cyrilzakka/clinical-trials huggingface dataset:
Study to Compare Milk Protein Isolate (MPI) With Caseinate in Terms of Protein Utilization

The Clinical Research Ethics Committee, Cork comprises of faculty representatives, external representatives, legal representatives and appropriate individuals and ex-officio administrative members with needed expertise. Ethics Committee members, including the Chair, are appointed by the Head of College, University College Cork, Medical School.

The Ethics Committee meets once a month.


Eligibility Criteria:
Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

1. Be able to give written informed consent.
2. Be between 65 and 75 years of age.
3. Be in generally good health as determined by the investigator.
4. Have no evidence of gastrointestinal disease or of a functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
5. Have a stable body weight over the past 3-months.
6. Have a Body Mass Index (BMI) greater than 22, for males and 20 for females and less than 30.
7. Have a satisfactory nutritional status.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

1. Are less than 65 and greater than 75 years of age.
2. Have evidence of gastrointestinal disease or other functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
3. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study).
4. Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include anti-inflammatory drugs, corticosteroids, laxatives, enemas, antibiotics (within 1 month), anti-coagulants, and over-the counter non-steroidal analgesics. Subjects should have a wash-out period of two-weeks.
5. Be a smoker.
6. Consume more than the recommended alcohol guidelines i.e. 3-4 alcohol units a day for a man and for a woman 2-3 units a day.
7. Suffer from psychiatric disease
8. Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding.
9. Have dietary habits (slimming or vegetarian diet) which could interfere with the assessment of the study product.
10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
11. Subjects may not be receiving treatment involving experimental drugs.
12. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
13. Have a malignant disease or any concomitant end-stage organ disease
Transcutaneous Bilirubinometers in the Community

Jaundice is the most frequent reason for readmission for healthy newborns after discharge from the nursery. In the Capital Health area, around 2.5% (315 babies in 2005) of all healthy newborns were admitted to the hospital for jaundice. Although jaundice is very common, it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe jaundice. So far, heel puncture of blood collection has been the traditional method to monitor jaundice in newborns. This causes pain to infants, generates anxiety in parents, and consumes significant health care resources. The aim of this study is to evaluate the efficacy of a new and noninvasive screening tool, the transcutaneous bilirubinometer, in detecting babies in our communities who require hospital readmission. This study will demonstrate whether incorporating transcutaneous bilirubinometer in the home care program delivered by nurses of Healthy Beginning allows the early detection of babies at risk of developing severe jaundice at a lower cost and with less discomfort.


Eligibility Criteria:
Inclusion Criteria:

* All near term (35 and 36 weeks gestational age) and term (37 to 41 weeks) babies living in Alberta Capital Health (CH) region
* Born at any Capital Health or Caritas delivery facility(Royal Alexandra Hospital, Grey Nuns Community Hospital, Misericordia Community Hospital, Sturgeon Community Hospital, Fort Saskatchewan Health Centre, and WestView Health Centre)
* Discharged home from the nursery within 96 hours of life

Exclusion Criteria:

* Babies who do not live in CH region
* Babies born at less than 35 weeks gestational age
* Babies initially admitted to a Special Care Nursery (SCN) or a Neonatal Intensive Care unit (NICU) for more than 72 hours
* Babies born to opting-out mothers will also be excluded
Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.

Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.

Eligibility Criteria:
Have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.
Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female Subjects of any race, aged 12 to 35 years inclusive,
2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),

Exclusion Criteria:

1. Subjects with more than 3 nodules or cysts on the face
2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
3. Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
4. Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
5. Subjects with impaired hepatic (ALT/AST \> 3xULN and bilirubin \> 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
6. Subjects with known intolerance to lactose,
A Blended Learning to Enhance Communication Skill Competence and Self-Efficacy of Nursing Students in Clinical Handovers

This study aimed to examine the efficacy of a blended learning programme in enhancing the communication skill competence and self-efficacy of final-year nursing students in conducting clinical handovers.

A clinical handover refers to the process of transferring the relevant information and facilitating continuity of patient care from one healthcare provider to another. It is an essential nursing practice that ensures patient safety. The information transmitted during the handover must be clear, concise and systematic to facilitate the provision of continuous patient care. Ambiguous communication and unsystematically transmitted information can often impede the clarity of ideas, result in the omission of important patient information and delay medical treatment, consequently endangering the safety of patients. Nursing students and newly graduated nurses often struggle with clinical handovers due to a lack of communication skill competence and self-efficacy in performing this practice.

