cyrilzakka/clinical-trials huggingface dataset:
Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

The high prevalence of prediabetes in HIV patients is also an outpost event for the further development of diabetes and cardiovascular events, as well as for the prolonged survival of HIV patients with metabolic problems and their complications. Based on the well-established experience in the field of traditional diabetes with prediabetes, the combination of SGLT2 inhibitors can target the pathophysiological mechanisms of HIV-induced metabolic disorders, and the results of a small pilot study of one of the representative drugs, cabergoline, in HIV-combined diabetic patients suggest its efficacy and safety in the treatment of HIV-combined diabetic patients. Combined with the advantages of the concentrated disease resources of HIV patients in the investigator's unit, this study is intended to use a single-center randomized controlled clinical trial design, giving the experimental group drug combined with lifestyle intervention and the control group lifestyle combined with placebo intervention, to verify whether the combination of cabergoline and lifestyle intervention can safely and significantly change the clinical outcome of glucose metabolism, as well as the effect on body weight and pancreatic islet function of patients The study provides top clinical evidence for the treatment of these patients and suggests a new set of interventions for patients with HIV combined with prediabetes. No similar studies have been found to be innovative in the literature search, and the implementation of this study will be of great clinical value.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HIV infection combined with prediabetes who are not treated with antidiabetic drugs
* Fasting blood glucose of 6.1-6.9 mmol/L or 2-hour oral glucose tolerance test of 7.8-11.0 mmol/L
* BMI \>24 kg/m2 and no more than 10% weight fluctuation in 3 months
* HIV-infected patients must be on antiretroviral therapy, no significant symptoms, have HIV RNA below the lower limit of detection for 3 consecutive months, and have CD4 cells greater than 200/uL

Exclusion Criteria:

* Patients with diagnosed diabetes
* Those who are unwilling to participate or unable to cooperate
* The patient has had an acute heart attack or cardiovascular disease in the last three months
* Positive pancreatic islet autoimmune antibody
* History of pancreatitis or pancreatic cancer
* Pregnant or breastfeeding women
* Liver function aminotransferases greater than 2 times the upper limit of the normal range
* Patients with previous recurrent urinary tract infections
* Glomerular filtration rate \<45ml/min/1.73m2
* Other serious co-morbidities
Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients

The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.

Coronaviruses are a group of viruses that cause diseases in mammals and birds. In humans, coronaviruses cause respiratory tract infections that can be mild, such as some cases of the common cold, and others that can be lethal, such as severe acute respiratory syndrome (SARS), (middle east respiratory syndrome) MERS, and COVID-19. They contain a positive-sense, single-stranded RNA genome. The genome size ranges from approximately 27 to 34 kilobases. It has a 5' methylated cap "5'leader, UTR", replicas/transcriptase enzyme, spike (S) protein, envelope (E) protein, membrane (M) protein, nucleocapsid (N) protein, 3'untranslated region (3'UTR), and a poly (A) tail, respectively. The S protein has a major role in eliciting the protective immunity during infection with SARS-corona virus (SARS-CoV) by inducing neutralizing-antibodies and T-cell responses. It is also the most mutated part of the coronavirus genome. The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified, which could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 Patients, and patients aged above 18 will be considered in this project.

Exclusion Criteria:

* Patients with more than one of these chronic diseases; diabetes mellitus, hypertension, cardiac diseases, and livers diseases grade 2 and 3 will be excluded.
Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial

The purpose of this research is to assess the feasibility (e.g., recruitment rate, adherence rate and retention rate) of a clinical trial using virtual assessments to investigate the effect of a 6-month administration of a specific multi-nutrient oral supplement on cognitive aging.

The study will also test whether a 6-month daily intake of a specific multinutrient can delay or reverse the effects of normal cognitive aging on other cognition domains as well as quality of life as measured by virtual assessments.

Participants with cognitive aging who meet the eligibility criteria are provided study information and scheduled for a screening visit via virtual encounter. At the screening visit, participants meeting criteria are enrolled, and a baseline visit is scheduled (same day, or separately.) The participants are then randomized to either the test product (specific multi-nutrient) or placebo. Study parameters will be assessed at baseline, and 6 months via a virtual online platform. Patients will be contacted monthly via telephone to promote compliance and monitor progress. An optional sample of blood may be provided by the participant if willing to participated in this optional sub-study.

Eligibility Criteria:
Inclusion Criteria:

1. English or Spanish speaking participants considered to have age-related cognitive decline based on the following criteria:

   A) RBANS (Verbal Memory Retention) A score ≥70% on list learning retention AND ≥80% on story memory retention and B) Subjective Cognitive Decline (SCD) 9-item brief screening tool score within the 25th percentile (SCD =1) and 75th percentile (SCD = 6) and C) MoCA ≥24
2. Age 55-89
3. Written informed consent provided by participant

Exclusion Criteria:

1. Enrollment in any other clinical trial within 30 days prior to participation
2. Major Neurocognitive Disorder ("Dementia") according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition and/or NIAA Criteria
3. Use of any AD medication (e.g., cholinesterase inhibitors, NMDA antagonists), or OTC supplements or cognitive/memory enhancers
4. Use of omega-3 fatty acids in the 30 days prior to participation
5. Intake of Vitamins B6 and B12, folate, Vitamins C and E \> 300% RDI in the 24 days prior to participation
6. Concurrent major medical or neurological illness
7. Prior clinical history of stroke
8. History of substance abuse (e.g., alcohol, drugs)
9. Untreated Major Depressive Disorder that has not been in remission for at least 6 months prior to participation
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis

The focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the short term effect over 6 weeks. Secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)


Eligibility Criteria:
Inclusion Criteria:

* 1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3 out of 10) because our aim of the study to reduce pain with combined treatment and pain lower than 3 out of 10 score might not allow to compared the pain reduction between the group.

