cyrilzakka/clinical-trials huggingface dataset:
Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.

PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD,
* diagnosis of MDD,
* age 18-55,
* no change in psychotropic medication for \>=4 weeks,
* no anticipated need to to alter psychotropic medication for duration of study

Exclusion Criteria:

* Unstable medical/neurological illness,
* diagnosis of bipolar disorder, schizophrenia or other psychotic disorder,
* cognitive disorder,
* substance dependence,
* positive urine drug screen at screening,
* use of hormonal supplementation,
* pregnancy/lactation,
* female patients who are sexually active and not using acceptable non-hormonal birth control,
* initiation/change of psychotherapy within 3 months of randomization,
* recent/current electroconvulsive therapy,
* regular use of opiates/barbiturates/benzodiazepines
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.

This study aims to assess the feasibility of conducting a phase IV, multi-centre, single-blinded, randomized control trial (VAPOR-C (Main)).

Primary aims To measure the ability to recruit eligible patients into the study.

To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-80 years
* Elective surgery
* Major cancer surgery expecting to last two or more hours, for:
* Breast (mastectomy or segmentectomy plus sentinel node dissection)
* Colorectal
* Lung
* Prostate
* Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction
* Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)

Exclusion Criteria

* Palliative surgery for end-stage disease with no curative intent
* Emergency surgery
* Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score \> 4
* Age \<18 or \>80 years old
* Refusal or inability to provide valid informed consent
* Risk of severe postoperative nausea and vomiting (PONV risk score \>3)
* Previous allergy or contraindication to either anaesthetic medication
* Indication for gas induction of anaesthesia
* Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.
Pressure Ulcer Prevention Study in SCI

The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.

Medically serious pressure ulcers are a common complication of spinal cord injury (SCI), and are associated with high treatment costs and reduced quality of life. This study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with SCI who have had serious pressure ulcers.

The intervention being tested, termed lifestyle redesign (LR), is based on prior SCI literature as well as on the results of a qualitative pilot study undertaken by our study group. This intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. Participants assigned to the LR condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. Participants in the control condition do not receive any study-based intervention, but (along with the LR group) have continuing access to the standard options for prevention and treatment that are available through Rancho Los Amigos National Rehabilitation Center.

In addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury (paraplegia or tetraplegia)
* Non-ambulatory
* Able to undergo intervention and testing in English or Spanish
* At least 6 months post-injury
* History of at least one serious (Stage 3 or 4) pressure ulcer in the past 5 years
* Cognitively intact
* Personally expressed willingness to undertake recommended lifestyle changes for ulcer prevention.
* Can be reached by telephone.
* Reside in or within 100 miles of Rancho Los Amigos National Rehabilitation Center (Downey, CA) with no plans to relocate beyond this area.
* Agreement to participate and completion of consent form.

Exclusion Criteria:

* Present serious stage 4 pressure ulcer
* Participation in our preliminary research studies
* Participating in the neuromuscular stimulation study
Effect of Health Education on Promoting Influenza Vaccination Health Literacy

The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China.

Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months.

Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.

Introduction: Influenza is a major public health threat, and vaccination is the most effective prevention method. However, vaccination coverage remains suboptimal. Low health literacy regarding influenza vaccination may contribute to vaccine hesitancy. This study aims to evaluate the effect of health education interventions on influenza vaccination rates and health literacy.

Methods and analysis: This cluster randomized controlled trial will enroll 3036 students in grades 4-5 from 20 primary schools in Dongguan City, China. Schools will be randomized to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is influenza vaccination rate. Secondary outcomes include health literacy levels, influenza diagnosis rate, influenza-like illness incidence, and vaccine protection rate. Data will be collected through questionnaires, influenza surveillance, and self-reports at baseline and study conclusion.

Ethics and dissemination: Ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. Findings from the study will be made accessible to both peer-reviewed journals and key stakeholders.

Eligibility Criteria:
Inclusion Criteria:

* Primary school students within the age range of 7-12 years.
* Students and their parents who voluntarily agree to participate in the study and provide signed informed consent.
* Permanent residents of Dongguan City who are expected to complete the project without transferring schools during the study period.

Exclusion Criteria:

* Individuals with contraindications to influenza vaccination, who have recently received an influenza vaccination, diagnosed with influenza or confirmed as influenza-like cases at the commencement of the study.
* Unwilling to participate in the project.
The Platform for Interdisciplinary Cardiovascular-metabolic-neurovascular Diseases (PICMAN)

Background Changes in metabolism and mitochondrial function appear to precede cardiac dysfunction, with much evidence supporting metabolic dysregulation as one of the earliest precursors of cardiovascular disease. We hypothesise that quantifiable metabolic inflexibility may be representative of an individual in his/her silent, but high-risk progression towards insulin resistance, diabetes and cardiovascular disease. The platform for interdisciplinary cardiovascular-metabolic-neurovascular diseases (PICMAN) across National University Health System (NUHS) is a pilot, prospective, multi-ethnic cohort study in Singapore.

