cyrilzakka/clinical-trials huggingface dataset:
The Effects of the Maternal Voice Combined With Lullaby to Reduce the Heel Puncture Pain in Preterm Infant

In Taiwan, 183,254 newborns were born in 2018, with preterm births accounting for about 8-10%. The preterm infant required frequent medical treatment from birth to hospital discharge, which is accompanied by a painful process that can cause unstable vital signs in the short term and may affect their biological and psychological development in the long term. Music therapy is a non-invasive and easily accessible intervention, can be used to reduce the discomfort of painful stimulation during hospitalization of preterm infants. Music therapies in this text are the mother's voice and lullabies.

This study was a quantitative study of a randomized controlled trial, designed by experimental research method, and followed the principle of Allocation Concealment to conduct a randomized assignment trial. Using G\*Power 3.1 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size is 120.

The subjects were divided into four groups, all four groups were administered general routine care, three experimental groups, and one control group, and the experimental group was a repetitive segment of audio recording edited to 13 minutes. There were three interventions: group A maternal voice reading children's books, group B lullaby, group C maternal voice reading children's books combined with lullaby, and the control group was the routine care group without any audio intervention. Physiological indicators, including heart rate, respiratory rate, oxygen saturation, and pain response assessed using the Neonatal Infant Pain Scale (NIPS), were recorded 3 minutes before, during, 1st, 3rd, and 10 minutes after heel lance puncture.

Eligibility Criteria:
Inclusion Criteria:

1. Babies born alive before 37 weeks of pregnancy.
2. Infants who were required to receive heel lance procedure every 8 hours after physicians' diagnoses.
3. Those who can record the mother's voice and whose mother can read Chinese.

Exclusion Criteria:

1. Abnormal ear appearance, chromosomal abnormalities, congenital or acquired infections.
2. Postnatal patients whose mothers are not in the postnatal ward, e.g., those who need to be admitted to the intensive care unit due to their medical condition.
3. Patients used high-frequency oscillatory ventilators, because the high-frequency oscillatory ventilator gives 600 oscillatory breaths per minute and it is not possible to evaluate whether the study subjects can effectively listen to the interventions given, so they were excluded.
4. Mothers who were unable to complete the recording because of emotional ups and downs during the recording process.
5. Mothers who smoked, drank alcohol or used illegal drugs during pregnancy.
6. the patients was diagnosed with Asphyxia of the newborn at birth
7. Painkillers used within 2 days of birth.
Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses

A wide variety of superficial soft tissue masses may be seen in clinical practice. Superficial soft tissue masses can generally be categorized as mesenchymal tumors, skin appendage lesions, metastatic tumors, other tumors and tumor-like lesions, or inflammatory lesions. The investigators will use doppler ultrasound in evaluation of superficial soft tissue masses characterization.

There are many examples for these benign superficial soft tissue lesions as lipoma, ganglion, Baker's cyst, giant cell tumor, lymphangioma, hernia, abscess, epidermoid cyst, hematoma, muscle rupture, glomus tumor, fibromatosis, lymphadenitis hemangioma, exostosis, fibroma, neurofibroma and schwannoma. Malignant lesions also could be seen as lymphoma, metastasis, osteogenic sarcoma, liposarcoma , leiomyosarcoma, rhabdomyosarcoma and synovial sarcoma.

Nowadays, High resolution ultrasound has a high sensitivity in detecting superficial soft tissue masses through the grey-scale grading that compose an image range from pure black at the weakest intensity to pure white at the strongest that can be used to evaluate its structure, some aspects of its function and to determine the nature of a mass lesion (cystic or solid) and with Doppler ultrasound which is an excellent imaging modality to determine the vascularity of superficial soft tissue masses that can be characterized in terms of their echogenicity, margin, shape, composition, acoustic transmission, size, the grading of color Doppler ultrasound , and resistive index in spectral Doppler as spectral Doppler will be applied in lesions with positive color flow signals.

