cyrilzakka/clinical-trials huggingface dataset:
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.

The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity.

The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.

Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome.

The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity (total 24 mg in Canada, 22.8 mg in Australia). There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses (Ninan et al JOGC 2020).

Pregnant people at 22 weeks and 0 days to \< 34 weeks and 6 days' gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection (of normal saline) or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity.

Please note: Based on Health Canada's' guidance the study phase is 'Other: Off-Label use'. However, on the clincaltrial.gov record, 'Phase 4' is selected as this is the most relevant phase and there is no option to select 'Other'.

Please note: McMaster University, Canada is the Canadian Regulatory Sponsor and Overall Sponsor, and the University of Adelaide Australia is the Australian Sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and \<34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours
2. Capable of giving informed, written consent.

Exclusion Criteria:

1. Contraindication to corticosteroids
2. Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).
3. Previous participation in this trial (in a previous pregnancy)
4. Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality)
5. Demise of one or more fetuses after 14 weeks and 0 days
Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is major risk factor for acute kidney injury/failure (AKI/F).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective cardiac surgery

Exclusion Criteria:

* patients receiving high dose vitamin B supplementation (defined as more that 200% of recommended daily allowances)
* patients under warfarin therapy
* urgent surgery
* end stage kidney disease
* therapy with multiple nephrotoxic drugs
* chronic kidney disease
* obstructive uropathy
* previous cardiac surgery procedure
* alcohol abuse
* malignancy
* allergy to any ingredient of Myoqinon capsule
* patients receiving Myoqinon and fail to demonstrate a significant increase in blood concentration of Q10
* uncontrolled hypertension
Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease

To evaluate the safety and effectiveness of computed tomography angiography in the diagnostic and therapeutic cycle as the first-choice method of imaging in the diagnosis of patients with a high probability of stable coronary artery disease according to European Society of Cardiology recommendations.

A prospective, randomized open-label, single center trial to evaluate superiority of angio-CT to a classic coronary angiography (concerning effectiveness and safety) in the diagnosis of stable coronary artery disease in patients with indications for invasive coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Patients providing written informed consent
3. Indications for elective invasive coronary angiography defined by European Society of Cardiology as:

   * Left ventricle ejection fraction \<50% and typical angina symptoms,
   * Probability of coronary artery disease due to criteria of age, sex and symptoms \>85%, or
   * Probability of coronary artery disease due to criteria of age, sex and symptoms 50-85% with positive or moderate cardiac stress test.

Exclusion Criteria:

1. No Consent to the study
2. Acute coronary syndrome
3. Recurrence of typical angina symptoms 1 year after the last percutaneous coronary revascularization,
4. Contraindications to invasive coronary angiography
5. GFR \<60 ml/min/1.73m2
6. Significant arrhythmia
7. BMI \>35 kg/m2
Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis

The term cellulitis is a medical term describing a bacterial infection of the skin and tissues beneath the skin. Although it is usually easily treated with antibiotics given either orally or through a vein (intravenously), knowing which route of antibiotic treatment to prescribe to a person attending an Emergency Department with cellulitis is not clear.

A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which patients require oral and which patients require intravenous antibiotics for cellulitis from their first visit to an emergency department. The aim of this is to provide safer care by reducing the risk of a patient returning to the hospital with a worsening infection. It will also promote more cost-effective care by reducing hospital re-attendance rates and wasted antibiotics.

Patients attending the department with cellulitis who are suitable for oral antibiotic treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of study participants in order to reduce bias. A set of physical signs and symptoms will be recorded from each patient in order to determine which ones are associated with them "failing" prescribed oral treatment. A study investigator will then phone the patient after 14 days to see whether they are better or whether they required intravenous antibiotics to get better.