Through extensive phenotyping in a preventive cardiology cohort, the central aim is to define the metabolic flexibility range in a cohort of individuals at elevated risk of atherosclerotic cardiovascular disease, to correlate metabolic flexibility to measures of cardiometabolic health, including diastolic dysfunction, coronary and cerebral atherosclerosis, body fat distribution and severity of non-alcoholic fatty liver disease.

Aims

1. Define norms for metabolic flexibility in a multi-ethnic Southeast Asian cohort of individuals without manifest ASCVD
2. Understand the association of metabolic inflexibility with cardiovascular measures of diastolic dysfunction and coronary and cerebral atherosclerosis
3. Understand the association of metabolic inflexibility with measures of body fat distribution
4. Understand the correlation between metabolic flexibility and insulin sensitivity along the spectrum of subclinical cardiovascular disease and severity of non-alcoholic fatty liver disease
5. Associations of the gut microbiome as well as metabolomic and molecular markers with cardio-cerebrovascular measures, metabolic flexibility and liver fibrosis

The PICMAN study seeks to lay the foundations for further future larger scale and more experimentally ambitious studies based on the overarching hypothesis that metabolic flexibility is an early marker in subclinical cardiovascular disease, indicating a point of timely intervention where the disease process is still reversible. The importance of a deeply-phenotyped local cohort will allow us to study the progression of CVD in seemingly well adults, converging imaging, biochemical, metabolic markers, and 'omics analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21-70 at screening
* 10-year ASCVD risk \> 5% measured by QRISK 3 calculator

Exclusion Criteria:

* Established DM (Prior diagnosis, long term medications or HbA1c \>=6.5)
* Established CVD, such as ischemic heart disease, cerebrovascular accident, heart failure, atrial fibrillation
* Pregnancy
* Known contraindications to CT scan, such as allergy to contrast
MCS in the Treatment of Lower Urinary Tract Symptoms

The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.

Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2.

Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 40 years old
* Not being treated for BPH or LUTS
* PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer
* I-PSS ≥ 10
* No known malignancy
* AST/ALT ≦ 3X UNL
* Creatinine ≦ 3X UNL
* Subjects who sign the informed consent form

Exclusion Criteria:

* Subjects' LUTS are not BPH-related
* Have been treated with pelvis irradiation or pelvic surgery
* Plan to undergo any invasive procedures within the study period
* Active infection or inflammation
* Considered ineligible by the investigators
Hyperbaric Oxygen for COVID-19 Patients

Hyperbaric oxygen therapy (HBOT) treatment will be provided to patients as an adjunct to standard therapy for a cohort of 40 COVID19-positive patients with respiratory distress at NYU Winthrop Hospital. All patients prior to the clinical application of HBOT will be evaluated by the primary care team and hyperbaric physician. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.

This is a single center prospective pilot cohort study to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as an emergency investigational device for treating patients with a novel coronavirus, disease, COVID-19. Patients that meet inclusion criteria will be consented by the hyperbaric physician. They will then be transported from the ED or other unit to the hyperbaric unit maintaining airborne precautions based on the most current hospital protocol. All study personnel will have proper PPE at all times. The patient will then be placed into the monoplace chamber and when the chamber door is closed the patient will remove any respiratory filter/mask that was placed. The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medical unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient. After the intervention portion of this study, a chart review will be performed to compare the outcomes of intervention patients versus patients who received standard of care.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male or female, age \> 18 years
2. Positive COVID 19 test
3. Respiratory compromise defined by SpO2 \<93%
4. Ability to sign informed consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnancy
2. Untreated Pneumothorax
Suggestive Effects on the Diameter of Coronary Arteries

The aim of this randomized controlled pilot study was to answer the following questions:

1. Is it possible to affect the diameter of coronary arteries through a placebo injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?
2. Is it possible to affect the diameter of coronary arteries through a pharmacologically underdosed nitroglycerine injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?

The present study is a randomized controlled double-blind single center study in order to investigate the effects of verbal suggestions ('vasodilatation') in combination with either a placebo-intervention (sodium chloride 0.9%) or an underdosed vasodilating medication (nitroglycerine) on the diameter of coronary arteries. 60 patients with a clinical indication to undergo a coronary angiogram were recruited in the German Heart Centre Munich. Patients with acute myocardial events and the necessity for coronary intervention were excluded from the study. Patients were randomized into one of four arms of the two experiments:

Experiment A: Intracoronary (i.c.) placebo-infusion together with a standardized verbal suggestion of coronary vasodilation vs. i.c. placebo-infusion without verbal suggestion.

Experiment B: i.c. infusion of a very low dosed nitroglycerin together with a standardized verbal suggestion of coronary vasodilation vs. i.c. nitroglycerine infusion without verbal suggestion.

To our best knowledge this study is the first to investigate the modulating effects of verbal suggestions going along with medical interventions on the diameter of coronary arteries during heart catheterization.

