cyrilzakka/clinical-trials huggingface dataset:
Impact of NMN Supplementation on CD4+ T Cell Recovery in HIV Patients With Immunological Failure

This proof-of-concept study aims to investigate the potential impact of supplementing with Nicotinamide Mononucleotide (NMN), a direct precursor of NAD+ on CD4+ T cell recovery in virologically suppressed HIV patients experiencing immunological failure on ART. We hypothesize that NMN supplementation will increase intracellular NAD+ levels, thereby improving CD4+ T cell function and potentially reversing immunological failure. A small cohort of patients will be recruited to evaluate the primary outcome of change in CD4+ T cell count from baseline to the end of the study period after receiving NMN daily for 12 weeks. Secondary outcomes including safety and tolerability, impact on pro-inflammatory markers, increase in NAD+ levels, immune activation markers and change in quality of life questionnaire scores. Patients will participate in two in person visits including a baseline and end of study with two telephone encounters. Patients will take 1,000mg NMN daily for a total of 12 weeks during which they will keep a daily log of doses taken and any side effects experienced. At all visits labs and quality of life questionnaire will be completed with complete physical exam to be done at baseline and end of study visit.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected adults aged 18 years or older
* Virologically suppressed on ART documented with two negative viral loads separated by at least 6 months
* Confirmed diagnosis of immunological failure (CD4+ T cell count \<350 cells/µL 2 years after effective ART initiation)
* Willing to provide informed consent

Exclusion Criteria:

* Active opportunistic infections
* Known allergies or sensitivities to NMN or any components of the NMN supplement
* Current or recent use of other supplements or medications known to affect NAD+ metabolism (Niacin, NR, NMNH, etc.)
* Pregnancy or breastfeeding
* Significant liver or kidney disease
* Active malignancy
* History of uncontrolled substance abuse
* Severe medical conditions that might interfere with study participation
* Unable to consent
Use of Prophylactic Lubricating Drops After Cataract Surgery

This is a randomised controlled trial to assess the use of prophylactic lubricant eye-drops for 6 weeks following uncomplicated, routine cataract surgery to improve patient satisfaction and symptoms of dry eye, compared to controls.

On entry into the study patients will be randomized to receive either lubricant eye-drops (phosphate-free, preservative-free lubricant eye drops containing 0.15% Sodium Hyaluronate with vitamins A and E (AEONTM Repair) to be administered four times a day for 6 weeks following surgery (in addition to the usual post-operative topical medications of Chloramphenicol 0.5 % eye drops for 1 week and topical dexamethasone 0.1% eyedrops (Maxidex) four times a day for 4 weeks) or no additional lubricant drops in addition to the usual medications described above

Eligibility Criteria:
Inclusion Criteria:

* Bilateral or unilateral cataracts requiring surgical intervention
* Age over 18 years
* Able to understand informed consent and the objectives of the trial
* Not pregnant, not breast feeding
* No previous eye surgery

Exclusion Criteria:

* age-related macula degeneration
* glaucoma
* previous retinal vascular disorders
* previous retinal detachment or tear
* any neuro-ophthalmological condition
* any inherited retinal disorder or pathology
* previous strabismus surgery or record of amblyopia
* previous TIA, CVA or other vaso-occlusive disease
* already enrolled in another study
Effects of Traditional Martial Arts, Open and Locked Exercise on the Physical and Mental Health of Drug Users

The aim of this study is to discuss the efficacy of Chinese traditional martial arts in reducing drug addiction and improving the physical and mental health of drug addicts.


Eligibility Criteria:
Inclusion Criteria:

* Normal mental state, able to understand and accept instructions
* Drug users who have survived the detoxification period
* Without major diseases

Exclusion Criteria:

* Drug use for more than 2 years
* Drug abusers who have entered a drug rehabilitation center more than once
Influence of HLA-DQA1*05 Genotype in Adults With Anti-TNF Treatment With Proactive Therapeutic Drug Monitoring.

