cyrilzakka/clinical-trials huggingface dataset:
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study

Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be harmful because studies suggest that melatonin is important in protecting the brain and reducing the risk of brain injury after preterm birth. The purpose of this study is to find the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24 babies less than 31 weeks gestation and who are less than 7 days old.

PURPOSE OF THE STUDY AND OBJECTIVES The overall purpose is to investigate whether melatonin, on achieving adult maternal peak blood levels in preterm infants, will reduce brain injury and white matter disease as defined by specialised magnetic resonance imaging (MRI) at term. Before testing this hypothesis in a clinical trial, the dose of melatonin required to achieve the desired concentration in preterm infants needs to be determined. This data will be used in the clinical double blinded randomised trial for which a separate application will be made to the ethics committee.

The principal research objective in this study is to determine the dose required to achieve physiological melatonin blood levels in the preterm infants similar to that of the mother. Secondary objective is to define the pharmacokinetic profile of melatonin in preterm infants.

STUDY DESIGN AND METHODOLOGY The proposed clinical trial is a single dose, open label, dose escalation pharmacokinetic study in preterm infants less than 31weeks gestation to achieve adult peak blood concentrations of melatonin (200-250 pmol/L).

The trial will be a multi centre study based in the Neonatal Intensive Care Units in UK.

TREATMENT A single intravenous infusion of melatonin will be given to each infant over 6 hours once in the first 7 days of life. The starting dose is 0.1 microgram/kg/hr which will be increased or decreased incrementally in subsequent groups of infants until the desired melatonin concentration is achieved.

DURATION The duration of treatment will be 6 hours only.

INVESTIGATIONS Pharmacokinetic assessment will be performed on the blood and urine samples will be collected 2 hourly at various timepoints.

STATISTICAL ANALYSIS Pharmacokinetic assessment will be done using appropriate software.

Eligibility Criteria:
Inclusion Criteria:

* Infants born less than 31 weeks gestation who are less than 7 days old, after parental consent for participation will be included in the study.

Exclusion Criteria:

* Those with major congenital malformation, or cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to enrolment will be excluded from the study.
Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.


Eligibility Criteria:
Inclusion Criteria:

* patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification
* patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease
* patients with progressive disease in the previous 6 months before their inclusion in the study
* patients with positive IN111 octreotide scintigraphy

Exclusion Criteria:

* patients with surgically removable localised disease
* patients with progressive disease in the first six months of being diagnosed
* patients with intestinal obstruction due to a carcinoid tumour
* patients who have received treatment with somatostatin analogues during the 6 months before being included in the study
* patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study
* patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics

The objectives of the present study are to:

1. Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective.
2. Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective.

Research question:

Which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia?

Patient Grouping and Randomization:

Patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1

Group 1 (Aloe Vera group)

Include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash

Group 2 (Thyme honey group):

Include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash

Group 3 (Saline control group):

Include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash

Saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. It is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. Subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.Diabetes mellitus is considered one of the main causes of xerostomia There are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.Recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.

Eligibility Criteria:
Inclusion Criteria:

1. Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.
2. Patients willing to follow all the instructions and attend all the study-associated visits.

Exclusion Criteria:

1. Patients who had received radiation therapy to the head and neck region.
2. Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
3. Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
4. Patients requiring hospitalization for any medical problem during the study.
5. Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
6. Vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners.
Topical Insulin Versus Autologous Serum After Corneal Surgeries

The aim of the study is to test whether use of topical insulin or autologous serum eye-drops can promote corneal epithelial healing following photorefractive keratectomy (PRK).

Topical insulin has been proved recently to enhance the corneal reepithelization rate and manage neurotrophic corneal ulcers unresponsive to conventional treatments. However, its effectiveness on corneal epithelial wound healing in patients who received photorefractive keratectomy (PRK) has not been reported. In this study, we plan to perform a prospective non-randomized study to determine the efficacy and safety of topical insulin as a primary treatment for a corneal epithelial defect in patients undergoing the PRK and compare that to autologous serum eye drops. The study eye will receive either the insulin or the serum eye drops, in addition to the conventional treatment, while the control eye will have the standard treatment. For each eligible candidate, the eye with a higher depth of ablation will be the study eye. If even ablation depth in both eyes, the right eye will be selected. The conventional postoperative eye drops include topical moxifloxacin 0.5% (Vigamox; Alcon Laboratories) four times per day, artificial tears (Systane Ultra; Alcon) every two hours, Dexamethasone 0.1% (Maxidex; Alcon Laboratories) four times daily for one month followed by fluorometholone 0.1% (Efemyo; OrchidiaLaboratories) four times daily for another two to four weeks depending on refraction and haze level. In study eyes, the patients receive either topical insulin eye drops or autologous serum in addition to conventional postoperative eye drops until complete epithelial healing. The duration for the corneal surface to completely re-epithelize, the grade of postoperative corneal haze, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the distant corrected visual acuity will be compared between these three groups.

