cyrilzakka/clinical-trials huggingface dataset:
Elongation of Foveal Tissue After Macular Hole Surgery

In our experience, elongation of foveal tissue after macular hole surgery which was undetectable by conventional time-domain optical coherence tomography was often observed on spectral-domain optical coherence tomography images. Elongation of tissues inevitably induces some degree of disorganization of tissue microstructure.

The purpose of the present study was to evaluate elongation profile of foveal tissue after macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with idiopathic macular hole

Exclusion Criteria:

* traumatic macular hole
* evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images
* presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma
* history of intraocular surgery other than uncomplicated cataract surgery, other ocular diseases that may influence the macular microstructure or visual function
* patients with indistinct intraretinal structure on spectral domain optical coherence tomography images
Does in Vivo Culture of Pre-cleavage Stage Embryo Reduce the Incidence of Aneuploidy?

This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo culture conditions on the euploidy of sibling blastocysts.

As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.

These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.

If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.

In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.

Preliminary data from the pilot study have shown a higher proportion of euploid embryos for sibling oocytes cultured in vivo vs. in vitro. Moreover, in animal models, in vivo cultured embryos have been described with significant reduction of aneuploidies and with differences in the gene expression levels patterns when compared to in vitro cultured embryos. There is also growing evidence that the culture conditions of human pre-implantation embryos can affect the gene expression regulation with measurable effects on embryos and on newborn children.

The investigators hypothesis is that in vivo produced embryos might have a higher percentage of euploidy when compared to their siblings cultured in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent by the subject and her partner
* Women, aged between 18 and 38 years (up to 38th birthday)
* ≤ 2 previous stimulation cycles
* Routinely measured hormonal levels within normal range (i.e. FSH, LH, E2, PRL)
* No uterine or ovarian anatomical abnormalities and/or alterations that would compromise device delivery or function in the uterus as demonstrated by ultrasound and trial insertion
* 19 ≤ BMI ≤ 29 kg/m2

Exclusion Criteria:

* History of previous moderate or severe ovarian hyperstimulation syndrome (OHSS)
* Severe endometriosis
* Any active infection that would contraindicate ART, at the discretion of the investigator
* Severe male factor in the partner (cryptozoospermia or non-obstructive azoospermia)
The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer

Clinicopathological data were collected from ovarian cancer patients treated with PARP inhibitors, with follow-up imaging conducted before and after treatment. The efficacy was evaluated according to RECIST criteria, comparing the correlation between different HRD statuses and the efficacy of PARP inhibitors in ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ovarian cancer (any histological type) and possessing complete pathological hematoxylin and eosin (HE) stained slides and paraffin-embedded tissue blocks.
* Patients must be 18 years of age or older.
* Patients should not have concurrent multiple primary cancers.
* Patients must undergo an MRI or CT scan prior to starting treatment.
* According to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, patients must have at least one measurable lesion.
* Participants must provide informed consent, voluntarily cooperate with clinical follow-up, and sign an informed consent form.

Exclusion Criteria:

* Patients who do not have accessible tumor tissue required for Homologous Recombination Deficiency (HRD) testing.
* Patients whose clinical records are incomplete, making it impossible to effectively compare treatment efficacy.
* Patients who are lost to follow-up and for whom subsequent treatment outcomes cannot be tracked.
Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition

The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).

Several studies documented the presence of a high variability in the individual response to antiplatelet therapies in terms of extent of platelet function inhibition. This laboratory finding is the so-called aspirin or clopidogrel resistance which we prefer to define residual platelet reactivity (RPR) on antiplatelet therapy.

A growing body of evidence is demonstrating the clinical relevance of this laboratory parameter, i.e. patients with RPR are at higher risk of a subsequent adverse cardiovascular event.

In particular, it has been demonstrated that RPR measured by light transmittance aggregometry induced by ADP or by the point of care assay VerifyNow P2Y12 identifies patients which, after coronary revascularization with stent implantation, at higher risk of a potentially catastrophic event such as stent thrombosis.

No randomized trials are available in the literature on the efficacy and safety of an antiplatelet therapy tailored on the extent of platelet function inhibition.

