cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery

This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.

This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.

The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.

A total of 60 subjects will be enrolled in this study at a single site.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery
* AVR
* CABG
* AVR/CABG

Exclusion Criteria:

* History of AF/Aflutter
* Less common cardiac surgeries:
* aortic root replacement
* aortic dissections
* myxoma
* pericardectomies
* off-pump procedures
* redo procedures
* Subjects with existing pacemakers, AICD
* Vulnerable population
* Emergent surgery
* Currently participating in investigational drug or device study.
* Subjects currently on antiarrhythmic drugs Class I and III including amiodarone.
Environmental Chemicals and Their Role in Obesity

Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. Recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. The industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health.

The aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

* adult
* Overweight (BMI \> 25 kg/m²) or obesity (BMI \> 30 kg/²)

Exclusion Criteria:

* Type 1 diabetes mellitus
* psychiatric illness
Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP09031 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male subjects aged 20 to 45 years
2. The subject has Broca's index ≤ 20%
3. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
4. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
2. A subject who shows vital signs with the number of systolic blood pressure of ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg
3. A subject who shows the following result in clinical laboratory test:

   AST,ALT\>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min
4. Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir

The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.

In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Serologically documented HIV infection.
* Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
* Parental consent for patients under 18.

Nelfinavir-Failure Group:

* Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
* Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).

Control Group:

* Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
* Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.

Exclusion Criteria

Prior Medication:

Excluded:

Control group:

* Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.

Required:

Nelfinavir-failure patients:

* At least 16 weeks of nelfinavir.

Control group:

* At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
Self-acupressure for Insomnia

Abstract

Objectives: To explore the clinical effects of self-acupressure for treating insomnia delivered by a training course.

Hypothesis: Subjects who have participated in the self-acupressure training course will have greater improvement in insomnia symptoms and daytime impairment than the sleep hygiene education control group at 4 and 8 weeks.

Design and subjects: A pilot randomized controlled trial. Subjects with insomnia will be recruited from the community. 30 subjects will be randomized to self-acupressure and sleep hygiene education control groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.

Interventions: Subjects in the self-acupressure group will attend two training sessions to learn self-acupressure and will practice self-acupressure every night for 4 weeks; subjects in the sleep hygiene education control group will receive two training sessions to learn sleep hygiene practice.

Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters using subjective sleep diary, Hospital Anxiety and Depression Scale, and SF-6D at 4 and 8 weeks. Acceptability and sustainability of self-acupressure will also be evaluated.

Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model.


Eligibility Criteria:
Inclusion Criteria:

* (1) Chinese Hong Kong residents who are able to communicate in Cantonese or Putonghua;
* (2) Aged 18 - 65 years;
* (3) A current clinical Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. (The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months.)
* (4) Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level; and
* (5) Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

* (1) Receiving acupuncture or practitioner-delivered acupressure treatment in the past 6 months;
* (2) Pregnancy;
* (3) Cognitive impairment as indicated by a Mini Mental State Examination ≤ 23;
* (4) At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
* (5) No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
* (6) Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults

This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults with poorly controlled moderate to severe asthma. The researchers believe that by using a local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma, such as decreasing the numbers of times patients have to use a rescue inhaler, and improving asthma treatment assessment questionnaire scores, with no bad changes to lung function and inflammation.

The proposed four-week, double-blind, placebo controlled study is designed to test the hypothesis that topical auricular anesthesia of the vagus nerve decreases the need for the usage of rescue inhalers in moderate to severe asthma in adults.

We anticipate that up to 50 patients will be enrolled in the trial. Particularly severe risks are not anticipated based on the prior investigational experience with this drug. This trial will be used to generate experience and data to support the design of a larger, crossover, comparator trial investigating the efficacy of antipyrine-benzocaine in reducing the need for rescue inhalers and hospital admissions in moderate to severe asthmatic adults.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe asthma
* Rescue inhaler 3 times per week
* Be able to give informed consent
* Must be on inhaled corticosteroid and long-acting beta agonist (LABA), (either individually or as a combination product) and report using a short-acting beta agonist (SABA) three or more times a week in at least 2 or 3 weeks prior to stud enrollment
* Moderate or severe persistent asthma according to the National Heart, Lung, and Blood Institute (NHLBI) Guidelines, (EPR 2007)
* At least one appointment scheduled with the asthma physician during the 4 weeks of participation.
* Must be able to complete questionnaires over the phone or in person
* Must be able to maintain a basic diary/log of inhaler use and any side effects for 30 days.