HLA-DQA1\*05 variant carriers are at risk of developing antibodies against infliximab and adalimumab with reduced TNF antagonist persistence.

The impact of proactive therapeutic drug monitoring (PTDM) on this association has been barely assessed.

Therefor, we propose a cohort study including adult patients with Crohn's disease and ulcerative colitis treated with TNF antagonists under proactive therapeutic drug monitoring.

Our hypothesis is that, proactive therapeutic drug monitoring could be an alternative to combination treatment with immunomodulators to increase TNF-antagonists' persistence in HLA-DQA1\*05 carriers.

Population study: patients with inflammatory bowel disease and initiation of anti-TNF therapy

Inclusion and exclusion criteria

The inclusion criteria are:

* Patient diagnosed with inflammatory bowel disease based on clinical, endoscopic, and pathological criteria according to ECCO criteria.
* Initiation of anti-TNf, including infliximab and adalimumab.
* Subjects naïve to biological treatment
* Age \>18 years.

The exclusion criteria are:

* No determination of HLA DQA1\*5 allele.
* No proactive drug monitoring
* Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, after that time, with a colonoscopy with a Rutgeerts 0-1
* Anti-TNF treatment with combined treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication
* Initiation of anti-TNF treatment for extraintestinal manifestation
* Initiation of anti-TNF treatment during pregnancy.

Proactive drug monitoring was defined as standardized determination of drug levels during induction and maintenance, with optimization independently of the patient's clinical status, until reaching target levels.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of inflammatory bowel disease according to ECCO criteria.
* Older than 18 years
* Subjects naïve to biological treatment
* Anti-TNF treatment initiation (infliximab or adalimumab) due to intestinal activity and/or perianal disease.
* Avaibility to evaluate HLA DQA1\*05 status
* Proactive therapeutic drug monitoring of anti-TNF levels

Exclusion Criteria:

* Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, afterwards, if endoscopic recurrence with a Rutgeerts 0-1.
* Initiation of anti-TNF treatment under combo treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication.
* Initiation of anti-TNF treatment due to extraintestinal activity.
* Initiation of anti-TNF treatment by a non-gastroenterologist specialist.
* Initiation of anti-TNF treatment during pregnancy.
Evaluation of the Index of Sexual Life Questionnaire

The purpose of the study is to assess the sensibility of the ISL questionnaire.


Eligibility Criteria:
Inclusion Criteria:

ED patient must:

* Be male, 18 years of age with no upper age limit;
* Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score 25. Erectile dysfunction is defined as "the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90);
* Have a stable female partner for at least 6 months prior to screening.

Exclusion Criteria:

* Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil
* Be currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms

This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them.

Studies show high touch areas maybe contaminated with organisms such as Methicillin-resistant Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at higher risk for developing a hospital-acquired infection.

This study is to determine if medication cabinets located outside of MRSA isolation rooms and their contents, particularly medications and the pharmacy delivery folders are at a higher risk of having MRSA colonization on them. This study will use conventional methods to determine if MRSA colonization is present and compare results between non-isolation and isolation rooms. This will evaluate if alternate measures for the reduction of MRSA colonization are needed for the MRSA isolation rooms in regards to medication delivery and storage.

Eligibility Criteria:
Inclusion Criteria:

* Patient rooms with isolation status for MRSA
* Patient rooms without isolation status for MRSA for 14 days

Exclusion Criteria:

* Rooms without medication cabinets directly outside the room
Chlorhexidine Gluconate Bathing Education Video Among Hospitalized Patients

Chlorhexidine gluconate (CHG) bathing is an effective intervention to reduce hospitalized patient's risk of acquiring a central line-associated bloodstream infection (CLABSI). While daily CHG bathing for hospitalized patients is widely supported in the literature, patient adherence with this practice is suboptimal. Written and verbal information is provided to patients by nursing staff regarding the importance of CHG bathing and the correct usage of the CHG cloths; however, these methods can be hindered by literacy and language barriers. Medical videos have become popular avenues to provide necessary education to patients, and have been shown to improve patient-reported outcomes. Whereas the benefits of educational videos has been described in previous studies on advanced care planning and postoperative quality of life, they have not been described for CHG bathing. In this study, we aim to provide education (including the rationale/importance of CHG bathing, and the appropriate process for bathing) through the use of a short video provided to hospitalized patients. The purpose of this study is to evaluate the use of medical videos to educate patients on CHG bathing while hospitalized in the inpatient setting.

