cyrilzakka/clinical-trials huggingface dataset:
Single Oral Dose of BeneFlax to Healthy Young and Older Adults

This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG.

It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults: 18-45 and 60-80 years of age

Exclusion Criteria:

* Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
* Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
* Individuals who smoke
* Individuals who have experienced diarrhea in the last three months
* Individuals who have taken oral antibiotics in the last three months
* Individuals who are currently taking warfarin or any of its derivatives
* Individuals with low haemoglobin (\<121g/L for women and \<137g/L for men)
* Individuals with BMI under 19 or over 28
* Pregnant or lactating women
* Women with child bearing potential not using contraceptives
* Current diagnosis of a bleeding disorder or at risk of bleeding
* Individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
* Individuals with diabetes mellitus
* Individuals currently taking a flax seed supplement
* Individuals with an allergy to flax seed
* Individuals who have donated blood or lost \> 450 mL of blood within 56 days of study duration
* Individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1

The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1).


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide written informed consent or assent and to comply with study requirements
* Confirmation of PH1 disease
* Meet the 24 hour urine oxalate excretion requirements
* If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days

Exclusion Criteria:

* Clinically significant health concerns (with the exception of PH1) or clinical evidence of extrarenal systemic oxalosis
* Clinically significant abnormal laboratory results
* Known active or evidence of HIV or hepatitis B or C infection
* An estimated GFR of \< 30 mL/min/1.73m\^2 at screening
* Received an investigational agent within 30 days or 5 half-lives before the first dose of study drug or are in follow-up of another clinical study
* History of kidney or liver transplant
* Known history of multiple drug allergies or allergic reaction to an oligonucleotide or GalNAc
* History of intolerance to subcutaneous injection
* Women who are pregnant, planning a pregnancy, or breast-feeding or those of child bearing potential and not willing to use contraception
* History of alcohol abuse within the last 12 months, or unable or unwilling to limit alcohol consumption throughout the study
West Philadelphia Consortium Randomized Control Trial

The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. The specific aims of this research are as follows:

1. To evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity.
2. To evaluate effects of integrated versus disease specific counseling on psychological outcomes. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes.
3. To identify the mechanisms through which integrated risk counseling leads to behavioral change. The investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.


Eligibility Criteria:
Inclusion Criteria:

* African American
* Age 18-75
* Resident of Philadelphia

Exclusion Criteria:

* Previous or current cancer diagnosis
* Previous or current diagnosis of a CVD
* Cognitive disorder
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)

This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.

This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit (ICU) adult patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age;
* Patients who are anticipated to require \>12 hours of invasive mechanical ventilation and continuous sedation in the ICU; and
* Receipt of continuous sedation due to clinical need for sedation to RASS \<0.

Exclusion Criteria:

* Need for RASS -5;
* Sedation for invasive mechanical ventilation immediately prior to Baseline for \>72 hours;
* Severe neurological condition before ICU admission that causes the patient to lack ability to participate in the study (ie, unable to be assessed for RASS and CPOT);
* Ventilator tidal volume \<200 or \>1000 mL at Baseline;
* Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive ventilation (HFPV) at Screening;
* Comfort care only (end of life care);
* Contraindication to propofol or isoflurane;
* Known or family history of MH;
* Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;
* Allergy to isoflurane or propofol, or have propofol infusion syndrome.
* History of ventricular tachycardia/Long QT Syndrome;
* Requirement of IV benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal
* Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc);
* Concurrent enrollment in another study that, in the Investigator's opinion, would impact the patient's safety or assessments of this study;
* Participation in other study involving investigational drug(s) or devices(s) within 30 days prior to Randomization;
* Anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for \>4 hours;
* Female patients who are pregnant or breast-feeding;
* Imperative need for continuous active humidification through mechanical ventilation circuit;
* Attending physician's refusal to include the patient; or
* Inability to obtain informed consent.
Flaxseed for the Treatment of Hot Flashes

Flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. In this study, flaxseed is being evaluated in regard to its capacity to safely and effectively treat hot flashes. Specifically, this study seeks to determine if flaxseed will lower the number and severity of hot flashes and if women experience any side effects from taking flaxseed for this purpose.


Eligibility Criteria:
Inclusionary Criteria:

* Age greater than or equal to 18 years
* Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer.
* Bothersome hot flashes (defined by occurenece of greater than or equal to 14 times per week and of sufficient severity to make the patient desire therapeutic intervention).
* Presence of hot flashes for greater than or equal to 1 month prior to study entry.
* Life expectancy greater than or equal to 6 months.
* ECOG Performance Status (PS) 0 or 1 (see Appendix VIII)

Exclusionary Criteria/Contraindications

* Any of the following current (less than or equal to 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but patient must have been on a constant dose for greater than or equal to 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a grocery store are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency)
* History of allergic or other adverse reaction to flaxseed, wheat, nuts, lactose, and/or certain spices
* Current or planned use of other agents for treating hot flashes (except stable dose of vitamine E or antidepressants are allowed as long as they wre started \>30 days prior to study initiation and are to be continued through the study period).
* Diabetes (as flaxseed can lower blood glucose levels and might have additive effects when used with antidiabetic drugs).
* Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture.
* Any of the following: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception
* Current use of anticoagulants including aspirin, clopidogrel (Plavix), ticlopidine (Ticlic), and coumadin (1 mg of dialy coumadin is allowed for central line patency).
* Diagnosis of/problems with von Willebrand's disease or other bleeding disorders.
Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training

Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.

