cyrilzakka/clinical-trials huggingface dataset:
KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease

The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence.

KNOW-CKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with CKD stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed patients or those with allograft kidney are excluded. At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, anemia, cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and mineral bone disorder. A biobank is also established for the DNA, serum and urine at regular interval. Information on the medical history, health questionnaires, QoL will also be collected. Web-based case-report forms (CRF) is developed for the systemic management of the patient data.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>20 and \<75 yr,
* CKD stage 1 through 5
* predialysis

Exclusion Criteria:

* Unable or unwilling to give consent
* Previously received chronic dialysis
* Previous any organ transplant
* Heart failure
* Known liver cirrhosis
* past or current cancer
* Pregnant women
* Single kidney due to trauma or donation
Prognostic Significance of Preoperative Hemoglobin A1c (HbA1c) in Renal Cell Carcinoma

The effect of preoperative glycemic control measured by HbA1c on renal cell carcinoma (RCC) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy. The investigators will prospectively collect the relevant data including preoperative HbA1c in 238 patients of RCC patients undergoing nephrectomy. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.

* This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy.
* Particularly, the investigators check the variables, including age at surgery, body mass index, sex, comorbidities, preoperative HbA1c levels, blood urea nitrogen (BUN)/creatinine levels, estimated-GFR, clinical TMN staging by CT scan, final pathological results (TMN stage, histology, and Fuhrman nuclear grade), warm ischemic time and surgical margin status (in the case of partial nephrectomy), postoperative recurrence and distant metastasis, renal function changes during follow-up periods.
* The study protocol is same with routine follow-up schedule of the patients with RCC treated with nephrectomy. Typically, the investigators check the patients at 1, 3, 6, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
* Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Renal cell carcinoma (RCC) by image work-up such as CT scan
* Clinically localized RCC
* Aged over 20 years
* Patients undergoing radical or partial nephrectomy

Exclusion Criteria:

* distant metastasis, preoperatively
* preoperative targeted therapy
* preoperative immunotherapy
* medications affecting glucose status other than diabetes mellitus
Outpatient Use of Ivermectin in COVID-19

Covid 19, a novel coronavirus, causes infection that, while mild to moderate in many people, can lead to severe disease in a significant portion. Currently, it is expected that the majority, 81%, of patients with COVID-19 will have mild to moderate disease, with 14% having more severe disease (2). There exists a number of candidate drugs that may inhibit SARS-CoV-2 infection or progression of disease. Simple, safe and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection.

Ivermectin is a drug initially synthesized and used as an anthelmintic. It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin α/β-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function. A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours. A recent multi-continent retrospective study of 1,400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 1.4% versus 8.5%. Given these findings and its safety profile, cost and ease of administration, Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Symptoms highly suspicious for COVID-19.
2. Age at least 18 years
3. Negative pregnancy test for women of child bearing age
4. Able to consent to participate in the study.

Exclusion Criteria:

1. Known history of Ivermectin allergy
2. Hypersensitivity to any component of Stromectol®
3. COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan
4. Fever or cough present for more than 7 days
5. Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening.
6. The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study:

   1. Immunosuppression
   2. HIV
   3. Acute or chronic renal failure
   4. Current neoplasm
7. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal within the prior 6 months if available OR clinical evidence of liver failure with jaundice, ascites, encephalopathy.
8. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
Assessing Motor Neuron Disease Mechanisms by Threshold Tracking Transcranial Magnetic Stimulation and Magnetic Resonance Spectroscopy

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which cases the death of neurons controlling the voluntary muscles. The death of motor neurons leads eventually to muscle weakness and muscle atrophy and as a consequence thereof, ALS patients die in average within three years after symptom onset due to respiratory failure.

No cure for ALS is currently known, and the medical diagnosis and clinical treatment are impeded by the lack of reliable diagnostic tools for objective disease assessment, and by the limited insight in disease pathophysiology since the underlying disease mechanisms still have not been fully elucidated.

An unbalance in the concentrations of GABA and glutamate, the most important inhibitory and excitatory brain metabolites, is suggested to play a role in the disease mechanisms of ALS. By applying Magnetic Resonance Spectroscopy (MRS), a magnetic resonance method which allows for quantification of brain metabolites, GABA and glutamate concentration can be quantified and thus hopefully elucidate their role in ALS disease mechanism.

Threshold Tracking Transcranial Magnetic Stimulation (TT-TMS) studies carried out by a single research group have demonstrated cortical hyperexcitability (a physiology state in which neurons in the cerebral cortex are easier activated) as an early feature in ALS patients. For this reason, TT-TMS was suggested as a biomarker of ALS by the research group. However, to be able to suggest a test as a biomarker, one must show the test is reliable and reproducible.

The objectives of this study are therefore: to explore the pathophysiology of ALS by investigating the interaction between neuronal networks as assessed by TT-TMS and conventional TMS and MRS, and to investigate the reliability and reproducibility of TT-TMS. The aim is to examine the utility of TT-TMS and MRS as diagnostic tools for objective detection of ALS in the early disease stage.

