cyrilzakka/clinical-trials huggingface dataset:
EARLY-MYO-AF Registry

The purpose of this registry is to depict the myocardial function improvement in AF patients by integrated therapy and to assess the prognostic discrepancies of various intervention modalities. Information will be collected prospectively in about 5000 AF patients. Subjects will be followed for up to 3 years.

This is a prospective, single-centered, non-randomized, observational registry study of AF patients that undergo radio-frequency catheter ablation, left atrial appendage occlusion or surgical ablation. Information of other medication intervention and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 5000 AF patients with follow-ups of up to 3 years.

The aim of the project will be as following:

1. To investigate pathophysiological changes of both atrial and ventricular myocardial function in AF patients.
2. To identify clinical indices (including baseline, comorbidities, medication or operational interventions) that are associated with adverse clinical outcomes.
3. To spot potential therapeutical targets in the continuum of AF: from risk-factors elimination to mortality and disability prevalence reduciton.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must be at least 18 years old at the time of enrollment.
* Patients who are clinically indicated catheter ablation or other interventions (LAAC or surgical maze procedure) for persistent or long standing persistent AF.

Exclusion Criteria:

* Contraindication for anticoagulation therapy
* Another (non-AF) indication for long term anticoagulation
* Patients who have been enrolled as a respondent on other clinical studies
* Inability to attend scheduled, periodic office visits for follow-up
* Pregnancy
* Patient has a life expectancy of less than 6 months due to any condition.
Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests

This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. The first group will receive sevoflurane, second grup will receive desflurane and third grup will receive total intravenous anaesthesia. Investigators are also going to evaluate blood gas analysis.

Investigators are going to evaluate forced expiratory volume in 1st Second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), potential of hydrogen (pH), arterial oxygen saturation (SaO2), base excess (BE), bicarbonate (HCO3) and partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio to compare the effects of drugs.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II patients

Exclusion Criteria:

* Significant cardiopulmonary disease,
* Diagnosed obstructive or restrictive pulmonary disease,
* Patients with chest wall deformities, liver or kidney failure,
* Postoperative lack of cooperation
Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Background: Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). Its clinical efficacies on oral malodor have been evaluated and reported, however, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Methods: A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8) were instructed to rinse with the experimental mouthwash containing ClO2 twice per day for 7 days, and those in group 2 (N = 7) to rinse with the control (placebo) mouthwash without ClO2. In the second test, phase after a one week washout period, each group had used the opposite mouthwash for 7 days. At baseline and after 7 days, oral malodor was evaluated with OM, and concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were evaluated with GC. Clinical outcome variables included plaque and gingival indices, and the Winkel Tongue Coating Index(WTCI). The samples of saliva were microbiologically investigated.

Outcome variables were compared by t-test and Mann-Whitney test.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oral malodor

Exclusion Criteria:

* Oral malodor caused by foods
Efficacy and Safety of Lumiracoxib

This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.


Eligibility Criteria:
Inclusion criteria:

* Osteoarthritis of the knee
* Pain intensity at baseline of at least 50mm on a 100mm visual analog scale

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)

To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB) treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered nebulizer.

BACKGROUND:

Intermittent positive pressure breathing may be a useful adjunct therapy for patients with chronic obstructive pulmonary disease. It is, however, quite expensive; moreover, in 1976 its treatment efficacy had not been determined. Although the effectiveness of IPPB had been previously studied, the influence of long-term treatment was not known for the following reasons: The individuals studied had been too few and were not randomly assigned to treatment groups, the patient groups were not homogeneous and their clinical and functional status were not well-documented, and precise descriptions of the manner in which IPPB was administered were not recorded.

Based on these facts, a conference on the Scientific Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division of Lung Diseases, issued a recommendation to develop a controlled clinical study of IPPB. Contracts were awarded to five clinical centers and a data center in November 1976. Planning of the trial ended in November 1977. Recruitment began in April 1978 for the 985 individuals who took part in this trial and ended in October 1980. Patients enrolled after March 31, 1980, were followed for 30 months instead of 36 months. Follow-up was completed in May 1983.

DESIGN NARRATIVE:

Randomized, fixed sample of 985 patients. Eligible patients were assigned to a treatment group using intermittent positive pressure breathing or to a control group using a powered nebulizer for treatment 3-4 times a day. Treatments continued for 3 years. Endpoints related to quality of life and respiratory function and capability.