To explore the potential of a daily app-based mindfulness mental training in improving AF symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter, within the first 12 weeks following AF ablation.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing AF ablation with symptomatic paroxysmal or chronic atrial fibrillation (EHRA II-IV)
* Availability of smart phone with the capability to run android 5 or iOS 9 or newer versions
* Capability to use mobile phone applications
* Internet access
* Consent to study participation

Exclusion Criteria:

* Patients \< 18 years of age
* Unavailability of smart phone running at least Android 5 or iOS 9
* Pregnancy
A Study of Emergency Department AI Prediction Impact

The purpose of this study is to evaluate the impact of an AI admission prediction tool on the number of preventable hospital admissions, emergency department (ED) length of stay, when the predictions are displayed only to a dedicated ED triage team. Also, to evaluate user perceptions of the AI tool among the triage team users and medical officer of the day users. Additionally, to evaluate any impact of the AI tool on the number of interventions performed by the triage team, and to evaluate the impact of the tool on time-to-admission after an admission order is placed.


Eligibility Criteria:
Inclusion Criteria:

* For the survey component, any HIM clinician that works a shift in the triage area, ED physicians, and the medical officer of the day will be included.
* For length of stay data, adult patients registered in the Mayo Clinic-Rochester St. Mary's Emergency Department will be included.

Exclusion Criteria:

* For the survey, clinicians not working a triage shift during the study period will be excluded.
* For the length of stay analysis, only adult ED patients will be included, who do not triaged to the behavioral health/psychiatry pathway, nor patients who are triaged to the Emergency Department observation pathway.
Study of Morphine in Postoperative Infants to Allow Normal Ventilation

OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine postoperatively as intermittent intravenous bolus doses or as a continuous intravenous infusion targeted to reach a steady-state concentration.

II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and analgesia (infant pain score) between the two treatment groups of infants.

III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.

PROTOCOL OUTLINE: This is a two part study. Infants are stratified by age (1-30 days vs 31-180 days vs 181-365 days) and by type of surgery. Infants are randomly assigned to one of two treatment arms.

In part I, following major thoracic, abdominal, or cardiac surgery, infants are randomized to receive either continuous IV morphine infusions (arm I) or to receive morphine by single IV bolus doses every 2-3 hours (arm II).

In part II, cyanotic and acyanotic infants following thoracotomy receive morphine by 2 loading doses over 15 minutes and then by continuous IV infusion.

Patients are followed for at least 2 days.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Infants scheduled for surgery with postoperative inpatient care
* Must be born after 35 weeks or more gestational age
* No prenatal opiate exposure

Part I patients:

* Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures
* No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects)
* No hepatic or renal transplantation

Part II patients:

* Less than 3 months of age undergoing surgeries using a thoracotomy approach
* Cyanotic congenital heart disease having palliative systemic to pulmonary artery shunts created OR Thoracotomy for repair of acyanotic lesions (e.g., repairs of coarctation of the aorta, tracheoesophageal fistula repair, PDA ligation)

--Patient Characteristics--

* Age: Part I: Less than 12 months Part II: Less than 3 months
* Hepatic: Normal hepatic function tests
* Renal: Normal renal function tests
* Pulmonary: No pulmonary disease causing baseline hypercarbia
* No pulmonary hypertension contraindicating use of 5% CO2 in rebreathing studies

Other:

* No allergy to morphine
* No severe developmental delay that precludes analgesia scoring
Comparison of the Efficacy and Safety of Risperidone Versus Risperidone Plus Low Dose of Haloperidol in the Treatment of Schizophrenia

The purpose of this study is to compare the efficacy and safety of risperidone and risperidone plus low dose of haloperidol in the acutely schizophrenic patients.

Antipsychotic monotherapy is recognized as the treatment of choice for patients with schizophrenia. Surveys have shown that antipsychotic drug combinations are frequently prescribed, yet few clinical studies have examined this practice. Risperidone, an atypical antipsychotics, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to haloperidol. It has been reported that a relatively low daily dose of haloperidol at which individual patients develop slightly increase in EPS and has neurocognitive benefits as risperidone. The objective of the study is to compare the efficacy and safety of the fixed-dosed risperidone and risperidone combined with haloperidol in the treatment of acute psychotic exacerbations of schizophrenia.In this 6-week, double-blind, fixed-dose study, patients with schizophrenic disorder (DSM-IV diagnosis) are randomly assigned to risperidone (4 mg/d) or risperidone (2 mg/d) plus haloperidol (2 mg/d). The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost. The primary efficacy measure is change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores; secondary outcomes include Clinical Global Impression-Change (CGI-C), the Calgary Depression Scale for Schizophrenics (CDSS), subject-reported outcomes via the Short Form-36 (SF-36), auditory evoked potentials (AEPs), and cognitive and social functioning. Safety assessments include the change from baseline on Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS), and UKU Side-effects Rating Scale (UKU), and the change from baseline in prolactin levels, body weight, AC glucose level, lipid panel (cholesterol, high density lipid protein \[HDL\], low density lipid protein \[LDL\], and triglyceride \[TG\])

