cyrilzakka/clinical-trials huggingface dataset:
Factors Associated With Mortality in Neonates

The purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. As a result, an improved neonatal mortality classification system may be defined.


Eligibility Criteria:
Inclusion Criteria:

* Neonates for whom healthcare was provided
* Born alive
* Neonate greater than or equal to 22 0/7 weeks estimated gestational age

Exclusion Criteria:

* Stillborn
* Fetal demise
* Neonates less than or equal to 21 6/7 weeks estimated gestational age
Study Into Treatment of Hyperplasia of Mammary Glands

Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.

Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Reported breast pain or breast lumps.
* Willing to be kept follow-up.
* Functions below are maintained in major organs: liver, renal and heart.
* Written informed consent will be obtained for patients for entering this study.

Exclusion Criteria:

* Typical breast cancer or fibroadenoma.
* Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS) 4.
* Oral contraceptive or hormone replacement therapy.
* History of breast cancer or other malignancies.
* History of pituitary gland disease.
* Potentially pregnant, pregnant, or breast-feeding.
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

During pressure injuries formation early sub dermal bio signal appear. By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 1 pressure injury
* Patients with high risk of developing pressure injury

Exclusion Criteria:

* Patients with stage 2 pressure injury or higher
Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.

By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.

Objectives:

1. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation.
2. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for LTOT, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-MWT, ergometer cycle).

Eligibility Criteria:
Healthy volunteers

Inclusion Criteria:

* Age 18 - 60 years,
* Non smoker,
* Good general health and physical fitness
* Informed Consent

Exclusion Criteria:

* Current or history of tobacco smoking (\> 5 py)
* Current alcohol or drug abuse
* Heart disease or untreated arterial hypertension
* Pulmonary disease
* Epilepsy or other major neurologic disease
* Dark skin colour
* Known anemia
* Severe metabolic disease (e.g. diabetes)
* Pregnancy

Patients

Inclusion Criteria:

* Age ≥ 18 years
* Long term oxygen therapy at rest and/or on physical effort
* Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or \< 60 mmHg with PHT or polycythemia (men Hb \> 174 g/L, women Hb \> 140 g/L) or:

Oxygen desaturation on effort (SpO2 \< 90%)

* Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease and Sarcoidosis
* Informed Consent

Exclusion Criteria:

* Severe hypoxemia (pO2 \<40 mmHg)
* Severe hypercapnia (pCO2 \>55 mmHg)
* Acute respiratory infection or systemic infection,
* Severe systolic heart disease (LVEF \< 25%)
* Myocardial infarction during the last month before inclusion
* Unstable angina pectoris
* Severe aortic stenosis (mean gradient \> 40mmHg, valve area \<1 cm2)
* Rhythmogenic heart disease
* Severe or untreated arterial hypertension (blood pressure \> 180mmHg systolic, \>100mmHg diastolic)
* Anemia (Hb \< 120 g/l)
* Known or suspected coagulation disorder (e.g. INR \> 4)
* Severe or untreated metabolic disorder
* Neurologic disease or dementia
* Pregnancy
* History of non-compliance to medical treatment
* Current alcohol, drug abuse or current tobacco smoking
* Dark skin color
This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery

Laparoscopic surgery is widely used now. These benefits included many items, e.g. reducing post-operative pain, cosmetic the result was improved, and the patient also had more satisfaction for the patient and reduced hospital stay. This surgery involved insufflation of gas into the peritoneal cavity, producing pneumoperitoneum, and causing an increase in intra-abdominal pressure. The raised intraabdominal pressure of the pneumoperitoneum, the patient's position alteration, and the absorption of carbon dioxide into the abdomen have a direct effect on causing a change in physiology, especially in the cardiovascular and respiratory systems. These effects, as well as a direct effect of gas insufflation, may have significant effects on the patient especially if the patient has a comorbidity or is elderly.