Eligibility Criteria:
Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.
Effect of Large Neutral Amino Acids in Adults With Classical Phenylketonuria

The overall aim of this study is to evaluate LNAA treatment as a potential alternative to conventional dietary treatment for PKU. This study investigates the effects of LNAA treatment compared to the classic dietary treatment on cerebral dopamine synthesis in patients with classic PKU. We will assess LNAAs effectiveness on neurotransmitter synthesis, cognitive function, mental health, and safety, compared to the standard diet.

Standard treatment for Phenylketonuria (PKU) involves a lifelong, phenylalanine-restricted diet. Strict adherence to the diet is crucial, but often challenging. Large neutral amino acid (LNAA) supplementation is a potential alternative therapeutic approach for PKU management. The proposed mechanism involves competitive inhibition of phenylalanine (Phe) transport across the blood-brain barrier by high-dose LNAA, leading to reduced brain Phe levels. However, further investigation is needed to validate its efficacy and safety for PKU management.

A randomized, open-label, crossover trial will be conducted to assess the safety and efficacy of LNAA supplementation in PKU patients. After completion of the crossover study, participants will have the option to participate in an open-label extension study aimed at evaluating the long-term safety and efficacy of LNAA.

A healthy control group will be recruited to obtain baseline outcome measures. This project is expected to provide much-needed insights into the potential of LNAA in PKU management. The study also aims to gain a deeper understanding of the underlying pathophysiology of the disease. Finally, this work could lead to more personalized management strategies for PKU patients.

Eligibility Criteria:
Patients ≥ 18 years of age with Classical PKU molecularly confirmed via the finding of two pathogenic variants in the phenylalanine hydroxylase (PAH) gene and/or historical evidence of Phe concentrations ≥1200 μmol/L in the medical history

Inclusion Criteria:

* Treatment initiation within the first month of life
* Intelligence quotient over 84, based upon the baseline neuropsychological evaluation
* Conventional dietary treatment up to minimum 15 years of age
* Signed informed consent
* Willing and able to comply with the protocol and study procedures

Exclusion Criteria:

* Unable or unwilling to adhere to the requirements of the study
* A female who is pregnant or breastfeeding or planning to get pregnant during the study period
* Concomitant medication that may interfere with the PET analysis, as judged by the investigator
* A serious neuropsychiatric disease that could interfere with the subject's ability to participate in the study at the discretion of the investigator
* Concomitant treatment with BH4 supplementation (sapropterin) or Pegvaliase-pqpz (PALYNZIQ)
* Failing to submit at least one blood Phe home sample during the year before study initiation
* Standard MRI contraindications
* Body weight over 110 kg
Comparison of Efficiency Between I-gel Blind Intubation and I-gel Bronchoscopic Intubation During Resuscitation

The investigators will compare conventional intubation using Macintosh laryngoscope, blind endotracheal intubation using i-gel for conduit and bronchoscopic intubation using Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest compressions continuously without interruption.

Moreover the investigators will compare the type of endotracheal tube. Reinforced tube has more soft tube tip, so the investigators think it is more acceptable for intubation using i-gel as conduit.


Eligibility Criteria:
Inclusion Criteria:

* emergency physician
* work at emergency department more than 1 year.
* 50 or more experience of endotracheal intubation

Exclusion Criteria:

* having backache or wrist pain
Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age or older
* referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
* Able to provide written informed consent and comply with protocol requirements
* Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol

Exclusion Criteria:

* pregnant or lactating females
* Known allergy to one or more of the ingredients in the products under investigation
* Significant congestive heart failure ( Class IV)
* Moderate to severe chronic kidney disease
* Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
* Vascular stents in vessels of interest
* Received another contrast agent in the 24 hrs preceding or proceeding each exam
* Previously entered into the study
* Contraindications to MRI
* Severe Claustrophobia Undergone DSA between the two exams
Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas.

To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question.

The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).


Eligibility Criteria:
Inclusion Criteria:

* Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
* Diagnosed with T1DM for at least 12 months
* Age over 18
* Total daily dose of insulin greater than 0.7u/kg/day
* Current use of a continuous glucose monitor
* Current use of smart phone
* Able to read and speak English
* Willingness and ability to download and provide CGM and pump (if applicable) data
* Reduction of pancreas volume (\<0.6mL/kg body weight)

Exclusion Criteria:

* History of celiac disease or inflammatory bowel disease
* Use of medication or supplements other than insulin to control blood glucose
* Pregnancy or breast feeding
* Following a restrictive diet (such as very low carb diet)
Aromatherapy Effect on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures

The goal of this study is to evaluate the effect of lavender essential oil on pre-procedure anxiety for patients undergoing ultrasound guided musculoskeletal procedures


Eligibility Criteria:
Inclusion criteria: Adults ages 18-85. Those undergoing ultrasound guided musculoskeletal procedures including joint, tendon, bursa, or periarticular structure injection/ aspiration. Proficient with English.

