cyrilzakka/clinical-trials huggingface dataset:
Tolperisone in Acute Muscle Spasm of the Back

This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory
* Current acute back pain and/or stiffness due to acute and painful muscle spasm starting within 7 days prior to study entry and more than 8 weeks after the last episode of acute back pain.
* Pain of 4 or more on the subject "right now" rating of pain intensity Numeric Rating Scale (NRS) scale of 0-10.
* Willing to discontinue all medication used for the treatment of pain or muscle spasm on study entry.
* Pain localized below the neck and above the inferior gluteal folds.
* Body mass index ranging between 18 and 35 kg/m².

Exclusion Criteria:

* Unwillingness to stop taking pain or antispasmodic medication other than the study medication (specifically opioid use \[e.g., Vicodin\], barbiturates, and cannabis).
* Chronic pain for the previous 3 months or longer, on more days than not.
* Radicular pain in the lower extremity (i.e. pain radiating below the knee), sciatica pain down the leg, or pain below the knee (indicating a lumber radiculopathy); radicular pain in the upper extremity, radiating into the forearm or hand (indicating a cervical radiculopathy).
* Concomitant severe pain in a region other than the back.
* Spinal surgery within 1 year of study entry.
* Back pain due to major trauma (e.g., motor vehicle accident, fracture of bone) unless resolved for more than 1 year.
* Treatment of back pain ongoing with non-pharmacological therapy (e.g., acupuncture, chiropractic adjustment, massage, Transcutaneous Electrical Nerve Stimulation \[TENS\], physiotherapy).
* Subjects who test positive for alcohol by breathalyzer test.
* Unwilling to stop taking moderate to potent inhibitors of cytochrome P450 (CYP) isozymes CYP2D6 and CYP2C19, which are likely to cause drug interactions with tolperisone HCl (e.g., medications such as paroxetine and fluvoxamine).
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery

The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
* Written informed consent
* Age≥ 18 years
* Not incapacitated patient

Exclusion Criteria:

* No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine
GnRH Agonist as Luteal Support in FET Cycles

Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.

Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing


Eligibility Criteria:
Inclusion Criteria:

* 20 - 45 year old women comig to frozen thawed embryo transfer

Exclusion Criteria:

* The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive
* Abnormal uterus
* Known abnormality of karyotype of the woman or her partner
* Severe male factor as an exclusive reason for subfertility
* Allegy for triptorelin acetate
The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Management of Pancreaticobiliary Disorders

At the time of endoscopic retrograde cholangiopancreatography (ERCP) examination of the pancreaticobiliary system is done indirectly by radiologic means. Contrast is injected into the bile and/or pancreatic duct and outline of the duct is then viewed by fluoroscopic imaging. Frequently this is followed by diagnostic maneuvers (tissue acquisition) or therapeutic interventions (stone removal, stent insertion). Direct visualization of the bile and pancreatic ducts (cholangioscopy/pancreatoscopy) was developed 15 years ago and was shown to be superior to the indirect radiological view. The procedure did not become widely used secondary to high procedure related costs and equipment prone to failure. Recently a much improved (more affordable and more durable) cholangioscope was developed and approved by the FDA. The goal of this study is to prospectively record our experience with cholangioscopy and pancreatoscopy performed as medically indicated as part of standard medical care.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older.
* Scheduled to undergo ERCP with cholangioscopy and/or pancreatoscopy at the University of Florida, Gainesville, FL as medically indicated.
* Subject must be able to give informed consent

Exclusion Criteria:

* Any contraindication to ERCP.
* The subject is unable to give informed consent.
A First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of a Novel CRISPR RNA-editing Therapy in Patients with Mecp2 Duplication Syndrome, a Rare Orphan Disease (HERO)

Methyl-CpG binding protein 2 (MECP2) is a dosage-sensitive, X-linked gene critical for central nervous system development and functional maintenance, which gain-of-function causes MECP2 duplication syndrome (MDS). Affecting primarily in males, this disorder is characterized by severe intellectual disability, motor dysfunction, infantile hypotonia, epilepsy, respiratory tract infections, and premature death before 25 years of age with no curative therapy.

HG204 is a CRISPR RNA-editing therapy packaging novel high-fidelity Cas13Y (hfCas13Y) technology, using one single adeno-associated virus (AAV) vector to target and knock down MECP2 mRNA in the brain. Preclinical studies showed that a single intracerebroventricular injection of HG204 persistently decreased MECP2 mRNA and MECP2 protein in the cortex of the MDS mice, reversed the abnormal motor and social phenotypes, and significantly prolonged survival in MDS mouse models.


Eligibility Criteria:
Inclusion Criteria:

* Males ≥ 2 and ≤18 years at the time of signing informed consent;
* Genetic test and clinical confirmed diagnosis of MDS;
* Stable pattern of seizures, or has had no seizures while currently receiving medical treatment (including antiepileptics) and physical therapy are stable for at least 2 months before screening;
* Willing to adhere to protocol, including biological samples collection and hospitalization for intracerebroventricular injection surgery;
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.

