cyrilzakka/clinical-trials huggingface dataset:
PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).

TThe research aims to verify the Italian adaptation of a parent-mediated group training focused on social skills for adolescents with autism spectrum disorder (ASD). The Program for the Education and Enrichment of Relational Skills PEERS® is an evidence-based program with substantial literature (over 40 studies) applied in several countries. For the present study, about 40 adolescents, both boys, and girls with ASD, are enrolled and randomized into two groups. Groups (experimental group and waiting list) took part in the Italian telehealth adaptation of PEERS® at different times and were evaluated at several time points (baseline, pre-treatment, post-treatment, and follow-up). The objective of the comparison was to explore the primary outcomes, such as the impact of training on social knowledge and performance, and secondary outcomes, like psychiatric comorbidities and neuropsychological profile. The hypothesis is that social skills (knowledge and performance) improve after training in the experimental group and affect the secondary outcomes, and the achievements are maintained at 3-months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* a previous and current diagnosis of ASD, by a clinical team, according to DSM-5, clinical observation and structured assessment with standardized tests (Autism Diagnostic Observation Schedule- Second Edition; ADOS-2; Lord et al., 2012)
* Verbal Comprehension Index scores at least 80 on the Italian version of the WISC-IV scale (Orsini et al.,2012).
* Chronological age between 12 and 18 years;
* Social problems as reported both by the parents and adolescents;
* Italian fluency for the adolescent and parent
* Abstention from other social skills training (following a manualized protocol).
* No history of adolescent major mental illness, such as bipolar disorder, schizophrenia, or psychosis;
* No history of hearing, visual, or physical impairmentsExclusion Criteria:

Exclusion Criteria:

* No diagnosis of ASD.
* IQ Total score below 70 or Verbal Comprehension Index scores below 80 on the Italian version of the WISC-IV scale (Orsini et al.,2012).
* Lack of motivation (both parents or adolescents).
* Participation in another social skills training (following a manualized protocol).
* Auto-aggressive behaviors
Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life

This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
* Age between 18 and 65 years.
* Duration since amputation is at least 6 months.
* Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
* Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
* Signed consent to participate in the study.

Exclusion Criteria:

* Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
* Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
* Presence of severe orthopedic deformity in the limb above the level of amputation.
* History of cancer.
* History of epilepsy.
* Complicated traumatic brain injury (TBI) or a history of stroke.
* Inability to undergo electrostimulation due to other somatic pathology.
* Purulent-septic pathology.
* Drug addiction (including a history of).
* Congenital anomaly of upper limb development.
* Anomalies in the development of the central and peripheral nervous systems.
Features of Regional Perfusion of Lung Consolidation

The aim of this study is to evaluate the potential usefulness of lung ultrasound to assess the size and perfusion of consolidation and explore their relationships with clinical outcome.

Lung consolidation is one of the most causes of hypoxia in intensive care unit(ICU) settings. A quantitative measurement of consolidation would be extremely benefit for the clinical management in hypoxemia, both as an index of severity and to predict outcomes.In order to quantify the lung consolidation and its effect on clinical outcomes, a simple and quantitative scoring system of the size and perfusion of lung consolidation was proposed by lung ultrasound. Subjects with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound examination. The size of consolidation and the richness of blood flow was computed upon lung ultrasound. The sensitivity, specificity and accuracy of the scoring system were calculated and compared to evaluate the diagnostic efficacy.

Eligibility Criteria:
Inclusion criteria:

1. Admission to ICU( 18yr\<age\<90yr);
2. Patients presented with acute respiratory failure;
3. Pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan).

Exclusion criteria:

1. Hemodynamic instability (i.e., severe hypotension with systolic arterial pressure\<60mmHg despite fluid expansion and vasoactive support; systolic arterial pressure\>180mmHg; uncontrolled cardiac arrhythmias);
2. Severe thoracic trauma;
3. Coronavirus disease 2019;
4. Pulmonary artery hypertension and pregnancy.
Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases

The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.

The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.

The objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph


Eligibility Criteria:
Inclusion Criteria:

* double amputated patients
* minimum of 3 months and maximum of 3 years interval between amputation and graft
* adult aged 20 to 40 years
* psychological maturity
* written informed consent

Exclusion Criteria:

* mono amputated patients
* previous history of malignant tumor in remission for less than 5 years,
* malignant tumor
* previous psychiatric history
* American Society of Anesthesiology (ASA) score \>2
* New York Heart Association (NYHA) \>1
* nenal insufficiency
* severe hypertension
Type 2 Diabetes Intervention by Gut Microbiota-directed Diet -a Open Labelled RCT

This study is a randomized, open labelled, placebo-controlled clinical trial. The main purpose is to verify the superior effect of gut microbiota directed diet intervention over standard diet intervention by evaluating the changes of HbA1c relative to baseline at 16 weeks and 28 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes mellitus patients who have been diagnosed or screened for treatment without any hypoglycemic drugs;
* 6.5%≤HbA1c≤8.5%；
* FPG\<10.0mmol/L;
* BMI≥24；

