cyrilzakka/clinical-trials huggingface dataset:
A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers

This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind, escalating single- and multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD Phase will be conducted first followed by the MAD phase of the study.

SAD Phase:

A total of 8 subjects will be randomly assigned in a 3:1 ratio to receive a single dose of either CNM-Au8 (n=6) or placebo (n=2) at an initial dose level of 15 mg CNM-Au8. Additional cohorts of 8 subjects will be enrolled to investigate escalating single doses of CNM-Au8 at 30, 60, and 90 mg. Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.

MAD Phase:

A total of 12 subjects will be randomly assigned in a 3:1 ratio to receive a multiple dose of either CNM-Au8 (n=9) or placebo (n=3) once daily for 21 days at an initial dose level of 15 mg CNM-Au8. Additional cohorts of 12 subjects will be enrolled to investigate escalating multiple doses of CNM-Au8 at 30, 60, and 90 mg CNM Au8 administered once daily for 21 days. Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.

Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
* Females will be non-pregnant, non-lactating, or post-menopausal
* All laboratory values at screening fall within normal range or are evaluated as not clinically significant
* Has not consumed and agrees to abstain from taking any dietary supplements or non-prescription drugs
* Has not consumed and agrees to abstain from taking any prescription drugs
* Has not consumed alcohol-containing beverages
* Has not consumed grapefruit or grapefruit juice
* Has not used tobacco- and nicotine-containing products
* Has the ability to understand the requirements of the study and is willing to comply with all study procedures.

Exclusion Criteria:

* Has a history of illicit drug abuse
* Has clinically significant medical or psychiatric history
* Has donated plasma or excessive blood loss
* Prior participation in another clinical trial
Hyperbaric Oxygen Therapy Combined with Polarized Light Therapy Effect on Neuropathic Foot Ulcer

Neuropathic ulcers develop due to nerve damage (neuropathy), commonly seen in conditions like diabetes, leading to loss of sensation, repetitive trauma, and poor wound healing. These ulcers typically occur on weight-bearing areas, hyperbaric oxygen and polarized light therapies may have a synergistic effect, improving oxygenation, cellular activity, and overall healing outcomes in neuropathic ulcers, particularly in diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* All patients had cardiac ejection fraction (CEF) 50%
* blood pressure (BP) 150/90mmHg.
* Chest X-ray was reported normal
* all patients were clinically evaluated by a specialized ear, nose, and throat (ENT) physician to ensure suitability for the hyperbaric chamber.

Exclusion Criteria:

* chronic obstructive pulmonary disease, malignancy
* cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
* chronic peripheral arterial disease.
Clinical Investigation of Omega Refractive Capsule, Model VI

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)

This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design.

Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older at the time of surgery diagnosed with bilateral cataracts
* Able to understand and sign an informed consent
* Willing and able to complete all study visits and assessments required for the study
* Calculated lens power within the available range
* Corrected distance visual acuity is equal to or worse than 20/40 in each eye with or without a glare source present
* Bilateral cataracts eligible for extraction by phacoemulsification and capsular bag fixated IOL implantation
* Potential postop visual acuity of 20/25 or better in the judgment of the surgeon
* Preoperative corneal astigmatism of 4.0 D or less with normal corneal topography
* Clear intraocular media other than cataract
* Preop endothelial cell density of 2000 cells/mm2 or more

Exclusion Criteria:

* Subject's best corrected vision is light perception or no light perception in either eye
* Cataract opacification preventing adequate Binocular Indirect Ophthalmoscopic retinal and macular examination.
* Orbital abnormalities, such as thyroid related orbitopathy, causing significant exophthalmos.
* Eyelid abnormalities causing lagophthalmos.
* Significant anterior blepharitis or meibomian gland dysfunction
* Corneal abnormalities or conditions, other than regular topographic corneal astigmatism
* Krukenburg's spindle (linear pigmentary deposits on the corneal endothelium)
* Abnormalities of the iris including trans-illumination defects
* Pupil abnormalities (abnormally shaped, fixed or non-reactive)
* Pharmacologic dilation less than 7 mm
* Axial length \<22.5mm
* Lens thickness \<4.1 mm
* Anterior chamber depth \<2.5mm
* Prior ocular surgery
* Epiretinal membrane
* Macular edema
* Retinal tears including operculated holes
* Amblyopia
* Glaucoma of any kind
* Pseudoexfoliation syndrome
* History of uveitis/iritis
* Diabetic retinopathy
* Acute, chronic or uncontrolled systemic or ocular disease that may confound the results of the study (including rheumatologic conditions such as Rheumatoid arthritis, ankylosing spondyliltis, Sjögren's syndrome, and neurologic conditions such as optic neuritis or multiple sclerosis).
* Prior or anticipated use of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) or similar medications
* Average Keratometry \<38D or \> 48D by topography
* Any pathology of the zonules including evidence of zonular weakness, zonular instability, zonular damage, or coloboma effecting zonules.
* History of ocular trauma
* Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes
Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society \[IHS\] Grade 1) of MM compared with patients' current treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Had MM headaches occurring between Day -2 and Day +3 of menses
2. Had at least one year history of MM headaches
3. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
4. Had regular predictable menstrual periods (28 ± 4 days)

Exclusion Criteria:

1. Had a history of more than 15 headache days per month
2. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
3. Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease
4. Had significant cerebrovascular disease, including basilar or hemiplegic migraine
5. Had uncontrolled hypertension: systolic blood pressure \>180mmHg and diastolic blood pressure \>95mmHg
6. Had severe hepatic or renal insufficiency
7. Used an analgesic medication (including both prescription and over-the-counter) for any reason \>50% of days per month
Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes

The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.

Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic epiretinal membranes symptomatic

Exclusion Criteria:

* Absence of ocular symptoms, previous retinal interventions
Lung Dose in Patients Treated With Yttrium-90 for Hepatocellular Carcinoma

To Calculate the amount radiation the lung receives in patients receiving Yttrium-90 for Liver Cancer.

To calculate the delivered lung dose using quantitative volumetric analysis in a cohort of patients with unresectable hepatocellular carcinoma who undergo selective internal radiation therapy (SIRT) with Yttrium-90 glass microspheres (TheraSphere®)-and compare this analysis to the lung dose estimated by established criteria. In addition, this study, will summarize the pre and post-treatment clinical data to describe the URMC Y-90 experience.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years with no upper limit.-Receiving Y-90 Therasphere liver directed therapy
* Pathology proven diagnosis of hepatocellular carcinoma, metastatic colon cancer or other metastatic diseases to be treated with SIRT (Y-90)
* surgical resection not feasible at time of initiation of pre-treatment workup

  -\> 6 months projected life span
* ECOG 0-2

Exclusion Criteria:

* previous radioembolization of one or more liver lobes or segments without available treatment planning and procedural documentation ie. at another facility prior to URMC Y-90 radioembolization.
Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI

The purpose of this study is to test the efficacy of mild breathing bouts of low oxygen (intermittent hypoxia) combined with transcutaneous electrical spinal cord stimulation on restoring hand function in persons with chronic incomplete spinal cord injury.

The goal of this study is to determine the effectiveness of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with non-invasive transcutaneous electrical spinal cord stimulation (TESS) on restoring hand function in persons with chronic incomplete SCI.

The fundamental hypothesis guiding this proposal is that daily AIH+TESS engage excitatory and inhibitory pathways, which converge on a common plasticity-promoting cascade that induces greater recovery of hand function than either one alone.

