cyrilzakka/clinical-trials huggingface dataset:
PGE2 Levels in Patient Treated With NSAIDs

The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.

All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis.

Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL.

PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.


Eligibility Criteria:
Inclusion Criteria:

* epiretinal membrane or full thickness macular hole scheduled for vitrectomy

Exclusion Criteria:

* vitreous hemorrhage
* diabetes
* glaucoma
* concurrent retinovascular disease
* previous ocular inflammation
* previous ocular surgery
* history of ocular trauma
* previuos intravitreal injections
* concomitant intake of topical or systemic NSAIDs or corticosteroid therapy
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
* Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR \>28mm/hour
* Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
* Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception

Exclusion Criteria:

* Have a diagnosis of any other inflammatory arthritis
* Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
* Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
* Subjects with known concurrent acute or chronic viral hepatitis B or C infection
* Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
* Subjects with known history of or current clinically active infection
* Subjects at high risk of infection
* Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
* Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
* Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
Clareon PanOptix Pro vs. Clareon PanOptix - Study B

The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Eligibility Criteria:
Key Inclusion Criteria:

* Understand and sign an ethics committee-approved informed consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Planned cataract surgery (both eyes);
* Preoperative corneal astigmatism less that 1.00 diopter in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
* Ocular conditions as specified in the protocol;
* Subjects who desire monovision correction.
* Other protocol-defined exclusion criteria may apply.
Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients

This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.

This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients: a randomized, double-blind, placebo-controlled crossover design, and parallel clinical investigation.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 30 to 70 years, whose native language is Chinese.
2. Patients diagnosed with Spinocerebellar Ataxia.
3. Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).
4. Individuals who can read and write in Chinese and communicate in Chinese.
5. Agree to participate in the study.

Exclusion Criteria:

1. Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.
2. Pregnant women and breastfeeding mothers.
3. Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.
4. Patients with other factors that prevent them from continuing to participate in this study.
Impact of Dietary Status on Vascular Function Before and After a Standardized Breakfast. an "exposed/unexposed" Study Embedded in the SUVIMAX2 Cohort

In France, primary cardiovascular and metabolic prevention is supported by the French National Program for Nutrition and Health (PNNS: Programme National Nutrition Santé).

The investigators made the hypothesis that, independently of other diseases, the non adherence in PNNS guidelines would lead to arterial stiffness, endothelial dysfunction, change in microcirculation and in cardiac autonomic system. These changes may exist at fasting but also be reinforced after a standardised breakfast.

The investigators aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.

This is a case / control pilot nested in SU.VI.MAX 2 (SUpplémentation en VItamines et Minéraux Anti-oXydants) study. The randomized longitudinal placebo controlled SU.VI.MAX study tested the preventive effect of vitamin and antioxidant minerals supplementation on the incidence and the mortality from cardiovascular pathologies and cancers. SU.VI.MAX 2 was the extension of the previous study and included 7200 subjects for whom food habits were known and characterized according to PNNS guidelines (PNNS score).

The subjects will be pre-selected from the original cohort SU.VI.MAX2 if they have a PNNS score in 2007 in the 1-40th or 60-100th percentiles of distribution. If they accept to participate, a new PNNS score will be calculated in 2012-2013 and the subjects in the 1-25th or 75-100th percentiles will be included and explored during one day of participation.

Our aim is to evaluate arterial stiffness, endothelial function, microcirculation and cardiac autonomic system according to PNNS status in a case control study.

Our secondary objective is to evaluate the same parameters in the same subjects but after a breakfast containing 75 g glucose.

Eligibility Criteria:
Inclusion Criteria:

* Social Security affiliation.
* Participation in SU.VI.MAX 2.
* Subjects without legal guardian who can freely agree to participate to the study.
* PNNS score in 2012 lower (cases) or upper (controls) quartile.

Exclusion Criteria:

* Known diabetes or prediabetes before the inclusion.
* History of cardiovascular disease.
* Treatment for hypertension.
* Treatment for dyslipidemia.
* Known Cancer
* Smoking or patients that have stopped smoking less than 3 years
* Cardiac pacemaker
A Study to Monitor Patients With Primary or Early HIV Infection

The purpose of this study is to monitor patients who recently have been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus acts in their bodies.

Primary HIV infection occurs within 20 days to 8 weeks following exposure to HIV. The symptoms of primary HIV infection are usually fever, tiredness, headache, or muscle aches. However, symptoms vary greatly from person to person, and some people might not experience any symptoms at all. Because these symptoms also resemble the cold or the flu, it is difficult to identify patients with primary HIV infection. Information gathered from this study will help doctors decide what kind of treatment is best to give patients who recently have been infected.

