cyrilzakka/clinical-trials huggingface dataset:
A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil

A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* adult female who is neither pregnant nor breastfeeding, or
* a healthy, adult male
* with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
* with a minimum weight of 50 kg (110 lbs).

Exclusion Criteria:

* history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
* clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
* history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
* history of coagulation disorder or current anticoagulation therapy;
* has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
* has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
Pressure Area Distribution on a Variety of Clinical Surfaces

Participants in the study will be adults with full mobility, with the capacity to give informed written consent. The investigators will recruit a group of volunteers in order to represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the population. The investigators will mimic current practices and standard equipment in order to replicate real conditions as closely as possible.

Participants will lay on the following surfaces in the following scenarios

1. Ambulance scoop: supine (lying flat on their back)
2. A\&E trolley: supine
3. Hospital bed: supine
4. Theatre table: supine
5. Theatre table: Left lateral (lying on their left side at 90 degrees to the operating table) with pelvic binders (pads designed to keep the hip immobile).

Each participant will remain in each position on that particular surface for a period of 25 minutes. A pressure mapping mattress will lie between the participant and the surface assessed to generate a pressure map.

Following completion of data collection, data will be analysed and any areas of potential pressure damage vulnerability will be identified.


Eligibility Criteria:
Inclusion criteria:

• Subjects will be individuals aged 18 and over, with good command of spoken and written English, full mobility, and the capacity to give informed, written consent. Provided there is no impairment to mobility, there is no upper age limit to participation.

Exclusion criteria:

* Inability to provide informed written consent
* Having a BMI that falls outside of the stated ranges for the study (\<19)
* Any significant impairment to mobility, for whatever reason, that prevents the patient from getting in and out of bed unaided, walking 100 metres unaided, or climbing a flight of stairs unaided.
* Patients who lack sufficient command of written and spoken English to allow them to give written informed consent take part.
A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood

This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T).

Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.

Previous ACTG studies show that discontinuation of one or two of a three-drug regimen (IDV, ZDV, 3TC) leads to prompt loss of viral suppression in the plasma. In this trial, it will be determined whether adding hydroxyurea (HU) to a suppressive regimen increases long term viral suppression. Important safety information on the tolerance of HU regimen will be characterized in asymptomatic patients with viral suppression.

Patients are equally randomized to one of three arms and receive treatment as follows:Arm A: IDV plus ddI plus d4T plus HU placebo. Arm B: IDV plus ddI plus d4T plus HU. Arm C: IDV plus 3TC/ZDV (or d4T plus 3TC). Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are 13 years or older.
* Have documented HIV-1 infection.
* Are currently receiving combined IDV, ZDV(or D4T), and 3TC for at least 6 consecutive months, resulting in HIV RNA less than 200 copies/ml and CD4 cell count greater than 200 cells/mm3.
* Had a CD4 count greater than 100 cells/mm3 before starting current anti-HIV therapy.
* Are of childbearing age and agree to practice abstinence or use of combined barrier and hormonal methods of birth control during and for 3 months after the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have taken various medications and have various laboratory results (see technical abstract).
* Have cancer requiring chemotherapy.
* Have an unexplained fever for 7 days or diarrhea for 15 days in the month before the start of the study.
* Had prior peripheral neuropathy or hepatitis.
* Recently underwent radiation, experimental, or infection therapy.
* Are pregnant or breastfeeding.
Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation

Complications associated with excess weight (hypertension, coronary artery disease and diabetes) have become major causes of morbidity and mortality after liver transplantation (LT). To ensure excellent long-term outcomes with LT it is critically important to understand the best strategies to minimize obesity and its associated complications in our patients. Weight loss can be achieved through dieting and exercise, but most patients are unable to maintain the weight loss. In the general population, bariatric surgery is much more effective than medical treatment for permanent weight loss and prevention or reduction of obesity-associated complications.

The purpose of this study is to determine the safety and effectiveness of performing sleeve gastrectomy (SG) procedure in the early post-LT period in obese patients.

The patient population for this study will be anyone listed for liver transplantation at Toronto General Hospital (University Health Network, Toronto, ON, Canada) and meeting the current standard criteria for bariatric surgery (BMI\>40, or BMI\>35 with at least 1 obesity-related complication).This study will randomly assign eligible participants to one of two groups (1:1). Patients in group 1 will receive standard lifestyle/diet counselling while patients in group 2 will undergo SG-specific counselling prior to transplant and the SG procedure within 2 weeks of LT (if safe to do so).

