cyrilzakka/clinical-trials huggingface dataset:
Stanford Kids CAMP Study

The Stanford Kids CAMP study aims to evaluate the feasibility of enrolling minority participants in school age children (5-13 years old) in a community summer camp setting along with the efficiency by which each participant's biologic specimens are collected. Using remote monitoring technologies and through partnering with community-based organizations, the investigators hypothesize that an increase in underrepresented minority participation in a clinical trial that is greater than the national average is possible.

The proposed study is an outpatient prospective, open-label clinical trial comparing 2 groups: Group 1 (aka BAWSI Camp): the Dexcom G6 Pro Continuous Glucose Monitor and the accelerometer and mobile connected device, Group 2 (aka YMCA of Silicon Valley Camp): the Abbott FreeStyle Libre 2 Continuous Glucose Monitor and the accelerometer and mobile connected device. Eligible subjects will be enrolled to each cohort based on their participation in the specific YMCA camp site.

The investigators will study up to 100 minority school-age children (5 - 13 years old) in the San Francisco Bay Area a 5-day summer camp. The study will be split in 2 sequential phases: (A) the BAWSI camp, (B) the YMCA of Silicon Valley camp, following a repeated measures design with the 5-day camp being followed by 5 - 9 days at home, under parental supervision. Study participants will be divided in two equal groups at each site with each wearing the specific manufacturers continuous glucose monitoring device.

Eligibility Criteria:
Inclusion Criteria:

* 5-13 years of age.
* Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
* Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
* A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the monitoring system at home.

Exclusion Criteria:

* Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason).
* Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in her native language).
* Are unable to read, understand or complete informed consent in English or Spanish.
* Are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the Principal Investigators.
A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections

The investigators propose to conduct both a randomized trial of HIV testing in community corrections, and a randomized trial of linkage to HIV care for people with HIV recruited through community corrections (probation and parole).

The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. Inclusion criteria will be: 1) Adult probationer/parolee; 2) not known to be HIV positive, and 3) resident of greater Baltimore or Providence throughout the study period. Exclusion criteria will be: 1) unable to give informed consent. The second study is a randomized trial, whereby all individuals identified at community corrections with HIV will be offered enrollment in a one-year intervention study to examine the ability to improve linkage into HIV care. Participants will be randomized to receive one of two conditions: 1) Project Bridge for one year, or 2) Treatment as Usual-referral to standard level of care. Moreover, those randomized to TAU will be given an opportunity to "crossover" to PB if they have failed to engage in treatment during the first three months. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction that is associated with multiple HIV-related risk behaviors in these two cities and a high likelihood of being on probation and/or parole. Furthermore, Maryland ranks 10th and Rhode Island ranks 4th in the nation in the number of probationers per 100,000 adult residents.

Eligibility Criteria:
Inclusion Criteria:

1. Probation or Parole;
2. Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV
The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity

This is a cross-sectional research. The Protection Motivation Theory (PMT) was applied as theoretical framework to analyze correlation of prevention knowledge, prevention intentions and anxiety, and prevention behavior of COVID-19 and HIV risk feature and behavior and stigma of people living with HIV/AIDS (PLWHA), and HIV high-risk groups. Purposive and snowball sampling will be applied to recruit participant who visit hospital, HIV/AIDS related institutions, and social media platforms. The investigators expect that the outcome could reveal the relationship of cognition and attitude of COVID-19 to HIV prevention and treatment.

The prevention strategies can effectively block the spread of Coronavirus disease (Coronavirus disease 19; COVID-19), and at the same time may indirectly reduce or increase the risk behaviors and factors of Human Immunodeficiency Virus (HIV) and sexually transmitted comorbidities. The main purpose of this research is to apply the Protection Motivation Theory (PMT) as the framework to analyze COVID-19 prevention knowledge, COVID-19 prevention intentions and anxiety level, and COVID-19 prevention behavior and HIV risk behavior and risk factors of people living with HIV/AIDS (PLWHA) and HIV high-risk groups. The cross-sectional research method was adopted, and the subjects included the northern, central, southern, and eastern regions of Taiwan.About 1100 PLWHA and 1100 high-risk groups will be recruited. The information of recruitment will be disseminated through the AIDS designated medical institutions and related institutions, and social media, Snowball recruitment of interviewees will also be used. After completing the online questionnaire, the structural equation modeling (SEM) will be applied to test the good of fit of the theory model and to explain the structural relationship between COVID-19 prevention knowledge, attitudes, behaviors and HIV risk factors. The relationship with the above variables and stigma also been discussed. In addition to verifying the theories proposition of PMT, the research results also contribute to the prevention and treatment of HIV high-risk groups, and provide important references for prevention strategies for susceptible groups during the epidemic of emerging infectious diseases in the future.

