cyrilzakka/clinical-trials huggingface dataset:
Computed Tomography (CT)--An Epidemiologic Study in the Young

To investigate the relationship between coronary heart disease risk factors and coronary artery calcification in middle age adults from the Muscatine Study. From 1992 through 1995, ultrafast computed tomography was used to measure coronary artery calcification. The study has been extended through January, 2001 in order to examine the role of electron beam computed tomography in detecting the presence and quantity of coronary artery calcification, a marker of the atherosclerotic process.

BACKGROUND:

Atherosclerotic heart disease, a major cause of mortality and morbidity in the United States, has been shown to have its origins in childhood. Deposition of calcium occurring early in the atheromatous process is often observed in postmortem studies of coronary arteries and the aorta. Ultrafast computed tomography (Fast-CT) provides a highly sensitive, non-invasive technique for detecting the presence and quantity of coronary artery calcification (CAC). The 'risk factors' for coronary artery disease have been determined by measuring levels of potential factors in middle-and older-aged adults and determining which predict atherosclerotic cardiovascular disease, including coronary artery disease (CAD), peripheral vascular disease, and cerebrovascular disease. Adult subjects with CAC have a greater number of coronary risk factors, including higher cholesterols. In the age group of 30-39 years, 30 to 40 percent have radiographic evidence of coronary artery or aortic calcification. In the Muscatine Study, the investigators examined coronary risk factors in 2400 subjects during childhood (ages 9-11 years) and again in young adult life (ages 20 to 30 years). This population can now provide important information related to measures of childhood and young adult coronary risk factors predicting the development of the atherosclerotic process in adults in their fourth decade of life.

DESIGN NARRATIVE:

Beginning in 1992, the longitudinal study used the non-invasive technique of ultrafast computed tomography to examine the relationship of known coronary risk factors measured in childhood and again in early adult life in order to correlate their association with coronary artery calcification. Risk factors included lipids, lipoproteins, apolipoproteins, lipoprotein(a), apo(a) genotypes, homocyst(e)ine, and left ventricular mass. Beginning in February 1996, electron beam computed tomography is used to associate risk factors with coronary artery calcification.

Eligibility Criteria:
No eligibility criteria
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y

This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Age: between 19 and 40 years old.
* Good physical condition as established by clinical examination and history taking at the time of entry.
* Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
* Written informed consent obtained from the subjects

Exclusion Criteria:

* Positive titres at screening for anti-hepatitis antibodies.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous participation in any other clinical trial.
* Previous vaccination with a hepatitis B vaccine.
* Previous vaccination with an MPL containing vaccine.
* Administration of immunoglobulins in the past 3 months and during the whole study period
* Vaccination one month before and one month after each dose of the study vaccine
Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Despite few scientific evidence that could support the use of ketamine in adult patients undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely employed in this setting. The aim of this study is therefore assess more definitively the real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and need for MV in order to establish or refute the use of this drug as "standard therapy" in these cases.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute exacerbation of COPD or status asthmaticus, undergoing controlled mechanical ventilation
* acute bronchospasm, defined as airway resistance value (Rsr max) greater than 12, use of inhaled therapy with bronchodilators and systemic corticosteroids
* patients requiring the use of continuous intravenous sedation for optimization of ventilation

Exclusion Criteria:

* contraindication or history of previous adverse events with the use of the studied drugs
* other diagnostic potential Rsr increase of not causing bronchospasm (bronchial obstruction, acute respiratory distress syndrome adult, pulmonary fibrosis)
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery

The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).

Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even less expensive and as safe alternative has to be shown.


Eligibility Criteria:
Inclusion Criteria:

* Valve replacement
* Coronary bypass surgery

Exclusion Criteria:

* Severe left ventricular dysfunction
* Coagulation disorders
Sarcopenia in Axial and Peripheral Spondyloarthropathies

Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.

The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).

This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18 to 80 years old
* Hospitalized or attending the rheumatology department for spondyloarthopathy.

Exclusion Criteria:

* no signed consent
* Immobilization for a period of more than 15 days during the last 3 months
* pregnant or breastfeeding woman
* Not affiliated to the national healthcare insurance
* difficulty in understanding French
* psychiatric disorder
GENYAL Study to Childhood Obesity Prevention

Obesity is a multifactorial, complex, chronic disease of special concern. It is originated as an interaction between genetic predisposition and environmental factors. Thus, knowledge of gene-diet interactions is especially important. However, most studies analyzing the efficacy of diet on body weight have not considered the genetic variability among the population.

Childhood and adolescence are critical periods in the development of obesity. This is because, on one hand, during infancy dietary patterns are being implemented. Moreover, it has been described that around the age of 6 it occurs the adiposity rebound, which consists in the increase in body mass index (BMI) that occurs after reaching a lowest point in infancy. It is believed that an early adiposity rebound is associated with a higher risk of developing obesity in the following years. The prevalence of overweight and obese children is increasing every year. Specifically, according to the World Health Organization (WHO) the number of overweight or obese children aged 0 to 5 years, increased from 32 million globally in 1990 to 41 million in 2016. Regarding Spanish children, they are amongst the highest levels of overweight and obesity in Europe. Precisely, in 2015 the Spanish Agency for Consumer Affairs, Food Safety and Nutrition reported 23.2 % overweight and 18.1 % obese Spanish children, according to the ALADINO study.