Eligibility Criteria:
Inclusion Criteria:

* Age \>16 years
* Suitable for treatment with flucloxacillin 500mg -1gram qds monotherapy or a suitable alternative for penicillin allergic patients as listed in the local prescribing guidelines.
* Appearance of typical, plaque-like area of erythema over any body part excluding the perineum within the preceding 5 days with any 2 of the following signs:
* 1.Increased warmth over affected area
* 2.Swelling of affected area
* 3.Pain over affected area
* 4.Regional lymphadenopathy

Exclusion Criteria:

* Requirement for IV antibiotics as decided by the treating clinician.
* Age less than 16 years.
* No telephone or access to a telephone.
* Abscess alone without co-existing signs of cellulitis
* Mammalian bite wounds.
* Infected diabetic foot ulcer
* Necrotising soft tissue infections.
* Perineal cellulitis.
* Suspected septic arthritis or osteomyelitis.
* Decubitus ulcers.
* Bilateral cellulitis (as this entity rarely exists).
* Acute lipodermatosclerosis.
* Acute dermatitis.
* Venous stasis dermatitis.
* Deep vein thrombosis.
* Pregnancy.
* Cognitive impairment.
* Any patient who through language barrier or diminished capacity is unable to understand the scope of the study
Clinical Pathways for Effective and Appropriate Care

The purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice.

The coordination of care has been proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, has become essential part of effective treatment, as well as organized rehabilitation. The importance of organized stroke care in facilitating recovery has been recognized for the last 10 years, but it is still unclear how organized care contributes to improved outcomes. Since clinical pathways aim to promote evidence- and guideline-based care, improve the organisation and efficiency of care, and reduce cost, their implementation may be a method for achieving the organizational standards required to grant appropriate care in stroke. Even though in the past decade, care pathways have been increasingly implemented as a tool in acute stroke care and stroke rehabilitation the evidence supports partially the use of clinical pathways in stroke because very little prospective controlled data demonstrated their effectiveness through the continuum of the care. Our study was designed in order to conduct a rigorous evaluation of clinical pathways for treatment of acute stroke patients in different types of organized stroke care.

Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of Ischemic Stroke (ICD9CM code 434.91)

Exclusion Criteria:

* Transient cerebral ischemia (ICD9CM code 435.9)
* Intracerebral hemorrhage (ICD9CM codes 431.xx)
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results

Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.


Eligibility Criteria:
Inclusion Criteria:

* Participant with eligible for laparoscopic surgery

Exclusion Criteria:

* Participant with umbilical scar due to previous surgery, burn eg.
Hypercoagulability After Breast Cancer Surgery

The risk of deep venous thrombosis after radical breast surgery is known. The objective of this study is to explore hypercoagulability after radical breast cancer surgery by studying several factors for haemostasis before, during and after surgery. Ultrasound Doppler examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen thrombin potential.


Eligibility Criteria:
Inclusion criteria:

* Breast cancer
* mastectomy

Exclusion criteria:

* thrombophilia
* anticoagulant treatment
The Effect of IoT-based Smart Exercises System in the Senior Adults

Subjects are divided into two groups, (1) Control (Ctrl) and (2) Smart Exercise (SE) group. Ctrl group are instructed to maintain their daily life. SE participants are instructed to do exercise with smart exercise system twice per week for 12 weeks. The physical fitness tests and questionnaire of both group are performed before and after the 12-week exercise program.

The smart exercise system contain an upper extremity cycle ergometer (UEE) and a lower extremity cycle ergometer (LEE). SE group are instructed to do once session of UEE and once session of LEE per week, 30 minute per session, lasting for 12 weeks. Before each exercise, the physiological parameter are measured to ensure safety. During exercise, heart rate of user and revolutions per minute (RPM) of the ergometer is detected per second. After each session of exercise, the rating of perceived exertion (RPE) of user is also inquired and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult over 50 years old
* No significant limb disability or joint deformation
* No history of cardiovascular disease
* Never lost balance due to dizziness in the past 12 months

Exclusion Criteria:

* limb disability or joint deformation
* history of cardiovascular disease
* lost balance due to dizziness in the past 12 months
* cognitive deficits
Energy Content and Energy Density of Pre-portioned Entrees

Pre-portioned entrées are commonly consumed to help control portion size and limit energy intake. Few studies, however, have investigated the influence of the characteristics of pre-portioned entrées on energy intake. This study investigates how the characteristics of solid pre-portioned entrées, specifically, variations in their energy content and energy density influence energy intake over a day. The investigators hypothesize that reducing the energy content and energy density of compulsory entrées will act independently and add together to reduce daily energy intake.

