cyrilzakka/clinical-trials huggingface dataset:
Effects of Respiratory Muscle Exercises on Glucose Tolerance in Healthy Adults

To evaluate the acute effects of respiratory muscle exercises vs. a control intervention on blood glucose kinetics in healthy adults after an oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Healthy
* Non-smoking
* Body mass index (BMI): 18.5 - 29.9 kg∙m-2
* Normal lung function
* Willing to adhere to study rules

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Intake of medications affecting metabolism, the cardiovascular or the respiratory system, or sleep
* Acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
* Pregnancy, breastfeeding, or intention to become pregnant during the study
Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

The clinical use of a flowable premixed calcium-silicate bioceramic sealer used in association with warm carrier-based/single-cone technique will be compared with epoxy resin-based sealer with carrier-based technique.

Healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in this study and divided in 3 groups (Group 1: Ceraseal + single cone cold technique n=47. Group 2: Ceraseal + Carrier-based technique n=47. Group 3 AH Plus + Carrier based technique n=47).

Periapical X-rays were taken preoperatively, after root canal filling and after 6, 12 and 24 months. Two evaluators blindly assessed the Periapical Index (PAI) and sealer extrusion in the 3 groups (k =0.90). Healing rate and survival rate were also analysed.

Chi square tests was used to analyse significant differences among the groups. Multilevel analysis was performed to analyse the factors associated to healing status and survival status.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years
2. no use of antiresorptive or antiangiogenic drug
3. healthy status (ASA 1 or 2).
4. Needing one or more root canal treatment

Exclusion Criteria:

1. Teeth with less than 2 walls of structural integrity
2. Wide apexes (\>40 diameter)
3. ASA \> 3,
4. Any pathology that could compromise bone healing or the immune response,
5. pregnancy or breast feeding
6. heavy smoking (\>15 cigarettes/day), (Tverdal \& Bjartveit 2006)
7. exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.
8. Lacks of occlusal contacts
Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors

This study aims to evaluate the effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory hypotension on an intravenous vasopressor for more than 24 h but deemed clinically stable.
* Patients on noradrenaline support \<10 μg/min

Exclusion Criteria:

* Known allergy to midodrine.
* Severe shock state, as evidenced by multiple vasopressor infusions or high vasopressor requirement (i.e. noradrenaline \>10 μg/min)
* Patients with severe organic heart disease (e.g., heart failure, sever aortic stenosis), pregnancy, thyrotoxicosis or pheochromocytoma.
* Those with no enteral route available.
Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients

Sleep is an important factor that influences long-term quality of life with known health consequences. Obstructive sleep apnea, the most prevalent disease that disturbs sleep, is considered a public health problem. Treatment with continuous positive airway pressure is cost effective and reverses the clinical consequences but there is a percentage of patients who do not tolerate it or leave it without treatment and with potential future health complications. Mandibular advancement device can be a valid and well tolerated alternative, it is known that it reduces apnea-hypopnea index, but its effect on the improvement of sleep quality is evaluated by polysomnography that interferes with the quality of sleep. There is an ambulatory monitoring device for sleep quality and circadian rhythms, which can register prolonged periods of time, under natural conditions and at a lower cost than a polysomnography. This pilot project assesses whether mandibular advancement device is an effective and well tolerated alternative in the treatment of obstructive sleep apnea to improve the quality of life and sleep in the medium and long term.

Design: observational, unicentric prospective. 50 patients / year will be included, for 3 years. The care protocol (evaluation and follow-up) of the multidisciplinary sleep unit will be followed. Demographic and anthropometric data will be collected. The dental status of the temporo-mandibular joint will be assessed. Radiological records, home respiratory polygraphy, ambulatory monitoring device for 7 days , quality of life questionnaires before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Obstructive Sleep Apnea Syndrome
* opt for mandibular advancement device as 1st treatment alternative
* opt for mandibular advancement device due to intolerance to continuous positive airway pressure

Exclusion Criteria:

* Patient with orthodontics, malocclusion and periodontal or temporomandibular joint disease who, after assessment by dentistry contraindicates it.
* Central Sleep apnea (more than 50% of central events in the baseline polygraph).
* Under 18 years old.
* Pregnancy
* Comorbidities that can potentially alter sleep architecture.
* Psychophysical inability to complete questionnaires.
* Not obtaining informed consent.
Mid- and Long-term Outcomes of Custom-made Aortic Devices

This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.


Eligibility Criteria:
Inclusion Criteria:

* Thoracic Aortic Disease

Exclusion Criteria:

* Urgent/Emergent treatment
Intensive Care Nurses' Training Package on the Safety Culture of Geriatric Patients

This study aims to determine the effect of intensive care nurses' training package on the safety culture of critically ill geriatric patients.

Study hypothesis:

Intensive care nurses who receive the proposed training package exhibit higher scores on critically ill geriatric patients' safety culture awareness than those who do not receive it.

