cyrilzakka/clinical-trials huggingface dataset:
A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
* Failed Gleevec treatment or intolerant to Gleevec therapy

Key Exclusion Criteria:

* Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec
Learning Lab for Diagnostic Fidelity

Diagnostic error and delay remain a leading cause of preventable harm and death in the United States. Using a learning laboratory structure, researchers will implement mixed-methods research approaches to identify the systemic weaknesses that contribute to diagnostic error and delay in the hospital setting. The knowledge gained from research innovative will allow researchers to design, develop, implement, and refined a suite of human-centered tools that can be deployed to reduce the risk of diagnostic error and delay in both community and academic hospital settings.

Despite the recognition that diagnostic errors an delays are a major contributor to preventable deaths in the USA, little progress has been made to reduce mortality outcomes from this known killer. An effective strategy leading to meaningful reduction in diagnostic error and delay rates has not made its way into practice. This proposal is unique and novel and combines mixed-methods research approaches with systems engineering research approaches to understand the interplay of the multiple factors contributing to diagnostic error and delay. The knowledge gained from this holistic approach will then be used within the learning laboratory to inform the design, development, evaluation, and refinement of the solutions to diagnostic error and delay. "Control Tower" will be the staging ground for the in situ learning laboratory and will be built on top of a well-established clinical informatics infrastructure and hospital environment open to innovation and practice change.

Eligibility Criteria:
Inclusion Criteria

* For EMR review all adults admitted to the hospital ages 18 and older with research authorization
* For survey-clinicians including physicians, advanced care practitioners
* For focus groups and interviews-clinicians including physicians, advanced care practitioners

Exclusion Criteria

* Age \<18 years old
* No research authorization
* Refusal to give consent
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI

Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using MRI.

Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported in migraine patients outside migraine attacks. What happens during migraine attacks has never been investigated. The hypothesis we will test is that pain related networks are affected during spontaneous attacks using functional MRI.

Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with migraine with aura, but not in those without aura. We hypothesize that CBF is altered regionally during attacks, which we will investigate in this study using arterial spin labeling (ASL).

Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been suggested but never investigated during migraine attacks. Our hypothesis is that pain related structures show altered VBM during spontaneous migraine attacks.

Brain MRI during and outside migraine attacks.

Up to 600 patients will be recruited, who will be given a phone number that they can call when they get migraine attacks.

The study will continue until 20 patients with migraine with aura, 20 patients without aura, 20 patients with chronic migraine have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of migraine with aura, migraine without aura, or chronic migraine according to the International Headache Society.
* written informed consent.
* use of anticonceptive method by women in childbearing age.

Exclusion Criteria:

* tension type headache more than 5/month during last year.
* tension type headache on the experimental day.
* use of antimigraine medication or pain-killer on the experimental day before MRI.
* pregnant or breastfeeding women.
* contraindications against MRI.
* history or clinical sign of cardio- or cerebrovascular disease.
* untreated severe mental disorder or drug abuse.
* other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
* not accepting information about potential accidental finding during experiment.
Intraoperative NIRS of Transplanted Kidney for Prediction of Acute and Sub-acute Injury

This is a prospective, observational cohort study, designed to explore the use of NIRS in kidney transplants. This study will investigate an association between measurements of intra- operative NIRS and post - operative graft dysfunction as manifested in initiation of renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant candidates (living/ cadaver donor) at TLVMC who will consent to participate.

Exclusion Criteria:

* Patients unable to give consent,
* patients whose surgeries were aborted before transplant,
* patients who were lost to follow up during the first 7 post-transplant days,
* patients who suffered from surgical graft failure (vascular problems or need for re exploration due to bleeding etc.)
* No pregnant patients will participate in this study.
* No minors will participate in this study.
Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury

OBJECTIVES:

I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone (MePRDL) versus tirilazad for patients with acute spinal cord injury.

II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.

PROTOCOL OUTLINE:

This is a randomized, double-blind study. Patients are stratified by participating institution.

Patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. Treatment begins within 2 hours of randomization.

One group receives a 24-hour methylprednisolone (MePRDL) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. A placebo for tirilazad is also administered.

A second group receives the same MePRDL loading dose but the continuous infusion is maintained for 48 hours. A placebo for tirilazad is also administered.

