cyrilzakka/clinical-trials huggingface dataset:
A Multiple-Dose Study of LY3502970 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation.
* Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Exclusion Criteria:

* Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
* Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
* Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
* Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.
* Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.
Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty

The total knee arthroplasty (TKA) is a well established option for the treatment of osteoarthritis in this joint. Nevertheless, there are still some concerns related to the peri-operative management of elderly patients, highlighting the complications related to medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease postoperative bleeding, which has been accumulating favorable evidence, is the use of tranexamic acid (TA). Several studies (including prospective randomized trials with placebo group) showed excellent results with TA intravenous administration during TKA, reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of thrombin and bovine gelatin. This substance has presented significant benefits on bleeding control in several areas of medicine, including orthopedic surgery, but no action has yet been established in TKA. The main objective is to evaluate the amount of bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal® and a control group. The secondary objective is to evaluate the rate of adverse events in the studied groups.


Eligibility Criteria:
Inclusion Criteria:

* Indication for total knee arthroplasty
* No previous knee surgery
* Absence of inflammatory arthritis
* Absence of stiff knee
* Absence of the following factors: renal failure, liver failure, severe heart failure, respiratory failure, history of thromboembolic events, bleeding disorders, previous strokes

Exclusion Criteria:

* None
Effectiveness of Strengthened Anticipatory Guidance Used in the MOH Malaysia Infant Oral Health Care Programme

This study aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC) lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's knowledge and practice on infant oral healthcare

This randomised control trial study will be conducted at six government Maternal and Child Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220 primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the control group). A strengthened infant oral health module named the Oral Health Infant Module Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the intervention group at three-month intervals over 6 months. The control group will receive the conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG on early signs of childhood caries lesions development, caries risk of infants, and primary caregivers's knowledge and practice on infant oral healthcare will be assessed after six months of intervention.

Eligibility Criteria:
Inclusion Criteria:

* The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen
* Primary caregivers can read and understand Bahasa Malaysia. This is because the AG will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa Malaysia.

Exclusion Criteria:

* Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of caries due to presence of hypomineralisation and hyperplasia) and require special oral health care.
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.


Eligibility Criteria:
Inclusion Criteria:

* Participant with moderate to severe HS for at least 1 year prior to baseline visit.
* HS lesions present in at least two distinct anatomical areas.
* Draining fistula count of ≤ 20 at Baseline visit.
* Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
* Participants are required to use a daily antiseptic wash on their HS lesions.
* Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.

Exclusion Criteria:

* Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
* Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
* Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
* Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
* Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
* Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.
Customizing Myopia Control With Multifocal Toric Contact Lens

This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.

The purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. Multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. This outcome is yet to be evaluated in children with myopia plus astigmatism.The secondary outcome is to measure the change in peripheral optics caused by the contact lens. This information is key to understanding the mechanism of multifocal contact lens optics on the eye. Ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. This software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.

Eligibility Criteria:
Inclusion Criteria:

* 8 to 12 years, inclusive, at baseline examination
* -0.50 to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
* ≥0.75 DC, cycloplegic autorefraction
* 0.1 logMAR or better best-corrected visual acuity in each eye

Exclusion Criteria:

* Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
* Ocular surgery, severe ocular trauma, active ocular infection or inflammation
* Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
Zevalin-beam for Aggressive Lymphoma

The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
2. Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
3. Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
4. Age ≥ 18 years and age ≤ 70
5. Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
6. Patients must sign written informed consent.
7. Adequate birth control in fertile patients.
8. All prior chemotherapy completed at least three weeks before study treatment.
9. Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
10. Negative HIV antibody.

Exclusion Criteria:

1. 1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
2. Two or more relapses after initial response to induction chemotherapy.
3. High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent all other selection criteria.
4. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit.
5. Creatinine \> 2.0 mg/dl.
6. ECOG Performance status \> 2.
7. Uncontrolled infection.
8. Pregnancy or lactation.
9. Abnormal lung diffusion capacity (DLCO \< 40% predicted).
10. Severe cardiovascular disease; New York Heart Association (NYHA) Functional Classification ≥2.
11. Active CNS disease involvement.
12. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy \> 5 years in relation to this prior malignance. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
13. Pleural effusion or ascites \> 1 liter.
14. Known hypersensitivity to rituximab.
15. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
16. Prior radioimmunotherapy.
17. Prior autologous or allogeneic HSCT.
18. Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
19. Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume.
20. Patients who have received \>500cGy radiation to the kidneys will be excluded from the study.
Scleral Contact Lens Insertion Solution Study

The purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (US Patent 2,259,437, Stone) which contains multiple essential ions and has a pH and tonicity which more closely mimics human tears as compared to the subjects' current habitual scleral lens insertion solution.

The sterile solution is provided by prescription for each patient by a local compounding pharmacy in unit dose containers. The initial exposure - filling the posterior bowl of the scleral contact lens by the Investigator and applying the lens to the eye - will be monitored in the office for one hour, prior to any dispensing of the solution to the patient for their use at home or work.

This is a one week, unmasked comparison of the new solution to the subject's habitual solution used for scleral lens insertion. The (historical) control is the saline habitually used by the subjects.

