cyrilzakka/clinical-trials huggingface dataset:
ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.


Eligibility Criteria:
Inclusion Criteria:

* Primary hypercholesterolaemia:
* Statin naïve subjects (LDL-C level \> 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level \> 3.1 mmol/L).
* CV risk \> 20%,
* history of CHD or other established atherosclerotic disease

Exclusion Criteria:

* History of severe adverse events with another HMG-CoA reductase inhibitor
* Secondary hypercholesterolaemia;
* Unstable cardiovascular disease;
* Uncontrolled diabetes, active liver disease;
* Severe hepatic or renal impairment;
* Treatment with cyclosporin.
Functional Mobility in the Elderly: Influence of Morphological, Neuromuscular and Training Parameters

Life expectancy and elderly population are increasing. Health professionals try to provide longevity with good quality of life for this population, through the functional independence maintenance. In this context, physical exercise has an important role, specially the strength training. The ability to produce muscle strength is positively associated with the functionality and independence of older people. Different types of strength training can lead to different neuromuscular and functional gains. These types of interventions can help health professionals to determine characteristics of training for the elderly, aiming the maintenance of their functional independence. Thus, the purpose of this study is to determine the effects of a concentric strength training versus a concentric-eccentric strength training for knee flexors and extensors on structural, neuromuscular and functional parameters in older people, as well as to investigate the effect of a detraining period. Additionally, the investigators will try to identify which structural and neuromuscular parameters of lower limbs are better related to the functionality.


Eligibility Criteria:
Inclusion Criteria:

* Male;
* 65 years of age or more;
* able to walk independently;
* not engaged in regular physical exercise.

Exclusion Criteria:

* Auditory, vestibular, visual and/or neuromusculoskeletal impairments that could influence the tests and the training;
* severe cognitive impairment;
* lower limb surgery;
* osteoporosis;
* lower limb pain.
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation

A study comparing atrioventricular junction ablation (AVJA) versus continued optimum medical rate control in patients with cardiac resynchronization therapy (CRT) and atrial fibrillation (AF) with suboptimal heart rate control on optimum medication.

Patients fulfilling the enrolment criteria will be randomly (randomization with variable blocks of 4, 6, and 8 patients) allocated to intervention and control groups in a 1:1 ratio. AVJA will be done in patients belonging to the intervention group without undue delay after the randomization. The procedure will be repeated in case of recovery of AV nodal conduction during the trial.

CRT device will be programmed to a base rate of 70 bpm, hysteresis switched off, and rate response functions activated unless not tolerated by the patient. The triggered mode will be encouraged.

All patients will be regularly followed in outpatient clinics. Cross-over to the AVJA study arm will be considered and performed at any time during the trial at the discretion of the operators. This may particularly concern patients with clinical deterioration in terms of functional status, quality of life, systolic left ventricular function, and/or repeated hospitalization, and in whom biventricular pacing (BiVP%) \<\<100% could be suspected as a significant underlying factor.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with CRT using either a biventricular pacemaker/defibrillator or conduction system pacemaker (\>6 months)
* Diagnosis of AF and classified as: permanent AF or recurrent persistent AF, requiring emergency visits and/or hospitalizations (at least one in recent year)
* Optimized HF medical treatment and rate control medication
* BiVP% + ventricular premature complex (VPC%) \<99% and \>85% during the minimum period of 1 month while already on optimum medical therapy (applicable only for patients with permanent AF)
* Age \>18 and \<85 years
* Signed informed consent

Exclusion Criteria:

* myocardial infarction (MI) or coronary artery bypass graft (CABG) \<3 months
* Technical failure of the CRT system
* Intentional preference for spontaneous AV conduction
* Expected survival \<1 year
* Other significant comorbidities and/or conditions that interfere with the proper conduction of the trial
* Dementia as assessed by mini-mental test (\<23 points)
Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist

This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.

This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 to 75 years old at the time of signing the informed consent.
2. Diagnosed with type 2 diabetes ≥ 180 days before screening.
3. HbA1c value at screening of ≥ 7.0% (53 mmol/mol) and ≤ 10% (86 mmol/mol).
4. On a stable maintenance dose of an injectable GLP-1 RA.
5. At Screening, have a BMI ≥ 27 kg/m2

Exclusion Criteria:

1. Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA).
2. Self-reported weight change of \> 5 % in the 3 months prior to screening.
3. Diabetes mellitus that is not clearly type 2 diabetes.
4. Use of insulin therapy for T2DM
5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis)

8. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
Bioactive Glass Composite Implants in Cranial Bone Reconstruction

The purpose of this study is to study composites of bioactive glass and methylmetacrylate with glass fibre reinforcement in cranial bone defect reconstruction.

Traditional skull and facial bone reconstructions with hard tissues have a long history with good clinical outcomes. However, they have certain disadvantages. The benefits of synthetic materials are the avoidance of donor-site morbidity and scars, but also shorter hospitalization time, lower expenses and known composition. Custom-made skull bone implant can produced based on patients clinical need utilizing rapid prototyping technologies. This will result in very high accuracy of the form of the skull defect.

