cyrilzakka/clinical-trials huggingface dataset:
COgnitive REhabilitation in Pediatric Patients with ABI, from Vegetative State to Functional Recovery

Acquired brain injuries (ABI) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progress of the last decade has increased the percentages of survivals, also in patients with the most severe clinical pictures. On the other hand, a brain injury reported in the first years of life presents with a more dramatic impact on cognitive and neurological development of patients and it may significantly interfere with adjustment, vocational perspectives and quality of life. Recent studies suggest that a brain damage at an early stage of development is related to more persistent sequelae in comparison with a comparable lesion reported by an adult patient, because of the neurological immaturity of the central nervous system at the moment of the insult. Furthermore, in most cases, a brain injury is related not only to motor and sensory deficits but also to significant behavioral and cognitive problems, that may occur immediately after the acute phase and persist or worsen over the years.

The aims of the present study are:

1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale for pediatrics, investigating behavioral responses of children across different age and developmental levels. Typically developing children and children with disorder of cosciousness due to ABI will be included;
2. For patients with an adequate cognitive profile, to compare the efficacy of two multidomain neuropsychological interventions: a personalized neuropsychological treatment and a sequential neuropsychological treatment. In the personalized neuropsychological treatment each patient will receive greater stimulation of the most deficient cognitive function(s), while at the same time being trained on all the other functions; in the sequential neuropsychological treatment, a fixed-dose stimulation of each cognitive function following a sequential order will be provided.

Eligibility Criteria:
-For the adaptation/validation of the Coma Recovery Scale for pediatrics for the Italian context (typically developing children, healthy volunteers)

Inclusion Criteria:

* children aged between 0 and 5 years
* no suspicion of the presence of a neurodevelopmental disorder
* For the preliminary validation of the Coma Recovery Scale in clinical subjects:

Inclusion criteria:

* age between 0 and 10 years at the moment of the pathological event
* LOCFAS score \<5
* a documented diagnosis of moderate-to-severe acquired brain injury of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS\<12)
* a brain lesion reported within one year from study inclusion
* For the evaluation and comparison of the efficacy of two multidomain neuropsychological treatments (CORE-ABI vs SET-ABI) in children emerged from a disorder of consciousness:
* age between 5:0 and 17:11 years at the moment of the ABI
* LOCFAS score\>5
* time between ABI and assessment \<3 months
* GCS \<12 in the acute phase
* negative anamnesis for other developmental disorders before the ABI
Micro-ultrasound for Prostate Cancer Diagnosis

This is a single-center, paired-cohort, prospective study. Patients with a clinical suspicion of csPCa will receive mpMRI and Micro-US in two different visits. The results of the diagnostic procedures will determine how many and which type prostate biopsies patients will undergo. During the following visit, patients with both positive mpMRI and Micro-US, defined as the presence of one or more lesions with PI-RADS ≥ 3 and PRI-MUS ≥ 3 respectively, will receive a 12-core TRUSBx in addiction to MRI-TBx and Micro-US-TBx (Group 4). Patients with both negative mpMRI and Micro-US will receive a 12-core TRUSBx (Group 1). Patients with only positive mpMRI will receive MRI-TBx and 12-core TRUSBx (Group 2). Patients with only positive Micro-US-TBx will receive Micro-US-TBx and 12-core TRUSBx (Group 3).

Our hypothesis is that the sensitivity for csPCa (defined as prostate cancer with Gleason score ≥ 3+4) of Micro-US will be superior or at least equal to that of mpMRI. Despite the introduction of the mpMRI and MRI-TBx has improved the diagnostic pathway of PCa, the proportion of men with negative mpMRI with a csPCa is still difficult to delineate due to the high variability of mpMRI negative predictive value (NPV) and specificity. In this context, a specific standardization of the use of Micro-US may play a crucial role to optimize PCa diagnostic pathway. Moreover, a direct comparison between Micro-US and mpMRI might be useful to determinate whether Micro-US could be more accurate than mpMRI for PCa diagnosis. Furthermore, in patients with suspicion of PCa the combined use between mpMRI and Micro-US might increase the detection of csPCa and reduce the number of unnecessary biopsies, improving mpMRI limitations in NPV and specificity. Demonstrating that Micro-US provides a similar sensitivity for csPCa as compared to mpMRI may lead to its definitive inclusion in daily clinical practice, potentially replacing mpMRI, streamlining the current diagnostic pathway of PCa.