The study will include 60 participants in total, subdivided into two groups: 30 healthy participants and 30 patients with clinical suspicion of motor neuron disease or ALS. Each participant will undergo examination with TMS and MRS, the primary outcomes will be compared between the two groups and the results from the TMS examinations and the MRS-scans will be correlated.


Eligibility Criteria:
Inclusion Criteria:

Patients with

* possible, probable or definite ALS according to international criteria;
* progressive muscular atrophy;
* clinical suspicion of motor neuron disease or ALS

Healthy participants: no younger than 45 years of age

Exclusion Criteria:

Patients and healthy participants:

* ealier central or peripheral nervous system disease
* pacemaker or other implants
* pregnancy
* use of medications known to affect central nervous system
Hemophilic Knee Arthropathy Virtual Reality

This study intended to examine the effect of a physical rehabilitation program incorporating Kinect-based virtual reality on gait characteristics, functional ability, and physical activity level in adolescents with hemophilic knee arthropathy.

The usage of virtual reality in clinical practice as an alternative for conventional procedures has recently sparked the interest of health professionals. Virtual reality is a type of computer technology that provides simulated sensory feedback to allow children to participate in activities and events that are comparable to those they could face in real life. It can be used therapeutically to enhance strength, range of motion, coordination, mental concentration, problem solving, decision making, balance, and gait.

Eligibility Criteria:
Inclusion Criteria:

* moderate hemophilia
* bilateral involvement of the knee joint
* medically stable and received their factor replacement therapy
* free from contracture or congenital anomalies
* didn't have persisting, disabling pain.

Exclusion Criteria:

* recent bleeding episodes
* severe radiological abnormalities such as bone erosions, degeneration, bone ankylosis, or joint subluxation
* engagement in a regular exercise program in the past six months
* the unwillingness to stick to the training schedule
Genetic Variants Replication Study Associated With Dependence on Sulfonylurea in Participants With Type 2 Diabetes

This study was designed to reproduce candidate single nucleotide variants found by whole exome sequencing in some type 2 diabetic patients dependent on sulfonylurea in a separate patient group. The validation of the dependence-related variations performed in this study is expected to help decision-making in the clinical use of sulfonylurea in the future.

Sulfonylurea, one of the oral hypoglycemic agents, is the oldest and most widely used drug. The use of sulfonylurea was overwhelming compared to metformin especially in East Asia, where insulin secretion was notable during the pathophysiology of type 2 diabetes. However, sulfonylurea causes hypoglycemia and weight gain, increases cardiovascular disease and mortality compared to other oral preparations. With the recent development of other oral hypoglycemic agents for lowering blood glucose without the risk of hypoglycemia and with cardiovascular protection, sulfonylurea is in a decreasing state of use worldwide.

But some patients tend to be highly dependent on sulfonylurea for blood glucose control. It suggests that there will be a group of patients whose the action of sulfonylurea is strongly influenced by genetic factor, since insulin secretion of pancreatic beta cells is very hereditary, genetic variations that increase the risk of type 2 diabetes are found mainly in genes related to beta cell dysfunction rather than insulin resistance, and the more risk variants of type 2 diabetes, the less likely the effect of sulfonylurea is.

The investigators had performed whole exome sequencing in patients showing dependence on sulfonylurea and identified tens of candidate variants.

In this study, the investigators will select patients with dependence on sulfonylurea by prospective intervention (by discontinuing and resuming sulfonylurea) and perform genetic tests.

Eligibility Criteria:
Inclusion Criteria:

Among patients with type 2 diabetes who visited Seoul National University Hospital endocrinology outpatient clinic, all of criteria (1)-(4) are satisfied

1. Adults over 19 years
2. More than 10 years of diabetes
3. Low dose sulfonylurea use: Equivalent capacity 2 mg or less of glimepiride
4. Less than 7.5% of glycated hemoglobin for more than 6 months
5. estimated glomerular filtration rate \> 50 mL/min/1.73㎡

Exclusion Criteria:

* Type 1 diabetics
* Insulin user
* Patients diagnosed with cardiovascular disease, cancer, and other critical illness within 6 months before the study
* Patients with severe hypertension
* Patients with treatment or diseases that may have a significant effect on blood glucose levels, such as glucocorticoids and thyrotoxicosis
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women

Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET).


Eligibility Criteria:
Inclusion Criteria:

* Female patients between the ages of 18 and 65 years
* Plasma HIV-1 RNA \<= 400 copies/mL, documenting HIV-1 infection, within 28 days prior to Study Day 0
* Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) \>= 100 cells/mm³ within 28 days prior to Study Day 0
* Patients who meet the following laboratory parameter:

  * Lymphocyte count \>= 1000 cells/mm³
  * Hemoglobin \>= 9.0 g/dl (men and women)
  * Platelet count \>= 75000 cells/mm3
  * Alkaline Phosphatase \<= 3.0 times the upper limit of normal
  * Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) \<= 3.0 times the upper limit of normal
  * Total bilirubin \<= 1.5 times the upper limit of normal
  * Creatinine \<= 2mg/dL
* Female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam)
* Patients who are informed of and willing and able to comply with the investigational nature of the study and had signed a written consent in accordance with institutional and federal guidelines
* Patients who have been on stable antiretroviral therapy (no changes in medication or dose) for at least thirty days prior to study entry and who will continue on background during study participation

