cyrilzakka/clinical-trials huggingface dataset:
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged ≥18.
* Normal healthy volunteers based on medical history, clinical assessments, and laboratory assessments.
* Body mass index 25-35 kg/m2.
* Willingness to maintain current activity level.
* Willingness to adhere to the Therapeutic Lifestyle Changes (TLC)diet during screening and treatment washout periods.

Exclusion Criteria:

* Intolerance to omega-3 fatty acids, ethyl esters, or fish.
* Unable or unwilling to eat the study meals.
* Use of fish oil, other EPA or DHA containing supplements, or EPA and/or DHA fortified foods within 60 days of Visit 2, or during the study.
* Consumption of any fish within 7 days of Visit 2, or during the study.
* Use of flaxseed, perilla seed, hemp, spirulina, or black currant oils within 7 days of Visit 2, or during the study.
* History of malabsorption syndrome, Crohn's disease, acute or chronic pancreatitis, pancreatic insufficiency, small bowel resection.
* Women who are pregnant, lactating, or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Examples of acceptable contraceptive methods include abstinence, intrauterine device (IUD) or double barrier method, oral or injectable contraceptives.
* Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
* Exposure to any investigational product, within 28 days prior to Visit 1.
* Any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
International Survey of Childbirth-Related Trauma - Swedish Part

The goal of this cross-sectional observational study is to analyze childbirth-related PTSD, traumatic birth experiences and stress symptoms postpartum. The main questions it aims to answer are:

* What is the prevalence of traumatic birth experiences, PTSD and stress symptoms in a Swedish postnatal sample?
* What are the risk factors for postnatal mental ill-health?

Additional goals are to make cross-cultural translations of the instruments City BiTS and Birth Satisfaction Scale - Revised.

Participants will answer an online surveys including several instruments measuring postnatal stress and mental ill-health.


Eligibility Criteria:
Inclusion Criteria: having given birth 6-16 weeks previously -

Exclusion Criteria: having given birth to a child that did not survive

-
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors

The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.

This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The control group will receive a brief consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs. Additionally, a written directory of a range of social support resources will be delivered to them via mail. The treatment group will receive the aforesaid intervention plus brief advice to quit smoking (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants' perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also important). The emphasis on smoking cessation induction (that is, the inducement or promotion of a quit attempt) is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit.

Eligibility Criteria:
Inclusion Criteria:

* Cervical or head/neck cancer diagnosis in the past 5 years
* Resident of rural and/or Appalachian Kentucky county at cancer diagnosis
* Current smoker of ≥ 10 cigarettes per day, on average
* Age 18-75 years old
* Able to read, write, and understand English

Exclusion Criteria:

* Unreliable phone access
* Smoking cessation treatment use in past 30 days
* Non-cigarette tobacco use in the past 30 days
* Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months
* Cognitive or psychiatric disorder that would interfere with ability to provide informed consent or answer survey questions reliably \*

  \* Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric disorders would make someone ineligible: bipolar; delusional; dissociative; intellectual developmental; neurocognitive; psychotic; schizophreniform, schizophrenia, and schizoaffective.
* For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months
* For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study
The Effect of Autologous Stromal Vascular Fractions on Skin Regeneration

The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.

This is a randomized controlled single blind clinal trial that designed to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.

The clinical trial will concentrate on the therapeutic effect of SVF after facial injection. After 1, 4, 8, 12, 24 and 48 weeks of treatment, a comprehensive examination of the facial skin was performed to assess the effect of the SVF. Skin texture, thickness and colour will be observed to evaluate the effect of SVF on skin regeneration

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 65.
* No other facial plastic surgery or cosmetic surgery was performed during the study period (frontal, temporal, and lower eyelid).
* Intends to undergo facial anti-aging treatment with SVF

Exclusion Criteria:

* Not fit for stem cells graft treatment.
* Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for SVF treatment; or history of delayed healing, radiational therapy.
* Significant renal, cardiovascular, hepatic and psychiatric diseases.
* Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV).
* Used external medication on the targeting area within 4 weeks.
* Skin invasive treatment including laser on the targeting area within 6 months.
* Hyaluronic acid injection on the targeting area within 12 months.
* Botulinum toxin injection on the targeting area within 6 months.
* History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis.
* Evidence of malignant diseases or unwillingness to participate.
Treatment of Great Saphenous Vein Varicosities

Venous insufficiency at lower extremities may result in clinical problems from cosmetic issues to ulcerations. When the frequency of venous insufficiency and its related problems are considered besides their diversity, it is encountered as a public health issue. This pathology is reported to affect 40% of women and 20% of men.1 Patients with varicose veins may complain of unsightly appearance, aching, heaviness, pruritus, and early fatigue of the affected leg. These symptoms worsen with prolonged standing and sitting and are relieved by elevation of the leg above the level of the heart. Also, mild edema is often present. More severe signs include thrombophlebitis, hyperpigmentation, lipodermatosclerosis, ulceration, and bleeding


Eligibility Criteria:
Inclusion Criteria:

* Patients presented by primary VV of the LL complaining of Leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at LL
* the incompetence of the saphenofemoral junction (SFJ) and or saphenopopliteal junction (SPJ).

