cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Parent-child Sleep Intervention

Background: Parents of healthy neonates commonly face sleep disruptions and disturbances after delivery. Notably, increasing challenges are evident among parents of ill infants who required clinical care after birth . These challenges can adversely affect psychological adaptation and parental efficacy which consequently impacting the infant's development. It is crucial to develop an effective parent-child sleep intervention for improving parent-infant sleep and mental well-being and uneventful family health outcomes.

Aim: To develop and evaluate the effects of parent-child sleep intervention on improving sleep quality, psychological health, and infant health in parents of infants at intermediate care nursery.

Methods: A randomized controlled trial will be conducted at the intermediate care nursery of a level III medical center at Taipei city. A total of 102 pairs of parents and infants will be recruited and randomly assigned to the experimental group or the control group. The intervention program consists of (1) parent-child sleep education, (2) heart rate variability biofeedback training, and (3) counseling and support. Data collection will be multiple time points, including baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum.

Anticipated results: Developing and evaluating a parent-child sleep intervention for postpartum parents and their infants. The findings will be an empirical evidence for pediatric care and family health promotion.

The following measures will be used, including Insomnia Severity Index, Pittsburgh Sleep Quality Index, Brief Infant Sleep Questionnaire-Revised short form, Parental Efficacy Scale, State-Trait Anxiety Inventory, Infant Health Outcome Questionnaire. Objective data included actigraphy, and heart rate variability. Data will be analyzed using descriptive statistics and One-Way repeated measure ANOVA to examine the effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women aged 18 years or older.
* Postpartum women with a singleton pregnancy, and the gestational age of their infant is at least 32 weeks.
* Postpartum women with a severe insomnia severity index score of ≥8 points.
* Postpartum women and their husbands or partners capable of reading, understanding, and communicating in Mandarin.
* Postpartum women and their husbands or partners with internet access and the ability to operate resources using a smartphone, tablet, or computer.
* Both postpartum women and their husbands or partners are willing to participate in the research process.

Exclusion Criteria:

* Postpartum women diagnosed with Insomnia Disorder, Anxiety Disorders, or Depression.
* Postpartum women suffering from arrhythmia or cardiovascular diseases.
* Postpartum women working in shifts.
* Infants with congenital abnormalities, neurological impairments (such as hydrocephalus, periventricular leukomalacia), requiring the use of tubes or respirators after discharge, or using medications that might affect sleep (such as caffeine, sedatives, muscle relaxant, anti-epileptic drugs, or pain medications).
Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder

Medical treatment for overactive bladder is acceptable widely. However, the effect of drug treatment is different due to compliance and side effect of the drug. Biofeedback-assisted pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder. The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation for continuous treatment and results in compliance difference. This slow effect also changes the degree of improvement in the treatment of overactive bladder. This study is designed to evaluate the efficacy of combination therapy for treatment of female overactive bladder.

Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) for the first month. Participant will continue to have biofeedback assisted PFMT for another two months without oral medication. The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

1. overactivity bladder for more than 3 months
2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
3. need to match schedule with the investigator's clinic for 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises

Exclusion Criteria:

1. Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
2. Glaucoma
3. Kidney disease
4. Liver disease
5. Patients with cardiac rhythm devices.
6. Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises.
7. Women during pregnancy.
8. Maternity within six weeks after delivery
Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately reduce cancer patients' financial toxicity associated with cancer care.


Eligibility Criteria:
Eligibility criteria for I Can Pic Arm only:

Inclusion Criteria:

* 18 years of age or older
* Must have been diagnosed with colorectal cancer, lung cancer, or gynecologic cancer \< 5 months ago and be patients of one of the 15 providers
* This cancer diagnosis must be the first and primary diagnosis

Exclusion Criteria:

* Not able to read and understand English
* Cannot give informed consent due to cognitive or emotional barriers
A Clinical Trial of YMC017 in Hypertensive and Hypercholesterolemic Patients With Metabolic Syndrome

This is a Randomized, open-label, 2 groups, parallel design.

This study objective is to compare the safety and efficacy between fixed dose combination (Duowell® tab) and free pill combination therapy of Telmisartan and Rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 19 and 79 years old at screening visit
* Subjects who have being used anti-hypertension drugs and Lipid lowering agents over 4weeks before randomization.
* Subjects who have been diagnosed with metabolic syndrome according to following criteria Definition of patients with metabolic syndrome: Patients satisfy two of the following criteria at least

  * Abdominal obesity: Waist measurement \> 90 cm(male), \> 80 cm(female)
  * Triglyceride(TG) ≥ 150 mg/dL(
  * High-Density Lipoprotein Cholesterol(HDL-C) \< 40 mg/dL(male), \< 50 mg/dL (female)
  * Fasting Plasma Glucose(FPG) ≥ 100 mg/dL or Subject who has being used oral hypoglycemic agents
* Childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state)
* Subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough.