Eligibility Criteria:
Inclusion Criteria:

* Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
* Serum PSA ≤ 20ng/ml
* Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer)
* Fit to undergo all procedures listed in protocol
* Able to provide written informed consent

Exclusion Criteria:

* Prior treatment for prostate cancer
* Prior diagnosis of prostate cancer
* Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min)
* Contraindication to prostate biopsy
* Men in whom artifact would reduce the quality of the MRI
* Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
* Unfit to undergo any procedures listed in protocol
The Effect of Different Treatment Modalities of Class II Malocclusion on Upper Third Molars.

What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars?

What is the effect of the different treatment modalities (distalization versus upper premolar extraction) of class II malocclusion on the position, inclination and incidence of impaction of the upper third molars? Pico P: Adolescent patients with class II malocclusion having bilateral developing upper third molars.

I: bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.

C: distalization orthodontic treatment. O: Primary: angulation of the maxillary third molars.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent males and females (16 -18 years) with Bilaterally developing maxillary third molars. Not more than two thirds of the root development of the third molars had taken place.
* Class II malocclusion cases that were treated by 1) maxillary premolar extraction with a moderate anchorage requirement and achieved full unit class II molar relationship or 2) Distalization treatment plan and class I molar relationship was achieved.
* Patients with high-quality pre- and post-treatment radiographs.
* Normal or increased vertical dimension.

Exclusion Criteria:

* Maxillary Premolar extraction cases requiring maximum anchorage preparation.
* Low vertical dimension.
* Patients without dentofacial deformities, severe facial asymmetries, microdontia or hypodontia.
Indoor Air Quality and Infectious Aerosols in Health Care Facilities

Outbreaks of emerging and re-remerging infectious diseases are frequently reported internationally in recent years, mainly due to global climate change, close human-livestock contact in developing countries, and globalization. Thus prevention, monitoring and control of infectious diseases are in urgent need to protect public health. High exposure risk to various infectious agents in health care facilities is of special concern, especially to airborne and droplet-borne respiratory diseases. To protect the health of public and health care workers the investigators will conduct a study to monitor indoor air quality and essential infectious aerosols in hospital(s).

A questionnaire survey will be used to evaluate the relationships between employees' health and measured indoor environmental factors. The investigators will also examine whether the current indoor air quality recommendation of their country can reasonably reduce the risk of hospital infection. In addition, simple infectious aerosol indices will be established for future environmental management and monitoring in health care facilities.


Eligibility Criteria:
Inclusion Criteria:

* people who work in Health Care Facilities

Exclusion Criteria:

* none
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
* indication for treatment of low back pain with acupuncture confirmed by a consultant
* at least 40 mm on a VAS pain scale

Exclusion Criteria:

* acupuncture during the last 6 months
* start of a new therapy for low back pain within the last 4 weeks
* pregnancy
* substance or drug abuse
Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection.

Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and autoimmune diseases in general.

Our study aim is:

* Using MRI to further characterize and find risk factors leading to aortic dilation.
* Using MRI to assess the degree of aortic distensibility.
* Using Computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies.
* Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as Pulse Wave Velocity, Augmentation Index and Central Pulse Pressure.

Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, congenital heart defects, hypertension, stroke, ovarian failure, infertility, decreased final height and autoimmune diseases in general

Our study aim is:

* Using MRI to further characterize and find risk factors leading to aortic dilation.
* Using MRI to describe aortic dimensions
* Using MRI to assess the degree of aortic distensibility.
* Using Computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies.
* Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as Pulse Wave Velocity, Augmentation Index and Central Pulse Pressure.

Eligibility Criteria:
Inclusion Criteria with respect to individuals acting as controls:

* Healthy age matched females

Exclusion Criteria:

* Contraindications for MRI
* Contraindications for CT
* Severe obesity
* Acute og Chronic disease with known or presumed significance with concern to outcomes of the study
* Previous or present malignant disease
* Clinically significant liver disease
* Mechanic or biological heart valves
Exercise and Pregnancy: Randomized Clinical Trial

The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.

The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group.

The objectives are:

1. To describe and compare biological and obstetrical variables.
2. To study doppler flow velocimetry indexes.
3. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.
4. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 13 weeks
* Single pregnancy
* Alive fetus
* No previous practice of physical activity

Exclusion Criteria:

* Smoking
* Chronic maternal diseases
* Placenta praevia
* History of preterm labor
* Bleeding
A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia

The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
* Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety
Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies

Venous thromboembolism (VTE) is the third leading cause of cardiovascular disease deaths globally, and its incidence is increasing over the years. Hospital-acquired VTE accounts for approximately 75% of all deaths attributed to VTE. However, only half of patients with indications for VTE prophylaxis take preventive measures, and high rates of inappropriate VTE prophylaxis prescribing contribute to the gap between VTE prophylaxis and guidelines. To further minimize the gap between clinical practice and guidelines, a range of strategies have been employed across various fields of VTE prophylaxis. One of the most effective measures is the utilization of a Clinical Decision Support System (CDSS). Smart technology-based CDSS facilitates automated evaluation of VTE risk and detection, addressing issues at both the beginning and end of the in-hospital VTE prevention process. but there is still a lack of research on how to effectively implement evidence-based VTE prophylaxis in the middle of the process.

