cyrilzakka/clinical-trials huggingface dataset:
Role of MDCT in Grading of Esophageal Varices

Esophageal varices are one of the major complications of liver cirrhosis.Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy is the gold standard for diagnosing and grading esophageal varices,Multi detector computed tomography (MDCT) has emerged as a non-invasive alternative for evaluating esophageal varices.it particularly appealing for patients who contraindicated to endoscopy .

Esophageal varices are one of the major complications of liver cirrhosis, with an estimated prevalence of approximately 80% with decompensated patients and 50% in compensated cirrhosis, pose a significant risk of life-threatening of bleeding due to portal hypertension. Accurate grading of these varices is essential for effective management . Traditionally, esophagogastroduodenoscopy (EGD) is the gold standard for diagnosing and grading esophageal varices . IT provides direct visualization, allowing for detailed assessment of variceal size and other risk factors for bleeding . However, it is an invasive procedure that requires sedation and carries some risks, such as bleeding or perforation .

Multi detector computed tomography (MDCT) has emerged as a non-invasive alternative for evaluating esophageal varices. It offers detailed cross-sectional images and is widely available, providing a broader assessment of abdominal pathology. Its non-invasive nature makes it particularly appealing for patients who contraindicated to endoscopy .

Eligibility Criteria:
Inclusion Criteria:

-Cirrhotic patients with portal hypertension undergoing upper GI endoscopy.

Exclusion Criteria:

-Contraindication to contrast:( severe renal insufficiency, allergy to contrast agents).

-Previous history of upper GI endoscopy with intervention (band ligation or sclerotherapy).-

* Pregnancy.
* Patients with previous transjagular intrahepatic portosystemic shunt (TIPS).
* Patients with contraindication to endoscopy (severe cardiopulmonary conditions, coma "unless the patient is intubated", and cardiac arrhythmias)
Magic Camp for Children With Hemiplegic Cerebral Palsy

The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children with spastic hemiplegic cerebral palsy (CP). A single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "Magic Camp" on improving upper limb motor function and health-related quality of life (HRQoL) in children with hemiplegic CP.

This project will employ a single group pretest-posttest design to investigate the impact of a "Magic Camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic CP. After the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks. The primary outcome measures will be unimanual function as measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the Children's Hand Experience Questionnaire. Secondary outcome measures will include HRQoL as measured by the Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.

Eligibility Criteria:
Inclusion Criteria:

* spasticity with Modified Ashworth Scale grades between 1 and 3;
* ability to lift the more affected arm 15 cm above a table surface;
* impairment of hand function at levels I to III of the Manual Activity Classification System
* ability to grasp and release light objects with the more affected hand
* largely nonuse of the more affected hand in daily activities as determined by the Pediatric Motor Activity Log
* are interested in learning magic tricks
* have the cognitive and social ability to participate in a camp setting;
* ability to follow directions in English; and
* ability to remember simple sequences of actions to perform magic tricks.

Exclusion Criteria:

* severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use
* dystonia
* severe visual or auditory disorders that prevent learning and carrying out the magic tricks
* serious or recurring medical complications
* participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months
* start muscle relaxant within the last 3 months; or
* plan to move to another state within the next 6 months.
Traditional Turkish Military Music and Endoscopic Retrograde Cholangiopancreatography

This study aims to investigate the effect of Traditional Turkish Military music on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.

The study will be conducted with two groups: the intervention group (n=36) and the control group (n=36). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to Traditional Turkish Military music, which consists of music selected by an expert on the type of music, by the researchers for 15 minutes before the procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 or above,
* with a scheduled ERCP procedure
* with the ASA grade level of I-II clinically
* without a hearing/speech impairment
* willing to participate in the research
* without a mental problem or diagnosis of psychiatric disorder
* without any a diagnosis of depression

Exclusion Criteria:

* patients below 18 years of age,
* Patients with an emergency ERCP procedure
* with a hearing/speech impairment
* not willing to participate in the research
* with a mental problem or diagnosis of psychiatric disorder
* with a diagnosis of depression
Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors

A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD.

In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.

Before your transplant you will receive conditioning therapy with fludarabine and busulfan given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood cells taken from your sibling or unrelated donor.

You will receive 3 drugs for your GVHD prophylaxis:

Tacrolimus will be started 3 days before your transplant. It will be given intravenously and later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.

Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.

Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4, 7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood work, and be asked to complete a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including myelodysplastic syndrome) that is unlikely to be cured by alternative therapies
* HLA-Matched unrelated donor; or 1-locus HLA-mismatched related or unrelated donor
* ECOG performance status 0-2
* Adequate organ function
* Able to understand and willing to sign a written informed consent document
* Agrees to practice adequate contraception per study requirements

Exclusion Criteria:

* Pregnant or breastfeeding
* Recipient of prior allogeneic or autologous stem cell transplantation
* Prior abdominal radiation therapy
* HIV-positive on combination antiretroviral therapy
* Seropositive for hepatitis B or C
* Allergies to bortezomib, boron, or mannitol
* Myocardial infarction within last 6 months, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias
* Uncontrolled bacterial, viral or fungal infections
* Seizures or history of seizures
* History of another non-hematologic malignancy unless disease-free for at least 5 years
* Uncontrolled intercurrent illness
Ultrasound Guided Needling Versus Ultrasound Guided Corticosteroid Injection Alone, a Randomized Controlled Trial.

Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. However, evidence for this treatment is lacking. The investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.

Calcifying tendinitis of the shoulder is a common cause of shoulder pain with an incidence ranging from 2.7 % to 6.8 %. This disease of the rotator cuff tendons is characterised by calcifications in the tendons, most commonly in the supraspinatus tendon up to 82%. The aetiology remains unclear.

Calcifying tendinitis is regarded as a self-healing condition with usually spontaneous resolution of the calcifications. But some patients have chronic or recurrent pain and disability of the shoulder which requires treatment. The treatment should be minimally invasive and effective in short and long term. Symptomatic treatment is indicated first using non-steroidal anti-inflammatory drugs, therapeutic exercise and non ultrasound guided subacromial corticosteroids injection.

The role of corticosteroid injections is unknown due to the lack of good studies. Family doctors and orthopaedic surgeons inject corticosteroids in the shoulder without the guidance of ultrasound; with this method accurate needle placement in the subacromial bursa is not possible. When this treatment fails other therapeutical methods can be used. Ultrasound guided needling is a percutaneous technique of fragmentation or extraction of calcifications in the rotator cuff tendon.

Literature shows favourable results but only a few randomized controlled trials were executed. Randomised controlled trials are needed to give more insight in the effectiveness of us guided needling. Comparing two groups of patients treated with us guided corticosteroid injection and one group combined with us guided needling can provide information of the usefulness of us guided needling.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain without improvement after 3 months despite conservative treatment
* Calcification on x-ray (Gartner type I of II) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment
* All patients are first seen and included by the orthopaedic surgeon

Exclusion Criteria:

* Previous operation of the shoulder
* Previous ultrasound guided needling of the shoulder
* Frozen shoulder
* Last corticosteroid injection less than 3 months ago
* Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...)
* No informed consent
* Pregnancy
Cetuximab Therapeutic Drug Monitoring in Squamous Cell Carcinoma Head and Neck Cancer Patients: Determination of the Predictive Value Exposure Levels Through a Single Arm Multicentric Study

Only about 30 percent of cancer patients have a clinical benefit upon cetuximab administration. Pilot studies in colorectal and head and neck cancer patients have suggested that cetuximab pharmacokinetics (PK), i.e. clearance values, could impact on clinical outcomes such as survival.