Considering the previous elaboration, we hypothesized that an early identification of SNPs associated with obesity will improve the strategies applied for its prevention. Moreover, an adequate nutritional counseling and a healthy lifestyle implementation during childhood will contribute to a higher quality of life in the adulthood.

Thus, schools from the Madrid Community agreeing to participate in the study will be randomly assigned to either control or intervention groups. Then, an initial evaluation where 26 SNPs associated with obesity and its related comorbidities will be carried out in all children involved in the study, in addition to anthropometric, blood pressure measurements, and physical activity and dietary patterns evaluation. Then, each group will be divided in two according to the genetic risk (high vs low) for presenting obesity and its related comorbidities. The initial evaluation was performed on all children at 1st and 2nd grades and it is going to be followed by 3 monitoring actions in the following years where the progression of anthropometric measurements and dietary habits are going to be studied. Besides, the intervention schools are going to receive healthy actions along the study aimed to reduce the risk of developing obesity.


Eligibility Criteria:
Inclusion Criteria:

Children at 1st and 2nd grades from schools of the Madrid Community that have accepted to participate in the study, whose parents have approved and signed the informed consent.
Platform Switching vs Regular Platform Implants. One Year Results From a RCT

The present study tested the hypothesis that Platform Switching (PS) and Regular Platform (RP) implants would have different outcomes in the bilateral single tooth replacements against the alternative hypothesis of no difference.

This study was designed as a randomised, controlled, split-mouth trial. Eighteen patients, with bilaterally missing single bicuspid or molar had one of the sites to be restored randomly assigned to be treated according to the platform-switching concept with (PS group), or with matching implant-abutment diameters, (RP group). A total of 36 implants, (18 Nobel Replace Tapered Groovy PS, 18 Nobel Replace Tapered Groovy), were bilaterally installed. All the implants were inserted with an insertion torque between 35 and 45 Ncm, in healed healthy bone and the healing abutment was connected at the same time. Both implants were delayed loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 2 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, soft tissue parameters (PPD and BOP). Clinical data were collected at baseline 6 and 12 months. Statistical analyses were conducted using computational program SAS (version 9.2), with 1-away ANOVA and F-test. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation with 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

* need for single bilateral fixed implant-supported prosthesis in molar area
* stable interocclusal contacts
* ≥18 years of age
* provided written informed consent
* residual bone height ≥10 mm
* residual bone thickness ≥6 mm with at least 5 mm of keratinised gingiva crestally

Exclusion Criteria:

* general contraindications to implant surgery
* lack of occluding dentition in the area intended for immediate loading
* periodontitis
* bruxism
* immunosuppression
* previous history of irradiation of the head and neck area
* uncontrolled diabetes
* heavy smoker (\>10 cigarettes/day)
* poor oral hygiene
* current or past treatment with bisphosphonates
* substance abuse
* psychiatric disorder
* inability to complete follow-up ≥1 year
* lactation
* implant insertion torque less than 35 Ncm
A Study of the Effect of Patient Education (Talking Health Together) in Improving Doctor-patient Communication

This study is being carried out to see if patients make the lifestyle changes or take their medication as instructed by their doctor during their visit as a result of the T.H.T. patient-education training. Proper information exchange between doctors and patients is an important part of quality health care. Although many patients would like more information, they often do not ask for it directly during doctor-patient visits. The patient-training in this study specifically aims at improving patient participation during medical appointments by building communication skills such as requests for information and sharing health concerns with the doctor.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 40 years of age or greater
* Clinical documentation of diagnosis not to target of at least one of the following: Type II Diabetes Mellitus, Hypertension or Hypercholesterolemia
* Receive a prescribed medication for the chronic disease for which they were included in the study

Exclusion Criteria:

* Patients in active phase of cancer treatment (i.e. chemotherapy or radiotherapy at time of study).
* Inability to carry out the encounter with their physician in English without need of assistance
* Uncomfortable using a computer for routine activities such as regular access to the web and e-mail.
Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers (COMMEF)

mPTP (Mitochondrial Permeability Transition Pore) is a channel formed by a protein complex integrated into the inner membrane of mitochondria. Its opening is related to the elevation of the intra-mitochondrial calcium concentration and will result in: a mitochondrial decoupling, a rupture of the metabolic gradient and the release of pro-apoptotic factors.

The objective of this study is the development of a new ex vivo technique for characterizing mPTP by a dual measurement combining oxygraphy and fluorimetry on permeabilized skeletal muscle fibers.

