cyrilzakka/clinical-trials huggingface dataset:
Exergaming on Hand Dexterity In Autistic Children

Through this study we aim to determine the effect of Exergaming on bimanual hand dexterity in Autistic children. This randomized controlled trial will recruit a sample of 20 autistic children as per the inclusion and exclusion criteria, through convenient sampling. The sample will be then randomly allocated to control group receiving the conventional dexterity training exercises and Intervention group which will be receiving conventional plus exergaming intervention.

A study showed that a structured traditional physical activity intervention that targets specific MS resulted in motor function improvement in children with ASD along with exergaming that can improve EF in children with ASD.

On a population of 20 patients with CP, Structured Neurodevelopmental Therapy-based hand rehabilitation (SNDTBHR) was applied and in the results Positive effects of both interventions i.e. SNDTBHR and LMBET were found. Significant differences were found between LMBET and SNDTBHR on GGF, pinch forces, JHFT, and WCST all being in the favor of LMBET. Exergaming interventions in the individuals with ASD showed significant improvements in the physical fitness, executive functioning, and their self perception. Exergaming increased the interest and participation of Autistic children in moderate-to-vigorous physical activity. In contrast, exergaming had small impact on emotional regulation As per the results of another study participants with poorer dexterity in the beginning of exergaming training program greatly improved their dexterity performance, which also improved their quality of life. Adherence and motivation increased significantly and system usability of the exergaming was acceptable. Participants with impaired dexterity showed improvement in the Nine-Hole Peg Test and the PDQ-39

According the researchers knowledge there have been numerous studies conducted on the effect of different exercise protocols on autistic children but there is lack of evidence in determining the effect of exergaming on specifically hand functioning/ dexterity in autistic population'. More studies should be done in order to check if exergaming or conventional treatment differ in their effect on hand dexterity in autistic children. Home based exergaming and low cost video assisted games for dexterity need more in depth study so that they can be readily used by general public.

Eligibility Criteria:
INCLUSION CRITERIA:

* Male and female children pre-diagnosed with autism spectrum disorder.
* Autistic Children who are compliant with exergaming

EXCLUSION CRITERIA

* Children not pre-diagnosed with autism spectrum disorder
* Autistic Children who have other coordination disorder such as developmental coordination disorder
* Autistic Children with upper limb amputation.
* Autistic children with loss of vision
ChiPP2: A Trauma-Informed Program for City School Parents

Purpose of this study is to assess the prevalence of adverse childhood experiences (ACEs) and positive childhood experiences (PCEs) among parents enrolled in the Chicago Parent Program (ChiPP) in their child's school and whether those experiences are associated with a) parents' participation in ChiPP and b) program benefits for parents and children.

Purpose of this study is to assess the prevalence of adverse childhood experiences (ACEs) and positive childhood experiences (PCEs) among parents enrolled in the Chicago Parent Program (ChiPP) in their child's school and whether those experiences are associated with a) parents' participation in ChiPP and b) program benefits for parents and children. Parents who enroll in ChiPP groups in their child school are eligible to participate in this study. Data on ACEs, and PCEs are collected at baseline. Parent perceptions of their children's behavior problems and their engagement in early learning are collected at baseline and post-intervention data. Parent satisfaction with ChiPP and their sense of connection with other parents in their ChiPP group are measured at post-intervention only.

Eligibility Criteria:
Inclusion Criteria:

* Parent of child enrolled in Chicago Parent Program group in Baltimore City Public Schools
* Parent age 18-99
* Child must be between 3-8 years old

Exclusion Criteria:

* Parent does not speak English or Spanish
Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.


Eligibility Criteria:
Inclusion Criteria:

* Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort

Exclusion Criteria:

* A device that does not support the Lead Integrity Algorithm,
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer

As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

Various solid tumors with available histopathological findings; Signed informed consent.

Exclusion Criteria:

pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors

The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment failure solid tumors are tumor response rate, while secondary goals are rates of acute and late adverse effects, local control rate, distant metastasis rate, progression-free rate and overall survival rate.

