cyrilzakka/clinical-trials huggingface dataset:
The Effect of the CO-OP Approach for Children With Cerebral Palsy

In the literature, despite the reported positive findings of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, studies in this area have been limited and it is stated that studies involving more sample groups are needed (24-27). In addition, no studies investigating the effect of the CO-OP approach on functional status were found. The purpose of this study was to investigate the effects of CO-OP approach in terms of occupational performance and satisfaction also functional status in children with cerebral palsy (CP) and to determine parents' satisfaction level from CO-OP.

The hypotheses of the study are: The CO-OP approach has no effect on occupational performance in children with CP. CO-OP approach has no effect on occupational satisfaction in children with CP. The CO-OP approach has no effect on the functional status of children with CP.

Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) version 22 (IBM SPSS Statistics; IBM Corporation, Armonk, NY). One sample Kolmogorov-Smirnov Test was used evaluate the distribution of variables prior to test selection. Group characteristics and outcome measures are described using mean and standard deviations for continuous variables and frequencies and proportions for categorical variables. Descriptive statistics were presented as median for the non-normally distributed quantitative and ordinal data and number (percentage) for the categorical variables. Differences in continuous variables (age, education, BMI, duration of diagnosis,) among groups were analyzed with the Mann Whitney U. Statistical differences in COPM and PEDI scores between baseline and post-treatment was analyzed with "Wilcoxon's signed-rank test" within groups. The z-score obtained from the Wilcoxon signed-rank test was reported to present a standardized measure of the difference between the mean ranks of the negative and positive groups. Comparison of changes between groups were analyzed with "Mann-Whitney U" test for COPM and PEDI scores. Statistical significance level was assumed at p\<0.05.

Clinical significance was calculated by using the Cohen d effect size index in independent groups. Clinical significance was determined according to Cohen's recommended limit values (0,2 small; 0,5 moderate and 0,8 large effect).

Eligibility Criteria:
Inclusion Criteria:

* being between 5-12 years of age
* being diagnosed with CP
* being at level I, II, or III according to the Gross Motor Function Classification Scale (GMFCS)
* being at level I, or II according to the Manual Ability Classification System (MACS)
* having experienced motor performance problems in daily activities, as reported by parents and/or children during interview; have sufficient language ability to communicate with and be understood during treatment.

Exclusion Criteria:

* receiving another treatment other than NDT
* being diagnosed with mental retardation
* having serious visual or hearing problems.
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children

This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.

The prevalence of childhood overweight and obesity is reaching epidemic proportions. There have been no effective methods for preventing or treating obesity in childhood so far prompting interest in new interventions. One potential option for obesity prevention is the use of the prebiotic oligofructose. Data from research on rodents shows that a high-fat diet enriched with oligofructose causes a decrease in energy intake, less weight gain and a lower level of triglycerides . A similar effect has been observed in healthy adults. Available evidence suggests that the addition of oligofructose to the diets of overweight or obese adults may increase satiety and thus reduce energy intake. Currently, there are no data on the effect of oligofructose in overweight and obese children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 7 to 18 years
* BMI \> 85 percentile
* Signed informed consent

Exclusion Criteria:

* Overweight / obesity secondary to genetic syndromes and/or endocrine diseases
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study

The goal of the study is to understand whether blood levels of hormones produced or metabolized in the stomach reflect the health of the stomach lining.

Specifically the study will determine whether the concentration of ghrelin, gastrin, pepsinogens and vitamin B12 reflect the condition of the stomach lining. Hormone concentrations for people with normal/mild gastritis will be compared to people with long-term inflammation of the stomach (chronic atrophic gastritis), and people with pre-cancerous cellular changes (intestinal metaplasia).

Previously published promising data show that blood levels of ghrelin, gastrin, vitamin B12 and pepsinogen are each associated with risk of developing stomach cancer. These studies used blood bank samples and looked at risk of cancer many decades later. This study was designed to explore whether these markers could be useful in a clinical setting for early detection of stomach cancer.

The study will recruit at 3 sites over 1 year identifying patients with chronic atrophic gastritis and intestinal metaplasia and those with mild gastritis.

Only the patient data which is absolutely necessary for analysis will be collected, to include basic demographics, relevant medical history and medications. These data will be used to analytically account for alternative explanations for variation in blood measurements of ghrelin, gastrin, pepsinogen and vitamin B12.

A one-time venous blood sample will be collected to enable measurement of the markers of interest.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18-80 years old) attending upper gastrointestinal endoscopy.
2. Patients able to read and comprehend English.
3. Patients willing and able to provide informed consent.
4. Patients willing and able to provide a venous blood sample.

