cyrilzakka/clinical-trials huggingface dataset:
Low Dose Methoxyflurane and Out-Patient Aesthetic Surgery and Facial Filler

The aim of the study is to generate real-world evidence on the effectiveness, safety and additional parameters of low dose methoxyflurane (PENTHROX®) in: aesthetic surgeries (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) and facial filler injections \[eg. hyaluronic acid (HA) and Sculptra®\] in an outpatient aesthetic practice. This will be an open-label study, with a total of 60 patients undergoing a planned outpatient aesthetic surgery or filler injection (30 patients in each group).


Eligibility Criteria:
Inclusion Criteria:

1. Conscious adult patients: ≥ 18 years of age
2. Patient is scheduled for an outpatient anesthetic surgery (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) or a facial filler injection (eg. HA, and Sculptra®).
3. Patient should understand the nature of the study and provide written informed consent
4. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion Criteria:

1. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
2. Clinically significant renal impairment
3. Women of child bearing potential who are pregnant or peri partum, including labour
4. A history of liver dysfunction after previous methoxyflurane use or other halogenated anesthetics
5. Hypersensitivity to methoxyflurane or other halogenated anesthetics, or to butylated hydroxytoluene
6. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
7. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
8. Clinically evident respiratory impairment as per the opinion of the investigator
9. Prior treatment with PENTHROX® within 3 months
Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia

The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)


Eligibility Criteria:
Inclusion Criteria

1. Patient has recurrent, symptomatic, monomorphic VT
2. Patient has drug refractory or drug intolerant VT following use of at least one Class III antiarrhythmic as demonstrated by a recurrent arrhythmia and is not a suitable candidate per the investigator's expert opinion for ongoing or alternative drug therapy
3. A prior failed ablation as evidenced by ICD device therapy within the prior 6 months.
4. Patient has minimum 3 month ICD interrogation history available for evaluation
5. Patient has LVEF \> 20%, confirmed by echo or comparable technique during baseline evaluation
6. Patient is at least 18 years old
7. Patient has signed the informed consent, and is willing and able to participate in all study procedures and follow up requirements

Exclusion Criteria

1. Patients with idiopathic VT
2. Patients with VT with ECG or MRI/CT findings suggestive of right ventricular free wall origin findings.
3. Patients with VTs of septal origin may be excluded as such ablations require special care to minimize the risk of heart block, particularly within 2 cm of the AV node/proximal conduction system. Patients requiring ablation at such locations should only be included when the arrhythmia itself is life-threatening or otherwise sufficiently severe to justify the risk.
4. Patient with myocardial infarction (MI) or unstable angina within previous 60 days
5. Patient with cardiac surgery or percutaneous coronary intervention (PCI) within previous 60 days
6. Patient with class IV (NYHA) heart failure
7. Patient with mechanical mitral valve, severe aortic stenosis or flail mitral leaflet
8. Patient with left ventricular assist device planned or required for the procedure
9. Patients with co-morbidities such that they have less than 1 year life expectancy
10. Patient with significant intracardiac and/or laminated thrombus evident by transesophogeal echo (TEE) or transthoracic echo (TTE) (with contrast) within 2 days of the ablation procedure
11. Patient with thrombocytopenia or other coagulopathy
12. Women who are or may potentially be pregnant. (must be post-menopausal or have a negative pregnancy test)
13. Patient with other acute illness or active systemic infection (unrelated to VT or its origin)
14. Significant congenital anomaly heart disease or anomaly
15. Allergy or contraindications to the medications/agents used during a standard ablation/EP intervention.
16. Patient concurrently enrolled in any other investigational drug or device study that the investigator deems would interfere with study results.
Heart Rate Variability in Pneumothorax

Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy


Eligibility Criteria:
Inclusion Criteria:

* age 15 - 50 years
* body mass index 25 - 45

Exclusion Criteria:

* heart rate other than sinus
* cardiac pacemaker status
* heart transplant
The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)

The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.

The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Male over 18 years-old
* Normal spermogram (concentration ≥15 million / ml or total count\> 39 million, progressive mobility ≥32% or total mobility ≥40%)
* Progressive mobility ≥70% after selection
* Total number of progressive motile spermatozoa recovered after TMS\> 10 million
* Patient affiliated or beneficiary of a social security scheme
* Patient having been informed and not opposing to this research.

Exclusion Criteria:

* Male over 65 years-old
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.


Eligibility Criteria:
Select Inclusion Criteria:

1. Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration
2. Age 40 to 80 at randomization
3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

Select Exclusion Criteria:

1. Forced expiratory volume in one second (FEV1)/FVC ratio \<0.8 after administration of bronchodilator at Screening
2. Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
3. Known explanation for interstitial lung disease
4. History of asthma or chronic obstructive pulmonary disease
5. Active infection
6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
Cessation in Non-Daily Smokers

The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).

