cyrilzakka/clinical-trials huggingface dataset:
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning

To learn if using the TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.

Primary Objectives:

To determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative SPECT/CT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device.

Secondary Objectives:

To determine the correlation of T:N ratios of all tumors 3cm based on 99mTc-MAA SPECT/CT and Y90 SPECT/CT imaging.

To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECT/CT.

To assess safety of TriNav catheter in this study population

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent.
* Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women.
* At least one lesion ≥ 3.0 cm in shortest dimension
* Negative pregnancy test in premenopausal women

Exclusion Criteria:

* Contraindications to angiography and selective visceral catheterization
* Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection.
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
* Infiltrative tumors
* Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm
Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
* Have at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision)
* Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens
* Have clear intraocular media other than cataract
* Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source

Exclusion Criteria:

* Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm)
* Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye
* Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
* Have undergone previous refractive corneal surgery in the operative eye
* Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this study

Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)

The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study will also test the safety of commonly used heart medications in people with lupus.

People with SLE are at much higher risk for mortality due to atherosclerotic vascular disease (ASVD). Available data suggest that the usual mechanics of and risk factors for atherosclerosis are enhanced by factors such as corticosteroid use and SLE itself. This study will evaluate a medication and education program designed to prevent ASVD complications (primary prevention) or their recurrence (secondary prevention). The study will also measure the compliance and retention rate for the prevention program over 4 years.

Participants in this study will be randomized to receive either preventive heart disease medications or placebo. Participants in the medication arm will receive pravastatin alone or in combination with the following: aspirin, ramipril, or a combination of vitamins B6, B12, and folate. All participants in this study will receive basic education on how to optimize their heart health. Educational material will be sent to the patients as well as to support persons whom they have named. One group will receive tailored education based on a particular risk factor. Participants will have three study visits and follow-up telephone visits four times a year. Study visits will include a medical history and basic laboratory blood tests. Participants with documented high blood pressure will receive a home monitoring unit and be asked to monitor their blood pressure. Participants will be followed for 2 to 4 years.

Eligibility Criteria:
Inclusion Criteria

* SLE as defined by the 1997 American College of Rheumatology criteria
* Acceptable methods of contraception

Exclusion Criteria

* Participation in another experimental protocol for ASVD prevention
* Heavy alcohol consumption ( \>= 3 drinks/day)
* Aspirin intolerance
* Certain medications, including coumadin, ACE inhibitors, potassium supplements, potassium sparing diuretics, cyclosporine, and lithium
* Peptic ulcer disease within 6 months prior to study entry
* History of an intracranial bleed or brain tumor
* Bleeding diathesis
* History of allergy or sensitivity to ACE inhibitors
* Uncontrolled high blood pressure (180 mm Hg/110 mm Hg)
* Creatinine \> 2.0 mg/dl
* Renal artery stenosis
* Pregnant or breastfeeding
* Abnormal liver function tests (ALT \> 2 X upper limit of normal)
* History of a muscle disease, or baseline CPK \> 500U/L or 2 X upper limit of normal
A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

This study will evaluate the safety and efficacy of a new allergy medication

Study withdrawn prior to determining study details

Eligibility Criteria:
Inclusion Criteria:

* Be at least 6 years of age, of any race, or either gender.
* Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
* Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
* Positive bilateral CAC reaction at Visit 1 \& 2.

Exclusion Criteria:

* Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
* Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
* Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3

To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Asymptomatic HIV-1 infection.
* CD4 count of 400-700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Significant illness.
* Acute illness at randomization.
* Hemodialysis.

Prior Medication:

Excluded:

* Antiretroviral use within 60 days prior to study entry.
A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia

In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells.

In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat.

The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.


Eligibility Criteria:
Inclusion Criteria:

* Female or male participants with a diagnosis of renal anemia
* Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice
* Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site)
* Signed informed consent

Exclusion Criteria:

- Contra-indications according to the local marketing authorization
Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture

Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures

The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,

Eligibility Criteria:
Inclusion Criteria:

- old age, fragility fracture, tibia

Exclusion Criteria:

* active osteomyelitis
Effects of Anticipation of Pain Relief on Brain Mechanisms

This study will use brain imaging technology to examine chemical systems in the brain that suppress pain and stress when an individual has an expectation of pain relief.