All participants will be followed for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* actively listed for liver transplantation at University Health Network
* BMI at screening of a) \>40; or b) BMI \>35 and 1 obesity-related complication \[diabetes (defined as hyperglycemia requiring medication(s) for control), hypertension (defined as a persistently elevated systolic pressure greater than 140 mmHg and/or requiring medication(s) for control), hypercholesterolemia (defined as elevated lipids requiring medication for control)\] OR a diagnosis of Non Alcoholic Fatty Liver Disease (defined as the presence of a fatty liver on imaging without a secondary cause such as alcohol abuse) or Non Alcoholic Steatohepatitis
* upper endoscopy showing no contraindications to a sleeve gastrectomy procedure

Exclusion Criteria:

* • Listed for re-transplantation, or transplantation of another organ (eg. kidney).

  * Previous bariatric surgery.
  * Contraindication to undergoing sleeve gastrectomy such as severe gastroesophageal reflux disease or Barrett's Esophagus
  * MELD (Model End-Stage Liver Disease) score \> 35 at the time of transplantation
  * Presence of any condition that in the opinion of the investigator(s) could compromise the patient's ability to comply with study procedures
  * Patients with a BMI \<32 at transplant or having weight loss of 20% or more (pre-transplant estimated dry body weight compared to estimated dry body weight at screening)
  * Presence of any other condition that, in the opinion of the investigator(s), could compromise the patient's ability to safely undergo, or benefit from, the SG procedure (eg. significant sarcopenia)
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma

The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
* HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with MYCN amplification (any age), metastatic disease \>18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy.
* HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible.
* Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. Plus:

  * Absolute neutrophil count (ANC) ≥ 500/mcl
  * Absolute lymphocyte count ≥ 500/mcl
* \>21 and \<180 days between completion of systemic therapy and 1st vaccination.
* A negative pregnancy test is required for patients with child-bearing capability
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA.
* History of allergy to KLH, QS-21, OPT-821, or glucan
* Prior treatment with this vaccine.
* Active life-threatening infection requiring systemic therapy.
* Inability to comply with protocol requirements.
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery

The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for short, non-laser laryngologic surgery

Exclusion Criteria:

1. Patients with significantly decreased myocardial function (ejection fraction \< 50%)
2. Patients with abnormal cardiac rhythm and conduction abnormalities, except for patients with isolated, asymptomatic premature atrial and ventricular contractions.
3. Patients with significant peripheral vascular disease, such as those with the symptoms of intermittent claudication.
4. Patients with known significant cerebrovascular disease, such as history of cerebrovascular accidents (CVAs) and transient ischemic attacks (TIAs).
5. Patients with significant renal insufficiency, as manifested by estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2.
6. Patients with electrolyte (K+, Ca++) abnormalities, as determined by the lab values outside of a normal range.
7. Patients with the history or symptoms of increased intracranial pressure or reduced intracranial compliance (e.g. headaches, nausea and vomiting, visual changes, mental changes).
8. Patients with skull base defects.
9. Patients with pulmonary hypertension who have pulmonary artery pressures above the normal range.
10. Patients with significant chronic obstructive or restrictive lung diseases, as manifested by known history of baseline chronic hypoxia and/or hypercapnia, and/or baseline room air SpO2 \< 95%.
11. Obese patients with BMI above 35 kg/m2.

13. Patients with severe and poorly controlled gastroesophageal reflux disease despite medical treatment.

14. Patients with hiatal hernia and full stomach patients. 15. Patient's refusal to participate in the study. 16. Patients who do not understand English or mentally handicapped. 17. Pregnant or breastfeeding patients.
A Pilot Study to Evaluate an Intervention for Gestational Weight Gain

The purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.

This proposed study aims to adapt intervention to address excessive gestational weight gain and psychosocial functioning among a socioeconomically and racially diverse sample of pregnant women .Additionally, data on behavioral mechanisms associated with self-regulatory capacity, such as impulsive control and the ability to delay rewards, that may be linked to self-regulation during pregnancy are needed to support future interventions.

In this study, the investigators will develop and adapt an intervention (Self-Management Around the Reproductive Transition; SMART) that addresses maternal weight, stress, and mood, and document the feasibility, acceptability and initial efficacy of the SMART intervention.

