cyrilzakka/clinical-trials huggingface dataset:
Prognosis of Patients With Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy

Upper tract urothelial carcinoma (UTUC) is a rare malignant disease which accounts for 5-10% of urothelial carcinoma in the western world and 9%-30% in China. About two thirds of patients have muscle invasive disease at diagnosis. Those patients usually have poor prognosis. The 5 year cancer specific survival is \<50% for pT2/T3 and \<10% for pT4. Radical nephroureterectomy is the standardized treatment for non-metastatic high risk UTUC. However, about half patients may suffer from impaired renal function after nephroureterectomy. On the other hand, kidney sparing surgery can avoid renal function impairment, but the therapy is only recommended for few patients with low-risk disease. The treatment for urothelial carcinoma has changed rapidly in the past few years. Immune checkpoint inhibitors and novel agents such as ADCs have shown promising therapeutic effect and were approved for patients with metastatic UTUC. Meanwhile, a recent study shows that patients with high-risk disease can also receive kidney sparing surgery without compromising cancer specific survival and overall survival. This prospective, observational study aims to evaluate the prognosis of contemporary kidney sparing surgery in patients with UTUC with or without perioperative therapy in the real world.

The patients that meet the Inclusion and Exclusion Criteria will enroll into this observational trial. The therapeutic schedule is purposed to spare the kidney of non-metastatic primary UTUC patients.

Eligibility Criteria:
Minimum Age: 18 Years Maximum Age: 90 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

1. Histopathological confirmed upper tract urothelial carcinoma;
2. Refused radical nephroureterectomy, or eligible for the indications of kidney-sparing surgery;
3. Participants must be willing to attend the follow-up visits;
4. Sign informed consent.

Exclusion Criteria:

1. Unable to undergo kidney-sparing surgery;
2. Life expectancy \< 6 months;
3. Previous anti-tumor therapy against UTUC, including systemic chemotherapy, surgery, radiotherapy, or immunotherapy identifying by investigators.
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake

This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants will eat to their satisfaction.

The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older will be enrolled to investigate the satiety and food intake at lunch after a breakfast consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120, 180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until satisfied. The subjects will have the two breakfasts in a balanced and random order and the two meal tests will be separated by at least a week.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and are healthy.
* Taking no regular medications other than birth control or hormone replacement therapy.
* Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.

Exclusion Criteria:

* Are a woman who is pregnant or nursing a baby.
* Have gained or lost 8.8 pounds or more in the last 3 months.
* Have diabetes or a fasting blood sugar over 126 mg/dL.
* Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
* Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.
A Commitment Device for Medication Adherence Among HIV Patients

We used a randomized trial design combined with a comparison to a non-randomized control group to study patients on appropriate antiretroviral therapy (ART) having virologic failure within a publicly-funded HIV clinic serving Atlanta, GA.

This study demonstrated the feasibility of using commitment contracts in HIV care. Many previous interventions have produced statistically significant effects on ART adherence that do not persist after the intervention ends. A notable feature of our study is that after the incentives for ART adherence and provider visits were removed, participants who had been offered a commitment contract for ART adherence were more likely to achieve virologic suppression relative to individuals who had been assigned a conditional cash transfer for provider visits and relative to individuals who had been assigned the standard of care, although the difference was only statistically significant in the latter comparison. There were differences in the prevalence of missing outcomes across groups, but these differences were not statistically significant for the unanticipated post-incentive visit and therefore were unlikely to be the explanation for the results. Thus, financial rewards coupled with individual choice can increase engagement in healthy behaviors after incentives are removed.

Eligibility Criteria:
Inclusion Criteria:

* Attended the Grady Health System Infectious Disease Program (IDP)
* Most recent HIV-1 plasma RNA viral load (pVL) \> 200 copies/mL; this value must have been measured within the prior 18 months and at least 6 months after starting the current ART regimen
* English-speaking

Exclusion Criteria:

* Using pillboxes
* Were planning to relocate
* Were enrolled in another trial
Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)

The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Greater than and equal to (\>=) 18 years of age at the time of Informed Consent
* Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 12 months
* Subjects must have active disease defined by DAS28 \>3.2
* Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab
* Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (SD1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Current neurological disease excluding migraine
* Inflammatory joint disease other than rheumatoid arthritis
* Any contraindication to rituximab as per national label
* Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen \>25 mg/week
* Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
* Prednisone dose regimen \>10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
* Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
* Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)
* Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
* Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
* Breastfeeding or pregnancy
* Other protocol defined exclusion criteria could apply
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP

This study will include a screening period, a 6-month treatment period, followed by long-term extension period expected to last approximately 72 months.