Eligibility Criteria:
Inclusion Criteria:

* Patients in different age groups with superficial soft tissue lesions

Exclusion Criteria:

* If the patient undergo previous operations at the same mass that could change the criteria of that mass or if the mass is recurrent at the same site.
The Correlation of Periostin and Renal Pathology in Chronic Kidney Disease Patients

The purpose of this study is to determine the location of periostin and urine periostin level in patients with lupus nephritis and IgA nephropathy.

Total of 50 lupus nephritis and IgA nephropathy patients who met the inclusion criteria were included in this study. The information sheet and informed consent will be obtained before collecting the patient's data. All patients were interviewed for collecting demographic data and laboratory testing were reviewed from patient's record. Kidney tissue and urine sample were collected at the biopsy date from patients.Kidney tissue were stained with hematoxylin and eosin (H\&E), Masson's trichrome solution and immunohistochemistry for periostin. The location of periostin staining in kidney tissue were assessed by renal pathologist.

The total of 50 urine samples from patients and 50 urine samples from healthy controls were measured for periostin level by enzyme-linked immunosorbent assay. The Mann-Whitney rank-sum test was used for comparing urine periostin level between patients and healthy controls and also other variables between patients with urine periostin detection and without urine periostin detection. Spearman correlation coefficients were used test correlations between urine periostin level in patients and other variables. Receiver operating characteristic curves was generated to calculate the area under the curve and find the best cutoff value of urine periostin level for distinguishing patients from healthy controls. P-values \< 0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* at least three glomeruli obtained at biopsy

Exclusion Criteria:

* Patients with urinary tract obstruction
* Patients with urinary tract infection
* Patients with kidney transplant
* Patients with cancer diseases
* Patients with asthma
* Patients with advanced heart disease
* Pregnancy and lactation
Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery

the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery

the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.
* underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.

Exclusion Criteria:

* Patients with distended abdomen due to bowel obstruction.
* Patients with uncorrected coagulopathy.
Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021

Out-of-hospital cardiac arrest rate is common problem, because of high mortality rate. It is not clear incidence rate, epidemiology and outcomes in Lithuania and Kaunas city included.

This data reported according to UTSTEIN guidelines could be compared with other countries from the region although not much data is available, but it will be a baseline for future references about processes in patient management, demographics, incidence rate and OHCA outcomes.

Eligibility Criteria:
Inclusion Criteria:

* OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel were included.

Exclusion Criteria:

* obviously dead patients, were excluded
The Effect of Education on Decreasing the Prevalence and Severity of Neck and Shoulder Pain

Neck and shoulder pain (NSP) is fairly common among high school students in Korea. Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an inappropriate static position for a prolonged period of time. We suspect that proper education and posture correction for Korean adolescents may decrease the prevalence or severity of NSP. Although several studies have focused on the etiology of NSP during adolescence, few studies have addressed the management or prevention of NSP in adolescents, despite its high prevalence in this age group. The aims of this prospective study was to identify the effects of education, in terms of recognition of this issue and posture correction, on prevalence and severity of NSP in Korean adolescents


Eligibility Criteria:
Inclusion Criteria:

* high school students

Exclusion Criteria:

* deny to participate
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer

RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer.

PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer.

OBJECTIVES:

Primary

* Compare the efficacy of hyperbaric oxygen (HBO) therapy vs standard management, in terms of reduction of lymphedema, in patients with chronic arm lymphedema after radiotherapy for cancer.