Exclusion Criteria:

* suspected other types of diabetes
* Moderate stroke occurred within one year;
* Frequent diarrhea or constipation in the past 3 months (more than 4 times / week);
* Acute complications occurred in the past 3 months, such as infection, ketosis and acidosis;
* Pregnant and lactating women (or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives);
* Drinking (1 weeks of drinking more than 5 times, on average 2 two Baijiu or half Jin of yellow wine or 5 bottles of beer above);
* Those who have received drug treatment for the following diseases in the past three months: cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other thyroid dysfunction;
* Gastrointestinal surgery (except appendicitis and hernia surgery);
* Antibiotics have been used in the past 3 months for 3 days or more;
* Physical methods, such as liposuction or gastrointestinal reconstruction, have been used to lose weight in the past 3 months;
* Physical disability, or inability to take care of themselves, recall and answer questions clearly due to other reasons;
* Anemia: hemoglobin \< 10g / dl;
* Patients with severe liver diseases such as chronic hepatitis, persistent hepatitis and cirrhosis, and hepatitis B virus surface antigen (HBsAg) positive and abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase are 2.5 times the normal value).
* Other serious diseases, such as malignant tumors, serious mental diseases, serious infectious diseases, etc;
* Patients who are participating in other intervention studies;
* In the judgment of the study physician, there are any conditions that affect the study compliance, such as:Alcohol or drug abuse in the past 12 months; Serious adverse drug treatment compliance in the past 12 months; The residence is far away from the research center, or it is planned to move far away or travel frequently in the next year; The clinical diagnosis of dementia or the judgment of cognitive function by the research physician will affect the research compliance; Other medical, psychological or behavioral factors that affect the study compliance are judged by the study physician.
Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF

A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization

Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?

Design This is a randomized controlled trial.

Research plan

Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.

Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger.

Comparator: Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

Outcomes: The primary outcome is the live birth rate the first FET.

Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.


Eligibility Criteria:
Inclusion Criteria:

* Age of women \<43 years at the time of ovarian stimulation for IVF
* Antral follicle count (AFC) on day 2-5 of the period≥5

Exclusion Criteria:

* Presence of a functional ovarian cyst with E2\>100 pg/mL
* Recipient of oocyte donation
* Undergoing preimplantation genetic testing
* Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis (IPF)

The purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or when patients are likely to experience a rapid decline in lung function due to disease progression.

People who are diagnosed with idiopathic pulmonary fibrosis are asked to participate in this study. The subject must be treated at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Subjects, if consented, are required to perform tests so that research data can be collected. At the initial visit, patients are subject to having a blood draw, pulmonary function testing, echocardiograms, and CT scans as well as completing several questionnaires designed to measure how the patient is feeling. Follow up visits are then scheduled in 3-4 month intervals. Every 3-4 months blood samples will be collected while every 6-8 months the questionnaires will administered. If the patient enters a stage of accelerated decline in lung function, a bronchoscopy will be performed to collect residual bronchoalveolar lavage fluid for testing. All of the results of clinical and laboratory testing will be placed into the subjects research file.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 or older
* Diagnosis of Idiopathic Pulmonary Fibrosis
* Treated at the Simmons Center

Exclusion Criteria:

* Other Lung Illness
A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy

The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy


Eligibility Criteria:
Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF)
2. Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients).
3. Body mass index (BMI) between 19 and 28 kg/m2.
4. Normal Electrocardiogram (ECG)

Exclusion Criteria:

1. History of persistent tachyarrhythmia and syncope;
2. A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice (SURE NETHERLANDS)

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
* Available and documented haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of semaglutide treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Treatment with any investigational drug within 90 days prior to enrolment into the study
* Hypersensitivity to semaglutide or to any of the excipients
Impact of the Coronavirus Disease 2019 (COVID-19) on Sperm Parameters

This study aims to better understand the effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, virus that causes the coronavirus disease 2019 (COVID-19), on male fertility.

After being informed about the study and potential risks, all patients giving written informed consent will produce a sperm sample by masturbation. Patients will also complete a questionnaire relating to their state of health. Six month following the first sperm sample, patients will produce another sperm sample by masturbation. These sperm parameters will be compared with the ones from a sperm analysis performed less than 2 years before the SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* All men aged 18 to 45 having a sperm analysis done at the Fertilys fertility center in the last 2 years who have not contracted COVID-19, agreeing to participate in the study and having signed the consent form to participate in the study.
* All men aged 18 to 45 having a sperm analysis done at the Fertilys fertility center in the last 2 years) who have contracted COVID-19 within the last 6 months, agreeing to participating in the study and having signed the consent form to participate in the study.
* All men aged 18 to 45 years with a sperm concentration ≥ 15 million/mL, progressive motility ≥ 20% and a percentage of normal forms ≥ 2%.