Our aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers (ITS), and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). This is a double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS. 600 ITS who are interested in quitting will be recruited through multiple channels. Enrollees will be randomized 1:1 to active 2 mg nicotine gum or an inert control gum. Participants will attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Short and long term abstinence will be assessed and biochemically validated. EMA data collection includes two weeks of baseline data on ad lib smoking patterns and 6 weeks of post-quit data. This will capture data on craving, withdrawal, and relapse among ITS, and relate relapse contexts to baseline smoking patterns.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Smoking for at least 3 years
* Smoking non-daily for at least one year (\< or = 27 days/month)
* Smoke at least weekly
* Intention to quit smoking within the next month and a desire to receive behavioral and medication treatment
* Willing and able to come to the laboratory for 8 visits over a 14-week period, as well as a ninth and final visit 6 months after their quit date
* Willing to monitor behavior via an electronic diary for 8 weeks
* Able to read and write English (in order to understand questionnaires and study instructions)

Exclusion Criteria:

* Regular use of any form of tobacco other than cigarettes
* Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, and or hospitalization in the past month for a psychiatric condition)
* Night and/or 'swing' shift work (which complicates EMA schedules)
* Known plans to relocate or move from the Pittsburgh area within the coming 6 months
* Received cessation treatment within past year
* Use of bupropion or varenicline in past 2 months
* Past use of nicotine gum (to avoid un-blinding)
* Contraindication to NRT
* (for women) Current pregnancy or breastfeeding or plan to become pregnant during the next 2 months
* Member of the same household already participating
Deep Tissue Massage in the Myofascial Pain Syndrome

This study aims to examine the effect of deep tissue massage (DTM) on myofascial trigger point (MTrP) number, neck range of motion (ROM), pain, disability and quality of life in patients with Myofacial pain syndrome (MPS).

A total of 88 patients with MPS were screened for eligibility. Of these patients, 80 who met the inclusion criteria were randomly divided into two groups using randomization with computer-generated random numbers as the control group (n=40) and DTM group (n=40).

The patients were evaluated at baseline (Day 0), and the end of treatment (Week 4).

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Have at least one active trigger point
* Have not previously undergone local injectable anesthetic blockage or acupuncture,
* Complaining of pain for the last three months
* Getting a diagnosis of MPS

Exclusion Criteria:

* Patients with infectious skin disease,
* Using analgesic and antidepressant medication,
* A history of major trauma or surgical intervention,
* Mini Mental State Examination (MMSE) score ≤ 24 according
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses

The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.

Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.

Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible.

The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.

Eligibility Criteria:
Inclusion Criteria:

* healthy normal
* good general health

Exclusion Criteria:

* pregnancy
* insulin dependent diabetes
* daily smoker
* skin disease on the hands/wrists
* immunological disorders
* occupation involving frequent handwashing
* common cold symptoms
Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass

The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium

Delirium is the most common surgical patients postoperative complications of brain dysfunction. Delirium is a kind of consciousness attention and cognitive function changes of acute brain dysfunction, with volatility and reversibility of postoperative delirium (POD), increased hospital costs and length of hospital stay and mortality rate, and can lower the quality of life, lead to long-term postoperative cognitive dysfunction and dementia. The incidence of postoperative cognitive dysfunction in patients undergoing cardiac valve replacement under cardiopulmonary bypass (CPB) can be as high as 44-53%. However, since the specific mechanism of POD is still not clear, there is still a lack of effective prevention and treatment measures. Therefore, early detection and identification are helpful for the early treatment of POD.When brain injury occurs, the levels of excitatory neurotransmitters (glutamate and aspartate) will rise in a short period of time, and the high concentration of glutamate causes excessive intracellular calcium flow, causing cellular calcium overload, and generating excitatory cytotoxic effects. And abnormal electroencephalogram (EEG) is a kind of due to brain excitability/inhibitory amino acid imbalance caused by brain excitability increased result in abnormal discharge mode, can affect cognitive awareness and activities. Increased brain excitability is harmful to the potential, should avoid to happen. At present, the relationship between brain excitability and POD is still in exploring. Therefore, it is important to clarify the correlation between brain excitability and POD in patients undergoing cardiac valve replacement under CPB for improving the pathogenesis of POD.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅱ - Ⅲ;
2. No cognitive impairment was assessed one day before surgery;
3. Patients undergoing elective heart valve replacement under CPB and signed informed consent.

