cyrilzakka/clinical-trials huggingface dataset:
Musical Training to Enhance Resilience in Children From Low-income Families

Child poverty is a prominent global health issue owing to its detrimental impact on a child's physical and psychosocial well-being. Nearly 356 million children lived in extreme poverty globally before the pandemic and this is estimated to worsen significantly. children growing up in poverty are more vulnerable to its effect and have an increased risk of psychosocial and developmental problems than children from affluent families. The impact of poverty is not only immediate during childhood but can persist into adulthood. Previous studies have shown that Chinese children from low-income families reported significantly higher levels of depressive symptoms, lower levels of self-esteem, quality of life, and life satisfaction than children from affluent families.

Recent studies have revealed the promising effects of musical training to promote psychological well-being among children and adolescents and paediatric brain tumour survivors, improving psychosocial skills of children with autism, to enhance the quality of life and psychological health by promoting positive emotions and cognitive and social development.

Promoting the psychological health of school-aged children from low-income families through enhancing their resilience has received limited research attention. Additionally, there is a lack of intervention studies to promote resilience in school-aged children from low-income families. This proposed research, therefore, aims to conduct a pilot randomised controlled trial to determine the feasibility, acceptability and preliminary effects of a musical training programme in enhancing resilience and self-esteem, reducing depressive symptoms and improving the quality of life among children from low-income families.

The findings from the study could inform the policymakers and healthcare professionals in health services design and the importance of advocating the psychological needs of children from low-income families by providing adequate community resources and support. If the programme demonstrates its effectiveness in promoting resilience and self-esteem among children from low-income families, further implementation could be done to maintain its sustainability in the community. Most importantly, the programme may potentially enhance the resilience of the vulnerable children from low-income families to combat poverty and hence break the intergenerational transmission of poverty.


Eligibility Criteria:
Inclusion Criteria:

* Chinese children aged between 8-12 years
* able to read Chinese and communicate in Cantonese
* from low-income families, that is, less than half the median monthly household income or recipients of Comprehensive Social Security Assistance

Exclusion Criteria:

* children who are currently receiving or had received musical training before the study
* children have chronic diseases, cognitive and learning difficulties
Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions. The ability to monitor ICP is a crucial aspect in the management of these patients. Currently, the diagnosis of whether ICP is elevated or not is determined either with clinical signs (headache, nausea and vomiting or visual disturbances) or from the changes in the preoperative neuroimaging modalities such as computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).

Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD).

The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP.

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions. The ability to monitor ICP is a crucial aspect in the management of these patients. Currently, the diagnosis of whether ICP is elevated or not is determined either with clinical signs (headache, nausea and vomiting or visual disturbances) or from the changes in the preoperative neuroimaging modalities such as computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).

Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD).

The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP.

Eligibility Criteria:
Inclusion Criteria:

* Intracranial pathology patients scheduled for elective or emergency surgery.
* American Anesthesiologist Society physical status classification system (ASA) 1-4

Exclusion Criteria:

* history of Glaucoma,
* previous retinal surgery,
* optic neuritis,
* lack of informed consent,
* pregnancy
Study to Identify the Genetic Variations Associated With Phantom Limb Pain

The purpose of this study is to determine if there is a genetic component to phantom limb pain. DNA will be analyzed for single nucleotide polymorphisms (SNPs) between the control and phantom limb pain group. Total RNA will also be isolated and profiled to asses the degree to which our gene(s) of interest are expressed in the presence or absence of phantom limb pain. Some proteins, such as inflammatory antibodies or the neurotrophin brain-derived neurotrophic factor (BDNF), will also be assessed for their association(s) with phantom limb pain.

Most patients (90-95%)with major limb amputations experience a phantom limb--the vivid impression that the limb is still present. In many cases, the sensation is painful for reasons that are currently not well understood. A small subset of amputees (\<10%) never experience phantom limb pain (PLP), the painful sensation felt in the amputated limb. This difference suggests that there may be a genetic component that precludes some patients from ever experiencing PLP. Understanding the genetic components of PLP may help in predicting which patients will experience PLP and which amputees will respond to the various treatment options available.

