cyrilzakka/clinical-trials huggingface dataset:
Insomnia, Physical Activity Level and Stress Level

Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance. Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level. Research shows that college students face more sleep problems than the general public. Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes. The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group. Examining levels and other behavioral factors. The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022. It will be held online via Google Forms with students between the ages of 18-25. Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index. An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from people participating in the research. Statistical analysis of the data will be done with IBM SPSS 23.0 software.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-25,
* Associate and undergraduate students studying in the field of health sciences
* Agreeing to participate in the study,
* Native speaker of Turkish,
* Male and female individuals

Exclusion Criteria:

* Refusing to participate in the study,
* Having a diagnosed psychiatric illness,
* Using any medical medication that affects sleep
* Having a health condition that prevents physical activity,
* Be missing data
Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium

Delirium is a disturbance in consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. 50% to 81.7% had delirium during their ICU hospitalization. Delirium is associated with increased physical restraint, ventilation use, length of ICU stay, and mortality. However, there is no established delirium care pathway in target hospital. Chen et al. (2014) demonstrated that structured assessment stations with immediate feedback may improve overall learning efficiency over an EBP workshop alone. However, no published delirium care education study has used OSCEs as an intervention for healthcare professionals. The aim is to evaluate the effects of implementing a Scenario- based education intervention, including objective structured clinical examinations (OSCEs) on delirium care among healthcare professionals. This is a knowledge translation research, builds on eight years of delirium care research in University of Wollongong, Australia. The research will be undertaken at ICUs in a medical center in northern of Taiwan. There are two phases: (1) systematic review to identify delirium screen tool, and (2) a randomized controlled trial was conducted to determine the effects of implementing a Scenario-based education intervention, including OSCE (experimental group), and on-line education only (control group) focused on recognition and management of delirium. The hypothesis is: Scenario-based education intervention, including OSCE can increase the competence and self-efficacy among healthcare professionals in delirium care.

OSCEs are an integral aspect of all levels of medical education but limited to undergraduate nursing and allied health education. OSCEs are rarely used in the workplace as learning activities with nursing and allied health clinicians. This is the reason why this education initiative was innovative. OSCEs are simulated 'real life' clinical scenarios presented to clinicians who are required to demonstrate to an assessor the clinical tasks which form an OSCE scenario.

Eligibility Criteria:
Inclusion Criteria:

1. Registered nurse worked in acute care unit and care with critical patients
2. Licensed physician which undertake the post graduate year program worked in acute care unit and care with critical patients

Exclusion Criteria:

1.Unwilling to involved the research
Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* COPD
* Forced expiratory volume in one second (FEV1) \< or = 50% of predicted
* Smoking history of at least 10 pack-years
* Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)

Exclusion Criteria:

* Currently taking \> 500 I.U. per day of vitamin D supplements
* Primary diagnosis of asthma
* Uncompensated heart failure
* Heart attack in the previous 6 months
* Kidney disease (glomerular filtration rate \< 45 mL/min/1.73m2)
Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Health Male Volunteers (Age : 19\~55 years)
* Body Weight : Male≥55kg, Female≥50kg
* 18.5≤BMI\<25.0

Exclusion Criteria:

* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73m²
* Heavy alcohol intake (more than 210g/week)
* Heavy smoker (more than 10 cigarettes/day)
* Heavy caffeine intake
Cultural Pathways to Develop Sustainable Health

The 2030 Agenda for Sustainable Development, adopted by all United Nations Member States in 2015 includes the goal 3 "Ensure healthy lives and promote well-being for all at all ages". One of the essential axes is to promote primary prevention in order to avoid the emergence of diseases and the treatments use with a high environmental impact. Physical activity (PA) is a means of primary prevention known to be very effective in the fight against chronic diseases.

Despite the recommendations on PA, a high number of people are sedentary and in particular in older persons. The main barriers are accessibility and lack of motivation for traditional PA. The investigators believe that the development of cultural pathways could be an excellent way to improve people's health.

The objective of this study is to assess the effects of cultural pathways on the physical abilities, well-being and sustainable health knowledge of sedentary people over 50 years old. This intervention will be compared to a control group visiting a museum freely. The hypothesis is that cultural pathways including games induce enough steps to be considered an effective activity to fight sedentary lifestyle. The number of steps should be higher than the control group. Fatigue, stress and well-being should be improved after the visit as well as sustainable health knowledge.

All the tests will be carried out during the same day by experienced physiotherapists. Physical and well-being tests will be performed before and after the intervention or control. The number of steps taken during the cultural activity will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Sedentary condition (\<150 minutes of physical activity per week)
* Medical stability
* Walking independently with or without assistance
* Ability to understand the instructions

Exclusion Criteria:

* Refusal to participate;
* Person with other conditions affecting independent walking;
* Contraindications to prolonged standing;
* Concomitant pathologies that may interfere with the results;
* Inability to follow the study procedure (cognitive disorders, dementia, psychological disorders, language problems...).
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of rheumatoid arthritis
2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Exclusion Criteria:

1. Patients who have taken the following drugs within the timeframe below:

   * Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
   * Rituximab - Within 12 months prior to the first dose of study medication;
   * Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
2. Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients

This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.


Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder

Exclusion Criteria:

* Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Use of botulinum toxin therapy of any serotype in the 3 months prior to screening
* Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)
China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients

Three purpose of this study:

1. Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients;
2. Evaluation on specificity and sensitivity of STAF score;
3. Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.