Blended learning programmes (BLPs) are commonly used as constructivist pedagogical approaches in nursing education. BLPs have been used successfully to teach theoretical courses and psychomotor skills in nursing education and have been proven to benefit the knowledge, self-efficacy, motivation, attitudes and perceived competence of students. However, no studies that examine the efficiency of BLPs in enhancing the communication skill competence and self-efficacy of nursing students in conducting clinical handovers have been found. Therefore, this study aimed to determine the efficacy of BLP in improving the communication skill competence and self-efficacy of nursing students in conducting clinical handovers.

Eligibility Criteria:
Inclusion Criteria:

* were Hong Kong residents who could speak Cantonese and read Chinese and English
* were aged at least 18 years
* had not previously enrolled in a clinical handover training programme.

Exclusion Criteria:

- NA
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections

This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 90 years of age, inclusive.
* Diagnosed with primary episode or first relapse of moderate C. difficile infection.

Received ≤24 hours of therapy effective for C. difficile infection prior to enrollment.

Exclusion Criteria:

* Severe C. difficile infection
* Expected to require more than 10 days of C. difficile infection treatment.
* More than one prior episode of C. difficile infection within the prior 3 months.
* Use of anti-peristaltic drugs (including tincture of opium, metoclopramide, loperamide),, cholestyramine, or colestipol

Other protocol-defined inclusion/exclusion criteria may apply
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.

This study enrolls pediatric patients undergoing surgery under general anesthesia with need for early reversal of neuromuscular blockade, aged between 2 and 18 years old.

After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance of anesthesia with total intravenous anesthesia is commenced. 15 minutes after rocuronium administration, 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.

For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9.

For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are analyzed via high-performance liquid chromatography with mass spectrometric detection.

Eligibility Criteria:
Inclusion Criteria: All of below

* Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
* Aged between 2 and 17
* American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion Criteria: Any of below

* One or more legal guardian declines to enroll in the study
* History of hypersensitivity to any anesthetic agents including rocuronium
* Presence of underlying cardiovascular or genitourinary disease
* Under usage of neuromuscular blocking agents before surgery
* Under usage of drugs influencing the effect of neuromuscular blocking agents
* History of malignant hyperthermia
* Anticipation of massive hemorrhage during surgery
The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg

The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher in Atorva group. Both treatments were well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were men or women aged between 20 and 79 years who have not achieved LDL cholesterol goals using the National Cholesterol Education Program Adult Treatment Panel Ⅲ (NCEP-ATP Ⅲ) guideline, with the treatment goal of LDL cholesterol being \<100 mg/dL for patients with coronary artery disease (CAD) or CAD-equivalent disease, \<130 mg/dL for patients with multiple risk factors (10-year coronary heart disease \[CHD\] risk ≤20%), and \<160 mg/dL for patients with 0 to 1 risk factors.

Exclusion Criteria:

* Exclusion criteria were as follows: currently taking any kind of anti-hyperlipidemic drug (within 4 weeks before enrollment); hypersensitivity or intolerance to atorvastatin or other HMG-CoA reductase inhibitor; newly diagnosed (within 3 months before enrollment) or uncontrolled diabetes (hemoglobin A1C \>9%); uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels ≥2 times the upper limit of normal \[ULN\]); an unexplained serum creatinine kinase (CK) elevation \>2 times the ULN, chronic renal failure (a serum creatinine concentration \>2.5 mg/dL); in patients who experienced operation at the time of screening, the patients must have a result of lipid profiles within 24 hours or after 6 weeks; a history of malignancy or cervical dysplasia; pregnant or breastfeeding women; women of childbearing potential had to be using adequate methods of contraception; a history of drug abuse or alcoholism; participation in other studies 4 weeks before enrollment. Patients could also be excluded if their participation was considered inappropriate by the study physician.
Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)

To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either gender must be 12 years of age or older.
2. Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
3. Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount
4. Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception

Exclusion Criteria:

1. Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;
2. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
3. Subjects who are immunocompromised (due to disease, e.g., HIV or medications
4. Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
5. Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
6. Subjects using the following medications:

   1. topical antifungal agent within 30 days of the baseline visit
   2. systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine)
   3. topical corticosteroid in treatment area(s) within 30 days of the baseline visit.
   4. systemic corticosteroids within 30 days of the baseline visit;
   5. any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.
Pharmacokinetics, Safety and Tolerability of Tamsulosin Hydrochloride in Children With Voiding Disorders

To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in children with voiding disorders