In order to understand the genetic aspects and ultimately develop more effective treatment options in the future, patients with and without PLP will be asked to give 30 mls of blood after overnight fasting. These blood samples will be de-identified and sent to the National Institutes of Health (NIH) in Bethesda, Maryland, where all of the genetic analyses will take place.

Eligibility Criteria:
Chronic PLP Group:

* At least 18 years of age.
* Written informed consent and written authorization for use or release of health and research study information
* Single or multiple upper and/or lower limb amputation
* At least three months post-amputation
* Ability to follow study instructions and likely to complete required visit(s)
* Experienced PLP for at least one month and at least 3 times per week
* Phantom limb pain differentiated from residual limb pain by physical exam.
* Subjects taking blood thinners or other medications that do not increase risk during a blood draw.

Non-Chronic PLP Group:

* At least 18 years of age.
* Written informed consent and written authorization for use or release of health and research study information
* Single or multiple upper and/or lower limb(s) amputation
* At least three months post-amputation
* Ability to follow study instructions and likely to complete required visit(s)
* Experienced PLP less than 10 times total and/or for less than two weeks
* Subjects taking blood thinners or other medications that do not increase risk during a blood draw.
The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet

Primary aim: Demonstrating the effect of carnitine supplementation on lipid profile and cardiovascular functions in patients with DRE on KD.

Secondary aim: To highlight the effect of carnitine supplementation on efficacy of KD in seizure control.

The KD, a strict diet high in fat and low in carbohydrates, increases the ketone body concentrations that could lead to an enhancement of inhibitory neurotransmission and thereby possibly reducing the seizure frequency (Seo et al., 2007).

Carnitine plays a major role in the degradation of fatty acids. As a trimethylated amino acid, it facilitates translocation of fatty acids into the mitochondrion and is therefore an essential cofactor in fatty acid oxidation and ketogenesis (Longo et al., 2016).

Carnitine transports dietary fat to the mitochondria to be oxidized into ketones, which are used for energy when sufficient carbohydrate is not available (Coppola et al., 2006; Mcnally \& Hartman, 2012).

Levocarnitine can improve cardiac function effectively through improving albumin, high sensitivity CRP, Brain natriuretic protein, troponin, and left ventricular end diastolic dimension (Zhao et al., 2020).

Due to the high fat intake, children following KD may have an increased demand for carnitine and therefore, may be at an increased risk for carnitine deficiency (Neal EG et al.,2008).

Although total carnitine decrease over the first few months of KD treatment, and in some patients, dip into the deficiency range, it then normalizes with no evidence of a continued decline (Berry-Kravis et al., 2001; Coppola et al., 2006).

Few studies was performed to evaluate carnitine effect in epileptic children and adolescents treated with old and new antiepileptic drugs with or without ketogenic diet Coppola et al., 2006).

The KD is mostly associated with Gastrointestinal (GI) disturbances, such as nausea, vomiting, diarrhea, and constipation, also were frequently noted, sometimes associated with gastritis and fat intolerance (Armeno et al., 2018).

Eligibility Criteria:
Inclusion Criteria:

- All aged from 1 month till 16 years old with DRE on KD.

Exclusion Criteria:

* Patients who are already on KD and carnitine supplements.
Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis

Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Traditionally, in Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.

The objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis.

Study design: 30 systemically healthy volunteers will be randomly allocated into two arms

Arm A: Lotus leaf mouth wash (aqueous) group \[Test group\] Arm B: Placebo mouth wash group \[Control group\]

All the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. Clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. All the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. All volunteers were recalled on 5th day for clinical and microbiological analysis. Statistical analysis and results are awaited

Eligibility Criteria:
Inclusion Criteria:

1. Subjects willing to comply with the study protocol \& instruction.
2. Clinically diagnosed with chronic gingivitis.
3. No history of allergies to herbal formulations.
4. No history of periodontal therapy within the previous 6 months.
5. No history of antibiotic therapy within the previous 6 months.