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (Study Day 0). Such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin
* Patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
* Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
* Patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the Investigator and Boehringer Ingelheim Pharmaceutical Incorporated (BIPI) Medical Monitor to be a significant impairment to health and compliance
* Patients undergoing treatment for an active infection
* Patients with hepatic insufficiency due to cirrhosis
* Patients with renal insufficiency
* Patients who are heavy smokers (e.g. \> 20 cigarettes per day)
* Patients currently taking Norvir® (Ritonavir) or Rescriptor® (Delavirdine)
Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Young Gay/Bisexual Minority Men (IMPACT)

The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk

IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT across various settings for translation into real-world practice using a hybrid effectiveness-implementation design.

The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV risk reduction (RR), 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention.

The enhanced Standard of Care (eSOC) group includes two HIV RR intervention sessions.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-24 years, inclusive, at enrollment
* Assigned male at birth
* Identifies as a cisgender boy or man
* Self-reports condomless anal sex (CAS) with another boy/man-receptive or insertive-while using stimulants (5 hours prior to, or during, sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)
* Willing and able to provide written informed consent for study participation

In addition, virtual participants must meet all the below criteria:

* Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)
* Provide a mailing address where they can receive a package
* Access to stable internet that they can use for more than 2 hours at a time
* Have a private place (where no one else can see or hear) where they can complete visits online
* Reside within the continental U.S.

Exclusion Criteria:

* Unable to provide informed consent due to severe mental or physical illness
* Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable
* Non-English-speaking
* Is currently incarcerated or pending incarceration
* Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Site Consortium Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results
Addressing Mental Health Disparities in Refugee Children

The proposed study will employ a cross-cultural Community Based Participatory Research (CBPR) approach to build from prior needs assessments and mixed-methods research to evaluate the effectiveness of the Family Strengthening Intervention for Refugees (FSI-R), a preventative family home-based visiting intervention intended to mitigate mental health disparities among refugee children and families using a hybrid implementation-effectiveness design. Results of the investigator's trial will expand the evidence-base on community-based interventions for refugees and has the potential to be replicated to reduce mental health disparities affecting diverse groups of refugee children and families.

Using a CBPR approach, a family based prevention model, the Family Strengthening Intervention for Refugees (FSI-R) was adapted from a tested model used in Africa and designed for delivery by refugee community health workers with through a process involving stakeholder consultation and local refugee Community Advisory Board input. Pilot data on the FSI-R demonstrates strong feasibility and acceptability, but further data are needed on effectiveness as well as barriers and facilitators to implementation by community health workers embedded in refugee-serving social services agencies. Specific aims are to (1) examine the impact of a family-based preventive intervention on outcomes of parent-child relationships, family functioning, and child mental health using a Hybrid Type 2 Effectiveness-Implementation Design (families with children aged 7-17 in a two-arm randomized controlled trial); (2) identify barriers and facilitators to implementation of the FSI-R by community health workers by conducting a process evaluation concurrent with the delivery of the intervention; and (3) strengthen the science of community engagement to address health disparities by fortifying CBPR-based pathways of change via collaborative partnerships between refugee communities, service providers, and academic stakeholders.

Eligibility Criteria:
Inclusion Criteria for families:

* being a resettled refugee family
* having one or more school-aged children living in the home (aged 7-17)

Inclusion Criteria for parents/caregivers:

* be aged 18 or older
* cares for and lives in the same household of the children at least 50% of the time
* is the child'd legal guardian

Exclusion Criteria:

* not meeting the above inclusion criteria
* families in the midst of a crisis (e.g. active suicide attempts)
A New Risk Score for the Emergency Department in Patients with Upper Gastrointestinal Bleeding

Abstract Background: The aim of this study was to develop a simpler, more practical, and highly effective risk scoring system for patients presenting to the emergency department with upper gastrointestinal bleeding.

Methods: This single-center retrospective observational study was conducted by reviewing data from patients aged 18 years and older who presented to the Emergency Medicine Clinic of Sakarya Training and Research Hospital with symptoms and signs of upper gastrointestinal bleeding between January, 2022 to June, 2023. Patients were divided into six groups for analysis. Patients included in the transfusion, intervention, intense care unit, readmission or mortality groups were classified as high risk. Using the obtained data, a new scoring system was developed, and its effectiveness in predicting high risk and all subgroups was compared with the Glasgow Blatchford Score, AIMS65, and pre-endoscopic Rockall Score.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years who presented to the ED with UGIB symptoms and signs (hematemesis, melena, and hematochezia) and were hospitalized between January 1, 2022, and June 1, 2023, were included in the study.

Exclusion Criteria:

* Patients with insufficient data, lower gastrointestinal bleeding, or those who did not undergo endoscopy due to death, refusal of treatment, or symptom resolution were excluded.