Exclusion Criteria:

* MECP2 gene triplication;
* Concurrent genetic syndromes other than MDS;
* Significant brain or cerebellar atrophy, or other significant degenerative changes as shown in cranial MRI at screening;
* Prior or current hypertension, cardiomyopathy, myocardial ischemia or atrial fibrillation and other cardiovascular diseases;
* Prior central nervous system surgery within 6 months before enrolment;
* Systemic use of immunosuppressive drugs within 3 months before enrolment;
* Prior gene therapy or oligonucleotide therapy treatments;
* Any other conditions that would not allow the potential subject to complete follow-up examinations during the study and would, in the opinion of the investigator, make the potential subject unsuitable for the study.
Product Performance of a New Silicone Hydrogel Contact Lens

The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson \& Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
* myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
* correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution \[logMAR\]) or better (2 meters distance, high-contrast chart) in each eye.
* free of any anterior segment disorders.
* adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
* access to internet connection and personal email to send/receive emails.
* habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night \& Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson \& Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Exclusion Criteria:

* participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
* have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
* using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
* refractive astigmatism of greater than 0.75 D in either eye.
* anisometropia (spherical equivalent) of greater than 2.00 D.
* amblyopic.
* have had any corneal surgery (e.g., refractive surgery).
The Effects of Mindfulness Training on Eating Behaviors and Food Intake

The investigators propose to study the effect of mindfulness training on the eating behaviors and dietary intake of overweight or obese persons. Mindfulness skills training involves bringing non-judgmental attention to thoughts, emotions and bodily sensations - including hunger and satiety cues. It is hypothesized that as subjects advance through the 8-week class series, developing their capacity for mindfulness and in effect learn to pay attention to the sensations, assumptions, cognitions, and beliefs that underlie their eating behaviors, that their eating behaviors will improve. Specifically, the investigators hypothesize that 1) there will be significant improvements in the areas of uncontrolled and emotional eating, 2) there will be significant decreases in total caloric intake and significant increases in fruits and vegetables, and 3) there will be a positive significant relationship between the frequency/consistency of mindfulness practice and improvements from baseline to follow-up measures.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \> 26

Exclusion Criteria:

* Psychotic disorders
* Poorly controlled bipolar disorder
* Borderline or antisocial personality disorder
* A diagnosed eating disorder
Positron Emission Tomography (PET) Imaging with Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2
* Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
* Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight over 350 lbs., due to the scanner bore size
* Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Obstetric Outcomes After Double Embryo Transfer

Aim ; to compare obstetric outcomes in relation to number of embryo transfer in ICSI

Assisted reproductive technology with intracytoplasmic sperm injection (ICSI) and IVF is becoming an international direction for couples struggling with infertility. The increasing popularity and frequency of these techniques and the data generated from it has given us a better overview of the efficacy, consequences and costs of these techniques.

The aim of assisted reproductive technology (ART) is to achieve pregnancy while decreasing the risk of multiple gestations. When compared with elective single embryo transfer (SET), double embryo transfer (DET) demonstrates a superior pregnancy and live birth rate with a significantly higher risk of multiple gestations. The high frequency of multiple births is the main factor which leads to adverse outcome in IVF/intracytoplasmic sperm injection (ICSI) treatment. Transfer of two embryos does not diminish the chance of a birth when compared with three embryo transfer. How would be the obstetric outcome in pregnancies resulting from DET in IVF/ICSI cycles.

Despite achieving a higher pregnancy rates, DET in ART leads to an increase in multiple gestation pregnancies, which are associated with increased both maternal and neonatal morbidity and mortality.

Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies. Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies.

Most patients prefer to have two embryos transferred, due to financial considerations being the main reason.

Studies demonstrate that patients are more likely prefer to choose SET when educated about the risks of multiple gestation pregnancy, but select two embryos for transfer if they have a lower pregnancy rate when compared with transferring one embryo .

Cost effectiveness research comparing single versus DET after in vitro fertilization (IVF) has previously been performed, with most studies taking place in areas with mandated IVF insurance coverage, and few incorporating hospital costs linked to obstetrical and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* all patients subjected with ICSI pregnancy

Exclusion Criteria:

* incomplete data
Comparative Effectiveness of Oral Anticoagulants

This cohort study plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.


Eligibility Criteria:
Inclusion criteria:

* A recorded diagnosis of atrial fibrillation (AF).
* Initiation of anticoagulant medication (dabigatran or warfarin).
* At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score \>=1

Exclusion criteria:

* Patients with missing or ambiguous age or sex information
* Patients with documented evidence of valvular disease
* Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
* Patients with prior use of any oral anticoagulant
Electroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients

A prospective exploratory study in patients with drug resistant epilepsy with a target comparison of long term outcome. NeuroScan software modules and a MagLink will be used to acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the MRI machine, without compromising the raw EEG data.