Both treatments appear to enhance motor function in persons with cervical SCI. Despite their independent effects on promoting functional benefits, it is not yet know if they may promote greater functional benefits when combined. To be effective as a long-term rehabilitation strategy, it is essential to determine the efficacy of combined protocols of recurring AIH+TESS.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* medically stable with medical clearance from physician to participate
* SCI at or below C3 and at or above C7
* non-progressive etiology of spinal injury
* American Spinal Injury Association Impairment Scale (AIS) C-D at initial screen
* at least 1 year post-injury (chronic)
* difficulty independently performing hand functions in activities of daily living

Exclusion Criteria:

* dependence on ventilation support
* implanted stimulator (e.g. diaphragm pacing by phrenic nerve stimulation, vagus nerve stimulator, pacemaker, cochlear implant, epidural stimulator, baclofen pump, etc.)
* spinal cord injury related complications including unhealed pressure sore, severe neuropathic or chronic pain syndrome, history of frequent autonomic dysreflexia, infection (e.g. urinary tract), cardiovascular disease (e.g. deep vein thrombosis), pulmonary disease, heterotopic ossification in the upper extremities, severe osteoporosis, unhealed fracture, contracture of the upper extremity joints
* received botulinum toxin injections in upper extremity muscles in the prior 6 months
* history of tendon or nerve transfer surgery in the upper extremity
* history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) or peripheral nerve injury in the upper extremity
* history of concomitant diseases that would prevent full participation in intensive exercise therapy, such as uncontrolled hypertension, rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), pulmonary disease, active cancer, chronic contagious disease, etc.
* anticoagulation medication
* pregnancy
* history of allergic reaction or any skin reaction to use of adhesive electrodes
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)

The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.

The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder\* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline.

\*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Patient that will be implanted with a Cardiac Resynchronization Therapy (CRT-D) with the MultiPoint Pacing (MPP) feature under the current Guidelines indications for CRT-D implant (including upgrades from single or dual chamber Defibrillator or Pacemaker).
* Patient that will be implanted with a Quartet Left Ventricular (LV) quadripolar lead.
* In sinus rhythm at baseline visit.
* Patients with Left Bundle Branch Block (LBBB)
* Must be willing and able to comply with study requirements.
* Older than 18 years
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form.

Exclusion Criteria:

* Already has a CRT device implanted.
* Myocardial Infarction or unstable angina within 40 days prior the enrollment.
* New York Heart Association (NYHA) Class IV
* Recent cardiac revascularization in the 4 weeks prior to enrollment.
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months.
* Primary valvular disease requiring surgical intervention.
* Atrial Fibrillation (AF):

  * Persistent AF at the time of enrollment or 30 days prior the enrollment
  * Permanent AF not treated with Atrio-Ventricular node ablation within 2 weeks after the CRT-D implant
  * History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
* Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained.
* Undergone a cardiac transplantation or being waiting for it
* Life expectancy \< 6 months
* Pregnancy or planning to become pregnant
* Unable to comply with the follow up schedule
* Currently participating in any other clinical investigation.-
Influence of n-Acetylcysteine Maintenance on Alcohol Effects

This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.


Eligibility Criteria:
Inclusion Criteria:

* able to speak/read English
* not seeking treatment at the time of the study
* one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
* recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
* ECG within normal limits
* otherwise healthy
* body mass index of 19-35
* females using an effective form of birth control and not pregnant or breast feeding
* judged by the medical staff to be psychiatrically and physically healthy
* able to abstain from alcohol for 12 hours prior to session
* no contraindications/allergies to n-acetylcysteine
Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers


Eligibility Criteria:
Inclusion Criteria:

* who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent;
* who have received complete primary vaccination with recommended licensed vaccines;
* who are available for all visits and telephone calls scheduled for the study;

Exclusion Criteria:

* whose parent or legal guardian is unwilling or unable to give written informed assent consent
* who had a previous or suspected disease caused by N. meningitidis;
* who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster;
* who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
* who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment;
* who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* who have previously received any measles, mumps, rubella or varicella vaccine either alone or in any combination;
* who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
* who have any serious acute, chronic or progressive disease such as, cancer, diabetes, heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome
* who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of the vaccine,
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired
* who have Down's syndrome or other known cytogenic disorders; bleeding diathesis
Cerebrolysin and Neurodevelopment in Preterm Infants

The overall aim of the study is to assess the effect of Cerebrolysin on physical and mental development of preterm infants by Denver Scale II at different ages of 5, 7 and 12 months

There is an inverse relationship between birth weight or gestational age and risk for developmental impairment, with increasing incidence as birth weight or gestational age decreases.