Determining cetuximab plasma clearance requires sophisticated PK modeling using population approaches, thus making it difficult to implement in routine clinical practice. In addition, all the preliminary studies with cetuximab were based upon Elisa determination of cetuximab plasma levels, an analytical method that fails to meet the requirements of daily practice in laboratories performing therapeutic drug monitoring. This pilot study aimed at evaluating the mass spec method analytical performance as part of a " real life " study, evaluating the inter-patient variability of exposure levels in head and neck cancer patients, and establishing a putative link between those exposure levels and clinical outcome. Results from 25 patients fully confirmed the analytical performance of the mass spec method (e.g., lack of matrix effect, acceptable sensitivity to monitor trough levels, lack of impact of sampling processing or freezing/thawing cycles). In addition, a large inter-individual variability (Superior at 50 percent) was observed, both in the peak concentrations (Cmax) and in trough levels (Cmin). Most interestingly, despite the limited number of patients enrolled, a statistically significant association was shown between exposure levels (i.e. calculated AUC) and clinical outcome (DCR). This difference was even more significant on Cmin, thus suggesting that simple trough levels monitoring could help to predict efficacy. Further analysis on survival showed that although not statistically significant, a trend towards longer both progression-free survival and overall survival was observed in the subgroup of patients with higher trough levels. In particular, 3-year survival was 29 percent and 0 percent in the subgroups with high and low trough concentrations, respectively (unpublished data).

Beyond tumoral factors, these preliminary data suggest that cetuximab Cmin levels could be a predictive marker of therapeutic efficacy and that simple therapeutic drug monitoring could help to forecast clinical outcome or enable dosage adaptation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years.
* Adult patient with recurrent or metastatic histologically proven head and neck Squamous Cell Carcinoma.
* Patients to be treated by standard treatment: chemotherapy with cisplatin or carboplatin and fluorouracil in combination with a cetuximab-based protocol
* Patients having signed the non-opposition form

Exclusion Criteria:

* Patient currently participating in or having participated to a study with another investigational agent.
* Patients minor
* Pregnant or breast-feeding women.
* Any contra-indication in the Second Primary Cancers
Effects of Pain Neuroscience Education Using an Infographic in Basketball Elite Athletes

The objective of this study is to analyze the effectiveness of a brief educational intervention supported by an infographic versus that supported by PowerPoint on the understanding of pain in elite athletes.

Secondary objective: to analyze whether a greater understanding of pain has effects on the intensity, extent and characteristics of pain experienced in the year after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Elite athletes over 18 years of age from the ACB Unicaja Basketball team during years 2021-2022

Exclusion Criteria:

-
Non-invasive Phrenic Nerve Stimulation in ARDS Patient

Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.

Mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (AHRF). However, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. In patients with AHRF undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD), thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ARDS) undergoing mechanical ventilation remain unclear and require further investigation.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ARDS patients undergoing controlled mechanical ventilation
2. The duration of endotracheal intubation \< 48 hrs

Exclusion Criteria:

1. Neurological condition affecting motor neuron or muscle (e.g. ALS)
2. Paralysis of the phrenic nerve
3. Proven or suspected spinal cord injury
4. Conditions that limit diaphragm movement
5. Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
6. Patients with implanted medical pumps
7. Pregnancy
8. Patients with skin lesions, infections or strictures in throat/neck area
9. Patients with metallic implants
10. Refusal to sign informed consent
Green Cart Program Evaluation

The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce market on access to healthy food and fruit and vegetable intake in 12 lower-income communities using a cluster-randomized design.

Lower-income and minority groups face significant health disparities with respect to obesity, cancer, heart disease and other chronic conditions. Poor diets, low in fruits and vegetables (F\&V) and high in saturated fat, sodium and sugar, contribute to many of the health problems faced by vulnerable groups. While poverty, low-educational attainment and personal food preference are all associated with reduced F\&V consumption, these individual-level factors must be viewed in an environmental context. Research has repeatedly demonstrated the important role that environment plays on health decisions and behaviors. Compared with higher-income neighborhoods, lower-income and minority neighborhoods are less likely to have a supermarket that sells a variety of F\&V and other healthy foods. This is perpetuated by an underlying misconception that there is limited demand or potential profit for new healthy food ventures in these communities. In the few cases where new food outlets have opened in underserved areas, they have been met with substantial customer support. The NC Green Cart program, which our team has already been funded to lead, uses a weekly mobile market model to deliver low-cost boxes of fresh F\&V to easily accessible community locations (such as churches and day care centers) and provide nutrition and cooking education. This program builds upon burgeoning support for a local sustainable food system in NC and leverages a public-private partnership to increase access to fresh F\&V in underserved communities. While current program funding allows for minimal evaluation, the present study hopes to demonstrate that selling affordable, accessible F\&V in lower-income communities is not only financially viable, but can impact behavioral risk factors of individuals in target communities. Working together with the Green Cart program team, this research will 1.) measure the impact of a mobile market at 6, 12 and 18 months on the primary outcome of F\&V consumption as well as BMI, perceived access to F\&V, and self-efficacy to purchase, prepare, serve and eat fresh F\&V using a randomized controlled design; and 2.) assess community support, feasibility, and financial sustainability of the public-private Green Cart partnership. Results of this research will inform our understanding of how the food environment impacts dietary choices and provide evidence for researchers, businesses, non-profits and policy makers on the potential impact and viability of using similar models to reduce food access disparities and improve diet.

Eligibility Criteria:
Inclusion Criteria:

* Receives services or lives within one of the communities selected for the study
* Main shopper for the household
* Intends to use Veggie Van if it comes to their community

Exclusion Criteria:

* Under 18
Antegrade Arterial and Portal Flushing Versus Portal Flushing Only in LDLT

Arterial flushing is a standard recommendation in deceased donor liver transplantation but not in living donor liver transplantation due to the risk of arterial intimal injury and short cold ischaemia time. There is recent evidence on benefit of retrograde arterial perfusion using hepatic venous occlusion and its benefits on post transplant cholestasis. However there is no data on antegrade arterial flushing.

Biliary reconstruction has been labeled the "Achilles heel" of liver transplantation and is a common cause of postoperative morbidity and also mortality .Living donor liver transplantation (LDLT) has a higher incidence of biliary complications of up to 30% which is higher than Deceased Donor Liver Transplantation and does not seem to improve significantly with experience.The virtually unchanged incidence of biliary strictures suggests that they are not simply "technical" in origin, but probably represent a mucosa ischemic injury inherent in the transplantation procedure. The blood supply of the bile duct is mainly from the arterial system and skeletonisation of the duct during dissection impairs the blood supply rendering it ischemic.

Various donor maneuvers for better flushing and preserving peribiliary vascular plexus and biliary mucosa have been studied to decrease biliary complications. LDLT have advantages of haemodynamic stable donor and short cold ischemia but also has disadvantages of small graft size, small ducts, complicated reconstruction and absence of arterial flush. Conventional portal flush in animal livers could not remove warm blood from the arterial system and grafts without retrograde arterial flush had higher post operative bilirubin.With further studies in Living Donor Liver Transplant, it was concluded that retrograde flushing may ameliorate post operative cholestasis. There has not been data published on antegrade arterial flushing and its effect on biliary complications in Living Donor Liver Transplant. This study aims to compare back table graft arterial and portal flushing with portal flushing alone and evaluate biliary and arterial complications.

Arterial flushing has been made part of standard protocol at our institute and its safety established. There are centers which routinely perform back table arterial flush.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing living donor liver transplant for decompensated chronic liver disease with right lobe grafts only

Exclusion Criteria:

* Donor artery size less than 2 mm
* More than one donor artery
* GRWR \<0.8
* ABO incompatible grafts
* Refusal to participate in the study
* Emergency transplants