The objective of this study was to assess the technique used in laparoscopic surgery and their associated complications, including some hematological parameters, (these include blood pictures and liver enzymes), respiratory, (including the inspired and expired tidal volume, oxygen saturation, airway pressure, plateau pressure, and use of PEEP) cardiovascular system (including the systolic, diastolic, and mean blood pressure, heart rate)

Eligibility Criteria:
Inclusion Criteria:

1. elective abdominal surgery
2. a healthy, fit person
3. use of general anesthetics
4. use of pneumoperitoneum and CO2 insufflation

Exclusion Criteria:

1. emergency condition
2. patient with cardiovascular disease
Efficacy of Transcutaneous Nerve Stimulation on Improvement of Overactive Bladder Symptoms

Overactive bladder (OAB) is a very common problem that impairs the quality of life of about 17% of adult population in USA above the age of 40. The issues becomes more prominent with getting older. OAB was determined by International Continence Society as urgency (immediate desire to urinate that could not be postponed) with or without incontinence usually associated with increased frequency and nocturia (urination at night). In 2012, American Urologic Association published clinical guidelines for the treatment of OAB of non neurogenic origin. Neuromodulation was proposed as the third line of treatment and two treatments were recommended: sacral nerve neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS). Each of above mentioned procedures are invasive. SNM involves lead implantation in operating room using X-ray guidance and anesthesia. PTNS involves needle insertion on the low extremity.

The investigators would like to examine the efficacy of transcutaneous nerve stimulation (TENS) in refractory to the first two lines of OAB treatment patients.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients
* age above 18
* OAB symptoms more than 6 months before run into the study
* OAB symptoms refractory to medical oral and cognitive treatments
* Adverse events or unwillingness to continue with abovementioned treatments
* patients with OAB symptoms with no evidence of neuropathic nature
* patients who signed informed consent fully understanding the treatment and study design

Exclusion Criteria:

* children
* patients who unable or did not sign an informed consent or do not understand the study design and the treatment
* patients who have implanted electric devices (eg. cardiac stimulators etc.)
* patients who have post voiding residual more than 100ml
* patients who have neuropathic OAB or pelvic ongoing malignancy or prior pelvic radiation
* patients who were treated in the last 6 months with SNM, PTNS or intravesical Botox injections
* patients with denovo OAB after recent implantation of tension-free vaginal tape (TVT) procedure
* stress urinary incontinence predominant complaints in mixed incontinence patients
* significant pelvic organ prolapse in women or an evidence of significant bladder outlet obstruction in male patients
* patients with a history of recurrent urinary tract infections (UTIs) during the last 2 years
* any medical condition that involves skin on the lower extremity
* bilateral leg amputation
* any medical condition that on investigator's mind could have an adverse impact on the patient during the study
* participation in a clinical study at the last 6 months
The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers

This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators. Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation at a teaching-hospital pacemaker clinic.

Assessment of liver fibrosis in patients with chronic liver diseases provides staging and prognostic information critical in establishing treatment priorities. The gold standard evaluation of liver fibrosis is hampered by the invasive nature of liver biopsies. FibroScan is a non-invasive alternative that has been extensively validated in chronic hepatitis C, chronic hepatitis B, alcoholic liver disease, and non- alcoholic fatty liver disease patients.

To avoid unknown risks of potential interaction, the manufacturer have advised against the use of the device in patients with active implantable medical device including cardiac pacemaker and/or implantable cardioverter-defibrillators(ICD). Review of the literature showed that these two population have been specifically excluded in all previously reported studies.

At the time of writing, no specific reports have demonstrated either safety or potential harm of the FibroScan in patients with pacemaker/ICD. Given the proven benefit of the FibroScan in chronic liver disease and the current policy of excluding patients with pacemaker/ICD in clinical practice, this study aims to formally evaluate the safe use of the FibroScan in this population within the controlled environment of a pacemaker lab.