Exclusion Criteria:

* Lower limb involvement by any of the following conditions; secondary VV, recurrent VV, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia
A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery

This is a single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7 days of ONS supplementation combined with resistance training and nutritional education compared to standard of care, consisting of nutritional education alone.

This proof of concept study is intended to demonstrate the ability of pre-habilitation to improve patient-related outcomes following pancreatic surgery, specifically postoperative complications. The rationale for using the designated oral nutrient supplementation is to preserve muscle mass, and decrease weight loss.

Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected pancreatic cancer represent the study population for this clinical trial.

Study subjects randomized to one of the ONS arms will be asked to consume the drink during the study intervention. Study visits immediately preoperative, and 1, 3, and 6 months following surgery will be in-person visits. If subjects are unable to return to our Institution for subsequent clinical care, these telephone interviews will be collected and acquisition of locally obtained laboratory tests will be attempted.

Assessments performed during postoperative visits include:

* Vital signs and physical examination
* Blood samples
* Performance status and strength
* Quality of life measures
* Postoperative complications and hospital readmissions (if any)

Eligibility Criteria:
Inclusion Criteria:

1. Age 40-89 at the time of study enrollment.
2. Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.
3. Ability and willingness to complete study related documents and activities.

Exclusion Criteria:

1. Severe malnutrition that in the judgment of the patient's supervising physician or an investigator would not permit surgical intervention without preoperative nutritional support (enteral or parenteral).
2. Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery.
3. Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention).
4. Known allergy to soy or milk, which are included in the oral supplement.
5. The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia).
6. Pregnancy, incarceration, or inability to provide written informed consent.
Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.

Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Healthy volunteers according to medical history, physical exam, clinical laboratory, chest X-rays and ECG.
* Gender: males and non pregnant females
* Age: 18 to 55 years.
* Body mass index: 19 to 27 kg/m\^2.

Exclusion Criteria:

* History of liver or renal disease, or psychiatric disorders.
* History of drug or alcohol abuse during the previous two years.
* Smokers of more than 10 cigarrettes a day.
* Any kind of medicines taken during the previous two weeks.
* Any history of disease or disorders clinically significant according to the Principal Investigator.
* Abnormal ECG.
* Abnormal chest X-ray.
* Hypersensitivity to quetiapine or excipients within the formulations.
* Positive diagnostic test for HIV or hepatitis A, B or C virus.
* Breast feeding females.
* Positive beta-HCG test.
* Positive drug test in urine.
* Participation in clinical trials in the previous three months.
* Blood donation in the previous three months.
* Clinically significant laboratory results.
* Subjects seeking to initiate any medical or pharmacological treatment.
* Subjects unwilling to keep fasting or diet indications.
* Uncooperative subjects.
Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation

Magnesium is essential in human physiology. Simultaneous pancreas-kidney (SPK) transplant recipients frequently experience hypomagnesemia. The effects of hypomagnesaemia are harmful. This observational study assessed intraoperative magnesium supplementation's utility in patients undergoing SPK transplantation. Perioperative hemodynamics were monitored. Postoperative serum magnesium was monitored at 12 hours and 48 hours.

A vital component of human physiology is magnesium. It is common for recipients of simultaneous pancreas-kidney (SPK) transplants to have hypomagnesemia. The consequences of hypomagnesaemia are detrimental. This prospective observational study evaluated the effectiveness and safety of intraoperative magnesium supplementation in adult SPK transplant recipients. Arrhythmia and perioperative hemodynamics were observed. Serum magnesium levels were checked 12 and 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult diabetic patients who require insulin therapy and hemodialysis due to pancreatic-kidney failure.

Exclusion Criteria:

* Adult diabetic patients who do not require insulin therapy and hemodialysis.
Optic Nerve Sheath Diameter in Hypertensive Emergency

This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of \> 200 millimetres of mercury (mmHg) systolic and/or \> 120 mmHg diastolic

Exclusion Criteria:

* Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible.
* Primary neurological cause of hypertension: ischemic cerebrovascular incident
Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude Illness

The purpose of this study is to determine whether regular oral use of sildenafil citrate can prevent or attenuate high altitude illnesses.

