cyrilzakka/clinical-trials huggingface dataset:
Functional Imaging of Tumor and Normal Tissue

Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.

Patients will undergo functional imaging studies, DCE-MRI pre-treatment (twice) and after 1 week of Radiation Therapy (RT) and PET scans - pre-treatment and after 1 week of RT. Parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0)
* Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx
* Curative intent concurrent chemoradiation
* Age \> 18 years
* Karnofsky Performance Status \> 60
* Able to undergo MRI with contrast (gadolinium) and/or FDG PET scan

Exclusion Criteria:

* Diabetes other than diet controlled
* MRI Absolute Contraindications including:

  * Glomerular filtration rate \< 60 ml/min
  * Weight \< 350 lb or current device limitations
  * Metallic foreign bodies in the eye
  * Cardiac pacemakers
  * Clips in the central nervous system (ferromagnetic haemostatic)
  * Automatic internal cardiac defibrillators
  * Cochlear implants
  * Shrapnel in vital locations
* Pregnant (positive pregnancy test) or lactating
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients

Chest trauma is common in traumatology. Its management is based on ventilatory therapies, among which non-invasive ventilation (NIV) is commonly used. Some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing mortality. However, these studies are old and underpowered. High flow oxygen therapy (HFO), which is frequently used in everyday practice, has only one study in chest trauma.

There is still a lack of data to really understand the effects of these techniques on the injured lung after trauma. Therefore, the investigators want to do a NIV or HFO session and directly assess the effects on participants' lungs by doing a CT at the end of the session.

This is a procedure carried out within five days of the initial trauma and consists of either a 10-minute session of non-invasive ventilation or a 10-minute session of high-flow oxygen therapy, depending on which arm the participant is allocated to.

Two chest CTs will be performed: the first as part of usual care before the non-invasive ventilation session or high flow oxygen therapy session, and the second immediately after the 10-minute session.

The investigator's objective is to demonstrate an improvement in lung recruitment with NIV or HFO using CT imaging.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Chest trauma \< 5 days
* At least 3 ribs fracture on initial CT-scan
* Need of oxygen moderated to maintain monitoring oxygen saturation Sp02 \> 92% or partial pressure of arterial oxygen Pa02/ Fraction of inspired oxygen FiO2 \> 200
* Intensive Care Unit admission
* Need a chest CT control during the five first days after the trauma

Exclusion Criteria:

* Patient intubated or with respiratory failure : measured or estimated Pa02/FiO2 \< 200 or indication for intubation (several with respiratory rate \> 35/min, abundant tracheal secretions, significant increase in work of accessory respiratory muscles on inspiration, signs of respiratory exhaustion on arterial blood gas with The potential of Hydrogen pH \< 7,3 or PaCO2 \> 50 mmHg, severe hypoxemia with PaO2/FiO2 ratio \< 100 or desaturation \< 88% for more than 5 minutes)

  * Inability to maintain 10 seconds of apnoea required for scan acquisition
  * Patient treated with ventilatory support by NIV or HFO in the 12 hours prior the investigation
  * Uncontrolled circulatory failure with need for introduction of Noradrenaline \> 0,15 ug/kg/min
  * Uncontrolled neurological failure with Glasgow Coma Scale (CGS \< 15
  * Unstable facial trauma or with pneumocephalus or basilar skull trauma
  * Large, undrained pneumothorax with lateral separation at the level of the hilum \> 2 cm and extensive throughout the axillary line
  * Patients with identified cognitive impairment
  * Persons deprived of liberty, persons under protective measures
  * Persons not affiliated to a social security insurance
  * Current pregnancy or breastfeeding
  * Refusal to participate in the study
The Effect of the Physiotherapy Program for Diabetic Individuals on Dexterity, Proprioception, and Functionality

The goal of our research titled "The effect of the exercise program developed for the upper extremity in diabetic individuals on dexterity, grip strength and proprioception" is to examine the effect of the exercise program created for upper extremity problems in diabetic individuals on dexterity, wrist proprioception and upper extremity functionality. Secondary aims of our study; the exercise program created for upper extremity problems; to investigate the effects of grip strength, neuropathic pain, light touch, proprioception, muscle viscoelastic properties, anxiety and depression levels and quality of life of individuals.

The strength of different grip types will be measured, and an evaluation will be made in a short time from the muscle surface with a device called MyotonPro to determine the characteristics of the muscles in hands and arms. In addition to these, 6 separate questionnaires will evaluate the functionality of hands, wrists and upper extremities, pain level, satisfaction level, difficulty level in daily living activities, neuropathic pain problems, depression and anxiety levels and quality of life. In addition, different senses in the upper extremity and hand-wrist will be tested. These measurements will take 1 hour in total and will be repeated 3 times at 6-week intervals. Participant will divide on 2 groups and treatment group will perform exercises with physiotherapist and control group will take conventional physiotherapy program for diabetes. Comparison will be between groups.