Secondary

* Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6 weeks.
* Arm II: Patients receive standard management. Patients are followed at 3, 6, 9, 12, and 15 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 63 patients (42 for arm I and 21 for arm II) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* History of early breast cancer (T1-3, N0-1, M0)
* Prior breast surgery with or without axillary dissection
* Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago
* Arm lymphedema

  * At least 15% increase in arm volume
* No evidence of cancer recurrence
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Over 18

Sex

* Female or male

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Pulmonary

* No chronic obstructive airway disease
* No bullous lung disease
* No acute or chronic pulmonary infection
* No uncontrolled asthma
* No untreated pneumothorax

Other

* Physically and psychologically fit for HBO therapy
* No claustrophobia
* No epilepsy
* No eustachian tube dysfunction
* No recurrent attacks of vertigo
* No contraindication to MRI (e.g., intracranial ferrous material)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* See Disease Characteristics
* No prior ear operations

Other

* No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness
Rhomboid Block,erectör Spiane Block, Thoracotomy

Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy.

Although thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In recent years, with the effective use of ultrasonography, different regional anesthesia methods have been developed to prevent such complications

A total of 75 patients will be included in the study in three groups: group ESPB, group RIB and control group (group K). Under general anesthesia, patients who will undergo both ESPB and RIB will be applied block with a 22 G and 100 mm block needle, accompanied by ultrasonography, and 20 ml 0.25% bupivacaine. Apart from the standard peroperative analgesia protocol applied to all three groups, no additional procedure will be performed in group control. Postoperative analgesic consumption amount, first analgesic requirement time and visual analog scale (VAS) values of the patients will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-75 years old
* ASA1,2,3 group patients
* Patients undergoing thoracotomy under general anesthesia

Exclusion Criteria:

* The patient's refusal to participate in the study
* Allergy to local anesthetics
Safe Excipient Exposure in Neonates and Small ChildreN

The purpose of this study is to explore the quantity of excipient exposure in neonatal and young pediatric patients in a Danish Hospital. The focus will be on the preservatives ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame, glycerol and sorbitol.

Studies have previously examined whether or not neonatal nor pediatric patients are exposed to excipients and what excipients they are possibly exposed to. They have shown that practically all neonatal patients receive one or more drug containing an excipient, known to be harmful. This observational study will look at both registered drugs and extemporaneous pharmaceuticals as possible sources of excipients. Based on information provided by the manufacturer (ex. the index-list), the investigator will calculate the amounts of excipients administered to the patient a week after hospitalisation. The investigator will calculate the blood alcohol content when the neonatal patient are exposed to ethanol and/or propylene glycol.

By grouping the patients according to age and subgrouping according to diagnosis/affected organ system and compare the amount of excipient exposure in each group, the study aims at identifying the most vulnerable neonatal and/or pediatric patients in terms of the amount and identity of excipients accumulated in the patient.

The study will use a descriptive, parametric statistic analysis to identify

* an average exposure rate (concentration i mg/l or amount in mg) of each of the listed excipients
* how much the average patient in each age-group is exposed to each excipient
* how much the average patient in each "affected organ system"-subgroup is exposed to each excipient

Eligibility Criteria:
Inclusion Criteria:

* if \< 28 days: must receive 2 or more prescriptions a day
* if 28 days ≤ 5 years: must receive 3 or more prescriptions a day
* must have been/be submitted and treated at the neonatal department (units 5021, 5023, 5024) or pediatric department (units 5061, 5062, 5054, 4144) of Rigshospitalet

Exclusion Criteria:

* no up-dated weight is listed
* \> 5 years old
Comparison of Isometric and Isotonic Strengthening Exercises in Chronic Neck Pain Patients.

Study will be a Randomized clinical trial to check the effects of isometric and isotonic strength training exercises on patients with chronic neck pain. The data will be collected in a hospital setting where patients of chronic mechanical neck pain will be screened out for the fulfillment of eligibility criteria of this study. After being eligible for this study their baseline outcome measures will be measured using Numeric pain rating scale, neck disability index, goniometer, dynamometer and short form 36 survey. Then they will be divided into two groups namely group A receiving isometric exercises with conventional treatment and group B receiving isotonic exercises with conventional treatment. Here conventional treatment includes thermotherapy, manual mobilisation of cervical and thoracic and trigger point therapy which will be a common treatment for both groups. The outcome measures will be measured later at 4th,8th and 12th week.

