cyrilzakka/clinical-trials huggingface dataset:
Study EvAluating Genotypes While Using Lucentis 2

The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Age-related macular degeneration (AMD) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. Although geographic atrophy and neovascularization represent the advanced forms of AMD, neovascular AMD is the more aggressive form and accounts for almost 90% of blindness from this disease. It is characterized by choroidal neovascularization (CNV) which is the development of abnormal blood vessels underneath the retina. Randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with Lucentis (ranibizumab) in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of Lucentis for the treatment of neovascular AMD (see investigator brochure). This study could provide insight as to the reasons that some patients do not experience vision stabilization with Lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving Lucentis.

This is an open-label study of 100 treatment-naïve (study eye only) AMD patients treated on-label with intravitreally administered Lucentis. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Their blood will be genotyped and sequenced for various SNPs on VEGF and HTRA1.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with the study assessments for the full duration of the study.
* Age \> 50 years.
* Treatment naïve (study eye only) AMD patients that are determined to be candidates for ranbizumab.
* Visual acuity 20/32 to 20/230.

Exclusion Criteria:

* Pregnancy
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD.
* Any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed
* Any participation in another simultaneous medical investigation or trial for AMD \*Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus

The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:

• To evaluate the safety and tolerability of ATHENA CAR-T.

After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.

This study is a single center, one-arm, open label, phase I study aimed at evaluate the safety and effectiveness of ATHENA CAR-T treating moderate to severe SLE patients.

A traditional "3+3" design is used with two doses. DLT is monitored. Safety and effectiveness are followed up until 24 months post infusion of ATHENA CAR-T. Besides safety monitoring, efficacy is evaluated via SLEDAI-2000, BILAG-2004, PGA.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, between 18 and 56 years old;
* diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
* anti-Nuclear Antigen Ab positive (titer NLT 1:80) and/or dsDNA ab positive and/or Anti-Sm ab positive at screening;
* at screening, SLEDAI-2000 scoring NLT 8 points, if low complement scoring and/or anti-dsDNA ab scoring is available, the SLEDAI-2000 scoring except low complement and anti-dsDNA ab should be NLT 6 points;
* should be subjected to at least 6 months of standard treatment for SLE, and disease active at least two months before screening;
* good organ functions;
* trial participants whose partner is fertile agree to use effective contraceptives til 24 months post transfusion, fertile female participants should have negative urine/blood pregnancy test results (participants who were sterilized or menopause for MT 12 months is not considered fertile);
* voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria:

* Had or has active malignancy;
* had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
* within 8 weeks before screening, had CNS disease caused by SLE or non-SLE diseases;
* within 8 weeks before screening, had lupus crisis;
* has following kidney diseases: within 8 weeks before randomization, had SLE with serious kidney involvement or need treatment using medications prohibited by protocol to treat active nephritis, or need hemodialysis or need treatment by prednisone MT 100mg/d for longer than 14d or equivalent therapy;
* had serious allergy to any lymphodepletion medication or ingredients of ATHENA CAR-T;
* has uncontrolled fungi, bacterial or viral infection or other infections investigator deemed not suitable to participate in the study;
* combined with other autoimmune disease that needs treatment;
* pregnant or lactating women;
* has other factors that deemed not suitable by investigator.
Predictive Model for Mortality in Older People With Critical Illness

The present study aims to develop a predictive model to identify elderly patients with the highest likelihood of mortality upon admission to an intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 75 or older.
* Admission to an ICU from the Emergency Department.
* Availability of or possibility to contact a participant's informant.
* Informed consent for participation in the study, either by the participant or a valid legal representative.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be included in the study:

* Patients transferred to the Emergency Department from a hospital ward.
* Patients who die within the first 24 hours of ICU admission.
* Patients admitted to Step-Down Units.
* Patients requiring ICU admission for any of the following reasons:

Orotracheal intubation or advanced cardiopulmonary resuscitation performed prior to arrival at the Emergency Department.

AV block awaiting pacemaker implantation. Activation of the STEMI or Stroke care pathway. Post-cardiac catheterization for acute coronary syndrome.

* Participation in another clinical study involving an intervention, procedure, or visit schedule that is incompatible with the present study.
Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer

MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.

The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:

1. To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
2. To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
3. To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
4. To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.