Evidence suggests that the expectation of pain relief, even if a person receives only a placebo, can provide actual therapeutic benefits. The µ-opioid receptor system, located in the brain, is activated during anticipation of pain relief; this activation suppresses stress and pain responses. This study will use brain imaging technology to examine the effects of a placebo intervention on µ-opioid neurotransmitters. Examination of the factors that regulate these placebo-activated neurotransmitter responses will clarify the overall neurobiology underlying variations in the responses to placebos, as well as pain and other stressful conditions, ultimately leading to the optimization of medical and psychological interventions.

This study will last several hours during one study visit. Participants will receive both a painful and a painless injection while undergoing positron emission tomography (PET) brain imaging. The painful injection will consist of small amounts of hypertoninc saline (concentrated saline that causes cell shrinkage) in the jaw muscle over a 20-minute period. Several minutes after participants receive hypertonic saline, they will receive an injection with isotonic saline not associated with pain in the opposite jaw muscle. After participants receive the injections, they will either be told or not be told about a pain relief intervention. PET imaging will continue as participants either anticipate or do not anticipate pain relief. Participants will be asked about their pain levels repeatedly throughout the study; their responses will be entered into a computer-controlled system which will modulate rates of saline infusion.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all study requirements

Exclusion Criteria:

* Presence of pain at study entry
* Personal or first-degree (e.g., mother, father, sister, brother) family history of neurologic or psychiatric disorders
* History of substance abuse or dependence
* Left-handed or ambidextrous
* Positive urine toxicology screen
* Acute or uncorrected medical illness that may interfere with the study
* Unable to tolerate brain scanning procedures
* Current treatment with antipsychotics, mood stabilizers, isoniazid (a drug for tuberculosis \[TB\]), glucocorticoids/mineralocorticoids, psychostimulant appetite suppressants, or centrally active antihypertensive drugs
* Treatment with hormones, antidepressants, or opioids within 6 months prior to study entry
* Treatment with sedative hypnotic medications or over-the-counter sleeping aids within 1 month prior to study entry
* Diagnosis of depression
* Competitive exercise, or exercise exceeding 1 hour each day
* Regular smoking within 5 years prior to study entry
Ocular Changes After Ivermectin - (DOLF IVM/Oncho)

The DOLF Ocular Changes after Ivermectin study will investigate the kinetics of O. volvulus microfilaria (Mf) in the eye following treatment with ivermectin. The primary objective is to determine the proportion of participants with complete Mf clearance from the eye at 3 and 6 months following treatment with ivermectin (IVM).

This study will examine the kinetics of Mf clearance in the eye following ivermectin treatment. Previous studies have been unable to fully assess clearance Mf from the posterior chamber of the eye. This study will be the first to use optical coherence tomography (OCT) in patients with onchocerciasis to document parasites and pathology in the anterior and posterior chambers of the eye, and assess ocular changes following standard ivermectin treatment.

This will be a biomedical prospective cohort study.

The cohort will be stratified based on Mf levels to achieve approximately the following distribution of individuals with roughly one-third of participants in each group.

1. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg), but no observable Mf in eyes using slit lamp and indirect ophthalmoscopy
2. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and 1-10 Mf in either eye at baseline (based on the highest number counted in either eye)
3. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and \>10 Mf in either eye at baseline.

All participants recruited into the study will be treated with a single dose of ivermectin (150 ug/kg) by mouth under direct observation. This is the standard of care for treatment with onchocerciasis.

Participants will be evaluated following treatment with detailed parasitological and ocular examinations 7 days, 3 months and 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have at least 1 palpable subcutaneous nodule (onchocercoma) and ≥ 1 Mf/mg of skin (by skin snip)

Exclusion Criteria:

* Pregnancy and breastfeeding mothers within 1 month of giving birth
* Have base line eye diseases including glaucoma, uveitis, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye.
* Prior allergic / hypersensitivity reactions or intolerance to ivermectin
* Treatment with ivermectin in the past 6 (six) months
Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

To establish efficacy and safety of HDM sublingual Immunotherapy (HDM-SLIT) by comparing Odactra and placebo, when given sublingually for 3 years to high risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment.

