cyrilzakka/clinical-trials huggingface dataset:
Disparities in National Kidney Allocation Policy

The purpose of the current study is to test a systems-level approach to disseminate a multicomponent, multilevel intervention consisting of educational materials about transplantation and the new kidney allocation system targeting dialysis facility Medical Directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 end stage renal disease Network regions across the United States will be randomized to receive intervention materials. The overall goal of the study is to extend the influence of the national allocation policy in reducing disparities in early steps in kidney transplant access.

The purpose of the ASCENT study is to test a systems-level approach to disseminate a multi-component intervention consisting of in the era of the new national kidney allocation policy and educational materials targeting dialysis facility Medical Directors, staff, and patients. The investigators will randomize \~750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States, where approximately half of facilities will receive the intervention materials and half will receive an informational brochure. This pragmatic, clinical effectiveness-implementation study will test the effectiveness of the multicomponent, multilevel interventions consisting of a tailored, facility-specific transplant and disparity performance report, educational videos for staff and dialysis patients, and an educational webinar for dialysis facility Medical Directors and staff.

Eligibility Criteria:
Inclusion Criteria:

Dialysis facilities with at least 25 patients composed of at least 10% African American and 10% Caucasian

Exclusion Criteria:

Dialysis facilities with wait listing rates above the national tertile
Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection

To evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus tenofovir disoproxil fumarate-based antiretroviral regimens in HIV-infected individuals with virological suppression.

This study is a multicenter, randomized, controlled, open labeled clinical trial, which aims to evaluate the safety and efficacy of B/F/TAF versus TDF-based antiretroviral therapy in HIV-infected individuals with virological suppression, and to evaluate the changes in quality of life and adherence after switching from a TDF-based regimen to B/F/TAF in HIV-infected individuals with virological suppression.

Eligibility Criteria:
Inclusion Criteria:

* Meet the Diagnostic Criteria for AIDS or HIV Infection (WS 293-2019);
* Age 18 or above (included 18);
* Continuous administration of a TDF-based triple ART regimen with a backbone of non-nucleoside reverse transcriptase or protease inhibitors ≥24 weeks and ongoing use;
* Maintaining virological suppression (viral load \< 50 copies/mL) for ≥ 24 weeks, and maintaining virological suppression at present;
* Glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (calculated according to the CKD-EPI formula);
* ECG is normal;
* White blood cell count ≥3×109/L, Neutrophil count ≥1.5×109/L, Hemoglobin ≥90 g/L, and Platelet count ≥ 75×109/L;
* Alanine aminotransferase and aspartate aminotransferase ≤5×ULN, direct bilirubin ≤1.5×ULN, amylase≤2×ULN；
* Those who volunteered for this study and were able to complete all follow-up visits and sign the informed consent form in accordance with the protocol.

Exclusion Criteria:

* In the 30 days(inclusive) before the screening period, an AIDS-related opportunistic infection or tumor occurred;
* History of known past HIV resistance (confirmed HIV viral load \> 200 copies /ml) or resistance to any nucleoside (acid) analogues;
* Decompensated liver cirrhosis;
* Female subject who has a positive urine pregnancy test;
* Lactating women;
* Women who are unable to take a reasonable method of contraception during the trial (including the Screening Period and 30 days after discontinuation of experimental drugs);
* Subjects had other medical conditions requiring treatment with either of the current ART regimens or other drugs which have drug-drug interaction with B/F/TAF and cannot be discontinued.
* Being involved in other interventional clinical studies;
* Those with allergic constitution or known allergy to the components of the drug;
* Suffering from serious mental or neurological diseases;
* Suspected or confirmed history of alcohol and drug abuse; Patients who were not considered by the investigator to be suitable for participating in this clinical trial (such as weak constitution, poor compliance, etc.).
Healthy Lifetime - Sustainability and Quality Study

HealthyLifetime (HL) is a person-centered program that enables older adults to maximize health and optimize functioning - the necessary requisite to successfully remaining independent in their preferred home setting as long as possible, i.e., to age in place.

HL seeks to intervene early in the aging process when individuals have the best chance for longer term benefits of changing their health behavior, as a means to stave off functional decline, and minimize the onset or exacerbation of chronic conditions. And, for individuals who are experiencing any of the barriers described above, our HL program's Nurse Coaches are prepared and experienced in helping them achieve their highest level of functioning and self-care capacity, while integrating and collaborating with, but not duplicating, their medical services such as primary care, specialty care, and case management or medical social services. While the latter medically oriented services support clinical management, they do not focus on helping older adults maximize health and function by building self-care capacity, long term health behavior change capacity and the functional resilience necessary to sustain or regain independent living.

