cyrilzakka/clinical-trials huggingface dataset:
Melatonin As an Analgesic in Preterm Neonate

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.

This is a randomized, double-blind, controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant
* less than 37 weeks gestational age
* who started enteral feeding.

Exclusion Criteria:

* Multiple congenital anomalies.
* Facial malformation.
* Receiving analgesia or sedation.
* Contraindication of enteral feeding.
* Clinical or laboratory signs of sepsis.
* Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

The survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe any change in compliance after treating with other drugs intended to treat ADHD for over 3 weeks

This is an Observational, survey study. The survey is designed to be administered in two stages. In the first stage, patients who were prescribed Immediate-Released Methylphenidate (IR-MPH) for over 3 months, who are also on IR-MPH 1 month prior and who meet inclusion criteria will be enrolled. On survey day 1, the patients, parents/caregivers, and clinicians will assess patient drug compliance. For patients considered non-compliant, the Investigator will decide whether or not to change current medication. Those patients whose medication is changed from IR-MPH to another treatment for ADHD, will be enrolled into the second stage. On survey day 1, Clinical Global Impression (CGI) and the effects of the medication on sleep quality, decreased appetite, dizziness and or headache, and gastrointestinal upset will be assessed based on clinical interview. Any other side effects shown during medication treatment will be also recorded in the first stage. Parent/Caregivers will need to complete the Swanson, Nolan and Pelham (SNAP) Questionnaire which will evaluate the ADHD child's symptoms of inattention, hyperactivity, impulsivity and oppositional defiant disorder. In the second stage, those ADHD patients who meet the definition of non-compliance will be treated with other medications for over three weeks. On the first visit back after starting treatment with other medications, drug compliance, CGI, any change in negative parent-child interaction, overall classroom behavior, overall academic performance, the effects on sleep quality, decreased appetite, diziness and or headache, and gastrointestinal upset will be assessed by Investigator interview. Parent/Caregivers will need to complete SNAP Questionaire which will evaluate the ADHD child's symptoms of inattention, hyperactivity, impulsivity and oppositional defiant disorder. It is a survey type of study. No study drug has been used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of DSM-IV ADHD
* Patients were previously treated with Immediate-Released Methylphenidate (IR-MPH) taken once a day, twice a day, three times a day, or four times a day over three months and who were also on IR-MPH the last month without severe adverse events or possible contraindications with MPH
* Patients whose parent or guardian has signed and dated an informed consent to participate in the survey of drug compliance
* Patients who are still at school

Exclusion Criteria:

* ADHD patients who have systematic disease or clinically significant gastrointestinal problems, including narrowing (pathologic or iatrogenic) of the gastrointestinal tract
* ADHD patients also diagnosed with psychosis except for Conduct Disorder and Oppositional Defiant Disorder
DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis

Cystic fibrosis related diabetes (CFRD) is a common co-morbidity in patients with CF. The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. In addition to localized tissue damage developing similar to that of the exocrine pancreas, other mechanisms may be involved. We have shown that a potential contributing factor to the patho-physiology of CFRD may be an abnormal gut derived hormonal profile, specifically of lower incretin hormone responses, prior to development of CFRD.

We propose that an altered incretin response, probably due to impaired interaction of nutrients with the gut mucosa due to thickened secretions, may play a role in the development of the disease. Specifically, low GIP and GLP-1, may explain the poor β-cell function observed in these patients prior to CFRD appearance. These incretins have known trophic effects on β-cells, and thus their lower levels may contribute to the development of quantitative as well as qualitative defects in β-cell function and thus may lead to the development of CFRD. Thus, increasing levels of these incretins using a DPP-IV inhibitor may improve glucose metabolism and delay/prevent the development of CFRD.

We hypothesize that Saxagliptin will increase the oDI compared to placebo and will thus provide relative protection from diabetes development and in addition we expect that Saxagliptin will lead to overall increased insulin concentrations and thus shift the metabolic milieu to a more anabolic state. This will manifest as weight gain and reduction in inflammation.

