cyrilzakka/clinical-trials huggingface dataset:
Irrigation Versus No Irrigation for Perforated Appendicitis

The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for perforated appendicitis.

This will be a prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.

Power calculation was based on abscess rate in the previous prospective study. An unacceptable abscess rate needed to be chosen. Our current rate is 20%, or one-fifth of the patients. If this were to increase by 15%, it would place just over one third of the patients at risk which would be unacceptable. This is comparable to the 36% rejection level we used for the previous IRB approved trial (#07 02-031). Using a delta of 0.15 with alpha of 0.05 and power of 0.8, the sample size is 109 patients in each arm. Therefore we will anticipate enrolling 220.

Subjects will be those children who are found to have severe inflammatory changes on imaging or a high clinical suspicion of perforation. Permission will be obtained from parents prior to the operation. All of these children will be under duress prior to randomization, therefore we request waiving assent as we have done with the previous perforated appendicitis studies.

The final decision to include a child in the study will made after perforation has been visually confirmed during surgery. Perforation will be defined as an identifiable hole in the appendix or stool in the abdomen. The randomization assignment will be made known at the initiation of the operation, and confirmation of perforation will confirm the patient will utilize the next randomization slot.

The irrigation group will have suction irrigator set up with a 1 liter bag of normal saline. The surgeon must use at least 500 ml of this bag but may use as much as they choose.

The no irrigation group will have the suction irrigator set up without the saline attachment. This will leave them with the capacity for suction only. Since several suction devices exist, this will assure the same type of suction for both groups.

After the operation, both groups will be managed in the same manner. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. If they stay until the 5th post-operative day, a white blood cell count will be checked, which if it is normal, they will be discharged to home without antibiotics. This is standard post-operative care as delineated by our previous prospective, randomized.

Eligibility Criteria:
Inclusion Criteria:

* Under 18 yrs old
* Perforation identified as hole in the appendix or fecalith in the abdomen

Exclusion Criteria:

* No perforation
* A significant comorbidity that would limit their ability to recover from appendectomy in a normal fashion
PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors

To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.

PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.

Eligibility Criteria:
Inclusion Criteria:

1. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
2. Age 18-85 years old, male or female;
3. Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
4. ECOG score is 0-3 points;

Exclusion Criteria:

1. Patients with a history or allergic constitution to any component of the developer, including alcohol;
2. pregnant or lactating women;
3. Patients with mental illness or related history;
4. Patients who cannot or cannot undergo a PET/CT scan;
REST Study (CompRESsion Therapy for RLS)

This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female over the age of 18.
2. Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
3. International RLS Study Group (IRLSS) Score ≥15.
4. RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.

Exclusion Criteria:

1. Known or suspected deep vein thrombosis.
2. Pregnancy
3. Prior use with home intermittent pneumatic compression (IPC) device
4. Currently using any other device to treat RLS
5. Active skin infections in the affected leg
6. Vein ligation or skin graft of the leg within past 12 months
7. Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
8. Physical impairments that would prevent the use of the CirvoTM device.
9. Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
10. If previously on medication to treat RLS, patient must have been weened under medical supervision and off medication for at least 14 days at time of enrollment
11. History of pulmonary vascular disease (PVD)
12. History of pulmonary edema
13. History of decompensated congestive heart failure (CHF)
14. Open surgery or major trauma to the legs within the last six months
15. History of lower limb malignancy, primary or secondary
16. Acute symptomatic lower extremity thrombophlebitis
17. Any chronic back pain or lower extremity pain
18. Other sleep problems that are felt to be currently affecting the quality of sleep
19. Calf geometry on which Cirvo™ device does not appropriately fit
20. Known sensitivity to any of the materials used in the Cirvo™ device
21. Currently participating or plans to participate in in any other investigational clinical evaluation during the 56 day study period that may, in the opinion of the investigator, affect RLS.
Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties

This study aims to explore the mechanical properties of the cornea using a non-invasive imaging technique called Brillouin microscopy. This innovative method measures corneal elasticity by detecting small shifts in light frequency, which occur due to interactions with acoustic waves in the tissue. These measurements can provide insights into how corneal stiffness is altered in various eye diseases or after surgery.

The study includes 100 participants, divided into different groups: patients with Fuchs' Endothelial Dystrophy (FED), Map Dot Fingerprint Dystrophy (MDFD), and those who have undergone corneal surgeries such as Penetrating Keratoplasty (PKP), Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK), and Descemet Membrane Endothelial Keratoplasty (DMEK). Healthy individuals will also be studied as a control group.