Exclusion Criteria:

1. Any individual diagnosed with gastric cancer, or with a history of gastric cancer, prior gastrectomy or bariatric surgery.
2. Any individual with a chronic inflammatory condition of the gastrointestinal tract (Crohn's disease or ulcerative colitis).
3. Once enrolment ceiling is reached for each group, enrolment will close for that group. The study will continue until all groups are complete.
Physical Exercise Controls Gestational Weight Gain

An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..

The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish

Exclusion Criteria:

* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old
Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer

This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.

Background: Cancer incidence is rising worldwide, therefore complications of this condition, such as bleeding, are also expected to be more frequently seen.

Tumoral bleeding is usually difficult to control and the bleeding episode may represent the end stage of the malignant disease. In this context, it is relevant to study the performance of prognostic scores to prediction of clinical outcomes in patients with cancer.

Objective: To evaluate and compare the performance of prognostic scores to predict clinical outcomes in a group of patients with cancer of any site that has presented a recent episode of upper gastrointestinal bleeding (UGIB).

Design: Prospective and observational study. Setting: Cancer Institute of São Paulo; University of são Paulo. Patients: All patients with cancer referred to the Endoscopy Unit because of upper gastrointestinal bleeding will be included consecutively.

Main Outcome Measurements: need and amount of blood transfusions administered, need for endoscopic therapy, surgery, rebleeding, and mortality at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of malignant neoplasm of any site, either located inside or outside of GI tract;
* Current evidence of bleeding in the last 48 hours, either by presenting hematemesis and/or melena, with or without hemodynamic instability. Patients with hematochezia or bright red blood per rectum due to a site of bleeding in upper GI tract will also be included.

Exclusion Criteria:

* Age \< 18 years-old;
* Suspicion or confirmation of pregnancy.
* Patients with no evidence of malignant neoplasm after curative surgery or oncologic therapy.
VALÉ: A Multidisciplinary Childhood Obesity Treatment Program for Latino Communities

This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested:

Specific Aim 1: To test the acceptability of a multidisciplinary group intervention targeted towards low-income Latino families with a child who is obese.

Specific Aim 2: To test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (BMI-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.

Eligibility Criteria:
Inclusion Criteria:

* Pre-pubertal (girls must not have started menses)
* Of Latino/Hispanic descent (parent self-identified)
* BMI for age \>85th percentile (based on CDC growth reference)
* Child between 5-11 years old
* Healthy (no known chronic diseases or regular medication)
* Parent/adult caregivers willing to participate in all study visits

Exclusion Criteria:

* Not of Latino/Hispanic descent
* \<5 years old or \>11 years old
* BMI for age \<85th percentile
* Not pre-pubertal (girls have experienced their first menses)
* Child has learning deficits or acute/chronic medical condition
* Parent/guardian has no transportation or unable to participate in sessions
An In-situ, Child-led Intervention To Promote Emotion Regulation Competence in Middle Childhood: Protocol For an Exploratory Randomised Control Trial

The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation -Purrble- that could be deployed across prevention and treatment contexts.

Background: Emotion regulation is a key transdiagnostic risk factor for a range of psychopathologies, making it a prime target for both prevention and treatment interventions in childhood. Existing interventions predominantly rely on workshop or in-person therapy-based approaches, limiting the ability to promote emotion regulation competence for children in everyday settings and at scale. Purrble is a newly developed, inexpensive socially assistive robot-in the form of an interactive plush toy-which uses haptic feedback to support in-the-moment emotion regulation. It is accessible to children as needed in their daily lives, without the requirement for a priori training. While qualitative data from prior studies show high engagement in-situ and anecdotal evidence of the robot being incorporated into children's emotion regulation routines, there is so far no quantitative evidence of the intervention's impact on child outcomes.

Objective: The aim of this study is to examine, for the first time, the efficacy of a new intervention model for child-led emotion regulation-Purrble-that could be deployed across prevention and treatment contexts.

Methods: A total of 120 children aged 8-10 will be selected from an 'enriched' non-clinical US population: for inclusion, the cutoff for parent's rating of child dysregulation will be 10 points or higher on the total difficulties score on the Strengths and Difficulties Questionnaire. This cutoff selects for a measurable-but not necessarily clinical-level of the child's emotion regulatory difficulties. The selected families will be randomly assigned with .5 probability to receive either Purrble or an active control (non-interactive plush toy). The primary outcome will be a daily EMA measure of child emotion regulation capability (as reported by parents) over a period of 4 weeks. Exploratory analysis will investigate the intervention impact on secondary outcomes of child emotion regulation, collected weekly over the same 4 week period, with follow-ups at 1 month and 6 months post-deployment. Quantitative data will be analysed on an intent-to-treat basis. A proportion of families (\~30% of the sample) will be interviewed post-deployment as part of process analysis.