Eligibility Criteria:
Inclusion Criteria:

* Unstable or NSTEMI

Exclusion Criteria:

Previous bleeding events which have required blood transfusion

* PT- INR \>1.5
* Platelet count ≤ 100000/ mm3
* Hb \< 10 g/dl
* Previous TIA/stroke (ischemic or hemorrhagic or unknown)
* Body weight \< 60 Kg
* Creatinine levels ≥ 4 mg/dl
* Cerebral neoplasia
* Recent major trauma/surgery/head injury (within 3 previous weeks)
* Gastrointestinal hemorrhage in the last month
* Aortic dissection
* Known haemorrhagic diathesis
* Oral anticoagulant therapy
* Pregnancy or 1 week after delivery
* Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>110 mmHg)
* Severe liver disease
* Infective endocarditis
* Major psychiatric disorders
* Alcool or drug abuse
* Active peptic ulcer Noncompressible arterial puncture within 14 days Prolonged cardiopulmonary resuscitation
Ertugliflozin: Cardioprotective Effects on Epicardial Fat

The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.


Eligibility Criteria:
Inclusion Criteria:

* patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery
* history of Diabetes Mellitus Type 2 currently diet controlled, or on metformin or dpp4 inhibitors

Exclusion Criteria:

* allergy or intolerance to interventional medication
* currently taking insulin, glp-1 inhibitors, or sulfonylureas
The TARGET-EFT Randomized Clinical Trial

Randomized clinical trial to determine whether a multicomponent intervention will lead to improvements in mobility, self-care, mood, pain, and physical activity among frail and pre-frail older adults (as measured with the Essential Frailty Toolset; EFT) hospitalized for an acute cardiovascular illness.

The investigators will conduct a single-center randomized clinical trial at the Jewish General Hospital; an academic tertiary care center in Montreal, Quebec. Researchers will pre-screen stable patients ≥65 years of age admitted to the cardiovascular unit. The investigators will target those that consent and have evidence of frailty or pre-frailty according to the EFT (score ≥1/5). The EFT consists of a chair rise test to screen for physical frailty, a mini-cog test to screen for cognitive impairment, a hemoglobin level and a serum albumin level. Patients will be randomly allocated to the usual-care control group, or the intervention group that will receive targeted treatments depending on the EFT deficits identified. All patients will be outfitted with a hip-worn accelerometer to monitor position, step count, and sleep data during the study period. Patients will undergo a structured questionnaire and physical performance assessment at baseline (upon index admission) and at discharge, and will be contacted by telephone 30 days post-discharge to assess their recovery. The primary endpoint will be represented by the EQ-5D scale (mobility, self-care, mood, pain, and physical activity) measured by blinded observers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Frail or pre-frail as defined by EFT score ≥1
* Admission to the JGH cardiovascular unit
* Signed informed consent

Exclusion Criteria:

* Expected discharge within \<3 days
* Clinically unstable (unstable vital signs, low-threshold coronary ischemia, uncontrolled heart failure, uncontrolled arrhythmia)
* Awaiting cardiac surgery during the index hospitalization
* Severe dementia (MMSE ≤10/30)
* Delirium (CAM positive)
* Psychiatric condition precluding cooperation
* Not English or French speaking
* Parkinson's disease
* Recent stroke \<7 days
* Bed-bound or paraplegic
* End-of-life care plan
Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing ACL Rupture

We introduced an automatic knee arthrometer (AKA) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing ACL rupture compared with the KT-2000.

The AKA was compared to the KT-2000 at 134 N in this study, the anterior displacement and difference of both knees of every subject were measured. The first protocol was designed to evaluate examiner effect (level of experience) and contralateral-side effect (left or right knee) in a single healthy subject, ten times, on ten consecutive days. The second was to compare the stability in 20 healthy subjects, with a single experienced examiner. Third, we recruited 200 ACL rupture and 200 healthy subjects as contrast to compare the accuracy of the devices in diagnosing ACL rupture.

Eligibility Criteria:
Inclusion Criteria:

* patients with ACL rupture from our institution were included. All patients were diagnosed by sports medicine specialists based on clinical manifestation, combined with imaging examinations, and hospitalized for further surgery.

Exclusion Criteria:

* Patients aged \<18 or \>45 years, with combined multiple knee ligament injury combinations, and/or limited range of motion of the knee (unable to flex to 20-30°)
Circadian Macular Volume Changes in the Choroid

Choroidal volume measured fluctuates significantly over a 24 hour time frame.

All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be performed in both eyes after pupil dilation.

Scanning Protocol: This studies choroidal volume measurement protocol has been previously published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a single investigator. To optimize image quality each B-scan will be averaged from at least 25 individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering, Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a 30x25 degree area around the fovea.

Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at 0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for examination at 0 and 3.

OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for automated choroidal volume calculation by the devices build in software. Choroidal thickness is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and the hyper reflective layer behind the large vessels of the choroid (chorio-scleral interface). The devices Software thus generates a three-dimensional choroidal thickness map, divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.

This is considered a pilot study, so explorative data analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65, signed informed consent form,

Exclusion Criteria:

* any ocular pathology, including history of ocular surgery or trauma, use of ocular medication, elevated intraocular pressure (IOP), or significant vitreous floaters. Further exclusion criteria were current use of any systemic medications, history of cardio-vascular disease, diabetes mellitus, or hypertension
Sphenopalatine Blockade Versus Clinical Treatment

Post-dural puncture headache leads to high morbidity and cost to the health system. Pregnant women have a higher incidence than other population groups. There are several treatments for post dural puncture headache mentioned in the literature, not all well established, with a wide heterogeneity of treatment between services. Sphenopalatine block then appears as an alternative treatment, having been described as effective in reports and case series, requiring comparative experimental studies.

Post-dural puncture headache leads to high morbidity and cost to the health system. Pregnant women have a higher incidence than other population groups. There are several treatments for post dural puncture headache mentioned in the literature, not all well established, with a wide heterogeneity of treatment between services. Sphenopalatine block then appears as an alternative treatment, having been described as effective in reports and case series, requiring comparative experimental studies.

OBJECTIVES: To evaluate the efficacy of sphenopalatine blockade in combination with multimodal treatment in reducing the incidence of epidural blood patch and pain intensity in patients who develop headache after dural puncture, compared with the clinical treatment in our service.

METHODS: A prospective randomized clinical, analytical study will be conducted at the Obstetric Center of the Central Institute of the University of São Paulo School of Medicine Hospital das Clínicas (ICHC-FMUSP). Women will be included who will undergo neuroaxis block for cesarean section, vaginal delivery or uterine curettage, and who later present headache after dural puncture, after evaluation and diagnosis by anesthesiologist. The patients will be divided into three groups at random. In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache. In group II, patients will receive clinical treatment, according to the new protocol of the institution. In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. They will be reevaluated after 12, 24 and 48 hours, and a visual analog scale will be applied to evaluate improvement. The pain will be quantified before and after treatment. Pain intensity will be evaluated by verbal numerical scale (EVN), incidence of need for epidural blood buffer in each group, as well as length of hospital stay (in days).

Eligibility Criteria:
Inclusion Criteria:

* women who will undergo neuroaxis block for cesarean section, vaginal delivery or uterine curettage, and who later present with cerebrospinal fluid hypotension headache, after evaluation and diagnosis by anesthesiologist.

Exclusion Criteria:

* patients previously diagnosed with chronic headache; patients with contraindication for neuraxial anesthesia, patients with contraindication for any drugs involved in the study and users of psychotropic intravenous drugs.
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
* Ages \>/= 1 and \</= to 30 years at the time of initial diagnosis
* Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
* Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
* Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
* Direct bilirubin less than or equal to Grade 2
* Amylase and lipase within normal limits (per institutional standards)
* Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.

Exclusion Criteria:

-
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain

1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging.

   Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.
2. Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis and multifidus) and the sensation and pain thresholds of patients with recurrent low back pain with asymptomatic subjects.

   Hypothesis: patients with recurrent low back pain have:

   (A) less activation of the transversus abdominis and multifidus, (B) peripheral and central sensitization, with decreased sensation and pain thresholds in the lumbar and foot areas.
3. Specific aim 3. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by use of ultrasound feedback training in asymptomatic adults, and to compare these results with the traditional training protocols for trunk stabilization.

   Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in asymptomatic adults.
4. Specific aim 4. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by using the ultrasound feedback training in adults with low back pain, and to compare these results with the traditional training protocols for trunk stabilization.

Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in adults with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* recurrent low back pain for at least the past year
* lumbar region discomfort more than one day in the past three months
* recurrent discomfort more than one time in the past three months

Exclusion Criteria:

* pregnancy
* carcinoma
* systematic disease (rheumatic arthritis, ankylosing spondylitis etc)
* had surgery on lumbar region or lower extremities
* neurological symptom on lower extremities(numbness, pain etc)
* spondylolisthesis
Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients

To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* S/P lexos VR/-T,DR/-T implantation
* Signed patient informed consent

Exclusion Criteria:

* CAF
* Life expectancy\<6 months
* Impending heart transplant
* Persistent recurring tachycardia
* Rhythm disturbances that preclude a meaningful HRV analysis
* Participation in another study.