cyrilzakka/clinical-trials huggingface dataset:
Multisensory Room in Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a complex neurological development with onset in infancy or early childhood. Atypical sensory processing has been widely reported in ASD, and recent literature suggest that this abnormality extends across the life span, with consequent important implications in every-day life of autistic individuals and their families. Multisensory environments have been used in children with ASD precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits. Therefore, the aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with ASD.

Autism spectrum disorder (ASD) is a complex neurological development with onset in infancy or early childhood. In the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders, sensory features were finally take into account and atypical responses to sensory stimuli was included in the diagnostic criterion, such as the presence of hyper- or hypo-responsiveness to sensory inputs or unusual interests towards sensory aspects of the environment, and it must be considered (APA 2013). Atypical sensory processing has been widely reported in ASD, and recent literature suggest that this abnormality extends across the life span, with consequent important implications in every-day life of autistic individuals and their families.

Multisensory environments have been used in children with ASD precisely as a function of this particular difference in sensory processing and some studies have highlighted potential benefits. The multisensory rooms were designed to provide multiple stimulation opportunities that cover all sensory channels. Among the present literature data, interventions targeting sensory integration seems to be useful in reducing challenging behaviors in many individuals with developmental disabilities including ASD (Novakovic N. et al. 2019; Kaplan H. et al., 2006; McKee et al. 2007). The aim of our study is to verify feasibility and efficacy of an integrated treatment program with the multisensory room compared to as usual treatment in patients with ASD.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with diagnosis of ASD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
* age between 3 and 6 years;
* signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process.

Exclusion Criteria:

* children not aged between 3 and 6 years;
* significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or significant genetic disorders.
* Informed consent not signed of at least one family member to participate in the diagnostic/therapeutic process.
Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

The overall purpose of this study is to characterize the effect of probiotics on the oral microbiota in older adults with dysphagia at risk for pneumonia.

The goal of this pilot study is to characterize the effects of probiotics on the oral microbiota in older patients with dysphagia at risk for pneumonia. A total of 20 participants will be recruited from the UW Health Inpatient Swallowing Consult Service. Participants will have a dysphagia diagnosis along with documented aspiration on videofluoroscopy. Each participant will receive a once daily VSL#3 probiotic blend (dissolved in thickened liquid as applicable) for 28 days. A baseline assessment will be completed to collect data on demographics, health history and behaviors, usual diet, level of oral intake, and patient-reported swallow function. Oral swab (buccal mucosa and tongue dorsum) as well as saliva sample collections will be completed. Data on adherence and adverse events will be collected weekly. Bacterial DNA will be extracted from oral samples and 16S rRNA sequencing techniques will be used to identify contents of oral microbiota at baseline, week 2, and week 4. Oral microbial composition will be compared between the time points, and treatment feasibility (recruitment and retention rates) in this population will be evaluated.

Eligibility Criteria:
Inclusion Criteria

1. 65 years of age or older
2. Dysphagia diagnosis based on videofluoroscopic swallow study with observed airway invasion (Penetration-Aspiration Scale score of 3 or higher)
3. Ability to provide consent
4. Ability to submit oral samples
5. Ability to swallow sachet of probiotic (dissolved in thickened liquid, as needed)
6. Ability to return to UWHC for week 2 and week 4 visits.

Exclusion Criteria

1. Currently taking antibiotics or probiotics
2. Actively receiving immunosuppressive therapy
3. Non-oral feeding with inability to swallow probiotic
4. diagnosis of head and neck cancer or upper airway disease
5. prior surgery to the head and neck region that would have affected the muscles of swallowing or the salivary glands
6. history of chemotherapy or radiation to the head and neck region
7. severe periodontal disease.
8. currently pregnant or planning to become pregnant
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

1. To determine the influencing factors of modified electroconvulsive therapy (MECT);
2. To determine the influencing factors and reversibility of the cognitive impairment caused by MECT;
3. To determine the duration of efficacy of MECT and its affecting factors.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years (when informed consent was got), male or female
* Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
* Scored 18 or above on the HAM-D Scale which included 17 items
* Clinical Global Impression(CGI)-severity score ≥ 4
* Provided written informed consent

Exclusion Criteria:

* Any depressive disorders not due to major depressive disorder
* Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
* With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
* With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
* With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
* Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial
* With no response to previous ECT treatment
* Received transcranial magnetic stimulation treatment in the last 6 months
* Allergic to propofol, etomidate and succinylcholine chloride
* During pregnancy or lactation
* With a history of stroke in the last month
* Enrolled in any other clinical trial 30 days prior to the baseline
Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses

Cannulation of complex arteriovenous fistula (AVF) or graft (AVG) is a challenge to renal nurses. Ultrasound (US) guidance on central and peripheral venous access visualisation has been widely adopted in nephrology and shown to reduce complications of vascular interventions. With broader adoption of handheld US devices in clinical services, renal nurses could acquire this point-of-care technique to increase the successful cannulation rate while facilitating confidence build-up during training and practice. We aim to evaluate the use of handheld US on difficult AVF/AVG cannulation in a hospital-based dialysis unit.