Exclusion Criteria:

1. Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
2. Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
3. Inability to communicate with language impairment or major hearing or visual impairment;
4. Liver function child-pugh Grade C, severe liver dysfunction;
5. Severe renal insufficiency requires preoperative renal replacement therapy;
6. A past history of intraoperative knowledge.
Computerised Intervention/Treatment for Adolescent Depression and Low Mood:

This study forms the second phase of previous work to examine the effectiveness of computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low mood/depression.

Depression affects around 2% of adolescents. Antidepressants are not recommended for this age range as a first line treatment because of concerns about their usefulness and side effects. Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is effective and one of the main treatments recommended for depression. It has been suggested that computerised versions of CBT (cCBT) may be effective for treating depression in young people who may prefer this to seeing a therapist face-to-face, but little research exists to date to support this. This study examines the feasibility of running a large scale randomised controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help websites for adolescents with low mood and depression (LMD).

Eligible and consenting participants will complete several questionnaires to assess their mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to selected websites providing self help for LMD. Participants will complete further mood questionnaires 4 and 12 months after treatment completion/withdrawal. We have already recruited 97 individuals to this trial but aim to recruit a further 48 participants to collect further information.

We are also keen to find out whether sending participants text messages before sessions and around follow up periods will increase attendance/completion. Therefore all trial participants will receive text messages from the research team during their participation.


Eligibility Criteria:
Inclusion Criteria:

* 12 to 18 years
* Low mood/depression
* co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety

Exclusion Criteria:

* Suicidality
* Postnatally depressed
* Suffering psychotic symptoms
Optimized Single-breath Helium Lung Volume in Obstructive Lung Disease

Whole-body plethysmography (WBP) is the gold standard for measuring lung volume, but its clinical application is limited because it requires expensive equipment and is complicated to use. Studies have shown that the single-breath helium dilution (SBHD) method, which is commonly used in clinical practice, significantly underestimates lung volume in patients with obstructive lung disease (OLD). Therefore, by comparing the differences in lung volume measured by the SBHD method and WBP in patients with different severities of obstructive lung disease, we aim to establish a correction equation for the SBHD method to determine the total lung volume in obstructive lung disease patients.


Eligibility Criteria:
Inclusion Criteria:

(1) age 18-80 years and (2) in line with the ATS/ERS definition of obstructive lung disease.

Exclusion Criteria:

(1) contraindications for spirometry, pulmonary diffusion function test, and WBP and (2) history of lung surgery and recent history of chest trauma.
Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females

The Norwegian Directorate of Health recently published the Norwegian food-based dietary guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main aims of these guidelines are to promote public health and prevent chronic degenerative diseases. Reaching the healthy population is crucial as only small proportion of the general population comply to the current public dietary advice in Norway. Thus, the objective of this study is to investigate whether a multi-faceted dietary intervention could increase compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy population.

The study was conducted as part of a master level course in Clinical Nutrition at the University of Oslo. Thus, the main objective of the study was to teach the master students about planning, conducting and analysing data from a clinical trial. The students themselves are subjects of the study, however the participation in the study was voluntary and did in no way affect the approval of the course.

Since the primary objective of the study was teaching, the study was confirmed by the "Regional Committees for Medical and Health Research Ethics" (REC) to be exempt from REC approval.

Eligibility Criteria:
Inclusion Criteria:

* female

Exclusion Criteria:

* serious chronic disease requiring medication
* pregnancy
Pediatric EEG Monitoring

The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.

The investigators propose to 1) optimize these devices for use in pediatric ICU patients, 2) demonstrate safety, reliability, and accuracy of these devices for continuous ICU EEG signal measurements, and 3) demonstrate these devices are preferred by patients and parents to current EEG devices. Once validated, such sensors could fundamentally change the way patients are monitored by EEG in the ICU, allowing wireless, continuous, real-time detection of brain wave activity in ICU patients, reducing limitations in mobility as well as access by staff and caregivers to the patient, and ultimately offering opportunity to reduce morbidity and mortality in ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be admitted to the PICU or EMU at Lurie Children's and are prescribed an EEG as part of their standard of care.

Exclusion Criteria:

* Anyone with a skin abnormality that would potentially increase the risk of device use will be excluded.
* Ages 18 years or older.
* Any patient or family determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family) will not be approached for recruitment.
Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers.

Objectives:

1. to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo
2. to establish SNX-001 pharmacokinetic profile.

This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females
* Physically and mentally healthy subjects
* Body weight \>60 kg and body weight ≤ 100 kg

Exclusion Criteria:

* Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities
* History of general malignant diseases
* Evidence of myasthenic weakness
* Acute infection or any other febrile illness