The researchers will prepare the proposed nurses' training package program. The program will be planned to be carried out in 10 sessions that will be classified into; sessions regarding knowledge about the age-related changes affecting elderly patients that should be considered while caring for them and how to care for and maintain the safety of the critically ill geriatric patients. The researchers will prepare an illustrative PowerPoint presentation of each study program's session.

Eligibility Criteria:
Inclusion Criteria:

* aged 20 years and above.
* provide direct care for critically ill geriatric patients.
* work for at least 1 month in the unit.

Exclusion Criteria:

• not involved in patient care.
Ranibizumab Versus Aflibercept for CRVO in Young Patients.

this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old

This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.

Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\\0.1ml. the second group will receive intravitreal injection of 2.0 mg\\0.1 ml Aflibercept. All patients will be followed up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients younger than 50 years with macular edema due to non-ischemic CRVO

Exclusion Criteria: Other conditions that might affect the macula as

1. diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
2. patients with ischemic type CRVO and patients who had recent intraocular surgery.
3. patients who had previous intravitreal injections, ophthalmic laser surgeries.
4. patients with dense cataracts whom fundus was difficult to scan.
5. Patients who were lost to follow up visits were also excluded
Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants

The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants. The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically significant ductus arteriosus. The investigators also hypothesized that new echocardiographic parameters such as isovolumic relaxation time (IVRT)is useful for the prediction of ductus intervention.

Urine samples were collected within 24 to 48 hours of age, on day 7, on day 14 and on day 28 of life. The samples were spun and the platelet-free urine was stored at -80°C until NT-proBNP analysis. The NT-proBNP assay was performed with an automated immunoassay (Roche Diagnostics). Color Doppler and tissue Doppler echocardiography was determined at the same time as the urine collection. New echo parameters such as IVRT, tissue velocity, strain and strain rate were measured and compared with the standard parameters for significant ductus arteriosus. Furthermore we compared the tissue Doppler measurements with clinical findings.

Eligibility Criteria:
Inclusion Criteria:

* Written parental informed consent
* VLBW infants
* Admitted to our NICU within 48 hours after birth

Exclusion Criteria:

* No written parental informed consent
* Congenital heart disease
* Death
A Culinary Intervention for Bone Health

This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass.

This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass. A total of 40 individuals referred to a tertiary osteoporosis centre for age-associated low bone mass will be will be recruited and randomized 1:1 to attend either: 1) a 2-hour hands-on culinary medicine program at a hospital-based teaching kitchen followed by three monthly virtual group meetings, each lasting 30 minutes and led by the facilitator of the culinary nutrition program (intervention group), or, 2) not to attend the culinary nutrition program (control group). Baseline data will be collected at the time of recruitment, and both the intervention and control group will be followed for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults referred to local tertiary osteoporosis centre for assessment of age-associated low bone mass or assessment of fracture risk
* Women must be postmenopausal (i.e. documented history of surgical menopause, or at least 12 months since last menstrual period), men must be age ≥45 years
* Self-determined ability to learn in classroom and kitchen environments and a virtual (video) learning environment
* Reliable access to hardware, software, and internet connection required to participate in an interactive virtual (video) conference
* Ability to attend local hospital-based teaching kitchen for culinary medicine intervention
* Willing to participate in a culinary medicine intervention and provide informed consent

Exclusion Criteria:

* Complex metabolic bone disease or on dialysis for end-stage kidney disease
* Exclusion on the basis of other active health conditions which may present a contraindication to intake of whole and calcium-rich foods will be determined by the medical team on a case-by-case basis
* Deemed by research team to be unable to learn in a group classroom or kitchen environment
* Unable to communicate in English
Botulinum Toxin A for the Treatment of Keratoconus

The purpose of this study is to associate the use of botulinum toxin type A for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.

Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin A over a period of 18 months.The measurements of the palpebral fissure will be performed by the Image J (version 1.34s) program, developed by the National Institutes of Health (USA).The unit of measure is the millimetre.The patients of the botulinum toxin A group will be compared with a control group, without any intervention.

Eligibility Criteria:
Inclusion Criteria:

* patients with documented keratoconus
* best-corrected visual acuity measurable at refraction test
* age between 10-40 years
* good health
* understand the procedure and its limitations

Exclusion Criteria:

* only one functional eye
* previous ocular surgery
* concurrent corneal infection and other ocular diseases that modified the visual acuity
* known allergy to botulinum toxin
* pregnancy
* poor collaboration for performing the examinations and the procedure
A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers

This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Japanese subjects must have Japanese parents and grandparents who were born in Japan
* Caucasian subjects must have Caucasian parents and grandparents
* Body mass index (BMI) 18 - 30 kg/m2 inclusive

Exclusion Criteria:

* Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
* Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
* Smokes more than 5 cigarettes per day during the three months prior to study conduct
* Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
* Positive test for drugs of abuse
* Any suspicion of or history of alcohol and/or other substance abuse or addiction
* Pregnant or lactating women
Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes

Background: Probiotics influence immune homeostasis, through altering gut microbiota. The efficacy of probiotics in diabetes has been shown in preclinical settings as well as in human trials. Interleukin (IL)-21 and IL22 have been implicated in the pathogenesis of T1D. Objectives: to assess the effect of oral supplementation with probiotics on glycemic control as well as IL-21 and IL-22 levels in children with T1D. Methods: This randomized-controlled trial study included 70 children with T1D. Enrolled children aged 5-18 years with disease duration \> 1 year. They were randomly assigned into two groups; intervention group (group A) who received oral probiotics containing Lactobacillus acidophilus La-14 (108 CFU) 0.5 mg once daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, IL-21 and IL-22 levels.