The following proposal includes testing the utility of DPP-IV inhibition in adult patients with CF without CFRD. This will be achieved by a randomized double blind controlled trial of Saxagliptin 5 mg vs. placebo which will be performed for 3 months in 60 patients with CF without CFRD. The study will be for 3 months of use and will consist of two arms:

1. Saxagliptin 5mg
2. Placebo. the primary outcome of this study will be the oral disposition index oDI , derived from the OGTT. The oDI has been shown across age groups and metabolic phenotypes to be an excellent predictor of diabetes development over time . We postulate that Saxagliptin will increase incretin concentrations and thus improve insulin secretion. This will manifest as an increased oral disposition index (oDI), reflecting an improved beta cell response in the context of prevailing insulin sensitivity. The oDI is a useful predictor of diabetes development over time and its increase will provide evidence for protection from diabetes in this special study population

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Diagnosis of CF
* No CFRD on baseline OGTT
* Normal kidney function
* No history of pancreatitis
* Able and willing to consent and participate

Exclusion Criteria:

* Acute illness/exacerbation of CF associated lung disease
* Receiving immune-modulators following lung/pancreas transplant
Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate

The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.

The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 and under 80 years of age.
2. Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.).
3. Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent.

Exclusion Criteria:

1. Patient who is expected to have less than two years of life expectancy.
2. Patient who have bleeding within a week of participation in the study
3. Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.).
4. A female patient who is likely to be pregnant or pregnant.
5. Female patients who are lactating or are scheduled to be lactated at the time of participation in the study.
6. Patients with severe renal disease and liver disease.
Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis

To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.

Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old;
* implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),
* implants placed in both maxilla and mandible
* patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm
* presence at least of 2 mm of keratinized mucosa (KT) at implant sites

Exclusion Criteria:

* presence of systemic diseases;
* pregnancy or lactating;
* use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;
* implants with modified (i.e., micro-rough) necks;
* interproximal open contacts between implant restoration and adjacent teeth; peri-implantitis (Berglundh et al., 2018)
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV-1b infected patient
* HCV RNA viral load of ≥ 100,000 IU/mL at screening
* Ages 20 to 75 years
* Non-responder to Interferon plus Ribavirin therapy
* Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

Exclusion Criteria:

Patients who have -

* Hepatocellular carcinoma
* Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
* Severe or uncontrollable complication
Longitudinal Evaluation of Teens Against Tobacco Use

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.

The investigators will collaborate with Austin High School, Wiggs Middle School, and Guillen Middle School of the El Paso Independent School District to implement smoke free youth coalitions as an after school activity. The coalitions will follow the Teens Against Tobacco Use (TATU) model developed by the American Lung Association, the American Cancer Society, and the American Heart Association. Participating youth will be trained to develop and deliver anti-tobacco presentations to younger students. Each school will have a separate youth coalition operating under the guidance of an adult coordinator. High school youth will present to middle school classes, whereas middle school youth will present to 4th and 5th graders.

To evaluate the efficacy of the smoke-free presentations, the investigators will first match pairs of classrooms willing to have a presentation and then randomly assign one classroom in each pair to either receive a series of two presentations first (intervention condition) or later in the school year (control condition). The day after each presentation to a classroom in the intervention condition, investigators will administer a brief survey about tobacco to students in both the intervention class and its matched control class, who have not yet received a presentation. Analyses will compare intervention and control classrooms on tobacco susceptibility.

Eligibility Criteria:
Inclusion Criteria:

* 4th to 8th grade student
* Classroom must be willing to be randomly assigned to either receive presentations earlier in the school year or late in the school year.

Exclusion Criteria:

* Classes in participating schools that are not in the 4th to 8th grade
* Students not able to read English or Spanish
Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream

KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.

The consumption of highly ultra-processed foods has been identified as having detrimental effects on human metabolic health, leading to various adverse health outcomes. The Metabolic Matrix represents a highly quantified, science-based tool for reengineering products with the aim of promoting positive metabolic outcomes. This approach may also contribute to creating shared value by solving important social problems such as obesity and type 2 diabetes by scalable products that are profitable.