We conducted a prospective randomised controlled study from January 2021 to January 2022. Ten renal nurses were trained by an interventional nephrologist before patient recruitment and had completed a pre- and post-training questionnaire on their confidence level. Fifty haemodialysis patients with complex AVF were randomised to US-guided or conventional cannulation. The total time spent on cannulation and patients' pain scores were also collected.

Eligibility Criteria:
Inclusion Criteria:

1. First-time cannulation, 2. Post-angioplasty or thrombectomy, 3. Partial stenosis confirmed with imaging or by vascular surgeons/interventional radiologists, 4. Failed cannulation by dialysis nurses at community centres, 5. Bruises or haematoma around AVF/AVG, 6. Presence of clots in AVF/AVG and 7. Deep-seated access by physical examination.

Exclusion Criteria:

complex access with a high risk of complications (calibre ≤0.4cm or vessels ≥0.8cm in depth from skin)
Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease

Alzheimer's disease (AD) is associated with significant, progressive cognitive decline. Key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to AD. This trial will investigate the effects of supplementing glycine and N-acetylcysteine vs. alanine as placebo on these defects in AD, and examine the effects on cognition.

Glutathione (GSH) deficiency, oxidative stress, mitochondrial dysfunction, insulin resistance and inflammation are linked to Alzheimer's disease (AD). In prior studies, investigators have shown that GSH deficiency contributes to mitochondrial impairment and oxidative stress, and that GSH deficiency can be corrected by supplementing its precursors glycine and cysteine (provided as N-acetylcysteine, NAC), with the combination termed GlyNAC.

This randomized clinical trial will evaluate the effect of GlyNAC vs. alanine placebo supplementation provided for 24-weeks to patients with AD, and measure changes in cognition, GSH concentrations, oxidative stress, brain glucose uptake, brain inflammation and insulin resistance.

Participants who are positive for a beta-amyloid PET scan and meeting cognitive screening criteria will be recruited, and enrolled only after meeting eligibility criteria. Before beginning study supplementation they will undergo imaging studies (MRI, FDG-PET and TSPO-PET scans), and only the FDG- and TSPO-PET scans will be repeated after completing 24-weeks of nutrient supplementation. Cognitive measurements, metabolic and mitochondrial measurements (as described below) will be done before supplementation, and after 12-weeks and 24-weeks of completing supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Age 55-85 years;
* Gradual and progressive memory loss for more than 1 year, with a Montreal Cognitive Assessment score of 10-20;
* Amyloid positivity on PET scan;
* Availability of a study partner.

Exclusion Criteria:

* hospitalization in past 3 months;
* use of insulin medications;
* untreated thyroid disease;
* creatinine levels \>1.5 mg/dL;
* hemoglobin concentration \<11.0 g/dL;
* known liver disease, or AST/ALT level \>2x ULN;
* history of stroke, brain tumor, active heart failure or active cancer (removable basal cell cancers will not be an exclusion criteria);
* untreated depression or other severe psychiatric disorders;
* pregnancy or nursing (unlikely in this population)
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study

Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
* TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
* Without extrahepatic metastasis
* The following laboratory parameters:

Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Known history of HIV
* History of organ allograft
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Serious non-healing wound, ulcer, or bone fracture
* Evidence of bleeding diathesis.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oligometastatic Renal Cell Carcinoma

Study the efficacy and toxicity of SABR treatment for oligometastatic/oligoprogressive renal cell carcinoma; investigate the effectiveness and safety of SABR combined with targeted immunotherapy; conduct stratified analysis to identify the optimal beneficiary population; establish a biobank to screen for biomarkers; and use radiomics analysis to identify characteristics of sensitive populations.

This study is a non-randomized, prospective, registry-based trial that aims to enroll 60 patients with renal cancer who will be diagnosed and treated at our hospital between May 2024 and May 2026. Without altering the patients' systemic treatment plans, those who meet the inclusion criteria after MDT discussion will receive SBRT (Stereotactic Body Radiation Therapy) for all lesions/all metastatic lesions in addition to the guideline-recommended medications. The radiotherapy plan is based on the SABR-COMET protocol and Timmerman's constraints. Patient data will be collected, including general clinical information, toxicity assessments during treatment and in the acute phase, detailed imaging data, regular assessments of pain and quality of life, and evaluations of late radiation therapy responses.

Eligibility Criteria:
Inclusion Criteria:

* 1: Patients with newly diagnosed M1 renal cancer or those with oligoprogression during systemic therapy, with no restrictions on the location or number of metastatic sites, but all metastatic sites must be evaluated by the radiation oncology department as safely able to receive a radical radiation dose (α/β value of 3, EQD2 ≥ 70Gy).

  2: Age ≥ 18 years. 3: ECOG score of 0-3. 4: Confirmed renal malignancy by pathology or imaging examination, with no subtype restrictions.

  5: Presence of evaluable lesions. 6: Patients with spinal cord compression or significant brain metastasis edema requiring surgical decompression can be enrolled after evaluation by the radiation oncology department if the aforementioned dose can be safely administered post-decompression.

  7: Able to tolerate radiation therapy and standard systemic therapy (targeted therapy or targeted immunotherapy combination).

