cyrilzakka/clinical-trials huggingface dataset:
The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms

The aim of the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.

The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Women of at least 18 years old
* Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
* Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
* Capacity to understand, consent, and comply with the trial procedures

Exclusion Criteria:

* Mixed vaginal infections
* Pregnancy or the intention to become pregnant during the study period
* Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
* Known allergies or contra-indications for Fluconazole or honey
* Candida with resistance for Fluconazole
* Women giving breastfeeding
Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome

This is a single-center, open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndrome(NSTE-ACS) for 24 hours

1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)
2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min

   * both agents will be given on top of aspirin

In combination with aspirin, P2Y12 receptor antagonist or glycoprotein IIb/IIIa inhibitor(GPI) is now a recommended drug as the standard dual antiplatelet regimen in patients with acute coronary syndrome(1).

Ticagrelor is a newly developed oral P2Y12 receptor inhibitor. It shows faster, greater and more consistent platelet inhibition as compared with previous P2Y12 receptor antagonist clopidogrel(2) and it also shows better clinical outcome and similar risk for bleeding as compared with clopidogrel(3).Interestingly, pharmacodynamic data of some studies showed excellent effect of ticagrelor in terms of inhibiting platelet activation apparently as high as that of GPI(2,4).

Primary hypothesis: Ticagrelor have a comparable efficacy in platelet inhibition to GPI in patients with non-ST segment elevation acute coronary syndrome.

Statistical design : non-inferiority test

Eligibility Criteria:
Inclusion Criteria:

* Patients with recent or current ischemic symptoms at the time of randomization will be eligible if 2 of the following criteria are met: ST-T change indicating ischemia; a positive test of biomarker indication myocardial necrosis; or one of several risk factors(age ≥60 years
* Previous myocardial infarction or coronary artery bypass grafting \[CABG\]
* Coronary artery disease with stenosis of ≥50% in at least two vessels
* Previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization
* Diabetes mellitus
* Peripheral arterial disease; or chronic renal dysfunction, defined as a creatinine clearance of \<60 ml per minute per 1.73 m2 of body surface area)

Exclusion Criteria:

1. Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current AMI
2. Major surgery or trauma within 30 days
3. Active bleeding
4. Previous stroke in the last six months
5. Oral anticoagulant therapy
6. Pre-existing thrombocytopenia
7. Vasculitis
8. Hypertensive retinopathy
9. Severe hepatic failure
10. Severe renal failure requiring hemodialysis
11. Documented allergy/intolerance or contraindication to tirofiban or P2Y12 inhibitor
12. Uncontrolled hypertension (systolic or diastolic arterial pressure \>180 mmHg or 120, respectively, despite medical therapy)
13. Limited life expectancy, e.g. neoplasms, others
14. Inability to obtain informed consent
A Two-Part Study to Determine: Best Medication Formulation and Food Effect

This is a two-part study. Part 1 is designed to find the best modified release formulation of GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if food affects the way the medication is processed by the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males \& females
* Part 1 ages 18-60
* Part 2 ages 18-50 \& 65-80
* Within normal weight range given your height
* Negative urine drug and alcohol test
* Willing to follow all study procedures

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ECG, or any other medical condition or circumstance making the subject unsuitable for participation in the study based on the Investigator's assessment.
* Subjects with either a blood pressure measurement \> 150/90 mmHg, or a history of coronary disease AND a blood pressure \> 140/90 mmHg, at screening.
* History of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation.
* Regular alcohol consumption averaging \>/7 drinks/week for women or \>/ 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the first dose of study medication.
* Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing in each study session.
* Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening.
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of study medication.
* Use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication and during the study. By exception, use of acetaminophen at doses of ≤ 2 grams per day, the use of contraceptives (oral, depots, patches, etc.) and anti-hypertensive medications will be permitted.
* Use of vitamins or herbal/dietary supplements within 7 days prior to administration of study medication and during the study.
* Subject is unable and/or unwilling to adhere to Lifestyle Guidelines
* Subjects who have donated more than 500 mL of blood or plasma within 56 days prior to administration of study medication.
* An unwillingness on the part of male volunteers to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness to use a condom and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant from the time of the first dose of study medication until completion of follow-up procedures.
* Pregnant or lactating woman. A pregnancy test will be performed for all women at screening and prior to each dosing session to confirm eligibility.
* The subject has a known hypersensitivity or idiosyncratic reaction to any drug chemical related to this study.
Clinical Values of Automated Electronic Alert for Acute Kidney Injury

Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.