Eligibility Criteria:
Inclusion Criteria:

* child aged 8-10
* parent-reported score of 10 or higher for the total difficulties score on the Strength and Difficulties (SDQ) questionnaire

Exclusion Criteria:

* child participating in another mental health intervention
* parent and/or child not fluent in English (as all measurement scales are in English)
The Influence of Collective Schemas on Individual Memory

Schemas describe mental structures storing recurrent and organized pattern of information. Schemas may have a strong influence on the process of storing and retrieving new information into memory. Previous approaches in the cognitive neuroscience of memory have entirely focused on the individual dimension of preexisting schemas. In the real world though, much of our experiences and knowledge are collective or shared. Such social-cultural frameworks stored in collective memory may also reshape and reconfigure the construction of individual memories. Attempting to ascertain the influence of collective schema on the neural substrates of individual memories using cutting-edge brain imaging methods represents the challenge that MULTIBRAIN seeks to tackle. To achieve this goal, we will record brain activity in a group of 24 participants while there are remembering pictures from a tour at the World War II Memorial of Caen. This study will seek to identify brain areas of the prefrontal cortex encoding the organization of knowledge in collective memory using multivariate analyses of brain patterns of activation, and then to understand how such regions might modulate the recruitment of the hippocampus during episodic memory retrieval using analyses of effective connectivity. The organization of knowledge in collective memory is measured in parallel through 1) the analysis of French social memory of World War II using a corpus of 100 000 television and radio shows from the National Institute of Audiovisual, and 2) an internet task measuring the organization of individual knowledge in a large group of individuals that will allow to separate shared from non-shared memories of the World War II. Once collected, these data will help us to understand how collective schemas may reconfigure the organization of individual memories.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between 20 and 38 years old
* Affiliated to the French national health care system
* French native speaker
* Participated in a tour trip at the Memorial of Caen within the last 3 months
* Right-handed
* At least 2 years of education after graduating from high school
* Body mass \< 30kg/m2
* Signed written consent form

Exclusion Criteria:

* Pregnancy or intent to get pregnant
* Person deprived of their liberty
* Person hospitalized without consent
* Minor
* Protected adults or people unable to give informed consent
* Person subjected to an exclusion period related to another protocol
* History of neurological or psychiatric disorders or existence of traumatic brain injury with loss of consciousness for more than one hour
* History of cancer with the last 5 years, excluding squamous cell carcinomas
* Alcoholism, antecedents of chronic alcoholism or drugs abuse
* Severe psychiatric disorders (according to DSM V diagnostic criteria) or psychological troubles which could affect participant's judgment
* Use of medication that may interfere with cognitive or cerebral functioning
* Presence of visual or hearing troubles that may compromise participant's ability to participate in the study
* MRI Contraindications
Stigma and Psychological profilE in REctal-anal caNcer pAtients

In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time.


Eligibility Criteria:
Inclusion Criteria:

Locally advanced rectal and anal cancer patients undergoing a long course of radiotherapy

* Patients in chemo-radiation treatment
* Ability to understand and complete the questionnaires
* Age ≥18 years
* Informed consent signed

Exclusion Criteria:

* Age \> 75 years
* Rectal and anal cancer patients undergoing short-course radiotherapy
* Rectal and anal cancer patients undergoing palliative radiotherapy
* Patients with inability to express informed consent
* Patients denying informed consent
* Patients with psychopathological disturbances preexisting to the cancer diagnosis
* Patients affected by severe language deficits
The Effect of GCSF in the Treatment of ALS Patients

The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 85
* definite or probable ALS according to revised El Escorial criteria
* maximum 2 years from initiation of symptoms to study entry
* mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)

Exclusion Criteria:

* familial ALS
* pregnancy or lactation
* myeloproliferative or hematologic disorders
* active immunological disease
* liver or renal or heart disease
* HIV positive
* significant cognitive disorder
* hypersensitivity to GCSF
Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence

This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.

A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC).

The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients.

The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).

Eligibility Criteria:
Inclusion Criteria:

Primary healthcare professionals and pharmacists who:

• Agree to participate in the pilot study.

Primary care patients who:

* Are prescribed a new treatment of cardiovascular disease o diabetes by a GP who participates in the clinical trial.
* Are \>18 years old.
* Do not reject to participate.