cyrilzakka/clinical-trials huggingface dataset:
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)

All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.

All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained. Our hypotheses are: A) GXR will be superior to placebo at reducing symptoms of ADHD as measured by standardized clinical diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment measures, GXR at week 4 of treatment will increase the amplitude of the right frontal N200 and frontal-central P300, and such changes will correlate with clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-12 years
* Meet criteria for Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

* Do not meet criteria for Major Depression, Bipolar, Autism
* Talking any psychotropic medication for a condition other than ADHD
* History of epilepsy, severe head injury or loss of consciousness
* History of Intolerance to guanfacine
Support Activities for the Reduction of Distress and Pain in Children During Venipuncture

To evaluate the efficacy of Health Support Activities (Animal Assisted Intervention, Clows, Musicians) in the reduction of pain and distress in children undergoing venipuncture.

Hypothesis: the investigators expect a reduction in in pain and distress.

Venipuncture is one of the most unpleasant procedures for children. Previous studies demonstrated the effectiveness of distraction techniques in reducing anxiety and pain but no one compares the specific activities of animals assisted intervention (AAI), clowns and musicians for this procedure.

In the Hospital involved in the present study, venipuncture service has a week schedule for Health Support Activities. In specific days children can benefit of Health Support Activities as part of routine care.

Aims of the present study are: evaluate efficacy of AAI, clowns and musicians in the reduction of childrens' distress and pain during venipuncture with respect of a control group undergoing venipuncture in the days where Health Support Activities are not scheduled; compare distress and pain levels between groups; evaluate caregiver's anxiety and its influence on child pain and distress; explore parents' and staff opinion.

Eligibility Criteria:
Inclusion Criteria:

* outpatients
* scheduled to venipuncture
* Italian speaking

Exclusion Criteria:

* cognitive and/or developmental impairment
Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis

This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.

This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk (CHR) for psychosis. Given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital DBT approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in CHR populations and may contribute to distress and progression of disease.

Participants will be randomized to receive either d-DBT or treatment-as-usual (TAU). The intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. Primary outcomes include measuring feasibility, acceptability, and usability. Secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. Results will inform future adaptations, larger trials, and clinical applications.

Eligibility Criteria:
Inclusion Criteria:

1. Be 16-29 years old.
2. Being competent and willing to consent to study participation.
3. Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.

Exclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
2. Diagnosis of intellectual disability
3. Severe developmental disorder
4. Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
5. Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.
Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer

The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.


Eligibility Criteria:
Inclusion Criteria

1. Malignancies that are refractory to or intolerant of established therapy known to provide clinical benefit. Patients must not be candidates for anti-tumor regimes known to provide clinical benefit.
2. All patients must have evidence of progressive disease on study entry. Previously untreated patients who are not chemotherapy candidates on Arm 2 may have advanced disease (without clear progression). There is no upper limit on the number of prior treatments provided that all inclusion criteria are met, and exclusion criteria are not met.

Exclusion Criteria

1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.
2. Patients with active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation except for patients with AML, where at least 2 months must have elapsed;
3. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);
4. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS symptom may be included.
5. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
6. Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
7. Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.
8. In the opinion of the investigator, patients who are significantly below their ideal body weight.
Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX

RATIONALE: Collecting and storing samples of tumor tissue from patients with soft tissue sarcoma to test in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory is collecting tissue samples from patients with soft tissue sarcoma of the arms, hands, legs, or feet treated on clinical trial CRUK-VORTEX.

OBJECTIVES:

* Determine early in the course of treatment which patients treated on clinical trial CRUK-VORTEX have an increased likelihood of distant metastases so as to highlight individuals who might benefit from early adjuvant systemic therapy.

OUTLINE: This is a multicenter study.

Tumour and normal tissue samples will be taken at the time of surgery during treatment on clinical trial CRUK-VORTEXand preserved for future microarray analyses. Tissue microarrays will be produced from both tumor and normal tissues. Blood samples will be collected for future DNA analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed soft tissue sarcoma
* Receiving treatment on clinical trial CRUK-VORTEX
* Underwent surgery to remove the tumor no more than 3 months ago

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No other major medical illness that would preclude study treatment
* No other prior or concurrent malignancy except adequately treated nonmelanoma carcinoma of the skin or in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the local site
* No prior neoadjuvant or adjuvant chemotherapy
GEnetic Counseling Through Virtual Visits in Parkinson's Disease

The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.