The sample size is determined to be manageable to insure close supervision of the subjects in these initial trials and to inform us for future safety and efficacy trials.

The primary safety outcome measure will be slit lamp examination of the ocular anterior segment and the secondary outcome measure will be photo-documentation by ocular coherence tomography of the clouding of the tears between the cornea and scleral contact lens. The primary efficacy outcome will be ocular comfort as assessed by questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older.
* Wear a scleral contact lens habitually 6 or more hours a day.
* Needs to remove scleral lens due to fogging and refill or definitely reports fogging.
* Must have worn habitual scleral lens for at least 3 months
* Willing and able to attend study visits.

Exclusion Criteria:

* Currently under treatment for an eye infection or inflammation such as adapted keratoconus or healed post penetrating keratoplasty. Stable keratoconus is acceptable.
* Currently taking topical ophthalmic prescription medications.
* Current medical eye complications such as glaucoma or uveitis.
* Recent corneal surgery
* Sjogrens or other clinically significant active ocular surface disease.
Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.

The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.

Eligibility Criteria:
Inclusion Criteria:

* Non-Ischemic Cardiomyopathy
* Ejection Fraction \</= 35% despite at least 3 months stable standard medical management
* New York Heart Association Class II-III symptoms
* Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
* Normal Atrioventricular conduction or Biventricular ICD
* QRS \< 120 msec (inherent conduction or paced with BiV ICD)

Exclusion criteria:

* Age \< 18 years
* Inability to ambulate safely
* Congenital or primary valve disease
* Left Ventricular thrombus
* Severe peripheral arterial disease
* Admission for life-threatening condition (eg heart failure, stroke) in the past 3 months
* Major surgery in the past 3 months or anticipated during the period of the trial
* Paced or intrinsic QRS \>120 msec
* Life expectancy \< 1 year
* Hemodialysis
* Hematocrit \< 30%
* Severe Chronic lung disease
* Pregnancy
* ICD battery longevity \< 1 year
* Unsuppressed atrial arrhythmias
* Already participating in an exercise programusion Criteria
New Vectorcardiogram Analysis a Good Predictor of Coronary Disease in Patients With Normal Rest 12-leads ECG

The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will facilitate the detection of significant coronary disease (CAD) in patients with normal rest 12-leads ECG (NE).

Patients with NE will undergo coronary angiography for routine indications. Prior to the angiography a computerized simultaneous multi-leads ECG will be recorded and, using a new dedicated algorithm for 3D electrical activity reconstruction, the investigators will plot the horizontal VCG of the whole ECG cycle. Using this new VCG analysis we will determine whether the patients have normal coronary arteries or coronary disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with normal rest 12-leads ECG

Exclusion Criteria:

* Patients with significant irregular heart beat
* Patients with heart failure
Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography

The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and study its reliability and ability to differentiate ALS patients from healthy controls.

Investigators will study 10 ALS patients and at least 10 age-matched healthy controls between the ages of 21 and 85 years old. For all subjects, EIM measurements will be performed on four muscles: two in the upper and two in the lower extremities, using 8 different EIM sensors. Measurements will be repeated one time.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable or definite ALS by the El Escorial Criteria

Exclusion Criteria:

* History of superimposed generalized neuromuscular disease
* Primary lateral sclerosis or other atypical motor neuron disorders
* Forced vital capacity of less than 50%
* Presence of disease for greater than 5 years since symptom onset
Resistance Exercise Volume and Hypertrophic Response Variability in Elderly

The study aimed to investigate the effects of resistance training volume manipulation on whole muscle hypertrophy among non-responders and responders to a low resistance training dose (single-set).

The magnitude of muscle hypertrophy in response to resistance training (RT) is highly variable between individuals (response heterogeneity). Manipulations in RT variables may modulate RT-related response heterogeneity; yet, this remains to be determined.

Eligibility Criteria:
Inclusion Criteria:

* 60 years and older
* not engaged in regular resistance and/or aerobic training for at least six months before the intervention

Exclusion Criteria:

* diagnosed type I diabetes mellitus
* arrhythmia
* noncontrolled hypertension
* any major orthopedic musculoskeletal condition
* use of any dietary supplement or drug with potential anabolic effects
Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma

Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. Adverse events and intraocular pressure will be assessed.

XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States.

All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months.

Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma in the study eye.

  1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
  2. Study eye that meet at least one of the following criteria:

     * Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
     * Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
     * Have neovascular glaucoma
     * Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG).

     Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.

     Exclusion Criteria:
* A lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area.
* Excessive intraoperative bleeding, such that visualization in the study eye is impaired.
* Any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva.
* Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.
Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans

The purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. In addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in Community Living Centers of the VA Maryland Health Care System.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 years or older.
* Living in a participating nursing home for at least 80% of the past 3 months-
* Willing to provide anterior nares, posterior pharynx, skin and throat specimens over the study period.
* Willing to use intranasal mupirocin and topical chlorhexidine over a five day period.
* Provide signed and dated informed consent from subject or LAR.

Exclusion Criteria:

* Recent history of MRSA colonization
* Use of mupirocin nasal ointment in past 3 months
* Use of topical chlorhexidine in past 3 months
* History of an allergic reaction to chlorhexidine or mupirocin