cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Patients With Primary Open Angle Glaucoma

A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)

This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS as a standalone procedure in patients with POAG.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 45 years or older.
2. History of uncomplicated cataract surgery and posterior chamber intraocular lens (IOL) implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit (pseudophakic subjects), OR, phakic and no anticipated need for cataract surgery over the study duration.
3. Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) either as monotherapy or in combination with one (1) adjunctive medication for a minimum of 6 weeks prior to the Screening visit.
4. Intraocular pressure (IOP) at the Screening visit of \>18 and not exceeding 36 mmHg.
5. Diagnosed with primary open angle glaucoma (POAG).

Exclusion Criteria:

1. Any of the following prior ocular procedures:

   * Laser trabeculoplasty ≤180 days prior to baseline
   * Durysta ≤12 months prior to baseline unless failure is documented and topical medication including a prostaglandin analog is in use as per Inclusion criterion # 3.
   * Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device; or
   * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe)
   * Retinal laser procedure ≤3 months prior to baseline
2. Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
3. Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.
4. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
Efficacy and Safety of FTY720 for Acute Stroke

Stroke is one of the main severe disease of public health importance. Increasing evidence suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator Fingolimod(FTY720)is an effective immunology modulator which has been widely used in autoimmune disease and has been testified effective on stoke animal models.

This study will enroll 87 stroke patients who have been diagnosed with stroke and meet the inclusion criteria.

After successfully meeting initial screening criteria, investigators will contact the family, explain the study, and send a consent form for their review.

After that, patients will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days , then investigators will make a neurofunctional assessment before and 7days, 30 days and 90days after oral fingolimod. And Magnetic Resonance of the brain before, 7days, 14days and 90days after oral fingolimod. Furthermore 5ml intravenous blood for flow cytometry is also taken before and 1day,3days,7days after fingolimod use.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Clinical presentation of spontaneous intracerebral hemorrhage/ischemic stroke
* MRI/MRA scan compatible with spontaneous intracerebral hemorrhage/ ischemic stroke
* Time to fty720 treatment\< 72 h from symptom onset
* Glasgow Coma Score \>6 on initial presentation or improvement to a Glasgow Coma Score \>6 within the time frame for enrollment.
* Primary supratentorial ICH of ≥5cc and \<30cc
* TOAST: Large-artery atherosclerosis

Exclusion Criteria:

* Patients who will undergo surgical evacuation of intracerebral hemorrhage
* Inability to undergo neuroimaging with Magnetic Resonance
* Glasgow Coma Score \< 6.
* Baseline modified Rankin Scale score \>1
* Primary intraventricular hemorrhage ICH due to coagulopathy (PT \> 15 s or International Normalized Ratio \> 1.3, Partial Thromboplastin Time \> 36) or trauma
* Thrombocytopenia: platelet count \<100 000
* Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs \>2x normal, coagulopathy as described)
* Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
* Pregnancy
* Malignancy (history of or active)
* Bradyarrhythmia and Atrioventricular Block
* Concomitant use with antineoplastic,immunosuppressive or immune modulating therapies
* Macular Edema
Properties of Dietary Fibre and Energy Intake

Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 year
* BMI 18.5-25 kg/m2
* Healthy as judged by the participant

Exclusion Criteria:

* Females
* Weight loss or weight gain of more than 5 kg during the last 2 months
* Using an energy restricted diet during the last 2 months
* Lack of appetite for any reason
* Restrained eater: \>2.89, measured by DEBQ (35).
* Smoking
* Heavy alcohol use: \>5 drinks/day (36).
* Reported stomach or bowel disease
* Reported diabetes
* Reported thyroid disease or any other endocrine disorder
* Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods
* Anemia: Hb\<8.0 mmol/l
* Fasting glucose levels \>5.8 mmol/l
* Blood donation from 6 weeks prior to the study until the end of the study
* Experienced any problems with drawing blood in the past
* Antecubital veins not considered suitable for blood drawing by means of a catheter
* Thesis students or employees of the division of Human Nutrition
Effects of Propofol and Isoflurane on Pulmonary Vascular Resistance

The investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (PVR).


Eligibility Criteria:
Inclusion Criteria:

* All children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a PVR study.

Exclusion Criteria:

* Children with a known adverse reaction to one of the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation.
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)

This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts. The main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the Catalys femtosecond laser using the Cassini Ambient equipment with iris registration in cataract surgery.

All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.

A preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the Cassini Ambient equipment (Cassini Technologies, The Netherlands, with CE marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the IOLMaster 700 non-contact optical biometer (Carl Zeiss, Germany, CE marked).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are going to undergo cataract surgery.
2. Low corneal astigmatism, between 0.50D and 1.25D.

Exclusion Criteria:

1. Previous corneal surgery.
2. Keratoconus.
3. Corneal scars
4. Pterygium
5. Glaucoma
Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students

This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

The purpose of this study is to develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students using a randomized-controlled intervention trial. The intervention program consists of a classroom-based curriculum and an interactive CD-ROM. Ten middle schools were recruited to participate in this intervention trial. Five middle schools were randomized to the intervention group; and five middle schools were randomized to the control group. The study is also developing a model for obtaining community support for the development of HIV, STD and pregnancy prevention programs for middle school youth.

The primary hypothesis to be tested is: Students attending middle schools who receive a multi-component HIV, STD, pregnancy prevention intervention will postpone sexual activity or reduce levels of current sexual activity relative to those in the comparison condition. The major dependent variables are proportion of students that are sexually active, and the proportion initiating sexual intercourse. Intentions to engage in sexual activity, number of times of unprotected sexual intercourse, and number of sexual partners will also be examined. Secondary hypotheses will examine the effect of the multi-component HIV, STD, and pregnancy prevention intervention on the student's knowledge, self-efficacy, attitudes, perceived norms, barriers, and communication with parents.

The specific aims of this project are to:

1. Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students.
2. Adapt a tested, school-based, HIV, STD, and pregnancy prevention curriculum for middle school students using qualitative data from the target population, parents, and community representatives.
3. Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students.
4. Evaluate the effect of the multi-component intervention (classroom curriculum and CD-ROM intervention) on sexual behavior outcomes (proportion of students who initiate sexual intercourse, proportion of currently sexually active students having unprotected sexual intercourse, number of sexual partners, and intentions to have sexual intercourse) among middle school students.
5. Evaluate the effect of the multi-component intervention on student impact variables such as knowledge, self-efficacy, attitudes, barriers, and perceived norms related to sexual risk-taking behavior and academic achievement among middle school students.
6. Disseminate findings to the scientific community, school districts, and community agencies.

Eligibility Criteria:
Inclusion Criteria:

* 7th Grade
* Attend one of the ten recruited schools

Exclusion Criteria:

* Non-English speaking
* Physical disability that prevents student from completing intervention and survey
Joy in Work, Resilience Capacity, and Patient Safety Culture Among Healthcare Professionals In-hospital

In this project, the investigators will investigate three important factors to optimize working conditions and patient safety: Joy in Work, Resilience Capacity, and Patient safety culture using both questionnaires and focus group interviews.

Already in 2021, the Norwegian Patient Safety Conference 'In Safe Hands 24-7' focused on adaptability: "How can health care professionals learn from what goes well?" Working to be excellent, identifying areas for improvement, and succeeding in a continuous improvement process. A solid patient safety culture requires competent and adaptable health care professionals, leaders, and health care systems. Joy in work is the experiential factor that revolves around opportunities for personal development, influencing one's own work, having individual contributions valued, and feeling like a meaningful part of the community.

This project spans three years-before (2024), during (2025), and after (2026) the physical co-location of Department of Cardiothoracic Surgery at Oslo university hospital. Four-hundred (n=400) health care professionals are working at Department of Cardiothoracic surgery, Oslo University Hospital, Norway and are eligible to be included in the study.

Health care professionals view of Joy in Work, Resilience Capacity, and Patient safety culture will be described using three international questionnaires. It is within the scope of the study to perform sub-analysis due to sub-categories of the questionnaires. Analysis across the questionnaires will be performed.

Furthermore, the three terms Joy in Work, Resilience Capacity, and Patient safety culture will be explored by approximately 10 % of the four-hundred (n=40) health care professionals in 5-6 focus group interviews, in 2024, 2025 and 2026..

Eligibility Criteria:
Inclusion Criteria:

* Health care professionals working at Department of Cardiothoracic Surgery

Exclusion Criteria:

* Not able to understand the Norwegian questionnaires
The Effectiveness of Gain- Versus Loss-framed Health Messages to Improve Oral Health Among Iranian Adolescents

This study explores the effectiveness of message framing, loss-framed vs. gain-framed messages on oral health in Iran.

This is a study to explore the impact of two pamphlets with gain-framed and loss-framed messages on brushing and flossing attitudes, intentions , behaviors and clinical characteristics among a sample of adolescent students.

Eligibility Criteria:
Inclusion Criteria:

* They are not involved in the oral health education
* Ability to understand Persian language Adolescents attending high schools in Qazvin

Exclusion Criteria:

* Does not meet inclusion criteria
Alexa, What is Eliquis and Xarelto?

The purpose of this study is to evaluate the effectiveness of providing patient medication education about Eliquis and Xarelto through an Amazon Alexa based voice recording.

Anticoagulants are considered high-risk medications due to the risk of major bleeding. The Federal Drug and Food Administration (FDA) MedWatch reporting system found that anticoagulants had the most adverse drug event (ADE) reports in 2011. Anticoagulants have also been reported as one of the leading drug classes contributing to emergency department visits3. Given the potential for serious adverse events, providing effective education to increase patient knowledge and awareness of those risks are essential. Incorporating technology into health care is becoming increasingly popular and has been shown to be effective for patient education. One reason is that technology can consistently provide complete patient education and is not subject to educator variability in providing this education.

