cyrilzakka/clinical-trials huggingface dataset:
Role of Epoxy-eicosatrienoic Acids in Post-occlusive Hyperemia and Thermal Hyperemia

The objective of this proof of concept study is to assess the involvement of epoxy-eicosatrienoic acids (EETs) in post-occlusive hyperemic and thermal hyperemia responses, and the interaction between nitric oxide (NO) and EETs, using the latest methods for the study of functional microcirculation.

The EETY study is a single-center proof of concept study in healthy volunteers. The main objective is to study the involvement of epoxy-eicosatrienoic acids (EETs) in the reactivity of cutaneous microcirculation during post-occlusive hyperemia and thermal hyperemia, by studying the response to microdialysis of fluconazole (an inhibitor of EETs) versus control, on the forearm.

Response is measured by the amplitude of the post-occlusive hyperemia and thermal hyperemia peaks (maximum amplitude as a percentage of maximal vasodilation and areas under the curve: AUC) during the injection of fluconazole compared to an intradermal injection of solvent (NaCl 9 ‰).

The subjects are healthy volunteers of both sexes, aged between 18 and 35, non-smokers and in good health. Over two years, 30 subjects will be included in the study for 6 to 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years
* Affiliated to the French social security system or beneficiary a similar regime
* In good health

Exclusion Criteria:

* Active smoker
* Pregnant, parturient, breast-feeding
* Person deprived of civil liberties by judicial or administrative measure; person under legal protection,
* Minor less than 18 years
* Within period exclusion for other clinical research studies
* Person has exceeded the annual compensation for participation in trials
* Person with active disease or with prolonged treatment, excluding oral contraceptives and paracetamol
* Asthma, urticaria, angioedema, known drug allergy
Impact of GPT Use on Essay Writing Performance and Cognitive Abilities

The goal of this randomized controlled lab experiment is to examine if using generated artificial intelligence (AI) technology will affect people's academic performance and cognitive abilities in the context of analytical writing among college students. The main questions it aims to answer are:

1. Does using the technology affect students' writing performance?
2. Does using the technology affect students' cognitive effort during the writing process?

Participants will be randomly assigned to either a control group, which is writing without AI assistance, or an experimental group, which is writing with the assistance of ChatGPT. Researchers will compare the two groups to see if ChatGPT affects students' writing performance and cognitive effort.

For each participant, the lab experiment will last for no more than 1.5 hours. An eye-tracker will monitor the participant's gaze activities and pupil size. A functional near-infrared spectroscopy (fNIRS) will monitor the participant's brain activities in the frontal lobe. During the experiment, participants will be asked to:

1. Read learning materials on analytical writing techniques.
2. Based on the previously provided materials, complete an analytical writing assignment that will take approximately 30 minutes either with or without the aid of ChatGPT.
3. Answer survey questions about their experience with the writing assignment, attitudes on using ChatGPT, and demographic backgrounds.


Eligibility Criteria:
Inclusion Criteria:

* Full-time university student.
* Able to read and write in English.
* Use the computer most days of the week.
* Have not taken, nor currently preparing for, the Graduate Record Examinations (GRE).
* Do not wear glasses (contact lenses are allowed).
* Have no eye impairment.
* Not currently taking any opioids, epinephrine, or anti-hypertensive drugs.
* During the experiment, not wearing any makeup around the eyes.
Opioid-free Accelerated Recovery Total Knee Arthroplasty

To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.

All study patients will receive a standardized protocol

* All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center
* Will attempt to minimize the number of anesthesiologists to further control variability in care

Methods:

1. Pre-op Optimization

   * All patients enroll in education program
   * All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
2. Total Joint Procedure

   * Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block
3. Data Collection

   * Electronic medical record chart review
   * Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge
   * Phone calls after discharge
   * Follow-up assessment in surgeon's office
   * Swift path / KOOS JR surveys
4. Pain Management Regimen

   * pre-op physical therapy teaching
   * post-op multimodal pain regimen

Eligibility Criteria:
Inclusion Criteria:

* Surgeries to be performed at hospital
* Surgeries to be performed at surgery center
* Ability to read and understand English
* Primary care clearance for patients diagnosed with high blood pressure

Exclusion Criteria:

* Disease states, patient conditions to exclude:

Schizophrenia Bipolar Disease Dementia

* Known allergies to local anesthetics
* Previous burn to affected extremity
* BMI \> 40
* Nonoptimized anemia
* Albumin less than 3.5
* A1C \> 8.0
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the lumbar spine, the femoral neck or total hip)
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
* Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that are accessible by DXA.