A prospective, randomly controlled cohort study will be conducted agmong the patients with AKI who are detected by the use of AKI sniffer. The investigators chose to assess all inpatient serum creatinine results using a combination of "KDIGO" criteria.

The investigators randomly divided the patients into two groups:

1. Usual care : patients will receive standard clinical care by the primary physicians
2. AKI alert : an AKI alert will be sent to the the doctor in charge. Our team of kidney experts would give a suggestion if the the doctor in charge issue consultation applications.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with an Alert for AKI(based on KDIGO guidelines)

Exclusion Criteria:

* patients already on dialysis for AKI at the time of alert
* patients with End stage renal disease
* patients \<18 years of age
* patients dissenting from participation according to the Ethics application
Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release

the purpose of this study is to compare the gain in length after postburn contracture release using two different techniques, the more commonly practised z - plasty and relatively newer technique, square flap


Eligibility Criteria:
Inclusion Criteria:- • Both genders.

* Joints supple.
* Linear contracture bands.
* Age between 5years to 50 years.
* Surrounding non scarred skin.
* Contractures of axilla, cubital fossa, popliteal fossa and digits.

Exclusion Criteria:

* Deep burns.

  * Joint contractures.
  * Surrounding skin scarred.
  * Broad, irregular contracture.
  * Neck, Perineal, wrist or toe contractures
Beta Blockers Plus Intravenous Flecainide for Paroxysmal Atrial Fibrillation: a Real-world Chios Registry (BETAFLEC-CHIOS)

BETAFLEC-CHIOS, is a single-center registry that was initiated in the "Skylitseion" General Hospital of Chios in January 2020 and is ongoing. The inclusion criterion is IV flecainide administration for recent-onset AF lasting less than 48 hours. Oral b-blockers are co-administered in all patients. The main exclusion criteria are severe structural or ischemic heart disease and conduction system dysfunction. Continuous monitoring is applied during and after administration of IV flecainide. If no conversion to sinus rhythm is achieved at 2 hours after flecainide infusion, the patient is recorded as "unsuccessful conversion attempt".

Patient population BETAFLEC-CHIOS, is a single-center registry that was initiated in the "Skylitseion" General Hospital of Chios in January 2020 and is ongoing. Patients are included in the registry if presenting with recent-onset atrial fibrillation (AF) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ECG and having received intravenous (IV) flecainide on treating physician's discretion. Exclusion criteria are severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time), atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block, abnormal electrolyte levels (especially hypo- or hyperkalemia) or known sensitivity to flecainide. Continuous monitoring is applied during and after administration of IV flecainide. If no conversion to sinus rhythm is achieved at 2 hours after flecainide infusion initiation, the patient is recorded as "unsuccessful conversion attempt" and forwarded for direct current cardioversion (DCC). All patients were anticoagulated according to the current European Society Guidelines (ESC) or the management of AF \[ESC Afib 2020\].

Flecainide administration Flecainide is given as an IV infusion of 1.5 mg/kg (max 150 mg) in DW 5% over 10 min under continuous monitoring. Concomitant administration of a b-blocker is also applied in all patients. The dose and type of b-blocker are selected according to heart rate during the AF and patient's medical history. "Time to conversion" is calculated as the time interval from the end of the infusion up to when sinus rhythm is observed on the monitor and confirmed subsequently with a 12-lead ECG.

Eligibility Criteria:
Inclusion Criteria:

1. Informed written consent.
2. Recent-onset atrial fibrillation (AF) (≤48 hours of onset) and lasting ≥30min, documented by a 12-lead ECG
3. Administration of intravenous flecainide
4. Administration of an oral b-blocker

Exclusion Criteria:

1. Age \<18 years
2. Severe structural or ischemic heart disease (previous cardiac surgery, any cardiomyopathy, myocardial infarction at any time)
3. Atrial flutter, sick sinus syndrome, high degree atrioventricular block, bifascicular block
4. Abnormal electrolyte levels (especially hypo- or hyperkalemia)
5. Known sensitivity to flecainide
Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.

This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer.

If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type.

defined below: NEXT 1 trial is screening and feasibility -\> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)-\>NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)

Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed metastatic malignancy
* Written informed consent

Exclusion Criteria:

* patients who do not agree with biopsy
* patients who do not have enough tissue for acquisition
Design and Usability Testing of a Tailored Intervention About Sleep and Sleep Disorders Among Transportation Workers

The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.