The goal of this study is to conduct a phase II clinical trial evaluating the safety and efficacy of combination of low temperature (40-43℃ range) hyperthermia and concurrent chemoradiotherapy (CCRT) in treatment failure solid tumors. There are 3 reasons of conducting this clinical trial. Firstly, it has been demonstrated that hyperthermia can enhance the efficacy of chemotherapy, radiotherapy or chemoradiotherapy in various cancers, with acceptable safety profiles. Secondly, the salvage outcomes for treatment failure solid tumors were frustrated. Thermal enhancement ratio (TER) was observed when using hyperthermia combining radiotherapy or chemotherapy. This strategy should be investigated in its efficacy in treating those failing from previous standard treatment and maybe several times of salvage therapy. Thirdly, biologically reciprocal complementation between hyperthermia, chemotherapy and radiotherapy was observed. The reason may be complicated, including theories involving hypoxia, immunomodulation and reperfusion ... etc. If the immunity microenvironment could be improved by addition of hyperthermia, an unexpected survival benefit as compared with the literature may be potentially demonstrated from this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 20-85 years, with ECOG performance 0-2.
2. Treatment failure solid tumor(s), with histologically or clinically confirmed recurrence or progression after primary treatment of either single modality of surgery, chemotherapy or radiotherapy or any combinations.
3. Complete surgical excision is NOT feasible as salvage treatment for the recurrent or progressive tumor(s), or the patient does NOT agree to receive the surgical procedure.
4. Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
5. Measurable lesions by image examinations or endoscopy within 2 months.
6. The distribution of the lesions of interest does NOT exceed 20cm range.
7. The patient can tolerate implementation of cisplatin and taxotere weekly therapy, with respect to hematopoietic status, renal function, liver function, allergy and other potential adverse effects.

Exclusion Criteria:

1. Re-irradiation of 50Gy/22fx is considered NOT tolerable.
2. Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
3. The patient is participating in other clinical trials.
4. Future regular clinical follow-up is NOT possible.
5. The patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers).
6. The patient has pacemakers.
Genetic Epidemiology of Change in CVD Risk Factors

To extend knowledge of the genetic factors affecting the course of cardiovascular disease risk factor development over a substantial portion of an individual's lifetime.

BACKGROUND:

While the onset of symptomatic cardiovascular disease (CVD) typically occurs in middle age or later, the development of the underlying pathology is clearly a long-term process, and early-state lesions having been identified at autopsy even in children. Understanding the course of CVD risk development from childhood into middle age will clearly be valuable both in understanding the pathology of CVD and in targeting preventive measures most effectively. Furthermore, while genetic factors are agreed to play a significant role in the development of CVD, most genes contributing to interindividual variation in CVD risk will have relatively small effects on risk for any given individual, even though their aggregate effects contribute significantly to CVD risk in the overall population. Relatively little is known about the effects of genetic variants on the course of CVD risk factor development in individuals over time. The Bogalusa Heart Study (BHS), which began in 1973 as a study of CVD risk factors in children but evolved to cover the development of CVD risk factors from childhood into early middle age, offers an unparalleled resource for investigating the genetic factors influencing within-individual changes over time in quantitative factors, such as serum lipids and blood pressure, related to CVD risk.

DESIGN NARRATIVE:

Approximately 1500 individuals who were examined in the BHS on at least three separate occasions over a period of up to 20 years, and who consented to participate in studies of genetic factors influencing CVD risk, will have genotypes measured at selected loci either known or strongly suspected to affect interindividual variation in CVD risk. Longitudinal multilevel regression will be used to measure the effects of variation at these loci on quantitative CVD risk factor profiles within individuals and to determine whether some gene effects on CVD risk variation are age-dependent.

Eligibility Criteria:
Schoolchildren from Bogalusa, Louisiana. All children in Bogalusa public schools were eligible.
Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation

This trial is a practical, multicenter, prospective, parallel grouping, randomized controlled,two-arm study. This study will be conducted in three centers including the First Hospital of China Medical University, Seoul National University Hospital and the University Clinical Center of Serbia. The investigators aim to investigate the effect of different occlusion angles of disposable tracheal blocker on right one-lung ventilation

This trial is a practical, multi-center, prospective, parallel grouping, randomized controlled,two-arm clinical study comparing the different occlusion angles of disposable tracheal blocker on right one-lung ventilation. It is planned to enroll 96 subjects requiring right-sided One-Lung ventilation, aged 18-65 years, at three centers. Patients will be randomly assigned to the tip opening angle to the right (Group R), or he tip opening angle to the left (Group L). The primary outcome is the satisfaction with intraoperative collapse of the right lung. The secondary outcome is the one-time success rate of occuder implantation

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 18 to 65 years old;
* American Society of Anesthesiologists (ASA) grade I-III;
* No history of drug allergy or abnormal anesthesia;
* Patients undergoing right thoracoscopic surgery;
* The preoperative oxygen saturation was not less than 94%.