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls with (or a history of) voiding disorders
* Age: 5 to 15 years
* Body weight and height ≥ 5 % and ≤95 % of normal using nomograms
* Signed and dated written informed consent by the parent or guardian and, where appropriate, informed assent by the child, prior to admission into the study in accordance with good clinical practice (GCP) and the local legislation, has been obtained

Exclusion Criteria:

* Clinically significant abnormalities found at, or before randomization at Visit 2 \[i.e., abnormal: vital signs (e.g., hypotension), ECGs, as well as significant findings during the physical examination\], as determined by the investigator
* Clinically relevant conditions including, but not limited to, the following: gastrointestinal, cardiovascular (e.g., subjects that fall above the 90th percentile according to the blood pressure nomogram in the ISF), hepatic, renal, hematologic, metabolic (including diabetes mellitus), immunological, hormonal disorders, respiratory disease or cancer
* Subjects who had surgery within the last 30 days
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Subjects that have a neurological impairment or psychiatric disorder that prevents their comprehension of consent and their ability to comply with the protocol
* History of relevant orthostatic hypotension, fainting spells or blackouts. Postdural symptoms occurring (e.g., lightheadedness, dizziness, and fainting) with or without a change in blood pressure and / or pulse rate within 6 weeks of Visit 2
* Relevant acute infections, especially with regards to urinary tract infections or active genitourinary infection
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other alpha-blockers
* Use of medications classified as cytochrome P450 3A4 (CYP3A4) inhibitors and inducers within 10 days prior to administration of trial drug
* Intake of drugs with a long half-life (\> 24 hours) within less than 10 half-lives of the respective drug prior to administration
* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
* Inability to comply with dietary regimen of study center
* Pregnancy or subjects that are breast feeding
* All subjects parents and guardians in the investigator's opinion who cannot understand the terms of the informed consent form and subject information
Quality of Life in Women with X-linked Adrenoleukodystrophy

X-linked adrenoleukodystrophy (X-ALD) is a hereditary white matter disorder caused by mutations in the ABCD1 gene leading to disturbances in the metabolism of fatty acids. This results in an accumulation of very long chain fatty acids (VLCFA) in the cells of the body causing damage to the central nervous system (white matter of the brain and spinal cord). The most common adult-onset X-ALD phenotype is adrenomyeloneuropathy (AMN), a slowly progressive myelopathic variant with demyelination of the long tracts in the spinal cord, clinically manifested as slowly progressive spastic paraparesis, sensory ataxia, bladder and sexual dysfunction.

Although this rare disease is inherited X-linked, previous research revealed that up to 80% of heterozygous women develop AMN symptoms during their lifetime.

The primary objectives of this study are 1) to assess the prevalence of symptomatic courses in female carriers of X-ALD and 2) to determine the impact of AMN symptoms on the quality of life of affected women in various areas (including everyday life, work, social network, sleep quality, sexuality, mood).

Participants are asked to fill in self-report questionnaires, which are available in English, German, French, Spanish, and Italian, and are provided electronically on the online platform Leuconnect (https://www.leuconnect.com) launched by European Leukodystrophies Association (ELA) international (https://elainternational.eu/).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from the participant
* Females ≥18 years at the time of consent, with proven X-ALD as defined by

  1. Elevated VLCFA values, or
  2. Mutation in ABCD1 gene

Exclusion Criteria:

* No informed consent and assent
* Current pregnancy
Comparison of the Incidence of Delirium Caused by Different Anesthetic Agents in Patients Undergoing Liver Transplantation

This study is a prospective observational study that analyzes the incidence of postoperative delirium in patients undergoing liver transplantation, based on the use of the inhalational anesthetic sevoflurane and the intravenous anesthetic propofol.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years and older
* Patients undergoing liver transplantation who are scheduled to receive anesthesia with the inhaled anesthetic sevoflurane or the intravenous anesthetic propofol.

Exclusion Criteria:

* Individuals with hearing loss, cognitive impairment or obvious dementia, hepatic encephalopathy, or difficulty in communication.
* Diagnosed with neurological disorders (e.g., brain hemorrhage, stroke, dementia, Parkinson's disease, cognitive impairment, etc.).
Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease for 3 months or more
* 18 years of age or older with a history of migraine with or without aura
* Must use acceptable contraception throughout the study

Exclusion Criteria:

* Pregnant, breast-feeding, or planning to become pregnant during this study
* 50 years of age or older when migraines began
* Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* History of gastric, or small intestinal surgery, or has a disease that causes malabsorption