cyrilzakka/clinical-trials huggingface dataset:
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor

The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.

This is a single-site before and after study comparing the strategy of liberal versus indicated use of maternal oxygen in the first and second stages of labor in the setting of a category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann Hospital in Houston, Texas during the time frame of the study will be included in the study. The study will be conducted over 18 weeks. It will involve two 8 week time periods during which all patients will under either a strategy of liberal administration of oxygen use (current practice) in the "before" portion of the study and indicated administration of oxygen in the "after" portion of the study (new practice). There will be a transition period where training, education, and audit + feedback will be done to prepare for a strategy of indicated administration of oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with singleton gestation between 37 weeks 0 days to 42 weeks 0 days gestation who present to labor and delivery at Memorial Hermann Hospital in Houston, TX for planned labor attempt.

Exclusion Criteria:

* Lethal fetal anomaly defined as anomaly in which the fetus is unlikely to survive or the neonate is not expected to survive to initial hospital discharge
* Antepartum or intrapartum fetal demise
* Preexisting maternal conditions requiring oxygen for maternal indication, including but not limited to: Asthma that has required intubation or hospitalization in the past or currently requiring steroids (either inhaled or oral); Chronic obstructive pulmonary disease; Chronic bronchitis; Congestive heart failure/peripartum cardiomyopathy; Pneumonia; Pulmonary edema; Pulmonary embolus
Oxidized LDL With Oxygen Therapy in Acute Coronary Syndrome.

Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor for the development of CAD. However, whether oxidized-LDL (ox-LDL) can be used as a risk factor for myocardial infarction (MI) has not been fully investigated. Therefore, the aim of the present study was to examine the role of ox-LDL as a risk factor for the presence and clinical outcomes in patients with MI.

Cardiovascular disease, which is multifactorial and caused by complex interactions of genetic and environmental factors, represents the main cause of death all over the world. Traditional risk factors for coronary atherosclerosis include age, smoking, male gender, hypertension and diabetes. Newly defined risk factors such as hyper-homocysteine, elevated plasma levels of OxLDL and oxidative stress are also emerging.

Lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is the major receptor of oxidized low-density lipoproteins which regulates the growth of a variety of cells and is important in inflammation, atherosclerosis, oxidative stress, and tissue remodeling. LOX-1 is expressed in various cells, including endothelial cells, macrophages, and chondrocytes, and its expression is enhanced by proinflammatory cytokines. The LOX1 gene, also known as OLR1, is located on the chromosome 12p13.1-p12.3. The LOX1 protein is synthesized as a 40-kDa precursor protein and is composed of four domains: an extracellular lectin-like domain at the C-terminal, a connecting neck domain, a transmembrane domain, and an N-terminal cytoplasmic domain. Three single nucleotide polymorphism (SNPs), namely, intron 4 (G→A), intron 5(T→G), and 3' UTR (T→C) in the LOX1 gene, have been previously reported. These polymorphisms have also been associated with CAD.

Oxygen is a lifesaving drug. Giving oxygen to a patient with an impending clinical emergency has become knee-jerk reflex reaction of the clinician. Patient with AMI has compromised myocardial perfusion and event arises due to myocardial hypoxia. It appears quite logical and biologically plausible to give oxygen in such situations to improve the oxygenation of the ischemic myocardial tissue and decrease ischemic pain. On the other side, oxygen may be harmful with a mechanism such as the paradoxical effect of oxygen in decreasing coronary artery blood flow and increasing coronary vascular resistance due to increased oxygen free radicals. The investigators aimed to examine the association of the OLR1 gene with AMI or CAD in a novel, well-phenotyped, and homogenous, population and its correlation with oxygen therapy in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included irrespective of concomitant risk factors for atherosclerosis such as smoking, arterial hypertension and diabetes mellitus.
* Participants were both sexes.

Exclusion Criteria:

* Congenital heart disease.
* Dilated, hypertrophic or restrictive cardiomyopathy.
* acute and chronic liver disorders.
Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test

Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs.

Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs. To investigate whether treatment decisions guided by MBDA scores result in reduced disease activity and overall medical cost among patients with RA relative to usual care (UC).

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign an informed consent form (ICF)
* Age at least 18 years old at screening visit
* Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology
* Actively managed by a CareFirst health care practitioner
* Currently taking one or more biologic and/or non-biologic DMARDs listed in Appendix 2
* Currently has CareFirst medical coverage

Exclusion Criteria:

* Active infection
* History of malignancy within the past 5 years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
* Current enrollment in another clinical trial
* On non-biologic DMARD monotherapy or combination therapy with stable disease for ≥6 months
* Any condition or circumstance that makes it likely the patient will not be able to complete the 9-month trial
Diet Intervention on Obesity Related Complication

Obesity has become a global epidemic, with more than 4 billion people expected to be overweight/obese by 2035, accounting for more than half of the world's population. Currently, there are sixteen recognized complications directly related to obesity, including gastroesophageal reflux disease. In recent years, people have increasingly paid attention to the damage caused by obesity to the stomach. In addition to gastroesophageal reflux disease, obesity also leads to various forms of gastric mucosal damage related diseases, such as gastric ulcers, chronic gastritis, intestinal metaplasia, and so on. This stuty aimed to observe the diet intervention on obesity related stomach.

Western foods high in fat, sugar, fiber and additives can lead to a series of health problems, ultimately leading to obesity and obesity-related complications. The gastrointestinal tract is directly connected to the outside world, so its influence on dietary factors cannot be underestimated. In recent years, the intake of ω-6 polyunsaturated fatty acids (ω-6 PUFAs) in the Western diet is 10-20 times higher than the normal range, of which the seriously excessive linoleic acid (LA) is also getting more and more attention

Eligibility Criteria:
Inclusion Criteria:

1. Obtain informed consent before carrying out any trial-related activity, which is any procedure carried out as part of a trial, including the identification of activities suitable for the trial
2. Men and premenopausal women, ages 18-65 at the time of signing the informed consent form
3. Obese patients are diagnosed based on a body mass index (BMI) of 28-40kg/m2

Exclusion Criteria:

1）Patients who do not possess or lose the ability to make their judgment, are unable to understand the purpose of the study, or are unwilling to cooperate with it; 2) Heart, liver, kidney dysfunction，and systemic diseases, such as various malignant tumors, systemic allergic diseases, and autoimmune diseases; 3）Drug or alcohol dependence, intellectual disability, mental disorders; 4）Pregnant and lactating women; 5) Confirmed Helicobacter pylori infection (PPI, bismuth, and antibiotics were stopped for at least 4 weeks, and any of the following tests were positive: non-invasive HP test such as urea breath test, monoclonal stool Helicobacter pylori antigen test, serum soluble Helicobacter pylori antigen test; Invasive Hp test included rapid urease test and tissue section staining); 6）diagnosis of acute gastric mucosal lesions; 7）the patient was diagnosed with chronic gastritis according to the new Sydney system visual simulation scoring method and the pathological diagnostic criteria of chronic gastritis in China; 8） histological and imaging examinations, adenocarcinoma was diagnosed.
Cohort Study of Risk Factors for Postoperative Cognitive Decline

Presently, the role of either genetic factors or biological sex in the development of postoperative cognitive dysfunction (POCD) is unknown. There is a critical need to determine which individuals are at high-risk for developing POCD by virtue of biological sex or genetic predisposition. The knowledge gained in the described research has the potential to shed light on mechanistic pathways, a necessary next step in order to ultimately identify therapeutic strategies.