In our hospital, routine use of DeVTEcare system (a CDSS for VTE risk assessment and integrated care) for in-hospital management of VTE has been launched since 2021. This study aims to investigate the effect of integrating bundled guideline-based VTE prevention strategies into the DeVTEcare system on in-hospital VTE prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Discharged patients who were ≥18 years of age at admission were included in the observation cohort. If a patient had multiple hospitalizations, information on only the longest hospitalization was included in the study.

Exclusion Criteria:

* Lack of diagnostic information；
* Length of hospitalization ≤ 24 hours；
* Patients on anticoagulation therapy at the time of admission: e.g., those with established VTE, atrial fibrillation, acute myocardial infarction, ischemic stroke, those on continuous renal replacement therapy, extracorporeal membrane pulmonary oxygenation, hemodialysis, and mechanical valve implantation status.
Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

Breast cancer patients who smoke, are at greater risk for treatment complications. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* MSK patients diagnosed with breast cancer or have a mass suspicious of breast cancer at the time of enrollment, as per clinician judgment or EMR;
* Self-reported current cigarette smoker (defined as daily smoking in the past seven days)
* Advised to quit smoking by their MSK physician and willing to receive smoking cessation counseling and treatment; as per self report
* Fluent in English

Exclusion Criteria:

* Patients less than 18 years of age because the safety and efficacy of varenicline have not yet been tested in children;
* Evidence of any known or suspected medical contraindications for use of varenicline (e.g., recent (within past two months) cardiovascular instability (including myocardial infarction or unstable angina; uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, or severe congestive heart failure (New York Heart Association class III or IV), severe chronic obstructive pulmonary disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe renal impairment.
* Self-reported evidence of significant psychiatric history (e.g., schizophrenia, unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in the investigators' judgment, to preclude participation in the clinical trial;
* Self-reported evidence of recent substance abuse or heavy alcohol use (\> 14 drinks weekly) in the last 6 months;
* Self-reported recent use (in the past 30 days) or planned use of nicotine replacement therapy (NRT) or other FDA approved cessation pharmacotherapy (bupropion);
* Pre-menopausal women who are pregnant as per EMR
* Women who are breast-feeding as per self-report.
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery

Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.


Eligibility Criteria:
Inclusion Criteria:

Necessary conditions: meet one of the following conditions

1. Difficult pelvis: narrow pelvis (diameter of ischial tuberosity \<10 cm, diameter of ischial spine \<12 cm) 13 or BMI≥30kg/m2 or tumor diameter≥5cm2.
2. To receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or ESD
3. The anastomosis is below the level of the levator ani muscle: such as ISR, TaTME surgery, etc.

Other conditions:

1. Age: 18 to 75 years old, male or female;
2. Preoperative biopsy pathological diagnosis of rectal adenocarcinoma;
3. Received MRI evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm;
4. The clinical stage is T1-3N0-2M0;
5. Undertake elective laparoscopic TME for colon-rectal or colon-anal anastomosis
6. ECOG score 0-2;
7. Heart, lung, liver, and kidney functions can tolerate surgery;
8. Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.

Exclusion Criteria:

1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
3. Neighboring organs need to be combined with organ removal
4. ASA grade ≥ grade IV and/or ECOG physical status score\> 2 points;
5. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
6. Have a history of severe mental illness;
7. Pregnant or lactating women;
8. Those with a history of taking hormone drugs;
9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

Eligibility Criteria:
Inclusion Criteria:

- 1)6 years \< age \< 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L, Hb ≥ 75 g / L, WBC ≥ 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy.

8)Patient's parent or guardian signs informed consent.

Exclusion Criteria:

* Patients with any of the following items will not be enrolled in this study:

  1. Local or systemic infection without adequate control;
  2. Severe visceral dysfunction;
  3. Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) \> 2 times of the upper limit of normal value;
  4. Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;
  5. Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
  6. Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;
  7. The researcher judged the patients who were not suitable to participate.