cyrilzakka/clinical-trials huggingface dataset:
Capnography Library - Data Collection in the Critical Care Environment Stage 2

Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in the expired respiratory gases; as such, it is a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. Capnography has proven to be more effective than clinical judgement alone in the early detection of adverse respiratory events. The shape of a capnogram is identical in all humans with healthy lungs; any deviations in shape must be investigated to determine a physiological or a pathological cause of the abnormality.

Data from a previous pilot study yielded two major findings:

1. Prediction of requirement for intubation, by the creation of an "Integrated Pulmonary Index" (IPI) based on non-invasive physiological parameters
2. Breathing patterns during weaning in order to identify specific patterns used to predict extubation success/failure

The intent of the current study is to gather sufficient data to either prove or disprove the findings of the previous study

The patient's monitoring period will be as follows:

Non-intubated patients - Initiation: As soon as possible after admission and/or extubation and no later than 24 hours after either. Termination- either 2 hours after intubation or after 8 hours of monitoring overall.

Intubated patients - Initiation: No later than 24 hours after a decision to begin weaning has been made . Termination: Upon ICU (Intensive Care Unit) discharge or for the duration of 10 days at most.

Data will be collected using three tools:

1. CapnoStream raw data (CO2 (Carbon dioxide) waveform, EtCO2 (End-tidal Carbon dioxide), respiratory rate, SpO2 (Saturation of peripheral Oxygen), pulse rate, IPI, alarms, events and any other messages generated by the monitor) will be transferred from the monitor to a laptop via a dedicated recording program.
2. Ventilator data (settings and resultant patient parameters) will be transferred from the monitor to a laptop via a dedicated recording program.
3. Patient monitoring parameters (heart rate, blood pressure, CVP (Central Venous Pressure), temperature, spirometry values etc) shall be recorded from the multi parameter monitors already in use in the ICU and transferred online to a laptop using dedicated recording software.

All recorded parameters will be synchronized. Data will be recorded from at least two of the tools, the Capnostream and the ventilator.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Suffering from severe illness requiring admission to the ICU
* Expected to be hospitalized in the ICU for a minimum of 8 hours

Exclusion Criteria:

* Under the age of 18
* The patient's refusal to participate in the study
* Any change in the patient's condition that may interfere with data collection
Physical Activity Program on Clinical Output in Heart Failure

Background: This study was carried out to determine the effect of physical activity program applied to individuals with heart failure on quality of life, functional capacity and mortality risk level.

Objective: The study, which was conducted as a randomized controlled experimental study, was completed with a total of 40 HF patients, 20 of whom were interventions and 20 were controls. A physical activity program lasting at least 30 minutes each session was applied to HF patients in the intervention group, three days a week for three months, and the walks of the patients were followed by a pedometer.

Background: This study was carried out to determine the effect of physical activity program applied to individuals with heart failure on quality of life, functional capacity and mortality risk level.

Objective: The study, which was conducted as a randomized controlled experimental study, was completed with a total of 40 HF patients, 20 of whom were interventions and 20 were controls. A physical activity program lasting at least 30 minutes each session was applied to HF patients in the intervention group, three days a week for three months, and the walks of the patients were followed by a pedometer. At the same time, a monthly home visit and weekly phone call were made to the patients. No intervention was applied to the patients in the control group, apart from weekly phone calls. All patients were receiving optimal stable HF therapy.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* Class I, II, III according to NYHA classification,
* Without any diagnosis of musculoskeletal deformity or disease that may prevent them from doing physical activity,
* Hypertension stage 1 and 2,
* Stable chronic disease processes such as diabetes,
* Patients whose treatment for these diagnoses has not been changed in the last month,
* Dyspnea status less than 4-5 degrees according to the Modified Borg Scale,
* Cognitive competence,
* At least primary school graduates

Exclusion Criteria:

