cyrilzakka/clinical-trials huggingface dataset:
Telmisartan in Mild to Moderate Hypertensive Patients

To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM


Eligibility Criteria:
Inclusion Criteria:

* Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex

Exclusion Criteria:

* Suspected or known diagnosis of arterial hypertension with a secondary cause
* Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
* Systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 115 mm Hg
* Laboratory test values two fold above the upper normal limit
* Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
* New York Heart Association class III or IV heart failure
* History of stroke in the 6 months prior to entry into the study
* Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels \> 140 mg/dL on 3 consecutive assessments
* Patients who were included in another investigational drug study in the past 30 days
Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.

Executive dysfunction is endemic after severe acquired brain injuries (ABIs) and is highly associated with long-lasting psychosocial distress, problems in a multiplicity of everyday activities and overall reduced quality of life. There is increasing evidence to suggest that a novel behavioral intervention is a treatment of choice for executive dysfunction. However few studies have addressed ecological relevance: failing to take into account the significant impact of the complex settings of real life on executive function. More data are desperately needed in this area given the devastating consequences of ABI. We propose to investigate the benefits of two community- based interventions.

Eligibility Criteria:
Inclusion Criteria:

* fluent in written and spoken English,
* have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke,

Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.
Fabry Screening Study

To determine if patients with a deficiency of alpha-galactosidase A are at-risk for cardiac complications that commonly occur in the general population

Fabry disease is an X-linked deficiency of alpha-galactosidase A resulting primarily in an accumulation of globotriaosylceramide (Gb3) in virtually all organs and systems. The main complications of Fabry disease are a 20-fold increased risk of ischemic stroke, cardiac disease including cardiomyopathy, atrio-ventricular conduction defects, a wide variety of arrhythmias, valvular dysfunction (insufficiency or stenosis) and cardiac vascular disease as well as progressive renal failure. Fabry disease cannot be easily diagnosed in patients with routine EKGs, echocardiograms or MRIs. Screening non-selected at-risk populations of patients with ischemic stroke or cardiac disease for urinary Gb3, alpha-galactosidase A activity and GLA gene mutations should enable the identification of patients previously undiagnosed with Fabry disease among the general population of patients with heart disease and stroke

Eligibility Criteria:
Inclusion Criteria:

* Any diagnosis of heart disease.
* Male or Female
* Able to donate 12 cc of whole blood and 10 cc of urine

Exclusion Criteria:

* No diagnosis of cardiac disease.
* Unable to donate 12 cc of whole blood and/or 10 cc of urine
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy

The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the study population: Adults, who consult at the department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* 40 patients
* ≥ 18 years of age
* scaling and rootplaning received at least 3 months ago
* Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:\> 5mm or 5 and BOP+
* Willing and able to give written informed consent

Exclusion Criteria:

* patients with aggressive periodontitis
* patients who smoke
* pregnant or lactating woman
* patients with poorly controlled diabetes
* patients taking bisphosphonate mediation
* patient who had taken systemic antibiotics 3 months prior to treatment
Effectiveness of an Oral Feeding Educational Nurse Program on Feeding Performance in Preterm Neonates

Poor oral motor development in preterm neonates is common. Feeding problems lead to longer hospital stay and higher hospital cost. Different interventions have shown their efficacy to accelerate transition and move faster to full oral feeding autonomy. Our study aimed to evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay of preterm neonates.

This is an interrupted time series study placed in Intensive Care and Neonatal unit of an university hospital located in Lyon, France. All preterm neonates are included in the study, from April 2013 to January 2016.


Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates of less than 34 weeks' of gestation
* Preterm neonates not requiring surgery with endotracheal intubation
* Preterm neonates hospitalized in the Neonatology and Neonatal Intensive Care Unit of an university hospital, Lyon.
* Preterm neonates discharged from hospital during the study period from April 2013 to January 2016

  --- Exclusion Criteria:
* Preterm neonates presenting delivery age above 34 weeks' of gestation
* Preterm neonates whose parents have expressed their opposition to participate to the study
Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed

SCV-07 (γ-D-glutamyl-L-tryptophan) is a new immunomodulatory compound that has been developed and patented both for composition and immunomodulatory use and is a synthetic dipeptide. The efficacy of SCV 07 in treating chronic hepatitis C virus (HCV) infection is expected to arise from the drug's ability to stimulate the T-helper 1 (Th1) type immune response and to block signal transducers and activator of transcription 3 (STAT3) mediated signaling. The purpose of this study is to determine if SCV-07 alone and/or SCV-07 in combination with ribavirin is safe and potentially effective for the treatment of genotype 1 compensated chronic hepatitis C in subjects who have relapsed after a response to a previous treatment course of at least 44 weeks with pegylated interferon and ribavirin. All subjects will receive 4 weeks of SCV-07 (Lead-in Phase), followed by 4 weeks of treatment with SCV-07 in combination with ribavirin (Combination Treatment).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects must have compensated liver disease
* Subjects must have a history of chronic hepatitis C (genotype 1), and must be relapsers
* Subject's HCV RNA viral load must be \> or = 300,000 IU/mL
* Subjects must have documentation of a liver biopsy within the last 2 years

Exclusion Criteria:

* Human immunodeficiency virus (HIV) infection or hepatitis B surface antigen (HBsAg)-positive
* Clinical evidence of cirrhosis
* Autoimmune hepatitis or other autoimmune/immune-active diseases
* Insulin-dependent diabetes
Conservative Management of CIN2 Lesions and Biomarkers Evaluation

Prospective study including women aged 25-45 years, adherent to the cervical screening program of four different centers of the Veneto region, with a diagnosis of CIN2 lesion. After enrollment according to predefined criteria, and informed consent to participate, the CIN2 lesions are managed by follow-up; cases with progressive lesions will be treated immediately, cases with CIN2 persistence for more than 12 months will be treated as well. Viral, molecular and immunocytochemical biomarkers will be studied, and evaluated in relation to the clinical outcome.

Women aged 25-45 years, adherent to the organized population-based cervical screening program, with a histological diagnosis of CIN2 and fulfilling the inclusion criteria will be invited to participate to the study, previously providing specific information; in case of acceptance, informed consent is signed.

STUDY PROTOCOL:

The adherent women will attend periodical control visits:

* every 6 months up to 24 months, with performance of: pap test (PT) and colposcopy (with biopsy in case of visible alterations);
* at 6 and 12 months control visit: a liquid-based sample of cervical cells will be collected for the biomarkers' analyses.

BIOMARKERS:

1. - HPV search and partial HPV16/18 genotyping, by cobas 4800 high-risk HPV assay (Roche); PCR with MY09/MY11 consensus primers and full genotyping by restriction fragment length analysis, plus PCR with beta-globin primers (in-house);
2. - methylation analysis of the cellular genes FAM194A and hsa-mir124-2, by methylation-specific quantitative PCR test (qMSP - QIAsure methylation test, Qiagen);
3. - methylation analysis of the L1 and L2 viral genes of HPV types 16 and 18, by pyrosequencing;
4. - immunocytochemical analysis for p16INK4A/Ki67 proteins (dual stain), by p16INK4A/Ki67 immunocytochemical analysis by CINtec Plus kit (Roche).

Eligibility Criteria:
Inclusion Criteria:

* age range 25-45 years,
* CIN2 lesions located in the exocervix and completely visible at colposcopy.

Exclusion Criteria:

* age \>45 years;
* history of previous high-grade lesions;
* squamo-columnar junction not completely visible (type 3);
* cytology with suspect or indicative for invasive lesion;
* lesions exclusively located in the endocervix;
* lesions located in the exocervix but not completely visible;
* pregnancy
Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG

In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.

Anaesthesia was induced by sevoflurane in oxygen. Cisatracurium 0.15 mg kg-1 was administered after loss of the lash reﬂex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow of 2 L min-1. Anesthesia was maintained by sevoflurane or sevoflurane+60% nitrous oxide respectively. The surgical incision was performed at least 30 min after tracheal intubation, provided that the predetermined end-tidal sevoflurane concentration had been constant for at least 30 min and that the difference between inspired and end-tidal concentrations was less than 10%.

Brain electrical activity was measured using Narcotrend Monitor and S/5 Compact Anaesthesia Monitor, which displayed unprocessed EEG and burst suppression ratio, respectively. The design of the experiment is referred to the "Dixon up-and-down" method. To avid anaesthesia awareness, the first subject was designed to receive end-tidal sevoflurane concentration of 2.5 %. The presence or absence of isoelectric EEG (Entropy Module) of the preceding patient determined the end-tidal concentration of sevoflurane given to the next patient (with an increment size of 0.2%). The isoelectric EEG was considered as significant when the isoelectric state last for more than 1 min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached.

Eligibility Criteria:
Inclusion Criteria:

* between 45 to 64 years old
* ASA physical status class 1 or 2
* elective abdominal surgery
* Informed Consent

Exclusion Criteria:

* history of neurological disease
* received central nervous system-active drugs
* cardiac ejection fraction less than 40%
* history of difficult intubation or anticipated difficult intubation
* daily alcohol consumption
* obesity, defined as a body-mass index of more than 30
* without informed consent
* others judged inappropriate as subjects for the study by the Study Chair
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control.