Eligibility Criteria:
Inclusion Criteria:

1. Refractory epilepsy cases, referred by the service of Neurology. These are cases whose pathophysiology is resistant to treatment, including change in medication and or added medication.
2. Patients will be included if they agree to sign an Institutional Review Board approved written consent.

Exclusion Criteria:

1. Patients with overt symptoms or signs of anxiety than cannot cooperate during the recording inside the scanner, unless consent is given for the procedure to be performed with sedation by the anesthesia department.
2. Patients who meet the regular exclusion criteria for Magnetic Resonance Imaging (MRI) studies per the prescreening form reviewed with all patients prior to exams
Incidence of MIS-C and Other Complications Following SARS-CoV-2 Infection

Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. It has been reported to occur in approximately one of 3,000 to 4,000 unvaccinated children during the COVID-19 waves dominated by variant Alpha of SARS-CoV-2. However, the incidences following SARS-CoV-2 infection with variant delta and omicron, as well as among vaccinated children and adolescents with SARS-CoV-2 is yet unexplored.

The investigators aim to estimate the incidence of MIS-C and in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, based on a nationwide prospective population-based cohort study.

AIM The project seeks to estimate the incidences of MIS-C in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, .

HYPOTHESIS The incidences of MIS-C following SARS-CoV-2 variant delta and omicron are similar to the risk following variant alpha in unvaccinated children and adolescents, while the incidences among vaccinated children and adolescents are significantly lower. Further, severe complications to SARS-CoV-2, e.g. PVL producing S aur. infection is increased, as well as severe RSV-complication in older children in the post-COVID-lock down RSV epidemic

METHOD Prospective nationwide population-based cohort study of all individuals aged 0-17 years hospitalized due to MIS-C, or other complications to SARS-CoV-2 in the period August 15, 2021 to August 14, 2022. The setting is a multicenter study including all 18 Danish Pediatric Departments, providing 24 hours emergency service, and in- and out-patient treatment for all Danish inhabitants aged ≤ 17 years. As part of a pediatric nationwide COVID-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of patients with MIS-C and other complications to SARS-CoV-2, including complications secondary to the lock-down.

To calculate the incidence of MIS-C among Danish children and adolescents, the number of individuals who has tested positive for a SARS-CoV-2 infection in the period July 15 2021 to July 14 2022 will be attained from the National COVID-19-vaccine Database at the Statens Serum Institut. From the Statens Serum Institut and the Danish Microbiological Departments, the numbers bacterial infections including PVL-producing S aureus bacteremias and RSV infection will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* MIS-C according to criteria devised by the World Health Organization and Centers for Disease Control and Prevention (CDC)
* Invasive bacterial infections and viral infections secondary to SARS-CoV-2 or as consequence of SARS-CoV-2 lock down

Exclusion Criteria:

-
A Study of Evacetrapib (LY2484595) in Combination With Atorvastatin in Japanese Participants With Primary Hypercholesterolemia

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese participants with primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Must be treated with atorvastatin 10 mg/day for at least 30 days prior to study initiation.
* Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C levels (measured by a direct method) that meet the following criteria. (Participant categories are based on the definition in Japan Atherosclerosis Society 2012 guidelines.)

  * Category I: 160 mg/deciliter (dL)≤LDL-C
  * Category II: 140 mg/dL≤LDL-C
  * Category III: 120 mg/dL≤LDL-C
  * Secondary prevention: 100 mg/dL≤LDL-C
* Have triglycerides (TG) ≤400 mg/dL.
* Have HDL-C \<100 mg/dL.

Exclusion Criteria:

* Participants on LDL apheresis or plasma apheresis.
* Participants with secondary hypercholesterolemia or homozygous familial hypercholesterolemia.
* Any planned angiography. If angiography is planned, participants may be screened and enrolled after all such planned procedures are completed.
* History of any of the following conditions \< 90 days prior to study initiation

  * acute coronary syndrome (unstable angina, acute myocardial infarction)
  * symptomatic peripheral arterial disease
  * invasive treatment of carotid artery disease
  * ischemic stroke or transient ischemic attack (TIA)
  * intracranial hemorrhage
* History of abdominal aortic aneurysm.
* Participants with a history of intolerance/hypersensitivity to ezetimibe or statins.
* Have systolic blood pressure (SBP) \> 160 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) \> 100 mm Hg.
* Have a hemoglobin A1c ≥8.4% (National Glycohemoglobin Standardization Program).
* During the study period, participants who plan to use, are likely to require, or unwilling or unable to stop with adequate washout any prescription, over the counter (OTC) medication, supplements or health foods with the intent to treat serum lipids (LDL-C, HDL-C, TG) including but not limited to these classes of drugs: statin (except for atorvastatin 10 mg), ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic agents within 8 weeks before study initiation are excluded from the study.
* Have been exposed to cholesteryl ester transfer protein (CETP) inhibitors (for example, anacetrapib or dalcetrapib).