Exclusion Criteria:

* Subjects who taking anti-hypertension drugs more than three agent
* Subjects who have mean Sitting Systolic Blood Pressure(siSBP) \> 160 mmHg (excluded if appliable, one of the arms)
* Subjects who have blood pressure ≥ 140/90 mmHg with taking 2 or more anti-hypertension drugs (except if any of the arms)
* Subjects that Low Density Lipoprotein-Cholesterol(LDL-C) isn't properly controlled according to National Cholesterol Education Program Adults Treatment Panel (NCEP ATP) III criteria
* Subjects who have triglyceride (TG) ≥ 400mg/dL
* Subjects who have a difference more than 20mmHg at the mean Sitting Diastolic Blood Pressure(siSBP) measured three times in both arms.
* Other exclusions applied
A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer

This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.

The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.

Eligibility Criteria:
Inclusion Criteria:

Patients

* Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted.
* Patients of age \>18 years, and all races will be included in the study.
* Patients must have an ECOG Performance Score ≤ 1
* All patients must sign an informed consent form

Caregivers

* Subject is age \>18 years
* Subject is English-speaking
* Subject must sign an informed consent form

Exclusion Criteria

Patients

* Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score.
* Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
* Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
* Patients who are undergoing chemotherapy for any reason
* Patients with evidence of metastatic disease

Caregivers

* Subjects that are unwilling or unable to provide informed consent
* Subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions
* Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
* Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis

The correlation of circulating serum miR-125ba and miR-146a expression and clinical response to green tea therapy were analysed in RA patients.Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores. Whereas , a decrease of 1.2 points or above in DAS28 scores at 24 weeks of treatment compared with baseline was defined as clinical response according to the EULAR response criteria.A ready-made solutions containing the primers and probes for human miR-146a and miR-125ba (Applied Biosystems, Foster City, CA) and real-time RT-PCR was estimated using an ABI 7300 system (Applied Bio systems).

1. participants: A total of 100 subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University were evaluated in this study.
2. patients were evaluated for therapeutic response at baseline and 12, and 24 weeks of green tea therapy. All patients with RA were subjected for estimation of ESR, CRP, disease activity score in 28 joints (DAS28), patient's global assessment (PGA), and health assessment questionnaire damage index (HAQ-DI) at each visits (0 week, 12 weeks, and 24 weeks).
3. Pain intensity was assessed by using a standard VAS of 100 mm previously validated to chronic and acute pains.
4. Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores.
5. human miR-146a and miR-125ba were isolated and subjected to RT-PCR analysis

Eligibility Criteria:
Inclusion Criteria:

* subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University, between 20 January/2015 and 20 September 2015 were recruited in this prospective study.
* According to the diagnostic criteria of the American College of Rheumatology (Arnett et al., 1988), all patients classified as showing established RA for more than 8 years.
* Only patients who had higher scores of DAS28-ESR, RA biomarkers, and established radiographic analysis, and were diagnosed with RA according to the 2010ACR/ EULAR classification criteria were included in this study.

Exclusion Criteria:

• Patients who received non-steroidal anti-inflammatory drugs, oral glucocorticoids, had a history of severe deformation of joint, pregnant or lactating women were excluded from this study.
Effects of Personalized Music Listening in Advanced Alzheimer's

Recent functional imaging studies have facilitated a better understanding of the neuroplasticity mechanisms underlying the strong and multifaceted effects of music on brain development. For this reason, music is considered a significant factor in improving recall and mood in individuals with dementia.

A review investigating the cognitive and behavioral effects of music listening in Alzheimer's disease (AD) reported that personalized (individualized) music listening yielded the best outcomes.

This study aims to examine the effects of personalized music activities on functional and cognitive status in individuals with advanced-stage AD.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and over
* Patients diagnosed with advanced-stage Alzheimer's type dementia according to the diagnostic criteria of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

Exclusion Criteria:

* Patients with hearing impairments that could interfere with music listening
* Individuals who have received music education and are able to play an instrument
* Patients with a history of heart disease, hypertension, or diabetes will be excluded from the study.
Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?

The goal of this study is to increase knowledge about how to treat patients after sinus surgery.

Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation.

Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are acute recurrent rhinosinusitis and chronic rhinosinusitis. The investigators used the classification of rhinosinusitis proposed by Lanza and Kennedy.

