cyrilzakka/clinical-trials huggingface dataset:
LANN-study: Lantus, Amaryl, Novorapid, Novomix Study

Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.

Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally accompanied by a substantial gain in body weight. This may lead to an increase in body fat resulting in a worsening of insulin resistance, leading to an increase in insulin dose needed to maintain glycemic control.

The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.

In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus. Metformin will be continued.

In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and HbA1C over 7.5% for three months or more
* BMI 25 - 35 kg/m2
* fasting plasma C-peptide level over 0.3 nmol/l
* stable metformin and sulfonylurea dose for at least three months
* stable weight for at least three months (change maximal 2 kg)

Exclusion Criteria:

* fasting glucose over 25 mmol/l
* use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
* renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
* heart failure
* pregnancy
* alcohol more than two units per day
* inflammatory or infectious diseases
* unstable chronic disease
* discontinuation of smoking within three months of randomisation date
* allergy for or intolerance of glimepiride or novorapid.
Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes

The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin, C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
* Body mass index (BMI) 20 - 40 kg/m2
* Age 18 - 70 years
* Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
* Glycated haemoglobin A1c (HbA1c) ≥ 6.0% and ≤ 7.9%
* Haemoglobin above the lower limit of the normal range (i.e. \>135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. \>10mcg/L)

Exclusion Criteria:

* Use of any medication that may influence gastrointestinal motor function, body weight or appetite
* Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
* History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests \[36\])
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal range))
* Allergy to vildagliptin or any other 'gliptin'
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Females who are pre-menopausal
* Inability to give informed consent
* Vegetarians
Development, ADL, Participation, and Quality of Life in Preterm Infants: A Longitudinal Follow Up Study

A Longitudinal Study of Function, ADL, and Quality of life of Patients with Developmental Disabilities

Preterm Infant is defined as a group of patients whose gestational age is lower than 37 weeks due to either iatrogenic reasons or maternal reasons. Preterm infant could be classified into 4 group according to gestational age: very early preterm infant, early preterm infant, midterm preterm infant, and late preterm infant. Moreover, they could be categorized into 3 groups of birth weight: extremely low birth weight, very low birth weight, and low birth weight. These varies of preterm infant are indicated to have further developmental and body-functional difficulties and lags. Under the basis of International Classification of Functioning, Disability and Health-Children and Youth Version (ICF-CY) framework, problems related to Preterm infant would further limit their activities of daily living (ADL), participation, and health related quality of life (HRQOL).

The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation and qualities in their lives. Understanding knowledges of these developmental patterns of Function and Participation in Life Activities (FPLA) and HRQOL may be helpful for anticipating and managing the problems. This study hypothesizes that the course of developmental patterns in FPLA and HRQOL of preterm infant evolve with their age. The functional recovery levels include developmental function, activity, participation, and quality of life (QOL).

This study included validity and reliability study and a prospective 2 phases, 3-years period longitudinal study of patient with preterm infant. From the first half year, 50 used-to-be preterm infant children and 50 used-to-be full-term infant children will be recruited to examine the reliability and validity of assessment tools and examiner. From the late half of the 1st and following years, 100 used-to-be full-term infant children (0-3 years old) and 200 used-to-be preterm infant children will be recruited for follow up research. All participants will receive a series of FPLA and HRQOL assessments, which are based on ICF-CY framework. Examiners will select assessment tools that appropriate to participant's age. Moreover, during this prospective longitudinal study, each participant will receive FPLA and HRQOL assessments as baseline, and re-evaluation every 6-months after the first data collection point. We believe the results of this study will refine services and supports for children with preterm infant to meet these goals.

Eligibility Criteria:
Inclusion Criteria:

* Children who were born before 37 weeks
* Age 0-3 y/o
* Agree to sign inform consent

Exclusion Criteria:

* Active medical condition (e.g. infection)
* Concurrent disease which affect nuerological development, such as cerebral palsy, or other disease not typically associated with preterm
Fluid Optimization With Crystalloids and Colloids in Neurosurgery

Fluid optimization in neurosurgical patients has an important impact on preservation of cerebral perfusion pressure and minimization of cerebral oedema during and after the craniotomy. The investigators would like to know if crystalloids or colloids are equally useful for goal directed therapy in this patients. The investigators will record haemodynamic stability, volume loading and postoperative complications and compare two groups of patients. One group will be optimised with crystalloids and the second with colloids. The investigators will compare also hospital stay and mortality in the two groups.