For this study, approximately 16 inpatient units will be included; 8 will be randomized to the intervention (access to patient-facing CHG video) with the remaining units continuing with usual care (providing education via verbal/written information). All patients who require a CHG bath would be eligible to participate.

Intervention Group: In addition to the current educational document available for CHG bathing, patients admitted to the intervention units will be provided access to a CHG bathing video through multiple avenues (QR codes placed in the room/unit, video provided on unit iPads). Nurses will be instructed to provide QR codes to patients to scan and watch the video. Patients can scan the QR code using their own smart device or through unit-based iPads. After viewing the video, patients will be directed to scan a separate QR code to complete a voluntary questionnaire.

Control Group: Patients in the control group would have access to the current education available (patient education document) - usual care

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an intervention unit who require a CHG skin treatment

Exclusion Criteria:

* CHG allergy
* Patients on comfort care
Effectiveness of AR in Ventilator Setting Education.

This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance. This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.

Background: Recently, the demand for mechanical ventilation (MV) has increased with the COVID-19 pandemic; however, the conventional approaches to MV training are resource-intensive and require on-site training. Consequently, the need for independent learning platforms with remote assistance in institutions without resources has surged.

Objective:

This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance.

Method:

This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.

Eligibility Criteria:
Inclusion Criteria:

We enrolled nurses who had no prior experience with ventilator setup or AR systems, regardless of their work department or age.

Exclusion Criteria:

We excluded nurses who had already experienced setting up a ventilator or who had trouble wearing or using a head-mounted device (HMD).
Inter-rater Reliability of the Clinical Frailty Scale in a Swedish Emergency Department Setting

Frailty is a common clinical syndrome in older adults, which may be assessed through various assessment tools. One frequently used tool is the Clinical Frailty Scale (CFS) which potentially can be adopted for daily use in the Emergency Department and has been appraised for reliability to some extent, but have so far not been evaluated in the Swedish emergency care context.

The purpose of this study is to evaluate the inter-rater reliability of the Clinical Frailty Scale (CFS) in a clinical Swedish Emergency Department (ED) setting. Members of multidisciplinary emergency care teams will conduct the assessments individually.

The CFS is introduced and tested as part of a quality-improvement process regarding elderly people within the Emergency departments (EDs) of Region Östergötland (Östergötland County) in Sweden.

CFS is a 9-point scale developed within the Canadian Study of Health and Aging. It comprises of a pictograms and a clinical description to help assign scores ranging from very fit to terminally ill. CFS enables clinicians to rapidly stratify the degree of frailty in the elderly with the help of questions and clinical assessment. However, since the assessment is judgement based, it is important that the inter-rater reliability is satisfactory.

This study is part of a larger project where all eligible patients who visit the ED (24/7) for a period of four weeks will be enrolled and then subsequently assessed with CFS by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). For this study, each professional on the team will individually assess each patient. First, a clinical judgement is performed (frail/not frail) without any instrument, and then the patient is assessed by using the CFS. This will take place during work shifts when someone from the research team is present and can arrange the assessments, as well as ensure that they are conducted independently. These work shifts will be selected using the online application Research Randomizer, to randomly include all hours of the day as well as eligible health-care professionals.

The research-team member will collect the assigned CFS-scores and information on the age, gender, profession, position (emergency physician or intern/resident from other specialities) and the number of years in the profession of each assessor. Informed consent will be obtained from all health-care professionals who participate. No data that can identify any patient will be collected.