Inclusion criteria:

1. Hospitalized patients with ischemic stroke that are diagnosed definitely;
2. Age ≥ 18 years;
3. Within 7 days after the onset of diseases;
4. Signed the consent informed form.

Exclusion criteria:

1. Patients with noncerebrovascular diseases that are diagnosed definitely;
2. Silent cerebral infarction (CI) without symptoms and signs;
3. Those refuse to sign the consent informed form of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients with ischemic stroke that are diagnosed definitely;
2. Age ≥ 18 years;
3. Within 7 days after the onset of diseases;
4. Signed the consent informed form.

Exclusion Criteria:

1. Patients with noncerebrovascular diseases that are diagnosed definitely;
2. Silent cerebral infarction (CI) without symptoms and signs;
3. Those refuse to sign the consent informed form of the study.
Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count

Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time.

Variables of study:

Each patient will be instructed to follow oral hygiene measures including aloe vera or fluoride toothpaste

Outcomes:

Salivary bacterial count will be evaluated using Mitis salivarius agar plates before the use of the aloe vera toothpaste then after 15 days then after 30 days .

Participant timeline:

Enrolment Baseline assessment 15 days 30 days

(1st visit ) (2nd visit) (3rd visit )

II.6.Sample size calculation :

Based on previous study , the mean percent change reduction in bacterial count was 3+4 . using power 80 % and 5 % significance level , we will need to study 29 in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I probability associated with this test of this null hypothesis is 0.05.

Recruitment \& Recruitment Strategy:

Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. Randomization and assignment of interventions:

Randomization will be done according to a check list including the number of participants divided into 2 groups according to interventions/Control assessment method

Allocation sequence generation:

The allocation sequence will be generated using (www.randomization.com).

Allocation concealment mechanism:

A checklist will be designed to identify each assessment method.

Implementation A participant will generate the random allocation sequence. The researcher will enroll the patients but an unbiased participant will assign the intervention/Control identification procedures to respective teeth.

Blinding:

The participants will be blinded to intervention/control assessment methods. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.

Data collection methods:

High caries index will be assessed 3 times , at base line , then 15 days and 30 days.

Funding:

The research will be self-funded by the researcher.

Eligibility Criteria:
Inclusion Criteria:

* Patients should have poor oral hygiene.
* Patients should have high bacterial count

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease .
Comparison of the Difficulty on Insertion of IUD Devices Between Nulliparous and Multiparous Women

In this study the investigators compare the difficulty at insertion of IUD between nulliparous and parous women. The investigators compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion.

The investigators hypothesis is that there is no difference between nulliparous and multiparous patients.

In our study we compare the difficulty at insertion of IUD between nulliparous and parous women with an without cesarean section.

We compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion. We also compare the pain the patient refers on the day of insertion and the pain the patient refers to remember a month after insertion.

Our hypothesis is that there is no difference between nulliparous and multiparous patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy WOmen

Exclusion Criteria:

* Pregnancy
* Use of pain medication previous to the insertion
* Prior use of IUDs
Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section

The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.

Procedures:

A list will be compiled of patients who underwent cesarean section at Memorial Hermann Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT patients who had their skin closed with Insorb or metal staples will be included in this list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. Any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. Additional notes will be made of any co-morbid conditions, including, but not limited to, \>30 BMI, chronic hypertension, diabetes mellitus, HIV, history of tobacco use.

Once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. In addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by Fisher's exact test, to determine statistical significance.

Course of Study: Data will be obtained from UT patients who underwent cesarean section from January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb or metal staples will be included in analysis.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean sections
* UT patients

Exclusion Criteria:

* Patients who have skin closed with suture, per attending choice.
Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age.
* Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)).
* Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months.
* Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.

Exclusion Criteria:

* Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial.
* Is a current suicide risk in the opinion of the Investigator.
* Has initiated cognitive therapy within two months of Study Day 1.
* Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS).
* Has taken a benzodiazepine within the past 30 days.
* History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs.
* If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods.
* Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert.
* Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert.
* History of phenylketonuria (PKU).
* Participation in a previous clinical trial within 30 days prior to Study Day 1.
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive
* Subject is a nonsmoker for at least 3 months
* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
* Fasting plasma glucose between 80 and 110 mg/dl

Exclusion Criteria:

* •Any clinically significant disease history of systemic or organ disease
* •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
* •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative
The Effect of GnRH Administration During Luteal Support in Frozen-thawed Transfer Cycles

GnRH administration during the luteal phase was found to significantly increase pregnancy rates in women undergoing fresh-cycle IVF cycles.

We aim to investigate the effect of GnRH administration during the luteal phase in women undergoing frozen-thawed IVF cycles.


Eligibility Criteria:
Inclusion Criteria:

Frozen-thawed IVF cycles

Exclusion Criteria:

Hydrosalpings Uterine myomas
Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat

Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation

Exclusion Criteria:

* Age \< 18 years or age \> 80 years
* Diseases or anatomic abnormalities in the neck, larynx, or pharynx
* Combined surgery such as breast reconstruction
* Active pulmonary disease
* Morbid obesity (body mass index ≥ 40 kg/m2)
* Pregnancy
* Refusal to join the study