KDD is committed to addressing the pandemic of metabolic diseases in Kuwait and would like to develop products that benefit the collective metabolic health of the Kuwait population. KDD is working with partners to assist in its ground-breaking work and to support its efforts with a strong evidence-base rooted in leading-edge science in metabolic health and nutrition. We hypothesise that no-added sugar-flavored ice cream have a substantially different postprandial glycaemic response compared to conventional products in patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. Aged over 18 years
3. HbA1c 6.5-8.5% (48-69 mmol/L)

Exclusion Criteria:

1. Lactose intolerant
2. Not liking chocolate ice cream
Orientation Effects of Breastfeeding for Mothers

The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO).

Simple Strategies to guide and support the mother contributes to increasing knowledge about breastfeeding and can have positive impacts on breastfeeding rates.

Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the first six months of a baby's life.

110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.

The first stage was carried out in the maternity - Orientation: Breastfeeding Importance Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the intervention group held three home visits:

10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Mothers living in the city of Porto Alegre

Exclusion Criteria:

* Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm infants, twin hospitalized
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 \[NCT00308581\]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients having completed study C87042 \[NCT00308581\] (previously treated with infliximab)

Exclusion Criteria:

* Subject withdraw from C87042 \[NCT00308581\] study
* Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 \[NCT00308581\] study
* Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
* Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
Microneedles for Diagnosis of LTBI

This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers

The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Sex : Male and Female
2. Age : 20-60 years
3. TB contacts or those at risk of TB e.g. health-care workers
4. HIV-negative healthy individuals

Exclusion Criteria:

1. Presence of an acute infection, as determined by investigators
2. Receiving immunosuppression drugs e.g. steroids
3. Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
4. Being pregnant or breastfeeding
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

The aim of this study is to evaluate the effect of acupuncture on inflammation and immune function after craniotomy. This study will be a single-center, parallel group clinical trial that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.

For Study group, The intervention will start no more than 48 hours after craniotomy and will be given once a day for 6 days (a total of 6 sessions within 8 days). Acupuncture, electroacupuncture, and intradermal acupuncture will be performed at every session.

For Control group, The subjects in the control group will only receive conventional treatment.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria in order to be included:

1. planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor;
2. age \> 18 years;
3. acupuncture treatment that can start within 48 h after craniotomy;
4. voluntary participation and provision of signed informed consent form.

Exclusion Criteria:

Participants with any of the following conditions will be excluded:

1. serum C-reactive protein (CRP) level ≥ 1.0 mg/dl before craniotomy;
2. a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy;
3. craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema;
4. medication use that can affect the immune system or white blood cell (WBC) count, such as immunosuppressive drugs, steroids, or anticancer drugs or use of these medications within one month prior to the craniotomy;
5. a history of surgery at the same site;
6. emergency surgery; or
7. a severe medical disease, e.g. congestive heart failure, chronic renal failure.
Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

This study will address the following questions:

* Does the use of oestrogen inserted vaginally with an applicator, help with the symptoms of faecal (bowel) incontinence in women who are past the age of menopause?
* Do women find it easy to use?
* Is the treatment safe for the womb lining?
* Is there any systemic absorption of the treatment?

Faecal incontinence affects about 5% of women, the most common cause is often cited by women as obstetric trauma. However in clinical practice many women report that their symptoms of faecal incontinence begin around the same time as menopause. A community survey examining the prevalence of faecal incontinence in menopausal women is in progress. If a correlation is found between the onset of menopause and the development of faecal incontinence, further investigation of effective treatment will be indicated.

The investigators want to investigate whether vaginally administered oestradiol can alleviate or improve symptoms in women who have faecal incontinence after the menopause. This is a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women with faecal incontinence

Exclusion Criteria:

* No hormone replacement therapy (HRT) for at least 8 weeks prior to screening
* Diabetes mellitus
* Neurological disorder
* Terminal illness
* Current treatment for breast cancer
* Unable to give informed consent