Primary HIV-1 infection is frequently identified as a nonspecific viral syndrome occurring within 20 days to 8 weeks following a documented HIV exposure. However, symptoms vary from person to person, and some people undergo asymptomatic seroconversion. Because of the difficulty identifying patients with either acute HIV infection (within 30 days of initial infection) or early infection (within 12 months of initial infection), no systematic review of viral dynamics or immunodynamics in this patient population has been undertaken. A better understanding of the virologic and immunologic parameters during acute and early HIV infection should provide information relevant to the optimal design of future clinical therapeutic trials.

The only patient intervention is obtaining blood, lymph node tissue, CSF, and semen or vaginal secretion specimens at designated intervals according to the schedule of evaluations. Patients are followed for 5 years. Patients may elect to start or discontinue antiretroviral therapy at any time; however, no antiretroviral therapy is administered as part of this study. Descriptive analysis includes tolerance and toxicity, magnitude and durability of RNA suppression, magnitude and durability of immunologic responses (CD4 and CD8 cells), and decay and emergence of resistant virus in tissue reservoirs (CSF, genital secretions, and lymph nodes).

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 13 years old (consent of parent or guardian required if under 18).
* Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests.
Maternal Depression Treatment in HIV

Cluster randomized controlled trial to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the prevention of mother-to-child-transmission (PMTCT) care cascade at 8 antenatal care (ANC) clinics in Uganda.

This study is a cluster randomized controlled trial (RCT) to compare the effects of task-shifted, evidence-based depression care vs. usual care on adherence to each step of the PMTCT care cascade at 8 ANC clinics in Uganda. At 4 experimental sites, task-shifted, depression care will include (1) depression screening and psychoeducation, (2) depression diagnosis, and (3) provision of evidence-based problem solving therapy (PST), or antidepressant therapy (ADT) for those with severe and refractory depression (or who decline PST), to be implemented by trained peer mothers and midwife nurses, respectively. The 4 control sites will use usual care services for managing depression, which consist of referrals to a mental health specialist and access to the Family Support Group program (comprehensive, monthly multi-session psychosocial program to enhance pregnancy management and PMTCT adherence). At each site, 50 HIV-positive newly pregnant women (total n=400) who screen positive for potential depression will be enrolled and followed until 18-months post-delivery to assess how depression and depression alleviation relate to primary (adherence to each component of the PMTCT care continuum, maternal virologic suppression) and secondary (infant HIV status; post-natal maternal and child health outcomes) outcomes, as well as processes of depression care (treatment uptake and depression alleviation among clinically depressed patients). A cost-effectiveness analysis will be used to compare the two study arms.

Eligibility Criteria:
Inclusion Criteria:

* detection of pregnancy through 24 weeks gestation (to ensure at least 12 weeks remaining antenatal period for assessing adherence to all stages of PMTCT care cascade)
* HIV-positive
* positive screen for potential depression on 2-item Patient Health Questionnaire (PHQ-2\>0)
* on ART for at least 4 weeks

Exclusion Criteria:

* unstable health (about to start ART or on ART \< 4 weeks; active, untreated opportunistic infection)
Extension of Rapid Response Team Operation Time and Cardiopulmonary Resuscitation Incidence

Although early rapid response team was reported as a full-time operating system, similar efficacy of part-time rapid response team has been recently reported. We sought to investigate the association between the duration of rapid response team operation time and the incidence of general ward cardiopulmonary resuscitation.

Rapid response team (RRT) was introduced to reduce the preventable cardiac arrest in general wards and it has been spread worldwide. RRTs usually consist of dedicated intensivists in RRT and nurse specialists in critical care.

Although RRT implementation could useful, it is not suitable for all hospital circumstances because it is required high cost and plenty of experience in critical care settings. For this reason, to minimize the RRT operating cost, the part-time RRT operation was reported. Recently similar efficacy in part-time operation RRT was reported. However, it is difficult to compare full-time and part-time RRT and no study has been reported the efficacy according to the intensity of RRT operation time.

Authors invested the incidence of general ward cardiopulmonary resuscitation according to the RRT operation time; from the initial implementation to the full-time RRT operation after stepwise extension.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to study hospital from April 1, 2014, to December 31, 2020

Exclusion Criteria:

1. Patients who developed CPR in elsewhere not GW (ICU, emergency department, operation room, outpatient clinics, cardiac catheterization laboratory)
2. younger than 18 years
3. Patients admitted via the emergency department
Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek.

