cyrilzakka/clinical-trials huggingface dataset:
Clinical Application of Cytokine Adsorption Technique in AIDS Patients With Severe Pneumonia and/or Septic Shock

Observing the Real-World Application Effectiveness of Cytokine Immune Adsorption Technology in AIDS Patients with Severe Pneumonia or septic shock.

This is a prospective, single-center, non-randomized, clinical observational cohort study primarily focused on observing the clinical effects of cytokine adsorption technology in patients with AIDS complicated by severe pneumonia and/or septic shock. Based on the real-world application of cytokine adsorption technology in AIDS patients with severe pneumonia or septic shock, the study divides patients into two groups: one receiving cytokine adsorption combined with standard treatment, and another receiving standard treatment only. The study aims to observe the impact of these two different treatment strategies on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection;
2. Progression to AIDS stage: CD4+ count \<200 cells/ul and/or occurrence of AIDS opportunistic infections;
3. Age between 18 and 65 years;
4. Meeting the diagnosis of severe pneumonia or septic shock:

   1. The criteria for severe pneumonia diagnosis refer to the 2021 ATS (American Thoracic Society) and IDSA (Infectious Diseases Society of America) guidelines for the treatment of community-acquired pneumonia;
   2. The criteria for septic shock refer to the Chinese Society of Critical Care Medicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018).

Exclusion Criteria:

1. Coexisting central nervous system lesions, severe liver disease, or cirrhosis;
2. Concurrent AIDS-related or unrelated tumors;
3. Women who are pregnant or breastfeeding;
4. Severe underlying diseases of the heart, lungs, liver, kidneys, etc.;
5. Alcohol abuse or drug use;
6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.
Post Dural Puncture Headache After Accidental Dural Puncture

Epidural anesthesia is associated with potential risks and complications, post dural puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A systematic review of the existing literature will identify if there is reliable evidence to support this theory. A secondary outcome, headache severity, will also be explored via incidence rates of epidural blood patch, as this intervention is performed as a treatment for the most severe headaches.

Post dural puncture headache (PDPH) is one of the recognized complications experienced with epidural or spinal anesthesia, resulting from needle puncture of the dura layer of the meninges. This puncture can be deliberate (during spinal anesthesia) or accidental (during epidural anesthesia). Dural punctures allow a leak of cerebrospinal fluid, leading to the characteristic syndrome of PDPH; also known as a spinal headache or low-pressure headache. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have estimated that, within the obstetrical population, headaches resulting from an inadvertent dural puncture are as high as 50% to 75%.

As the risk of accidental dural punctures (ADP) cannot be eliminated, research has focused on possible interventions that may be taken in order to avoid the onset of a PDPH, eliminate its severity, or treat effects. One of the most common and effective treatments being an epidural blood patch (EBP). More recently, threading the epidural catheter directly into the intrathecal space after the dural puncture has been recognized as a viable option.

Eligibility Criteria:
Inclusion Criteria:

* any comparative methodology, including case-control studies, cohort studies, randomized clinical trials, and chart reviews.
* Insertion of the epidural catheter into the intrathecal space at the level of dural puncture, was compared to resiting an epidural catheter at another level

Exclusion Criteria:

* Any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded
Comparison of Novo Rapid 30 Mix Injection FlexPen® and Humalog 25 Mix Injection KwikPen® in Type 2 Diabetic Patients

The purpose of this study is to investigate patient's usability, preference and blood glucose control for the new prefilled disposable insulin lispro mixture (Humalog Mix 25 injection KwikPen®). For that purpose, randomized open-label, 2-period direct comparative crossover study is planned in comparison with insulin aspart mixture (Novo Rapid 30 Mix injection FlexPen®).

* Concomitant drugs The treatment with other insulin preparation is prohibited during the study period. As to the drugs except insulin that have been used for the treatment of diabetes and its complication since the time before the study, the content should not be changed during the study in principle unless the complication is cured. If any new complication occurs during the study period, an appropriate treatment is given by the judgment of investigator.
* Compliance with treatment method The investigator gives sufficient explanation on the following contents to the patient.

  * To inject the prescribed volume of insulin at the prescribed time.
  * To observe the appointed date for the next visit.
* Termination of assessment The study is discontinued if any of the following events occurs after the start of study.