A third group receives a 48-hour infusion of tirilazad with an initial bolus dose of MePRDL. Eight additional doses of tirilazad are administered by intravenous push. The MePRDL loading dose may be omitted for patients who received a prestudy MePRDL dose.

Patients are followed at 72 hours, 6 weeks, 6 months, and 1 year after the injury.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam

Glasgow Coma Score greater than 9

Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury

No root involvement only; no cauda equina only

--Prior/Concurrent Therapy--

Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed

--Patient Characteristics--

Hematopoietic: No hematologic contraindication to protocol therapy

Cardiovascular: No vascular contraindication to protocol therapy

Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status
Accuracy of Gastric POCUS in Pediatric Trauma

The goal of this observational study is to detect the predictive accuracy of the gastric POCUS in pediatric trauma patients undergoing urgent and semi urgent operative procedures.

The main question it aims to answer is :

What is the predictive value of the gastric POCUS in pediatric patients? Participants are pediatric patients who will be scheduled for operative procedures within one hour of performing gastric POCUS.

Reflux aspiration of gastric contents is a critical concern in the perioperative setting, as it can result in severe complications such as aspiration pneumonia, acute respiratory distress syndrome, and even death. The risk is heightened during general anesthesia and is influenced by the quality and quantity of stomach contents. To mitigate this risk, the American Society of Anesthesiologists (ASA) recommends fasting guidelines prior to elective procedures. However, factors like trauma, acute and chronic pain, opioid use, and certain medical conditions can delay gastric emptying, complicating adherence to these guidelines.

Recent advancements in ultrasound techniques enable comprehensive evaluations of the nature and volume of gastric contents, making this tool convenient, noninvasive, and applicable at the bedside with minimal contraindications.The Perlas Model has been developed to identify surgical patients with "at-risk" stomachs, aiding in preoperative planning and airway management during general anesthesia. This model facilitates decisions regarding rapid sequence induction (RSI) and the choice of airway management techniques. However, there is a notable lack of research focusing on the use of ultrasound techniques in pediatric trauma patients to determine their diagnostic performance and predictive accuracy regarding gastric contents. Therefore, the aim of this study is to investigate the efficacy of POCUS in assessing the nature and volume of gastric contents in pediatric trauma patients undergoing urgent and semi-urgent surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients who will be scheduled for operative procedures within an hour of performing gastric POCUS.
2. Age group 1-18 years
3. ASA Physical status (I-III).
4. Both gender

Exclusion Criteria:

1. Children with known abnormal upper GIT anatomy or prior upper GIT surgery.
2. Children with wounds of the epigastrium precluding probe placement.
3. Children deemed unable to tolerate the US probe
Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery

The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type.

For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the Swedish Hernia Registry (SHR), which covers \> 95% of all groin hernia repairs in Sweden. The very large cohort of more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.

Eligibility Criteria:
Inclusion Criteria:

* All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.

Exclusion Criteria:

* Open repairs.
* Hernioplasties that were converted from laparoscopic to open surgery.
* Age \< 15 years.
* Patients not having a 10-digit state-assigned Patient Identification Number.
The Effect of Stress Ball on COPD Patients Receiving Noninvasive Mechanical Ventilation Support

The aim of this randomised controlled trial was to investigate the effect of a stress ball on pain, anxiety and physiological parameters in Chronic Obstructive Pulmonary Disease (COPD) patients on non-invasive mechanical ventilation (NIMV).

Continuous Positive Airway Pressure (CPAP) therapy used in NIMV reduces the need for IMV in COPD patients and shortens hospital stays. Negative states resulting from the difficulty of treatment lead to increased pain and anxiety in patients and negative results in vital signs. There is a need for non-invasive, low-cost and easy-to-use methods that can be used by nurses to address these problems in patients. This study will investigate the effect of a stress ball on changes in pain, anxiety and vital signs in patients diagnosed with COPD and receiving CPAP treatment during treatment. The stress ball will be applied to the patients during two consecutive CPAP treatments and pain, anxiety scores and vital signs will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD
* Receiving CPAP therapy
* Those who voluntarily agreed to participate in the study
* Turkish speaking, understanding,
* No cognitive and cognitive problems
* glasgow coma scale score of 13 and above
* Those who have not participated in stress ball etc. application before

Exclusion Criteria:

* Refused to participate in the research
* People with visual and hearing impairment
* unable to speak and understand Turkish
* Cognitive and cognitive problems
* glasgow coma scale\<13
* Infection, wound, burn, plaster, traction etc. in the hand and arm area
* During the research, those who wanted to leave voluntarily
* General condition deteriorated during NIMV treatment
The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population

Prevalence of soft tissue calcifications in the head and neck region is not clearly studied in the Egyptian population.