Transportation shift workers (TSW, e.g., overnight, on-call, or rotating) have been identified as a high-risk group for health conditions (e.g., obesity, cardiovascular disease). Also, TSW are at risk for obstructive sleep apnea (OSA). According to one study, approximately 36% of TSWs have OSA, a condition that exacerbates health risks and daytime sleepiness. A recent report from the American Academy of Sleep Medicine (AASM) showed that those with untreated OSA cost on average $4,261 more than those without OSA. Also concerning, workers with OSA who are non-adherent to recommended OSA treatment (i.e., continuous positive airway pressure, CPAP) are at particularly high risk for motor vehicle accidents compared to those who are adherent.

This protocol outlines focus groups that will aim to identify knowledge, attitudes, and beliefs about OSA among TSW. Results of these focus groups will be used in future research to design a tailored website for relaying OSA information to TSW.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Access to a smartphone device
3. Commitment to completing all study activities
4. Score 4 or higher (mild or higher on OSA risk) according to the Apnea Risk Evaluation System (ARES) questionnaire.

Exclusion Criteria:

1. Significant medical or psychiatric illness according to the PROMIS Short Form (SF-12)
2. No OSA risk (a score below 4 on the ARES).
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers


Eligibility Criteria:
Inclusion Criteria:

* Medical history of gastric and/or duodenal ulcer
* A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

* Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
* History of esophageal, gastric or duodenal surgery
* Having severe liver disease or chronic renal disease
Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Subjects

Primary objective - To evaluate food effect on the pharmacokinetics and the pharmacodynamics (PD) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.

Secondary objectives

- To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female healthy volunteers in the age between 19 and 50 years old.
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
* Helicobacter pylori (H. Pylori) negative.
* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

* Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.).
* Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
* Heavy smoker (\>10 cigarettes/day).
A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain

This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain intensity rated as 3/10 or higher in the past 24 hours

Exclusion Criteria:

* Non-English speaking
* Systemic medical conditions that affect sensation, such as uncontrolled diabetes
* History of shoulder surgery or fracture within the past 6 months
* blood clotting disorder, such as hemophilia
* contraindication to the application of ice ((blood pressure \> 140/90 mmHg, cold urticaria, cryogobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* Unable to exercise without a medical clearance (assessed on the PAR-Q+ on the first visit)
* Exceed pressure and sensory safety thresholds (assessed on the first visit)
* Categorized as low irritability (assessed on the first visit)
* currently pregnant
* currently receiving physical therapy to treat shoulder pain
The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.

The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:

* Does the App-based intervention improve the quality of life?
* Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms.

Participants will:

* Use an App-based intervention or be in the control group (no App-use) for 6 months
* Visit or have a telephone consultation after 3 and 6 months
* Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Age 18 or older
* Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
* Endometriosis, confirmed by surgery or clinically suspected
* Possession of a smartphone

Exclusion Criteria:

* Planned endometriosis surgery or planned hormonal therapy in the study period
* Surgery and/or new hormonal therapy in the last three months
* Malignant diseases
* Pregnancy
* Breastfeeding
* Active desire for pregnancy in the study period
* Fertility treatment
* Simultaneous participation in other intervention studies
Exercise in Children Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous neurodevelopmental disorder characterized by carelessness, hyperactivity and impulsivity, in which genetic, social and physical factors play an important role. Few studies have revealed the physical activity levels and importance of children with ADHD, but there is no consensus on the components of the physical activity program such as intensity, frequency, and severity. The aim of the present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD.

The aim of present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD. Children will be randomly divided into 3 groups, for 8 weeks the first group will undergo a combined exercise training under the supervision of a physiotherapist, while the second group will receive a home exercise program. children included in the third group will form the control group.

The following assessments will be applied at the beginning and end of treatment.

1. Revised Conners Parent Rating Scale Short Turkish Form
2. Powers and Challenges Survey
3. Edinburgh Hand Preference Survey
4. Two-minute walking test
5. Ten meter walking test
6. Munich Fitness Test
7. Bruininks-Oseretsky Motor Proficiency Test-2
8. Muscle strength evaluation
9. Dynamic Occupational Therapy Cognitive Assessment
10. Open-ended questions

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with ADHD according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders-V) diagnostic criteria,
* Being between the ages of 7-12,
* Right hand being dominant according to Edinburgh Hand Preference Questionnaire,
* After the purpose of the study and the procedures to be explained, both the child and his family agree to participate in the study,
* An appropriate drug treatment program has been organized by the psychiatrist,
* The absence of a contraindicated condition to exercise in physical and medical examination.

Exclusion Criteria:

* A major psychiatric and / or neurodevelopmental problem accompanying,
* A history of head injury or chronic neurological disease,
* Having additional medical diseases that require medication,
* Any changes made in the psychiatric drug treatment by the attending physician for the last 1 month,
* Have participated in a regular exercise program or sporting activity for the past 6 months.