cyrilzakka/clinical-trials huggingface dataset:
The Use of Music for Neonates Post-Cardiac Surgery

The purpose of this study is to explore the feasibility of implementing nurse-led music therapy in a cohort of neonates admitted to the Cardiac Intensive Care Unit (CICU) post congenital heart surgery. In the proposed setting, the use of a standardized nurse-led music therapy protocol for post-operative neonates would build upon current successful nurse-led efforts to wean sedatives and opioid use for patients admitted to the CICU. The investigators believe data generated from this exploratory feasibility study may serve to further inform a larger study involving the use of music therapy in the cardiac intensive care.

A predetermined recording of a music playlist meeting the properties of sedative music is being developed in consultation with a Boston Children's Hospital (BCH) music therapist. Properties of sedative music include soothing, stable, constant, and relatively unchanging, slow tempo and light rhythmic emphasis, constant volume and rhythm, lullaby style, repetitious and no separate melody for chorus/bridge. The music recorded for the neonates has been produced specifically for this study. In accordance with the recommendations for soothing music, BCH Music Therapists have recorded English nursery rhymes (Figure 1) in the key of C major at 60bpm with acoustic guitar and voice. The playlist will be stored on an Apple iPod Touch and will be delivered through a Bluetooth speaker that is positioned centrally (so that the sound input is received binaurally) at the subjects head or feet for a period of 20 minutes once during a 12-hour shift for 14 days or until mechanical ventilation has been discontinued, whichever is first.

The literature supports a duration of up to 30 minutes of music therapy followed by at least 30 minutes of silence, with a maximum of four hours per day. Music played for longer than 30 minutes has the potential to be a source of over-stimulation/agitation. There is some evidence to suggest that playing music for long periods of time (two four-hour segments) has a negative effect. In addition, it seems reasonable and likely to assume that the neonate could have a period of 30 minutes when they will not require an intervention associated with post-operative care. The protocol will target a 20 minute playlist. This will allow for variation in the length of songs while ensuring that music will not be played for longer than 30 minutes. There will be at least 30 minutes of quiet between music therapy session.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 37 weeks gestation,
* Between 0 to 30 days of age
* 24 hours post congenital heart surgery
* Receiving mechanical ventilation
* Background noise level (at bedside) at the time of music therapy must be 55dB or less.

Exclusion Criteria:

* Hemodynamically unstable or end of life
* If patient is in a closed Giraffe bed
* Evidence of hearing impairment
* Patient has known or suspected active seizure disorder
Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial

The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.

The main questions it aims to answer are:

* What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?
* What are the changes in absence from work after treatment with HBOT?
* What is the cost-effectiveness of treatment with HBOT?
* What are possible mechanisms of action of HBOT?

Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Cognitive and/or physical symptoms ≥ 12 months after acute COVID-19 infection
* Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by questionnaires and/or NASA LEAN test
* Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical functioning' score of ≤ 50 at baseline).
* Current treatment regimen is stable for at least 1 months before inclusion

Exclusion Criteria:

* Unfit for hyperbaric treatment
* Previous diagnosis of ME/CFS
* Unable to provide informed consent
A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment

This study is designed to determine the effects of a single dose of the study medication in subjects with and without hepatic impairment. 18 to 24 subjects will participate by having multiple blood draws taken to measure the level of study medication in their blood over time.

This study will look at the effect of a single does of study medication in three groups. Each group will have 6 - 8 subjects with similar levels of hepatic impairment. Group 1 will have normal hepatic function. Groups 2 and 3 will be made up of subjects with mild to moderate hepatic impairment. Subjects will have blood taken at specific intervals to measure study medication levels. Subject participation will last approximately 7 to 9 days.

Eligibility Criteria:
Inclusion Criteria:

A total of 18 to 24 subjects will be studied in 3 groups of 6-8 subjects per group. Group 1 will consist of 6-8 males or females with normal hepatic function, 18 to 65 years of age inclusive. Groups 2-3 will consist of 6-8 males or females per group with varying degree of stable hepatic impairment.

