cyrilzakka/clinical-trials huggingface dataset:
Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.

The overarching objectives of the Investigating Dyadic Expectations about ARF Survivorship (IDEAS) cohort study are to learn how expectations about ARF survivorship are related to dyadic mental health symptoms and dyadic coping. Specifically, the study aims are:

* Aim 1: To determine whether health expectations and self-efficacy after acute respiratory failure (ARF) are associated with mental health outcomes in survivor-care partner dyads.
* Aim 2: To assess whether concordant expectations within survivor-care partner dyads are associated with better dyadic coping (primary outcome) and exploratory secondary outcomes.

The term dyadic coping refers to the ways two people interact as the pair manage illness-related stressors. Concordant expectations within dyads, also called shared appraisal, refers to both members of a dyad being "on the same page", and is hypothesized to lead to better dyadic coping behaviors.

Eligibility Criteria:
Patient Inclusion Criteria:

* ≥18 years old
* Meets study definition of ARF:

  * The study defines ARF as meeting 1 of the following 3:

    1. Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
    2. Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
    3. High flow nasal cannula with fraction of inspired oxygen (FIO2)≥.5 and flow rate ≥ litres per minute (LPM) for ≥24 consecutive hours.
  * Occasional rest periods of ≤1 hour are not deducted from the calculation of consecutive hours. Patients who are intubated for mental status or airway obstruction are not eligible unless they have simultaneous ARF.
* Survival to hospital discharge to home
* Speaks or reads English or Spanish
* Identifies an adult who is expected to act as a primary care partner for at least the next 6 months.

Patient Exclusion Criteria:

* Pre-existing cognitive impairment (IQ-CODE \>3.6)
* Residing in a medical institution at hospital discharge
* Receiving hospice care or life expectancy \<6 months
* Homelessness or recent history of psychosis

Care Partner Inclusion Criteria:

* ≥18 years old
* Speaks or reads English or Spanish

Care Partner Exclusion Criteria:

* Pre-existing cognitive impairment (IQ-CODE \>3.6)
Study of High Flow Nasal Cannula Oxygen for Bronchoscopy With Bronchoalveolar Lavage in ICU Patients

Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in patients with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC) improves hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive care unit patients admitted for ARF requiring BAL.

Prospective, observational, multicenter study in ARF patients (minimal pulse oximetry -SpO2- of 92% with an minimal oxygen flow of 6 L/min , respiratory rate \> 25/min (20/min if use of accessory respiratory muscles) with a compatible etiology. Primary outcome measure is increase in ventilatory support (non-invasive positive pressure ventilation (NPPV) or endotracheal intubation (ETI)) within the first 24h following BAL.

Eligibility Criteria:
Inclusion Criteria:

* presence of acute respiratory failure: defined as respiratory rate greater than 25/min, (or greater than 20/min if use of accessory respiratory muscles was present), in patients requiring oxygen greater than or equal to 6 L/min to obtain a pulse oximetry greater than 92%
* need for bronchoalveolar lavage (decision to perform BAL was left at the physician's discretion)

Exclusion Criteria:

* at least one contraindication to the bronchoscopy with BAL: acute coronary syndrome within 6 weeks; neurologic failure; thrombocytopenia less than 30 000/mm3; respiratory acidosis with a pH lower than 7.30 or hypercapnia higher than 60 mmHg; pneumothorax undrained.
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria:

* Subjects with risks of hemorrhage
* Subjects with thrombolic risks
* Subjects who weigh less than 40 kg
* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.


Eligibility Criteria:
Inclusion Criteria:

* A previous established diagnosis of non-verbal learning disability (NVLD) or DSM-V Autism Spectrum Disorder and/ or combined T-scores on the Child Behavior Checklist \> 195 on the Withdrawn + Social Problems + Thought Problems subscales.
* Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales.
* Subjects and their caregivers must be English-speaking and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their caregivers must be willing and able to comply with all study procedures.
* Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
* Subject must be able to swallow pills.
* Subject must have access to a computer with a camera, speaker, microphone, and internet connection.