Exclusion Criteria:

* Patients with a history of acute lung injury or ARDS within 3 months;
* Cardiac function class IV (New York Heart Association classification);
* Chronic renal failure (renal cell filtration rate \<30ml min-11.73m-2), severe liver disease;
* Patients with blurred consciousness and cognitive dysfunction;
* Patients with severe coagulation dysfunction;
* Without preoperative oxygen inhalation, blood oxygen \<94%, severe pulmonary dysfunction;
* Patients with endotracheal tube admitted to ICU after operation;
* Body mass index (BMI) \>30;
* Patients who had had lung surgery；
* Inability to complete the study;
Adenovirus Keratoconjunctivitis and Ophtalmology

Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.

The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist.

Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave),infections characteristics; and risk factors.

Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.

The investigation tream create a nationwide anonymous retrospective questionnaire using the secure internet application REDCap® to build and manage the questionnaire addressed to ophtalmologists (interns, graduates and retirees) and orthoptists.

Investigator collect several characteristics such as general characteristics (sex, age range, profession), administrative procedure declaration (occupational disease declaration, sick leave, cessation of surgery); infection characteristics (bilaterality, season, anteriority, sequels, current therapy, professional discomfort), risk factor (refractive surgery history, wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy).

The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist. Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave), infections characteristics; and risk factors such as a refractive surgery history, the wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ophtalmologist or orthoptist (interns, graduates and retirees)
* French

Exclusion Criteria:

- Foreign practitionner
Accelerometer Based Objective Clinical Outcomes of Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS)

This study is a single site, prospective, observational trial utilizing a wrist-worn accelerometer to evaluate clinical outcomes of SCS and PNS in the treatment of chronic pain.

Up to 150 evaluable subjects will be recruited at this site on an ongoing basis. Evaluable subjects are defined as subjects that complete the End of Study visit. Each subject will be assigned an accelerometer and have data recorded for a seven-day period pre-implant trial to collect baseline data. The accelerometer will also be worn during the trial for a period of up to seven (7) days. If the trial is successful and the subject is implanted, the subject will wear the accelerometer for a seven-day period at least six (6) weeks post-permanent implant. The following assessments will be administered to subjects at the baseline (pre-implant trial) visit, the end of implant trial visit and the end of study visit (8 weeks post-permanent implant): the Numerical Rating Scale (NRS) 11-point scale for pain; the SF-36 Health Survey; the Oswestry Disability Index (ODI). Subjects treated for neck pain will also complete the Neck Disability Index (NDI). Additionally, the subjects will be asked to complete a subject diary to record average daily NRS scores for days the accelerometer is worn.

Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled in this study must meet the following criteria:

1. Subject is 18 years of age or older
2. Subject is a candidate for on label use of a SCS or PNS device
3. Subject is ambulatory
4. Subject is able to understand and willing to comply with study procedures and requirements
5. Subject is able to provide informed consent to participate in the study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they meet any one of the following criteria:

1. Subject has comorbidities that, in the judgment of the investigator, may confound the reliability of the information acquired in this study
2. In the judgment of the investigator, the subject is not seeking an improvement in physical function as a treatment goal of SCS or PNS
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation

The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.

In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* male or female subjects
* aged 18 - 65 years
* ability to understand and fulfill the study requirements

Exclusion Criteria:

* affected skin in designated test area
* pregnancy or lactation
* not willing to comply with study requirements
Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects

The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS) on the colonic metabolism and microbial composition, and to compare these effects with the reference prebiotic fructo-oligosaccharide enriched inulin.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* 18-45 years
* regular eating pattern

Exclusion Criteria:

* gastrointestinal complaints
* antibiotic intake
* medication influencing gut transit or microbiota
* abdominal surgery
* pregnancy
Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study

Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.

study the diagnostic performance of diffusion MRI performed in early post treatment, notably changes in the ADC factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat.

compare the characteristics of diffusion MRI, such as ADC coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.

Eligibility Criteria:
Inclusion Criteria:

* patients with head and neck squamous cell carcinoma
* patients with indication of a treatment by chemoradiotherapy (without surgical indication)
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patients with contraindications for MRI
Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib

This is a single-arm, multi-cohort, multi-center, open-label, phase II clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications. The study involves a Screening Period, a Treatment Period and a Follow-up Period. It is planned that about 30 study sites will enroll 75 patients

Eligibility Criteria:
Inclusion Criteria:

1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
2. Age ≥18 years;
3. Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma
4. MET gene amplifications
5. Cohort 1: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
7. Survival is expected to exceed 12 weeks;
8. Adequate functionality in bone marrow, liver, kidney
9. Able to take or swallow the drug orally.
10. Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;

Exclusion Criteria:

1. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
2. Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;