Patients will receive daily IV infusions of ORGN001 (formerly ALXN1101) starting on Day 1. After a prescribed period, dosing will increase monthly based on defined patient safety measures. After Month 6, patients will continue daily dosing at their last tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a genetically confirmed diagnosis of MoCD Type A (MOCS1 mutation)
* Currently treated with rcPMP infusions

Exclusion Criteria:

- Current or planned treatment with another investigational drug or device, with the exception rcPMP treatment through Day -1.
Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction

The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.

Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).

There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.

Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* The isolated ACL lesion
* The absence of the previous surgery on the knee joint
* The body mass index (BMI) less than 30.

Exclusion Criteria:

* Associated injuries of the tissue around the knee joint
Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein.

Coaches of teams at the 12U and 13U levels within the six youth football organizations will be invited to pilot test the intervention program. Intervention outcomes will be compared to historic controls (K25HD101686 - NCT04908930). Video taken at all practices will be used to monitor team activities of 12U and 13U teams across all organizations participating in the intervention; incidence of injuries will be monitored across all teams. Athletes (n=30) enrolled across two of six participating teams will be recruited to participate in parallel biomechanical and video data collection to evaluate the frequency and severity of head impacts experienced throughout the season. Biomechanical data will be collected using instrumented mouth guards and verified with video. Preliminary effectiveness will be measured by the percentage of coaches who choose to adopt and maintain the intervention program. Head impact exposure and injury rates will be compared across the intervention and control teams.

Eligibility Criteria:
Inclusion Criteria:

* All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months

Exclusion Criteria:

* Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging

This study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.

The study involves a within-subjects, pre/post design to assess the effects of a moderate dose of alcohol on immune biomarkers, neurobiological measures, and cognitive functioning. The study recruits healthy adults (ages 21-45) from the community to complete the experimental protocol. Participants complete magnetic resonance imaging scans, blood sample collection, and cognitive testing in the context of alcohol consumption.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-45 years
* Able to speak and read English at least at 8th grade level
* Moderate self-reported alcohol use in the past year
* Body mass index in normal to overweight range
* Right-handed

Exclusion Criteria:

* History of heavy drinking
* Currently seeking alcohol or drug treatment
* Chronic disease requiring use of medication
* Recent antibiotic or probiotic use
* Chronic daily use of NSAIDs
* Chronic GI disorder
* Use of illicit drugs
* Major psychiatric disorder or suicidality
* Fainting, weakness, infection, excessive bruising, or distress resulting from standard blood draw
* Safety contraindication for MRI scan
* Inability to abstain from use of tobacco products prior to or during study
* Inability to abstain from use of cannabis prior to or during study
* Pregnant, nursing, or may become pregnant
Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms

The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials.

In this investigation, 4 Polyurethane (PU) condom variants and 4 Natural Rubber Latex (NRL) condom variants will be tested by participants to explore condom experience.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent before participation in the clinical investigation.
2. Cisgender male, aged 18 - 55 years.
3. In the opinion of Investigator, experienced user of condoms who use condoms to prevent pregnancies and / or contracting STIs.
4. Able and willing to achieve a penile erection following self-stimulation.
5. Able and willing to masturbate with a PU or NRL condom on.
6. Agree to use only lubricant provided by the study for use with IMDs, if required.
7. Agree not to wear any genital piercing jewelry while using the study condoms.
8. Agree not to use sex toys, consume alcohol or use drugs intended to enhance or diminish sexual response when using study condoms.
9. Agree to perform erected penis size measurement at site and at home.

Key Exclusion Criteria:

1. Participants with known trouble attaining or maintaining an erection.
2. Participants presenting clinically abnormal findings on the penis that in the opinion of the investigator can affect the study outcome.
3. Participants with an allergy or sensitivity to the ingredients of the test products, including the test condoms or any lubrication products provided.
4. Use of any topical medications applied to the penis between screening and visit 3.
5. Participants with diagnosed or suspected erectile dysfunction.
6. Participants with a history of prostatectomy.
7. Participants with a history of urethral surgery.
8. Participants with any other congenital or acquired genital abnormalities (e.g. peyronies disease, hypospadias, intersex, phimosis, penile cancer).
9. Psychiatric conditions that might limit the participation in the clinical investigation and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
10. Participants with any medical condition in the opinion of the investigator which poses a risk to the participant or is detrimental to the objectives of the clinical investigation.
11. Participants who should not participate in the clinical investigation for any other reason as judged by the investigator.
12. Participation in a pharmaceutical trial with investigational products or in a clinical investigation with another medical device within the last 30 days prior to the visit 2 (day 1) and / or during this clinical investigation.
13. Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company.
Improving Diabetes Efforts Across Language and Literacy (IDEALL)

The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.

