cyrilzakka/clinical-trials huggingface dataset:
A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64

Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences including development of necrotizing enterocolitis (a serious, potentially life-threatening gastrointestinal illness in premature babies), late-onset infections, resistance to antibiotics, increased length of hospital stay, and death.

Starting and continuing antibiotic therapy for blood culture-negative infections in the neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying from 20%-90% of infants undergoing a sepsis evaluation in the NICU.

While blood culture results are the gold standard, there is usually a delay of up to 48-72h before the results are known. Hence, initiation and continuation of antibiotic treatment are usually based on clinical evaluation and blood count criteria which do not possess high specificity or sensitivity, and may be unreliable in the first few hours after birth or in the early stages of infection.

Since the investigators found that neutrophil CD64 (a type of protein found on the surface of a type of white blood cell that can be detected quickly in a very small amount of blood sample) has high accuracy for early detection of blood culture-proven infections in newborn babies, with extremely high negative predictive value (can identify babies definitively with no infection), the investigators will use this test to decide whether to stop or continue antibiotics in the NICU.

The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue antibiotics in newborns suspected of having infections.

The investigators aims are to utilize sequential measurements of CD64 values to stop antibiotics early in neonates being investigated for both early and late-onset infections in the NICU.

This is a prospective, randomized, controlled (RCT) trial. The study population will be derived from the sub-set of all newborn infants who have undergone investigations for presence of infection in the NICU.


Eligibility Criteria:
Inclusion Criteria:

* Infants undergoing a sepsis evaluation in the NICU

Exclusion Criteria:

* They have a major life-threatening congenital malformation
* The attending neonatologist has objections to the infant participating in the study
Tart Cherries and Melatonin Content

The aim of this investigation was to examine the effects of tart Montmorency cherry juice on urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled, cross-over design.

The aim of the study is to examine the efficacy of tart cherry juice on sleep quality, quantity, and timing. Naturally circulating melatonin is instrumental in regulating sleep/wake schedules. Tart Montmorency cherries (Prunus Cerasus) contain high levels of melatonin and may be a useful intervention to supplement for realignment of circadian phase and by increasing the robustness of circadian amplitude. In normal healthy adults, with experimentally induced phase advanced circadian misalignment, the administration of a 3mg supplement of melatonin significantly increased sleep architecture characteristics. In this study we want to examine the efficacy of tart cherry juice in increasing urinary levels of melatonin and the subsequent impact this will have on sleep parameters.

Eligibility Criteria:
Inclusion Criteria:

* Equal numbers of healthy, non-pathological males and females aged between 18-39.

Exclusion Criteria:

* history of epilepsy, current episode of major depressive disorder or anxiety disorder, or a current sleep problem or an inability to comprehend English, travel over two time zones within the last six months, excessive alcohol (over 3 units per day) or caffeine consumption (more than 6 caffeinated drinks or 1 after 6pm), a smoker, a shift worker, a familial history of diabetes, users of medication or supplements, or if the participant is pregnant or currently lactating.
Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations

The purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie, France) when administered to healthy volunteers under fasting conditions. The plasma pharmacokinetic data of gliclazide obtained from two formulations will be used to access the interchangeability of the products.

The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, healthy male subjects will be administered a single oral dose of 80 mg gliclazide (one BF-Gliclazide Tablet 80 mg or one Diamicron 80 mg Tablet) after an overnight fast of approximately 10 hours. 20% glucose will be given orally to each subject at 2 h after drug administration to minimize the risk of hypoglycaemia. Venous blood samples will be collected at pre-dose (0 h) and up to 72 hours post-dose. The plasma concentrations of gliclazide will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf and T1/2. ANOVA will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one-sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two products.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18 to 27
* Accessible vein for blood sampling
* High probability for compliance and completion of the study
* No significant abnormalities in general physical examination
* ECG recording within normal limits
* Biochemical and haematological parameters within normal limits
* Subjects must agree to take effective contraceptive methods to prevent his partner from becoming pregnant during the time of first dose of study medication until one week of last dose administration

Exclusion Criteria:

* History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
* Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test
* Tabacco use in any forms
* Regular consumer of alcohol
* Blood donation within 4 weeks prior to the start of the study
* Use of gliclazide within 4 weeks before the study
* Use of antidiabetic medications within 4 weeks before the study
* Volunteer in any other clinical drug study within 2 months prior to this study
* Hypersensitivity to gliclazide or other drugs in its class
* History of drug abude in any form
Impact of COVID-19 on Mental Health of Patients With Skin Picking

Skin Picking Disorder (SPD) affects up to 10% of the general population, causing significant socioeconomic damage in 75% of affected individuals. It is characterized by the repeated habit of touching the skin itself, causing or aggravating wounds, with difficulty in controlling the habit. It is associated with anxiety disorders in about 20% of cases and with depressive disorder in about 50%. Patients with SPD have difficulties in regulating emotions, being more vulnerable to having their mental symptoms aggravated in face of stressful situations, such as the current coronavirus-19 pandemia. Among the treatments available to SPD, cognitive behavioral therapy is the only intervention superior to placebo, and there is still no medication approved by the FDA indicated specifically to SPD. The effectiveness of cognitive behavioral therapy was assessed in a randomized clinical trial with Brazilian patients with SPD, but its long-term benefit has not yet been evaluated. Additionally, telemedicine interventions can be effective and used during pandemia, but the effectiveness of internet delivered cognitive behavioral therapy for SPD is not clear yet.

This study is a randomized clinical trial, in which patients diagnosed with skin picking disorder (SPD) will be evaluated and, if symptomatic for the disease, will be randomized to one of the arms: intervention arm with 2 booster sessions of cognitive behavioral therapy in online format; active control arm, in which individuals will watch videos with quality of life orientation. Patients included in this study are coming from a brazilian clinical trial conducted between the years of 2014 and 2018, in wich patients with SPD were treated with a cognitive behavioral treatment protocol in individual or group formats, resulting in improvement of SPD symptoms and comorbid anxiety and depression. Before the intervention, individuals will be evaluated by a psychiatrist, to assess SPD and comorbid symptoms severity, thru the application of some instruments to assess SPD, anxiety, depression and emotional regulation. Also, the CRISIS questionnaire, about the impact of COVID-19 in mental health, will be applied. After the interventions, the instruments will be applied again, by the same evaluator, wich is blinded to the type of intervention that the patient received.

Eligibility Criteria:
Inclusion Criteria:

* Skin picking as a primary diagnosis
* Treatment with cognitive behavioral therapy in the past, received in previous clinical randomized trial conducted by our research group between 2014 and 2018

Exclusion Criteria:

* Acute psychotic disorder, bipolar affective disorder in an acute episode, substance use disorder (except tobacco), severe depressive episode or suicidal ideation, dementia
In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.

Non-dispensing, single-masked (subject-masked), randomised, controlled study.

Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy
3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
4. be able and willing to adhere to the instructions set forth in the protocol.
5. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
6. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
7. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
8. be in good general health, based on his/her knowledge.
9. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion Criteria:

1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
2. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
3. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
4. Slit lamp findings that would contraindicate contact lens wear such as:

   * Pathological dry eye or associated findings
   * Pterygium or corneal scars within the visual axis
   * Neovascularization \>1mm in from the limbus
   * History of giant papillary conjunctivitis (GPC) worse than Grade 2
   * Anterior uveitis or iritis (past or present)
   * Seborrhoeic eczema, seborrhoeic conjunctivitis
5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
6. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
7. Aphakia, keratoconus or a highly irregular cornea.
8. Current pregnancy or lactation (to the best of the subject's knowledge).
9. Active participation in another clinical study at any time during this study.
Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkins lymphoma patients to compensate for reduction in RT.


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed primary diagnosis of classical Hodgkin's lymphoma.
2. patients under 18 years of age on the date of written informed consent. In specialized Teenage and Young Adult (TYA) units in Australia, France, Italy, New Zealand and United Kingdom patients up to under 25 years of age can also be enrolled. Lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients.
3. written informed consent of the patient and/or the patient's parents or guardian according to national laws.
4. negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential

Exclusion Criteria: (Patients with one or more of the following criterion are excluded)

1. prior chemotherapy or radiotherapy for other malignancies
2. pre-treatment of Hodgkin's lymphoma (except for steroid pre-phase to a maximum of 7-10 days for emergency treatment of a large mediastinal tumour).
3. diagnosis of lymphocyte-predominant Hodgkin's lymphoma
4. other (simultaneous) malignancies
5. contraindication or known hypersensitivity to study drugs
6. severe concomitant diseases (e.g. immune deficiency syndrome)
7. known HIV-positivity
8. residence outside the participating countries where long term follow-up cannot be guaranteed
9. pregnancy and / or lactation
10. patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
11. current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial
Sirtuin Mediated Effects of 36 Hour Fast and 1 Hour Exercise

Hypothesis: during fasting and exercise will there be an activation of sirtuins (Sirt1).

