cyrilzakka/clinical-trials huggingface dataset:
The Effect of Music on Preterm Infant's Brain Development

Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants: 33 weeks \< gestational age \< 37 weeks
* Full-term newborns: 37 weeks gestational age \< 42 weeks

Exclusion Criteria:

* Neurological issues or malformations (such as III-IV stade Intraventricular hemorrhage, micro or macrocephaly, hydrocephaly...)
* Because of the high noise caused by nasal continuous positive airway pressure (nCPAP), preterm newborns without at least nCPAP pause before 32 6/7 gestational age will be excluded
A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia

The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.

The main questions it aims to answer are:

1. What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?
2. Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?
3. What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?

Participants will fill out the questionnaire to complete the study.

The study design of this research is cross-sectional. The participants are primary caregivers of dementia patients diagnosed by specialists, aged 18 and above, who spend 8 hours or more daily (including overnight caregivers) providing care. Data is collected using instruments including the Self-Compassion Scale, the PHQ-9 Scale (Patient Health Questionnaire,PHQ-9）, and the Quality-of-Life Scale to investigate the relationship between self-compassion, depression, and quality of life among primary caregivers of dementia patients.

The study uses independent samples t-tests and one-way ANOVA( analysis of variance,ANOVA) to explore differences in self-compassion, depression, and quality of life among primary caregivers of dementia patients based on different background variables. Pearson correlation is used to analyze the relationships between these variables. Finally, linear regression is used to predict the performance of primary caregivers of dementia patients in self-compassion, depression, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. primary caregivers of dementia patients diagnosed by specialists
2. aged 18 and above
3. who spend 8 hours or more daily (including overnight caregivers) providing care

Exclusion Criteria:

1. Those who do not agree to participate in the research
2. Caregivers in a paid relationship with dementia patients, such as foreign domestic helpers and government-provided resident care attendant
A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects

This is a double-blind, randomised, 2 single-doses and then repeated-dose (5 days), 2-arm, 2-period crossover phase 1 study in 24 healthy male or female subjects. Subjects will be randomised to one of two treatment sequences in 2 treatment periods: JHL1922 (test treatment) first and then Pulmozyme (reference treatment) or Pulmozyme (reference treatment) first and then JHL1922 (test treatment).

All 24 subjects will receive either JHL1922 or Pulmozyme as single doses of 2.5 mg and then 10 mg per eRapid nebulizer, followed after a washout by a 5-period of daily dosing of 10 mg of either JHL1922 or Pulmozyme per eRapid nebulizer.

The primary objective is to assess the similarity of safety and tolerability of test products, and the exploratory objective is to assess the similarity, if possible, of the systemic levels and sputum levels of dornase alfa after administration of test products.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years, inclusive
* Body Mass Index: 18.0-30.0 kg/m2, inclusive
* Weight: between 55 and 105 kg
* Condition: healthy; normal pulmonary function by spirometry

Exclusion Criteria:

- Any medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, incl. active, or history of, pulmonary disorders incl. asthma or chronic obstructive pulmonary disease (COPD)
Multi-modal Exercise Program in Older Adults

Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults.

* Aim: To evaluate the short-term effects of a 16 weeks home-based multi-modal exercise program on physical performance variables in community-dwelling older adults.
* Design: randomized controlled trial.
* Setting: home-based intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Community-dwelling

Exclusion Criteria:

* Unable to ambulate independently
* Mini-mental state examination score \< 24
* Barthel Index score \< 80
* Unstable cardiovascular disease
* Neurological disorder that could compromise exercising
* Upper or lower-extremity fracture in the past year
Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges

The multiple baseline single subject design study with replication across three participants in a public-school setting. The 15-week independent variable will be a direct service occupational therapy intervention, combined with teacher consultations, based on the STAR (Sensory Therapies and Research) Frame of Reference. Frequently measured dependent variables, as the main determinants of change resulting from the intervention, will be student's video-recorded performance in the areas of functional regulation and active participation in the classroom, as rated by a trained observer. Findings of the single subject study will be corroborated via semi-structured interviews with the student participants and their teachers, administration of systematic assessments and Goal Attainment Scaling.