Eligibility Criteria:
Inclusion Criteria for HIV/AIDS participants:

1. Participants who diagnosed with HIV/AIDS.
2. Age over 18 years old.
3. Participants who can read and communicate.

Exclusion Criteria for HIV/AIDS participants:

1. Participants who can't read and communicate.

Inclusion Criteria for HIV high risk group:

1. Participants who have experienced unsafe sex, regardless of their gender orientation, such as those who describe themselves as men who have sex with men (MSM), heterosexuals, transgender, sex workers, etc.
2. Injecting Drug User(IDU)
3. Age over 18 years old.
4. Participants who can read and communicate.

Exclusion Criteria for HIV high risk group:

1. Participants who can't read and communicate.
Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* Adult over 19years
* Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL
* Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004)
* Those who voluntarily written consent to participate in this clinical trial

Exclusion Criteria:

* Uncontrolled hypertension
* Severe renal impairment(CrCl\<30mL/min)
* Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal
* Serum creatinine \> 2.0mg/dL
* Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe
* Combined cyclosporine -treated patients
* HbA1c ≥ 9%
* TSH ≥ 1.5 X ULN
* HIV-positive person
* Congestive heart failure patients classified as NYHA Class III or IV
* Patients with uncontrolled arrhythmias
* Patients who have malignant tumors needed chemotherapy, radiation therapy, etc.
* Blood clotting disorders
* Patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty
* Patients who had a history of anxiety or severe typical peripheral arterial disease within three months
* Women of childbearing age who don't agree with contraception during this clinical trials
* Pregnant women or nursing mothers
* Those who take the drug in combination taboo
* Who have been treated for another investigational drug within 30 days
* Unsuitable characters in a clinical trial to test self- determination
Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

1. Age less than 18 years
2. Confirmed pregnancy
3. HCV-HIV Co infection
4. HBV-HCV co infection
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves

The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.

To determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radiofrequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radiofrequency ablation.

This will be accomplished by comparing the results between the newly proposed parasagittal approach and the traditional approach of medial branch RFA done on the same patient (different sites) with bilateral low back pain (LBP).

Traditional approach:

The electrode is introduced at a 15-20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process (SAP) and transverse process (TP) of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament (MAL) that may be ossified in up to 10% of the normal spine and, in such cases, potentially prevent proper coagulation of the medial branch nerve during the RFA procedure.

Parasagittal (new) approach:

Recently, Tran et al. showed that MAL is located more dorsally than it was thought earlier and, therefore, can't interfere with nerve coagulation during the RFA. Consequently, they proposed abandoning the 20-degree angle used for the traditional approach and placing the radiofrequency cannula parasagittally and more dorsally. It is proposed that, in order to achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral equally intense axial low back pain
2. Pain duration of ≥ 6 months
3. Three-day average NRS scores of ≥ 3/10
4. Age greater than 18 years
5. Failure of conservative treatment, including nonsteroidal anti-inflammatory medications and physical therapy
6. Positive response to a series of two bilateral diagnostic lumbar medial branch nerve blocks (≥ 80% pain relief). This is the current standard of care.

Exclusion Criteria:

1. Radicular pain below the knee
2. Systemic infection or localized infection at the anticipated introducer entry site
3. Pregnancy
4. Allergy to Lidocaine
5. Bleeding dyscrasias
6. Patients unable to give informed consent
7. History of lumbar spine surgery at the affected levels
8. History of previous bilateral lumbar RFA of medial branches within the past six months.
9. Significant comorbid somatization or widespread pain with central sensitization
10. Secondary gain identified due to ongoing legal proceedings or worker's compensation
11. Cognitive impairment
12. Any pre-existing condition at the discretion of the provider that may confound interpretation of results -
Biodesign® Otologic Repair Graft

The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.


Eligibility Criteria:
Inclusion Criteria:

* Patient requires tympanic membrane closure.

Exclusion Criteria:

* Life expectancy \< 12 months
* Known sensitivity to porcine material
Pilot Study of a New Nicotine Replacement Therapy

Pilot study of a new nicotine replacement therapy for smoking cessation.

This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older male and female cigarette smokers motivated and willing to stop smoking
* female participants of child-bearing potential should use a medically acceptable means of birth control
* evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate

Exclusion Criteria:

* unstable angina pectoris or myocardial infarction during the previous 3 months
* pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential)
* participation in other clinical trials within the previous three months and during study participation
MuSK Myasthenia 1000 Study

The MuSK myasthenia gravis 1000 study seeks to collect saliva samples from 1000 subjects with laboratory confirmed diagnosis of MuSK myasthenia to identify genetic variations associated with MuSK MG. The data collected may be used by researchers to gain a better understanding of the cause of MuSK MG and to identify biomarkers and targeted therapy for MuSK MG.