Participants will first receive a standard eye exam, including a slit-lamp examination. Then, Brillouin microscopy will be used to measure the cornea's mechanical stiffness. Additional tests include optical coherence tomography (OCT), corneal topography and tomography, pachymetry (measuring corneal thickness), endothelial cell count, and intraocular pressure (IOP) measurement.

The purpose of this study is to better understand how diseases and surgeries affect corneal biomechanics. The researchers will also examine how well the Brillouin measurements match with findings from other clinical imaging tests. The results may help improve diagnosis and treatment options for corneal disorders.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to surgery
* Patients aged 18 years and older
* Patients who have undergone one of the following corneal surgeries or are diagnosed with one of the following dystrophies:

  * Penetrating Keratoplasty (PKP) and no longer have sutures following PKP o Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
  * Descemet Membrane Endothelial Keratoplasty (DMEK)
  * Fuchs' Endothelial Dystrophy (FED)
  * Map Dot Fingerprint Dystrophy (MDFD)
* Healthy Controls: healthy eyes without any history of corneal diseases or surgeries

Exclusion Criteria:

Any of the following will exclude a subject from the study:

* Patients with inadequate corneal imaging or corneal scarring that would impact results
* Patients with other corneal dystrophies or corneal diseases
* Patients with active ocular infections or inflammatory conditions
* Patients unable to undergo Brillouin imaging adequately
* Patients that suffered an eye trauma according to their medical history
* Patients with fixational problems (e.g., head tremor) or with any medical condition that could interfere with the measurements
* Pregnancy (pregnancy test will be performed in women of reproductive age)
The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment

To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients.

This is an observational pilot study in patients with definitive relapsing-remitting multiple sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric oxide levels during a clinically observed increase in disease activity. Each subject will followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a week.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple sclerosis per update of McDonald criteria
* Initiating treatment with interferon beta 1a subcutaneous injection with minimal dosing of 22mcg.
* 18-60 years of age.
* Women who are not pregnant or breast feeding, and who do not intend to become pregnant.
* Stable dose of concomitant medications for 30 days prior to baseline. Efforts should be made to maintain steady doses of concomitant medications for the duration of the study.

Exclusion Criteria:

* Treatment on other interferon preparations, glatiramer acetate, in last 30 days or 6 months on Natalizumab, mitoxantrone, cyclosporine or other immunomodulators as determined by the PI.
* Treatment with any other investigational treatments within the past year or treatment with any investigational treatments for multiple sclerosis within the last year.
* Any progressive form of MS.
* Known Hypersensitivity to interferon beta 1a.
* Inability to administer subcutaneous injections
* Inability to undergo laboratory evaluation.
* Seropositivity for HIV (by medical history)
* Diabetes Mellitus Tyle I or II (by medical history)
* Hepatitis B or C (by medical history)
* Uncontrolled psychiatric disorder.
* Any unstable illness that the investigator's opinion precludes participation in this study.
* Inability to maintain compliance with study protocol.
* Implanted devices or metal which would contraindicate MRI.
* Clinically significant abnormalities in CBC or CMP
* MMSE \<25
Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit

Studying clinical characterization of critically ill COVID-19 patients in a single center Studying Risk factors for Day 28 Mortality in COVID-19 patients admitted to intensive care unit

An observational study looking into clinical characterization of the novel Coronavirus Disease 2019 (COVID-19) in patients admitted, critically ill, into Intensive Care Unit of Hospital Queen Elizabeth between 1st October 2020 until 31st January 2021. Analysis also would be looking into the risk factors into Day 28 mortality of these patients

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021
* Confirmed COVID-19 Positive using RT-PCR or RTK-Ag either before or during admission in ICU

Exclusion Criteria:

* Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative
The Effects of Perioperative Nutritional Optimization on Blood Markers

The purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition Shake) before and after lumbar spine surgery affects blood tests related the nutritional status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine surgery are at increased risk for complications and longer hospitalizations.

The study will examine whether a simple and cost-effective perioperative nutritional program will affect blood markers of nutritional status (albumin, pre-albumin, transferrin, electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our institution by a single surgeon and meet all inclusion criteria will be added to this study. Patients will be randomized into one of two arms; the interventional group will be provide with daily Ensure protein drinks for two weeks pre-operatively and four weeks post-operatively, while the control group will be instructed to continue their current diet plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin, electrolyes) will be obtained to assess objective differences in nutritional status.