Exclusion Criteria:

* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* History of bleeding diathesis, including those with von Willebrand disease.
* Uncorrected hypothyroidism or hyperthyroidism.
* History of sensitivity to omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician.
* Severe allergies or multiple adverse drug reactions.
* Unstable or untreated seizure disorder.
* DSM-IV substance use, abuse or dependence.
* Judged clinically to be at serious suicidal risk for C-SSRS score ≥ 4.
* Current diagnosis of schizophrenia.
* Current diagnosis or symptoms of psychosis.
* IQ \< 70.
* Pregnant or nursing.
* Weighs less than 12.5kg.
Influence of the Neuromuscular Blockade on Mask Ventilation

Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation. We will study different dosages of rocuronium; we assume that higher dosages of rocuronium will improve mask ventilation compared with lower dosages.

Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and saline (placebo group) before starting with mask ventilation. We will grade mask ventilation based on various scores before and after rocuronium application. Afterwards patient's tracheas will be intubated. We assess risk factors for difficult mask ventilation.

We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.

Eligibility Criteria:
Inclusion Criteria:

* patients with ASA I-III
* required tracheal intubation
* informed consent

Exclusion Criteria:

* known allergy against anesthetics
* known difficult airway
Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will compare a new application of a technology, the CSS device, to reference standards for assessment of carotid disease.

The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS) can accurately detect significant carotid artery stenosis.

Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 referred for carotid duplex ultrasound.
* Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries

Exclusion Criteria:

* Previous history of carotid endarterectomy, carotid artery stent
* Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)
* Patients with prosthetic heart valve
* Patients unable to provide informed consent.
The Anti-inflammatory Effects of Harkány Medicinal Water

The study aims to provide evidence on the effectiveness of Harkány medicinal water in psoriatic and rheumatoid arthritis patients using subjective and objective methods. It is a cross-over study, so first half of patients will receive medicinal water, the other half will receive tap water treatment, and after 6 months treatments will be repeated, but patients will receive the other type of water.

Several studies have shown that medicinal waters are highly effective in the treatment of many diseases. Existing clinical trials were unable to provide scientific evidence by using the highest international standards to justify the efficiency of thermal waters. Harkány medicinal water has been used for rheumatic, skin and locomotor diseases for more than 100 years. Its beneficial effects are indisputable. However, to introduce these effects, internationally high-level scientific methods and investigations are needed.

Psoriasis is among the most common dermatological diseases worldwide. Its significance is emphasized by adverse effects on quality of life, caused by chronic pain, physical and psychical disability due to psoriatic plaques. Former studies revealed an increased risk of inflammatory bowel disease, cardiovascular disease and certain types of cancer. Moreover, excessive oxidative stress can be responsible for the onset of psoriasis complications.

Rheumatoid arthritis (RA) is an autoimmune disease responsible for significant morbidity, characterized by articular inflammation. Oxidative stress is a key marker for determining pathophysiology of patients with RA.

The pathophysiological link between these conditions is the presence of excessive oxidative stress.

Subjective methods will include questionnaires, objective markers of disease severity will include the measurement of biomarkers from blood samples.

Eligibility Criteria:
Inclusion Criteria:

* signed consent statement
* over 18 years of age
* lack of underlying renal disease (GFR \>60 mL/min/1.73m2)
* lack of severe inflammation (WBC \<20.000 G/l; CRP \<50 mg/l; WE \<40 mm/h)
* psoriasis vulgaris with skin lesions
* mild and inactive RA

Exclusion Criteria:

* having received any kind of balneotherapy within 1 year before admission
* discontinuance of rehabilitation
* withdrawal of consent
* clinically significant difference in severity of the patient's condition on 1st or 2nd admission
* severe RA
* patients suffering from cancer
* patients suffering from inflammatory bowel disease
* patients underwent stroke within 1 year
* severe hypercholesterolemia
* severe diabetes
* patients with renal insufficiency
* patients receiving any kind biological therapy
* patients whose medication has changed during the study period or one month prior to the second treatment session
Referral Training and eGen Trials

Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused interventions effectively prevent behavioral health problems such as depression and conduct disorders and can provide a downstream economic benefit to society by reducing criminal activity, education costs, and health care use.

Unfortunately, parenting programs are not widely available, accessible, nor well-attended.