Myasthenia gravis is a rare, neuromuscular (disease of the muscle and nerves) autoimmune disease characterized by weakness of the muscles. MG has a prevalence of approximately 14-40 per 100,000 people in the United States. There is no cure for MG, however understanding the disease is crucial to pave the way for development of new therapies. Important to note, the most common subtype of MG associated with Acetylcholine receptor antibodies (AChR) are found in more than 80% of patients with generalized myasthenia gravis, whereas muscle-specific kinase (MuSK) antibodies are found in only 8% of MG patients. These are found in patients with the AChR antibodies. Since the discovery of MuSK antibodies in patients, much has been learned. It has become clear that MuSK antibody MG differs in many ways from AChR antibody MG. There is some information that specific genetic factors play a role in development of MuSK MG.

Our objective is to collect saliva samples from 1000 subjects with laboratory confirmed diagnosis of MuSK myasthenia. These saliva samples will be then sent to the laboratory of Bryan Traynor who directs the Neurogenetics Laboratory at NIH. Dr. Traynor will conduct a genome-wide association study (GWAS). This study will provide important information of genetic factors leading to MuSK MG.

GWAS, also known as genome-wide association study, is a study performed to identify genetic characteristics associated with a particular disease. GWAS is currently used across various disciplines in medicine to better understand complex conditions where genetic risk factors contribute to the development of diseases.

Presently, this study has not been done in patients with MuSK MG. Researchers can use information from this study to develop quality treatment and ultimately, move toward targeted therapy approach for patients. We hope to find unique results and further enhance myasthenia research.

Eligibility Criteria:
Inclusion Criteria:

* Lab test confirming diagnosis of MuSK myasthenia gravis
* Willingness to provide saliva sample via mail or in person

Exclusion Criteria:

* Inability to provide informed consent
* Unwillingness to provide lab results of elevated muscle specific kinase antibody
* Unwillingness to provide saliva sample
A Group-Based Walking Study Using WeChat to Enhance Physical Activity Among Older Adults

The aim for the study is to use the function WeRun in the application WeChat to encourage physical activity and social engagement among community dwelling older adults and their family members and friends. The specific aims are to test the effectiveness of a social contact and comparison intervention for increasing regular daily physical activity among community dwelling older adults, and to examine the potential effectiveness of WeChat in cultivating social engagement and well-being among community dwelling older adults.

The aim for the study is to use the function WeRun in the application WeChat to encourage physical activity and social engagement among community dwelling older adults. The investigators asked participants in the social engagement group to use the WeRun function in WeChat to track their daily walking steps and to compare their performance with their group members for 4 weeks. To encourage social engagement among their group members, the daily walking steps were calculated and the participant who has the highest step count in the group will be indicated each day.Those in the control group will only use the WeRun function in WeChat to track their own walking steps.

The investigators expected that the participants in the social contact group will walk more often and report more social activities than those in the control group, who will not compete with their peers in daily walking. To test these predictions, daily walking steps and the total walking steps per week were obtained and compared across groups. The nature and the extent of change was analyzed over the four weeks. Exercise self-efficacy was measured using a measure based on Bandura's model. Social engagement was measured using the short Lubben Social Network Scale, a self report measure of social engagement on a 12-item scale, and physical activity was measured using International Physical Activity Questionnaire (IPAQ), a self-report measure of physical activity on a 12-item scale.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are 60 or older who have a cellphone, with either android or iPhone system with data plan.
* They must be fit enough to walk for at least 20 minutes at a time.
* English speaking

Exclusion Criteria:

* Unable to walk more than 20 minutes;
* do not have smart phone with data plan.
* younger than 60
Suicide Intervention for Alaska Native Youth

Two interventions will be delivered virtually to American Indian/Alaska Native youth who have been hospitalized with suicidal attempt, suicidal ideation, or associated risk behaviors, including alcohol-related injury.

The investigators will conduct a randomized controlled trial whereby Alaska Native (AN) youth who are hospitalized for suicide risk will be randomly assigned to either Qungasvik/Tools for Life or Tools for Life + Motivational Interviewing Social Network (MISN) intervention after their baseline survey, and followed up at 3-, 6-, and 12 months. All youth will receive Tools for Life and two 30-minute virtual follow-up visits (at 2- and 6-weeks post intervention) focused on connectivity to culture and obtaining support from intergenerational social networks in their home communities. Half of the youth will also receive MISN in addition to Tools for Life. Both interventions will be delivered virtually by a wellness team comprised of Alaska Native community behavioral health aides, prevention specialists and/or Elders who function in their communities as natural healers.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Alaska Native youth
* Between the ages of 14 and 24
* Admitted to the hospital for suicide attempt, ideation, or associated risk behaviors including alcohol-related injury or acute intoxication

Exclusion Criteria:

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