Aim to prevent the development of asthma in children by intervening at a time when the developing system in still amenable to immune modulation, by using the only therapy that has proven ability to change the natural history of allergic diseases and induce clinical remission. We hypothesize that three years of HDM Immunotherapy in high-risk infants will prevent the development of asthma assessed over a period of 1.5 years after discontinuation of treatment and HDM immunotherapy will result in (a) a significant reduction in the number and pathogenic features of HDM-reactive TH2 cells, and (b) an increase in the numbers of HDM-reactive TH and TREG cells expressing the interferon-response signature. The study is a Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study with a 3 year treatment phase and further 1.5 year follow-up phase. The study duration for each participant is 4.5 years. Overall study duration is 84 months (7 years); which include 9 months preparation and regulatory approvals, 15 months accrual, 36 months treatment and 18 months follow-up observation period.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 6 to 12 months of age
2. history of physician diagnosed atopic dermatitis OR
3. allergen sensitization OR
4. family history of asthma or allergy

Exclusion Criteria:

1. Evidence of sensitization to house dust mite (SPT ≥3 mm OR sIgE (\> 0.35 kU/L)
2. Prematurity (\<37 weeks)
3. Failure to thrive
4. Need for oxygen for more than 5 days in the neonatal period
5. history of intubation or mechanical ventilation
Phase II Study of TKI258 in Advanced Urothelial Carcinoma

This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis
* Patients who have archival tumor tissue available for FGFR3 mutational status screening
* Patients with progressive disease
* Patients with measurable disease by RECIST
* Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting
* Age ≥ 18 years
* WHO Performance Status ≤ 2
* Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests
* Patients with signed and witnessed informed consent form
* Patients with adequate organ function

Exclusion Criteria:

* Patients with brain cancer
* Patients with other cancers except for certain skin, cervical \& prostate cancers
* Patients who have not recovered from previous cancer treatment
* Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study

Other protocol-defined inclusion/exclusion criteria may apply
Real-Time MV/kV Image Guided Radiation Therapy

In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. A tumor target may change its position during the dose delivery process. The goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.


Eligibility Criteria:
Inclusion Criteria:

* The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.

Exclusion Criteria:

* The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.
The Relationship of Multifidus and Gastrocnemius Muscle Thickness With Postural Stability in Patients With Stroke

This study aims to investigate the relationship between multifidus and gastrocnemius muscle thickness with postural stability in patients with stroke.

Multifidus and gastrocnemius muscle thickness will be measured using ultrasound imaging. Postural stability will be assessed using the Berg Balance Scale, a clinical balance test that assesses an individual's ability to maintain balance during various functional tasks. The Berg Balance Scale includes 14 items, such as standing unsupported, reaching forward, turning, and standing on one leg. The Berg Balance Scale is a widely used clinical balance test that has good reliability and validity in stroke patients. Data will be analyzed using appropriate statistical methods, including correlation and regression analysis, to investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stroke: Patients who have a confirmed diagnosis of stroke based on medical history, clinical examination, and diagnostic imaging.
* Time since stroke onset: The trial may include patients who are at least 6 months post-stroke onset.
* Ability to understand instructions: Patients who are able to understand and follow instructions provided for the study procedures.
* Ability to provide informed consent: Patients who are able to provide informed consent or have a legal representative who can provide informed consent on their behalf.

Exclusion Criteria:

* Cognitive impairment: Patients who have significant cognitive impairment that may affect their ability to follow instructions or participate in the study procedures.
* Severe motor deficits: Patients with severe motor deficits that may limit their ability to perform the study procedures.
* Other medical conditions: Patients with other medical conditions or comorbidities that may affect muscle thickness or postural stability, such as Parkinson's disease, multiple sclerosis, or severe osteoarthritis.
* Inability to tolerate testing: Patients who are unable to tolerate the testing procedures, such as the Berg Balance Scale or ultrasound imaging.
* Implanted devices: Patients with implanted devices, such as pacemakers, that may be affected by the ultrasound imaging.
* Not giving consent.
Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Diagnosed with axSpA or PsA.
* Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
* Had at least 3 months follow up from first bDMARD administration.
* Patients with EHRs.

Exclusion Criteria:

• Receiving bDMARD within a clinical trial from January 2018 to data collection.