Primarily the investigators will investigate Sirt1 activity in muscle- and fat-biopsies after fasting for 36 hours and after 1 hour of ergometer-cycling at 50 Vo2max.

In addition to this the investigators will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.


Eligibility Criteria:
Inclusion Criteria:

* healthy men
* Body mass index (BMI) 20-26
* age 18-45 years

Exclusion Criteria:

* any kind of disease
* any use of medicine
Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent surgery for pelvic floor prolapse

Exclusion Criteria:

* Women who did not have surgery for pelvic floor prolapse.
Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis

The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.

Flexion contractures of the knee are quite disabling. They produce deleterious effects on knee biomechanics, quadriceps function, energy expenditure during gait and the overall ability to ambulate. These deformities occur secondary to a number of different etiologies including; congenital, traumatic, inflammatory and neuromuscular disorders with cerebral palsy (CP) being on the top of the list.

The main aim of correction of sagittal plane deformities of the knee is to restore the range of motion. Surgical options available for correction of knee flexion contractures include soft tissue modification, acute correction by osteotomies, gradual correction by external fixators and growth modulation by hemiephysiodesis.Extensive soft tissue surgery may be needed for correction of knee deformities with potential risk of neurovascular damage and wound complications. Supracondylar extension osteotomies have been widely used, however prolonged immobilization and associated neurovascular insults have always been major concerns. External fixators are cumbersome and may produce muscle tethering and pin tract infections.

There are few studies in the literature reporting the use of anterior hemiepiphysiodesis for correction of knee flexion contracture.

Our study question can be summarized as follows; Is hemiepiphysiodesis by eight plates effective for correction of fixed knee flexion deformities in children ?

Eligibility Criteria:
Inclusion Criteria:

* Fixed knee flexion deformity more than 10°
* Unilateral or bilateral cases
* 12 months or more predicted growth remaining
* No response to non-operative treatment (physical therapy, bracing, casting);
* Recurrent cases

Exclusion Criteria:

* Dynamic deformities due to spasticity
* Deformities responding to conservative treatment
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ICH and no acute medical therapies have been shown to definitely alter outcome in ICH.

The INTERACT2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive BP lowering, and effects on haematoma expansion within 6 hours of onset of ICH. Having established 'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion, INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in patients with ICH recruited from an expanding clinical network around the world.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
* Elevated systolic blood pressure (\>150mmHg and \<220mmHg)
* Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
* Able to be 'actively' treated and admitted to a monitored facility

Exclusion Criteria:

* Clear indication or contraindication to intensive BP lowering.
* Evidence ICH secondary to a structural abnormality
* Use of thrombolytic agent
* Previous ischaemic stroke within 30 days
* A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
* Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
* Significant pre-stroke disability or advanced dementia
* Planned early neurological intervention
* Participation in another clinical trial.
* A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
The Effect of Cold Application on Patient's Pain, Comfort and Satisfaction After Cesarean Section

A healthy postpartum period is important for the health of the mother and baby. One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. However, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain. Non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine. The cold application examined in our research, is among these applications. participants will be determined by the block randomization method. Cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up. Only the routine practice of the clinic will be applied to the control group. Data; will be collected using the introductory information form, visual analog scale (VAS) and cold application satisfaction evaluation form. When the studies were examined, no other study was found in the same application as our study. Therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women who had cesarean section surgery
* Having had a previous cesarean section,

Exclusion Criteria:

* Those who have problems in postpartum vital signs and bleeding control
* Those who have systemic diseases that may affect cold application
* Those who are distressed and not suitable for practice by the service midwives and doctors,
* Those who do not want to participate in the research