Exclusion Criteria:

1. Any systemic diseases
2. Use of tobacco or tobacco related products
3. Pregnant woman and lactating mothers
4. Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.
Which Analgesia is Better for Proximal Femoral Fractures?

This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes.

Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.

The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery.

Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control.

A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.

The ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I, II and III.

Exclusion Criteria:

* Patient refusal.
* Neuromuscular diseases
* Hematological diseases
* Bleeding abnormality
* Coagulation abnormality.
* Psychiatric diseases.
* Local skin infection at the site of the block.
* Local skin sepsis at the site of the block
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Multiple trauma patients.
Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer

The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.

Phase II, open, not randomized clinical trial, to evaluate the sequential Taxotere®, followed by Myocet® and Cyclophosphamide first line treatment in her2 negative breast cancer patients.

The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Brest adenocarcinoma stages II/III
* Female
* Informed consent signed
* HER2 negative
* Age\>18 years old
* ECOG \< 1
* Proper organic function regarding the following criteria:

  1. ANC \> 2,0 x 109L, platelets \> 100 x 109L and hemoglobin \> 10g/dL (transfusion is allowed)
  2. Hepatic Function:

  i.Bilirubin \< 1,5 x UNL ii.AST ,ALT \< 2,5 x UNL iii.Alkaline phosphatase \< 5 UNL iv.Patients with AST and /or ALT \> 1.5 x UNL and alkaline phosphatase \> 2.5 x UNL will not be selected for the study c.Renal function: creatinine \< 1,25 x UNL, or creatinine clearance \> 60 mL/min d.Normal Cardiac function, confirmed with FEVI \>50% and electrocardiogram.
* Patients should be available for treatment and follow up and must be treated in investigator or co-investigator site
* Negative pregnancy test(performed 7 days before treatment)

Exclusion Criteria:

* Previous treatment for breast cancer (CT, RT, IT, HT)
* Stages IIIb, IIIc or IV or invasive bilateral breast cancer
* Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel)
* Pregnant or breastfeeding females
* Neurotoxicity Grade 2
* FEV≤50% or any cardiac disease in which anthracyclines are contraindicated
* Other severe diseases regarding investigator criteria
* Any neurological or psychiatric pathology
* Previous neoplasia different from breast cancer except:

  1. skin cancer(no melanoma)
  2. In situ cervix Carcinoma
  3. Ipsilateral in situ ductal carcinoma
  4. In situ lobular in situ carcinoma
  5. Any other carcinoma without evidence disease in last 10 years
* Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (\* 20 mg methylprednisolone or equivalent)
* Concomitant treatment with Hormone ovarian replacement therapy
* Contraindication for corticoids
* Concomitant treatment with another investigational drugs
* Included in another clinical trial with any drug in 30 days before inclusion study
* Concomitant treatment with another anticancer therapy
* Male patients
* Hypersensibility to any study drug or components
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

In this project, the investigators will realize an observational, prospective, multicentric and international clinical trial, to objectively compare patients with SSCC according to 3 arms of treatment:

* Arm 1: Radiotherapy ± chemotherapy
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

The main goal is to evaluate the efficacy of each treatment with four classes of outcomes:

* The quality of life (QoL) before and after each treatment option, using validated questionnaires
* Oncological outcomes
* Functional outcomes
* Economical Resources

The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SSCC (with histological confirmation)

  * cT1-T2 / cN0-N1/ M0 according to 8th TNM classification (UICC/AJCC)
  * WITH a Multidisciplinary Tumor Board decision according to the NCCN or European guidelines
* Diagnostic imaging (Head and neck and pulmonary CT or PET/CT, +/- IRM if needed) realized within 1 month before the study inclusion
* ≥ 18 years old and able to provide an informed consent
* ECOG/WHO performance status ≤ 2