* 12 weeks/ 3 days a week/ 40 minutes of physiotherapy program will be planned. Patients will complete the exercises with a physiotherapist once a week, and home programs given as homework according to weekly targets will be checked by phone calls twice a week. In the first session, information about diabetes will be given and training will be given.
* Content of the exercises; There will be warm-up exercises, pinch grip, full grip, nerve and tendon gliding exercises, exercises that improve proprioception, functional exercises, strengthening exercises and stretching exercises. Control group will be in conventional physiotherapy program once a week as treatment group. The program is going to include aerobic exercise recommendation and basic stretching and strengthening exercises focusing upper extremity muscles.

This research will shed light on the rehabilitation programs to be planned for problems involving the hand in individuals with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)

Exclusion Criteria:

* Insufficient cognitive level
* Traumatic nerve injury
* Presence of congenital anomaly in the upper extremity
* Presence of systematic disease (eg rheumatologic)
* Having a problem involving the neurological system
* Having undergone surgery involving the upper extremity in the last 6 months
Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery

Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery.

The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients.

The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM).

A secondary aim is to determine a cost-effectiveness of this monitoring modality.

The investigator will collect delirium, stroke, transient ischemic attacks, myocardial infarction (troponin essays), pulmonary embolism (clinical, echocardiography and computer tomography assessments), renal failure (creatinine increase by at least 50% from baseline), pneumonia (clinical, X-ray), atrial fibrillation (documented electrocardiogram), bleeding requiring a transfusion of more than or equal to 4 units of red blood cells within 72 hours of surgery, mechanical ventilation for 2 days, major wound disruption, surgical site infection, sepsis, septic shock, systemic inflammatory response syndrome (vasoactive medication requirement), unplanned return to the operating room, and vascular graft failure, for the duration of hospital stay, as well as, all-cause 30-day mortality. Frailty scale \& DASI questionnaires will be administered at screening visit. Postoperative quality of recovery score (QoR-15) with be performed at baseline, POD 1 \& 5 (discharge if earlier)\]. Disability Free Survival (DFS) at 6 months (administer WHODAS).

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 60 years of age
* Undergoing elective major non-cardiac surgery with an anticipated surgical duration of 4 hours or more,
* Preoperative written informed consent.

Exclusion Criteria:

* Emergency surgery
* Laparoscopic/Robotic surgery
Efficacy of Topical Antioxidants in Tretment of Photoaging

This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.

•Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group.

•Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers \< 50 years old
* Clinical and dermoscopic features of photoaging.

Exclusion Criteria:

* Genodermatoses associated with photosensitivity.
* Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment.
* Any recent cosmetic procedures.
The Cultural Sensitivity Education Program

The research was carried out with a randomized controlled experimental design in order to determine the effect of intercultural sensitivity training applied to nurses on intercultural sensitivity and compassion level. Nurses working in a private hospital were included in the sample of the study. A total of 66 nurses, 32 of whom were in the intervention and control groups, were included in the study. "Personal Information Form", "Intercultural Sensitivity Scale" and "Compassion Scale" were used to collect data. "Intercultural Sensitivity Training" consisting of four sessions was given to the intervention group.

Within the scope of the research, an intercultural sensitivity training program for nurses was created. The training program was implemented and an evaluation was made after the implementation.

Eligibility Criteria:
Inclusion Criteria:

* Being a nurse working under the Nursing Services Directorate
* Volunteering to participate in research

Exclusion Criteria:

* Having a disease that prevents participation in the study
Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being

After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Women with elective cesarean delivery at 39-42 wks gestation.

Exclusion Criteria:

* Women who shorter than 5'0" in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded.
* Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded.
* If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.
Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.

Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.

Hypothesis: Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.

The research objective of this proposal will be accomplished through 3 specific aims:

1. Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.
2. Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.
3. Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.

Eligibility Criteria:
Inclusion Criteria:

* \> 21 years of age
* African American or Hispanic
* English speaking
* Has been on warfarin therapy \> 3 months
* Plan to be on warfarin therapy \> 12 months
* Willing ( or caregiver be willing) to do self-monitoring
* Willing to be randomized

Exclusion Criteria:

* Lack of access to a telephone
* Moderate to severe dementia (if lacks caregiver)
* Severe hearing impairment ( if lacks caregiver)
* Blindness ( if lacks caregiver)
* Life expectancy \< 6 months
* Antiphospholipid antibody syndrome
Filgrastim for the Promotion of Collateral Growth in Patients With CAD

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* 1- to 3-vessel coronary artery disease (CAD)
* Stable angina pectoris
* At least 1 stenotic lesion suitable for PCI
* No Q-wave myocardial infarction in the area undergoing CFI measurement
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients admitted as emergencies
* Acute myocardial infarction
* Unstable CAD
* CAD treated best by CABG
* Patients with overt neoplastic disease
* Patients with diabetic retinopathy
* Liver or kidney disease
* Pre-menopausal women
Prospective Femoral Versus Femoral and Sciatic Nerve Block for Anterior Cruciate Ligament (ACL) Reconstruction

The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (PACU) length of stay. The investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.