Exclusion criteria:

Patients currently on benzodiazepine anxiolytic therapy Those with significantly impaired sense of smell Allergy/aversion to lavender essential oils Patients with asthma Patients with history of migraines Patients with any other condition that, in the opinion of the investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements Adults unable to consent Individuals who are not yet adults Pregnant women Prisoners
Clinical Characteristics and Microbiology of Community-Acquired Pneumonia

Community-Acquired Pneumonia has become common. Additionally, the mortality is high. But the epidemiology of pathogen is various in different areas, which is crucial for the key treatment. In addition, the risk factors of patients who died in 3 or 7 days in china is not clear, comparing with patients who died in 14 or 28 days or who survived.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed community acquired pneumonia
* Age≥18 ys

Exclusion Criteria:

* HIV infection
Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II

The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.

Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care, or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcome measures will be collected at baseline and at the end of the patients' primary cancer treatment. The study will be performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary objective is to determine the efficacy of the nurse-led telephone-based palliative intervention on improving patients' quality of life, symptom burden, and satisfaction of care. In addition, using validated instruments, the investigators will assess the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care. The results of this study will inform a future effectiveness/implementation study.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA with a primary diagnosis of lung cancer that requires more than surgical resection:

* diagnosed within 8 weeks of recruitment
* must have telephone access
* ability to understand English
* able to participate in informed consent process

Exclusion Criteria:

Patients not eligible to participate in the study include those who are inpatients prior to randomization,

* those who are under the care of palliative care or hospice at the time of randomization
* those who have severe mental health disorders
* those who are unable to speak directly with the nurse over the telephone
* or those that have the inability to provide informed consent
Topical Oral Anesthesia Adjuncts in Conventional Intubation on First-Pass Success Rate

This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.

In Thailand, conventional intubation or sedation without paralysis is still the most common method of intubation due to the lack of emergency physicians at primary care centers. A pilot study had shown that topical oral anesthesia can improve the first-pass success rate in conventional intubation by direct laryngoscopy. This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients in emergency department that have indication for conventional intubation
* Age \> 18 yr

Exclusion Criteria:

* Patient who undergo RSI
* Patient who falls in cardiac arrest airway algorithm
* Patient who is currently pregnancy
* Known allergy to lidocaine
ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

ISIS 104838 is an antisense oligonucleotide drug that reduces the production of a specific protein called tumor necrosis factor (TNF-alpha), a substance that contributes to joint pain and swelling in rheumatoid arthritis. ISIS 104838 works by blocking TNF-alpha messenger RNA, the "instruction" molecule that is required for the production of TNF-alpha protein. This trial will assess the safety and efficacy of ISIS 1048383 by subcutaneous injection, administered by 3 different dosing regimens for 3 months, versus placebo. Approximately 160 TNF-alpha inhibitor-naïve rheumatoid arthritis patients will be evaluated at 32 sites in the U.S. and Canada.


Eligibility Criteria:
Inclusion Criteria

1. Age \>/= 18 years.
2. Rheumatoid arthritis for \>/= 6 months.
3. Active disease as defined by \>/= 6 swollen and \>/= 9 tender joints, AND an abnormal C-reactive protein or Westergren Erythrocyte Sedimentation Rate lab test, OR Morning Stiffness \>/= 1 hour.
4. Use of at least one DMARD, and ability to discontinue any current DMARD.

Exclusion Criteria

1. Onset of rheumatoid arthritis before the 16th birthday.
2. Wheelchair or bed-bound functional level.
3. No previous infliximab or etanercept treatment, or investigational therapy (not placebo) with other TNF-alpha inhibitors.
4. Prednisone \> 10 mg per day or more than one nonsteroidal anti-inflammatory drug.
5. Patients with an active infection, a history of tuberculosis, multiple sclerosis, other poorly controlled medical illness, or a malignancy within the last 5 years.
6. Patients who require intravenous heparin therapy or with a history of a bleeding problem.