Adults 65 years and older represent the fastest-growing age group in the United States, and account for one third of all surgical patients. These older adults are at the highest risk for deleterious postoperative neurocognitive outcomes. Postoperative cognitive dysfunction (POCD) occurs in up to 40% of older adults after major non-cardiac surgery. POCD is a syndrome characterized by a decrease in performance on neuropsychological test battery from before to after surgery. Neuropsychological testing for POCD typically spans cognitive domains including memory, attention, concentration, and/or executive function. There is an increasing body of literature suggesting that exposure to surgery and anesthesia increases the risk of Alzheimer's disease (AD). Surgery and anesthesia enhance neuropathologic changes known to underlie AD including amyloid beta accumulation and aggregation, neuroinflammation, increased levels of tau and tau phosphorylation, and memory decline. However, not everyone with a history of surgery and anesthesia develops POCD, suggesting biological risk factors are involved.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an in-patient, elective spine surgery where subject will receive general anesthesia
* Presenting to spine clinic and undergoing conservative, non-surgical management of spine disorder
* Subjects must have sufficient vision and hearing to complete neuropsychological testing
* Proficient in spoken and written English language

Exclusion Criteria:

* Diagnosed dementia or dementia-related treatment (i.e. donepezil prescription, or memory-care facility residence)
* Significant disease of the central nervous system (CNS) (i.e. Parkinson's disease)
* History of stroke or traumatic brain injury
* Major psychiatric disorder (i.e. schizophrenia)
* Alcohol or drug abuse according to DSM-V within the last 2 years
* Need for urgent/emergent surgery
* Surgery/anesthesia within prior 12 months
* Refusal of consent
Lung Function After Abdominal Surgery

The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.

Inclusion: Patients undergoing surgery for abdominal surgery

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Investigation: The day before surgery and the day after surgery

Primary outcome measures:

* Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.
* PaO2, PaCO2 and oxygen saturation (blood gas)

Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%.

The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.

Design: Prospective cohort study

Inclusion: Patients undergoing surgery for abdominal surgery

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Method: The day before surgery and the day after surgery: Lung function (Vital capacity and FEV1) using box and diffusion capacity measurements and blood gas measurement

Primary outcome measures:

* Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.
* PaO2, PaCO2 and oxygen saturation (blood gas) Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery, previously known lung disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years old and older) scheduled for surgery in the abdomen at department of Surgery, Urology and Gynecologi, Umeå University hospital.
* Must be able to perform a lung function test

Exclusion Criteria:

• Dementia or severe cognitive impairment
Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial

The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven gastric or gastroesophageal adenocarcinoma
2. ≥ D2 lymph node dissection, curative gastrectomy
3. Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
4. Age \> 19
5. ECOG 0-2
6. No distant metastasis
7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
10. Written informed consent
11. Possible oral intake (food, drug)

Exclusion Criteria:

* Subjects presenting with any of the following will not be included in the study

  1. Active infection requiring antibiotics
  2. Pregnant, lactating women
  3. Concurrent systemic illness not appropriate for chemotherapy
  4. Resection margin (+) at permanent pathology
  5. Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
  6. Inadequate surgery including D0, D1 resection, dissected LNs less than 12
  7. Paraaortic lymph node (+), pathologically proven
  8. women of potential childbearing not employing adequate contraception
Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses

This study evaluates the optical quality and clinical performance of the Asqelio™ EDOF Toric intraocular lens (IOL) in patients undergoing cataract surgery or refractive lensectomy. The Asqelio™ EDOF Toric IOL aims to provide improved vision at various distances and correct astigmatism compared to monofocal IOLs. Postoperative outcomes, including visual clarity, refractive correction, and patient satisfaction, will be assessed three months after surgery.

Cataract surgery is one of the most common procedures worldwide, typically involving the replacement of the cloudy natural lens with an intraocular lens (IOL). Traditional monofocal IOLs correct vision for a single distance but do not address intermediate or near vision, leading to dependence on glasses. The Asqelio™ EDOF Toric IOL is designed to provide extended depth of focus, smoother transitions across distances, and astigmatism correction, potentially enhancing overall visual quality and reducing the need for glasses.