Exclusion Criteria:

* - Previous radiotherapy +/- chemotherapy treatment of the head and neck region
* Previous history of head and neck cancer within 5 years
* Prior invasive malignant disease unless disease-free for at least 5 years or more, with exception of non-melanoma skin cancer
* Non-supraglottic or unknown primary site
* Clinical and radiological signs of nodal extracapsular extension
* Significant trismus (maximum inter-incisal opening ≤ 35 mm)
* Pre-existing dysphagia not related to the cancer or the biopsy (from neurological disorders for example)
* Unable or unwilling to complete Quality of Life questionnaires
* Serious medical comorbidities or contraindication for surgery and/or radiation
* Pregnancy and lactation
Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention

Participants included in SCAPIS2 (Swedish Cardio Pulmonary bioimage study) are screened regarding swallowing difficulty using a timed water swallow test. Participants who show signs of swallowing difficulty (dysphagia) are included in the present study, which encompasses s flexible endoscopic evaluation of swallowing function (FEES). Participants showing a moderate-severe dysphagia are randomized into one of three intervention groups: muscle strengthening training, skill-based swallowing training and a control group who will receive compensatory treatment. The study is expected to improve diagnostics and treatment of swallowing difficulties in an ageing population.


Eligibility Criteria:
Inclusion Criteria:

* Participation in SCAPIS2
* Swallowing dysfunction according to timed water swallow test or
* Swallowing dysfunction according to self-report

Exclusion Criteria:

* Severely impaired intellectual abilities.
* Inability to consent to inclusion in the study.
* Inability to answer written questionnaires in Swedish

Inclusion of non-dysphagia control cohort: No signs of aspiration, slow swallowing (\&lt;10 ml/sec) or self-rated difficulties with eating and swallowing in sub-study SCAPIS2
Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients

The aim of this study is to investigate comparison of preemptive analgesic effects of dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal hysterectomy.

Abdominal hysterectomy is associated with moderate to severe postoperative pain which has unfavorable effects on patient's recovery and procedure's outcome. Administration of opioid analgesics is routinely practiced but is limited with dose-related adverse effects.\[1\] Within this concept, combining an opioid with different analgesics acting by different mechanisms as multimodal analgesia is recommended for effective post-operative pain control Dexketoprofen trometamol is a newly developed, centrally acting NSAID with potency similar to that of μ-opioid agonists.\[4\] In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability.

Dexmedetomidine is a highly selective α2 adrenoceptor agonist that provides sedation, analgesia, and sympatholysis. These characteristics make dexmedetomidine useful anesthetic adjunct during operation. Previous studies report that intravenous has a definitive role in postoperative analgesia through the reduction of opioid consumption The aim of this prospective randomized, double-blind study is to evaluate the analgesic efficacy and opioid sparing effects of preemptive single dose of dexketoprofen trometamol in comparison with dexmedetomidine in the patients abdominal hysterectomy , over a 24-hour (h) investigation period.

After institutional approval and informed consent had been obtained, 60 patients scheduled for abdominal hysterectomy randomly allocated into two equal groups. Patients received ıv dexketoprofen 50 mg (Group I), ıv dexmedetomidine 1mcg/kg (Group II) after anesthesia induction and 10 minutes (min) before surgical incision. Patient controlled analgesia was supplied postoperatively using morphine. Hemodynamics, visual analogue scale (VAS), sedation score, morphine consumption, and side effects were recorded every and at 2, 6, 12 and 24 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18- 65 year female
* Scheduled for elective abdominal hysterectomy
* No known allergies to drugs
* ASA I-II patients

Exclusion Criteria:

* Pregnancy
* Drug or alcohol abuse
* History of allergic reaction to any of the study drugs
* Ongoing opioid, and non-steroidal anti-inflammatory
* Analgesic therapy
* Cardiac, respiratory, hepatic and/or renal failure
* History of peptic ulcer disease