Eligibility Criteria:
Inclusion Criteria:

* T1D

Exclusion Criteria:

* other types of DM
Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome

The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS).

It is planned as an observational, single-center clinical study.A total of 28 patients diagnosed with mild-moderate carpal tunnel syndrome who meet the inclusion criteria will be included in the study.Patients who had been experiencing trigger finger symptoms for at least three month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine.

Patients will be divided into two groups. One group will receive 5% dextrose, the other group will receive 1 session of local injection by mixing Celeston chronodose \[1ml/3 mg betamethasone acetate+3,947 mg betamethasone disodium phosphate (equivalent to 3 mg betamethasone)\] and 1 ml 2% prilocaine.

Evaluations will be made before injection, at weeks 4 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Paresthesia and pain symptoms in the region corresponding to the distribution of the median nerve
* Detection of mild or moderate CTS by electromyography
* One or both of the Phalen test and/or Tinel sign are positive on physical examination
* Symptoms have persisted for at least 3 months

Exclusion Criteria:

* Those diagnosed with polyneuropathy, plexopathy, radiculopathy, thoracic outlet syndrome
* Having had surgery or any injection for carpal tunnel syndrome within the last year
* History of wrist fracture
* Those with rheumatoid arthritis, uncontrolled diabetes, gout, chronic renal failure, malignancy, active systemic infection
* Those with cognitive impairment
* Coagulopathy or bleeding tendency
* Pregnancy
Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery

The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.

In the past decades, there has been a paradigm shift in the field of vascular surgery, with endovascular interventions replacing traditional open surgical procedures on an increasing scale. Most of these interventions are performed via the femoral artery. Even with modern percutaneous vascular closure devices, interventional laboratories report a high incidence of vascular complications, most commonly bleeding. Interventional procedures are gaining ground as an alternative to surgery. Having regard to the fact that femoral arteries are in constant motion due to their location and are subject to intense bending forces, the long-term durability of stents has been questioned in the absence of long-term follow-up data. There is currently no broad consensus on the strategy of care for vascular complications, and overall the decision is left to the discretion of the interventionalist, largely determined by the available local resources and infrastructure. The use of covered stents is an option for endovascular treatment of the complications: the self expanding nitinol framed stent graft with polytetrafluoroethylene (PTFE) coating and the cobalt-chrome framed, also PTFE coated balloon expandable stent. The main aim of this research is to analyse the short- and long-term outcome of these alternatives.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* intervention from the left or right common femoral artery
* access complication treated by balloon expandable covered stent(s) or common femoral artery disease treated by balloon-expandable covered stent(s)

Exclusion criteria:

* none
Pupillography as Screening Tool for Brain Insulin Resistance

Cerebral insulin action is important in the regulation of whole body glucose metabolism. However, the cerebral insulin action differs between individuals - there is a so called cerebral insulin resistance. The influence of central insulin action on peripheral metabolism seems at least partially mediated via the autonomous nervous system. A noninvasive method to measure autonomic function is the pupillography. The aim of the study is to find out whether pupillography can be used to assess central insulin activity. Thus, pupillography will be performed in 30 normal weight and 30 overweight subjects before and after application insulin intranasally.


Eligibility Criteria:
Inclusion Criteria:

* voluntary adults
* HbA1c \<5.8%
* Age between 18 and 60 years
* written consent

Exclusion Criteria:

* There is a pregnancy or pregnancy can not be excluded
* lactating women
* Minors or non-consenting subjects are also excluded
* Acute illness or infection within the last 4 weeks
* Neurological and psychiatric disorders
* intake of centrally acting drugs
* Subjects with hemoglobin levels Hb \<12g / dl (in females), Hb \<14g / dl (males)
* Allergic diseases against one of the substances used
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.

This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\])" as the primary endpoint; and to investigate safety of TAU-284.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 7 and 15 years
* Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
* Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.

Exclusion Criteria:

* Patients with vasomotor rhinitis or eosinophilic rhinitis
* Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
* Patients with a history of any of the nasal surgical procedures
* Patients who have a positive result for pollen antigens which are dispersed during the study period
* Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats.
* Patients with current or previous history of drug allergy
* Patients who concurrently have renal function abnormalities that may cause safety problems etc.