This research will evaluate different virtual methods of pre-test genetic counseling and post-test genetic results disclosure in people with Parkinson's disease. Participants will be randomized to receive different methods of genetic counseling using web-based, telephone, or telehealth methods. In both pre- and post-test counseling phases, remote genetic counseling methods will be compared to demonstrate equivalence. The primary outcomes will be equivalence on genetics knowledge and outcomes scales, and the revised impact of events scale. The purpose is to develop effective and scalable approaches to genetic counseling. This work is crucial for patient safety and will improve access to care through novel genetic counseling approaches.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study
* Male or female, over the age of 21.
* English Speaking

Exclusion Criteria:

* Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
* Montreal Cognitive Assessment (MoCA) \< 21, or a prior diagnosis of dementia during the screening phase
A Study of the ApricityCare Program for Early Detection and Management of Treatment-related Adverse Events in Patients With Metastatic Cancer

To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with metastatic cancer using ApricityCare.

Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.

Primary Objective

• To determine the rate of therapy discontinuation due to toxicity in participants using ApricityCare

Secondary Objectives

* To measure frequency of participants check-in via ApricityCare to report symptoms
* To assess participants engagement with ApricityCare
* To evaluate time to respond to participant-reported symptoms via ApricityCare

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older
* Confirmed diagnosis of metastatic cancer (for the Run-in Phase only: prostate, kidney, and/or bladder cancer will be enrolled)
* Planned to receive systemic anti-cancer therapy
* Ability to understand and the willingness to sign a written informed consent document
* Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin Chinese
* Ownership of a smartphone and willingness to use it as outlined by the protocol and described in the ICF

Exclusion Criteria:

- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).
The Evaluation With Artificial Neural Network of Pain Scales in Children (ANN)

The study evaluates with Artificial Neural Network (ANN) of pain scales in children. Pain of these patients' will be evaluated by many pain scales in the postoperative period.

Pain of these patients' will be evaluated by many pain scales in the postoperative period. These scales include OUCHER, Visiuel Analog Scale, FLACC, Faces Pain Scale revise, Wong Baker Faces Scale, Faces Pain Scale, Numeric rating Scale, Verbal Rating Scale, CHEOPS and also age, blood pressure, respiratuar rate, heart rate will be recorded.

In the first step of this study, the parameters taken into account on widely used each pain scale practically and importance level of each parameter will be examined. The parameters taken into account in determining the degree of pain and degree of each pain scale will be recorded. Independent t-test of the pain scales will be analyzed whether different statistically. Pain scales used in the application at conclusion statistical analysis will be grouped.

In addition, parameters considered to be effective on pain (pulse, blood pressure, etc.) will be determined and also recorded. The degree of importance on pain of the current scales and other parameters to be determined and as result, new pain scale will be created. While determining the the level of importance will be utilized from the analytic hierarchy process (AHP). Making binary comparisons between AHP and parameters, the level of importance and weightiness score of each parameter will be determined. The mathematical formulation of the pain points will be presented considering AHP weightiness score of each parameter.

Although pain scores obtained mathematically, pain score with Artificial Neural Network (ANN) will be estimated considering the parameters that impact on the pain score.

The final step, the creation of new pain scale comparing the pain scores obtained by mathematical formulation and Artificial Neural Network and, it is intended to be compared with the current scales.

Eligibility Criteria:
Inclusion Criteria:

* 2 months -18 years
* Children undergoing elective surgery

Exclusion Criteria:

* Children with mental and motor development retardation
* Patients scheduled emergency surgery
* Patients and parents, who refused to participate in this study
HepZero:Heparin Free Dialysis With Evodial

The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring heparin free dialysis treatments on nephrologists' prescription,
* Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months,
* Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min,
* Patients aged 18 years or more,
* Written consent to participate in the study (informed consent).

Exclusion Criteria:

* Patients in ICU settings,
* AKI patients,
* Patients dialyzed in self care, satellite HD units,
* Patients treated in single needle mode,
* Known heparin contraindication (HIT type II),
* Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc ...) transfusion during hemodialysis treatment,
* Patients receiving oral anticoagulants (including Anti vitamin K),
* Patients receiving a combination of anti-platelets agents,
* Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis,
* Pregnant/ planning pregnancy and lactating women during study period,
* Adult patients protected by the law,
* Patients are not affiliated to health insurance system (beneficiary or dependant)
* Participation in other interventional studies during the study period,
* Patients that have already been included in this study.
Cognitive and Neurological Pathologies in Pompe Disease

The purpose of this study is to better understand the long-term health effects of Pompe disease and to determine if there are any abnormal changes in the brain and peripheral nerves. Additionally, the investigators will study the relationship between the abnormal changes in brain, nervous system findings, and developmental outcomes.