* Known and diagnosed moderate or severe mitral/aortic regurgitation, hypertrophic obstructive cardiomyopathy, uncontrollable arrhythmia (atrial fibrillation etc.), bundle branch block on ECG,
* Acute myocardial infarction in the last three months,
* Unstable angina pectoris, pacemaker, valve surgery, coronary artery bypass surgery history, newly diagnosed or suspected thromboembolic event,
* Diagnosed with cerebrovascular and peripheral vascular insufficiency, other chronic diseases (such as chronic obstructive pulmonary disease, chronic kidney failure, pulmonary emphysema, rheumatic valve disease, cancer diagnosis),
* Chronic fatigue syndrome
Moesin Expression in Clear Cell Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most frequently occurring primary renal neoplasm. There are several histological variants of RCC that are associated with variable prognostic outcomes. Epithelial-mesenchymal transition (EMT) is a phenomenon in which the epithelial cells acquire some mesenchymal criteria as enhanced invasive potential. There are several cell surface molecules that are implicated in EMT. Moesin is one of these molecules that is involved in EMT, which is associated with enhanced invasive potential and poor prognosis. Targeting Moesin by novel therapeutic agents may prevent EMT and improve prognosis of patients with RCC.


Eligibility Criteria:
Inclusion Criteria:

1. All cases of ccRCC.
2. Tissue blocks with material adequate for immunohistochemical evaluation.
3. All cases with accessible clinical data.

Exclusion Criteria:

1. Cases of renal neoplasms other than ccRCC.
2. Patients who received preoperative chemotherapy or radiotherapy.
3. Patients with ccRCC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
4. Cases with insufficient/destructed material.
5. Patients with inadequate clinical data.
The Role of Perfusion Index in Children

The purpose of our study is to test the usability of the perfusion index in evaluating the success of the peripheral nerve block applied under sedation in children.


Eligibility Criteria:
Inclusion Criteria:

* will undergo elective upper limb surgery,
* 2- 10 years old,
* ASA I

Exclusion Criteria:

* have regional anesthesia contraindications,
* allergic to local anesthetics,
* having an infection at the injection site
* patients who do not accept the procedure
Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis

Since the majority of patients with necrotizing pancreatitis will experience a leak from the pancreatic duct during their course of disease resulting in intra- and peripancreatic fluid collections, it is reasonable to hypothesize that placement of a ductal stent may prevent some of the late complications and morbidity associated with pancreatic necrosis. This prospective, randomized, controlled multicenter trial investigates the role of early prophylactic ductal stenting in acute necrotizing pancreatitis.

The purpose of the study is to determinate the safety and feasibility of early prophylactic pancreatic duct stenting in necrotizing pancreatitis in reducing complications, length of stay in hospital and in in-tensive care unit compared to the traditional treatment.


Eligibility Criteria:
Inclusion Criteria:

In patients with suspected necrotizing pancreatitis a pancreatic protocol 3-phase contrast enhanced (CE) CT shall be performed. Since a very early CT may underestimate the extent of pancreatic necro-sis, it is recommended to wait at least 72 hours after the onset of symptoms before CT is done. The CECT may be repeated if the initial CT shows no necroses and the clinical course continues to indicate a severe case.

MRI may be used instead of CT in case of contraindication to intravenous contrast due to renal failure.

If CECT reveals pancreatic necrosis affecting the head, neck, or body of pancreas and the necrosis is suspected to include the main pancreatic duct an informed consent to participate in the study is ob-tained, after which the patient will be randomized to either a) the control group with traditional treat-ment (i.e. at the discretion of each participating center) or to b) the intervention group with same treatment as in the control group plus ERP and PD-stenting. Patients with isolated necrosis of the tail will not be included in the study.

Exclusion Criteria:

All consecutive patients (age between 18-75 years) admitted to the participating centers for acute pan-creatitis with an area of non-enhancing pancreatic parenchyma on CT believed to represent necrosis are prospectively enrolled in the study. At initial presentation the age, gender, etiology of the pancreatitis, clinical and laboratory findings will be recorded. Patients with malignancies and patients from whom an informed consent to participate in the study cannot be obtained will be excluded.

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Simultaneous FMRI and NIRS to Estimate Brain Cerebral Metabolism

The principal advantages of functional magnetic resonance imaging (fMRI) with blood-oxygenation- level-dependent (BOLD) contrast for studying brain function are: non-invasiveness, ubiquitous availability, relatively high spatiotemporal resolution, and the ability to map function over the entire brain. Thus, BOLD fMRI is the most widely applied technology to study healthy brain function and pathophysiology associated with disease. In studies of drug abuse and psychiatric illness though, normal assumptions mapping BOLD signals to neurometabolism may be violated. Generally, these effects are ignored, resulting in large study-to-study variability.

Quantitative fMRI (qfMRI) measures metabolism directly and is more suitable for studies of drug abuse and psychiatric illness. However, qfMRI is too complex for routine use. Cerebral metabolism during brain activation during visual stimulation measured with a new fMRI approach that is simple enough for clinical applications will be compared to CMRO2 activation measured using standard qfMRI.

Healthy subjects will undergo a single imaging session. During the imaging session, fMRI and simultaneous near-infrared spectroscopy measurements will be made during visual stimulation (e.g., viewing a flashing checkerboard). This is a methods development study focused on comparing a new method for estimating CMRO2 associated with brain activation with the standard fMRI approach for estimating CMRO2.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18 to 40 years old
* Physically healthy by self-report

Exclusion Criteria:

Diagnosis of current drug abuse/dependence, including nicotine, as assessed by DSM-IV criteria

* Current diagnosis of Axis I disorder using DSM-IV criteria, or any Axis I disorder within past 5 years
* Current daily use of antipsychotic, antidepressant, or other psychoactive prescription drug, as well as daily use of non-prescription drugs
* Life threatening or unstable medical illness, or one that can create marked change in mental state
* Heavy caffeine use (greater than 300 mg on a regular, daily basis)
* History of seizure disorder
* Subjects that report any history or current major medical illness (cardiovascular, pulmonary, psychiatric, or neurological disorders)
* Subjects who have metal in their body or suffer from claustrophobia cannot participate in this research study.
* Additional MR exclusion criteria may include people with:
* Cardiac pacemakers
* Metal clips on blood vessels (also called stents)
* Artificial heart valves
* Artificial arms, hands, legs, etc.
* Brain stimulator devices
* Implanted drug pumps
* Ear implants
* Eye implants or known metal fragments in eyes
* Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
* Other metallic surgical hardware in vital areas
* Certain tattoos with metallic ink (subjects are asked to inform research staff if they have a tattoo)
* Metal Containing Intrauterine Devices (IUDs).
* Certain transdermal (skin) patches such as Transderm Scop (scopolamine for motion sickness).
fFN Clinical Evaluation in Asymptomatic Women at High Risk for Preterm Birth

This study is designed to determine if quantitative analysis of fetal Fibronectin (fFN) can be used to advance prediction of spontaneous preterm birth (sPTB). This will be a prospective observational multi-center study with approximately 15 to 20 US sites, and approximately 1210 subjects evaluating the clinical utility of the Rapid fFN 10Q system for preterm birth risk assessment. A single fFN specimen will be collected from each subject between 16 weeks, 0 days and 21 weeks, 6 days. The primary and secondary maternal outcome measures will be determined based on the date of delivery and the estimated date of confinement (EDC), which will be evaluated in a standardized manner.

Hologic has developed a quantitative test to assess the amount of fetal fibronectin (fFN) present in cervicovaginal secretions, and evaluate the clinical utility of the test in assessing spontaneous Pre-Term Bith risk in a high risk population. Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy. The goal of this study is to evaluate the benefits of collecting fFN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women from 16 weeks, 0 days to 21 weeks, 6 days' gestation
2. Maternal age ≥18 years of age
3. Subject has signed and dated an Institutional Review Board (IRB) approved consent form to participate in the study
4. Subjects for this study must be at high risk for preterm birth as indicated by at least one of the following:

   * A previous delivery of a live born singleton between 20 weeks, 0 days and 36 weeks, 6 days due to spontaneous preterm premature labor or preterm rupture of fetal membranes
   * Short cervical length (≤25 mm) determined by transvaginal ultrasound
   * Current twin pregnancy
   * Cervical cerclage in a prior pregnancy
   * Prior cone biopsy
   * Prior LEEP / LLETZ

Exclusion Criteria:

1. Maternal age under 18
2. Suspected or proven rupture of fetal membranes at the time of specimen collection
3. Known significant congenital structural or chromosomal fetal anomaly
4. Women with moderate or gross bleeding evident on speculum examination
5. Women who have had sexual intercourse within 24 hours prior to specimen collection
6. Cervical cerclage at time of specimen collection
7. Current triplet (or more) pregnancy
8. Placenta previa with active bleeding
Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes

Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles

Exclusion Criteria:

* Infertile women aged \> 38 undergoing fresh invitro fertilization cycles
* Patients undergoing frozen embryo transfers
* Patients undergoing donor-egg cycles
* Patients who have a contraindication to receiving Vitamin D (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)
Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites

For the management of peridontal and peri-implant conditions, free epithelial grafts have been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing confort during brushing and reducing the level of inflammation. Nevertheless, these are subjected to dimensional changes that may jeopardise the final outcome of providing sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim at shedding light on the dimensional changes and the variables affecting these changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of keratinized mucosa to improve the periodontal and peri-implant condition
* With no uncontrolled disease
* Non-smokers

Exclusion Criteria:

* Patients with uncontrolled diseases and conditions
* Smokers
* Patients with sufficient keratinized mucosa
Crizanlizumab for Treating COVID-19 Vasculopathy

The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.

Infection with severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) causes coronavirus disease 2019 (COVID-19). The clinical course of COVID-19 is variable, and some patients develop severe pneumonia, multi-organ failure, and shock.

Severe COVID-19 is characterized by a hyper-inflammatory and hyper-thrombotic state. We propose that this state is caused by viral injury of the vascular endothelium, leading to endothelial release of von Willebrand Factor (VWF) and P-selectin, which in turn drive thrombosis and vascular inflammation.

Crizanlizumab is a monoclonal antibody that targets P-selectin. Crizanlizumab can decrease inflammation by binding to P-selectin, blocking leucocyte and platelet adherence to the vessel wall.

We now plan to test the safety and efficacy of crizanlizumab in decreasing biomarkers of inflammation and thrombosis in a placebo-controlled, double-blind randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

1. Willing to provide written informed consent
2. Willing to comply with all study procedures and be available for the duration of the study
3. Male or female ≥ 18 years of age
4. SARS-CoV-2 infection (COVID-19) within the past 10 d documented by laboratory test (nucleic acid test (NAT) or reverse transcriptase-polymerase chain reaction (RT-PCR))
5. Currently hospitalized
6. Symptoms of acute respiratory infection (at least one of the following: cough, fever \> 37.5°C, dyspnea, sore throat, anosmia),
7. Radiographic evidence of pulmonary infiltrates
8. Requiring supplemental oxygen or the peripheral capillary oxygenation saturation (SpO2) \< 94% on room air at screening
9. Elevated D-Dimer \> 0.49 mg/L
10. Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

1. Use of home oxygen at baseline
2. Current use of mechanical ventilation
3. Inability to provide consent
4. Do not intubate status
5. Prisoner or incarcerated
6. Pregnancy or Breast Feeding
7. Participation in other interventional therapy trials for COVID-19.
8. International normalized ratio (INR) \> 3 or activated partial thromboplastin time (aPTT) \> 60
Investigation of Eating Awareness,Eating Cravings, Wellness Awareness and Health Perception

In this project, eating awareness, acceptance of food cravings, healthy life awareness and health perception will be examined in healthy young adults.

In this project, eating awareness, acceptance of eating desire, healthy life awareness and health perception will be examined in healthy young adults. Accordingly, 356 healthy young individuals between the ages of 18-30 will be included in the study. The questionnaires and scales used as data collection tools in this research, which is planned as a survey study, will be filled in by face-to-face interview method after the written and verbal voluntary consent of the individuals is obtained. The evaluation consists of five sections. It is aimed to raise awareness about the conditions that are found to be related.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old

Exclusion Criteria:

* Under 18 years old
* not volunteering
Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

Exclusion Criteria:

* Patients with overactive bladder on urodynamic study.
* Patients with voiding dysfunction.
* Patients with intrinsic sphincteric deficiency.
* Patients with previous anti-incontinence surgery.
* Patients on anti-coagulant therapy.
* Immune-compromised patients (DM, patients on corticosteroids treatment).
* Refusal of surgery.