cyrilzakka/clinical-trials huggingface dataset:
Computed Tomography Angiography Accuracy in Brain Death Diagnosis

The purpose of this study is to assess the reliability of computed tomography angiography (CTA) to diagnose brain death, face of several conditions that make impossible to define such diagnosis using clinical criteria exclusively.

Critically ill patients, presenting Glasgow Coma Score 5 or lower, will be submitted to the Computed Tomography Angiography (CTA) of the skull assessment, and follow a clinical evaluation for brain death, additionally, transcranial Doppler would be applied as the gold standard for brain death.

We will exclude patients whose do not can be submitted to contrast injection, or if a brain death clinical evaluation has been performed prior the CTA.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of any age or sex with brain death suspicion raised, before clinical test.
* Comatose patients presenting Glasgow Coma Score as or under 5 points, under sedative agents or not.

Exclusion Criteria:

* Brain dead patients clinically confirmed.
* Contraindications to the use of contrast medium (renal failure or allergy).
Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients

This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of volatile anaesthetics on the incidence of postoperative depression and anxiety among elderly patients.

Studies have suggested volatile anaesthetics may alleviate depression and anxiety in patients. However, there is a paucity of research in this area. The investigatorswanted to determine the association between volatile anaesthetics and depression/anxiety in elderly patients within 7 days after surgery.

This study retrospectively analysed data from a prospective database of patients aged 65 and above who underwent non-cardiac, non-neurosurgical elective surgery in 18 tertiary hospitals across 10 provinces in China. Patients receiving volatile anaesthetics received at least one volatile anaesthetic (sevoflurane, isoflurane, desflurane), and those who received non-volatile anaesthetics did not receive any volatile anaesthetic. Binary logistic regression analyses were conducted, and propensity score-matching (PSM) and subgroup analyses were also applied.

Eligibility Criteria:
Inclusion Criteria:

Geriatric surgical patients ≥65 years old Non-selective cardiac surgery Non-neurosurgical

Exclusion Criteria:

1. underwent reoperation within 7 days
2. ASA classification of Ⅳ or above
3. history of serious mental illness or long-term use of psychotropic drugs
4. patients either died or were transferred to the intensive care unit within 7 days of the surgery
5. subjects with missing covariate data
Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation.

Objectives:

1. To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) \& Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance
2. To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.

Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment.

Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65
* HCV RNA positive
* HCV genotype 1
* Histologically proven chronic hepatitis
* No previous antiviral treatment

Exclusion Criteria:

* Liver histology showing cirrhosis
* Decompensated liver function
* WCC \< 1500/mm3 or platelet count \<90,000/mm3
* Co-infection with HIV or HBV/HAV
* Alcohol intake greater than 40 units/week
* Current intravenous drug dependence
* Pregnancy or breast feeding of infants
* Inadequate contraception
* Neuropsychiatric disorder
* Neoplastic disease
* Other significant medical problems
Endometrial Markers in Autoimmune Diseases

Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.

The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.

The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.


Eligibility Criteria:
Inclusion Criteria:

Study group:

\* Females with infertility combined with autoimmune disease and in fertility treatment.

Control group:

\* Female from couples with severe male infertility and in fertility treatment.

Exclusion Criteria:

* Language problems to such an extent that the subjects do not understand the scope of the study.
* Abnormal follicle stimulating hormone (FSH),
* Abnormal antral follicles Count
* Genital infections
* Endometriosis
* Tubal occlusion
* Polycystic ovarian syndrome
STOP AF First Post-Approval Study

The STOP AF First PAS is a prospective, global, multi-center, observational trial.

The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed with symptomatic paroxysmal AF
* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1

. Subjects under the following conditions may be included in the study:

1. Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of \<4 weeks prior to the index PVI procedure)
2. Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation
3. A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.

   * Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
   * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
   * Subject with exclusion criteria required by local law
Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.

