cyrilzakka/clinical-trials huggingface dataset:
Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.

NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Age ≥18 years;
* Localized T1a renal cell carcinoma;
* Maximum tumor volume of 25.0 mL;
* Performance Status (ECOG) 0-2;
* Life expectancy of at least 6 months;
* Adequate marrow, liver, and renal function;

  * ANC ≥ 1.5 x 109/L
  * Hemoglobin ≥ 9.5 grams/dL
  * Platelets ≥ 75 x 109/L
  * Total bilirubin ≤ 1.5x institutional ULN
  * AST/ ALT ≤ 2.5x institutional ULN
  * Creatinine ≤ 1.5x institutional ULN
  * eGFR \< 60 mL/min/1.73m2
* Adequate method of birth control.

Exclusion Criteria:

* Renal cyst;
* Multifocal or bilateral renal mass;
* Known hypersensitivity to any of the study drug or reconstitution components;
* Pregnant or breastfeeding female;
* Administration of an investigational product in a clinical trial within 3 months prior to consent;
* Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
* Known drug or alcohol abuse.
App-guided Training in eFAST Ultrasound

This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound training compared to self-directed training with written handouts on subsequent performance on simulated patient cases and theoretical cases.


Eligibility Criteria:
Inclusion Criteria:

* First year medical doctor
* Provided written informed consent

Exclusion Criteria:

* Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.
Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand

Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.

Objective: To evaluate the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.

Methods: Through a randomized controlled clinical trial with blind assessment and follow-up of six months. Fifty-Two participants were randomized into two groups: group orthosis and control, and made a night orthosis II and or III fingers, thermoplastic will be used as a treatment for participants orthosis group. The participants underwent four evaluations at time 0, 45 days, 90 days and 180 days after its inclusion in the study. The variables studied were: the visual analog scale of pain, grip and pinch strength, questionnaires Cochin and Australian/Canadian Hand Osteoarthritis Index and functional Pick-up test.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 40 and 80 years.
* Patients diagnosed with osteoarthritis (OA) hand according to the American College of Rheumatology classification criteria.
* Pain symptom in proximal interphalangeal (PIP's) or distal interphalangeal (DIP's) dominant hand in II and III or fingers.
* Provide greater pain symptom of II and III or fingers between each other.
* Complains of pain symptom measured by a visual analog scale (VAS) pain between 3 to 8 cm in the II and III or fingers of the dominant hand reported to perform joint movement (activity).
* Thumb abduction with the II and III fingers without changing the pincer movement pulp-pulp.

Exclusion Criteria:

* Other rheumatic diseases, neurological and skeletal muscle that can affect the upper limb.
* Fibromyalgia uncontrolled.
* Pregnancy.
* Geographical inaccessibility and transport.
* Cognitive impairment that prevents the understanding of assessment tools.
Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

To determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous NSCLC

This two-stage phase 2 study will determine the safety, tolerability, recommended phase 2 dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers of combined EGFR inhibition (afatinib) and TNF inhibition (prednisone) in previously treated NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
* Previously treated (up to three prior lines of therapy), histologically proven advanced squamous NSCLC.
* No prior treatment with EGFR inhibitors, IMIDs (eg, thalidomide, lenalidomide), or anti-TNF antibodies.
* No treatment with systemic glucocorticoids within 3 weeks of initiation of study therapy (topical and inhaled glucocorticoids are permitted).
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ and marrow function as defined below:
* absolute neutrophil count ≥ 1,000/μL
* platelets ≥ 50,000/μl
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
* CrCl ≥ 45 ml/min
* For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
* Adequate archival tissue (5-10 slides) for correlative studies.
* Subject must have measurable disease per RECIST 1.1

Exclusion Criteria:

* Chemotherapy, radiotherapy, or other cancer therapy within two weeks prior to starting study treatment. Subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
* Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
* Symptomatic brain metastases or brain metastases requiring escalating doses of corticosteroids
* History of hypersensitivity or allergic reactions attributed to afatinib or prednisone.
* Uncontrolled intercurrent illness including but not limited to poorly controlled diabetes (which may worsen in setting of chronic prednisone therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Suiting up to Empathy

Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students

Healthcare professionals with a positive attitude and empathetic towards older adults are at a better position to deliver quality healthcare. In this study, the investigators randomized pharmacy students to either a polypharmacy workshop or an immersive aging simulation suit and polypharmacy workshop to examine if simulation will enhance empathy levels among students. This will be performed in all year 1 pharmacy students

Eligibility Criteria:
Inclusion Criteria:

* All pharmacy students enrolled in the Pharmacy program
Evaluation of mHealth for Serious Mental Illness

This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission)
* Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression
* English speaker

Exclusion Criteria:

* Does not live in the U.S.
* Has already participated in the study
* Unavailable for 60 days
* Currently incarcerated or hospitalized
Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.

A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.

The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing \[SRP\].


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes
* Patients in the age group of 25-60 years
* Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in \> 30 % of the probing sites
* The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
* Subjects in good general health

Exclusion Criteria:

* No antibiotic therapy in the past 2 months
* Medically compromised patients
* Subjects who are pregnant/ lactating
* Smokers and/or alcoholics.
* Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.
Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder

The purpose of this research study is to determine whether a new drug for schizophrenia is better for the maintenance treatment than a standard drugs currently prescribed. The new medication is called quetiapine and it will be compared with a standard medication called haloperidol decanoate. The study will determine if quetiapine causes fewer problems than haloperidol with side effects such as stiffness and restlessness and whether it costs the VA more or less to treat patients with quetiapine. In addition, blood samples will be collected every three months to determine if certain chemicals in the blood can influence the outcome of the subjects' illness.


Eligibility Criteria:
Inclusion Criteria

1. Schizophrenia or Schizoaffective Disorder diagnosed by DSM-IV
2. Between the ages 18-60.
3. A candidate for maintenance antipsychotic therapy. This means that patients will have had at least two documented episodes of acute schizophrenic illness or at least two years of continuing psychotic symptoms.

Exclusion Criteria

1. Organic brain disease.
2. Mental Retardation
3. Chronic medical illness which would make antipsychotic medication inappropriate.
Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in NSCLC

Inhibitors of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) are effective therapies for metastatic NSCLC lacking sensitizing EGFR or ALK mutations. First-line combination regimens that include a PD-1 or PD-L1 inhibitor may maximize the chance of response and lead to prolonged survival. PD-L1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment. However, it is far from being the ideal biomarker and its role in predicting efficacy from ICPIs remains undefined due to conflicting results from randomized clinical trials. The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources. Further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers. Therefore, our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors, by combining the evaluation criteria of solid tumor efficacy evaluation criteria (RECIST1.1), clinical pathological characteristics of patients, and dynamic monitoring of peripheral blood molecular biological markers, finding the correlation with the efficacy of immunotherapy, establish a detection mode for selecting patients with clinical benefits.


Eligibility Criteria:
Inclusion Criteria:

Ages ≥18 years of age. Histologically confirmed stage IIIB-IV non-squamous non-small cell lung cancer. Life expectancy of at least 3 months.

Exclusion Criteria:

* Previous treatment . Untreated CNS metastases. Active autoimmune disease. Surgery or significant traumatic injury. Active infection. History of allergy or hypersensitivity to immunotherapy components. Women are breastfeeding or pregnant. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration

A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME) or neovascular Age-Related Macular Degeneration.