Half of the patients will not receive fascia iliaca compartment block.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III (American Society of Anesthesiologists classification)
* intertrochanteric fractures
* fractures of femoral neck

Exclusion Criteria:

* existing pain in hip Joint to be operated
* cognitive or mental disorder
* administration of analgesic drugs prior surgery
* contraindications of spinal anesthesia
* refusal to participate in the study
Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) to improve exercise capacity and delay clinical worsening.

This study is a Phase 2, open-label, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.

This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled clinical trial) and meet the eligibility criteria for Study EIG-UBX-002. The primary objective for this study is:

- to obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily \[TID\]) in patients with PAH (WHO Group 1).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed Study EIG-UBX-001 through Week 24.
* In the opinion of the Principal Investigator, has been generally compliant with study requirements during Study EIG-UBX-001.
* Agrees to use a medically acceptable method of contraception throughout the entire study period.
* Willing and able to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.

Exclusion Criteria:

* Is pregnant or lactating.
* Concurrent regular use of another leukotriene pathway inhibitor.
* Any reason that, in the opinion of the investigator, precludes the patient from participating in the study.

  1. Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study
  2. A serious uncontrolled medical disorder/condition that in the opinion of the investigator would impair the ability of the patient to receive protocol therapy
* An ongoing, drug-related, serious adverse event (SAE).
* Significant/chronic renal insufficiency.
* Transaminases (alanine transaminase, aspartate transaminase) levels \>3 × upper limit of normal (ULN) and/or bilirubin level \>2 × ULN.
* Absolute neutrophil count \<1500 mm3.
* Hemoglobin concentration \<9 g/dL at Screening.
Researching AXIUM Coiling Experience and Recanalization (RACER)

The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.

This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.


Eligibility Criteria:
Inclusion Criteria:

* Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
* Must be at least 18 years of age
* Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable
* Patient is willing to conduct follow-up visits

Exclusion Criteria:

* Aneurysm was previously treated
* Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures
* Patient is participating in another clinical research Study
* Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up
* Female patient is pregnant or breast-feeding
Testing the Efficacy of an Online Social Network Intervention to Increase Social Support for Physical Activity

This study was designed to determine whether participation in an online social network intervention increases perceived social support for physical activity versus a minimal education control group by conducting a randomized controlled trial with 140 female undergraduate students. The investigators hypothesize that participants in the physical activity centered online social network intervention group will have greater increases in perceived social support for physical activity compared to minimal web based physical activity education controls.


Eligibility Criteria:
Inclusion Criteria:

* female
* under the age of 25
* currently enrolled full time or part time student at the University of North Carolina at Chapel Hill
* classified as an undergraduate
* answers no to all questions on an exercise risk factor questionnaire (PAR-Q) or is cleared in writing by a physician to participate in an independent exercise program
* a score of less than 3 on the SCOFF eating disorders questionnaire
* less than 30 minutes per day of self reported moderate or vigorous physical activity
* regular Facebook use as defined by self reported owning of an account and use of at least 30 minutes per day
* willing to provide informed consent
* willing to participate in the intervention
* literate in the English language.
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass

Ovarian cancer is a serious health risk with the highest death rate among gynecological cancers. Unfortunately, it's only possible to definitively diagnose ovarian cancer after surgery, as there are no reliable tests to determine if an ovarian abnormality is cancerous or benign before surgery.

Cleo Diagnostics have developed a new test that uses five biomarkers in the blood to better differentiate between benign and malignant ovarian conditions. In initial studies, this test outperformed the current standard test, CA125, in identifying cancer.

This study aims to evaluate the effectiveness of the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System. This test measures five analytes in the blood and provides a score indicating the likelihood of cancer in patients with an adnexal mass requiring surgery. The test is designed to assist doctors in making better-informed decisions about surgery and patient care by providing a more accurate pre-surgical assessment of cancer risk. By doing so, it aims to improve patient outcomes and ensure that those with malignant conditions receive the appropriate specialist care.


Eligibility Criteria:
Inclusion Criteria:

* female patients =\> 18 years of age at the time of consent
* Can provide written informed consent
* Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (e.g. transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery

Exclusion Criteria:

* Any prior confirmed diagnosis of, or treatment for, ovarian cancer
* Any prior surgery resulting in removal of both ovaries
* Prior history of gynecological malignancy (within last 2 years)
* Prior history of melanoma (within last 2 years)
* Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy
* Immune-compromised. Definition: those whose weakened immune system may render them more susceptible to infection, illness, or complications. These may include patients with immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-, chemo- or radio-therapy (within the last 12 months) for any reason, receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease), or with a primary immunodeficiency disorder (e.g. Lupus).
* Pregnant currently or within the last 3 months based on participant self-report