This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer.
* With axillary lymph node with thickened cortex.
* Planned for sentinel lymph node biopsy or axillary clearance.

Exclusion Criteria:

* Nodes ultrasonographically normal.
* Nodes with hilar displacement .
* Palpable matted nodes.
Eye Pressure Lowering Surgery

The purpose of this study is to determine if lowering the pressure inside the eye improves blood flow to the eye.

Using high-speed ocular coherence tomography (OCT) systems, we have developed new methods to image and measure optic nerve head (ONH) and retinal blood flow. Preliminary results have shown that visual field (VF) loss is more highly correlated with retinal blood flow as measured by OCT than any neural structure measured by OCT or other imaging modality. Accordingly, the goal of the proposed project is to improve the diagnostic and prognostic evaluation of glaucoma by further developing novel functional OCT measurements using ultrahigh-speed (70-100 kHz) OCT technology.

Retinal blood flow, ONH circulation, optic disc rim volume, peripapillary nerve fiber layer volume, and macular ganglion cell complex volume are all pieces of the same glaucoma puzzle. This project will develop novel imaging methods that allow us to look at the whole picture using one tool - ultrahigh-speed OCT.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with perimetric open angle glaucoma or chronic angle closure glaucoma.
* Subjects scheduled to undergo trabeculectomy or tube shunt surgery

Exclusion Criteria:

* Best-corrected visual acuity less than 20/40
* Age \< 18 or \>85 years
* Refractive error of \> +3.00 D or \< -7.00 D
* Previous vision correction surgery such as Laser-Assisted in situ Keratomileusis (LASIK) or Photorefractive Keratectomy (PRK)
* Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
* Diabetic retinopathy
* History of heart failure, myocardial infarction, transient ischemic attack or stroke
* Other diseases that may cause VF loss or optic disc abnormalities
* Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
* Inability to perform reliably on automated VF testing
* Life-threatening or debilitating illness making it unlikely patient will successfully complete the study.
* Refusal of informed consent or of commitment to the full length of the study
Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

Chronic kidney disease has become an important Public Health issue in most developed and developing countries, with increasing incidence and prevalence rates. The cost associated with chronic kidney disease patients is very high, derived from renal replacement therapy and the cost associated with the high cardiovascular risk of this population. Primary and secondary preventive measures are imperative. In this sense, the comprehension of mechanisms and biomarkers associated with CKD progression and mortality risk in this population is an important area of research. Cohort studies are important tools for testing risk factors and biomarkers. Currently, CKD cohorts, particularly of those not on dialysis, are few and restricted to North America and Europe.

The present study established a cohort of 454 CKD participants (not on dialysis) in Sao Paulo, Brazil, who will be followed for 7-10 years. Baseline data collection was wide, including medical history, diet (food frequency questionnaire), calcium score, echocardiography, pulse wave velocity, cardiac frequency variability, carotid intimal media thickness, retinography, and an extensive biobank. Follow-up is ongoing and made through annual telephone interviews including questions on death, hospitalizations, and need of renal replacement therapy (RRT). Vital status is investigated periodically by a hot-pursuit strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending the outpatient service of Hospital das Clínicas, São Paulo, Brazil.
* ≥ 30 years.
* at least two measurements of creatinine (with a minimum interval of 3 months) ≥ 1.6 mg/dl for men and ≥ 1.4 mg/ dl for women.

Exclusion Criteria:

* Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis and glomerulonephritis services were excluded.
* hospitalization within the last six months;
* acute myocardial infarction within the last six months;
* autoimmune diseases;
* current pregnancy;
* psychiatric diseases;
* ongoing chemotherapy or immunosuppressive therapy;
* current renal replacement therapy;
* HIV/AIDS infection;
* hepatitis B or C;
* any organ transplantation.
Assessing Fatiguability of Tongue Muscles in MS

Multiple Sclerosis (MS) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. A maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (MIP) at the anterior tongue, followed by a MIP at the anterior tongue. Cut-off criteria are a MIP \<50% of the baseline MIP, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.

Eligibility is Mini-Mental State Exam-score (MMSE) \> 23, a Eating Assessment Tool-score (EAT-10) \> 3, or a Functional Oral Intake Scale-score (FOIS) \< 7, or failing the Yale Swallow Protocol.

Eligibility Criteria:
Inclusion Criteria:

* proven MS
* subjective dysphagia

Exclusion Criteria:

* MMSE \< 23
* major head and neck surgery
* history of cancer
Diaphragm Ultrasound in Weaning From Mechanical Ventilation

This study aims to evaluate the efficacy of ultrasound derived variables in prediction of success of weaning from mechanical ventilation in critically ill patients with abdominal sepsis

Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume); however, sensitivity and specificity for most variables are still variable in literature.

Diaphragmatic dysfunction is a common cause of weaning failure (2) however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.

Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening. In this study we will evaluate the ability of the diaphragmatic function to predict weaning success in patients with abdominal sepsis.

After weaning, patients will be divided into two groups; group of successful weaning (group S) and group with failed weaning (group F) both groups will be compared as regards all clinical, laboratory, and ultrasonographic parameters recorded before weaning, further analysis will be done for patients with repeated trials of weaning (more than one trial or more than one week MV) and those with simple weaning (first time for weaning).

A 7-10 Mega Hertz linear ultrasound probe (Mindray machine) set to B mode, the diaphragm will be visualized by placing the transducer perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and the midaxillary lines, to observe the zone of apposition of the muscle 0.5 to 2 cm below the costophrenic sinus.

The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then, the diaphragmatic fraction thickening (DTF) will be calculated as percentage Diaphragmatic movement will be measured in all patients with a 3.5 Mega Hertz US probe placed over one of the lower intercostal spaces in the right anterior axillary line for the right diaphragm and the left midaxillary line for the left diaphragm.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with abdominal sepsis with history of MV for more than 48 hours

Exclusion Criteria:

* Age \< 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. Also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases
Axillary Reverse Mapping

It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.

Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast.

On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur \< 3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios. The site of all injections (radioactivity and/or blue dye) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 100 years old
* Not pregnant or breastfeeding
* Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy
* Willing participation after obtaining informed consent

Exclusion Criteria:

* \< 18 or \> 100 years of age
* Pregnant or breastfeeding
* Blue dye allergy
* Cosmetic allergy
* History of primary lymphedema
* Prior breast augmentation
The Relationship Between Fasting Time and Delirium

We investigated the relationship between fasting times and delirium in children undergoing MRI under anesthesia. Paediatric Anaesthesia Emergence Delirium (PAED) scale, last oral intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation (SpO2 \<95%), bradycardia, allergy, nausea and vomiting were recorded.


Eligibility Criteria:
Inclusion Criteria:

* children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II
* Patients undergoing MRI under sedation

Exclusion Criteria:

* ASA 3-4-5
* under 2 years old, over 6 years old
* cognitive or psychological disorder
* serious central nervous system diseases, including a brain tumor or uncontrolled seizures
* type 1 diabetes
* detection of ≤ 50 mg/dl in fasting blood glucose measurement
* whose parents did not want to participate in the study
Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso

Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.


Eligibility Criteria:
Inclusion Criteria:

* Weight \> 5 kg;
* Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
* Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
* Haemoglobin value above 5.0 g/dl;
* Absence of febrile conditions caused by diseases other than malaria.

Exclusion Criteria:

* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand;
* Signs of severe malaria (WHO 2000);
* Mixed malaria infection;
* Severe malnutrition;
* Other underlying diseases (cardiac, renal, hepatic diseases);
* History of allergy to study drugs;
An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes

The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of signing the informed consent

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Diagnosed with Type 1 diabetes
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients with known congenital heart disease/malformation