Hemodynamic stability and maintenance of cerebral perfusion pressure (CPP) are important in neurosurgical patients. Fluid management includes maintenance of intravascular volume, preservation of cerebral perfusion pressure and minimization of cerebral oedema. Fluid management of the neurosurgical patient has advanced from "run them dry" to "run them isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by current strategies are still unknown. Advanced techniques provide goal directed fluid therapy which is currently the gold standard in fluid strategy. In patients undergoing craniotomy diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding may lead to hypovolemia and poor cerebral perfusion. On the other hand fluid overload increases complications and hospital stay after surgery. It is, therefore, important that optimal fluid levels are achieved.

The aim of the study was to compare intraoperative hemodynamic stability, volume loading and postoperative complications between group optimised with crystalloids and group optimised with colloids in patients undergoing neurosurgical procedure. The investigation will include 80 patients, 40 optimised with crystalloids and 40 with colloids.

Hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality will be monitored during and aftre the surgery.

Eligibility Criteria:
Inclusion Criteria:

* neurosurgery (tumour, vascular, adenoma), haemodynamic stability

Exclusion Criteria:

* arrhythmia
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception for up to 10 years.

This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include provision of information to understand efficacy and safety within the widest range of possible users of the LNG20. Typically, intrauterine contraceptive studies only include women 18-35 years of age for efficacy and safety, and place limits on parity and larger body size. Women outside of these characteristics also desire an effective intrauterine contraceptive. Accordingly, this study will include women who are both nulliparous and parous as well as women less than 18 years of age in the primary efficacy and safety analyses

Eligibility Criteria:
Inclusion Criteria:

* Healthy women requesting contraception
* 16-35 years old
* Cohort 36-45 years old
* Sexually active

Exclusion Criteria:

* Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy within 24 months of study entry
* Currently breastfeeding
* Current persistent, abnormal vaginal bleeding
Pulmonary Function Tests in Children and Adolescents With End Stage Renal Disease On Regular Hemodialysis

to study pulmonary function tests in children with ESRD on regular HD and its correlation with dialysis duration and other various risk factors

End stage renal disease (ESRD) is irreversible and progressive disease which characterized by irreversible loss of kidney function. The ESRD is terminal and final pathway that resulted eventually in most of the patients suffering from medical problems affecting their renal function. Patients with ESRD need renal replacement therapy once they are established the ESRD stage via and that may either be achieved by dialysis (hemodialysis or peritoneal dialysis) or need kidney transplantation so as to be able to keep functioning normal renal life. There was an observed increase in the morbidity and mortality in ESRD patients because of the presence of the renal replacement therapy (HD or renal transplantation). Despite that ESRD may appear as a single organ dysfunction, it also affects multiple organs with variable and numerous complications which resulted in multi-organ dysfunction so the systemic complications presented in ESRD patients are very important .

One of the most important of these complications is the respiratory system dysfunction related to renal dysfunction which is a very common complication in ESRD patients . Rising in the blood urea level, may be the cause that affects the respiratory system in the form of pulmonary edema, pleural effusion and acute respiratory distress syndrome (ARDS) .

Dialysis may have beneficial effects at least in the initial stages of some respiratory disorders among CKD patients without primary lung disease. It may lead to improvement of respiratory symptoms and even pulmonary function test values.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents(more than seven years old and less than 18 years old) with ESRD on regular maintenance HD for at least six months before inclusion on the study

Exclusion Criteria:

* patients with age less than seven years or more than 18
* patients with congenital heart diseases
* patient with bronchial asthma
* patient with musculoskeletal disorders
* patient who were unable to cooperate
Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.

The goal of this clinical trial is to determine the effectiveness of a palliative care protocol in improving the quality of care of adult patients at high risk of dying hospitalized in the critical care unit.

Assessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)

Researchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.

Participants will:

1. Symptom management.
2. Respect for the autonomy of the patient and his/her family environment.
3. Respectful management of clinical information.
4. Provision of holistic care and support.

We designed a stepped wedge cluster randomized trial The study is implementation in 5 Chilean hospitals, admitting 248 patients.

Pre-intervention (control): The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.

Post-intervention: Palliative care protocol to improve the quality of care

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Hospitalization in critical care unit for more than 48 hrs.
* Medical indication of therapeutic effort limitation, defined as: a) Non-initiation or withdrawal of life support therapies: invasive mechanical ventilation, vasoactive drugs, cardiopulmonary resuscitation, renal replacement therapy.

Exclusion Criteria:

* Severe communication disorder and cultural language limitation (language other than Spanish).
* Absence of legal representative and/or caregiver.
* Brain dead patient.
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial

The primary aim of this pragmatic trial is to determine the effectiveness of a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients.

The primary objective is to determine the effectiveness of this WGS DST strategy in patients diagnosed with RR-TB. We will additionally perform an exploratory health economics evaluation of both arms, and will determine the feasibility of the WGS DST strategy.