Exclusion Criteria:

* Evidence or history of any underlying condition, other than primary osteopenia, that affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism).
* Subjects with pre-existing periodontal/dental disease or those who have undergone invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior to Day -1.
* If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening

The investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.

184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based decision aid in addition to routine counseling or routine counseling only during a single study visit. This decision aid was developed at a 10th grade literacy level using input from Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20 English and Spanish speaking women of varying education levels. Following completion of genetic counseling, participants will complete several surveys assessing knowledge and decision conflict. Data will be abstracted regarding demographics, screening and diagnostic testing uptake, and testing results.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy at less than 22 weeks gestation
* English or Spanish speaking
* Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy screening

Exclusion Criteria:

* Known fetal anomalies
* Known multiple gestations
* Prior genetic counseling or aneuploidy screening in current pregnancy
The Effect of Probiotics (VSL) on Portal Hypertension

The investigators will address the hypothesis that portal hypertension is mediated in part by bacterial or endotoxin translocation and the production of inflammatory mediators (tumor necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and improving systemic and splanchnic hemodynamics.

We have recently completed an open-label uncontrolled trial of the probiotic VSL#3 in 8 patients with compensated cirrhosis and evidence of portal hypertension (VIP study) to determine whether this agent would have beneficial effects in portal pressure reduction (unpublished data Tandon, P. et al.). The open label design and the inclusion of compensated (Child Pugh A) cirrhotic patients in this initial study were chosen to confirm the safety and tolerance of VSL#3 and the safety of the portal pressure measurements at our center. No changes of physical status occured. There was a non-significant reduction in portal pressure from 19.7 to 18.1 mm Hg after 2 months of VSL#3 supplementation. Furthermore, there was a significant reduction in the serum aldosterone level (p=0.03). IL-8 levels were reduced in 4/6 patients analyzed to date. These results suggest that VSL#3 results in cytokine reduction and an improvement in the effective circulating volume even in these well-compensated cirrhotic patients. The comparison of the rest of the pro-inflammatory mediators and stool microflora is still being analyzed.

The data in our initial study is very promising. As our patients were compensated cirrhotics with normal intestinal permeability and only mild baseline perturbations in hepatic function parameters (INR, bilirubin, albumin) and neurohormonal markers (aldosterone, renin), it is not surprising that a reduction in portal pressure was not identified. Consistent with previous studies however, these local results confirm the safety and tolerance of both VSL#3 as well as portal pressure measurements in cirrhotic patients (20,24,25).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Cirrhosis
* Childs-Pugh Class B/C

Exclusion Criteria:

* Bacterial infection
* Grade 3-4 hepatic encephalopathy
* GI bleeding in the past 2 weeks
* Hepatocellular carcinoma beyond the Milan criteria
* Transjugular intrahepatic portosystemic shunt (TIPS), surgical shunt
* Portal vein thrombosis
* Antibiotics in the past 2 weeks
* Myocardial infarction, stroke or life-threatening arrhythmia within the last 6 months
* Active alcohol or illicit drug use
* Failure to consent to the study
Autologous Dendritic Cell Vaccine in HIV1 Infection

This study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patient's own cells and virus. It also aims to explore the virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks after analytic treatment interruption.

This is a phase I/II, open label, single-arm, single-site clinical trial designed to evaluate the safety and antiviral activity of the ApB DC vaccine, a therapeutic vaccine derived from autologous dendritic cells loaded with autologous HIV-1 infected apoptotic cells. The study will be conducted in three phases. The first is the pre-vaccination phase that includes study entry, isolation of autologous virus, and initiation of antiretroviral therapy. Once the patient's viral load has been suppressed to undetectable levels (\<50 copies/mL) and sufficient virus has been isolated, the second phase will begin. This includes leukapheresis in order to harvest monocytes and lymphocytes necessary for vaccine preparation. Three vaccine doses will be administered subcutaneously every other week. Six weeks after the last vaccination, the third phase, analytic treatment interruption (ATI) phase, will begin. A fourth, booster dose of vaccine will be given two weeks after the start of treatment interruption. The treatment interruption will be continued for twelve weeks after which the primary HIV provider will decide whether or not antiretroviral therapy should be restarted. CD4 and viral load will be closely monitored throughout the study especially during treatment interruption. Follow-up will be continued for 24 weeks after the 12-week treatment interruption.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection.
* CD4 greater than or equal to 350 cells/mL within 8 weeks prior to study entry.
* Plasma HIV-1 RNA level of 5000-100,000 copies/mL within 8 weeks prior to study entry.
* Antiretroviral therapy naive.
* Willingness to interrupt ART for at least 12 weeks.
* Written informed consent.