This experiment uses a crossover design with repeated measures within subjects. One day a week for four weeks, participants are provided with all of their foods and beverages for breakfast, lunch, and dinner meals. Across test days, the entrée at each meal is varied in both energy content and energy density between a standard level (100%) and a reduced level (64% of the standard). Following consumption of a compulsory entrée, a variety of unmanipulated foods will be served for ad libitum consumption. The order of experimental conditions is counterbalanced across the subjects.

Eligibility Criteria:
Inclusion Criteria:

* regularly eat three meals per day
* do not smoke
* do not have any food allergies or restrictions
* are not athletes in training
* are not dieting
* are not taking medications that would affect appetite
* are willing to consume the foods served in the test meals

Exclusion Criteria:

* a score \> 40 on the Zung scale
* a score \> 20 on the Eating Attitudes Test
* reported known health problems
* weight not maintained within 10 lb during the 6 months before the start of the study
Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)

To explore the reliability of P-31 MR spectroscopy mitochondrial function in patients with peripheral arterial occlusive disease.

Peripheral arterial occlusive disease (PAOD) is defined as the partial or total obstruction of one or more lower extremity arteries, most often of atherosclerotic origin. It is a common disease whose 5-years mortality is near 30%.The positive diagnosis is based on clinical examination and measurement of the ankle-brachial index (ABI), which is the ratio of systolic pressure of ankle and brachial systolic pressure. The threshold value for the diagnosis is \<0.90. Physiopathologically, mitochondria have the predominant role of providing the ATP necessary for the energetic needs of myocytes, which increase drastically during muscle contraction during exercise. This energy production is of course conditioned by the availability of oxygen. In patients with PAOD, the decrease in blood flow secondary to significant stenosis has the direct consequence of disrupting oxygen delivery to distal muscles and thus limiting muscular performance. Because mitochondrial respiration is the only metabolic pathway capable of providing the energy needed to sustain an effort of several minutes, intermittent claudication in PAOD has logically been related to a hemodynamic mechanism of intermittent muscle hypoperfusion. Recently, an increasing number of histological or functional studies have suggested that episodes of ischemia-reperfusion could induce mitochondrial dysfunction. Medical treatment of patients frequently includes statins while a direct deleterious effect on mitochondrial function has been suspected, inducing a deterioration of the muscular oxidative capacity which would increase the factors hemodynamics and may accumulate in mitochondrial myopathy. In the light of these elements, it is clear that there would be a benefit in being able to distinguish and quantify 1) the part of the reduction of mitochondrial activity secondary to the hemodynamic factor alone due to a decreased muscle perfusion 2) the mitochondrial involvement (mitochondriopathy) potentially induced by oxidative stress in PAOD. 2 sub-groups are distinguished to identify the statin-induced mitochondrial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Peripheral arterial occlusive disease (PAOD) with claudication and surgery planning with proximal lesion (iliac or femoral (x-ray angiography or CT or MRA) and no distal lesions (doppler)
* ABI\<0.90 or \>1.30
* signed consent form
* health insurance coverage

Exclusion Criteria:

* Contraindication in the practice of MRI: pacemaker, metallic cardiac valve, intra-ocular metal part, claustrophobia
* critical ischemia \>15 days
* Type 1 or 2 diabetes
* weight \>200kg
* non stabilized hypertension
* beta-blockers
* non-atherosclerotic vascular occlusive disease (Buerger disease, Takayasu disease, venous disease, trapped popliteal artery etc..)
* Neurological pathology/non-voluntary contraction
Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial

The objective of this study is to compare two metabolically distinct diets, WFKD vs Med-Plus, in order to examine the potential benefits, and unintended consequences, of going beyond a focus on maximally avoiding added sugars and refined grains, to also avoiding legumes, fruits, and whole grains.