Polymethylmetacrylate (PMMA) is one of the most widely used alloplastic material in surgery. Bioactive glass S53P4 (BAG) particles have been used in various clinical indications. BAG was added to composite implant of PMMA with glass fibre reinforcement to enhance bone ingrowth to implant, and to utilize BAG's antimicrobial effects. Ten patients cranial defects are treated with composite implants.

Eligibility Criteria:
Inclusion Criteria:

* patients with cranial bone defect larger than 4x4 cm after trauma or tumor surgery
* patient signs written study consent

Exclusion Criteria:

* patient is unlikely to adhere to study procedures
* patient has a disease or condition that in the opinion of investigator is contraindicating participation
* patient is participating another medical device or drug trial
Bioimpedance Analysis for Hemodialysis

The goal of this clinical trial is to learn if bioimpedance-guided fluid management can help decrease hemodialysis complications. The main questions it aims to answer are:

Does bioimpedance-guided fluid management decrease major cardiovascular events? Does bioimpedance-guided fluid management decrease other hemodialysis complications?

Participants will:

Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group

The goal of this clinical trial is to learn if bioimpedance-guided fluid management can decrease major adverse cardiovascular events (MACE), symptoms during hemodialysis, or other important outcomes such as vascular access patency, fluid overload admissions, etc. in maintenance hemodialysis patients. The main questions it aims to answer are:

Hypothesis 1: bioimpedance-guided fluid management decreases MACE Hypothesis 2: bioimpedance-guided fluid management decreases intradialytic hypotension, cramps and fatigue Hypothesis 3: bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis

Participants in the control group will decide their target weight according to physician's suggestion and the patient's preference, according to symptoms that are thought related to fluid status aberrancy (for example, edema, crackles for fluid overload, and cramps, intradialytic hypotension, fatigue for fluid insufficiency, given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5% of previous weight)

Participants in the active (bioimpedance) group will adjust their dry weight as those in the control group, if symptoms of fluid status aberrancy present. However, if no symptoms occur, they will receive adjustment according to measurements by bioimpedance analysis.

Eligibility Criteria:
Inclusion Criteria:

* Has received hemodialysis \>= 3 months
* Has at least 1 pair of intact same-side upper extremity and lower extremity

Exclusion Criteria:

* Pregnant
* With a cardiac pacemaker
* With metallic implants that may interfere with measurements (cardiac stents acceptable)
Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Diagnosed with Schizophrenia or Schizoaffective disorder
* Ability to visit the doctor's office for scheduled visits

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Have a body mass index (BMI) greater than 40
* Have diabetes, heart disease or any other unstable illness
* Have known positive human immunodeficiency virus (HIV)
* Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics
Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group

Acute abdomen can be defined as "A syndrome induced by wide variety of pathological conditions that require emergent medical or more often surgical management" \[1\].There are a plethora of causes that can lead to acute abdomen in children, they vary depending on the ages of the children and can be divided into diseases that can be treated with medical care and those in which emergency surgical intervention must be considered \[2\]. Ultrasonography is the initial choice in the diagnosis of the different causes of acute abdomen in children \[3, 4\]. It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation exposure, as good as laparoscopy, can be done even in patients with scarred abdomen \[5\].

-Patient preparation:

* No specific preparation is needed.
* Demographic data including age, sex, detailed history, clinical presentation, laboratory tests, and data of any other investigations or operation will be obtained.
* Clinical examination will be done in emergency pediatric unit for provisional diagnosis.

  -Study instruments:• Patients will examined by Grey-Scale Ultrasonography (U/S) combined with Color Doppler Ultrasonography (CDUS).

  3-Technique of examination
* will be in supine position.
* Patient First examination of whole abdomen will be done by Grey -Scale U/S using both 3.5 MHZ and 7.5 MHZ transducers .It will be done in both longitudinal ( parallel to long axis of the patient ) and transverse ( perpendicular to long axis of the patient ) orientation .
* Then finally examination by Color Doppler US will be done for assessment of organ perfusion and diagnosing inflammation.

Eligibility Criteria:
Inclusion Criteria:

* -In this study, 100 patients referred from the emergency Pediatric Unit for the assessment of the cause of acute abdomen.

Exclusion Criteria:

* - Patients of age group above 18 years
* Patients with trauma.
The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.

Introduction: Systemic microvascular reactivity (MR) is an essential component of cardiovascular physiology, being studied through non-invasive techniques in readily accessible body regions, such as the skin surface. Heart transplant (HT) is a treatment considered to selected patients, with advanced heart failure. The main cause of long-term mortality after HT is graft vascular disease (GVD), a condition which starts with endothelial dysfunction. To know the evolution of systemic MR in patients subjected to HT can help to find prognostic factors. Objective: The present study aims to perform the prospective evaluation of systemic MR in adult patients, before and two years after HT, at a quaternary hospital, correlating the findings with clinical variables. Methods: Systemic MR will be evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis, followed by postocclusive reactive hyperemia (PORH), before and after HT. Measurements will be correlated to patient clinical profile, hemodynamic and echocardiographic data. Expected results: The evolution of systemic MR may aid in the comprehension of cardiovascular physiology in HT patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.