The development of new expertise in the study of mPTP is part of an approach to optimize the processing of muscle samples. The aim of this work is to evaluate the feasibility and reproducibility of a method of analysis on muscle fibers only permeabilized, while coupling two complementary techniques, oxygraphy and fluorimetry. Its principle is based on the knowledge that the opening of the mPTP leads to an inhibition of respiration at the level of the complex I of the respiratory chain. This inhibition is the consequence of the escape from mitochondria of the reduced form of nicotinamide adenine dinucleotide (NADH, i.e. substrate of complex I) concomitant with the opening of mPTP. Thus, the oxygraphy must allow the observation of the inhibition of respiration synonymous with the non-availability of the substrate of the complex I and thus indirectly reflect the opening of the mPTP. For its part, the fluorimetry must allow, in the presence of a fluorescent calcium indicator (i.e. Calcium Green), the observation of the release of calcium synonymous with the opening of the mPTP.

Once validated, this technique should make it possible to evaluate in situ the sensitivity of mPTP to calcium. In a context of application within clinical protocols, the evaluation of the mPTP calcium sensitivity should contribute to a better understanding of the physiological and physio-pathological mechanisms of adaptation of muscle tissue.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 ;
* Patients referred for a knee ligamentoplasty (DIDT technique) ;
* Patients who signed the non-opposition form after being informed ;
* Patients benefiting from or affiliated to a social security.

Exclusion Criteria:

- Patients under guardianship, curatorship or deprived of liberty.
Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea

The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.

Obstructive sleep apnea (OSA) is characterised by repetitive episodes of upper airway obstruction during sleep. Systemic and airway inflammation has been recently shown to be associated with OSA and is hypothesized to contribute to the clinical manifestation and the complications of OSA patients.

Continuous positive airway pressure (CPAP) is a first-line treatment for OSA and improves diurnal and nocturnal symptoms. However, the effectiveness of CPAP in reversing airway inflammation is less compelling in comparison to systemic inflammation.

This study will assess NO in exhaled breath, inflammatory biomarkers in induced sputum and blood of OSA patients and other clinical measurements before and after 3 months of CPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
* Subjects diagnosed with OSA (apnea hypopnea index \>=20/hour) by overnight polysomnography.

Exclusion Criteria:

* Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
* Treatments with corticosteroids or other immunosuppressive drugs.
DETECT and Retinal Outcomes in Hypertension

The purpose of this study is to study the impact of blood pressure on cognitive performance.

Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients triaged to the Grady Memorial Hospital Emergency Department or Marcus Trauma Unit
2. Age \>18 and \<65
3. Documented history of hypertension plus one or more of the following:

   * current antihypertensive use with controlled blood pressure
   * elevated Emergency Department systolic blood pressure or diastolic blood pressure
   * OR -
4. Acutely elevated Emergency Department systolic blood pressure or diastolic blood pressure on 2 separate Emergency Department measurements in the absence of a history of hypertension

   * OR -
5. Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension.

Exclusion Criteria:

1. Non-English speaking
2. Pre-visit cognitive impairment
3. Physical or psychological impairments that would prohibit comprehension and completion of DETECT testing
4. Inability to obtain adequate fundoscopic photos
5. Acute intoxication, altered mental status, or head injury within the last 6 months
6. Opiate or benzodiazepine administration by treating providers
7. Clinical condition not allowing testing.
Mass Balance Study of ASP1941

This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive

Exclusion Criteria:

* Pulse \<40 or \>90 bpm; Systolic Blood Pressure \> 140 mmHg; Diastolic Blood Pressure \>90 mmHg
Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy

To determine the effects of functional kinesio taping on subacromial space in athletes with rotator cuff tendinopathy.

Subacromial impingement is a condition among athletes those involved in overhead sports activities such as swimming and volleyball. According to Neer there are two main categories of shoulder impingement, these are structural and functional. Structural: caused by reduction of the subacromial space (SAS) due to bony growth, calcification or soft tissue inflammation whereas functional is caused by or superior migration of the humeral head due to muscular weakness imbalance. In some cases subacromial impingement can be result from a combination of both structural and functional factors.Maintenance of the SAS during arm elevation is thus essential for the prevention of Rotator cuff tendinopathy.

The aim of this randomized controlled trial (RCT) is to evaluate the long-term effects of scapular KT, added to a 6-week rehabilitation program, on the subacromial space at different arm positions in athletes with Rotator cuff tendinopathy. To better understand the underlying mechanisms of KT, our secondary objective addressed the effects of KT on reliving pain-free and full ROM of shoulder joint.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 35 years
* Both gender
* Athletes participating in volley ball, tennis, badminton and golf.
* Presence of shoulder pain in abduction and external rotation during training for more than three months
* Three out of five positive results for the following: painful arc, pain or weakness with resisted external rotation, abduction, Neer test, Hawkins Kennedy test, empty can test/Jobe test

Exclusion Criteria:

* H/O shoulder fractures,
* Instability or dislocation (positive apprehension and relocation tests)
* Frozen shoulder (All stages)
* Recent shoulder surgery for a shoulder injury