N/A

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 55 years and older undergoing primary lumbar spine surgery for the treatment of radiculopathy and other lumbar pathologies
* Patients have the willingness and ability to participate in a study procedure

Exclusion Criteria:

* Patients who are younger than 55 years old
* Patients undergoing revision surgery
* Patients undergoing surgery due to trauma/fractures
* Patients with lactose intolerance
Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients

To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects

Primary endpoints:

1. estimated GFR (MDRD equation) 12 months after randomization
2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)


Eligibility Criteria:
\<Inclusion criteria\>

1. The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study.
2. Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months
3. Patients with serum creatinine (sCr) level ≤ 2.0 mg/dL and variation of sCr \< 30% for recent 3 months
4. Patients with urine proteinuria/creatinine ratio (PCR) ≤ 1 g/g, or 24 hour urine protein ≤ 1g/day for recent 3 months
5. Patients who provided informed consent.

\<Exclusion criteria\>

1. Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation
2. Patients whose graft from non-heart beating cadaveric donor
3. graft from HLA-identical living related donor
4. ABO blood group incompatible donor or HLA desensitized recipients
5. Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients
6. Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome
7. Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy)
8. Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus
9. Patients with liver function test abnormality (alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> 3 times from upper normal limit), neutropenia (absolute neutrophil count \< 1,500/uL or white blood cell count \< 2,500/uL), or thrombocytopenia (platelet \< 75,000)
10. Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer
11. Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months
12. Patients who taken medicine from other trial within 30 days.
A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

This is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.


Eligibility Criteria:
Inclusion Criteria:

* 12 years ≤ age ≤ 18 years
* With atopic dermatis
* Voluntarily sign the informed consent form

Exclusion Criteria:

* Weight \< 30 kg
* Major surgery planed during the study
A Safety Study of SGN-CD33A in AML Patients

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.

This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment.

Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant.

Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia, positive for CD33
* Eastern Cooperative Oncology Group status of 0 or 1
* Adequate baseline renal and hepatic function
* Central venous access
* Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
* Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients

Exclusion Criteria:

* Inadequate lung function
* Prior allogeneic stem cell transplant, except for a specific cohort
* High-dose chemotherapy within 4 weeks of study drug
* Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration

Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.

Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP \[interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9\]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes.


Eligibility Criteria:
Inclusion criteria comprised:

1) diagnosis of stage III or IV periodontitis (Papapanou et al. 2018b); 2) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) of \<15%; 3) completion of steps I-II of periodontal treatment at least 2 months priorly; 4) tooth with residual PPD ≥ 6 mm, BoP+, and a radiographic intrabony component ≥ 3 mm, lacking furcation involvement (Aimetti et al. 2023), considered suitable for a minimally invasive procedure (Cortellini and Tonetti 2007) (Fig. 1A).

Exclusion criteria encompassed:

1) age \< 18 years; 2) current smokers; 3) contraindications to surgery; 4) systemic diseases that could impact periodontal healing; 5) pregnancy and lactation; 6) a history of periodontal surgery at the experimental teeth.
Developing an Online Clinical Trial Specific Question Prompt List

The investigators will leverage e-technologies to provide an online version of the Question Prompt LIst (QPL-CT), that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the electronic medical record (EMR) prior to a consultation to discuss a clinical trial

The investigators propose to conduct pilot work to inform our knowledge of optimal methods of utilizing QPLs and will use the QPL-CT as an example. The investigators will leverage e-technologies to provide an online version of the QPL-CT, that patients access via available iPads, enabling both the real-time prioritizing of patient questions as well as the seamless delivery of these questions to their treating physician (and other members of their clinical team) via the VCU Health System (VCUHS) patient portal, and the EMR prior to a consultation to discuss a clinical trial. The investigators will use a pilot randomized clinical trial design to demonstrate the efficacy of the online QPL-CT versus a paper and pencil QPL-CT to increase question asking, patient understanding of trial information and reduce patients conflict over their upcoming decision to join a trial

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis
* Fluent in English
* eligible for a therapeutic clinical trial
* Patients of recruited oncologists

Exclusion Criteria:

* Healthy subjects
* Not eligible for a therapeutic clinical trial