Eligibility Criteria:
Inclusion Criteria:

* Be able to read, speak English and hear - but may use glasses or hearing aids, if needed;
* Be able to tell us their age, their date of birth, address, and phone number, as well as write down and explain their health problems;
* Have their own computer or iPad (Tablet) with an Internet connection, a working camera and microphone. and
* Be able to use their computer/tablet to connect to video chat sessions like Zoom in a private space in their home or a private room.

Exclusion Criteria:

* People who, in the last month, have used the Emergency Room (ER) or stayed in the hospital.
* Are not verified users of Medicaid Home Help services \[we will check with the Michigan Department of Health and Human Service to verify that you receive these services using your name, date of birth, and Medicaid identification number\];
* Have a new major health problem that they are seeing a doctor about more than once per month;
* Have been told their illness is not curable;
* Cannot remember their name, date of birth or their health problems;
* Cannot use glasses or a hearing aid to see or hear well enough to read materials on the computer or talk to the nurse easily; and,
* Do not have, or cannot use, a computer, iPad or other device with the Internet at home to use Zoom (e.g., internet streaming).
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

A Multi-center, Randomized, Double-blind, Placebo control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged ≥ 19 years with persistent or permanent Atrial Fibrillation
* Patients with modified EHRA(The European Heart Rhythm Association score of atrial fibrillation) score ≥ 2a
* Patients with resting HR ≥ 80 beats per minute(bpm)
* Patients with 24-h mHR ≥ 80 bpm on Holter ECG

Exclusion Criteria:

* Treatment with antiarrhythmics within 2 weeks(Those who had washout period can be included)
* Pacemaker or implantable cardioverter defibrillator
* Catheter ablation for atrial fibrillation within 12 weeks before first investigational product(IP) administration
* Treatment for heart failure (New York Heart Association functional class 4)
* Myocardial infarction or unstable angina pectoris within 12 weeks before first IP administration
* Wolff-Parkinson-White syndrome
* Hepatic or renal disorder
* Systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg
* Uncontrolled Diabetes(HbA1c \> 9%)
Analysis of Balance in the Aging Process

Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge.

Objective: To evaluate the functional balance in the aging process.

Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.

48 individuals of both sexes and aged between 10 and 85 years were chosen. These individuals were divided according to age, into four groups (each group containing 12 individuals, 6 men and 6 women): Group I (G1): 10 - 18, Group II (G2): 20 - 35; Group III (G3): 45 - 60, Group IV (G4): 65 - 85.

The instruments used for assessment of the balance were: (1) Berg Scale - consists of 14 items with common activities of daily life, with progressive degree of difficulty (2) Assessment of Gait and Balance for Performance Oriented (POMA), consists of a protocol that evaluates the static and dynamic balance, with operations similar to the activities of daily living, (3) Test Support Unipodal; (4) adapted Functional Reach Test, which assesses the stability in the standing position, (5) Test and Romberg Romberg's test Romberg-Barré or sensitized conducted in stable and unstable soil, and all positions were first with open eyes and then with closed eyes. The duration of each exposure was 30 seconds, with different positioning of the feet.

Eligibility Criteria:
Inclusion Criteria:

* Absence of the basic pathology that interferes directly in the balance

Exclusion Criteria:

* Neurological changes
* Cognitive impairment
* Orthopedic injury
* Use of orthoses for lower limb
* Obesity
* Exercise frequently (more than twice a week)
* The bearer of any commitment to stay in their standing position
Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function

The goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function.

Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Obstructive Pulmonary Disease
* FEV1 ≤ 45% pred and FEV1/FVC\<70%
* TLC\>100% pred and RV\>175% pred
* CAT score≥18
* Emphysema damage\>50%
* Complete interlobar fissure \>95% based on quantitative analysis of CT measurement
* No smoking\>6 months
* Sign the informed consent form

Exclusion Criteria:

* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
* 6-minute walk test\<160m
* Obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases
* More than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment
* Previous lobectomy, LVRS or lung transplantation
* LVEF\<45% and or RVSP\>50mmHg
* Anticoagulant therapy that cannot be stopped before surgery
* Patients with obvious immune deficiency
* Participated in other lung drug studies within the first 30 days of this study
* Pulmonary nodules requiring intervention
* Any disease or condition that interferes with the completion of the initial or subsequent assessment
Assessment of Corneal Endothelium After Collagen Cross Linking

The aim of this study is to assess the effect of accelerated corneal collagen cross linking on corneal endothelium using the specular microscopy

Keratoconus (KC) is a progressive, non-inflammatory corneal degenerative disease. It is a pathology characterized by a progressive thinning and protrusion of the cornea that ends in a cone-shaped cornea. This results in progressive myopia and irregular astigmatism with associated progressive loss of vision and thus reduced quality of life.Collagen cross-linking (CXL) is a relatively new conservative approach for progressive corneal ectasia. The main indication for CXL is to slow the progression of corneal ectatic diseases, such as keratoconus, pellucid marginal degeneration (PMD), keratoglobus and iatrogenic ectasia.The basic principle of this method is the chemical interaction of ultraviolet A radiation (315-400nm ) and riboflavin to induce covalent bond formation between collagen fibers of the cornea. In this way, the stiffness and rigidity of the cornea are provided.Corneal collagen cross-linking (CXL) was first introduced by Wollensak with an ultraviolet-A (UVA) protocol of 3 medium wave mW/cm2 intensity at 370 nm over an exposure time of 30 minutes (now termed the "Dresden protocol"). Researchers have proposed accelerated CXL (ACXL) protocols, to improve convenience and comfort for patients. These ACXL protocols have the aim of decreasing UVA exposure time by increasing UVA fluency to achieve the same overall total UVA dosage.Despite corneal CXL is a safe and effective procedure with few known side effects .Persistent corneal edema and possible endothelial cell damage have been reported in a few cases after CXL. Based on the extent of endothelial damage, patients may require penetrating keratoplasty.

Eligibility Criteria:
Inclusion Criteria:

1. patients with mild to moderate corneal ectasia who are candidates for CXL.

Exclusion Criteria:

1. patients with advanced corneal ectasia with maximum keratometry readings \<56 diopters.
2. corneal pachymetry \>380um.
3. corneal scarring.
4. previous corneal surgeries (e.g intrastromal corneal ring segments)
Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid

The purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an Italian population.

We submitted the Quality of Life in spina bifid Questionnaire to subjects who participated in the study and the Spinal Cord Independence Measure to the parents of subjects.

Eligibility Criteria:
Inclusion Criteria:

* recurrence of clinic control in Unit for Spina Bifid in Parma
* 14-21 years old

Exclusion Criteria:

* subjects unable to understand the items of the questionnaire (mental retardation and need for help at school )
* subjects without any caregiver
Target ADHD Executive Working Memory Study

This study will assess whether or not a novel executive working memory training intervention for Attention-Deficit/Hyperactivity Disorder can engage frontoparietal brain network treatment targets and behavioral performance.

This proposal seeks support for a 2-year milestone-driven R61 initial test of target engagement in n=62 ADHD diagnosed adolescents randomized to a 'sham training' placebo or to train 4 times each week using 4 different EWM exercises that have been combined into the format of a typical cognitive training intervention. Exercise difficulty levels in the active intervention will increase across 5 weeks to continually challenge EWM ability. EWM training will use a novel, remotely-supervised 'at home' computerized training approach. If R61 EWM training target engagement milestones are met, a 3-year R33 phase will begin. The R33 will replicate target engagement in another randomized placebo-controlled trial of n=90 new ADHD adolescents and attempt to establish a convincing link between the hypothesized targets and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in an n=40 non-ADHD control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD
* English speaking
* Right-handed
* \>5th grade reading level
* \>80 IQ level

Exclusion Criteria:

* Braces, metal or implant devices
* Brain abnormality, neurological disorder
* TBI or loss of consciousness\>30 minutes
* Diagnosis of Psychosis, Bipolar Disorder, ASD, PTSD, OCD, SUD, Tourette's Disorder
Writing About Experiences and Health in Older Adults

UCLA researchers looking for healthy females (age 60+) to participate in a study investigating how writing about your experiences may be related to your health.