The trial will be a single blinded randomised controlled, pragmatic, medical device trial evaluating a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients. A total of 248 patients diagnosed with RR-TB in the South African Free State province will by randomised to one of two trial arms. 124 patients will be assigned to the intervention arm, consisting of a WGS DST strategy for diagnosing drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation. 124 patients will be assigned to the control arm where the diagnosis of Mtb drug resistance and individualisation of RR-TB treatment will happen according to the Standard of Care (SOC) procedures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RR-TB
* Diagnosed with pulmonary TB (PTB) or PTB plus extra-pulmonary TB (EPTB)
* ≥18 years of age
* Able to sign informed consent
* Not on TB treatment at time of enrolment

Exclusion Criteria:

* Patients diagnosed EPTB without pulmonary involvement
* Patients with TB Meningitis or TB of the bone.
* Has any condition that, in the opinion of the investigator or physician, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives or compromise patient safety.
Surveillance of Ocular Surface Flora (SURFACE)

Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo cataract surgery
* Able to provide written informed consent

Exclusion Criteria:

* NSAID in the eye to be swabbed within the past 30 days
* Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days
* Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial
* History of conjunctivitis or any ocular infection within the past 3 months
The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine

This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.

Procedure:

Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 yo who have provided written informed consent
* Patients with an indication for elective spinal surgery using laparotomy
* Patients with national health insurance cover

Exclusion Criteria:

* Adults under guardianship
* Pregnant or breast-feeding women
* allergies or contra-indication for paracetamol, morphine-based drugs
* Contra-indication for ropivacaine
* Contra-indication for sodium chloride
* inability to understand PCA (patient-controlled anaesthesia)
* Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics
* Hypovolemia
Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury

The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation.

The aim of this study is to evaluate the effectiveness of integrated pressure index of airway occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure of weaning from mechanical ventilation in patients with traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic Brain Injury (TBI)
* Patients using artificial airway (intubation and / or tracheostomy)
* Recovery from the acute phase of the disease underlying
* Both sexes
* Ventilation mode pressure support (PSV), pressure support (PS) required to ensure a tidal volume (VT) = 6 to 8 ml / kg
* Age over 18 years
* Hemoglobin \> 7 g/dL
* Duration of mechanical ventilation longer than 24 hours
* Body temperature \< 38 degrees
* pH ≥ 7.30
* PaO2 ≥ 60 mmHg with FiO2 ≤ 0.4 and PEEP ≤ 8 cmH2O
* Glasgow Coma Scale ≥ 8 or tracheostomized
* Sedative agents minimum dosages to to maintain values of 2 or 3 on the Ramsay Scale

Exclusion Criteria:

* Admitted to the ICU with artificial airways held in other institutions
* Surgery scheduled for the next 72 hours
* Withdrawal of consent from parents at any stage of the research
Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes

A hospitals manual method of patient monitoring will be implemented in an automated system and supported by an early patient deterioration detection for timely escalation. The purpose of this study is to assess if clinical outcomes of patients in Acute Care are significantly improved by such a system.

The purpose of this study is to assess if the Philips IntelliVue Guardian Solution (IGS) with all its components can significantly improve clinical outcomes for deteriorating patients on a general medical ward prior and after referral to the hospitals' Acute Care Team (ACT). Further, to provide evidence that the Philips IGS assists to increase the efficiency of a hospital's Early Warning Scoring process (afferent and efferent arm of the escalation system).

The introduction of such an intelligent automated system offers a unique opportunity to address the breakdown in the chain of prevention by strengthening the reliability of calls-for-help to responders through a technical solution with the potential for a more timely escalation where appropriate.

In this study the hospital's Standard of Care protocol for the monitoring of vital signs (including timing, vital signs collected and escalation instructions) will be implemented in a commercially available intelligent automatic monitoring and notification system. No investigational procedures or devices are associated with this protocol.

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to the study units during the period of data collection

Exclusion Criteria:

* less than 24h on ward
Monitoring of Intensity of Stimulation and Injection Pressure in US Guided Peripheral Nerve Block According to Anatomic Needle Type Position

The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade

The needle is placed at the target under ultrasound guidance the nerve stimulator is turned on and the intensity increased until motor response is observed the Minimum Intensity Observation (MIS) is recorded before injection of local anesthetic

Eligibility Criteria:
Inclusion Criteria:

* Patient who need a Orthopedic surgery
* Peripheral nerve block
* More or equal to 18 years old
* I to III ASA classification status
* Benefit from an insurance regimen

Exclusion Criteria:

* severe coagulopathy
* allergy to local anesthetics
* local cutaneous lesion