Eligibility Criteria:
Inclusion Criteria:

* stable refraction of at least one year, normal corneal topography, and a minimum central corneal thickness of 500 μm.

Exclusion Criteria:

* unstable refraction, dry eye, blepharitis, corneal disease, glaucoma, systemic diseases including infectious and collagen vascular diseases, diabetes, and topographical evidence of keratoconus.
Preventing the Spread of Infection in Nursing Homes

This study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent Staphylococcus aureus (SA) acquisition and infection.

Nursing homes are settings with a high rate of Staphylococcus aureus (SA) acquisition, which leads to infection, particularly for short stay residents. The current standard of care for preventing SA acquisition and SA infection in nursing homes is Standard Precautions (gowns and gloves for anticipated contact with blood, body fluids, skin breakdown or mucous membranes) for all residents.

The investigators propose a feasibility study of a novel strategy, the addition of targeted gown and glove use, to prevent SA acquisition and SA infection in residents of nursing homes. Rather than wearing gowns and gloves for all care activities to prevent transmission, gown and glove use can be targeted to specific high risk "moments" of care for specific high risk residents. High risk "moments" for gown and glove use are care activities most likely to transmit SA based on prior research. Residents with chronic wounds and medical devices are: 1) most likely to be colonized with SA; 2) most likely to acquire SA; 3) most likely to transmit SA to healthcare worker clothing and hands; and 4) most likely to develop a SA infection based on prior research and thus would be considered high risk residents.

The investigators will perform a quasi-experimental (before-after) study of this intervention, targeted gown and glove use, at two community-based nursing homes to demonstrate its feasibility and evaluate its effect on SA acquisition and SA infection rates.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Reside in a participating nursing home

Exclusion Criteria:

* Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
MHealth Biometrics for Young People with Diabetes

The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in children with diabetes. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.

Staff from the Children's Diabetes team at Oxford University Hospitals NHS Foundation Trust will identify patients during routine multidisciplinary team (MDT) clinics. 30 young people with diabetes will be recruited and randomly assigned to one of two groups (Active control n=15, Intervention n=15). Following baseline measures all patients will then complete the 12 week Here for Health (HfH) Healthy lifestyle programme designed by the Diabetes team at Oxford University Hospitals NHS Foundation Trust. Following the initial HfH intervention period assessments will be repeated (T2) before a second 12 week intervention period is completed. Active control patients will receive no further input. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 5 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates. Following the second intervention period assessments will be repeated for a final time (T3). Testing at baseline and following the 2 interventions will include changes in physical activity, blood pressure, glycaemia control, body composition and diet.

Eligibility Criteria:
Inclusion Criteria:

* Receiving input from the Here for Health Healthy Lifestyle Programme
* Aged 12-18 years
* Diagnosed with type 1 diabetes
* Type 1 diabetes diagnosis more than 1 year ago
* Hypoglycaemic aware or on a continuous glucose monitor (CGM) with alarms
* Willing to attend additional education on managing blood glucose and exercise
* Diagnosed with type 2 diabetes and on a stable metformin dose for 3-months or more
* BMI centile \> 91st
* Access to internet-enabled device for video calling

Exclusion Criteria:

* Severe learning/behaviour difficulties
* Severe autism
* Unstable blood glucose levels
* Glucose lowering medications other than metformin
* Underlying medical conditions that contraindicate physical activity
Osteomyelitis: Procalcitonin to Diagnose and Monitor Osteomyelitis

The investigator plans a cohort study of 80 subjects admitted to hospital with a diabetic foot infection in order to compare serial bone biopsies (the current "gold standard") and procalcitonin to diagnose and monitor the effectiveness of therapy for osteomyelitis. The investigator will collect specimens as part of an existing trial to evaluate negative pressure wound therapy in diabetic infected wounds. A high proportion of these patients have osteomyelitis and will receive standard therapy including repeat bone biopsy and parenteral antibiotics. The investigator expects repeated measurement of procalcitonin will be highly correlated with repeated bone biopsy after antibiotic treatment has been completed to determine if therapy has been successful or if additional antibiotic therapy is needed.