Eligibility Criteria:
Inclusion Criteria:

-Any outpatient undergoing routine pacemaker interrogation at pacemaker clinic

Exclusion Criteria:

* Pregnancy
* BMI\>35
* Person with active implantable medical devices other than cardiac pacemaker and/or ICD
* Person who are unable to tolerate lying flat for the FibroScan examination.
Early CPAP in COVID-19 Patients With Respiratory Failure. A Prospective Cohort Study.

This cohort study aims at prospectively collecting detailed clinical information on patients positive to or suspected of COVID-19 visiting Italian emergency departments (EDs). The objectives of the study are:

1. To monitor and describe the COVID-19 patients visiting Italian EDs.
2. To assess the prognostic impact of demographics, clinical characteristics, risk factors and pre-existing diseases.
3. To develop a predictive model, providing estimates of the prognosis using multiple relevant factors.
4. To construct a detailed database to enable comparative effectiveness research (CER), with the goal of generating hypothesis of efficacy and effectiveness of treatments, therapies and interventions, in the management and treatment of COVID-19 patients.

All the ED patients positive to or suspected of COVID-19 infection will be included in the study. Descriptive reports of the collected data will be produced regularly. Different levels of aggregation will be considered: single center, province, region. In addition to providing useful elements to describe the evolution of the epidemic, the results presented in these reports will provide an accurate clinical description of a large sample of COVID-19 patients.

The study data will be leveraged to identify the most important risk factors and clinical conditions to predict poor patient outcomes. The most relevant factors will be selected using state-of-the-art techniques.

These factors will be used as predictors in multivariable predictive models, which will be developed to estimate the expected prognosis of the patients. The study outcomes will be death or need of intubation within 7 days since ED arrival and 30-day mortality. Given the dichotomous nature of these variables, the models will be developed with logistic regression. The models will be first developed when the study will enroll the minimum number of necessary patients, and periodically updated. In this way, predictive tools capable of making accurate estimates of the prognosis of patients will be returned to the clinical practice as soon as possible.

The study will record the use of treatments and drugs, such as antivirals, ACE inhibitors and sartans, whose effect on COVID-19 patients is not yet clear and mostly based on small studies. The large cohort of patients will be used to perform CER analyses and evaluate the effect of these treatments on the prognosis of patients, with appropriate statistical methodology to account for the observational nature of the data. These results will be used to refine and improve the experimental design of this project.

Eligibility Criteria:
Inclusion Criteria:

All the ED patients positive to or suspected of COVID-19 infection with at least one of the following symptoms:

* fever
* cough/dyspnea
* SpO2 \< 95% in ambient air (\< 91% if BPCO patient).
* positive Quick Walk Test
* respiratory symptoms or admission in ED for respiratory reason

Exclusion Criteria:

* age \< 18 years
* intubated patients or patients discharged in ICU in 1 hour from ED arrival
* denied consent
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain

To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.

Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.

The lower age limit for the clinical trial was initially set to 3 years of age in the protocol. The trial planned for the inclusion of participants in three age categories. Age 3 to less than 6 years (young children), age 6 to less than 12 years (older children) and age 12 to less than 18 years of age (adolescents). There was a request by the Paediatric Committee (PDCO) at the European Medicines Agency to include participants 2 years of age (very young children). The protocol amendment thus planned to combine the two youngest age groups into a single reporting group. The protocol amendment only planned that the very young children group would have separate analysis for the Faces Pain Scale Revised (FPS-R) Scale and for the presentation of the serum concentrations, because the pharmacokinetic sampling scheme used in the 2 year old participants was different from the young children group (aged 3 to less than 6 years).

Eligibility Criteria:
Inclusion Criteria:

* A maximum body weight of 85.0 kg.
* A minimum body weight of 10 kg for participants aged 2 years to less than 3 years old.
* If female and post-menarchal, or 12 years or older, the subject has a negative urine pregnancy test within 24 hours before surgery.
* Having completed either dental surgery or tonsillectomy with or without adenoidectomy surgery (age group: 6 to less than 18 years of age).
* Having completed ear, nose, or throat surgery (including but not limited to tonsillectomy (age group: 2 to less than 3 years of age).
* Participant aged 6 to less than 18 years has a post-operative pain intensity score greater than or equal to 4 on the Color Analog Scale (CAS) as a result of the surgical procedure or the participant has a pain level that the usual standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment.
* Participant aged 2 years to less than 6 years has a pain level following a surgical procedure that reliably produces moderate to severe pain, for which the usual standard of care requires opioid treatment.
* Participant is alert, orientated, and able to follow commands and complete the post-operative required procedures.