Exclusion Criteria:

* Men aged under 18 and over 45.
* Men who cannot produce a sperm sample by antegrade ejaculation.
* Men whose sperm concentration is \<15 million/mL, progressive motility \<20% and a percentage of normal forms \<2%, determined following the production of a "reference" sperm sample, carried out before March 2020, i.e. before the COVID-19 pandemic.
Experience of 177Lu-PSMA-617-administration on Port Reservoir (TIVAP)

According to Pluvicto® indication, most of patients treated are elderly, with limited/poor venous peripheric access but they received previously chemotherapy through TIVAP and TIVAP generally stays in the body of patients when they are referred for Pluvicto® therapy. This is why TIVAP could be an interesting alternative for administering of 177Lu-PSMA-617. The aim of this study is to assess potential retention of 177Lu-PSMA-617 on TIVAP during administration through in vitro/ex vivo experimentations then in in vivo analysis.

Pluvicto® (177Lu-PSMA-617) was approved in the USA by the Food and Drug Administration (FDA) in March 2022 and in Europe in December 2022 for the treatment of adult patients with progressive, prostate-specific membrane antigen (PSMA)-positive, castration-resistant, metastatic prostate cancer (mCRPC) who have been treated with androgen pathway-inhibiting hormone therapy and taxane-based chemotherapy. The European Medicines Agency (EMA) and FDA recommends using an intravenous catheter exclusively for Pluvicto® administration, which implies that Pluvicto® administration has not to be administreted into a Totally Implantable Venous Access Port (TIVAP). In fact, administration through central venous access is preferred for repeated venous infusion in particular in oncology patients for preventing damage veins, and painful and TIVAPs is particular used for intensive and long-term chemotherapy in most oncology departments. However, according to Pluvicto® indication, most of patients treated are elderly, with limited/poor venous peripheric access but they received previously chemotherapy through TIVAP and TIVAP generally stays in the body of patients when they are referred for Pluvicto® therapy. This is why TIVAP could be an interesting alternative for administering of 177Lu-PSMA-617. The aim of this study is to assess potential retention of 177Lu-PSMA-617 on TIVAP during administration through in vitro/ex vivo experimentations then in in vivo analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an injection of Pluvicto as part of the treatment of their prostate cancer, having had a SPECT/CT scan for dosimetry within 2 to 4 hours after injection.

Exclusion Criteria:

* Patients who have refused to have their data used for research purposes
Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease.

This randomized controlled trial will compare ultrasound-guided interscalene block (ISB) and supraclavicular block in patients undergoing arthroscopic shoulder surgery.

The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10.

Our research hypothesis is that interscalene and supraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroscopic shoulder surgery
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy
* Coagulopathy
* Obstructive or restrictive pulmonary disease
* Renal failure
* Hepatic failure
* Allergy to local anesthetics
* Pregnancy
* Prior surgery in the corresponding side of the neck or supraclavicular fossa
* Chronic pain syndromes requiring opioid intake at home
Data Construction Project for Artificial Intelligence Learning: Chest Auscultation Sound Data

The purpose is to establish chest auscultation data and related clinical data for diagnosing heart and lung diseases.

The incidence of cardiovascular diseases worldwide is steadily increasing. According to the report of the American Heart Association, there were 271 million cardiovascular diseases in 1990, and 523 million cases in 2019, about doubling in 30 years. The number of deaths due to cardiovascular disease is also steadily increasing from 12.1 million in 1990 to 18.6 million in 2019.

Physical examination, which is the most basic skill in patient care, consists of inspection, auscultation, percussion, and palpation. Among them, auscultation is the most widely used test in all areas where a stethoscope is used, and it is a basic examination that is essential from primary medical institutions to tertiary medical institutions for non-invasive initial diagnosis in patients complaining of chest symptoms.

However, if a specialist in the field with a lot of experience does not interpret it carefully, it is difficult to make a decision, and the deviation of the test results is large, so a significant number of patients depend on expensive follow-up tests (ultrasound, CT, MRI, etc.) This leads to a vicious cycle of incurring costs and unnecessary treatment.

Recently, with the development of machine learning techniques, computing technologies, and artificial intelligence (AI) based on a lot of data, various learning technologies are applied as tools for disease diagnosis and prognosis prediction in medicine.

Through machine learning-based chest auscultation sound analysis, there is an expectation that disease diagnosis and prognosis prediction will be able to overcome differences and interpretations by examiners. It can be very helpful in preventing overuse of tests and reducing medical costs.

Eligibility Criteria:
Inclusion Criteria:

* Adults who are 20 years and older

Exclusion Criteria:

* Patient refusal
* Uncertain radiographs
* Uncertain tests results