See above

Eligibility Criteria:
Inclusion Criteria:

* have type 2 diabetes
* have a HbA1c equal to or \> 8.0%
* must speak English, Spanish, or Cantonese.

Exclusion Criteria:

* Dementia
* Psychosis/Schizophrenia
* End Stage Renal Disease
Pilot Study of Autologous Chimeric Switch Receptor Modified T Cells in Recurrent Glioblastoma Multiforme

CAR T cell immunotherapy has achieved great success in CD19+ B-cell malignancies. Whether this new generation of cell-based immunotherapy can be applied to solid tumors remain to be investigated, partly due to hostile immune-suppressive tumor microenvironment which favors tumor growth but not immune system. Signaling pathway of programmed death 1 (PD-1) and its ligand PD-L1 plays an important role in suppressing immune response against tumors. PD-L1 is over-expressed in 88% of glioblastoma.

We constructed a chimeric switch receptor (CSR) containing the extracellular domain of PD1 fused to the transmembrane and cytoplasmic domain of the costimulatory molecule CD28. CSR modified T cells are able to recognize PD-L1-expressing tumor cells and transduce signals to activate T cells, which results in tumor killing. A truncated EGFR (tEGFR) which lacks of the ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CSR vector and is used for in vivo tracking and ablation of CSR T cells when necessary. This pilot study is to determine the safety and efficacy of autologous CSR T cells in patients with recurrent glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. abilities to understand and the willingness to provide written informed consent;
2. patients are ≥ 18 and ≤ 70 years old;
3. recurrent glioblastoma patients with measurable tumors. Patients have received standard care of medication, such as Gross Total Resection with concurrent Radio-chemotherapy (\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
4. Malignant cells are PD-L1 positive confirmed by IHC;
5. karnofsky performance score (KPS) ≥ 60;
6. life expectancy \>3 months;
7. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin \> 10 g/dL; platelets \> 100000 /mm\^3; Bilirubin \< 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5×ULN; creatinine \< 1.5×ULN;
8. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
9. satisfactory heart functions;
10. patients must be willing to follow the orders of doctors;
11. women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.

Exclusion Criteria:

1. a prior history of gliadel implantation 4 weeks before this study start or antibody based therapies;
2. HIV positive;
3. hepatitis B infection or hepatitis C infection;
4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
5. history of allergic disease, or allergy to CAR T cells or study product excipients;
6. patients already enrolled in other clinical study;
7. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

A 4-week treatment of essential amino acids or placebo to participants with: 1) negative COVID-19 test with exposure, or 2) positive COVID-19 test and no or mild symptoms. The study team will measure change in symptoms. Participants will complete symptom surveys for 4 weeks and once at 8 and 12 weeks as well as pre- and post-assessments.

In people who have been exposed to COVID-19 and have been tested (positive or negative) with no to mild symptoms, the study team will administer a treatment of essential amino acids (EAA). The study team will examine if this treatment compared to placebo will reduce the development, length and the severity of symptoms. Participants will consume the treatment or placebo for 4 weeks, and will complete symptom surveys, as well as pre- and post-assessments. Individuals who receive a COVID vaccination will continue to complete symptom surveys for 1 week and take the essential amino acid supplementation for 2 weeks following a vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Exposure to COVID-19 in the last 60 days with no symptoms, with a COVID negative test Close contact: within 6 feet of a COVID-19 positive person for more than a few minutes without wearing PPE, or having direct contact with infectious secretions without PPE
* Positive COVID-19 test with or without symptoms

Exclusion Criteria:

* COVID-19 positive hospitalized patient
* Patients who have symptoms of COVID but have not been tested.
* Unable to tolerate oral intake
* In hospice or palliative care
* Unstable medical or psychiatric condition
* Other criteria deemed acceptable by principle investigator
Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?

Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar.

CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar.

Two CBCT scans were acquired of each examination site: one scan using the standard clinical protocol (90kV, 5mA, 9.4s) and one, the low-dose protocol (90kV, 2mA, 9.4s). All exposures were made with a Veraviewepocs 3D F40 (J Morita Corp.; Kyoto, Japan) using a field of view (FOV) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.

Eligibility Criteria:
Inclusion Criteria:

* a need for a CBCT investigation of the mandibula third molar

Exclusion Criteria:

* been involved in radiographic examinations for science beforer.