Eligibility Criteria:
Inclusion Criteria (Patients):

* 18 years of age or older
* Have been prescribed either apixaban or rivaroxaban during their inpatient stay
* Consent to participating in the study

Inclusion Criteria (Nurses):

* Providing direct patient care in select general medicine and orthopedic surgical units
* Consent to participating in the study

Exclusion Criteria:

* Patients will be excluded if they have documented altered mental status, do not speak English, or are being prescribed rivaroxaban or apixaban on discharge only.
* Nurses will be excluded if not providing direct patient care in select general medicine and orthopedic surgical units
* Nurses declining participation
Irrigation Versus Suction in Complicated Acute Appendicitis

This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage.

Despite the available literature for and against the irrigation of the abdominal cavity in complicated acute appendicitis, in the current practice of this and other centres, the irrigation and no irrigation is made equally depending on the surgeon who performs the intervention.

Those who systematically irrigate the abdominal cavity in laparoscopic appendectomies do it as an inherited act from open surgery and those who systematically do not irrigate the abdominal cavity base their choice in theories such as abscess migration due to the irrigation and difficulty of the suction of all the irrigated fluid, spreading, therefore, the infection.

The intention of the investigators is to provide evidence about this technique in order to either systematize peritoneal irrigation in laparoscopic appendectomy for complicated appendicitis or avoid an unnecessary gesture, if it were established so.

This will be a prospective, randomized clinical trial involving patients who present to the hospital with complicated acute appendicitis. Power calculation was based on abscess rate in the investigators' hospital calculated retrospectively (15%) Subjects will be those patients above 18 y.o. who are found to have complicated acute appendicitis (defined as perforated appendicitis before or during surgery, gangrenous appendicitis and/or purulent peritonitis).

The final decision to include a patient in the study will made after complication has been visually confirmed during surgery. The randomization assignment will be made known at the initiation of the operation, and confirmation of complication will confirm the patient will utilize the next randomization slot.

The irrigation group will have suction irrigator set up with a 1 liter bag of normal saline. The surgeon must use at least 300 ml of this bag but may use as much as they choose.

The no irrigation group will have the suction irrigator set up without the saline attachment. This will leave them with the capacity for suction only. Since several suction devices exist, this will assure the same type of suction for both groups.

After the operation, both groups will be managed in the same manner. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. If the participants stay until the 5th post-operative day, a white blood cell count will be checked, which if it is normal, they will be discharged to home without antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complicated acute appendiccitis
* Laparoscopic approach

Exclusion Criteria:

* Open approach
* Medical or psychiatric condition of the patient that compromises the informed consent authorisation
* Non complicated acute appendicitis
* Underage patients (\<18)
* Refusal to participate in the study.
BMS-599626 in Patients With Advanced Solid Malignancies

The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic cancer that has progressed on currently available therapies;
* At least 3 month life expectancy;
* Primary cancer must be solid (non-hematologic);
* Adequate bone marrow, liver \& kidney function;
* Negative pregnancy test.

Exclusion Criteria:

* Serious, uncontrolled medical disorder;
* Individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study;
* Pregnant or breastfeeding women;
* Patients with known brain metastasis;
* Uncontrolled or significant cardiovascular disease;
* Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)
N-Acetylcysteine in Patients With Sickle Cell Disease

The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the frequency of pain in daily life in patients with Sickle Cell Disease (SCD).

Pain is an invalidating hallmark of this disease and has a considerable impact on the Quality of Life of patients and the medical health care system. Oxidative stress is hypothesized to play a central role in its pathophysiology. In pilot studies the administration of N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress. Moreover, administration of NAC seemed to decrease hospitalization for painful crises in a small pilot study in patients with SCD.

This study will be performed as a multicenter, randomized, controlled trial where patients will be treated with either NAC or placebo for a period of 6 months. The investigators expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving their quality of life and participation in society.


Eligibility Criteria:
Inclusion Criteria:

* Age 12 years or older
* Sickle cell disease, either homozygous sickle cell disease (HbSS), compound heterozygous sickle cell disease (HbSC), HbSβ0 or HbSβ+ thalassemia
* History of at least 1.0 painful crisis per year in the past 3 years (visit to medical facility is not required)

Exclusion Criteria:

* Chronic blood transfusion or transfusion in the preceding 3 months
* Painful crisis in the last 4 weeks (with respect to the moment of inclusion)
* Pregnancy, breast feeding or the desire to get pregnant in the following 7 months
* Known active gastric/duodenal ulcers
* Hydroxycarbamide (HC) treatment with unstable dose in the last 3 months or started on HC shorter then 6 months prior to study
* Known poor compliance in earlier trials regarding the completion of pain diaries
* Insufficient compliance in run-in period
* Known hypersensitivity to acetylcysteine or one of the other components of the study medication
* Use of pain medication for sickle-cell related pains on more than 15 days per month in the past 6 months ('chronic pain').