The investigators will collect clinical information from clinic visits as well as assessments such as neuroimaging (magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), and diffusion tensor imaging (DTI)), cognition, academic skills, speech and language function, physical therapy and quantitative muscle ultrasound. Subjects will be in this study for at least 3 years and up to 6 years.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed and documented diagnosis of infantile Pompe Disease (IPD) or Late onset Pompe Disease (LOPD)

Exclusion Criteria:

* Refusal to give informed consent
A Social Network AOD Intervention for Homeless Youth Transitioning to Housing

This project will pilot test a computer-assisted social network intervention, using motivational interviewing techniques, that can help case managers work with formerly homeless young adults who recently transitioned to supportive housing to reduce substance use and increase permanent supportive connections during this critical transitional period.

The goal of this study is to conduct a pilot evaluation of a motivational network intervention (MNI) to reduce substance use and strengthen supportive connections for recently homeless 18-25 year-olds who have transitioned to a housing program. The goal of this pilot study is to evaluate, through a small randomized controlled trial (Stage 1b), the added benefit of incorporating the MNI into case management for transitional age youth (TAY) residents of housing programs. We hypothesized that residents receiving the MNI as part of case management would show more positive changes in their substance use behaviors and the composition and structure of their personal networks (i.e., greater proportion of network members who are low-risk) over a 3-month follow-up period compared to residents receiving usual case management only.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* In a housing program for homeless transition age youth
* Past month substance use
* Screen positive for past-year harmful substance use

Exclusion Criteria:

• Not able to speak/understand English
Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis

This study aims to compare the outcomes of surgical treatment and conservative treatment at medium- and long-term period (minimum 2 years) in patients with lumbar stenosis who come to the observation of the PI's Team at the Rizzoli Orthopaedic Institute, through a series exhaustive questionnaires to self-administer to patients in order to define a path of "decision-making" as effective as possible for the patient and the doctor.

Non-surgical treatment:

Conservative treatment may include different approaches, such as analgesics, anti-inflammatories, muscle relaxants, physical therapy, Global Postural Rehabilitation, magnetic therapy, laser therapy, TENS, massage, cognitive-behavioral therapy and all those procedures that can bring benefit in back and legs pain.

Surgical treatment:

Surgical treatment of lumbar stenosis is the decompression surgery which relieves the nerve structures to prevent permanent neurological damage. Decompression can be made on one or more segments of the spine and can be done with laminectomy, hemilaminectomy, laminotomy.

During a laminotomy part of the vertebral lamina is removed above and below the compressed nerve. The opening created is sometimes enough to relieve the compression on the nerve. In most cases, also the disc material and bone spur that compress the nerve are removed.

During a laminectomy the vertebral lamina is completely removed, along with the disc and the bone material that compress the nerves. The opening produced by the removal of the lamina is protected by back muscles and ligaments.

If the damage has occurred at several levels and bone of the vertebral support structures must be removed to achieve decompression, it can be performed a stabilization surgery with vertebral bone fusion (arthrodesis) in order to avoid instability of the column. Fusion is carried out to eliminate the mobility between different vertebrae and it is achieved using bone derived from the patient's iliac crest or from a donor. The bone gradually grows and melts with the same vertebrae. This limits the movements that may have been one of the causes of back pain. It takes about six months for it to achieve a solid bony spinal fusion.

Eligibility Criteria:
Inclusion Criteria:

* Confirmatory imaging study (MRI or CT) showing lumbar spinal stenosis at one or more levels (L2 to sacrum) defined as narrowing of the central spinal canal, lateral recesses, or neural foramens due to encroachment on the neural structures by the surrounding bone and soft tissue.

Exclusion Criteria:

* Patients are not eligible if they have evidence of instability on lateral flexion- extension radiographs, defined as a change of #10° of angulation of adjacent segments by Cobb measurement or a change of more than 4 mm of anteroposterior or posteroanterior translation.
ICT-supported Multidimensional Approach for Frailty Screening in Community-dwelling Individuals Aged ≥ 65 Years

SUNFRAIL+ is a prospective observational cohort study aimed to carry out a multidimensional assessment of community-dwelling older adults, through an IT platform, which allows to connect the items of the SUNFRAIL frailty assessment tool with a cascading multidimensional in-depth assessment of the bio-psycho-social domains of frailty. It is a multicentric study. Seven centres will administer SUNFRAIL questionnaire to 100 older adults each and, according to the specific "alerts" triggered by the answers provided, older adults will be subjected to one or more validated in-depth tests in order to perform further diagnostic or dimensional evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years;
* Living at home;
* accessing participating centres for social and healthcare services other than those covered by this study;
* ability to sign the informed consent

Exclusion Criteria:

* Age \<65 years;
* Residents in care facilities (hospital, nursing home);
* have overt frailty or disability; are already enrolled in home care; are unable to understand the study aims and sign the informed consent