cyrilzakka/clinical-trials huggingface dataset:
Perioperative Hypoxemia in Pediatrics

The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing general or spinal anesthesia and monitored anesthesia care

Exclusion Criteria:

* none
Impact of COVID-19 Infection During Pregnancy

To asses impact of the COVID-19 infection during Pregnancy on maternal and fetal outcome in relation to gestational age.

COVID-19, caused by SARS-COV-2, was first reported in the city of Wuhan, Hubei province, China, at the end of December 2019. The exact origin of human infection has not yet been clearly identified.SARS-CoV-2 is a member of the Coronavirus family, and other pathogens from this family have inflicted a range of viral infections, including Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The incubation period varies from 2 days to 2 weeks following exposure to the virus.The global pandemic caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2) has been growing at an accelerating rate. The increasing mortality rate warrants identification and protection of the vulnerable populations in society.It is well known that pregnancy-related immune suppression makes mothers more vulnerable than non-pregnant women to several viral infections, including SARS-COV, hepatitis E virus, influenza, and herpes simplex virus.

Furthermore, changes in pulmonary function during pregnancy, including decreased total lung capacity and functional residual capacity, may cause susceptibility to viral pneumonia.

Data on clinical outcomes of pregnant women suffering from COVID-19 are therefore relatively scarce. Recently a meta-analysis of 13 publications reported preterm births, neonatal pneumonia, and respiratory distress syndrome in infants born of COVID-19-positive mothers. The rates of cesarean deliveries and adverse pregnancy outcomes were substantially higher

Eligibility Criteria:
Inclusion Criteria:

-All medical records of the pregnant women admitted to EL Bagour Quarantine hospital, Menoufia governorate due to SARS-CoV-2 infection, as confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens.

Exclusion Criteria:

* Patients who had equivocal or negative testing results were excluded from the study
Salivary Glycated Albumin

(1) to determine whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin (HbA1c).


Eligibility Criteria:
Inclusion Criteria:

* 123 individuals with type 1 or type 2 diabetes
* 53 non diabetic controls
* Age: 18 to 80
* Body mass index \>18.5kg / m2

Exclusion Criteria:

* Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis infection, severe allergies.
* Individuals with known sickle cell, pregnancy, hemoglobinopathies, renal failure
* Subjects unable to give voluntary informed consent
Use of CoG by Patients With Diabetes Mellitus

The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose teststrips and requiering a capillary blood sample obtained from a fingerstick and in addition, a non-invasive optical component for prediction of tissue glucose at the fingertip. In this study, participants will use both devices during meal tests and also at home during routine care. The results from the device will be compared to a standard reference method and will be used to determine the accuracy of the two device components.

The trial starts with a screening and training visit (V1). This is followed by an individual calibration period for the non-invasive device component by means of multiple parallel measurements with the invasive and the noninvasive device component. This will be done by the participants at home. Thereafter, the participants will come to the study site and will ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary blood samples for comparator readings with the two CoG components and with a laboratory reference method (YSI gucose analyzer). The patients will now continue to use the devices at home for three months, but are not allowed to use any CoG result for treatment decisions. In an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety parameters and three comparison measurements will be made with the CoG device components and the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of the first meal test visit (V2) will be repeated, which conludes that study. In addition, the participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American origin
* Subjects who are able to provide informed consent (by him/herself or by his/her guardian);
* 18 years old and above;
* HbA1c \< 10 %
* Anatomically suitable finger as determined by the clinical investigator and detailed in section 4

Exclusion Criteria:

* Does not meet inclusion criteria;
* Subjects requiring dialysis;
* Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars and/or tattoos;
* Pregnancy;
* Nursing mothers;
* Any skin injuries on the measured finger;
* Severe disease conditions (cancer etc.)
* Any condition that may prevent patients from successful participation in the trial (in discretion of the investigator)
Automated Ultrasound Cardiac Guidance Tool

This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed

The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, aged 18 years and older
2. Subject willing and able to give written informed consent

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
6. Subjects with BMI above 40.
7. Subjects experiencing a known or suspected acute cardiac event.
8. Subjects with severe chest wall deformity as per previous medical records and physical examination.
9. Subjects who have undergone pneumonectomy.
10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).
Taste Physiology in Healthy, Normal-weight Volunteers

Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. The objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.


Eligibility Criteria:
Inclusion Criteria:

* right-handed healthy males
* Body-mass index of \< 25
* Age 18-45 years
* no drugs
* non-smoking

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia
* History of gastrointestinal disorders
* Food allergies, glutamate intolerance
* Body piercings that cannot be removed
Consequences of At-risk Alcohol Consumption in ICU Patients

At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.

Alcohol-use disorder has a significant impact on morbidity in surgical intensive care units and is known to cause alcohol withdrawal syndrome which mortality can reach 50% if left untreated. The aim of the study was to assess the impact of alcohol use disorder on one-year mortality and adverse ICU outcomes such as agitation in a Medical Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients aged 18 years old or more admitted in ICU

Exclusion Criteria:

* No exclusion criteria
Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform

The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical device that is available for distribution in the EU (European Union) under CE Mark for use in general surgery, thoracic surgery, gynecological surgery and urological surgery. The main research question is to assess, from a retrospective poit of view, the safety and feasibility of this new robotic platform in the colorectal surgery.