Secondary Objectives:

1. To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
2. To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
3. To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer

Inclusion criteria for sub-group follow-up scans:

1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)

Exclusion Criteria:

* Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
* The presence of an implanted pacemaker or implanted defibrillator device.
* Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
* Implanted medical device not described above that is not MRI-compatible;
* Known history of severe claustrophobia;
* For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) \< 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed;
* Minors will be excluded.
* Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.
3. Eastern Cooperative Oncology Group performance status grade of 0 or 1.
4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.

Exclusion Criteria:

1. Prior treatment with CAR-T cell therapy directed at any target.
2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
3. Allogeneic stem cell transplant within 6 months before lymphodepletion.
4. Known active or prior history of CNS involvement.
5. Stroke or seizure within 6 months of signing ICF.
6. Seropositive for or history of human immunodeficiency virus.
7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
8. Hepatitis B infection.
9. Hepatitis C infection.
10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Discovering Factors in Cervical Cancer Patients' Clinical Trial Experiences

The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for cervical cancer.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future cervical cancer studies.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration

The purpose of the Phase 1 study is comprised of single ascending-dose component (Part 1) and multiple ascending-dose component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in patients with neovascular age-related macular degeneration (nAMD).

The Part 1 of study is a multicenter, open-label, sequentially, single ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.

The Part 2 of study is a multicenter, open-label, sequentially, multiple ascending-dose (3 doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.

Subjects will be sequentially enrolled into different dose-level cohorts following the "3+3" design to determine the maximum tolerated dose (MTD) or the maximum administered dose has been reached.

Eligibility Criteria:
Inclusion Criteria:

* 1. Signed the informed consent form;
* 2. Male or female subjects with 50\~80 years of age;
* 3. Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesions secondary to neovascular age-related macular degeneration(nAMD);
* 4. Total lesion area ≤ 12 disc area(DA);
* 5. BCVA letter score measured at screening of 19\~78 letters.

Exclusion Criteria:

* 1. History of uveitis in either eye；
* 2. Current active inflammation or infection in the study eye;
* 3. Central foveal scar, fibrosis or atrophy of macular in the study eye;
* 4. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
* 5. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
* 6. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of ASKG712 or require medical or surgical intervention.
* 7. Presence of retinal pigment epithelial tear;
* 8. Previous intraocular operations in the study eye;
* 9. Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
* 10. Previous anti-VEGF drug treatment within 30 days prior to screening；
* 11. Diseases that affect intravenous injection and venous blood sampling;
* 12. Systemic autoimmune diseases;
* 13. Any uncontrolled clinical disorders;
* 14. History of allergy or current allergic response to ASKG712 or fluorescein;
* 15. Pregnant or nursing women;
* 16. Subjects should be excluded in the opinion of investigators.
Effects of Combinations of Performance-enhancing Supplements on Exercise Performance

The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* VO2max of \>50 ml/min/kg for men and \>45 ml/min/kg for women
* Performs endurance training \>3 times per week

Exclusion Criteria:

* Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
* Smoking
* Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
Caffeine Mouth Rinse on Salivary Immunoglobulin A, Lactoferrin and A-Amylase Levels

The goal of this clinical trial is to investigate the effects of the mouth rinse form of caffeine (400 mg) on salivary lactoferrin, α-amylase and secretory immunoglobulin-a levels after incremental exercise in young amateur football players. The main questions it aims to answer are:

* Caffeine in mouth rinse form increases salivary immunoglobulin a after incremental exercise
* Caffeine in mouth rinse form increases salivary lactoferrin after incremental exercise
* Caffeine in mouth rinse form increases salivary a-amylase after incremental exercise.

This 3-session study will use a double-blind, randomized, placebo-controlled crossover experimental design. participants will complete three different treatments \[caffeine (CAF), control (C) and placebo (PLA)\] separated by at least 1 week. Baseline saliva samples will be collected while sitting in a chair and then:

* CAF Group: They will rinse a solution containing a total of 400 mg caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and try to continue the exercise against increasing resistance until exhaustion.
* Control Group: Only rinse a solution containing a total of 400 caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and receive no exercise treatment.
* Placebo Group: They will rinse 20 mL of distilled water in the mouth for 20 s and try to continue the exercise against increasing resistance until exhaustion.