Eligibility Criteria:
Inclusion Criteria:

* capability to understand the objectives of the research and to fulfill the Term of Consent

Exclusion Criteria:

* Pregnancy, acute infection diagnosis, use of circulatory assistance devices
Hepatectomy With or Without the Thoraco-abdominal Approach

The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA) versus the abdominal approach (AA) is still debated.

The aim of the study is the analysis of the perioperative outcome of patients operated with or without the TAA for liver tumors.

The prospectively maintained database was queried. A 1:1 propensity score-matched analysis was applied. Among 744 patients, 246 undergoing hepatectomy with TAA and 246 undergoing hepatectomy with AA were compared. These patients were matched for baseline characteristics, underlying liver disease, comorbidity, tumor features, and extent of the resection. The rates of morbidity and mortality were the study endpoints.

Eligibility Criteria:
Inclusion Criteria:

* First liver surgery;
* Any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis.

Exclusion Criteria:

* Previous history of liver surgery;
* Any type of benign liver tumor;
* Incomplete clinical, surgical, pathological or postoperative data;
* Patients treated with radiofrequency ablation alone or in combination with surgery were also excluded.
Parental Touch Trial (Petal)

This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.

This is a multicentre randomised-controlled interventional trial, with two research sites (John Radcliffe Hospital, Oxford, and Royal Devon and Royal Devon and Exeter Hospital, Devon). In this study we aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia.

The primary objective is to determine whether parental touch reduces noxious-evoked brain activity following a heel lance. In addition, our secondary and exploratory objectives include investigating the effect of touch on behavioural and electrophysiological measures evoked by a heel lance. Neonates will be randomised to receive parental touch either prior to or post a clinically required heel lance. We will also investigate how parental touch impacts post-procedural clinical stability and explore whether this intervention affects parental anxiety.

Neonates will be recruited during a 9-month period. Participants will be studied on a single test occasion while they are in hospital, when they require a clinical heel lance. No extra blood tests or noxious procedures will be performed for the purpose of the study. Participants will be included in the study for approximately an hour period. This will be approximately 30 min before and after the time when the heel lance is performed. Individual babies will only be included in the trial once. If a neonate requires additional heel lances to acquire sufficient blood for clinical assessment at the time of the test occasion, we will also record the responses to this.

Eligibility Criteria:
Inclusion Criteria:

* Participants born at the John Radcliffe Hospital, Oxford or the Royal Devon and Exeter Hospital, Devon
* Neonates born at or after 35+0 weeks gestation
* Neonates with a postnatal age of 7 days or less
* Neonates who clinically require a heel lance
* Neonates for whom parents/guardians have given written informed consent for inclusion in the trial

Exclusion Criteria:

* Intraventricular haemorrhage (IVH) \> grade II
* Received any analgesics or sedatives in the last 24 hours
* Congenital malformation or genetic condition known to affect neurological development
* Born to mothers who have a history of substance abuse.
Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery

The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 year-old.
2. In sinus rhythm.
3. Affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation.
4. Women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study.

Exclusion Criteria:

1. Urgent surgery.
2. Surgery due to endocarditis.
3. Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
4. Treatment with beta-blockers at time of randomization
5. Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
6. Chronic using of NSAIDs and / or corticosteroids at time of randomization
7. Uncontrolled thyroid disease.
8. Active liver disease and / or history of previous chronic liver disease.
9. Alcoholism.
10. Predisposing factors to statins adverse effects:

    * Increased transaminase levels at baseline (x3 normal value).
    * Renal failure (creatinine levels over 2 mg/dl).
    * Previous diagnosis of myopathy of any etiology.
11. Known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
12. In women of childbearing age, positive pregnancy test the day of inclusion in the study.
13. Not signed informed consent.
14. Inability to understand objectives of the study.

Exclusion criteria of the study once started:

* Withdrawal of patient's consent.
* Modification in liver laboratory parameters (transaminases above three times normal value) and / or creatine-fosfokinase level suggesting adverse effects of statins.
Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.

Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.

Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.

The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients on PD at least one month prior to study entry.
2. Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
3. Residual GFR ≥3 ml/min/1.73m2.
4. Residual urine volume ≥ 500 ml/24h.
5. No history of taking α-Keto Acid within 2 weeks.
6. Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. History of peritonitis or other infection within one month.
2. History of taking drug which may affect amino acid metabolism within one month.
3. Incapable of following study requirements to control diet.
4. With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
5. Participation in another clinic trial within one month prior to screening.