Exclusion Criteria:

* Treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period.
* Receipt of any vaccinations other than routine ones within 6 months of study entry
* Pregnancy or breastfeeding
* Previous or current CDC Category C event
* Receipt of any investigational product within 12 weeks prior to study entry.
Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible

Atrophic alveolar bone presents a unique difficulty, preventing correct implant placement and affecting long-term results. There are different techniques that are recommended to restore the proper length of the posterior ridge of the mandible and thus achieve proper form and function, one of those is distraction osteogenesis. Refinements in the technique of distraction can improve the treatment outcome and decrease postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the posterior atrophic mandible.
* The distance from the alveolar crest to the upper border of the canal is not less than 5 mm.
* Adult patients from 30-60 years old with no gender predilection who agreed to present for follow-up visits for a minimum postoperative period of 4 months.
* Patientswithanadequateoralhygiene.
* The patient should be psychologically accepting of the involved procedures.

Exclusion Criteria:

* Medically compromised patients contradicting operation (ASA III, IV \& V).
* Patients receiving radiotherapy or chemotherapy or bisphosphonate.
* Bonediseases(Osteoporosis,Osteopetrosis,Osteomalacia...etc.)
* Any habits that might retard healing such as heavy smoking and alcoholism.
* A history of any grafting procedure at the designated area.
Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and overall mortality. Also the initiation of an efficacious early anticoagulation protocol is important because of its potential impact on the rate of early thromboembolic complications after mechanical valve implantation. An important question that remains to be answered is whether the combination would be cost effective than Warfarin alone, with a reduction in major bleeding. In addition, the knowledge about its cost-effectiveness has not yet been established in Egypt. The aim of this trial based economic evaluation is to conduct a cost-effectiveness analysis for combination of low-dose Aspirin and Warfarin versus Warfarin alone in prosthetic valve patients from the medical provider perspective specially that a misconception is still existed between the physicians in Egypt that the cost of complications is not worthy so our main aim is to test the cost of complications.

The measurements will be assessed:

A- Number of patients improved during follow up:

1. Demographic data
2. Diagnosis
3. Laboratory tests (CBC, Prothrombin Time, liver and renal function tests)
4. Echocardiography profile

B-Costs:

Direct medical costs will be assessed directly from hospital's records and tender lists.

Eligibility Criteria:
Inclusion Criteria:

Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.

Exclusion Criteria:

* Congenital blood disorders, Hemophilia.
* Advanced liver disease
* Advanced renal disease (dialysis patients)
* Aspirin sensitivity
* Autoimmune diseases
* Biological bioprosthesis valves
* Non-compliant \& Drop out patient
* Pregnant women
* Caucasians.
abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003

This is a monocentric, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged ≥ 18 years.
2. Apparently healthy as determined by a subject questionnaire.

Exclusion Criteria:

1. Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to

   1. Renal disease
   2. Stoke
   3. Liver disease
   4. Pancreatic disease (including diabetes)
   5. HIV AIDS
   6. Receiving antibiotic therapy
   7. Suspected infection
   8. Immunosuppression
2. Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
3. Current diagnosis of uncontrolled diabetes.
4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.
5. Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.
6. Diagnosis and/or treatment of cancer within the last 12 months.
7. Received immunosuppressive therapy.
8. Hospitalization for more than 24 hours within the last month.
9. Reported as currently pregnant or nursing a child
10. Unable or unwilling to provide the required blood sample for testing.
A Pilot Study of Acupuncture Treatment for Dysphagia

The current standard of care for advanced HNC is concurrent chemoradiation therapy (CRT), which has led to increased survival rates, but with significant acute and long-term toxicities. Dysphagia, or difficulty with swallowing, is a common and expected side effect during and following CRT. Dysphagia occurs in up to 50% of patients and significantly impairs the quality of life (QOL) of patients during delivery of and recovery from CRT. Clinical trials evaluating promising and innovative adjunctive approaches that could increase the rate and magnitude of recovery from dysphagia in HNC patients are needed. Acupuncture is a traditional Chinese medical technique that has been found to reduce symptoms and side effects associated with primary cancer therapy. This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.