Pediatric primary care is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal contact point to increase access. However, primary care clinicians (PCCs) often have insufficient training in behavioral health topics and typical referral practices are inadequate.

There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to develop effective referral practices in conjunction with increasing the accessibility of parenting programs. The study long-term goal is to prevent significant behavioral health problems through widespread access to effective and accessible parenting programs through primary care referrals.

In this study there are two trials: First is the primary care clinicians "PCC" trial, testing the effectiveness of referral training (aim 1). Second is the parents "eGen" trial provided by therapists, testing the effectiveness of eGen parenting intervention (aim 2).


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for parent in the randomized controlled trial include being a parent or caregiver of a child ages 3 to 8 and having a referral to a participating therapist from a primary care provider.
* The only inclusion criteria is that participants be a PCC who sees children between the ages of 3- 8 years old. PCCs must also have approval from their clinic to participate. Vulnerable populations will not be targeted from inclusion but may be included if they meet the previously stated inclusion criteria.

Exclusion Criteria:

* Parents would be excluded if there is a reasonable belief that participating could increase danger to a child or if they are psychologically unable to engage in the intervention activities.
Clinical Outcome of Electrical Transcutaneous Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure

This study aims to investigate whether electrical vagus nerve stimulation in the auricle has an impact on the clinical presentation of heart failure. The device used, P-STIM, is already successfully applied in pain therapy and angiology (peripheral arterial disease, PAD) and will also be tested against a placebo in this study.

In preliminary studies, acupuncture was shown to improve the 6-minute walking distance in heart failure patients (Kristen et al., 2010). The investigators assume that acupuncture and P-STIM have similar effects, and this study also aims to improve the 6-minute walking distance as its primary endpoint. Additional endpoints include LVEF (left ventricular ejection fraction), NYHA classification, inflammatory markers (e.g., CRP, pro-BNP), and patients' quality of life.

Study Design:

Patients will be randomly assigned to either the placebo or the verum group. They will receive treatment for five weeks (with the device being replaced weekly) and undergo a follow-up examination after four weeks.

At the beginning and during follow-up, Left ventricular ejection fraction (measured by cardiac ultrasound), inflammatory markers in the blood, NYHA classification, and quality of life (assessed by questionnaire) will be recorded. The primary endpoint, the 6-minute walking distance, will be measured at baseline, two weeks after the start of treatment, and at the follow-up examination.


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure
* NYHA Classification II-III
* Stable medication since at least 1 months
* LVEF \<40%
* Patients must be able to understand study conditions
* No exclusion criteria
* Signed informed consent 6.1.3 Exclusion criteria
* Any electrical auricular vagal stimulation treatment within 6 months prior to base line visit
* Participation in another clinical trial within 3 months prior to base line visit
* Ventricular tachyarrhythmia within 1 month prior to base line visit
* Psoriasis vulgaris
* Hemophilia
* Cardiac pace makers
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C

The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece in a clinical practice patient population.

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[SVR12\] and sustained virologic response 24 weeks after the end of treatment \[SVR24\]).

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
* Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

* None
Neurofeedback for Borderline Personality Disorder

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as an intervention for borderline personality disorder.

We will assess the treatment effects of real-time fMRI neurofeedback in adults with borderline personality disorder. This is an experimental longitudinal design where participants will be followed every two weeks after receiving 2 sessions of neurofeedback from the amygdala . Procedures involve a battery of self-report measures, fMRI and psychophysiological indices (heart rate, respiration).

Eligibility Criteria:
Inclusion Criteria:

* right-handed adults (ages 18 - 55) with a primary diagnosis of Borderline Personality Disorder according to diagnostic criteria in the Structured Interview for DSM Personality Disorders
* must be able to give written informed consent prior to participation
* unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
* English speaking

Exclusion Criteria:

* have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
* Current moderate or severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild alcohol or substance use would also interfere with the effects of the intervention.
* have a history of traumatic brain injury
* are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
* are currently pregnant or breast feeding
* are unable to complete questionnaires written in English
* current (within 3 weeks of testing) use of any antipsychotics, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
* have a DSM-5 diagnosis of psychotic or organic mental disorder
* have any eye problems or difficulties in corrected vision.
* Serious suidicial ideation