Eligibility Criteria:
Inclusion Criteria:

1. Student has a) suspected sensory processing challenges and b) difficulty with functional regulation and active participation in the classroom.
2. not remediated by Tier 2 intervention
3. Evaluation finds:

   1. total score, or 3 or more scales, for the main classroom on the Sensory Processing Measure are more than one standard deviation, namely is in the some problems or definite difference range,
   2. clinical determination that the student demonstrates disrupted sensory processing issues that are impacting his or her ability to participate in the school setting, and
   3. student requires specialized intervention in the form of direct pull-out service delivery in order to access his or her education.

Exclusion Criteria:

1. The student has an autism diagnosis or a primary genetic, orthopedic, or neurological disorder.
2. The student is participating in occupational therapy outside of school.
Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.


Eligibility Criteria:
Inclusion Criteria:

* Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
* Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening
* Has a screening serum testosterone level \>150 ng/dL
* Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2

Exclusion Criteria:

* Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit
* Is currently treated with a 5-alpha reductase inhibitor
* Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
* Is in need of neoadjuvant hormonal therapy
* Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
The Safety and Efficiency of Luspatercept in Chinese Adults With Transfusion Dependent β-thalassemia: a Real-world Study

This is a prospective, single-arm, open-label study. Twenty adult patients with transfusion-dependent β -thalassemia will be enrolled to receive Luspatercept with optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice. The main objective of this study was to evaluate the efficacy and safety of Luspatercept in the treatment of adult patients with transfusion-dependent β -thalassaemia in Chinese clinical practice, and to provide evidence reference for subsequent clinical use.

Twenty adult patients with transfusion-dependent β -thalassemia will be enrolled to receive Luspatercept with optimal supportive care, being injected subcutaneously every 3 weeks ,by the dose of 1-1.25 mg/kg. The main objective of this study was to evaluate the efficacy and safety of Luspatercept in the treatment of adult patients with transfusion-dependent β -thalassaemia in Chinese clinical practice, and to provide evidence reference for subsequent clinical use.

Eligibility Criteria:
Inclusion Criteria:

-≥18 years old

* The patient was clearly diagnosed as transfusion-dependent β -thalassemia, the blood transfusion period was ≤60 days, and the red blood cell infusion volume was not less than 3-12U in the 12 weeks before enrollment, which could provide the red blood cell infusion volume record in the 12 weeks before enrollment
* Patients who were treated with thalidomide before enrollment were required to stop the treatment for more than 4 weeks, and their hemoglobin decreased to below 90g/L. Blood transfusion was required, and records of blood transfusion within 12 weeks could be provided
* Voluntarily participate in the study and sign the informed consent;

Exclusion Criteria:

* (1) Pregnant or lactating women
* persons known to be allergic to Luspatercept and/or Luspatercept excipients for injection
* Severe liver dysfunction (liver enzyme (ALT or AST) ≥3 TIMES ULN)
* Severe renal impairment (eGFR \< 30 ml/min/1.73m3 or patients with end-stage renal disease)
* Heart disease, heart failure classified as Class 3 or higher by the New York Heart Association (NYHA), or severe arrhythmia requiring treatment, or recent myocardial infarction within 6 months of randomization.
* The patient has uncontrolled hypertension. According to NCI CTCAE version 5.0, controlled hypertension in this protocol is considered to be ≤1.
* Patients with a history of deep vein thrombosis or stroke within 24 weeks prior to enrollment
* Erythropoietin, Luspatercept or hydroxyurea were used 8 weeks before enrollment
* Any other significant medical condition, laboratory abnormality, or mental illness that the Investigator deems inappropriate for inclusion.
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging

Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension. Isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. To facilitate patient screening, a new clinical and functional TR staging system has recently been proposed. This classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (RV) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. Rather than simply assessing the degree of TR, this new staging mechanism also focuses on symptoms, RV remodeling and function, medical therapy, and right heart failure hospitalizations.

Investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe TR, who were classified at baseline according to this clinical and functional staging system. Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR.

The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Affected by severe tricuspid regurgitation (TR), both of degenerative and functional etiology and;
* Patients underwent isolated surgery, either repair or replacement, of the tricuspid valve
* Patients operated on at theCardiac Surgery Department of San Raffaele Hospital from May 2004 to May 2020.

Exclusion Criteria:

- Patients with non-isolated tricuspid valve surgery (concomitant surgery on other valves).
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

The purpose of this study is to learn more about how muraglitazar lowers blood sugar in people with type 2 diabetes. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes;
* Serum triglyceride concentration \< or = 600 mg/dL;
* Body mass index \< or = 37 kg/m2

Exclusion Criteria:

* Type 1 diabetes;
* History of myocardial infarction (MI), coronary angioplasty, bypass graft(s), valvular disease, unstable angina pectoris, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within 6 months;
* Congestive heart failure (NYHA Class III and IV);
* Uncontrolled hypertension;
* Women of Child Bearing Potential
* History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease, or endocrine disease
Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma

BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.

Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month (cycle). Subjects will take a daily oral dose of BKM-120 at the dose level assigned.

Subjects will have a clinic visit weekly during Cycle 1 and then on Day 1 and Day 15 of each cycle for blood tests and physical exam.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic RCC with clear cell component or papillary RCC
* Life expectancy \> 12 weeks
* Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC

Exclusion Criteria:

* Prior treatment with a P13K inhibitor or bevacizumab
* Untreated brain metastases
* Acute or chronic liver or pancreatic disease
* Major mood disorder
* Concurrent severe and/or uncontrolled medical condition
* Diabetes mellitus
* GI disease
* Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
* Pregnant or breastfeeding
* HIV positive
* History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix
* Uncontrolled hypertension
Real-world Data of Paclitaxel and Ramucirumab Compared to Other Treatment Regimens in Advanced Gastric Cancer

Our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. This study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the Oncology Departments affiliated with the Hellenic Cooperative Oncology Group (HeCOG).


Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus
* Treated at Departments of Medical Oncology affiliated with the Hellenic Cooperative Oncology Group (HeCOG)
* Second-line treatment for advanced disease
* Treatment for at least two months of second-line treatment.

Exclusion Criteria:

* Lack of informed consent in case the patient was alive
Comparative Effects of Variable Pressure Support, NAVA and PAV

Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.

The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.

Cross-over, prospective, randomized controlled monocentric trial . Patients on pressure support ventilation will be ventilated with PSV, NAVA, PAV, and V-PSV (in a randomized sequence).

In each mode the level of assistance will be set to achieve a similar tidal volume of 6-8 ml/kg.

The following data will be measured and recorded: airway flow and pressure, electrical activity of the diaphragm (EAdi), blood gases, electrical impedance tomography, end tidal partial pressure in carbon dioxide (PEtCO2).

Will be calculated: the coefficient of variation (CV, standard deviation (SD)/mean) of the peak pressure (Ppeak), EAdi and of the main descriptors of the breathing pattern, the prevalence of the main patient-ventilator asynchronies, the prevalence of tidal volume (VT) \>10ml/kg, ventrodorsal repartition of ventilation and inhomogeneity index, dead space

Eligibility Criteria:
Inclusion Criteria:

* patient on mechanical ventilation for \>48 h
* estimated duration of mechanical ventilation \>24h
* hemodynamic stability

Exclusion Criteria:

* pregnancy
* impossibility to insert an EAdi catheter
* neuromuscular disease, phrenic nerve lesions
Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

Pupillar diameter variation to predict success or failure of external ventricular derivation clamping.

Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways :

* earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration
* limit the medical imagery prescription and radiation exposition
* avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs


Eligibility Criteria:
Inclusion Criteria:

* Neurologic ICU hospitalization
* Traumatic brain injury
* External ventricular drain

Exclusion Criteria:

* Legal protection
* refusal
* therapeutics limitation
* craniectomy
* pupillar anomaly
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (not pregnant and not nursing)
* Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
* Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
* If taken, background medication must be stable

Exclusion Criteria:

* Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
* Body mass index (BMI) below 18 kg/m\^2 or above 38 kg/m\^2
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)

The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study)

Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open

Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and females, ≥ 18 years of age
* HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
* HCV RNA ≥ 10,000 IU/mL
* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria:

* Prior treatment of HCV with HCV direct acting antiviral (DAA)
* Evidence of a medical condition contributing to chronic liver disease other than HCV
* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
* Diagnosed or suspected hepatocellular carcinoma or other malignancies
* Uncontrolled diabetes or hypertension
Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.


Eligibility Criteria:
Inclusion Criteria:

* Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
* Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
* Age ≥ 18 years
* Written informed consent by patient

Exclusion Criteria:

* Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
* Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
* Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
* Part A only: abnormal routine coagulation test values at baseline (defined by INR \> 1.2, Quick \< 70% or aPTT \> 40 sec)
* History of coagulopathy