There is a world-wide epidemic of diabetes. As part of the epidemic lower extremity amputations are dramatically increasing. Soft tissue and bone infections are one of the most common reasons for amputation. It is often difficult to determine if diabetic foot ulcers have an underlying bone infection. Inaccurate diagnosis of osteomyelitis leads to unnecessary antibiotic treatment, surgery, and amputation. In addition, we do not have good diagnostic tools to determine when osteomyelitis has been treated successfully.

The role of biomarkers specific to bone turnover (resorption and formation) in relation to bone infections is poorly understood. We know that remodeling is an essential function in bone physiology with increased osteoclast production leading to resorption of old bone coupled with increased osteoblast production associated with new bone formation. The balance between these two functions is known to be disrupted in disease states including osteoporosis, but has not been examined specifically in infected bone. Procalcitonin has been suggeasted as a tool to both diagnose and monitor the effectiveness of therapy for various infections, but there is very little work in diabetic foot osteomyelitis.

Aim 1. To evaluate the role of procalcitonin as a screening tool to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis.

Aim 2. To determine the role of procalcitonin as a management tool to determine osteomyelitis treatment success versus treatment failure (indicated by bone biopsy) after completing a standard course of antibiotics for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Age ≥ 21 years
* Infectious Disease Society of America stage 3 infection

Exclusion Criteria:

* History of previous bone infection in the study foot
* Unable to provide informed consent
* HIV, Hepatitis, osteomyelitis at other sites
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis

This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \\and hardware complications.


Eligibility Criteria:
Inclusion Criteria:

* Painful Hallux Limitus or Rigidus
* Painful Geriatric Hallux Valgus
* Failed prior 1st MTP joint arthroplasty (hemi-total)
* Arthritis of any etiology other than degenerative causes

Exclusion Criteria:

* Age less than 18 years
* Pregnant Females
* Active or prior infection at the target joint
* Immunocompromised patients
* Patients unwilling to sign informed consent
* Patient's unwilling to participate the in study protocol
* Subject with known sensitivity to titanium implants
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.

Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 30 study subjects for a period of one year with serial testing of cognition and function.

Eligibility Criteria:
Inclusion Criteria:

* NINCDS-ADRDA Criteria for Alzheimer's disease
* CT or MRI consistent with AD

Exclusion Criteria:

* active infection
* CHF
* demyelinating disease
* uncontrolled diabetes mellitus
* vascular dementia
* clinically significant neurologic disease other than AD
* Hachinski \>4
* history of lymphoma
* TBC
* wbc\<2500
* platelets\<100,000
* HCT\<30
* pregnancy
* premenopausal, fertile not on acceptable birth control
* change in neuroactive medication within 4 weeks of study initiation
Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV) bundle strategy compared with a conventional treatment in postoperative patients with ARF.

This is a randomized, prospective, open-label study. Postoperative patients with ARF included in the study were randomly assigned to intervention group or conventional treatment group. In the intervention group, NIV was early used for treatment of postoperative respiratory failure, if patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions , if patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol during the NIV session.

Patients assigned to the control group received supplemental oxygen, Respiratory therapists delivered this intervention using conventional masks or venturi oxygen, and adjusted FiO2 to achieve arterial O2 saturation of more than 92%. The application of noninvasive ventilation was considered, if patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate\>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2\> 0.5 or breathing at least 10 l/min oxygen.

All the patients were continuous monitored of vital signs.whereas arterial blood gases were analyzed before NIV and 1h after NIV, before and after FBO, and once a day and in the case of any change either in the ventilatory settings or in the FIO2; duration of noninvasive ventilation, the rate and cause of endotracheal intubation, ICU and hospital mortality and length of stay in the ICU and in hospital, study procedure related complications.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative patients with acute respiratory failure (ARF) were included in the study,who had to meet one of the following criteria
* Respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more)
* Partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 250
* Dyspnoea with respiratory rate \> 25 breaths/min or use of accessory respiratory muscles or paradoxical abdominal breathing

Exclusion Criteria:

* Cardiac or respiratory arrest; loss of consciousness
* Facial trauma or surgery or deformity sufficient to preclude mask fitting
* Active upper gastrointestinal bleeding
* Haemodynamic instability or unstable cardiac arrhythmia
* Multiple organ failure