cyrilzakka/clinical-trials huggingface dataset:
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.

Detailed information is provided elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years and able to give consent
* Persistent angina despite medical therapy and/or evidence of inducible ischemia
* De-novo lesion in a native coronary artery
* Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation
* Severe calcification of the target lesion as determined by visual estimation at coronary angiography
* Unsuccessful lesion preparation with standard non-compliant balloon (\< 30% reduction of baseline diameter stenosis at maximal pressure)
* Written informed consent.

Exclusion Criteria:

* Target lesion is located in a coronary artery bypass graft
* Target lesion is an in-stent restenosis
* Target lesion is a chronic total occlusion
* Target vessel thrombus
* Limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months
Recollection Training in Healthy Older Adults and Older Adults With Amnestic Mild Cognitive Impairment

We have developed a training intervention that successfully improves older adults' memory. We have also shown that older adults whose memory is as good as younger adults' memory (Hi-Old) use an altered pattern of memory-related brain activity compared to younger adults, whereas healthy older adults with poorer memory (Lo-Old) do not. We have also shown that individuals with amnestic Mild Cognitive Impairment (aMCI) have impairments of conscious, effortful, Recollection-based memory processes, whereas their automatic, Familiarity-based memory processes are intact. Our primary current goal is to investigate whether our successful memory intervention will improve Recollection and produce induce altered patterns of brain activity in the Lo-Old and aMCI.

Young, Lo-Old, Hi-Old, and aMCI will be scanned using functional magnetic resonance imaging while performing two memory tasks. Half of the Lo-Old and half of the aMCI will then receive the memory intervention, while the other half in each group will receive a control program consisting of information and games about aging. The Lo-Old and aMCI will then be rescanned while performing the two memory tasks. We predict that the memory intervention will improve performance on a number of memory tasks, and will induce altered patterns of brain activity. In the Lo-Old, their brain activity after the memory intervention will look more like the Hi-Old, while brain activity will become more focal in the aMCI.


Eligibility Criteria:
Inclusion Criteria:

* 65-90 years old
* English as a first language or learned before kindergarten
* Right handed

Exclusion Criteria:

* Neurologic disorder
* Major medical disorder affecting cognition
* Psychiatric disorder
* Metal in the body that poses a hazard in the MRI scanner
High-Intensity Laser Therapy in Patients With Sacroiliitis

To investigate the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain and improving function in patients with sacroiliitis, aged 40-60 years.


Eligibility Criteria:
Inclusion Criteria:

* Age: Adults aged 40-60 years old
* Diagnosis: Confirmed diagnosis of sacroiliitis by a specialist (e.g., rheumatologist, orthopedic surgeon, or radiologist) based on a combination of clinical findings, laboratory tests, and imaging studies
* Clinical findings: Presence of at least one or more of the following clinical signs and symptoms suggestive of sacroiliitis:

  1. Low back pain, buttock pain, or hip pain, worsened by prolonged sitting, standing, or walking
  2. Stiffness in the lower back, buttock, or hip region, particularly in the morning or following prolonged inactivity
  3. Pain improvement with physical activity or exercise
* Duration of symptoms: Experiencing symptoms for at least 3 months

Exclusion Criteria:

* Previous surgery or invasive procedures targeting the sacroiliac joints
* Contraindications to physical interventions (e.g., spinal instability, fractures, or severe neurological deficits)
* Presence of other spinal pathologies or systemic inflammatory conditions that could confound the assessment of sacroiliitis (e.g., lumbar disc herniation, ankylosing spondylitis, or rheumatoid arthritis)
* Pregnant or breastfeeding women
Poke and a Placebo

To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.

The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. One script will contain the wording "Poke and a burn" prior to subcutaneous local anesthetic administration for the epidural placement and one will contain "this is numbing medication, which will make the rest of the procedure go easier". There will be no difference in the epidural placement, medications, or the rest of the script.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy
* requesting an epidural for the first time

Exclusion Criteria:

* previous epidural (either for labor or for surgery)
* BMI greater than 40 kg/m\^2
* previous lumbar spine surgery
* inability to speak English
* a history of chronic pain or are on chronic opioids
* a history of opioid drug abuse
Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy

The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy

The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels.

We will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.