Determining the incidence of these calcifications can improve the knowledge of dental practitioners and allow such practitioners to initiate proper diagnostic. And if patients need treatment they can start early by the right therapy to stop the.

The aim of this research is to detect and quantify the prevalence of the soft tissue calcifications by cone beam computed tomography (CBCT) images of the head and neck region in the Egyptian population.

Calcification of various structures located in the head and neck region are reported in patients seeking dental care.

Although most of the soft tissue calcification within the head and neck region might not be accompanied by clinical symptoms; the investigators should not assume that their detection do not has a strong clinical significance .

Some soft tissue calcification may suggest the presence of a systemic condition and may cause threatening consequences .

Understanding of the nature of soft tissue calcification in the head and neck helps in proper diagnosis of these calcification and in turn taking the right decision of asking for further investigation; referral or do nothing .

Also; many of the structures in the head and neck region are in close proximity to one another which makes identification and localization difficult and this may lead to false diagnosis .

CBCT is a valuable imaging modality to overcome this difficulty. The data collection for this study will be obtained from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university

The following information will be recorded for each patient by :

1. Age of the patient at the time of the scan . 2. Sex (male or female). 3. Type of the scan (mandible only, maxilla and mandible, and full scan).

* Assessment will be made for the following;

  1. Presence or absence of calcification.
  2. Type of calcification present (or what is this soft tissue structure).
  3. Side (i.e. unilateral or bilateral and what side) .
  4. Single or multiple occurring.
* During assessing the CBCT images; neither clinical information nor demographic data of the patients will be available to any of the two radiologists.
* Then inter-observational and intra-observational variability between the observers will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* CBCT scans of 0.2 mm Voxel size will be included
* Scans that clearly show mandible only; maxilla only; maxilla and mandible or whole face will be included.
* Patients age 10-80 years old .

Exclusion Criteria:

* • Images with (Field Of View) show only one tooth or teeth.

  * Images of poor quality will be excluded.
  * Images showing artifacts caused by metallic implants or osteosynthesis plates.
  * Images subjected to patient movement during acquisition will be excluded also.
Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim

RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.

OBJECTIVES:

Primary

* To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies with clinical outcome.

Secondary

* To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical outcome.

OUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF neutralizing antibody assay.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with melanoma

  * Stage IV disease
  * HLA-A2\^+ and A2\^+
* Received sargramostim on clinical trial ECOG-4697
* Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity

Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score \[SAAS\], global alignment and proportion \[GAP\] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of treatment;
2. Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;
3. Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°.

Exclusion Criteria:

1. Any type of previous spinal surgery;
2. Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson\&#39;s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy;
3. Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;
4. Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and/or knee joint pain, and/or previous joint replacement.
Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial

This study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. Additionally, it sought to explore potential indications for the use of aseptic wound care liquid dressings in these ulcers, with the goal of obtaining evidence-based medical data on their clinical efficacy.

Participants will be assigned with a 1:1 ratio into intervention group and control group.

Participants in the intervention group will be irrigated with sterile liquid dressing for each wound treatment on the basis of clinical standard treatment protocols for 2 weeks, until the end of the 2-week observation period. Participants in the control group will be irrigated with normal saline for each wound treatment for 2 weeks on the basis of the clinical standard diagnosis and treatment plan, until the end of the 2-week observation period.


Eligibility Criteria:
Inclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected.
2. Poor glycemic control; fasting blood glucose \>15mmol/L; glycosylated hemoglobin \>12%.
3. Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
4. Serum albumin \<20g/L; hemoglobin \<60g/L; platelets \<50×10\^9/L
5. Advanced malignant tumor patients
6. Autoimmune disease activity period
7. History of allergy to aseptic wound care liquid dressing
8. Patient unable to cooperate or has mental disorders
9. Pregnant and lactating women
10. Eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity
11. Skin tumors
12. Active skin diseases
13. According to the researcher's judgment, patients who clearly have factors affecting wound healing that cannot be removed are not suitable for this study or cannot comply with the requirements of this study