Chronic neck pain is a burden to health globally and is the major reason behind years of disability. This is due to the higher prevalence, persistence and recurrence.It is a frequent reason for visit to physical therapist or a physician. It is the major health concern for society these days with highest recurrence rate combined with its chronicity. The overall worldwide prevalence for it is 16.7% to 75.1%. There is scarce knowledge of use of isotonic neck muscles strengthening in clinical trials. Moreover the literature has not satisfied the long term effects of isometric and isotonic strength training exercises of cervical muscles on improving the health related quality of life and restoring the normal function of cervical spine.

The findings of current study will help to establish long term effects of isometric and isotonic strengthening exercises on pain, strength, function and quality of life in chronic mechanical neck pain patients.

Neck strength training exercises have shown to reduce neck muscle injuries in sports.Neck strength training has also proved beneficial in reducing neck pain as part of training.

The static muscle contractions of neck muscles of patient being seated with the resistance of palm of physiotherapist being standing will be performed in six cervical movements i.e. flexion, extension, right lateralflexion, left lateral flexion, right rotation, left rotation.

The dynamic muscle contractions of neck muscles will be performed using thera-band for resistance tied on the wall for all six movements of cervical spine.

Eligibility Criteria:
Inclusion Criteria:

* No discrimination against gender
* Age group 25-55 years
* Complain of chronic mechanical neck pain for more than 3 months

Exclusion Criteria:

* Spinal cord injury
* Malignancy
* Cervical fracture
* Any bony or soft tissue systemic disease
* Ankylosis spondylitis
* Craniovertebral disorders
* Any cervical deformity
Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients

Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic NF1 patients
* aged 0-17y and 11 months

Exclusion Criteria:

* clinical heart failure,
* history of cardiovascular disease
* chronic renal insufficiency
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
* Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 \>12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
* Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
* Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.

Exclusion Criteria:

* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
* Pregnant or breast-feeding women.
* Women of child-bearing potential not using or not willing to use highly effective contraception.
* Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
* Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
* Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
HMO Research Network CERT: Acute Myocardial Infarction

The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings designed to increase patient's adherence to prescribed beta-blockers following an acute myocardial infarction (AMI).

Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an acute myocardial infarction (AMI) to identify the issues and information that patients felt were important to include in our materials as well as the best way to present the information. Additionally, patient materials were "pre-tested" with AMI patients to ensure that the materials were clear and easy to read and that the key messages were understood.

Specific Aims:

1. Assess the persistence of beta blocker use for post-acute myocardial infarction (AMI) patients following a direct to patient intervention designed to increase rates of evidence-based long-term use of medications (beta blockers, lipid lowering agents, aspirin and ACE inhibitors) that increase survival following AMI.
2. Describe patient and system characteristics associated with differences in impact of the intervention

Research Design and Methods:

We will conduct a randomized controlled trial within the 4 participating HMOs (Kaiser Permanente Northwest, Harvard Pilgrim Health Care, Health Partners, and Kaiser Permanente Georgia). Inpatient data will be used to identify patients with a primary discharge diagnosis of AMI 4-6 months before the extraction date. Practices will be block-randomized to the intervention group or to usual care. To increase repetition of the message, there will be two personalized mailings, occurring at 4-6 months post AMI, and at 9 months. The first message will include elements in the table below, and the repeat message will be shorter, but include similar information. The message will come from the patient's own health plan with the choice of specific individual (e.g. quality assurance department, medical director, or Chief of Cardiology) being informed by our qualitative work. This intervention will be done in collaboration with the cardiovascular care committees and quality assurance departments of participating Health Maintenance Organizations (HMOs).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute Myocardial Infarction (AMI) from 12/1/03 to 5/31/04
* Beta-blocker dispensing following AMI
* Beta-blocker dispensing prior to intervention date

Exclusion Criteria:

None