High altitude pulmonary oedema (HAPE) is a life-threatening non-cardiogenic lung injury precipitated by exaggerated pulmonary hypertension. The incidence of this rapidly progressive illness, among the estimated 40 million visitors to high altitude each year, may be as high as 0.5-2.0%. The pathogenesis of HAPE is multifactorial and may include impaired clearance of alveolar fluid, increased pulmonary vascular permeability and genetic susceptibility. Elevated pulmonary artery pressure (PAP) caused by hypoxic pulmonary vasoconstriction (HPV) is a key prerequisite for the development of HAPE and thus the reduction of PAP is paramount in the prophylaxis and treatment of this devastating illness.

Nitric oxide (NO) is thought to play an important role in the exaggerated HPV that characterises HAPE. NO, constitutively produced in the lung by the enzyme endothelial nitric oxide synthase (eNOS), increases intracellular cGMP in pulmonary vascular smooth muscle and activates cGMP-dependent protein kinase, ultimately leading to a reduction in intracellular calcium and smooth muscle relaxation. HAPE-susceptible individuals exhale less NO during both normobaric and hypobaric hypoxia suggesting that a deficiency of NO synthesis may predispose to HAPE. At high altitude, inhaled NO causes a significantly greater reduction in the systolic PAP of HAPE-susceptible individuals compared to its effect on the PAP of HAPE-resistant subjects, but the administration of NO would be impractical in the field. Most recently, work has concentrated on another target in the NO pathway.

Sildenafil citrate is an orally active, potent and selective phosphodiesterase type-5 (PDE-5) inhibitor. PDE-5 is the predominant enzyme responsible for degradation of cGMP in the lung. In a small sea level study, Zhao et al. demonstrated that pre-treatment with sildenafil nearly completely abolished the pulmonary vasopressor response to breathing hypoxic gas in healthy humans. More recently, studies at altitude have also shown reductions in pulmonary artery systolic pressure (PASP) in subjects taking sildenafil at high altitude.

One potential problem with the use of sildenafil at altitude is that PDE-5 inhibitors may worsen symptoms of acute mountain sickness (AMS). Headache is a defining symptom in AMS and is a prominent side effect of sildenafil.

We conducted a double-blind placebo-controlled randomised trial to assess the effect of regular sildenafil administration on PASP and Lake Louise AMS score at an altitude of 5200 m.

Eligibility Criteria:
Inclusion Criteria:

* Participant in Apex 2 high altitude expedition

Exclusion Criteria:

* Previous history of high altitude pulmonary edema
Transfusion Requirements in Orthopedic Surgery (PHASE 2)

The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.

Hypothesis: we hypothesize that a threshold hemoglobin concentration exists below which functional recovery becomes difficult, even if the vital prognosis of patients is not impaired.

Anemia is frequent after a surgical procedure. Postoperative anemia is associated with an increased incidence of transfusions and, probably, with an increased incidence of morbidity and mortality. However, the majority of studies evaluating the consequences of postoperative anemia are retrospective and, since anemic patients were transfused, they are unable to distinguish between the effects of anemia per se and those of transfusion. In orthopedic surgery, only two randomized controlled trials (RCT) have attempted to determine the benefits of transfusions in this patient population. The first evaluated the benefits of allogeneic transfusions in patients undergoing surgery for a fractured hip while the second evaluated autologous transfusions in patients undergoing total knee replacement. The small number of patients included in both studies did not allow definitive conclusions on the benefits (or lack thereof) of transfusions in orthopedic surgery.

Traditionally, a transfusion trigger of 100 g/L has been recommended in the postoperative period, especially in older patients and in those with serious comorbidities. In the Transfusion Requirements in Critical Care trial, a much lower transfusion threshold (70 g/L) was adopted in the group of patients in whom transfusions were restricted. This prospective randomized trial that included 838 patients, is, to this day, the most important in the field and generated unexpected results. Serious morbidity (cardiac and respiratory in particular) and mortality were not increased by the adoption of a low transfusion trigger while the number of transfusions was decreased significantly.

On the other hand, it is common to observe fatigue, decreased exercise capacity and muscle strength, and impaired performance of activities of daily life in the presence of anemia, especially when the hemoglobin concentration decreases below 90 - 100 g/L. In orthopedic surgery, a decrease in "postoperative vigor" can prevent patients from undertaking the rehabilitation program required to improve functional recovery after hip fracture repair.

The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.

Exclusion Criteria:

* Since this an observational study, all patients conforming to inclusion criteria will be included.