Serious impairment, defined as problems in body function or structure which may be temporary or permanent, is generally a more stable condition and typically leads to a disability requiring rehabilitation. Mild impairment is a more reversible condition amenable to early intervention. Studies that have followed extremely preterm and extremely low birth weight infants into school age and early adulthood have shown higher rates of motor, cognitive or behavioral impairments as compared with infants born at term. The neurologic consequences of extreme prematurity range from mild behavioral and cognitive defects to severe disability. Perinatal neuroprotection aims to reduce these outcomes.

Cerebrolysin is a porcine brain-derived peptide preparation that acts like endogenous neurotrophic factors. It is produced by a standardized enzymatic breakdown of lipid-free brain protein powder and consists of low molecular weight peptides and free amino acids.

The pharmacodynamic effects of Cerebrolysin can be categorized in terms of neuronal survival (e.g. trophic and survival promoting actions), neuroprotection (e.g. limiting neuronal dysfunction, especially in adverse conditions), neuroplasticity (e.g. adaptive responses to changing conditions) and neurogenesis (e.g. promoting differentiation of progenitor cells). We aim to assess the effect of Cerebrolysin on physical and mental development of preterm infants at different ages of life at 5, 7 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* High risk preterm infants born with gestational age less than 32 weeks and have a corrected postnatal age of 5 months at time of enrollment. Included preterm infants should have one or more of the following risk factors which may affect their neurodevelopmental outcome.

  1. Infants diagnosed with bronchopulmonary dysplasia requiring oxygen therapy more than 30% FIO2 at 36 weeks corrected gestational age.
  2. Infants with culture proven early or late onset neonatal sepsis with or without neonatal meningitis.
  3. Infants diagnosed to have peri- ventricular leukomalacia diagnosed by brain imaging.

Exclusion Criteria:

1. Patient with persistent uncontrolled fits (all possible reasons for these uncontrolled seizures, including non-epileptic seizures, pseudo intractability, and medically refractory epilepsy.
2. Patient with brain malformation.
Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas

Tamoxifen for Solid Pseudopapillary Tumor of the Pancreas

Solid pseudopapillary tumor of the pancreas (SPTP) is a rare neoplasm, predominantly affecting young females, with unclear pathogenesis and hormonal receptor (estrogen/progesterone receptor) expression potentially influencing tumor behavior. While surgical resection is the standard treatment, patients with advanced, metastatic, or recurrent disease lack effective therapies. Case reports suggest tamoxifen, a selective estrogen receptor modulator, may improve outcomes in hormone receptor-positive SPTP. This trial aims to evaluate tamoxifen's efficacy and safety in advanced SPTP.

Eligibility Criteria:
Inclusion Criteria:

1. Age 14-80 years.
2. Histologically confirmed advanced SPTP with ER/PR+.
3. Advanced disease:

   * Unresectable primary tumor or distant metastasis (liver, lung, peritoneum, etc.).
   * Recurrent or refractory after prior surgery/systemic therapy.
4. ≥1 measurable lesion.
5. ECOG performance status 0-2.
6. Life expectancy ≥1 month.
7. Able to comply with study visits and oral medication.

Exclusion Criteria:

1. Non-SPTP pathology.
2. Active gastrointestinal inflammation/infection (e.g., pancreatitis).
3. Pregnancy/lactation.
4. Severe organ dysfunction (renal, cardiac, hepatic, or pulmonary).
5. Uncontrolled comorbidities (e.g., CNS disorders, unstable angina).
6. Conditions compromising patient safety or data integrity.