This study compares the optical performance and patient outcomes of the Asqelio™ EDOF Toric IOL with those of monofocal IOLs. Key measures include optical quality, visual acuity at multiple distances, refractive correction, and patient-reported satisfaction. Results will be collected during a three-month postoperative follow-up. The findings aim to inform the effectiveness of the Asqelio™ EDOF Toric IOL in improving visual outcomes and quality of life for patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 years or older who have undergone cataract surgery with phacoemulsification or refractive lensectomy, with bilateral implantation of the Asqelio EDOF toric IOL model ETLIO130C/ETPIO130C with a cylinder value of 0.0 D, or the spherical monofocal J\&J TECNIS 1-Piece IOL model ZCB00.
* Patients who have signed the informed consent form.
* Clear intraocular media, except for the presence of cataracts in both eyes prior to surgery.
* Postoperative potential visual acuity of 20/25 or better

Exclusion Criteria:

* Preoperative corneal astigmatism greater than 1.00D.
* Patients who do not provide informed consent.
* Patients who do not understand the study procedure.
* Previous corneal surgery or trauma.
* Irregular cornea (e.g., keratoconus).
* Choroidal hemorrhage.
* Microphthalmos.
* Severe corneal dystrophy.
* Uncontrolled or medically controlled glaucoma.
* Clinically significant macular changes.
* Severe concomitant ocular disease.
* Cataract unrelated to aging.
* Severe optic nerve atrophy.
* Diabetic retinopathy.
* Proliferative diabetic retinopathy.
* Amblyopia.
* Extremely shallow anterior chamber.
* Severe chronic uveitis.
* Pregnant or breastfeeding.
* Rubella.
* Mature/dense cataract preventing preoperative fundus examination.
* Previous retinal detachment.
* Concurrent participation in another drug or clinical device investigation.
* Expectation of needing another ocular surgery during the study period
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
Long-Term Effects of Aortic Valve Mismatch

The real impact of the existence of an aortic valve mismatch after aortic valve replacement in various studies conducted so far is a source of controversy. There is currently no long-term impact of the aortic valve mismatch on the reversal of left ventricular remodeling and its impact functional.To evaluate these effects of aortic valve mismatch on abilities to the effort, the quality of life and the regression of left ventricular hypertrophy long term after a aortic valve replacement, conducting a new study is fundamental. This study is even more essential in patients with a young life expectancy theoretical long and physical activity.Our study aims to determine whether the existence of an aortic valve mismatch has an influence on: The functional capacity to the effort by measuring the maximum oxygen consumption during a stress test (VO2 max) The reversal of left ventricular remodeling (cardiac ultrasound doppler), diastolic dysfunction (cardiac ultrasound and Doppler measurement Brain Natriuretic Peptide (BNP). This study will analyse these data in patients who received youth a VAN by mechanical aortic valve prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patient major ≤ 60 years at the time of the aortic valve replacement.
* Patient affiliated with a social security
* Consent dated and signed by the investigator and the subject
* Subject having been informed of the results of the visit prior aortic valve replacement by mechanical prosthesis for pure aortic narrowing.
* Fraction left ventricular ejection ≥ 50%, when aortic valve replacement and at the time of inclusion.
* Aortic insufficiency at aortic valve replacement associated \<II / IV.
* aortic valve replacement exclusive (no gestures associated: coronary bypass, enlargement of the ring, another valve surgery,...).
* Coronarography normal at the aortic valve replacement.
* Normal renal function.
* No history of heart failure episode in the previous month inclusion.
* No indication against a stress test on bicycle ergometric

Exclusion Criteria:

* Refusal of the patient to be included in the study.
* History of cardiac surgery under extra body movement before and / or after the aortic valve replacement.
* Aortic insufficiency associated with the time of the transaction\> II / IV.
* Chronic respiratory insufficiency.
* Track cancer or cancer evolving.
* Evolutionary Osteoarthritis of the lower limbs or widespread.
* Myopathy device.
* Alteration higher making it impossible to carry out the test effort and response to the questionnaire on the quality of life.
* Coronaropathy documented.