  * Important protocol violation
  * When continued treatment is judged difficult due to the onset of an adverse event
  * Death
  * When the follow-up of patient becomes impossible
  * Other than the above, when the investigator judges it necessary to discontinue the study

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients
* Patients who have used Humalog Mix 25 injection KwikPen® or Novo Rapid 30 Mix injection FlexPen® for 3 months or more.
* Outpatients regularly visiting hospital
* Patients 20 years old or older but under 80 years old (gender is disregarded)

Exclusion Criteria:

* Patients with a serious complication in the heart, liver or kidney
* Pregnant or possibly pregnant patients, or lactating patients
* Patients complicated with a malignant tumor at present.
* Patients allergic to insulin analog preparations.
* Patients taking an illegal drug.
* Patients participating in other clinical study.
* Other than the above, patients judged inappropriate as the subjects of this study by the investigator
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Patients who took part and completed in the core CAIN457A2209 study
* Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:
* No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR
* Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as \>=20% worsening and an absolute worsening of \>=1 unit)

Exclusion Criteria:

* Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
* Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
* Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study
* Pregnant or lactating women
* Presence of active infection
* Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

Eligibility Criteria:
Inclusion Criteria:

* A person is eligible for inclusion in the study if he/she:

  * Is between 18 and 40 years of age (inclusive)
  * Has had a self-reported visual exam in the last two years
  * Is an adapted soft toric contact lens wearer
  * Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
  * Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.
  * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  * Has clear corneas and no active ocular disease
  * Has read, understood and signed the information consent letter.
  * Patient contact lens refraction should fit within the available parameters of the study lenses.
  * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
  * Is willing to comply with the visit schedule

Exclusion Criteria:

* A person will be excluded from the study if he/she:

  * Has a CL prescription outside the range of the available parameters of the study lenses.
  * Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye.
  * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
  * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  * Presence of clinically significant (grade 2-4) anterior segment abnormalities
  * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10
  * Slit lamp findings that would contraindicate contact lens wear such as:

    * Pathological dry eye or associated findings
    * Pterygium, pinguecula, or corneal scars within the visual axis
    * Neovascularization \> 0.75 mm in from of the limbus
    * Giant papillary conjunctivitis (GCP) worse than grade 1
    * Anterior uveitis or iritis (past or present)
    * Seborrheic eczema, Seborrheic conjunctivitis
    * History of corneal ulcers or fungal infections
    * Poor personal hygiene
  * Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  * Has aphakia, keratoconus or a highly irregular cornea.
  * Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  * Has undergone corneal refractive surgery.
  * Is participating in any other type of eye related clinical or research study.
C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study)

This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.

A 12-week pilot intervention study introducing a high-intensity functional training program to 100 cancer survivors and evaluate the effects of this program on patient quality of life, functional capacity, and body composition. Response rates will be determined using various recruitment methods and estimate differences in response rates by patient characteristics including race, gender and age. Barriers to participation in the program in contacted patients who do not enroll as well as patients who enroll and do not complete the program will be described, as will participant satisfaction with enrolled participants who complete the program. The goal of this pilot study is to help refine the recruitment and program methods for a larger intervention study to test the superiority of a high-intensity interval functional training program compared with current American Cancer Society guidelines in improving functional capacity, body composition and patient reported quality of life.

Surveys will be completed by each participant weekly and physical assessments will be completed monthly.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older at time of program recruitment
* Diagnosed with an invasive cancer
* Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).
* Available transportation to and from the facility on session days
Transition From Ticagrelor to Clopidogrel Following Acute Coronary Syndrome: To Bolus or Not?

After a heart attack patients are routinely started on drugs to inhibit platelets. Ticagrelor is a powerful anti-platelet drug with clinical benefits. However it must be discontinued in some, because of increased risk of bleeding or intolerance. These patients need to be transitioned to another agent, such as Clopidogrel. At present, there is no clinical consensus on the optimal strategy for this switch. Some clinicians elect to give a bolus dose of clopidogrel with 600mg, while others start directly with a 75mg daily dose, with no evidence regarding the benefits or potential complications associated with each strategy. The present proposal will evaluate the pharmacodynamics of 2 strategies with specialized platelet function testing. We hypothesize that a bolus dose of clopidogrel during the switch will confer better ischemic protection without increasing bleeding risk for patients undergoing a switch in therapy.

The overall objective is to evaluate the need for a clopidogrel bolus dose among patients being switched from a regimen of ticagrelor to clopidogrel. In a randomized pharmacodynamics study of 48 patients, we will conduct serial measurements of platelet function/inhibition using the Accumetrics Verifynow assay (platelet inhibition will be expressed as P2Y12 reaction unit \[PRU\]). Platelet inhibition will be assessed at specific time points over the first 72 hours following the change in medications, which will enable us to determine whether patients in the 2 different strategies may be at increased ischemic or bleeding risks. We hypothesize that a bolus dose of clopidogrel during the switch will confer better ischemic protection without increasing bleeding risk for patients undergoing a switch in therapy.