AIMS:

Aim 1. To assess the feasibility of recruiting and retaining HNC patients with dysphagia into a randomized sham-controlled trial of acupuncture.

Aim 2. To collect preliminary data on the efficacy of acupuncture in changing scores of HRQOL in post CRT head and neck cancer patients.

Aim 3. (Exploratory) In a subset of HNC subjects treated with both active and sham acupuncture, to collect objective measures on swallowing functions using Videofluoroscopic swallowing study (VFSS); salivary flow production; and plasma Transforming Growth Factor (TGF)-β1, Interleukin 6 (IL-6), Tumor necrosis factor-alpha (TNF-α) and Interleukin 13 levels.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) at stage II, III and IV, without evidence of distant metastasis. Stage I disease will also be permitted if the patient is receiving CRT;
* Primary tumor sites eligible: nasopharyngeal, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary squamous cell carcinoma (SCC) in the neck will also be eligible. SCC of the oral cavity will also be eligible with the approval of the treating staff;
* Receiving chemoradiation;
* Currently or recently undergoing swallowing therapy program with or without feeding tube use, with or without neck dissection;
* Age ≥ 18 years;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Adequate hematological function: neutrophil count \>1.0 x109/L, platelet count \>50x109/L
* Signed informed consent.

Exclusion Criteria

Patients with the following criteria will NOT be eligible for the study:

* Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
* Wearing a pacemaker or implantable cardioverter-defibrillator;
* History of significant neurologic disorder that affects swallowing, including stroke, neurodegenerative disease, advanced dementia, or uncontrolled seizure disorder;
* Active clinically significant uncontrolled infection;
* Prior use of acupuncture for dysphagia;
Immune Profiling in Multiple Myeloma

This study propose to investigate the immune repertoire of MM patients at the time of diagnosis vs. 1st vs. 2nd vs. 3rd relapse. This study will provide insights into the immune status of MM patients before and after disease transformation and help identify patients who will benefit from immunotherapy. It will also allow us to predict the efficacy of these immune-mediated strategies and their associated toxicity. By understanding the immune-microenvironment in MM patients during disease progression, the investigator will be able to better design immunotherapeutic strategies for maximal success.

Background: Immunotherapy has emerged as a new therapeutic strategy for the treatment of multiple myeloma (MM). The current immune-based strategies include the FDA-approved monoclonal antibodies elotuzumab1 and daratumumab2 targeting SLAMF7 and CD38 respectively, as well as immune approaches undergoing active clinical investigations such as bispecific T-cell engager,3 antibody-drug conjugate4 and cellular therapies like chimeric antigen receptor T cells.5-7 All of these treatment strategies are currently being tested in relapsed and refractory MM. However, MM patients, particularly those in the later stage of the disease, often have an impaired immune system.8-13 Given their curative potential, the investigator believe that immunotherapies should be used up front when the patient's immune system is still capable of mounting a normal immune response. Here the investigator propose to investigate the immune repertoire of MM patients at the time of diagnosis vs. 1st vs. 2nd vs. 3rd relapse. This study will provide insights into the immune status of MM patients before and after disease transformation and help identify patients who will benefit from immunotherapy. It will also allow us to predict the efficacy of these immune-mediated strategies and their associated toxicity. By understanding the immune-microenvironment in MM patients during disease progression, the investigator will be able to better design immunotherapeutic strategies for maximal success.

Samples: Peripheral blood samples from 20 newly diagnosed, 20 relapsed and/or refractory MM patients and 10 healthy donors will be collected before therapy. An additional peripheral blood sample will be collected at relapse in patients experiencing an early relapse (within 12 months from the start of therapy).

The project will include both a retrospective collection and a prospective collection of samples. Samples will be used for the current study after informed consent from the patient. The samples will be processed by Ficoll Paque gradient to isolate peripheral blood mononuclear cells (PBMCs). Peripheral blood serum will be collected as well.

Enrollment time: 9 months

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed MM patients or
* refractory MM patients or
* healthy donors.

Esclusion criteria:

* not newly diagnosed MM patients or
* not refractory MM patients or
* no healthy donors.