Exclusion Criteria:

* Severe psychiatric or cognitive problems
* Known or suspected sensitivity to the investigational medication
* Have a stenotic ear canal
* Have a perforated ear drum
* Active Otitis Media, Otitis Externa, or Mastoiditis
* Allergic to Benzocaine
* Unable to communicate in English
* Any other significant cardiopulmonary disease
* Smokers
* Hospitalized in the last 6 months for pneumonia
* Long term or lingering side effects to COVID19
* Lack of telephone or mobile phone
* Subjects who have received any investigational drug for asthma in the past 60 days
Psychobiotics and Mental Health in Obese Women on a Weight-Loss Diet

The aim of this study was to evaluate the effect of psychobiotic supplementation containing Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071 and Bifidobacterium longum R0175 strains on mental health, quality of life, anthropometric measurements and some biochemical parameters in obese women. In the randomized double-blind placebo-controlled study, 28 obese female participants (14 psychobiotic, 14 placebo) will be given psychobiotic supplement/placebo together with a weight loss diet once a day every day for 4 weeks. Before and after the intervention, anthropometric measurements, blood samples and 24-hour retrospective 3-day food consumption records of the participants will be taken. In addition, the Depression Anxiety Stress Scale (DASS-21) will be administered to measure mental health, the SF-36 Quality of Life Scale to determine quality of life, and the International Physical Activity Questionnaire (IPAQ) to determine physical activity levels. Psychobiotics, which have entered our lives in recent years, have many beneficial effects on mental health through gut microbiota. However, while the effects of psychobiotics on mental health have been studied, their effects on obesity have not been investigated much. This study is unique in that it is the first study to investigate the effect of psychobiotic use on mental health in obese individuals. However, obesity is known to be an inflammatory disease and there is no study in the literature that includes the systemic immune inflammation index (SII) as a biomarker. SII is effective in evaluating the inflammatory and immune response in the body and determining prognosis; it adds value to clinical practice with early diagnosis of diseases, treatment follow-up and a wide range of uses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥ 18-65 years
* BMI ≥30 kg/m2
* Willingness to volunteer
* Able to give written consent

Exclusion Criteria:

* Co-administration of probiotics. However, subjects will be eligible to participate after a four (4) week washout period.
* Pregnant or planning to become pregnant within the next two (2) months.
* Positive pregnancy test in women of childbearing potential.
* Use of antibiotic medication (e.g. neomycin, rifaximin) within the last 1 month. If this is the case, the participant will be eligible to participate four (4) weeks after completion of antibiotic treatment (washout period).
* Individuals with physician-diagnosed psychiatric and neurological conditions.
* Individuals with irritable bowel syndrome or gastrointestinal disorders.
* People with immune disorders or possible immunodeficiency states (e.g. due to surgery).
* Use of anti-inflammatory drugs
* Use of corticosteroids
* People who are allergic to milk, corn starch or soya.
* Foreign nationality.
The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients

Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.

Treatment with only protease inhibitors might benefit HIV patients, who experience problems with the other antiretrovirals drugs classes. Another reason to only use protease inhibitors is that the remaining classes are spared. This leaves the option to use these classes in the future, for instance in cases of drug resistance. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent
2. ARV-naïve
3. HIV-1 infected Thai male or female \> 18 years old
4. Documented positive test for HIV-1 infection

Exclusion Criteria:

1. Inability to understand the nature and extent of the study and the procedures required.
2. Pregnancy or lactating
3. Active opportunistic infection
4. ALT/ AST more than 2x upper limit
5. creatinine more than 1.5 time the upper limit
6. Smoke cigarettes more than 10 cigarettes a day.
7. Drink alcohol more than 2 units a day
8. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
9. Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir
Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens

The objective of this study is to demonstrate that the OxyAqua silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.