  2- Definitive medial joint narrowing higher or equal to the lateral side and osteophytes on X-Ray A-P or PA view in weight bearing position if possible.

  3- Medial joint tenderness either by patient's indication or the clinician under the clinical examination indicating tenderness in the tibiofemoral joint.

  4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological plain x-ray will be used.

  5- Being able to walk without assisted devices for 100 meters non-stop because he or she will not be able to complete this study protocol.

Exclusion Criteria:

* 1- More pain localized to patellpfemoral or lateral joint than the medial knee side on examination.

  2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any other realignment operation. 6- Total knee replacement. 7- Any condition contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected intra-articular knee joint space in the previous month.

  9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher will be excluded because previous study showed that individuals with 33 BMI.

  11- Lower than 35 years and higher than 85 as this period was identified to highest incidence period (Losina et al., 2013). Although individuals with 86 and higher has high prevalence to the knee OA, exclusion this population was important due to high amount of walking and balance test.
An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic Radiographs

This study will attempt to validate a method of estimating root length on panoramic radiograph by crown measurement on intraoral digital scans.

Intraoral digital scans will be taken on patients who have completed orthodontic treatment, and measurements will be made on the crown dimensions. These dimensions will then be applied onto the same teeth as seen on panoramic radiographs and a mathematical relationship will be determined for root length. Changes in root length will be measured from initial records to treatment complete panoramic radiographs and these estimates will be compared to actual root length changes as measured in CBCT (Cone Beam Computed Tomography) records.

Eligibility Criteria:
Inclusion Criteria:

* Subject has initial records including CBCT scan and panoramic radiograph that are clear. Subject must have no restorations or significant loss in tooth structure in target teeth or teeth adjacent to target.

Exclusion Criteria:

* Subjects who have records that are not clear, and who are missing target teeth.
Integrative Multi-Omics Testing for Immunotherapy Response in Non-Small Cell Lung Cancer

The objective of this study is to use blood and urine proteomic and metabolomic features to monitor lung cancer immunotherapy response.

Observational, ambispective single-center cohort study, including 400 patients with locally advanced unresectable or metastatic NSCLC who received or are receiving immunotherapy in routinely clinical practice.

For the part of retrospective study，the investigators intend to include 200 patients who received immunotherapy at Nanfang Hospital from January 1, 2020 to March 1, 2023.

For the part of prospective study，the investigators intend to include 200 patients who will receive immunotherapy at Nanfang Hospital from March 1, 2023 to December 31, 2025.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 18 years or older at the time of signing the informed consent form;
2. Patients with histologically or cytologically confirmed non-small cell lung cancer that is metastatic or locally advanced unresectable, not eligible for local curative treatment (Stage IIIB or IV according to AJCC);
3. Patients without contraindications for immunotherapy according to CSCO guidelines for Non-Small Cell Lung Cancer (NSCLC) version 2022（No EGFR mutations, ALK or ROS1 rearrangement);
4. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1;
5. Patients who have not received systemic treatment in the past, or who have previously received (neo) adjuvant treatment/radical treatment programs and have relapsed for more than 6 months;
6. Patients who signed the informed consent and are willing to participate in the study.

Exclusion Criteria:

1. Patients with the history of autoimmune disease or immunodeficiency disease;
2. Any severe, uncontrolled diseases, including: (1) Active or uncontrolled heart diseases, (2) Renal failure requires hemodialysis or peritoneal dialysis; (3) Liver diseases such as liver cirrhosis, decompensated liver disease, chronic active hepatitis;
3. Any severe, uncontrolled urological diseases, or urine total protein \>1.0g/day.
4. Any severe, uncontrolled metabolic diseases, including uncontrolled diabetes mellitus (fasting blood glucose (FBG)\>10mmol/L);
Impact of IDH Mutation and Adjuvant Chemo(radio)therapy on Survival Outcome in Grade II/III Astrocytoma