Eligibility Criteria:
Inclusion Criteria:

* age 18-70
* screening colonoscopy

Exclusion Criteria:

* Failed prior colonoscopy
* pain as a main referral indication
* complications during previous exam
* Inpatients
* Excision of more than 3 polyps
* Diagnosis ofCancer, IBD
* Incomplete exam
Comparative Effectiveness of Targeted Therapy in RA Patients

The objective of a multicenter prospective observational study is to compare effectiveness and safety of biologic disease-modifying antirheumatic drugs and small molecular inhibitors in patients with moderately to severely active rheumatoid arthritis patients who have had an inadequate response or intolerace to methotrexate.

This study is a multicenter prospective observational study to show non-inferiority of clinical efficacy for small molecular inhibitors after 48 week of treatment to biologic disease modifying anti-rheumatic drugs (bDMARDs) in patients having moderately to severely active RA and who have been intolerant to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) including methotrexate.

Primary end point is a percentage of participants of achieving low disease activity according to Disease Activity Score in 28 joints-Erythrocyte Sedientation Rate (DAS28-ESR) at weeks 24. A total of 506 RA patients will be included, and allocated in ratio of 1:1 to bDMARD group and small molecule inhibitor group. Group allocation is determined by shared-decision making, so that the number of participants could be re-assessed according to recruitment status of participatns.

Eligibility Criteria:
Inclusion Criteria:

Patients are included in this study if they are:

* 19 years or olders
* Patients who satisfy the 1987 American College of Rheumatology (ACR) or 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA
* Patients having moderately to severely active RA who are intolerant to csDMARDs including methotrexate and those who have never been exposed to bDMARDs or small molecular inhibitors before
* Patients who provide written consent to participate in this study

Exclusion Criteria:

* Patients who are contraindicated to bDMARDs or small molecule inhibitor
* Patients who have plans for pregnancy or elective surgery
* Patients who had ever diagnosed with any malignancy or are treated for malginancy
* Patients who cannot voluntarily provie a written consent to participate in this study
* Patients who did not provide a written consent to participate in this study
Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.

Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator

Exclusion Criteria:

* Age \<18 years
* Pregnant or breastfeeding
* Non-English-speaking
* Unable to give informed consent
* Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
* Patients unable to complete a device-assisted 140 foot walk at baseline
* Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
* Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
* Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)
Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery

To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.

64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.

Eligibility Criteria:
Inclusion Criteria:

* patients 4-6 years after standard cataract surgery
* pseudoexfoliation Syndrome (PES)

Exclusion Criteria:

* Diabetic retinopathy
* Age related macula Degeneration
* retinal bloodvessel disease
Intranasal Oxytocin and Enhancement of Team Cohesion

This study attempts to identify the psychological, behavioral, physiological, and hormonal predictors and mechanisms of an individual's ability to develop cohesion in a group working together as a team; and examine if administration of the prosocial neuropeptide oxytocin enhances the development of team cohesion. Through a deeper understanding of the underlying psychobiological predictors and mechanisms of team cohesion, the prospective identification of individuals whose unique characteristics promote or inhibit the development of group cohesion will become possible.

The investigators will study up to one thousand subjects who will be randomized into same-gendered teams of three or volunteer as acquainted groups of three . Teams will be randomized to receive oxytocin or placebo. The investigators will first measure baseline personality traits including prosocial orientation. Cohesion will then be measured using a cooperative, virtual unmanned aerial vehicle (UAV) flying mission. All online behavior will be recorded within the task and all offline, real world, behavior will be video recorded throughout the study by digital cameras for later behavioral coding. To measure biobehavioral synchrony, autonomic physiology will be recorded and saliva samples will be taken throughout behavioral testing.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-28
* Speak English
* Ability to use a nasal spray

Exclusion Criteria:

* Positive urine pregnancy test
* History of psychiatric or neurologic disorder
* Use of illicit drugs in the past month
* History of moderate-severe alcohol use disorder as defined by DSM-V criteria
* Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
* Nasal obstruction, discharge, or bleeding
* Habitually drinks large volumes of water
* Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists
* Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis

Osteoarthritis is the 11th highest contributor to disability world wide. In terms of conservative management of patients with knee osteoarthritis, Resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. But, research shows that co supplementation can further augment the effects of resistance exercise. However, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to resistance exercise training in patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Knee OA with history not less than three months.
* Radiological evidences of grade III or less on Kellgren classification.
* Knee pain on VNRS no more than 8/10

Exclusion Criteria:

* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
* History of trauma or fractures in lower extremity.
* Signs of lumbar radiculopathy or myelopathy.
* History of knee surgery or replacement.
* Patients on intra-articular steroid therapy within two months before the commencement of the study.
* Impaired skin sensation.
* Impaired renal function
Overture Metabolomics Non-Selection Study

In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo.