This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs from one hospital. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should have normal eyes and use no ocular medications. They may have worn contact lenses previously, provided their eyes are shown to be normal at the start of the investigation. A normal eye is defined as having the following characteristics:

  1. No anterior segment infection, inflammation or abnormality.
  2. No other active ocular or systemic disease that would contraindicate contact lens wear; and
  3. No medications that would contraindicate contact lens wear.
* VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
* 1.00 to -10.00 D myopia, astigmatism less than 2.00 D
* Willing to comply with all study procedures and be available for the duration of the study.
* Provide signed and dated informed consent form.

Exclusion Criteria:

* Have history of allergies that would contraindicate "normal" contact lens wear.
* Have other active ocular or systemic disease such as, but not limited to: anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I (such as cornea or interstitial edema).
* Have medications that would contraindicate contact lens wear.
* Have had any cornea surgery.
* Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
* Any active participation in another clinical trial within 30 days prior to this study.
* The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
* A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
* A history of papillary conjunctivitis that has interfered with contact lens wear.
* No monocular or monovision fits.
* Alcoholic or Drug Abused.
Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)

Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™. Whilst rosacea is showing features of an inflammatory skin disorder \[1\], particularly stage 1 is poorly understood and treatment options are limited and therefore this study - within the target indication - will contribute to the learning about rosacea.

Male or female subjects ≥18 and \< 85 years with a clinically diagnosed rosacea subtype 1 (erythematotelangiectatic) defined by a score of 6-15 for the primary and secondary features of the rosacea standard grading system (RSGS; Wilkin et al, 2004) will be enrolled.

The study will consist of a Screening visit, Baseline visit (Week 0), a telephone call at Week 1, visits at Week 2 and 4, and a follow-up telephone call at Week 5. Eligible subjects may or may not be using medication for their rosacea at the time of screening. Subjects with concomitant use of rosacea treatments will be taken off their current medication and will return for a Baseline Visit at the end of the wash-out period.

Eligible subjects will be stratified by gender at a ratio of 4:1 (Female: Male). Within the strata, subjects will be randomised at Baseline in a 2:1 ratio in favour of Rossoseq™ to receive either Rossoseq™ or vehicle.

Efficacy will be evaluated using subject rating of the rosacea specific quality of life instrument (R-QOL; Nicholson et al, 2007) during office visits and applied over the phone during the week 1 and follow-up telephone call at Week 5. An investigator rating will be performed using a "0=absent" to "3=severe" grading of the RSGS primary features flushing, nontransient erythema, papules and pustules, telangiectasia and the secondary features burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous changes during the office visits. Ocular manifestations and phymatous changes need to be absent to be eligible for the study.

Photographs to document treatment effects will be taken at screening, baseline, week 2 and week 4.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent prior to any study-mandated procedure
* Clinically diagnosed rosacea defined by a score of ≥6 and ≤15 out of a maximum score of 30 for the primary and secondary features of the RSGS
* Female subjects of childbearing potential must be using appropriate birth control

Main exclusion Criteria:

* Pregnancy or lactation
* Women with the following menopausal symptoms within the last two years prior to screening: excessive sweating, flushing, mood changes
* Ocular manifestations of rosacea
* Peripheral location(s) of rosacea
* Phymatous changes
* Severe facial skin dryness or xerosis
* Keratoconjunctivitis sicca
* Flushing due to conditions other than rosacea
* Any other abnormal facial skin conditions, e.g., eczema, perioral dermatitis, broken and bleeding skin on area of application
* Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention

Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk.

The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years-old
* underwent DAIR with modular component exchange for acute TJA PJI, as defined by Musculoskeletal Infection Society Criteria, with symptom duration less than 4 weeks
* on postoperative oral SAT for at least 3 months

Exclusion Criteria:

* underwent aseptic revision surgery
* had one-stage, 1.5-stage, or two-stage revision surgery
* did not have postoperative SAT
* did not have follow-up that allowed for evaluation of SAT sequelae