The rationale of this study is to investigate the perioperative and the short term perioperative outcomes of this new robotic Platform in minimally invasive colorectal surgery. Tha ALF-X utilizes fully reusable along with haptic feedback and an innovative vision control system.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by colorectal disease (benign or malignant) having undergone surgery using ALF-X platform

Exclusion Criteria:

* none
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection

To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population


Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects that are between 0 to 70 years old.
* Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.

Exclusion Criteria:

* Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications.
* Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
* Patients who the PI deems ineligible at the PI's discretion
Effectiveness of Gut Microbiota-targeted Diatery Intervention Among Older People Living With HIV

The goal of this clinical trial is to conduct a dietary intervention targeting HIV specific gut microbiota alterations for primary atherosclerotic cardiovascular disease (ASCVD) prevention and evaluate its effectiveness in preventing ASCVD among older people living with HIV (PLWH).

The investigators utilize a pragmatic randomized controlled trial design to evaluate the effectiveness of dietary intervention in real-world conditions, without strict control, thereby enhancing the generalizability and clinical applicability of our study findings. Participants at Shenzhen Third People's Hospital, exhibiting HIV with CVD risk will be enrolled. Upon providing informed consent, participants will undergo dynamic randomization into intervention and control groups, aiming for a 1:1 ratio while preserving maximum unpredictability. The intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly healthy diet guidance for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months. Primary outcomes will assess ASCVD risk via the pooled cohort equation and evaluate gut microbiota diversity and composition. Secondary outcomes will encompass biomarkers and predictors associated with atherosclerotic cardiovascular disease, as well as symptoms related to the condition.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines;
2. Aged 40 years and above;
3. at risk of CVD: having any two of those risk factors: dyslipidemia, DM or elevated blood glucose, smoking, hypertention or elevated blood pressure, metabolic syndrome,overweight/obesity; or PCE score\>5%,
4. Those with a predicted survival time of \>1 year;
5. No plans to leave the depth in the next 3 months;
6. Voluntary participation in this study and signing the informed consent

Exclusion Criteria:

1. Those with a previous history of CVD;
2. Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections;
3. Currently suffering from malignant tumors, gastrointestinal diseases; People with an aversion to eating;
4. Allergic to nuts and fish;
5. People who take medicinal calcium \>1000 mg per day or omega-3 supplements;
6. Plan to become pregnant within 6 months;
7. Are participating in other HIV-related or dietary intervention-related scientific research programs.
Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)

Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more insulin resistant than women without the condition and may be at greater risk of developing cardiovascular disease. It is not know whether it is the overweight and insulin resistant component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The aim of this study was to examine cardiovascular risk markers in women with PCOS versus a control population matched for body mass index (BMI), and or, insulin resistance


Eligibility Criteria:
Inclusion Criteria:

* Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
* Were between the ages of 18 and 40

Exclusion Criteria:

* Were under 18 years or greater than 40 years old,
* Were non-Caucasian
* Were pregnant, lactating or trying to conceive
* Had a body mass index (BMI) \<18kg/m2 or \>50kg/m2
* Had a recent illness or any chronic illness likely to influence results
* Were taking hormonal contraception
Boron Neutron Capture Therapy in Treating Patients With Melanoma

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.

OBJECTIVES:

* Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy.
* Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen.
* Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen.
* Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc).

Patients undergo boron neutron capture therapy.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma
* Evaluable disease
* Lesion(s) to be irradiated must be located in 1 of the following areas:

  * On an extremity
  * On the head or neck (including the scalp)
  * In the subdermal lymphatics (excluding the proximal axilla)
* Area to be irradiated must not exceed a maximum dimension of 10 cm

  * Maximum tumor depth from the surface of the skin cannot exceed 6 cm

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* More than 6 months

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Creatinine normal

Cardiovascular

* No history of severe cardiac disease
* No uncontrolled arrhythmias or conduction defects
* No unstable or newly diagnosed angina pectoris
* No recent coronary artery disease
* No congestive heart failure

Other

* Not pregnant
* Negative pregnancy test
* No history of phenylketonuria
* Must have sufficient mental competence

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to study sites

Surgery

* Not specified
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 2 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Maintenance Extension.

Eligibility Criteria:
Key Inclusion Criteria:

* Has signs/symptoms of CD for at least 3 months prior to Screening
* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products)
* Agrees to abide by the study guidelines and requirements
* Capable of giving signed informed consent

Key Exclusion Criteria:

* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
* Has had extensive bowel resection (\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
* Has positive findings on a subjective neurological screening questionnaire
* Has a concurrent, clinically significant, serious, unstable comorbidity
* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
* Is currently participating in any other interventional study or has received any investigational therapy within 30 days
* Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
* Unable to attend study visits or comply with study procedures
Effectiveness of Smartconsent in Improving Understanding of Informed Consent

The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice.

A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.

Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria.

Inclusion criteria:

* Patients willing to receive information via tablet.
* Patients who know how to and can read.

Exclusion criteria:

-Not applicable.

Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient.

This test evaluates the comprehension of the information provided through the informed consent.

Eligibility Criteria:
Inclusion criteria:

* Patients willing to receive information via tablet.
* Patients who know and can read.

Exclusion Criteria:

* Not applicable
Metastatic Pathologic Fractures, Short Term Results

This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.

The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic.

Pathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible.

The aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation.

The primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively.

The type of the operation will be decided at the multidisciplinary tumor council of ankara University.

Eligibility Criteria:
Inclusion Criteria:

* metastatic pathologic fracture
* operated via endoprosthesis, intramedullary nail or plate \& screws

Exclusion Criteria:

* primary bone tumor
* conservative management
* neuromuscular disease
* periprosthetic fractures
* less than 1 month follow up