cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Reusable Soft Contact Lenses

The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.

This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants were randomized to wear the Test or Control lens for 30±2 days.

Eligibility Criteria:
Inclusion Criteria:

* Have had a self-reported oculo-visual examination in the last year.
* Are at least 18 years of age and has full legal capacity to give their informed consent.
* Have read and understood the informed consent letter.
* Are willing and able to follow instructions and maintain the appointment schedule.
* Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)
* Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Have spectacle cylinder of ≤ 0.75 D in both eyes.
* Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week)
* Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names:

  * Bausch and Lomb BioTrue Multi-Purpose Solution
  * Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution
  * Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution
  * Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution
  * Alcon Opti-Free Replenish Multi-Purpose Solution
  * Alcon Clear Care Plus Hydrogen Peroxide Solution
  * Acuvue RevitaLens Multi-Purpose Solution
* Have clear corneas and no active ocular disease.
* Have not worn habitual lenses for at least 12 hours before the baseline/screening examination
* Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week

Exclusion Criteria:

* Have never worn contact lenses before.
* Are currently wearing daily disposable contact lenses.
* Have any systemic disease affecting ocular health.
* Are using any systemic or topical medications that will affect ocular health.
* Have any ocular pathology or abnormality that would affect the wearing of contact lenses.
* Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Are aphakic.
* Have undergone corneal refractive surgery.
* Are participating in any other type of eye related clinical or research study.
* Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.
Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and to investigate if the progesterone serum levels might be a useful predictor for the success rate of the ongoing pregnancy rates


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment
* Aged ≥34 and ≤42 years
* Body mass index of \>18 and \<28 kg/m\^2
* Normal pelvic ultrasound at Screening
* No more than two previous gonadotrophin stimulated cycles of IVF or intracytoplasmic sperm injection (ICSI) in the history of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not count; Clomifen cycles are no exclusion criterion)
* At least 3 consecutive ovulatory menstrual cycles of 24-35 days
* No fertility stimulating drugs at all
* Sperm of partner classified as normal according to World Health Organisation (WHO) 2010 criteria
* Clinically normal baseline haematology, clinical chemistry, and urinalysis values
* Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening
* Endocrine test results within the clinically normal limits at Screening

Exclusion Criteria:

* Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus)
* A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
* A history of coagulation disorders
* Persistent ovarian cysts (\>3 months)
* A history of hypersensitivity to any of the constituents of the study medication or related compounds
* Diagnosed poor (\<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
* History of severe ovarian hyperstimulation syndrome in former gonadotrophin stimulated assisted reproductive technology (ART)-cycle
Multivariate Risk of CVD in Diverse Populations

To statistically examine cardiovascular disease (CVD) risk in different populations based on data from studies representing national samples, cohort studies, and clinical trials.

BACKGROUND:

Several algorithms have been developed to calculate multivariate risk of CVD based on characteristics associated with the disease. Framingham Heart Study data were used to develop the original algorithms, along with later models, using different mathematical forms, outcomes, and characteristics. Researchers then began to investigate the issue of generalizability, whether these risk estimates could be applied to new populations. For these algorithms to have general application, they must be able to rank risk correctly. And, when Framingham models were compared to new models developed for other studies, resulting orderings of risk were, in fact, similar.

The ability to order risk correctly, however, does not imply that estimated probabilities are right in terms of predicting disease for individuals. Methods are needed to assess individual risk to make treatment decisions, do cost-benefit analyses, and quantify benefits. These methods must be based on the patient's absolute risk, and existing equations may be incapable of establishing absolute risk across populations.

Earlier comparisons of multivariate risk among studies have made comparison populations as homogenous as possible before analysis. However, if multivariate risk estimates are to be truly useful, they must be applicable to the general population, and to be applicable, estimates must be based on comparisons of cohorts that include women and ethnic minorities. Also, in statistical terms, estimates must be robust enough to allow for minor shifts in methodologies for data collection and endpoint definition.

DESIGN NARRATIVE:

The heterogeneity of multivariate risk in different populations was examined based on data from studies representing national samples, cohort studies, and clinical trials. An analysis of these studies was conducted that included both sexes, various risk profiles, and representatives from several nationalities and ethnic groups. The pooled sample involved 20 studies, 233,833 participants, and over 47,000 deaths. Based on a common statistical approach, proportional hazards models were developed for each study to relate a set of essential characteristics to the prediction of CVD mortality. The characteristics included body mass index, age, blood pressure, serum cholesterol, smoking, and diabetes status. The models were then compared in terms of their ability to predict absolute risk of mortality across studies.