This study looked at a type of brain tumor called astrocytoma and how specific genetic changes like IDH mutations affect patients outcomes. Recent studies found that people with IDH-mutated astrocytomas tend to live longer and have better survival rates compared to those without these mutations. One reason for this is that IDH-mutated tumors usually grow more slowly and are less aggressive. These findings suggest that testing for IDH mutations could help doctors make more personalized treatment plans for patients, which may lead to better results. However, larger studies are needed to confirm these observations. the investigators used the Surveillance, Epidemiology and End Results (SEER) database to obtain the data of 811 patients with grade II/III astrocytoma. The data are publicly available and no consent or ethical approval is needed for this study. The clinicopathological data of patients, including the age, gender, race, IDH status (mutant/wild), astrocytoma type (diffuse/anaplastic), surgery (tumor destruction, Local excision, partial, radical, total gross resection, Surgery), radiation (Beam radiation, Radioactive implants including brachytherapy, Radioisotopes, Combination of beam with implants or isotopes, Radiation, method or source not specified), chemotherapy, vital status, and survival months, were extracted. Patients were sub-grouped according to the IDH type into IDH mutant-type and wild-type. with further stratification according to the treatment modality into three groups: adjuvant chemotherapy, adjuvant radiotherapy, and combined adjuvant chemoradiotherapy. The Observed survival and cause-specific survival were calculated using SEER\*stat software version 8.4.3 and SPSS version 25 was used for survival analysis. Significance was achieved at 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Patients were selected only if they had astrocytoma with malignant behavior
* Grade II-III astrocytoma
* First primary tumor with sequence 0 or 1
* Had surgical intervention (tumor destruction, Local excision, partial, radical, total gross resection, Surgery)

Exclusion Criteria:

* unknown survival time
* patients with unknown age
* death certificate only and autopsy only cases
Hyperthermic Intra-Vesical Chemotherapy

The purpose of the HIVEC II trial is to find out if the combination of the new technology called hyperthermia (the use of heat) and a drug called mitomycin is more effective than mitomycin alone which is the standard treatment for bladder cancer in reducing the chances of bladder cancer returning.

The concept of hyperthermia plus MM has been demonstrated and a phase II randomized controlled trial of ablative HM versus MM using an alternative device (Synergo) has reported tumor ablation complete response (CR) rates in 66 % of tumors treated with hyperthermia plus mitomycin compared to 22% CR for MM mono-therapy.

Registered patients will be randomised to receive either Hyperthermia and Mitomycin or Mitomycin alone. Following treatment, patients will be followed up by surveillance cystoscopy for 24 months for disease recurrence. In the first year, the follow up visits will be every 3 months from the date of start of treatment and in the second year, the visits will be every 6 months.

The study also includes translational components to determine biomarkers of response to Heated Mitomycin. Urine samples will be collected prior to surveillance cystoscopies.

This study will address the problem of how to improve the disease free survival in patients with intermediate-risk NMIBC, the treatment must have acceptable side-effects, low toxicity, and show a significant benefit over MM alone.

Eligibility Criteria:
Inclusion Criteria:

1. New or Recurrence of intermediate risk NMIBC following TURBT defined as;

   * Grade 2 or grade 1 stage Ta or T1 disease\*.
   * Any grade G2 or G1 other than Low risk
2. Age ≥ 18 yrs
3. WHO performance status 0, 1, 2, 3
4. Pre-treatment haematology and biochemistry values within acceptable limits:

   * Haemoglobin \> or =10 g/dL
   * Neutrophil count \> or =1.5 x 109/L
   * Platelets \> or = 100 x 109/L
   * WBC \> or = 3.0 x 109/L or ANC \> or = 1.5 x 109/L
   * Serum creatinine \< 1.5 x UNL
5. Negative pregnancy test for women of child-bearing potential.
6. Available for long-term follow-up.
7. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
8. Written informed consent.

Exclusion Criteria:

1. Grade 3 TCC
2. Carcinoma in situ.
3. New solitary Ta G1 (small)
4. New solitary Ta G2 (small)
5. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
6. Bladder capacity \<200cc.
7. UCC involving the prostatic urethra or upper urinary tract.
8. \> or =T2 UCC
9. Known allergy to mitomycin
10. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
11. Other malignancy within the past five years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer with more than 5yrs life expectancy or any non lifethreatening tumours that have been curatively treated.
12. Concurrent chemotherapy.
iLookOut Micro-learning to Improve Knowledge Retention

This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs.

The primary purpose of this study is to understand the optimal timing to administer iLookOut Micro-Learning to boost ECPs waning knowledge and preparedness to protect children from abuse. Additionally, this study will conduct a randomized controlled trial to examine how interactive, gamified micro-learning promotes knowledge retention and fosters behavior change with regard to child abuse and its reporting, and to establish that implementation of this intervention is feasible.

All components of the learning module being studied are online, and will be accessed by participants through a secure website.

Once they complete the Core Training, participants who identify as ECPs will receive an email indicating which randomization arm they are in (regarding access to the advanced training) - immediate, 3 months, 6 months, or 9 months. Non-ECPs will be able to complete the advanced training as soon as they complete the Core Training. All non-ECPs will be used as a comparison group to determine if the iLookOut trainings are effective for improving and retaining knowledge, and changing behavior among Non-ECPs compared to the ECP participants.

Separate mixed-effects linear regression model will be applied to assess (1) the knowledge decay effect based on the data collected at different time-points and (2) the behavior change between the various time-points and how it is correlated to the knowledge score, after controlling for participants' baseline characteristics and work setting. In addition, the regression model will adjust effects for allocation blocks and the factors for stratification in the analysis to reduce group variability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Younger than 18 years of age