cyrilzakka/clinical-trials huggingface dataset:
Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs

The investigators will examine smokers without cardiovascular disease treated with transdermal nicotine patches and/or varenicline at before, 4, 12, 24 and 48 weeks after treatment during validated smoking cessation program. The investigators will measure changes between baseline and 4,12,24, and 48 weeks after treatment of :

1. exhaled carbon monoxide (CO, ppm) and self-reported number of cigarretes/day
2. carotid-femoral pulse wave velocity (PWVc m/sec-Complior SP ALAM) and augmentation index (AI %-Arteriograph,TensioMed)
3. perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glucocalyx thickness because of a for deeper penetration of the RBC in the glucocalyx
4. oxidative stress, thrombosis and inflammatory biomarkers in blood samples.

Non smokers of similar age and sex will serve as controls.

Eligibility Criteria:
Inclusion Criteria:

* Smokers

Exclusion Criteria:

* Coronary artery disease
* Heart failure
* Diabetes mellitus
* Dyslipidemia
OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

Obstructive Sleep Apnea (OSA) is a prevalent nocturnal breathing disorder among the general population. Oropharyngeal myofunctional therapy (OMT) is an alternative conservative treatment used to improve OSA, associated health problems, and to improve the efficacy and tolerability of CPAP.

The objective is to determine the effect of OMT in the general population with mild-moderate OSA.

The overall study design will be a randomized controlled clinical trial with parallel groups. Both the control group and the intervention group will receive the same indications on the hygienic-dietary measures to be followed. The intervention group will also follow an exercise program based on OMT for 20 weeks. The effect on the apnea-hypopnea index and other variables will be determined by means of respiratory polygraphy before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance and signature of the informed consent
* Diagnosis of OSA with mild-moderate AHI without criteria for treatment with CPAP and/or other treatments (DAM).
* Patients who refused CPAP, were not candidates and/or refused DAM.
* Age \> 18 years and \< 70 years

Exclusion Criteria:

* Craniofacial malformations. Severe developmental delay. Intellectual disability.
* Diagnosis of neurodegenerative disease.
* Limited tongue mobility/presence of ankyloglossia as well as Temporo-Mandibular Joint pathology.
* Regular use of hypnotic medications
* Bulbar pathologies
* AHI of central origin above 50% of the total sleep time.
* Obesity grade II or more.
* Severe cardiovascular, neuromuscular or pulmonary pathology or chronic domiciliary oxygen use. Hypoventilation-obesity syndrome.
* Refuse to participate in the clinical trial despite fulfilling the inclusion criteria and not presenting any exclusion criteria.
BOTOX® in the Treatment of Upper Facial Lines in Japan

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).


Eligibility Criteria:
Inclusion Criteria:

-Moderate to severe Crow's Feet Lines and Frown Lines

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
* Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
* Medium-depth or deep facial peels within 5 years
* Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims

The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital providers.

This study will be divided into three parts. The first portion involves the education/inservices of the aeromedical prehospital providers to document the knowledge and skills necessary to perform and interpret eFAST exams using ultrasound pre hospitalization.

The second portion involves testing the logistics of utilization of prehospital ultrasound. Data will be collected by the participating aeromedical prehospital providers to rate the durability of the equipment, difficulty in preforming the eFAST exam, interference with other actions and ability of retention of images.

The third portion will involve the aeromedical prehospital providers performing the eFAST exam using the ultrasound prehospital and comparing their findings with the gold standard exam, CT scan, while patient is in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Code 3 trauma activation Admitted directly from scene Transported via Life Flight (aeromedical ambulance)

Exclusion Criteria:

* transfer from outside hospital
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

The goals of this study are:

* to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
* to assess response to treatment in patients with NSCLC six months after beginning study treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
* ECOG performance status score of 0 or 1

Exclusion Criteria:

* Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
* Symptomatic or uncontrolled brain metastases
* Evidence of meningeal metastasis
* \> 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed \> 12 months prior to regiment)
* Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline

Subjective cognitive decline (SCD) is the transitional state between normal aging and mild cognitive impairment. SCD is defined as having self-perceived declines in any cognitive domain over time; having normal performance on cognitive testing; no dementia or depression. Cognitive difficulties can lead to a decline on daily function and quality of life. Early intervention can prevent SCD from developing into dementia.

Cognitive strategy training (CST) aims to generate individualized strategies to solve cognitive problems, which can be effective to improve daily functions and performances. However, there is limited clinical research aimed at improving daily functions for SCD. Most non-pharmacological studies have conducted objective cognitive training, which may not enhance daily performance. Previous studies also seldom examine the effectiveness of the intervention to improve daily function, quality of life, self-efficacy and motivation.

This study adopts a quasi-experimental design. The investigators will recruit 80 community-dwelling people with SCD who are aged 55 and older. There will be 40 participants in each group. The experimental group will receive the CST. The active control group will receive group interactive game. Both groups will have 8 sessions for one hour per week for a total of 8 weeks. Outcome measures include daily function, self-efficacy, motivation for change, and quality of life. Assessments will be performed at baseline, post-intervention, and 3-month follow-up. The demographic data of the two groups will be compared using the independent sample t-test and chi-square test. Changes on outcomes between the two groups will be analyzed by two-way ANOVA. This study was approved by the Human Research Ethics Committee at National Cheng Kung University. All participants provided written informed consent before testing.

This study aims to (1) examine the feasibility of the CST in community-dwelling people with SCD; (2) explore the efficacy of the CST on daily function, self-efficacy, motivation for change, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* aged 55 and above
* live in community
* self-perceived decline in cognition compared to five years ago
* subjective cognitive decline, Cognitive Failure Questionnaire (CFQ) score above zero.

Exclusion Criteria:

* objective cognitive impairment, Taiwanese version of the Montreal Cognitive Assessment (MoCA-T) scores below 24
* any medical, neurological or psychiatric disorders, Brief Symptom Rating Scale (BSRS-5) scores 10 or more
* severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
* participate in other research related to cognitive strategy at the same time.
Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence

DIALOG is a study to assess the efficacy and safety of remote patient monitoring using virtual operator voice technologies and a business intelligence (BI) system for timely detection, prevention of early complications, worsening of the condition, and other adverse events in patients who have been discharged from the hospital.

After ensuring that the patient\&#39;s characteristics meet the inclusion and exclusion criteria and confirming the patient\&#39;s ability to use the \&#34;voice assistant\&#34;, as provided in the research protocol, patients who have completed the briefing will be able to use the voice assistant at home. During the month, robotic remote monitoring of patients using unique algorithms developed for virtual operator speech technology and a BI system will be conducted for five groups of patients (CHF, DM, AH, LPD, and patients who underwent total knee replacement) who have been discharged from the hospital. The system developed allows for quick surveys, collection of data on patient conditions, and convenient transfer of this data to the physician. The physician will receive information on patient status in a graphical form using a traffic light system. In the event of any red flags, the physician will contact the patient for further discussion on treatment strategies. The study will evaluate the efficacy and safety of utilizing the \&#34;voice assistant\&#34; by assessing the achievement of target values for controlled parameters, evaluating patient satisfaction and adherence to treatment, reducing the number of repeat hospitalization, and reducing overall mortality and cardiovascular-related mortality.

Eligibility Criteria:
Inclusion Criteria:

* Disease diagnosed according to the latest Clinical practice guidelines
* Stable condition at the time of discharge from the hospital
* Written informed consent to participate in the study

Non-inclusion criteria:

* Diagnosed dementia or severe cognitive impairment
* The inability to use automatic devices to register blood pressure at home, a blood glucose meter
* Alcohol or drug abuse
* Inability to contact a voice assistant and other study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures

Exclusion Criteria:

* Unwillingness of the patient to continue participating in the study
* The development of conditions related to the criteria of non-inclusion
A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension

Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)

Pfizer decided to stop this trial early upon Stage 1 completion due to change in PF-00489791 development and not as a result of safety concerns for PF-00489791. Date of termination (LSLV) occurred on July 28, 2010.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic or familial pulmonary arterial hypertension (PAH)
* Mean PAP at least 25 mm Hg, PCWP \< 15 mm Hg at rest
* For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
* Signed and dated informed consent
* Willingness to comply with the study plan and procedures

Exclusion Criteria:

* pulmonary arterial hypertension (PAH)other than idiopathic or familial
* For females, pregnancy or lactation
* Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
* Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
* Large shift in altitude (defined as \>5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
* Subjects with intracardiac shunts and/or serious heart, lung or other health conditions
* HIV positive subjects
* Subjects participating in another clinical trial with an investigational drug or device
* Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
* Allergies and previous intolerance of PDE5 inhibitors
* Alcohol or drug abuse
* Blood donation during the study, or 1 month before or after the study
Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD

The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.

The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. The recommended way to remove a IUD is by grasping the threads with forceps and applying gentle traction until the IUD is extracted from the external os.

Absent of the threads at the time of IUD removal is reported in 4.5 to 18% of cases. If the IUD is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. However, blind manipulation may cause uterine perforation . In cases where such devices have failed (retained IUD ), If in office extraction of IUD by these instruments failed, removal of this retained IUD in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed.

In the last decade, several studies reported in office extraction of retained IUD by office hysteroscopy or under ultrasound guidance. No studies compared the efficacy or safety of these procedures

Eligibility Criteria:
Inclusion Criteria:

* Patients with retained IUD

Exclusion Criteria:

* Active pelvic infection
* Viable intrauterine pregnancy
* Cervical pathology
Pneumococcal Conjugate Vaccine Followup

Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.

Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.


Eligibility Criteria:
Inclusion Criteria:

* PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area
* Informed parental/guardian consent

Exclusion Criteria:

* Known HIV infection or other immunosuppressive condition or treatment.
* Prior receipt of 2 doses of pneumococcal polysaccharide vaccine
Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)

Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)

To evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 20mg and Nexium tab 20mg and the effects of food influence the PK/PD of YYD601 20mg in a healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of over 19 years old at the time of screening.
* Volunteers weighing over 50 kg with ideal body weight (IBW) between -20% \~ 20%
* Subjects don't have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
* Subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry and urinalysis, etc and electrocardiogram(ECG).
* Subejctys who signed on the written informed consent form and comply with study requirements after listening adn fully understanding the details of this study.

Exclusion Criteria:

* Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
* Who has genetic problem like fructose tolerance, glucose-galctose absorption, deficiency or sucrase-iso maltase deficiency.
* Medical history or evidence (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) that can affect absorption, distribution, metabolism and excretion of a given drug.
* Subject who has over 141mmHg or under 89mmHg of systolic pressure or over 95mmHg of diastolic pressure in vital sign or over 100 times/min of pulse rate.
* Who has active liver disease, (AST, ALT, total bilirubin \> 2 x LNR), (BUN, creatinine \>1.5 x LNR) or clinically abnoramal result at screening test.
* Creatinine clearance \< 80 mL/min (calcaulated by Cockcroft-Gault formula using serum creatinine)
* History of gastrointestinal disease (e.g., Crohns disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
* Treatments for peptic ulcer, esophageal disease, Zollinger-Ellison syndrome diagnosis therapy or clinically related histories within 3 months prior to the first dose.
* Positive 13C-urea breath test
* A history of serious trauma within 4 weeks, or resection operation (exculding simiple appendectomy or herniorrhaphy) and/or relevant history or laboratory or clinical findings indicative of acute disease.
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Criteria:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Eligible cohort entry dates:

Zoledronic acid indication for treatment of postmenopausal women with osteoporosis was approved by FDA on Aug 20, 2007.

* For IBM MarketScan: Aug 21, 2007 - December 31, 2018 (end of available data)
* For Optum CDM: Aug 21, 2007 - Mar 31, 2020 (end of available data)

Inclusion Criteria:

* Postmenopausal women between the ages of 65 and 89 years
* Osteoporosis diagnosis

Exclusion Criteria:

* Bisphosphonate users
* Previous use of:

  1. Any use of parathyroid hormone
  2. Use of anabolic steroids or growth hormone within 6 months before cohort entry date OR
  3. Use of oral or intravenous systemic corticosteroids within 12 months of cohort entry date
* Serious disease that may limit life expectancy to less than 6 months
* Malignant neoplasm diagnosis within 12 months prior to the cohort entry date
* Conditions that influence bone metabolism
* Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
* Treatment of Paget's Disease of Bone
* Alcohol abuse/dependence OR Drug abuse/dependence OR Non-compliance
* Pregnancy
* Diagnosis and procedure for amputee of lower limb
* Use of Zoledronic acid within 450 days prior to the cohort entry date
* Use of Denosumab within 450 days prior to the cohort entry date
* Diagnosis of End-Stage Renal Disease OR Diagnosis and procedure for Kidney transplant
* Diagnosis of End-Stage Liver Disease: Cirrhosis, Hepatic decompensation
* Blindness or compromised vision
* Use of Abaloparatide within 450 days prior to the cohort entry date
* Use of Romosozumab within 450 days prior to the cohort entry date