Secondary analyses were conducted to discover factors associated with inaccurate prediction and study characteristics associated with particular findings, such as interaction terms. An empirical examination was conducted of methods for adding newly discovered risk factors to existing prediction equations.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Exercise and Soft Tissue Sarcoma

The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females within the ages of 18-85
2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
3. Sarcoma of the upper or lower extremity location
4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
5. Expected primary wound closure performed at the time at surgery
6. Any disease stage
7. Any tumor grade
8. Any histologic subtype
9. First or recurrent presentations
10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
12. Must be able to comply with follow up visits
13. Must be able to provide own consent

Exclusion Criteria:

1. Patients under the age of 18, or over the age of 85
2. Treatment plan that does not include neo-adjuvant radiation and surgical excision
3. Sarcoma location other than the upper or lower extremity
4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
5. High dose steroid therapy (defined as \>5mg prednisone, or equivalent, with the last 30 days)
6. Active treatment with chemotherapy within the last 30 days
7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
8. Plan for post-operative radiation therapy
9. Underlying severe cardiopulmonary disease
10. Prior surgery, other than a biopsy, at the site of disease
11. Tumors that are ulcerative or fungating through the dermis at the time of presentation
12. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
13. Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion)
14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c\>8)
15. Active deep vein thrombosis in the treatment extremity
16. Inability to comply with follow up visits
17. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Transplantation of Autologously Derived Mitochondria Following Ischemia

The investigators propose a robust therapeutic intervention to ameliorate myocardial ischemia/ reperfusion injury and significantly decrease morbidity and mortality in patients requiring extracorporeal membrane oxygenation (ECMO), by direct injection of autogeneic mitochondria into the ischemic myocardium.

Autologous mitochondria will be delivered to the ischemic heart muscle in one of two ways, during clinically indicated surgical procedure or during clinically indicated cardiac catheterization.

For surgical re-operation subjects:

After the subject's chest is open, 1-2 6mm biopsies will be collected from the exposed skeletal muscle of the chest wall. The tissue will be processed at bedside to extract the autologous mitochondria. Surgery will proceed as clinically indicated. Prior to closure of the chest, autologous mitochondria will be injected via 5-10 injections of approximately 0.1 mL each to the damaged area (if damaged muscle is local) or via injection into the proximal aorta while cross-clamped for clinically indicated surgery for global distribution of mitochondria via the coronary arteries if there is no evident area of damage. Following completion of surgical maneuvers the mitochondria will be injected into the aorta and the cross-clamp will be removed. If there is global injury but a cross-clamp is not clinically indicated, direct injection into the myocardium will occur throughout the ventricle as previously described. Chest closure will then occur as and if clinically indicated for both techniques.

For catheterization subjects:

Once in the catheterization lab, the temporary chest closure will be removed and 1-2 6 mm biopsies will be collected from the exposed skeletal muscle of the chest wall by the cardiac surgery team. The tissue will be processed at bedside to extract the autologous mitochondria. The catheterization will proceed as clinically indicated. Prior to completion of the procedure (interventional to restore blood flow or hemodynamics), mitochondria will be infused in 5 mL of buffer as conducted in large animal studies (5) via intracoronary infusion followed by a 5 mL flush with normal saline. Total dose of mitochondria will be equal to direct injection subjects, with a larger dilution to allow to infusion via cardiac catheter.

If there is no marked improvement in ventricular function following the injection/infusion of autologous mitochondria and the subject has a clinically indicated procedure in the days following the initial delivery, a second injection/infusion will be completed. At this time the follow up schedule will be reset to Day 0.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric cardiology patients under the age of 18 on ECMO
* concerns for ischemic injury on the Cardiac Intensive Care Unit

Exclusion Criteria:

* Known mitochondria disorders
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial

The use of peri-arrest bolus epinephrine (PBE) has emerged as a rescue strategy for life-threatening hypotension in pediatric intensive care units (ICU) despite scant published data supporting its use in this setting. As optimal dosing of PBE in this population is unclear, we aim to determine if an initial dose of 0.5 mcg/kg versus 1.0 mcg/kg yields differences in hemodynamic outcomes. The EPI Dose Study is a single-center, prospective, randomized, double-blind, dose-effect trial measuring systolic blood pressure (SBP) before and after PBE is given. We hypothesize that the 1.0 mcg/kg group will have more robust increases in SBP.

In order to test the hypothesis that PBE doses of 1.0 mcg/kg will have more robust increases in SBP as compared to 0.5 mcg/kg in critically ill children and young adults with acute hypotension, we plan to conduct a Phase II, single-center, prospective, randomized, double-blind, dose-effect trial. Children and young adults \<26 years of age who, at the discretion of the clinical team, require rescue PBE for life-threatening hypotension and meet inclusion/exclusion criteria will be enrolled. Prior to randomization, our pharmacy team will prepare treatment packets with 3 pre-mixed PBE which will be stocked in the ICUs with either 5 mcg/mL or 10 mcg/mL of epinephrine. Clinicians will be instructed to use 0.1 mL/kg of the experimental syringe for the initial dose, resulting in target doses of 0.5 mcg/kg (Arm 1) or 1 mcg/kg (Arm 2), respectively. Treatment packs will be labeled according to the randomization scheme, and only the pharmacy team will have knowledge of the concentration of epinephrine in each package. Nurses will be instructed to record the exact time of the experimental dose, around which all time-sensitive data will be collected. The clinicians, patients and research team will be blinded to the intervention. We will not restrict any other interventions chosen by the clinical team. Unblinded interim analyses will be performed after the first 6 months of enrollment, and every 12 months thereafter through study completion and reported to the Data and Safety Monitoring Board (DSMB).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female less than 26 years of age.
2. Admitted to BCH and receiving care in a participating ICU.
3. Is prescribed BDE for acute hypotension deemed to be life-threatening in the judgement of the treating clinician.

Exclusion Criteria:

1. Has opted out of the study prior to enrollment.
2. Has orders in place which limit resuscitation efforts.
3. Is actively receiving chest compressions while PBE is administered.
4. Is receiving care in the neonatal intensive care unit.
5. Is receiving care outside of the ICU at the time PBE is administered (i.e procedural areas).
6. Is pregnant or breastfeeding.
7. Is a prisoner.
8. Is a ward if the state (DCF custody).
The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Prone Position

A total of 40 ASA (American Society of Anesthesiology) physical status I-III who underwent lumbar disc hernia repair for one or two levels were included in this prospective study. A standard anesthesia protocol was performed in all patients. Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Patients' demographics such as age, gender, height, weight, BMI, smoking status and pre-existing medical conditions were recorded.The patients were allocated equally to two groups according to BMI as Group I: BMI ≥30kg/m2,Group II \<30 kg/m2.

Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Frontal lobe oxygenation was monitored continuously and recorded every 5 minutes.Before positioning patients on the operating table, a Foley catheter was placed. IAP was measured in the following positions in all patients: 1) in the supine position after intubation 2) in the prone position before the skin incision.All patients were placed into the prone position on the silicone pads after general anesthesia.Before statistical analysis, the 40 patients were allocated equally to two groups according to the World Health Organization Guideline of BMI: Group I: BMI ≥30kg/m2, Group II \<30 kg/m2

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels

Exclusion Criteria:

* Age smaller than 18 or older than 70 years,
* ASA physical status more than III,
* Patients with a history of carotid artery stenosis, prior neck surgery, cervical canal stenosis, stroke, neurological deficit, myocardial infarction, spinal cord injury and sudden vision loss
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. The investigators are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for post-cardiac arrest status epilepticus (PCARSE) prevention after cardiac arrest.

More than 500,000 Americans have a cardiac arrest every year and 100,000 survive to hospital admission. Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. Seizures with or without muscle jerks, i.e. myoclonic seizures, are the most common seizure type after a cardiac arrest. Despite being common, seizures are usually refractory to treatment (post-cardiac arrest refractory status epilepticus) and the vast majority of patients with this diagnosis die. We are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for PCARSE prevention after cardiac arrest. Perampanel is a non-competitive AMPA glutamate receptor antagonist approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures, however there are no randomized trials in critically ill cardiac arrest patients at risk for seizures. This medication has been used for the management of refractory status epilepticus, including status epilepticus post-cardiac arrest. We will randomize patients to placebo or perampanel after admission to the intensive care unit. The study's primary outcome will be the incidence of severe adverse events. Secondary efficacy and safety endpoints include incidence of seizures and PCARSE, seizure frequency, time to seizure control, number of anti-seizure medications necessary for seizure control, duration of treatment with anesthetics for seizure control, and time to coma awakening. This study will help determine the safety and feasibility of primary seizure prophylaxis after cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Non-traumatic, out-of-hospital cardiac arrest
* Comatose on admission - defined as not following commands
* Return of spontaneous circulation (ROSC) within less than 45 minutes from the time of cardiac arrest (defined as the time of 911 or EMS (emergency medical services) witnessed arrest)
* Admission to the intensive care unit at Zuckerberg San Francisco General Hospital

Exclusion Criteria:

* Acute cerebral hemorrhage or infarction
* Pregnancy
* Prisoner
* Severe kidney function impairment with creatinine clearance inferior to 30 ml/min
* Severe liver impairment with liver function tests five times above the upper limit of normal
* Electrographic or electroclinical seizures diagnosis using American Clinical Neurophysiology criteria confirmed by an epileptologist after cardiac arrest
Myocardial Damage in COVID-19

This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.

The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging.

Exclusion Criteria:

* No cTnI test on admission