Once a week for 6 weeks, participants will write about their experiences and fill out online questionnaires. Participants will also come to the UCLA campus for blood draws and to fill out questionnaires 3 times: once prior to the 6-week writing period, once immediately after the 6-week period, and once 2-months after the writing period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 60 years and older

Exclusion Criteria:

* Following a structured telephone interview, participants with the following conditions will not be able to participate:

  1. current smokers
  2. active, uncontrolled medical disorders
  3. chronic infection (e.g., Hepatitis C, HIV)
  4. use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
  5. psychiatric disorders (e.g., current major depression, bipolar disorder)
  6. body mass index (BMI) greater than 35

Other exclusion criteria may apply.
PI Vs. NNRTI Based Therapy for HIV Advanced Disease

Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with CD4 counts ≤ 200/mm3.

Current guidelines for initial therapy in HIV infection recommend 2 NRTIs plus either a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor (NNRTI). Recent data suggests that the rate of response to PI based therapy may be slightly compromised if the baseline CD4 count is ≤ 200/mm3 and the plasma HIV-1-RNA ≥ 100,000 copies/mL. This may not be equally apparent if ritonavir boosted protease inhibitors are used. The effect of baseline CD4 count and HIV-1-RNA levels on the antiviral efficacy of NNRTI based regimens has been less well characterized. A significant number of patients currently initiate therapy at late stages of progression, typically with baseline CD4 count is ≤ 200/mm3. In Mexico approximately 60% of patients who initiate therapy are within this range of CD4 cell counts. Currently, the two combinations recommended as preferred are with two NRTIs and either Efavirenz or Lopinavir/ritonavir, while other combinations of PIs and ritonavir are considered alternative.

Comparison: The efficacy of ritonavir boosted protease inhibitor based therapy versus NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with a CD4 count ≤ 200/mm3.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected individuals
* Men or women at least 18 years old
* CD4+ T cells ≤200/ml
* Antiretroviral naive

Exclusion Criteria:

* Suspected or documented active, untreated HIV 1 related opportunistic infection (OI) or other condition requiring acute therapy (e.g., hepatitis C virus infection)
* Platelet count \< 75,000 cells/mm3.
* Hemoglobin \< 9 g/dL .
* AST and/or ALT greater than 5 times the upper limit of normal
* Documented or suspected active tuberculosis
Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension

This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with essential hypertension and a minimum age of 18 years

Exclusion Criteria: (Not applicable)
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.

Safety and efficacy data through 13 October 2021 are included in the interim analysis, which was conducted after all participants completed the post-treatment Week 65 visit or discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

* Adequate hematology, kidney and liver function as described in the protocol
* Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1
* CLL/SLL requires treatment according to the IWCLL criteria
* Medium tumor burden (any lymph node \[LN\] 5 to \< 10 cm OR absolute lymphocyte count \[ALC\] ≥ 25 × 10\^9/L) OR High tumor burden (any LN ≥ 10 cm OR ALC ≥ 25 × 10\^9/L and LN ≥ 5 cm)

Exclusion Criteria:

* Presence of 17p deletion at Screening
* Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma)
* Prolymphocytic leukemia
Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning for five days before operation can improve the outcomes of patients with coronary heart disease undergoing geriatric non-cardiac surgery.

BACKGROUND:

With the development of surgical techniques, more and more people with coronary heart disease underwent non-cardiac surgery, which include abdominal, urologic, orthopedic surgeries. Due to the vulnerable heart function, geriatric patients suffer high incidence of cardiovascular events during the peri-operative period. Some studies found that EA preconditioning have a protective effect for the patients underwent Cardiac surgery. But non one addresses the effects of EA preconditioning on the outcomes of the patients with coronary heart disease who undergo non-cardiac surgery.

DESIGNING:

The patients with coronary heart disease who will receive abdominal surgery will be randomly assigned into EA preconditioning group and control group. The patients in EA preconditioning group was treated at bilateral Neiguan (PC 6)，Lieque (LU 7) and Yunmen (LU 2) with electrical stimulation (5-30 Hz，2．34-6．24 mA，30 min) for 5 consecutive days before surgery．Before operation and before surgery, after surgery, 24h, 72h post surgery, all patients will be subjected to test the serum level of c-reactive protein and Troponin I. The EEG and heart ultrasonic exam will be used to evaluate the condition and function of heart before and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* elective abdominal surgery with coronary heart disease

Exclusion Criteria:

* serious bradycardiac arrythmia