SPECIFIC AIMS:

1. Primary Aim: To determine with platelet function testing the pharmacodynamics effects of a 600mg bolus dose of clopidogrel compared with no bolusing among patients being switched from ticagrelor to clopidogrel.
2. To determine if patients receiving a clopidogrel bolus have improvement in ischemic protection relative to patients without a bolus dose.
3. To determine if patients receiving a clopidogrel bolus may be exposed to increase bleeding risk relative to those without a bolus dose.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18,
* admission for acute coronary syndrome,
* on dual anti-platelet therapy (including ticagrelor)
* Being transitioned to clopidogrel by their treating physician
* provided informed consent

Exclusion Criteria:

* Bleeding/intolerance to clopidogrel
* Thrombocytopenia (platelet count \< 100, 000 per uL)
* Hematocrit \<30% or \>52%
* treatment with glycoprotein IIb/IIIa inhibitor, 24 hours prior to randomization
Patient Reported Outcomes for Opioid Use Disorder

The goal of the project is to build a clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient reported outcomes measures (PROs) to conduct opioid related research in emergency departments (EDs). 200 adult patients with a history of non-medical opioid use, opioid use disorder, or acute opioid overdose will be enrolled and will be asked to complete three PRO surveys (baseline, 3 days post ED discharge, and 30 days post discharge).


Eligibility Criteria:
Inclusion Criteria:

* Adult patient presenting to the Yale New Haven Hospital York Street Campus emergency department
* History of opioid use disorder or non-medical use of opioids, as measured by screening assessment OR receiving treatment for opioid overdose
* Willingness and ability to complete electronic surveys via a smartphone or computer

Exclusion Criteria:

* \<18 years of age
* Inability to communicate in English
* Inability to provide consent (for example, due to psychosis, intoxication, severe mental illness or other reason)
* Transfer from the ED for psychiatric evaluation
The Effectiveness of Epidermal Growth Factor Serum in Improve Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles.

EGF is a polypeptide that promotes cell differentiation and collagen production while decreasing melanin production. This study is designed to study its effectiveness in improving the texture and appearance of facial skin after daily topical application. We hypothesized that EGF would improve facial skin hydration, elasticity, pigmentation, and wrinkles.

All patients gave written informed consent for epidermal growth factor serum application on the face. The pilot study enrolls thirty patients compared to pre and post-serum used to evaluate facial skin hydration, transepidermal water loss, elasticity, pigmentation, and wrinkles measured by corneometer, tewameter, cutometer, visioscan, and mexameter respectively on day 0, then 8, 12, and 16 weeks. The study evaluates subject satisfaction and side effects after serum application as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Thai
* Mild to moderate facial skin condition, as measured by 1-2 points on the hyperpigmentation status scale or 2-3 points on the wrinkle severity grading scale.

Exclusion Criteria:

* Use of lotions or skin care products containing ingredients such as vitamin A/C, hydroquinone, or anti-aging agents.
* Sunbathing
* Hypersensitivity to serum components
* Pregnancy and breast-feeding
* Active skin diseases such as eczema or atopic dermatitis at the application site
Nutritional Supplementation in Patients With no Signs of Malnutrition

The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition

In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary resectable gastrointestinal and abdominal malignancy
* No signs of malnutrition at qualification for surgery
* General performance \>70 Karnofsky scale
* Informed consent

Exclusion Criteria:

* history of radio or chemotherapy
* signs of mechanical ileus
* other major gastrointestinal diseases
* type 1 diabetes
* autoimmunological diseases requiring systemic steroids
* signs of infection
* renal and/or liver failure
Electrical Impedance Scanning of Thyroid Nodules Prior to Thyroid Surgery: a Prospective Study

Patients over the age of 18 with thyroid nodules scheduled for surgery will undergo EIS scan. Each node will be scanned and graded form 1-5 (1=benign, 5=malignant). Results will be compared with final histopathology.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 with thyroid nodules scheduled for surgery.

Exclusion Criteria:

* Pregnant patients
* PAtients with electrical powered devices (cardiac pacemakers)
Evaluation of FeNO During and Following Acute COPD Exacerbation

The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes up during an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and whether the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation.

The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes up during an acute exacerbation of COPD and whether the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation. FeNO is measured with a medical device called the NIOX MINO®. The NIOX MINO® device has been cleared by the Food and Drug Administration (FDA) for use in children and adults age 7 and older to measure Fractional Exhaled Nitric Oxide (FeNO) in human breath.This information will be useful for determining whether FeNO may help predict the development of a COPD exacerbation and/or be useful for identifying patients who will have a beneficial therapeutic response to inhaled or systemic corticosteroids during a COPD exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 years and above, inclusive
* Sex: Males and Females
* Smoking History: ≥20 pack years.
* COPD Defined as an FEV1/ FVC or FEV1/SVC ratio \<70% predicted.
* AECOPD defined as a clinically significant worsening of COPD symptoms requiring treatment with antibiotics and/or systemic steroids and/or hospitalization for same.

Exclusion Criteria:

* Use of Systemic Corticosteroids for more than 48 hours prior to Visit 1.
* AECOPD requiring mechanical ventilation
* Study Participation Outside of This Protocol: Patients currently enrolled in studies of Investigational or non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded.