cyrilzakka/clinical-trials huggingface dataset:
PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and female over 18 years using acceptable methods of contraception

Key Exclusion Criteria:

* Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
* History or evidence of alcohol or drug abuse
* Pregnant or lactating females
* Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.
* Use of prohibited concomitant medication
* History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
* Relevant history of a suicide attempt or suicidal behavior

Note: Other protocol defined inclusion/exclusion criteria may apply
AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol

The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more years post implant.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (documentation may include an electrocardiogram (ECG), Holter, or event recorder)
* Subject must be ≥18 years of age

Exclusion Criteria:

* Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
* Subject who has a history of surgical ASD or PFO repair
* Subject with a history of stroke and unrepaired PFO
* Subject who has moderate to severe aortic or mitral valve stenosis or regurgitation as assessed by the investigator
* Subject who has a mitral or aortic prosthetic valve
* Subject who has a planned ablation procedure for atrial fibrillation 30 days after the ACP implant
* Subject with New York Heart Association (NYHA) grade 4
* Subject with evidence of pericardial effusion at baseline evaluation
* Subject who has complex atheroma with mobile plaque of the descending aorta and/or aortic arch
* Subject who has an intracardiac thrombus
* Subject who has carotid disease as assessed by the investigator, requiring treatment, which includes revascularization and/or medical treatment
* Subject with active infection or active endocarditis
* Subject who has an acute or recent myocardial infarction (MI) or unstable angina (recent is defined as within 6 months of implant date)
* Subject who has had recent major cardiac surgical procedure (recent is defined as within 6 months of implant date)
* Subject with malignancy or other illness where life expectancy is less than one year
* Subject who is pregnant, breastfeeding, or desires to become pregnant during their first six months of follow-up
* Subject or legally authorized representative who is unable to provide informed consent
* Subject who will not be able to be followed for the duration of the clinical study
* Subject with any medical disorder or severe disability that would interfere with completion or evaluation of clinical study results (for e.g. uncontrolled hypertension, uncontrolled diabetes, renal failure, in situ inferior vena cava (IVC) filter)
Female Urethral Catheterization - Instillation of the Lubricating Gel Into the Urethra or Pouring it on the Catheter's Tip?

Currently, there are no specific guidelines or best practice suggestions for female catheterization. However, there is a consensus that an anesthetic lubricating gel should be routinely used in women as well.

Urethral lubrication can be performed in two different techniques: instillation of the gel directly into the urethra or pouring the gel on the catheter's tip. In this study, we will evaluate the pain level during female urethral catheterization in each technique.

Our hypothesis is that the level of pain will be much less if the lubrication agent will be instilled directely to the urethra.

This is a randomized prospective study that will compare the pain levels of urethral catheterization in women randomized to intraurethral lidocaine gel instillation or lubrication of the catheter's tip with lidocaine gel.

Women aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptomswill be included.

Patients will be randomized to 2 groups: (1) 5mL of 2% lidocaine gel instilled directly into the urethra 5 minutes before catheterization; (2), 5mL of 2% lidocaine gel poured on the distal part of the catheter. The randomization technique will be employed by a computerized random number generator.

A 12F Nelaton urethral catheter will be introduced in order to measure post-void residual volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling will be carried out using room temperature saline at a filling rate of 50 ml/min.

Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (VAS) in different time points: prior to gel instillation (baseline), immediately after gel instillation (only in group 1), immediately after the introduction of the Nelaton catheter, 5 and 30 minutes after the catheter will be taken out.

Time frame of the study: 30 minutes before the test and 1 hour after the test. Since the study evaluates pain during the procedure the time frame of the study and assessment is very short. longer follow-up is not needed.

Eligibility Criteria:
Inclusion Criteria:

women aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms.

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Exclusion Criteria:

use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), known allergy to lidocaine or inability to cooperate with pain assessment due to mental disorders.

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Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer

RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may help doctors learn about the side effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying quality of life in patients undergoing embolization using yttrium Y 90 glass microspheres for primary or metastatic liver cancer.

OBJECTIVES:

Primary

* Assess the quality of life (QOL) as defined by the presence or absence of physical, social, emotional, and functional distress in patients with primary or metastatic liver cancer undergoing treatment with radioembolization or transcatheter arterial embolization.
* Compare the time course of QOL measures between treatment groups in patients treated with these regimens.
* Compare the time course of QOL measures between patient subgroups defined by pre-treatment quality of life or tumor burden.

OUTLINE: Patients complete FACT-Hep version 4 surveys on quality of life prior to initiation of embolization, and at 2 weeks and 1 month after completion of embolization.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary hepatocellular cancer or metastatic liver cancer
* Planning radioembolization or transcatheter arterial embolization using yttrium Y 90 glass microspheres
* No encephalopathy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Bilirubin ≤ 3 mg/dL
* Able to comply with study procedures

PRIOR CONCURRENT THERAPY:

* No prior treatment with radioembolization or transcatheter arterial embolization
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults

This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis diagnosis

Exclusion Criteria:

* Respiratory infection within 3 weeks
* Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
Non-Invasive Reduction of Abdominal Fat

This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.

The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has clearly visible fat on the abdomen.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
5. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
3. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
4. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
9. Subject is taking or has taken diet pills or supplements within the past month.
10. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
11. Subject is pregnant or intending to become pregnant in the next 6 months.
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Functional Magnetic Resonance Imaging Study of the Central Auditory System After Single Sided Deafness

The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.

Background Single sided deafness (SSD) and asymmetrical hearing loss are common hearing impairments, and their social consequences are well established. At the central auditory system level, the single sided deafness is associated with a reorganization of auditory temporal cortices that leads to a reduction of inter hemispheric asymmetry.

Purpose : Our main objective is to study the relation between the reorganization of the central auditory system, namely the inter hemispheric asymmetry, and the psychophysical deficits in binaural hearing in subjects with SSD.

Abstract : Binaural hearing enables spatial localization of the sound source and improves speech recognition in a competing noise. SSD and asymmetrical hearing loss are common hearing impairments, which affect 0.3 to 1/1000 children. In the adult population, this prevalence increases with age. The impact of SSD and asymmetrical hearing loss on quality of life indices is well established and some reports underline its consequences in children scholarship. Previous neuro-imaging and electro physiological studies highlighted the reduction of normal inter hemispheric asymmetry in subjects with SSD. To the best of our knowledge, there is no report about the relation between the central auditory system reorganization and its behavioural deficits.

The investigators propose to conduct a study which analyzes the relationship between the reduction of inter hemispheric asymmetry and performance in binaural hearing tests. Thus, the auditory plasticity will be studied using functional magnetic resonance imaging and more specifically BOLD variations in auditory temporal cortices. A set of binaural hearing assessments will be performed, including speech recognition in noise and localization abilities. The correlation between the lateralization ratio and binaural measurements (speech reception threshold (SRT) in dichotic hearing, diotic hearing, reverse dichotic hearing) will be estimated. Likewise, the impact of SSD duration on cortical reorganization and binaural tests will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed subjects
* SSD confirmed using evoked auditory potentials

Exclusion Criteria:

* Associated neurological disorder
Cross-sectional Study of Chinese Liver Cancer Patients

The goal of this cross-sectional study is to investigate the prevalence and risk factors of anxiety and depression and their relationships with immune functions and quality of life among liver cancer patients in the COVID-19 pandemic era. The objectives of this study are:

1. To examine the prevalence of anxiety and depression among patients with liver cancer during the COVID-19 pandemic.
2. To identify risk factors associated with anxiety and depression among these patients.
3. To determine the association between anxiety, depression, immune function, and quality of life among liver cancer patients.

Participants will be asked to fill a digital questionnaire.


Eligibility Criteria:
Inclusion criteria

Participants must meet all the following criteria for study entry:

1. Aged 18 or older.
2. Participants have a confirmed diagnosis of liver cancer in the medical records.
3. Participants are able to communicate with Chinese. Exclusion criteria

Participants who meet any of the following criteria will be excluded from study entry:

1. Participant has multiple organ failure which makes him/her incapable to comply with the study protocol.
2. Participant has hepatic encephalopathy or severe mental disorder which makes him/her incapable of understanding the meanings of the questionnaires.
Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase

Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase.

Overall objectives:

Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers).

Primary objective:

* Assess the clinical response of the NECT co-administration under field conditions.

Secondary objectives:

* Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these.
* Assess the feasibility of the implementation of the NECT coadministration by the health center.
* Assess the effectiveness of the NECT co-administration at 24\* months after treatment.


Eligibility Criteria:
Inclusion Criteria:

All patients diagnosed as stage 2 HAT according to the diagnostic protocols in use at the treatment center (generally, if presence of parasites in blood, lymph node fluid or CSF and an elevated white blood cell count in the CSF, but this can vary from center to center) will be included if a written Informed Consent is given by the patient or a legally acceptable representative if the patient is a minor or unable to communicate.

* Pregnancy and breastfeeding women: On a case by case basis according to the guidelines of the National HAT Control Programme or the NGO, the Investigator will decide to treat the patient or to defer the treatment. In case of inclusion, the mother-child pairs or the children of lactating mothers will be closely monitored during treatment and follow up.
* Children under 2 years of age: On a case by case basis, the Investigator will decide to treat an infant with NECT or an alternative treatment (preferably eflornithine). In case of inclusion, these infants will be closely monitored during treatment and follow up like all children less than 12 years of age.

Exclusion Criteria:

* Unable to take oral medication, and impossibility to use a nasogastric tube.
* Treatment failure after nifurtimox-eflornithine treatment.
* Any other condition or reason for which the Investigator (or the responsible treating staff member) judges that another or no HAT treatment is warranted.
Genetics in the Effect of Caffeine on Fat Oxidation

Genetic polymorphism on the effect of oral caffeine intake on fat oxidation during exercise has been studied in active and healthy population performing an incremental test on a cycle ergometer with 3-min stages at workloads from 30 to 70% of maximal oxygen uptake (VO2max). Participants performed this test after the ingestion of a) placebo; b) 3 mg/kg of caffeine; c) 6 mg/kg of caffeine. Fat oxidation rate during exercise was measured by indirect calorimetry. The influence of the CYP1A2 c.-163A\>C, GSTP c.313A\>G and PGC1a polymorphisms was evaluated to determine the effects on fat oxidation during exercise

Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge. Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs. Genetic factors like CYP1A2 c.-163A\>C, GSTP c.313A\>G and PGC1a c.1444G\>A and C\>T polymorphisms could be associated with the capacity for fat oxidation during exercise. To date, it is unknown if genetics increases fat oxidation and MFO in the same proportion during morning and evening exercise trials in women. For this reason, the aim of the present study was to evaluate the influence of the tCYP1A2, GSTP and PGC1a polymorphisms on the effect of caffeine on fat oxidation and MFO in active and healthy population. The authors hypothesised that genetics would increase fat oxidation and MFO during exercise and this effect would be of similar magnitude at several caffeine doses.

Eligibility Criteria:
Inclusion Criteria:

To be non-smokers. To have low caffeine intake (i.e., \< 50 mg of caffeine per day in the previous 2 months) To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.

Exclusion Criteria:

To have VO2max values below 40 ml/kg/min To be sedentary
Dietary Intervention for Cardiovascular Disease

Incidence of cardiometabolic disease (CMD) continues to rise, which consumes huge medical resources in Taiwan. The effectiveness of dietary therapy for CMD has not been locally evaluated in detail. CVD is an important risk factor for dementia. At the present time, there is no effective treatment available for dementia. Early prevention is extremely important. Our previous studies have shown that Taiwanese dementia protective diet is very similar to cardiovascular prevention and control diet, meaning that effective dietary therapy may not only control CVD but also prevent dementia development. Therefore, this study intends to document the effects of dietary intervention on cardiovascular disease risk factor control, the long-term outcomes on the occurrence of cardiovascular events, and the maintenance of cognitive function for patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

1. Have received percutaneous transluminal coronary artery surgery.
2. Stable drug control for more than one month

Exclusion Criteria:

1. Suffer from cancer and undergo chemotherapy or surgery within one year.
2. Those who have a major illness in hospital within one year.
3. Those with kidney disease stage 5 (inclusive) or above
4. Those whose life expectancy does not exceed half a year
5. Patients with diagnosed dementia
6. Those who do not want to be tracked