  8: Expected survival \> 6 months. 9: Able to sign the informed consent form. 10: Has conditions for follow-up.

Exclusion Criteria:

* 1: Patients with other comorbidities that prevent the use or tolerance of targeted immunotherapy drugs, such as targeted immunotherapy drug allergies, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension, grade III-IV cardiac dysfunction (NYHA criteria), severe hepatic and renal insufficiency (grade IV), etc.

  2: Patients with other comorbidities that prevent tolerance of radiation therapy.

  3: Complete response to first-line drug therapy (i.e., no treatable targets for SABR).

  4: Previous history of radiation therapy to the same site. 5: Pregnant or lactating women. 6: Patients with other severe medical comorbidities that prevent participation in the study.
Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease

The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.

This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.

Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 55 years
* BMI \> 25

Exclusion Criteria:

* Present smoker or smoked within the last 2 years
* HBA1C \> 6.0%
* eGFR\<60
* LFT \>/= 3 times upper limit of normal
* Hypertension: systolic blood pressure \> 160mmHg; diastolic blood pressure \> 90mmHg, or on medication for hypertension.
* Chronic disease, likely to be clinically relevant (eg:

cardiorespiratory, rheumatological, cerebrovascular or neoplastic disease)

* Vitamin supplements within the previous 14 days
* Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).
RTMS Feasibility Study on Adolescent Depression Stimulation

This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.

The intervention follows the identical clinical procedure used for adults. Initially, the resting motor threshold will be determined by stimulation over the motor cortex, by finding the minimal intensity that produces a motor response in the corresponding distal wrist muscles. The rTMS will be delivered with a powerMAG research ppTMS stimulator (Mag \& More), and a figure-of -eight coil, PMD70-pCool (Mag \& More). The intervention is within the intended use of this CE-marked medical device. The research participants will receive 1Hz rTMS with daily sessions on 20-30 consecutive week days. The magnetic pulses will be applied at 120% of the resting motor threshold with a figure-of-eight coil at a 45 degree angle towards the midline. The 1Hz rTMS protocol is applied 6 trains of 1-min duration separated by 30-sec inter-train "off" periods over the right DLPFC (F4 site 5 according to the10-20 system). The total duration of one 1 Hz rTMS session is 8 min 30 s.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from parents and legal guardian
* Age 13-19 years
* Diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID)
* Treatment with at least two SSRIs at an adequate dose for at least 8 weeks

Exclusion Criteria:

* Epilepsy or medical history of seizures
* Conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil
* Implanted device that is activated or controlled in any way by physiological signals
* Implanted medication pumps
* Intracardiac lines (even if removed)
* Active substance use disorder
* Treatment with any medication that could lower the threshold for seizures
* Usage of benzodiazepines both as prescribed drug and illegal use
* Any condition that seriously increases the risk of non-compliance or loss of follow-up
Testing of the Smartphone App to Enhance HIV Prevention Cascade Among Malaysian MSM

The investigators will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.

mHealth is a promising and cost-effective strategy to reach stigmatized and hard-to-reach populations and link them to care. Leveraging mHealth reduces individuals' discomfort and distrust of disclosing risk behaviors to providers, providers' low cultural competency for working with individuals of diverse sexual identities, and bypasses barriers to care for marginalized populations, - all features crucial for HIV prevention in MSM in Malaysia. Results from the investigators' studies show Malaysian MSM often do not get HIV tested or initiate PrEP. Mixed methods suggest MSM want these services but prefer a streamlined system to access them that reduces interaction with clinicians where disclosure and perceived judgment occurs. mHealth may overcome these barriers by facilitating prevention services delivery and health decision-making in a confidential, less-stigmatizing, and convenient manner. Overall smartphone growth in Malaysia (63% in 2015 to 89% in 2017), and the investigators' parallel work with MSM indicates that nearly all (\>97%) MSM own a smartphone. Findings from qualitative interviews with MSM further indicate preferences for interfacing with 'apps' rather than health professionals as well as local stakeholders indicating strong interest in using such platform to deliver HIV prevention services align with developing culturally tailored mHealth strategies and to engage MSM in virtual communication with providers - all embedded within one app.

To the investigators' knowledge however, no mHealth intervention has been developed to improve access to HIV prevention services in Malaysia. The investigators, therefore, propose to pilot test their new clinic-affiliated app (JomPrEP) to promote HIV testing and PrEP uptake in Malaysian MSM. They will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.

The investigators will enroll 90 participants who will be randomized (1:1) to receive either the JomPrEP app or the control group and assessed at 3- and 6-months. Randomization will be stratified by ATS use (16% to 24%) and age. They will conduct exit interviews with participants and clinical staff to examine the barriers and facilitators to the app and obtain feedback to further optimize the app.

Eligibility Criteria:
Inclusion Criteria: MSM

* HIV-negative MSM
* Age more than or equal to 18
* Cis-gender men
* Condomless sex in the last 30 days
* Own a smartphone

Exclusion Criteria:

* Unable to provide informed consent
* Unable to read and understand English or Bahasa Malaysia