This study will take place at multiple locations in the United States and Spain.

Patients will undergo ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.

Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis. Details of sample collection and analysis are provided in Sections 6.3.1 \& 6.3.2.

Single embryo transfer will be performed with the best morphology blastocyst being selected for transfer by the New Hope embryologist.

Approximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. Should the test be negative, they will be closed out of the study. Should the test be positive, they will continue to be monitored.

The patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. The outcome will be documented, and the patient monitored until 12 weeks of gestation at which time they will be closed from the study.

The embryo transfer outcome will be compared to MPI and MEI result to determine the NPV and PPV of metabolomics vs implantation.

Eligibility Criteria:
Inclusion Criteria:

* Women of any age, including egg donors. 50% will be \<35 and the rest 35 and older.
* Signed Subject Consent Form. No inferior limit on number of eggs

Exclusion Criteria:

At the time of initial visit:

* Require or request PGT of any kind
* Low ovarian reserve defined as follicle stimulating hormone (FSH) \>10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) \<15 pmol/L (or \<2 ng/ml) within prior 12 months of cycle start

At the time of embryo selection:

-Patients without at least one embryo to transfer.
Late Pregnancy Sample Collection Study

This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. All urine samples will be stored and used for research or product validation purposes.

The study will also gather information from volunteers regarding a woman's health during her pregnancy.

This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. It is anticipated 20-40 pregnant women will be recruited to the study.

Urine samples will be delivered to SPD either via post, or by hand and form part of the SPD BioBank. All urine samples will be stored and used for research or product validation purposes.

The study will also gather information from volunteers regarding a woman's health during her pregnancy, including any bleeding, discharge, discomfort, contractions/ Braxton Hicks via the use of a daily diary.

Pregnancy outcome details including labour specifics and birth outcomes such as birth date, weight, and sex of the baby will be obtained 4-6 weeks after the volunteer has given birth via email correspondence between the volunteer and study co-ordinator.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female in 3rd trimester of pregnancy

Exclusion Criteria:

* Prescribed bed-rest during third trimester or any other pregnancy
* complication that would affect the ability to participate in the study
* more than 38 weeks pregnant
* Have a planned caesarean section
The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion

The investigators developed a modified regadenoson nuclear stress test of the heart that incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The modified (ASSUAGE) protocol has been associated with fewer side effects and was better tolerated by patients.

This study will investigate whether the modified regadenoson stress protocol (ASSUAGE) produces blood flow pattern to the heart similar to that of a standard regadenoson stress protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a wide scale instead of the current standard protocol.

Patients who had regadenoson stress nuclear stress test of the heart will be invited to return to undergo a modified nuclear stress using the modified (ASSUAGE) protocol. Images from the original scan will be compared to those from the second scan to determine whether the blood flow pattern is similar between the two scans.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a qualifying regadenoson stress myocardial perfusion imaging (regadenoson nuclear stress test).

Exclusion Criteria:

* inability to provide an informed consent
* known allergic reaction to aminophylline or regadenoson
* systolic blood pressure \< 90 mmHg
* unstable abnormal heart rhythm
* pulmonary edema
* acute coronary symptoms, myocardial infarction within 48 hours
* active dipyridamole, aminophylline or theophylline use
* pregnancy
* any contraindication to aminophylline according to the drug's package insert: uncontrolled seizure disorder, sepsis with multi-organ failure and liver impairment
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are:

* Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone?
* Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone?
* Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.

This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.

Eligibility Criteria:
Inclusion Criteria:

* Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health

Exclusion Criteria:

* Subjects with congenital syndromes and/or developmental delay
* Subjects with cancer
* Subjects with gastrostomy tube use or dependence
* Subjects undergoing intracapsular tonsillectomy