Saliva samples will be collected at 6 different time points: 5 minutes before exercise (or caffeine mouth rinse) (T0-reference), immediately after caffeine mouth rinse (or immediately before exercise) (T1), 5 minutes/midway through exercise (T2), and immediately after exercise (T3), 60 minutes after the end of exercise (T4) and 120 minutes after the end of exercise (T5).All data will be statistically analyzed using SPSS 25.0 software (Chicago, IL, USA) and expressed as mean ± standard deviation. Shapiro-Wilk and Levene tests will be used to determine whether the data are normally distributed and whether the variance is homogeneous. Repeated measures ANOVA test will be used to compare group means. If there is a difference between the groups as a result of the analysis, post-hoc tests will be used to find out from which group this difference originates. In cases where the data are not normally distributed, nonparametric test methods will be used. The significance level of the tests will be accepted as p\<0.05


Eligibility Criteria:
Inclusion Criteria:

* Healthy men who have not had any previous injuries, do not have a chronic disease, do not use medication, do not smoke, and have played or are playing football as an amateur.

Exclusion Criteria:

Those who have had any previous injury, have a chronic disease, use medication, or smoke.

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Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program

This study will test the weight loss efficacy of a mobile diabetes prevention program intervention. Half of the sample of prediabetic adults will receive the virtual DPP and half will receive usual medical care.

There were 84.1 million people with pre-diabetes, 30.3 million people with diagnosed and 7.2 million with undiagnosed diabetes in the United States in 2015, and nearly 2 million are diagnosed with it every year. By 2050, the CDC estimates that 1 in every 3 people globally will have diabetes, a leading cause of death and disability.

The primary goal of this study is to evaluate the efficacy of the Noom Coach Diabetes Prevention Program mobile platform versus usual medical care. The best intervention to date for prediabetes is the Centers for Disease Control and Prevention's Diabetes Prevention Program, yet there is limited research investigating a mobile-based delivery of the DPP. Pre-diabetes is often discovered during routine medical visitation/annual screening (usual care), but face-to-face time with clinicians is often limited. Exploring novel ways, such as mHealth interventions to empower patients to pursue lifestyle change and prevent or delay diabetes onset is critical to addressing the growing diabetes epidemic.

Eligibility Criteria:
Inclusion criteria:

* English-speaking
* 18 years of age and older
* Referral from the patient's physician
* Hemoglobin A1C: 5.7 - 6.4 within the 3 months prior to enrollment
* Own a smartphone (Apple or Android)

Exclusion criteria:

* Recent weight loss (by patient report, \>5 lbs in the 6 months preceding enrollment visit)
* previous diagnosis of type 1 or type 2 diabetes
* serious or persistent mental illnesses
* more than 72 hours of hospitalization in the last 30 days
* Enrollment in a structured weight-loss program currently or within the 1 month preceding study enrollment
* Pregnant
* Currently nursing
* Have given birth within the past 3 months
* Has been discouraged by a physician to enroll in a DPP program
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24.

The secondary objectives are:

* To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC
* To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients
* To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE)
* To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations
* To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time


Eligibility Criteria:
Key Inclusion Criteria:

* Patient has a clinical history of allergy to peanuts or peanut-containing foods (symptom\[s\] of reaction due to exposure).
* Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening DBPCFC conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines. And not experiencing dose limiting symptoms to placebo
* Serum IgE to peanut of ≥10 kilo units (kUA)/L and/or a SPT to peanut ≥8 mm compared to a negative control
* Patients/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
* Patients with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study

Key Exclusion Criteria:

* Any previous exposure to marketed dupilumab or dupilumab in a clinical trial
* Member of the clinical site study team or his/her immediate family
* History of other chronic disease (other than asthma, AD, or allergic rhinitis) requiring therapy
* History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock as defined by more than 3 episodes of anaphylaxis within the past year and/or an episode of anaphylaxis within 60 days of screening DBPCFC
* History of eosinophilic gastrointestinal disease
* History of eosinophilic granulomatosis with polyangiitis
* Severe, unstable asthma at time of enrollment or any patient with Forced Expiratory Volume in 1 Second (FEV1) \<80% of predicted or asthma control questionnaire (ACQ)\>1.5
* Use of systemic corticosteroids within 2 months prior to screening

Note: Other protocol Inclusion/Exclusion Criteria apply