Although femoral nerve blocks improve analgesia after anterior cruciate ligament (ACL) reconstruction, patients often complain of posterior knee pain, which can be treated with a sciatic nerve block. In a prospective randomized study, we compare preoperative femoral nerve block to a combined femoral and sciatic block in patients undergoing ambulatory ACL reconstruction. We hypothesize that the combined femoral/sciatic nerve block patients would have improved analgesia, fewer opioid-related side effects, and shorter PACU length of stay and improved patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* ASA status I-II
* Scheduled for ambulatory Arthroscopic ACL Surgery

Exclusion Criteria:

* Allergy to Local anesthetics or opiates used in the study
* Contraindications for regional anesthesia
* coagulopathy, anticoagulation, Thrombocytopenia
* infection at site of injection
* Chronic pain and high preoperative opiate requirements
* High risk for PONV
Performance of Artificial Intelligence Tools and Ultrasonographers With Different Skills

Artificial intelligence versus different skilled sonographers.

Comparison of artificial intelligence and ultrasonographers with different skills in diagnosing intussusception in children and identifying indications for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-36 months with suspected ileocolic intussusception

Exclusion Criteria:

* Children younger than 3 months or older than 36 months with suspected ileocolic intussusception
Inulin Supplementation in Patients With Type 1 Diabetes

The aim of this study is to compare the glycemic and metabolic control of type 1 diabetic patients in replacement therapy with insulin, comparing those treated with a supplementation of prebiotics (inulin) and those treated with a placebo.

Therefore, the primary objective of the study is represented by the proportion of patients with better glycemic control (basal and post-prandial euglycemia time) and optimal metabolic control (HbA1c, lipid profile, C-RP).


Eligibility Criteria:
Inclusion Criteria:

* Patients with T1D, diagnosed before 35 years of age will be enrolled

Exclusion Criteria:

* advanced complications of T1D (established renal failure, severe retinopathy and diabetic neuropathy)
* BMI\> 30 kg / m2.
Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery

Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated.

Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. It can be used as a single dose and it is a reasonable tool do decrease cardioplegic interventions. Recent meta-analysis based on 9 retrospective studies has shown that "clinical outcomes of Del Nido cardioplegia are noninferior to the outcomes of conventional cardioplegia in adult cardiac surgery".

To assess the potencial benefits of Del Nido cardioplegia we performed this clinical trial to evaluate superiority of Del Nido cardioplegia compared to cold blood cardioplegia in terms of myocardial protection and clinical-related outcomes. 474 participants will be randomized either into Del Nido cardioplegia protocol or into the cold blood cardioplegia protocol. Perioperative outcomes will be presented.

This clinical trial is performed at Puerta de Hierro Hospital in Spain. The protocol has been approved by institutional ethical committee and Spanish Agency of medicines and medical devices (AEMPS).

The aim of the study is to evaluate superiority of Del Nido cardioplegia solution compared to cold blood cardioplegia solution in terms of myocardial protection and clinical-related outcomes.

According to results in recent meta-analysis, the author estimated a total sample size of 474 participants to give 80 % of power at the 5% significant level.

Participants aged 18 years or older undergoing elective cardiac surgery are randomized 1:1 to receive Del Nido cardioplegia solution (study group) and cold blood cardioplegia solution (control group).

Primary outcome will be assessed by biochemical variables of myocardial injury (troponin T level at inmediate post-op, 3-12 hours, 12-24 hours, 24-48 hours post-op); and clinical variables: "Presence of acute myocardial infarction within 72 hours after surgery", "Prolonged low cardiac output", "Prolonged postoperative vasoplegia" within 48 hours after surgery and/or "Ventricular tachyarrythmias" within 24 hours after surgery.

Secondary outcomes include intraoperative variables of myocardial protection (incidence of ventricular fibrillation, inotropic and vasopressor support at the end of surgical intervention, cardiopulmonary bypass time, aortic cross-clamp time) and postoperative clinical outcomes variables (mechanical ventilation time, incidence of delirium, stroke, acute renal failure, atrial fibrillation, length of stay in intensive care unit, length of stay in hospital and In-hospital mortality).

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years or older undergoing adult cardiac surgery.
* Elective surgical procedures requiring cardiopulmonary bypass and myocardial arrest.

Exclusion Criteria:

* Emergency surgery.
* Patients on preoperative inotropic support and/or mechanical circulatory support.
* Patient who refuse to participate in the study.
* Lidocaine allergy.
* Port access mitral valve surgery.