Exclusion Criteria:

* History of brain injury.
* Clinically relevant abnormal ECG.
* Clinically unstable vital signs and/or a saturation of oxygen saturation (SpO2) less than 93%. During surgery SpO2 may decrease \<93%.
* Clinically relevant abnormal values for clinical chemistry, hematology, or urinalysis at enrollment.
* Body temperature above 38.5°C within 48 hours prior to dosing.
* Positive drugs of abuse test result.
INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.

There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation.

The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.

The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.

Eligibility Criteria:
Inclusion Criteria:

* all extra-articular tibial fractures
* simple distal tibial intra-articular fractures amenable to IMN
* open and closed fractures
* bilateral tibiae
* willing and able to consent, follow protocol and attend follow-up visits
* able to read and understand English or have interpreter available

Exclusion Criteria:

* patients with contralateral femur and/or hip fracture requiring retrograde IMN
* patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
* associated knee injury
* previous symptomatic knee pathology
* ipsilateral injuries to the same limb that would interfere with rehab or outcome
* neurovascular injuries at the level of the knee requiring surgery
* open or closed fractures \> 14 days (times of injury to OR)
* non unions
* pathologic fractures
* periprosthetic fractures
* spinal injury
* non-ambulatory patients
* incarceration
* limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)
* likely problems, in the judgment of the investigators, with maintaining follow-up
Clozapine Plasma Levels and the Relationship to the Genetic Polymorphism in Shizophrenic Patients

Approximately 30-60% of all schizophrenia patients who fail to respond to typical antipsychotics may respond to Clozapine. Clozapine has long been considered the "gold standard" within the atypical neuroleptic spectrum, backed by years of clinical experience and research, but uncertainties remain in some aspects of this drug. One such question is the link between dose, blood levels and patient clinical response. The Clozapine therapeutic plasma levels range between 250 - 450 ng/mL creating difficulties in using these results in routine clinical practice. Approximately 30% - 51% of "treatment-resistant schizophrenia" patients do not fully respond to Clozapine, a poorly understood phenomenon. Factors relevant to Clozapine-resistance include co-morbidity, drug misuse, poor adherence, inadequate duration of treatment and inadequate dose/plasma-levels. Pharmacogenetic factors such as different polymorphisms in involved genes may play a role. Pharmacodynamic and genetic data appear important in determining the clinical response to Clozapine. Clozapine-treated patients possessing different 3A4 polymorphisms, may respond differently as compared to other patients having normal 3A4 alleles. Recently, the CYP2D6 has also been involved in this drug metabolic pathway. Population pharmacokinetics of clozapine evaluated with the nonparametric maximum likelihood method. This pharmacogenetic explanation/hypothesis may explain Clozapine- resistance in schizophrenics.

The high variability in plasma levels requires a large study in order to be able to determine correlation between clinical efficacy and plasma levels and genotyping. A preliminary study will enable power analysis and adequate determination of sample size.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for schizophrenia (American Psychiatric Association 2000)
* All clozapine mono-therapy patients (only 300 mg/day) who respond to treatment and achieved symptomatic remission (45, 46) and were stable for at least 3 month will be included
* No change in benzodiazepine medications for the trial period.
* Legal ability and willingness to sign an informed consent form for participation in the study.

Exclusion Criteria:

* Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushing's disease, thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance- induced, as judged by a study physician.
* Unstable medical illness or neurologic illness (seizures, CVA); breast, uterine, or ovarian cancer.
* Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen. \[Female patients will also have a pregnancy test.\].