The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.

Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. The aim is to investigate this association with an interventional studydesign.

Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up.

The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24 hour period.

Eligibility Criteria:
Inclusion Criteria:

* Chronic acidosis (plasma-bicarbonat under 22 mmol/l at multiple measures within the last 12 months).
* Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below 30 ml/min/1,73 m2)
* Of legal age and over 18 of years
* Understand danish and understand the written material
* Able to cooperate about the diet
* Able to take pictures with their phone or willing to learn

Exclusion Criteria:

* Vegan and vegetarian with very low intake of animal protein (below 25 g/day)
* Pregnant or breast feeding
* Patients with short bowel syndrome, brickre's bladder, pancreatitis or any other known malabsorption problem
* Potassium above 5 mmol/l
* Ongoing infection
Combined Ultrasound and Fluoroscopy-guided Technique for Anterior Hip Denervation

Hip fracture is a challenging geriatric problem for health care professionals, especially in patients with multiple comorbidities. In patients with inoperable hip fractures secondary to severe comorbid conditions, the pain can lead to significant challenges in nursing care.

A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported.

The aim of this study is to help to target a suggested optimum landmark and determine the volume of injectate that can cover the distribution of the anterior articular branches supplying the hip joint.

The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as reported by previous anatomic studies. The anterior capsule is the most richly innervated section of the joint.

Ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline.

With the current understanding of the complex innervations of the hip joint, it is difficult to provide complete effective radiofrequency ablation to the articular branches supplying the hip joint. Chemical hip denervation using ultrasound was reported by previous case reports or series without mentioning a well-defined target point or an optimum injectate volume.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I, II, and III.
* Patients scheduled for elective or emergent hip fractures.

Exclusion Criteria:

* Patient refusal.
* Neuromuscular diseases (as myopathies, myasthenia gravies...)
* Hematological diseases, bleeding, or coagulation abnormality.
* Psychiatric diseases.
* Local skin infection and sepsis at the site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Multiple trauma patients.
Non Invasive Continuous Blood Pressure Sensor

The primary objective of this study is to collect training data in order to establish a method for correlating arterial blood pressure with voltage output signals from a non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery.

The primary objective of this study is to collect training data in order to establish a method for correlating arterial blood pressure with voltage output signals from a non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery. The development of this sensor could allow for non-invasive continuous measurement of arterial blood pressure.

The key hypothesis is: if the piezoelectric array sensor can detect pulsatile pressure waves when placed on a near surface artery and pulse wave analysis has been shown to allow for accurate beat-to-beat estimation of blood pressure, then the device placed superficial to a near surface artery should allow for the non-invasive estimation of continuous blood pressure.

Secondary objectives include identification of any significant ergonomic and motion artifact issues that could affect sensor utilization in future applications.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18yr and older)
* Undergoing a planned (non-emergent, non-urgent) surgical procedure at DHMC for which an invasive arterial pressure monitor is standard clinical practice. Typical surgical procedures include but are not limited to craniotomy, thoracic surgery, abdominal surgery, and others.

Exclusion Criteria:

* Morbid obesity (BMI \>40)
* Radial artery depth \> 1cm from skin at location of sensor
* Peripheral vascular disease
* Atrial fibrillation
* Sensitivity or allergy to silicone or medical adhesive tape
* Inability to consent.
Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. Patients with cirrhosis \& type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.

Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH \& regular insulin or Glargine \& Glulisine.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized type 2 Diabetes Mellitus with liver cirrhosis
* Entry blood glucose (fasting or random) greater than 180 mg%

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Pregnancy
* Steroids: prednisone greater than 7.5mg/day or equivalent
* Serum Creatinine \> 3 mg/dl
* Patients in intensive care units.
Carbohydrate Use During and Following Exercise

Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO) during exercise delays the onset of fatigue and improves exercise performance by maintaining high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the preferential CHO source found in sports drinks. However, during the intestinal absorption of large amounts of glucose (\>1.2 g/min), sodium-dependent glucose transporters (SGLT1) may become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an effort to evade this limitation, research has suggested using multiple transportable carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are combinations of simple sugars that use different intestinal transporters during the absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to provide exogenous fuel during and following prolonged exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* 18 - 40 years of age
* Endurance trained cyclist/triathlete
* VO2 max ≥ 50 ml/kg/min
* BMI \< 25 kg/m2

Exclusion Criteria:

* Use of medication
* Smoking