Eligibility Criteria:
Inclusion Criteria:

* medical indication for heart catheterization
* written informed consent

Exclusion Criteria:

* acute myocardial infarction
* acute elevation of cardiac enzymes
* regular intake of drugs containing nitroglycerin
* intolerance of nitroglycerin
* hypotension
* renal insufficiency
* diabetes mellitus
* hyperthyroidism
* pregnancy
* acute psychiatric disease
* cognitive impairment
* prinzmetal's angina
PRO Development for ANCA Associated Vasculitis

A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure

Patients with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) have inflammation in the small blood vessels leading to involvement in different body areas, e.g., the kidneys, lungs and skin. Untreated, the risk of death is over 80%; with current treatment, patients often suffer from ongoing disease activity, damage or treatment side effects which have a negative impact on quality of life. Because patients with AAV can have a wide range of disease features, the investigators hypothesise that general patient reported outcome (PROs) measurements, may not be specific enough to describe the full impact on quality of life.

The main objective of this project is to start from patients' experiences to develop a disease specific PRO for patients with AAV. Patients diagnosed with AAV will be recruited through clinics or inpatients at the Oxford University Hospitals (OUH) National Health Service (NHS) Trust, or, if the patients have previously consented to be contacted about future studies, through the Diagnostic and Classification of Vasculitis (DCVAS) or The Characterisation and Determinants of Quality of Life in ANCA Associated Vasculitis (VasQoL) study databases. After informed consent is obtained, individual patient interviews will be conducted; these will last for approximately one hour and will be recorded and transcribed. Themes will be independently extracted and amalgamated by the researchers. Approximately 25 patients with different types of ANCAassociated vasculitis and varying disease duration will be interviewed until saturation, i.e., no new substantive themes emerge. These themes will then evolve into individual candidate questionnaire items. Candidate items will be piloted on approximately 25 different patients with AAV using questionnaires and interviews, until no further comments arise, to produce a final set of candidate questionnaire items. The duration of the study 1.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female
* Aged 18 years or above (no upper limit).
* Diagnosed with granulomatosis with polyangiitis- Wegeners (GPA), Churg Strauss Syndrome (CSS) or microscopic polyangiitis (MPA)and fulfil either Chapel Hill consensus conference definitions or American College of Rheumatology (ACR) classification criteria.

Exclusion Criteria:

* Unable or unwilling to give independent written informed consent
* Significant communication barrier e.g., inability to speak English
* Membership of the steering committee
Assessment of the Numen Stent With Evaluation in a Randomized Study

The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent

The success of bare metal coronary stenting is limited by the restenosis phenomenon, with rates depending on patient vascular morphology and lesion-related factors, the indication for and technique of stent deployment, and others. Drug-eluting stents (DES) improve the treatment of many coronary artery lesions by significantly reducing in-stent restenosis. However, there have numerous limitations resulting from the need for long-term dual antiplatelet therapy, the consequent bleeding risk (old patients, surgery, colon or gastric cancer, trauma), the unknown side-effects of long-term antiplatelet therapy, the cost associated with a long-term thienopyridine regimen, the body's reaction to the stent polymer, and the 0.2% per year increase in late stent thrombosis in comparison with bare metal stents (BMS).

For these reasons, continuous research is devoted to improve the effectiveness of bare metal stents. The ideal stent should be non-thrombogenic, with a low rate of restenosis and late thrombotic events. The NUMEN stent has been designed to meet these criteria, using an extremely low stent strut thickness.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Clinical or instrumental documentation of stable/unstable myocardial ischemia or angina with a \>50% lesion on a major coronary vessel and/or side branch \> 2.0 mm
* Lesion length ≤ 20 mm
* Vessel requiring stent size with diameter ≥ 2.5 mm

Exclusion Criteria:

* Age \< 18 years
* Life expectancy \< 6 months
* Chronic renal failure (serum creatinine \> 2 mg %)
* Ongoing acute myocardial infarction
* Left ventricular ejection fraction (LVEF) \<30%
* Cardiogenic shock
* Documented or suspected systemic and/or infectious disease
* Hypersensitivity to cobalt chromium or contrast media
* Anti-thrombotic drug intolerance
* Cardiac and/or extracardiac documented disease requiring surgical repair
* Patient is not an acceptable candidate for emergent coronary artery bypass surgery
* Primary or secondary pulmonary hypertension (by echo-doppler)
* Planned \> 2 stent implantation (except bail-out)
* Recent (\< 6 months) PCI or CABG
* Other type of stent implantation (also in case of bail-out)
* Visible endocoronary thrombosis
* Diffuse, severe coronary calcifications
* Use of debulking devices
* Extreme vessel tortuosity
* Unprotected left main stenosis (ULM)
* Bifurcation lesion
* In stent restenosis (ISR)
* Saphenous vein graft (SVG) and arterial by pass (internal mammary artery,IMA)
* Chronic total occlusion (CTO)