cyrilzakka/clinical-trials huggingface dataset:
Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign an informed consent document.
* Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
* Stable treatment of an IOP-lowering medication.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant, breastfeeding, or not using adequate birth control.
* Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
* Other protocol-defined exclusion criteria may apply.
Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery

The goal of this proposal is to prospectively collect data from a series of 100 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (CPB) to:

1. Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels
2. Understand the correlation between GABA and inflammatory cytokines (and/or activated monocytes) and
3. Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.

Often when people undergo heart surgery, they are placed on cardiopulmonary bypass (CPB). Sometimes clotting of the blood occurs during and after heart surgery with CPB, which can lead to multiple complications. In order to try to avoid abnormal/excessive clotting that may lead to complications, it is important to understand the specific causes of why the blood sometimes clots abnormally during and after heart surgery.

Currently, tests looking at how the blood clots (coagulation assessment) are usually performed as standard laboratory testing during and after surgery. However, these tests are not able to predict the future development of abnormal clots.

This study will be looking at the role that immune cells (monocytes) have in the formation of abnormal clots after heart surgery. It is possible that these immune cells produce signals that can contribute to the formation of clots. Using experimental tests (monocyte analysis and mediator analysis), the hope is to understand if these cells participate in forming abnormal clots in any meaningful way. Although these tests are not yet approved for use in children, this study plans to use these new methods to understand this phenomenon by analyzing the blood at different times during the surgery and recovery period.

Overall, the purpose of this study is to look at these tests in people undergoing heart surgery to help the investigators understand why the blood sometimes forms clots abnormally. Results from this study may help treat future patients who experience abnormal clotting during and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients (all ages) undergoing complex cardiac surgical procedures with CPB.

Exclusion Criteria:

* undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent
* patient in a moribund condition American Society of Anesthesiology (ASA 5) -patient with a hematological and/or oncological disease
* Jehovah witnesses.
Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years old)
* Patient referred to the cardiology department for a right heart catheterization with measurement of RAP, regardless of the indication.
* Free subject, without guardianship or curatorship or subordination
* People affiliated to or beneficiary of a social security schemes
* Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Minor patient (age \< 18 years)
* Refusal to participate in the study
* Patient with hemodynamic instability, unable to tolerate a delay in treatment caused by the ultrasound examination.
* Patient requiring diuretic treatment within the next 4 hours
* Patient with a life expectancy of less than 24 hours.
* History of proximal deep venous thrombosis involving the inferior vena cava and/or common iliac veins and/or femoral veins.
* History of extrinsic venous compression on the inferior vena cava and/or common iliac veins and/or femoral veins.
* Persons who do not benefit from a Social Security scheme or who do not benefit from it through a third party.
* Persons benefiting from reinforced protection, namely minors, pregnant and nursing women, persons deprived of liberty by a judicial or administrative decision, persons staying in health or social institutions, adults under legal protection and finally patients in emergency situations.
The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects

The purpose of this study is to investigate the effects of berry juices containing different levels of polyphenols on blood pressure and other cardiovascular risk factors.

The study is a 12 week double blinded randomized controlled intervention trial. The subjects will be divided in three groups where one receives a placebo juice while the two other will consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be monitored and blood samples will be taken.


Eligibility Criteria:
Inclusion Criteria:

* Pre-hypertension or hypertension systolic blood pressure in the 130-179 mmHg range and/or diastolic blood pressure in the 85-109 mmHg range)
* BMI 20-35 kg/m2
* Stable weight (change \<4 kg previous 12 weeks)

Exclusion Criteria:

* Regular use of blood pressure lowering agens
* Diabetes type I or II
* Smokers
* Allergy to grape, cherries, blueberries/bilberries, black currant, aronia
* Supplements for weight loss
* Changes in pharmacological treatment of hyperlipidemia or hyperglycemia (initiation, termination or changes in dosage) last 30 days prior to inclusion or during the study period (run-in and intervention)
* Participation in a drug trial during the previous 30 days
The Effect of Virtual Reality Glasses Used Before Cesarean Section

The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety

Hypotheses 01; there was no difference between the Surgical Fear and Anxiety score of the Virtual Reality Glasses group and the control group.

The study will be carried out in two different groups. The practice will start with meeting the women whom will go to cesarean section in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Glasses Group; the intervention will be given glasses before the surgery and will be shown a video (30 minutes) of the 9-month fetal development process. Among the women who were admitted for a planned caesarean section, those who met the criteria would first be given the Informed Consent Form and a data collection form including sociodemographic characteristics, surgical fear scale, Spielberg State-Trait Anxiety Scale, and then randomization would be applied.

control group; the first surgical fear scale, anxiety scores will be recorded. After cesarean section anxiety scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Will undergo a cesarean section for the first time,
* Are over the age of 18,
* Have no diagnosed mental illness,
* Have no diagnosed physical illness in themselves or their baby,
* Volunteer to participate in the study

Exclusion Criteria:

* Have previously undergone a cesarean section,
* Are under the age of 18,
* Have a diagnosed mental illness,
* Have a diagnosed physical illness in themselves or their baby, Do not volunteer to participate in the study. -
Endoscopic Strip Craniectomy for Treatment of Sagittal Craniosynostosis

* Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. ESC is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference.
* Previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes.
* The purpose of this study is to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. In addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.

* This prospective, randomized parallel study seeks to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis.
* Both arms of the study will undergo standard care throughout their participation which includes preoperative \& postoperative measurements of cephalic index using the STARscanner© (Orthomerica products Inc.), preoperative \& postoperative photographs, post-operative helmeting, and standard post-operative visits.
* Additional research-related activities include chart review. Primary outcomes include degree of cranial expansion at 1 year post-operatively.
* Secondary outcomes include aesthetic appearance at 1 year post-operatively (using a 5-point Likert scale) and a multitude of intraoperative clinical variables including estimated blood loss, instances of transfusion, instances of dural tear, instances of 30-day readmission, and instances of needing further surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital.

Exclusion Criteria:

* Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
Drug Discrimination in Methadone-Maintained Humans Study 2

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Must be between the ages of 18-65.
2. Participation in the UAMS Substance Abuse Treatment Clinic Methadone Maintenance Program or the Catar Clinic Little Rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry.
3. Subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. This would be defined as \< 3 missed methadone medications and missed \< 3 group or \<3 individual therapy sessions in the month prior to study participation
4. Subjects must submit a urine sample negative for illicit drugs prior to study entry.
5. Subjects must be able to read and understand English.

Exclusion Criteria:

1. Unstable medical condition or stable medical condition that would interact with study medications or participation.
2. Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
3. History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
4. Pregnancy, plans to become pregnant or inadequate birth control.
5. Present or recent (\< 1 week) use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. Recent use will be defined based upon the pharmacokinetics of the drug and dosing schedule. Thus, a short-acting antihistamine taken as needed (e.g., once the night before) will not necessarily rule out a participant; however,
6. History of severe reaction to Narcan challenge, which may have been given as part of admission into the Methadone Maintenance Program or to reverse overdose.
7. Liver function tests (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
8. ECG abnormalities including but not limited to: bradycardia (\<60 bpm); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma

Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best supportive care. This study will compare survival of previously treated patients with malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the survival of similar patients who receive best supportive care alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of mesothelioma of the pleura.
* received only one prior systemic chemotherapy regimen for advanced or metastatic disease
* Performance status of 70 or higher on the Karnofsky Performance Status Scale
* Males or females at least 18 years of age
* Adequate organ function

Exclusion Criteria:

* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
* Pregnancy or breastfeeding
* Brain metastasis
* Prior treatment with Pemetrexed
* Inability or unwillingness to take folic acid or vitamin B12 supplementation
Spinal Anesthesia for External Cephalic Version

This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.

Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.

The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.

The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant nulliparous women.
* Breech presentation of fetus, eligible for external version.

Exclusion Criteria:

* Unwilling to participate.
* Unable to understand written and oral Swedish in the absence of interpreter.
* Contraindications to spinal anaesthesia.
ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts;
* Calculated lens power is within the available range;
* Willing and able to complete all required postoperative visits;
* Planned cataract removal by phacoemulsification;
* Potential postoperative visual acuity of 0.2 logMAR or better in study eyes;
* Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study;
* Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye;
* Clear intraocular media other than cataract;
* Able to comprehend and sign a statement of informed consent;
* Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR;
* Pupil size greater than or equal to 6 mm after dilation;
* The subject must be able to undergo second eye surgery within 30 days of first eye surgery.

Exclusion Criteria:

* Irregular corneal astigmatism;
* Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana;
* Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis;
* Previous corneal refractive surgery;
* Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR;
* Amblyopia;
* Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
* Diabetic retinopathy;
* Extremely shallow anterior chamber, not due to swollen cataract;
* Microphthalmos;
* Previous retinal detachment;
* Previous corneal transplant;
* Recurrent severe anterior or posterior segment inflammation of unknown etiology;
* Rubella or traumatic cataract;
* Iris neovascularization;
* Uncontrolled glaucoma;
* Aniridia;
* Optic nerve atrophy;
* Pregnancy;
* Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
Safety Study of Dabigatran in CADASIL

This study is a Phase II, randomized, crossover trial designed to compare one fixed dose of dabigatran with open-label use of ASA in patients affected by CADASIL; the study is a safety trial, and the primary objective is to assess that dabigatran is not less safe than ASA in subjects with CADASIL.

The primary endpoint is the number of microbleeds, as measured by MRI, at 90 days of follow up.

The study is based on the hypothesis that drugs inhibitor of the thrombin is more effective than ASA in preventing vessel obstruction. The rationale behind the study is based on the assumption that: a) the formation of microthrombi is relevant to the clinical expression of the CADASIL disease, and b) thrombin inhibitors are more effective than antiplatelet drugs in preventing lesions by microvessel obstruction.

Eligible patients will be randomized into one of the 2 treatment groups:

1. One week wash-out (W1), Dabigatran one tablet 100mg twice a day for 12 weeks, a second one week wash-out (W2), treatment with ASA one tablet of 100mg/day once a day for 12 weeks;
2. The same scheme repeated with reversed sequence No initial wash-out week will be required for patients in group 2 already treated with ASA.

Clinical and instrumental evaluations will be carried out during the first (W1) and second wash-out weeks (W2), and at the end of the study (during the week that follows the second treatment regimen (W3). Each evaluation will consist of physical examination, blood tests and MRI.

Safety is evaluated on the basis of brain microbleeds and severe haemorrhages.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older diagnosed with CADASIL according genetic test will be eligible.

Exclusion Criteria:

* Treatment with antiplatelet drugs for a condition different from CADASIL;
* conditions associated with an increased risk of bleeding (major surgery within the previous month, planned surgery or intervention within the next 3 months;
* history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding;
* gastrointestinal hemorrhage within the past year;
* symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days; hemorrhagic disorder or bleeding diathesis;
* need for anticoagulant treatment of disorders other than atrial fibrillation; fibrinolytic agents within 48 hours of study entry; uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 100 mm Hg);
* recent malignancy or radiation therapy (within 6 months) and not expected to survive 3 years; severe renal impairment (estimated creatinine clearance 30 mL/min or less);
* active infective endocarditis;
* active liver disease (including but not limited to persistent ALT, AST, Alk Phos greater than twice the upper limit of the normal range; active hepatitis C (positive HCV RNA);
* active hepatitis B (HBs antigen +, anti HBc IgM +), active hepatitis A);
* women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.