The proposed randomized clinical trial will investigate differential population-specific effects of two low-carbohydrate (low-carb) diet patterns, addressing a gap in the evidence base in this area that will lead to 1) improved treatment strategies for common adverse clinical conditions, 2) improved health for these individuals, and 3) long-term decreases in health care costs. This impactful research will advance the field of personalized and precision medicine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c \</= 5.7% OR Fasting Glucose of \>100 mg/dL)

Identify exclusion criteria.

* Weight \< 110 lb
* BMI \> 40
* LDL-C \>190 mg/dL
* Blood pressure: SBP \> 160 mmHg OR DBP: \> 90 mmHg

Exclusion Criteria:

* Weight \< 110 lb
* BMI ≥ 40
* LDL-C \>190 mg/dL
* Systolic blood pressure (SBP) \> 160 mmHg OR Diastolic blood pressure (DBP) \> 90 mmHg
* Diagnosed with type 1 diabetes or history of ketoacidosis
* Uncontrolled and untreated diabetes (by discretion of study physician)
* Active cardiovascular disease (in past year with myocardial infarction, coronary stent or bypass surgery)
* Kidney disease (eGFR less than 50 mL/min per 1.73 m2)
* Liver disease (liver transaminase higher than 3 times the normal range for the laboratory)
* Symptomatic gallstones
* History of bariatric surgery
* Anemia
* Taking any of the following medications in past 3 months: SGLT-2 inhibitors, GLP-1 receptor agonist, Insulin, Amylin analog, Alpha-glucosidase inhibitor, Dopamine agonist, Bile acid sequestrant.
* Taking any medications for weight loss
* History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
* Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
* Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or \> 14 drinks/week.
* Women: Pregnant currently or planning to become pregnant during the course of the study, and/or breastfeeding
* Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products
* Regular use of prescription opiate pain medication
Indicated Prevention With At-Risk Gamblers

The overall purpose of this study is to reduce the prevalence of gambling risk in college students by evaluating the effectiveness of different treatments in reducing gambling behavior and related negative consequences.

Participants in this study will be randomly assigned to a personal feedback intervention (PFI) or assessment only for 3 years. The PFI intervention will be delivered in a single session. Measures will include the NORC DSM Screen for Problem Gambling (NODS), the South Oaks Gambling Screen (SOGS), Gambling Quantity and Perceived Norms, Perceived Injunctive Gambling Norms, Gambling Problems Index, gambling frequency, attitudes and beliefs about gambling and self-control, readiness to change, gambling expectancies, gambling motives, gambling risk perception, psychiatric symptoms, assertiveness, coping skills, substance use, alcohol-related problems, self-determination, and social desirability.

Eligibility Criteria:
Inclusion Criteria:

* College student
* South Oaks Gambling Screen (SOGS) score greater than 3

Exclusion Criteria:

* None, other than not meeting inclusion criteria
Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

The purposes of this study are to determine:

1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
2. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
3. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
4. To see if patients feel better while taking pemetrexed plus Gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy
* Have received no prior chemotherapy for Non-Small Cell Lung Cancer
* Have at least one measurable lesion
* Have an adequate performance status
* Sign an informed consent

Exclusion Criteria:

* A female who is pregnant or breastfeeding
* Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed
* Treatment with radiation therapy within the last 1-2 weeks
* Brain metastasis that is uncontrolled
* Active infection or other serious condition
Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2

Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age,
* Endotracheal intubation in pre-hospital and mechanical ventilation,
* Monitoring of Etco2 in pre-hospital settings

Exclusion Criteria:

* Identification of a chest wound blowing during pre-hospital care,
* No technical possibility for performing or analysing arterial sampling,
* Death during pre-hospital care,
* A person who has objected to the processing of his data for research at minimal risk and constraints (category 2) or for research on data, as well as persons subject to legal protection measures.