Sample size is determined to be 100 patients, which would be more than sufficient with a power of 90% and α 0,05.

Eligibility Criteria:
Inclusion Criteria:

Health-care professionals:

- Working in the ED, as part of the emergency-care team that are responsible for a patient ≥65 years

Patients:

- ≥65 years

Exclusion Criteria:

Health care professionals:

- Unwilling to provide informed consent

Patients:

- ≤65 years
Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.

The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."


Eligibility Criteria:
Inclusion Criteria (prospective cohort):

* Adults over 18 years old
* Lung transplant recipients (D+/R-) pre-transplant.
* Having an undetectable CMV polymerase chain reaction assay (PCR) within the 96 hours prior to the start of letermovir prophylaxis.
* Patients who have provided written informed consent.

Exclusion Criteria (prospective cohort):

* HIV-infected patients.
* Patients with multivisceral transplant.
* Patients unable to comply with the follow-up protocol.
* Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis.
* Patients with concurrent renal and hepatic insufficiency.

Inclusion Criteria (retrospective cohort):

* Adults over 18 years old. Lung transplant recipients (D+/R-) pre-transplant.
* Patients treated with Valganciclovir prophylaxis for 12 months.
* Patients transplanted within 2 years prior to the start of the study.
* Patients with a complete 13-month follow-up and comparable data to the prospective cohort to evaluate the study's primary variables.

Exclusion Criteria (retrospective cohort):

* HIV-infected patients.
* Patients with multivisceral transplant.
Supported Employment COVID-19 Rapid Testing for PWID

This community-engaged project aims to improve the accessibility of rapid tests through a supported employment program for people who inject drugs (PWID). The program is called Peer Connect2Test (PeerC2T). PWID will be recruited by a community partner who provides syringe exchange services. PWID will the trained by the community partner to become peer health workers (PHW) to distribute SARS-CoV-2 rapid tests to other PWID. Investigators expect that PeerC2T will improve knowledge, self-efficacy, and health behaviors among PHW (Aim 1). The study will use the RE-AIM framework in Aims 2 and 3 to evaluate whether PeerC2T improves SARS-CoV-2 testing uptake among other PWID (RE; Aim 2), and identify intervention considerations (AIM; Aim 3). The overall goal of this project is develop a transformative community-driven intervention in partnership with a community partner to promote widespread access to rapid testing among PWID.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older, understand English

Exclusion Criteria:

-
Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.

The study will be conducted in the Department of Hepatology, Institute of Liver \& Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. This administration of sample, 50 ml daily will occur once a month every month for 6 months. The liver function parameters will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.


Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years.
2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
3. Histological evidence of definite or probable NASH (Non Alcoholic Steatohepatitis) based upon a liver biopsy prior to enrollment and a NAFLD (Non Alcoholic Fatty Liver Disease) activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
4. No history of recent spontaneous bacterial peritonitis.(1 month)
5. Child Pugh Score of 6 - 10

Exclusion Criteria:

1. Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
2. Ongoing bacterial infection requiring antibiotic treatment.
3. Current or history of significant alcohol consumption for a period of more than 3
4. consecutive months within 1 year prior to screening
5. Treatment with antibiotics or probiotics in the preceding 3 months.
6. Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
7. Pregnant patients
Renal Function During Laparoscopic Surgery

Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I
* age 24-42
* patients undergoing gynaecological laparoscopy

Exclusion Criteria:

* cardiovascular diseases
* renal and endocrine disorders
* obesity (BMI \> 30 Kg/m2)
* the assumption of drugs that could interfere with renal parameters considered in the study
Dexmedetomidine Infusion in Hypospadias Surgery

The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-12 years undergoing hypospadias repair

Exclusion Criteria:

* Allergy to Dexmedetomidine
* Preoperative use of sedatives or analgesics
* cardiac diseases
* Children with mental retardation