Exclusion Criteria:

Any Subject meeting the following criteria must be excluded from the trial:

1. Known history of clinically significant arrhythmias.
2. Acute illness, especially any infection, within 2 weeks of dosing.
3. History or presence of:

   * Alcoholism or drug abuse within the past 2 years.
   * Hypersensitivity or idiosyncratic reaction to compounds related to the study drug or related compounds.
4. Any History of Bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
5. Blood donation or significant blood loss within 56 days prior to Day 1.
6. Plasma donation within 7 days prior to Day 1.
7. Any subject who has participated in a previous clinical trial with VI-0521.
8. Any subject who received an investigational drug within 30 days prior to dosing in this study.
9. Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
10. Serum creatinine \> 1.5 for male subjects, and \>1.4 for female subjects.
11. History of kidney stones in the last 6 months
12. Female subjects, who may be pregnant, or are lactating.
13. Use of any drug that is known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism.
14. Use of tobacco or nicotine products within last 6 months unless subject is hepatically-impaired.
Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA)

based on international guide lines, antibiotic prophylaxis in Orthoaedic major surgery has to be done with a Cephalosporin 1st generation (e.g. Cefazolin 1 g 30' before surgery).

Since more than 10 years ago the investigators started evaluatinf infections in such a surgery, well demosntrating a level below 1% and, more important, a responsability of MRSA. considering Cephalosporin 1st generation useful but not determinat in such a surgery, investigators consider the use of a Glycopepide (Vancocyn 1 g in Very short. The primary outcome is to evaluate the validity of such proposal, performing a study of prevalence.

Patients enrolled in the study have to follow rhese steps:

T0: Clinical evaluation and Cephalosporin VSS prophylaxis, as usual T1: Surgery for TKA or THA T2: Post-operative --\> control and, if an infextion is supposed, Coltural examination and ABG T3: Post-op orthopedic control at 6 months, to evaluate any possible infection T4: Post-op clinical valuation at 12 months, with the same goal

Eligibility Criteria:
Inclusion Criteria:

Patiens male and female, old more than 40 years TKA or THA Surgeryntervento di chirurgia protesica ASAC II or even III, without any acute coexisting disease Informed consent -

Exclusion Criteria:Patients with infection before surgery Immunocompromise patient (e.g. Diabeties with glicate HB indicating a metabolic bad compensation) Patient with coagulation disorders Pregnancy Informed consent denied

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Photodynamic Therapy Incubation Times for Actinic Keratosis

This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.

Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.

This study is a pilot study designed to determine feasibility of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have been diagnosed with actinic keratosis.
2. Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.
3. Males or females ≥ 18 years old
4. Fitzpatrick skin types I-VI
5. Subjects are in good health as judged by the investigator.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion criteria:

1. Subjects who by the investigator are not suitable for photodynamic therapy.
2. Lesions suspicious or proven for skin cancer
3. History of 2 or more ALA- PDT treatments within the past 6 months.
4. Use of keratolytics within 2 days of initiation of treatment (e.g., \>5% urea, glycolic acid, lactic acid, salicyclic acid)
5. Cryotherapy within the past 2 weeks.
6. Topical retinoids within the past 4 weeks
7. Procedures, such as microdermabrasion, ablative lasers, ALA-PDT, chemical peels, 5-fluorouraci, diclofenac, imiquimod within the past 8 weeks
8. Systemic retinoids within the past 6 months
9. Pregnant or breast feeding
10. Uncooperative subjects or subjects with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
11. Subjects who are unable to understand the protocol or give informed consent.
12. Subjects who in the opinion of the investigator are not suitable for the study.
Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis

OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine.

II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.

PROTOCOL OUTLINE:

Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms
Improved Effects of MI Plus Alpha-LA in PCOS

PCOS patients are initially treated with 2 g myo-inositol and 0.2 mg folic acid, two times per day by oral route, for three months. Among them, the subjects who have not ovulated despite this treatment are administered with 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. Most of them improve and achieve ovulation. Therefore, the combination of α-lactalbumin with myo-inositol allows to get a significant result in the treatment of PCOS patients.

Polycystic ovary syndrome is a complex chronic condition inducing several related disorders, such as subfertility and pregnancy complications. So far myo-inositol, successfully used in PCOS, has not been always effective in all patients. Aiming at overcoming this drawback, we tested a new formulation with myo-inositol and α-lactalbumin, in consideration of the effects exerted by α-lactalbumin in favoring molecule passage among body compartments, and also in consideration of its anti-inflammatory activity.

Only PCOS patients, according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility \> 1 year, were included in the study. Following a treatment with 2 g myo-inositol and 0.2 mg folic acid, a part of them are resistant and do not ovulate.

These non-responders to myo-inositol alone undergo the second phase of the study, receiving 2g myo-inositol and 0.2 mg folic acid plus 50 mg α-lactalbumin for three months. After this combined treatment, the majority of them ovulate, showing a hormone and lipid profile improvement. In addition, myo-inositol plasma levels at the end of the treatment are significantly higher than at baseline and comparable to those patients who respond positively to myo-inositol alone.

Eligibility Criteria:
Inclusion Criteria:

* patients affected by PCOS according to Rotterdam ESHRE-ASRM criteria, with anovulation and infertility \> 1 year

Exclusion Criteria:

* presence of other conditions causing ovulatory dysfunction, such as hyperprolactinemia or hypothyroidism, or androgen excess, such as adrenal hyperplasia or Cushing's syndrome, and also in the case of intake of other drugs that can potentially influence the ovulation.
Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Obstructive Sleep Apnea is of increasingly high prevalence.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years diagnosed with Obstructive Sleep Apnea by polysomnography
* Patients with moderate to severe Obstructive Sleep Apnea.
* Patients who have undergone continuous positive airway pressure (CPAP) treatment for at least 3 months but have not achieved satisfactory therapeutic effects
* Patients who voluntarily agree to receive stellate ganglion block (SGB) treatment and sign the informed consent form

Exclusion Criteria:

* Patients with a history of allergy or contraindications to local anesthetics or corticosteroids
* Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases
* Patients with a history of neck surgery or cervical spine disease
* Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of SGB treatment
* Pregnant or lactating women
* Patients who have participated in other clinical trials within the past 3 months
Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index

The purpose of this study is to examine the psychometric properties of a Turkish shortened version of the Western Ontario Rotator Cuff Index (SHORTWORC).

Many of the musculoskeletal diseases that doctors treat every day affect both quality of life and functionality. Rotator Cuff diseases are highly prevalent shoulder disorders associated with pain and functional limitations. Thus, surveys measuring treatment outcomes and activity limitations have become important in clinical research. Such scales can be time consuming or impractical for the patient, depending on the areas they evaluate. For this reason, the development of scales focusing on specific areas facilitates evaluations in the clinical environment. The purpose of this study is to examine the psychometric properties the Turkish SHORTWORC index, which is designed to focus on a single parameter.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-64
* the presence of rotator cuff pathology requiring surgical treatment

Exclusion Criteria:

* Chronic inflammatory diseases
* cervical spine radiculopathy
* different structural shoulder problems in the last three months
* previous surgery and associated additional pathologies requiring stabilization or other major \*surgery such as superior labral repair
* any history of systemic disease
* being an athlete
Efficacy Evaluation of Pitaya Ovule Extract on Skin

To assess the efficacy of Pitaya Ovule Extract on skin


Eligibility Criteria:
Inclusion Criteria:

* 20 to 65-year-old males or females

Exclusion Criteria:

* Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial
* Outdoor workers (exposed to the sun more than 5 hours a day)
* People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
* People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
* People who have undergone major surgery (according to medical history)
* People who take drugs for a long time
* People with mental illness
* Students who are currently taking courses taught by the principal investigator of this trial
Iron Overload in Stem Cell Transplant Recipients

The goal of this study is to examine the impact of iron overload in patients undergoing a bone marrow transplant. We believe that the iron status in these patients is associated with complications for transplant survivors. We will examine the iron status in these patients by MRI and by screening for mutations in genes known to cause iron overload. We will also determine the levels of hepcidin (a hormone produced in the liver that appears to regulate iron homeostasis) from blood and urine.


Eligibility Criteria:
1. Undergoing allogeneic HSCT for malignant or non-malignant conditions
2. Age greater than or equal to 5 years
3. Able to undergo MRI without a need for general anesthesia
4. No metal implants
5. Signed informed consent (by parent if patient is less than 18 years old, or by patient, if he or she is greater than 18 years old).
Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day

Primary Objective:

To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen

The study duration for each patient is 24 weeks +/- 1 week broken down as follows:

* Run-in phase: 8 weeks
* Follow - up Period: 16 weeks

The maximal possible time window during the study is +/- one week throughout the study.

Eligibility Criteria:
Inclusion criteria:

Run-in period:

1. Type 2 diabetes
2. HbA1c≥ 8.5% (in a test of the last month)
3. Age above 21 years
4. Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
5. Signed informed consent form
6. Patients who according to their physician are eligible to the study

Randomization:

1. HbA1c \> 7.5%
2. FPG \< 130 mg/dl

Exclusion criteria:

1. Type 1 diabetes
2. Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
3. Pregnant or breastfeeding women.
4. Patients with allergy to insulin.
5. Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
6. Patients with mobility difficulties and/or difficulties communicating with the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
CPAP Versus HFNO for the Treatment of Acute Hypoxemic Respiratory Failure Due to Community Acquired Pneumonia

the study compares two non-invasive respiratory support modalities ie CPAP and High Flow nasal cannula oxygen for the treatment of severe hypoxemic respiratory failure attributed to Community acquired Pneumonia.

CPAP and High Flow nasal cannula oxygen are two established modalities for non-invasive respiratory support . In COVID pandemic era both CPAP and HFNO were widely used in the ward for the treatment of COVID-19 induced acute hypoxemic respiratory failure in order to prevent progression to intubation. Head to head comparison between the two modalities mentioned for the treatment of severe hypoxemic respiratory failure is not available neither in COVID pneumonia or Community acquired pneumonia (CAP).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age \>18 year old.
* Been hospitalized with community acquired pneumonia
* hospitalized in common ward (not ICU)
* Patients should have pneumonia- pulmonary infiltrates in chest-xray and hypoxemic respiratory failure.
* Patients should be unable to keep: SpO2\>93% with FiO2 50%, or SpO2 95% with FiO2 50% and have evidence of respiratory distress defined as Respiratory rate -RR\>35/min

Exclusion Criteria:

* Need for immediate or imminent intubation
* not fit for escalation of treatment: defined as intubation, mechanical ventilation and ICU support.
* Pregnant women
* Contraindication to CPAP or HFNO
Protein Top-up Acceptability Study for Patients With Increased Protein Needs

The aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.

Increased protein needs are frequently observed in disease and can be difficult for patients to achieve where oral food intake is compromised.Where a standard ONS or enteral tube feed cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie, low volume, ready to use, high protein liquid may help meet protein needs while preventing caloric overfeeding.

40 patients will be recruited in an attempt to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs. After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake with their currently prescribed nutritional regimen, each patient will receive the high protein liquid feed daily for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older.
* Patients under the care of a Dietitian requiring oral or enteral nutritional support, with -increased protein needs.
* To receive a minimum of 1 x 40ml HPLM daily (orally or via enteral tube) while on the study.
* Informed consent obtained from the patient

Exclusion Criteria:

* Total parenteral nutrition (100% of requirements).
* Patients with major hepatic dysfunction (i.e. decompensated liver disease).
* Patients with major renal dysfunction (i.e. requiring filtration or Stage 4/5 chronic kidney disease (CKD)).
* Participation in other studies within 1 month prior to entry of this study.
* Patient with severe lactose intolerance.
* Pregnant or lactating.
* Patient lacks capacity to consent for themselves.