Exclusion Criteria:

* Previous FESS
* Systemic disease with affection of the nose (Wegener's granulomatosis, cystic fibrosis, Kartagener's syndrome, sarcoid)
* Primary ciliary dyskinesia
* Pregnancy
* Septoplasty in the same surgery
* Ongoing treatment for cancer
European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients

The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

* Duration of treatment: 18 months
* 3 treatment arms:

Placebo and 2 different doses of active drug.

Eligibility Criteria:
RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.

INCLUSION CRITERIA:

Participants must meet the following inclusion criteria to be eligible.

* Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
* Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
* Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
* Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
* Potential participant must be treated with an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
* Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study.
* Fluency (oral and written) in the language in which the standardized tests will be administered.
* Signed informed consent from potential participant or legal representative and caregiver.

EXCLUSION CRITERIA:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

* Potential participant with any other cause of dementia.
* Life expectancy less than 2 years.
* Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
* Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease.
* Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
* Previous exposure to 3APS.
* Inability to swallow pills.
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants\<3rd percentile\* born at 26-32 weeks GA.


Eligibility Criteria:
Inclusion Criteria:

* Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
* Birth weight ≥ 450g
* Singleton or twin birth

Exclusion Criteria:

N/A
Real World Use of Tocilizumab Biosimilar studY

The goal of this non interventional study is to evaluate the use of Tyenne, a tocilizumab biosimilar, in a real world setting in Rheumatoid Arthritis (RA) patients over a period of 12 months.

The main questions it aims to answer are:

* What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 6 months after treatment start?
* What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 12 months after treatment start?

The decision of prescribing Tyenne will be done by the physician independently, prior to patient enrolment in the study. Enrolled patients will be followed for 12 months following Tyenne treatment start, or until they permanently discontinue Tyenne.

There will be one baseline visit and three follow-up visits at approximately 3, 6 and 12 months after Tyenne treatment initiation. All follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients initially diagnosed with moderate to severe rheumatoid arthritis (RA) according to ACR/EULAR 2010 rheumatoid arthritis classification criteria
* Patients for whom the decision to prescribe Tyenne, a tocilizumab biosimilar has been made by the investigator prior to the inclusion, in accordance with the Summary of Product Characteristics (SmPC), local label and physician' current clinical practice
* Patients able to understand and complete the study questionnaires in local language during the study visits
* Patients are willing to enter the study (signed informed consent)

Exclusion Criteria:

* Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar
Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

The objective of the study is to compare the bioavailability of a generic product of paracetamol (immediate-release) with that of a reference product when administered to healthy volunteers under fasting condition. The test product is Fortolin Tab 500mg manufactured by Fortune Pharmacal Co. Ltd., and the reference product is Panadol Caplet 500mg manufactured by GlaxoSmithKline (Dungarvan) Ltd. The plasma pharmacokinetic data of paracetamol obtained from two formulations will be used to evaluate the interchangeability of the products.


Eligibility Criteria:
Inclusion Criteria:

1. Male and non-pregnant female, 18 to 55 years of age
2. Body Mass Index (BMI) between 18 to 25 kg/m2
3. Accessible vein for blood sampling
4. High probability for compliance and completion of the study
5. Female subjects who are surgically sterile or post-menopausal. Or female subjects of child bearing potential agree to practice abstinence or take effective contraceptive methods (e.g.implanted contraceptives, intra-uterine device or consistent condom plus spermicide use) from the start of screening until two weeks of last dose administration to prevent pregnancy.
6. Have signed the written informed consent to participate in the study.

Exclusion Criteria:

1. Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic and other diseases
2. Clinically significant abnormality in physical examination, vital signs, laboratory test results and ECG evaluation
3. Positive results of hepatitis B
4. Moderate smoker (more than 2 cigarettes a day within 3 months prior to the start of first dosing)
5. Moderate consumption of alcohol (more than one drink per day within 3 months prior to the start of first dosing)
6. Have lost or donated more than 350 ml of blood within 3 months prior to the start of first dosing
7. Subjects who are taking prescription or non-prescription medications (except for contraceptives, refer to "Inclusion Criteria" section) which is likely to be required during the course of the study
8. Use of paracetamol or other analgesic/antipyretic medications within 4 weeks before first dosing
9. Volunteer in any other clinical drug study within 2 months prior to the start of first dosing
10. Hypersensitivity to paracetamol or other drugs in its class
11. History of drug abuse in any form
12. Female subjects who are breastfeeding or pregnant
13. Subjects who are considered not suitable in participating the study due to other factors judged by investigators