Eligibility Criteria:
Inclusion Criteria:

* At least 14 years of age
* Less than 16 weeks gestation
* English speaking
* Singleton pregnancy
* Receiving care at Magee-Womens Hospital, Latterman family health or other UPMC practices that provide obstetric care

Exclusion Criteria:

* Preexisting diabetes
* Use of medications known to affect weight
* Enrolled in current weight management programming
* History of weight loss surgery
* Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate care
Do Emotions Affect Mechanical Pain Thresholds in Individuals with Chronic Pain?

The purpose of this study is to investigate if different emotional states could influence mechanical pain thresholds in individuals with chronic pain.

Participants will be randomized into 4 different groups watching different short video-clips (2.20 min). The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video about how to paint a house, and the control group will just wait for 2.20 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clips.

Eligibility Criteria:
Inclusion criteria

* Above 18 years of age
* Fluent in Swedish
* Persistent chronic pain with duration \> 6 months Exclusion criteria
* Known neurological disease
Families In Recovery From Stroke Trial (F.I.R.S.T.)

The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.

Prior research shows that, after a stroke, emotional support from friends and family is very important in recovery from stroke. This study was designed to test whether a program of family sessions would lead to a faster recovery for stroke patients and lower stress for their families. The sessions were designed to mobilize the family and close friends of a stroke patient and help them to provide effective support to the patient. The aim of the study was to help patients who have recently had a stroke to achieve greater functional ability. Participants were randomly assigned to either the standard care or the treatment group. Those in the treatment group received standard care plus a maximum of 16 home-based sessions, or family meetings, with a specially-trained clinician. (The majority of participants received 14 or 15 sessions.) The sessions included stroke education, information about services and community resources, assistance with problem solving to aid in gaining independence, help with coping, and emotional support. The study is no longer enrolling patients and the study data has been collected. The data is now being analyzed.

Eligibility Criteria:
Inclusion:

* patients with ischemic stroke or non-traumatic intracerebral hemorrhage, with residual deficit origin;
* age 45 or older
* stroke severity (3-8 on the NIH stroke severity scale); and
* able to participate in the intervention (due to, for example, ability to communicate or level of social connectedness).

Exclusion:

* patients living outside the greater Boston area;
* admitted from a nursing home;
* terminally ill;
* severely aphasic;
* significantly cognitively impaired;
* unable to speak English; and
* under 45 years of age.
Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol

Sleep disorders are very common in alcohol patients (40-90% according to studies) These sleep disorders may persist after withdrawal and represent a major factor in relapse.

In a previous study, the investigators validated a simple sleep questionnaire (the "Short Sleep Index = SSI") from a multicentre series of 602 American patients (Perney et al., Alcohol Alcohol 2012) The SSI is obtained from the Hamilton score (baseline score for anxiety and depression)

to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index) in alcohol patients in different situations: Ambulatory or hospitalization

Eligibility Criteria:
Inclusion Criteria Sick people with alcohol abuse or dependence Inpatient or outpatient follow-up (Nîmes University Hospital, Grau du Roi Hospital, Montpellier, Centre de Soins d'Accompagnement et de Prévention en Addictologie (CSAPA of Nîmes University Hospital) Agreeing to answer the questionnaire Not having a cognitive deficit or psychiatric pathology that makes interrogation unreliable

* Exclusion criteria : NA
Evaluation of Attachment, Self-compassion and Coping Strategies in Chronic Pain Patients

Compare the self-compassionate score by type of attachment, "safe" or "insecure", in chronic pain patients.

Attachment theory proposes a theoretical model that helps us explain how the process of developing interpersonal relationships can affect the search for care and the response of individuals to an illness.

Self-compassion is a concept developed by Kristin Neff. It refers to the disposition of each individual to contain their feelings of suffering by a feeling of warmth, connection and care.

The coping corresponds to the answers, the reactions, that the individual will develop to control, reduce or simply tolerate the aversive situation. Coping can take the form of cognitions, affects and behaviors that an individual will put in place to deal with a situation.

The three concepts (attachment, self-compassion, coping) seem to be interrelated, and they contribute to the explanation and management of chronic pain, in the spectrum of the bio-psycho-social model of pain. Yet no study has measured these three variables together in chronic pain patients

Chronic and Newly Assisted Patients at CETD (Neurosurgery Department, Pain Assessment and Treatment Center) (ie any patient seen for the first time in pain center, and included in the research during one of the three medical consultations preliminary to overall care at the CETD).

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain

Exclusion Criteria:

* Legal protection measure
* Patients followed for cancer
* Patients followed for multiple sclerosis
* Patients followed for Parkinson's disease
* Patients already followed in another CETD
* Decompensated psychiatric pathology