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Clinical Global Impression large than 3
* Written informed consent

Exclusion Criteria:

* Comorbid of substance abuse/dependence
* Present or history of tardive dyskinesis or neuroleptic malignant syndromes
* Severe physical problems
* pregnant or lactating women
Report of Ten Cases of Venous Aneurysm in Extremities

Venous aneurysms are not common in general, but because of the inherent risk of thrombosis in aneurysms, their timely diagnosis and treatment are recommended in most of the current sources. Ten cases of venous aneurysms were diagnosed and managed in our vascular surgery department from October 2018 to January 2024. Patient information was extracted from their files retrospectively.

A vascular aneurysm is defined as the focal dilatation of a vessel. Aneurysm is classically used for arterial dilatations, although dilatations can occur in any part of the vascular system including veins. Venous aneurysms are not common in general, but with the increase in the use of duplex ultrasound, the number of cases diagnosed with venous aneurysms has recently increased. Venous aneurysms are more common in the lower limbs, and in the lower limbs, the involvement of the deep venous system is much more than the superficial venous system. According to reports, 77% of venous aneurysms are present in the lower limbs, of which 57% are in the deep venous system and 1.5% in the superficial venous system.

Considering their rarity, venous aneurysms may cause diagnostic challenges in some cases.

The importance of these aneurysms, especially in the lower limbs, which inherently have relative stasis due to the opposite flow direction of gravity, is that by creating venous stasis and whirlwind blood flow inside the aneurysm, they increase the susceptibility to clotting. Also, due to dysfunction of the pigeon nest valves, they cause chronic venous insufficiency. Although clot formation and subsequent pulmonary embolism are more common in deep venous aneurysms, cases of pulmonary embolism secondary to superficial venous aneurysms of the lower limbs have also been reported.

Complications caused by chronic venous insufficiency are more common in aneurysms that occur at the main junctions of superficial and deep veins, including saphenous femoral and saphenous popliteal junctions.

Considering the possible complications mentioned about venous aneurysms, these aneurysms need treatment, regardless of their location, and although in the superficial system, surgical resection is the most commonly recommended method, other surgical methods such as aneurysmectomy and primary repair, resection, and graft interposition, and also endovascular methods have been used. Of course, in case of insufficiency in the venous system, specific treatment of the cause of insufficiency (such as stripping of the large saphenous vein) is necessary in addition to the treatment of the aneurysm.

Regarding the follow-up after the treatment of aneurysms of the superficial system, most articles have recommended short-term treatment with anticoagulants and control of the superficial and deep systems through color doppler.

In this case series, we present 10 cases of venous aneurysms and discuss their presentation, diagnosis, and management.

Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of venous aneurysm

Exclusion Criteria:

• Patient's non-consent
Do Educational Digital Films Enhance Patient COPD Outcomes?

This study aims to assess the efficacy of Pocket Medic to promote self-management and pulmonary rehabilitation adherence in COPD patients.

Chronic Obstructive Pulmonary Disease (COPD) refers to a group of lung conditions characterized by airways inflammation, small airways obstruction and progressive loss of lung function. There are 900,000 people diagnosed with COPD in England and Wales but allowing for under-diagnosis, the true prevalence could be 1.5 million. Sufferers are extensive health care users; where COPD is the second most common cause of emergency hospital admission in the United Kingdom with direct National Health Service costs over £800 million per year. Pulmonary Rehabilitation programs (PRPs) aim to provide education and support for patients whilst improving clinical outcomes, however, attendance to these programs can be low.

This study aims to trial a series of digital films aimed at educating patients about their condition from the comfort of their own home. Approximately 80 patients eligible for PR will be allocated to an experimental condition to receive a series of 10 digital films alongside their standard 7-week PR, solely to receive 10 digital films, or to a control condition in the form of standard PR (no digital films). Outcome measures such as PR attendance, hospital admissions, quality of life (QoL), disease knowledge, psychological need satisfaction and motivation will be measured pre and post. Analysis of this data between the experimental and control conditions pre-post intervention will provide useful information regarding the efficacy of digital film prescriptions as an adjunct to usual PR, or on its own, and the role this may play is encouraging PR attendance.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.

Exclusion Criteria:

* Unwilling or unable to give informed consent
* life expectancy of less than 6 months
* unstable cardiovascular disease, dementia, cancers other than non-melanoma skins cancer
* any condition that precludes patients using laptops or mobile phones (e.g. blind, deaf)