This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort in order to address the primary objective. Up to an additional 6 nAMD patients will be enrolled in the highest dose cohort. A single dose of UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:

* nAMD patients who, in the opinion of the Investigator, are inadequately responding to or failed current treatment options.
* Active choroidal neovascularization (CNV) associated with age-related macular degeneration as evidenced on FA and SD-OCT at Day 1, including presence of intraretinal or subretinal fluid.
* BCVA in the study eye (most affected) of 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse at screening and on Day 1.
* Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria:

* Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening.
* Subretinal hemorrhage with bleeding area ≥4 disc area in the study eye
* Concomitant therapy with anti-VEGF therapies (e.g., Avastin®, Lucentis®, or Eylea®) or previous use of these agents in the study eye within approximately 28 days of study enrollment
* Any retinovascular disease or retinal degeneration other than nAMD in the study eye.
* History of systemic and intraocular steroid use for 6 months prior to Day 1. The use of intravitreal nonbiodegradable steroid implants (ex. Iluvien®, Yutiq®, Retisert®) is prohibited.
* Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging.
* Any uncontrolled medical condition that, in the opinion of the investigator, would preclude participation in this study.
Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance

Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and insulin responses and hence promote well-being. It has previously been observed that consumption of a bilberry drink decreases the postprandial insulin demand. In the present study, the impact of probiotic fruit beverages with different polyphenol profiles on the postprandial levels of glucose and insulin, were investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, not on medication, non-allergic, individuals aged 18-65 years old, having a BMI between 20-30 kg/m2 and also maintaining stable body weight, i.e. less than 5% weight change in the last three months before the study.

Exclusion Criteria:

-
AR Training Platform at Home

Video Communications, like ZOOM, have been widely used in the time of this epidemic. But how about to design an AR / VR communication system with coaching from clinician to facilitate training at home in this time of epidemic. Vulnerable individuals at home can interact with the training platform and his/her clinician can provide online training progamme with guidance.


Eligibility Criteria:
Inclusion Criteria:

1. age \>=65 years old or suffering from chronic disease;
2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study MoCA\> 21); and
3. Home setting: TV with HDMI input, internet access, and a distance of 1.5m away from TV.

Exclusion Criteria:

1. Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
2. Severe shoulder or arm contracture/pain;
3. Severe knee or hip contracture/pain;
4. Pregnant women
Single Arm Clinical Trial (Gut Microbiota and HCC)

To evaluate the efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination with anti-angiogenesis targeted agents.

This is a prospective, single-center, single-arm clinical study. For those who meet the enrollment conditions, the original regimen of immune checkpoint inhibitors combined with anti-angiogenic targeted drugs will remain unchanged after enrollment.On this basis, the study subjects started oral enterobacterial capsules to see whther enterobacterial capsules could improve the efficacy of patients receiving the above treatment regimens.

Oral administration of intestinal bacteria capsules 6 capsules/day, after observing no adverse reactions, oral administration for 10 consecutive days, 6 capsules/day from the second day to the tenth day, and then discontinued to the next course of treatment.

Total course of treatment: a total of 4 courses of oral intestinal bacteria capsules, each course of oral administration for 10 days, and a course of 21 days; A course of TKI combined with immune checkpoint inhibitors treatment is 21 days until the disease progresses or intolerable toxicity and side effects appear.

Observe the metrics: Primary Clinical Endpoint - Progression-Free Survival (PFS); Secondary Clinical Endpoints - Overall Growth Phase (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR). The new RECIST1.1 criteria were used for the efficacy evaluation system, the CTCAE5.0 grading system was used for the evaluation of common adverse reactions during treatment, and other indicators included imaging including conventional biochemical indexes such as CT and ultrasound, as well as quality of life scores.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old, gender is not limited;
2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
3. Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;
4. Not suitable for local ablation or chemoembolization;
5. Child-Pugh Grade A;
6. ≥ 1 measurable lesion (RECIST v1.1)
7. ECOG PS 0-1

Exclusion Criteria:

1. Usage of antibiotics within 2 weeks prior enrollment;
2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
3. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
4. Female patients who are pregnant or breastfeeding;
5. Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
6. Patients are currently undergoing clinical trials of other drugs;
7. Patients are considered by the investigator to be unsuitable for inclusion.
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.


Eligibility Criteria:
Inclusion Criteria:

* Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
* The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
* A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
* A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
* A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Exclusion Criteria:

* Has prematurely discontinued study intervention in their parent study
* Has received any protocol-specified prohibited medications during their parent study
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients