requiring more specialized care (e.g., psychotic disorder, severe eating disorder, severe substance use disorder, severe neurological disorder), or marked cognitive impairment
* Currently treated by psychiatrist or psychologist during timeframe that the treatment is offered through STAND and is unwilling to fully transfer care to STAND
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase

This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.

Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer's disease or related dementias-almost two-thirds of long-stay NH residents-are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer's Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency.

This is an incomplete stepped-wedge randomized controlled trial to test the impact and sustainability of the LOCK sleep program. In 24 community nursing homes (NHs)-eight from each of 3 national NH corporations-our multi-disciplinary team will examine these aims: (1) Implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK sleep program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program's implementation and its sustainability.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents aged \>=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems

Exclusion Criteria:

* Residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.
* Residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in combination with atezolizumab versus sorafenib in adults with advanced HCC who have not received previous systemic anticancer therapy in the advanced HCC setting. The primary objective of this study is to evaluate the effect of cabozantinib in combination with atezolizumab on the duration of progression-free survival (PFS) and duration of overall survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of single-agent cabozantinib compared with sorafenib in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines.
* The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
* Measurable disease per RECIST 1.1 as determined by the Investigator.
* Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
* Child-Pugh Score of A.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
* Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors (ICIs). Subjects who have received local intratumoral or arterial chemotherapy are eligible; local anticancer therapy within ≥ 28 days before randomization
* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization.
* Concomitant anticoagulation with oral anticoagulants
Preventing Sexual Aggression Among High School Boys

The present research creates a partnership between researchers and a community agency to evaluate whether a sexual assault prevention program for high school students reduces perpetration of sexual violence among high school boys.

The present research advances the science of sexual assault prevention by creating a mutually beneficial partnership between well-established sexual assault prevention researchers and a CDC Rape Prevention and Education Program (RPE)-funded community agency to conduct a rigorous experimental evaluation of universal primary prevention programming designed to reduce sexual aggression among high school boys. The present research tests multi-session prevention programming that targets change at multiple levels of the social ecology (i.e., individual-, peer- and community-level) through social norms theory and bystander education. Specifically, the present research evaluates Your Voice Your View. Your Voice Your View was developed and is currently administered in Rhode Island High Schools by the CDC RPE-funded agency Day One of Rhode Island. The program will be tested in a group randomized cluster trial among 10th graders at 30 high schools, with the aim of reducing perpetration of sexual aggression among high school boys.

Specifically, this research will conduct a randomized controlled trial with a sample of 10th grade students to demonstrate efficacy of the intervention in reducing rates of sexual aggression among high school boys, rates of dating violence involvement, and related risk and protective factors over a 2- and 6-month follow-up in comparison to a wait-list control group. Thirty schools will be matched on demographic characteristics (i.e., % receiving subsidized lunch, racial/ethnic minority enrollment) and randomized to receive Your Voice Your View or to the wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents at Rhode Island high schools will be eligible for enrollment according to the following criteria: 1) adolescent assent given; 3) passive consent of a parent/legal guardian is given. Teachers will be eligible to participate in educator assessments if consent is given.

Exclusion Criteria:

* There are no exclusion criteria.
Fortified Foods in Older Inpatients

Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.

Malnutrition is a significant problem amongst hospitalised older people, and can impede effective recovery. Oral nutritional supplements (ONS) are limited by their poor tolerability and an alternative strategy is food fortification, the addition of protein/energy/micronutrients to frequently eaten food. The aim of this pilot study is to establish the feasibility and acceptability of delivering fortified foods to older people including those who have dementia and frailty whilst in hospital and to assess whether fortified foods could increase the energy and protein intake.

This is a quasi-experimental study on acute medical wards for older inpatient in two UK hospitals, with a before and after comparison. The intervention involves the provision of additional between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation. Daily energy and protein intake will be assessed for three consecutive days during the baseline period and then in the intervention period. Likeability of fortified food and food choices (the number, type, and frequency of fortified foods consumed) will be examined. Likeability of fortified food by patients will be assessed using likeability scales. Interviews or focus groups will be conducted with staff to assess the acceptability of fortified food. Costs related to developing, packing and delivering the fortified foods will be calculated.

The findings of this pilot study will identify whether delivering fortified food is feasible in acute elderly care wards, which foods are preferred and their acceptability. The results will inform the design of a definitive clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Both female and male participants in each hospital.
2. Patients aged 70 years and above including those who have dementia and frailty.

Exclusion Criteria:

1. Patients receiving enteral tube feeding or parenteral nutrition
2. Patients with a known food allergy, eating disorder or illness, which requires a therapeutic diet incompatible with fortification.
3. Patients who are receiving end of life care.