cyrilzakka/clinical-trials huggingface dataset:
Functional Inspiratory Muscle Training in Obese Individuals

In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.

This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals.

Obesity is characterized by increased adipose tissue and systemic inflammation that play a key role in the development of non-communicable chronic diseases. It is well known that individuals with obesity have decreased exercise capacity and muscle weakness in both peripheral and respiratory muscles.

Exercise training is recommended in addition to healthy dietary habits in managing obesity. Current literature demonstrated beneficial clinical outcomes of isolated inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals.

Functional inspiratory muscle training is a method that combines both aerobic exercise and inspiratory muscle training. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals. The aim of this study is to investigate the effect of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength and respiratory muscle performance in obese individuals.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 25-60
* According to the World Health Organization (WHO) classification, those with a body mass index between 30-40 kg/m2
* Volunteering to participate in the research

Exclusion Criteria:

* According to the World Health Organization (WHO) classification, body mass index is over 40 kg/m2
* Functional class III or IV according to the New York Heart Association (NYHA) classification
* Those with a Charlson comorbidity score of 3 and above
* Uncontrolled hypertension, diabetes and unstable angina pectoris
* Cooperative disorders, orthopedic and neurological problems that may interfere with evaluation and treatment
* Individuals with a history of lower extremity-related injury or surgery in the last six months
* Being diagnosed with diabetes and having complications such as nephropathy, retinopathy and neuropathy
* Those with accompanying chronic respiratory disease
* Those with acute infection
* Individuals with middle ear-related pathologies (such as tympanic membrane rupture, otitis)
* Those with a STOP-Bang score of 3 and above
* Individuals with a history of spontaneous or trauma-related pneumothorax
* Smokers
* Pregnancy
Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation

The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.

Irritant contact dermatitis (ICD) is a frequent cause of hand eczema and occupational skin disease. One way to study ICD is to expose healthy volunteer skin to chemicals and evaluate the skin response. Because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. In this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. Treatment of ICD has classically involved topical steroids and/or emollients. However, the outcome is variable with some patients being very refractory to this regimen. This study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% Glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.

Eligibility Criteria:
Inclusion Criteria:

* caucasian
* normal skin on both volar forearms
* oral and written informed consent

Exclusion Criteria:

* pregnant, lactating women
* no safe anticonceptive method used
* intake of systemic immunosuppressants (e.g. prednisolone)
* endocrine, immune, or liver disorders
* known allergy towards drugs applied to the skin
SPSIPB and CPB on Clavicle Surgeries

Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS).


Eligibility Criteria:
Inclusion Criteria:

* Five American Society of Anesthesiologists (ASA) Ⅰ-II- III patients scheduled for clavicle surgery will be included in the study

Exclusion Criteria:

* patients with bleeding disorders
* patients with signs of infection in the block application area
* patients with unstable haemodynamics
* patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases
* patients with vascular disease,
* patients with respiratory distress
* patients whose consent for the study could not be obtained or who did not accept to participate in the study
Virtual Reality Distraction Versus Positive Pre-Visit Imagery Intervention on Children's Dental Fear and Anxiety

Aim

This study aimed to determine the effect of virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety during local anaesthesia injection.

Research Hypotheses

1. Children who receive Virtual reality distraction or Positive pre-visit imagery intervention exhibit less dental fear and anxiety levels during LA injection than those who do not.
2. Children who receive Virtual reality distraction exhibit less dental fear and anxiety levels during LA injection than those who receive Positive pre-visit imagery intervention.

Promoting children's health is a crucial nursing role. Dental health and psychological well-being are basic components of the health promotion for young children. Dental procedures especially local anesthesia injection is one of the most unpleasant experiences for young children. Dental Fear and Anxiety are considered pervasive psychological problems accompanied with strong negative feelings among a large portion of young children. Basically, dental fear and anxiety have been reported as one of the most important reasons for avoidance of dental treatments among young children, thereby results in an adverse effects on their oral and psychological health.

Nurses face a great challenge to minimize dental fear and anxiety and stabilize young children psychologically during restorative dental procedures. Such stabilization is the cornerstone of successful local anaesthesia injection and facilitating dentist's mission.

Virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. It integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. Virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience.

Positive pre-visit imagery is one of the superior cognitive- behavioral interventions. It is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach. It helps them to anticipate, deal with, and be empowered to gain mastery over the events they will experience. It also plays a role in counteracting the distorted beliefs that invading the children's conscious awareness.

Eligibility Criteria:
Inclusion Criteria

* Age ranged from 4- 6 years.
* Had a previous experience of dental local anaesthesia injection.
* Had carious mandibular primary molar and planned for restorative dental treatment.

Exclusion Criteria:

* Age more than 6 years.
* visual or auditory deficits.
* chronic or mental disabilities that affect their understanding.
GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight

To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.

A randomized, double-blind, placebo-controlled 12-week study with GLP-1 analogue (semaglutide) in men and women with obesity (BMI 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a GLP-1 analogues may exerts significant weight effects in obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI ranging from 30-49.9 kg/m2
* No significant medical problems, including diabetes
* No history of HgbA1c \<6.5%
* English speaking and able to read English and complete study evaluations
* Able to provide informed written and verbal consent

Exclusion Criteria:

* Any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of T2DM or T1DM by American Diabetes Association (ADA) criteria
* Meet current or past DSM-IVR criteria for alcohol dependence or any substance use disorders, including nicotine, or psychiatric disorders, including eating disorders, or use of any psychiatric medications, including anxiolytics, antidepressants, naltrexone or antabuse, anti-smoking medications
* Current active participation in a weight loss program or weight loss of \>10% of total body weight during the prior 6 months
* Taking any other anti-obesity medication
* History of pancreatitis, medullary thyroid cancer, or MEN syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal
The Effects of Ethanol on Intestinal Permeability and Gut Hormones

The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian male between 20 and 50 years of age
* Body mass index (BMI) between 19 and 25 kg/m2
* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal fasting plasma glucose concentration (i.e. \<6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (i.e. ≤42 mmol/mol)
* Normal haemoglobin
* Informed consent

Exclusion Criteria:

* First-degree relatives with diabetes and/or liver disease
* Liver disease or other alcohol-related diseases, diabetes mellitus
* Liver disease (serum ALAT and/or serum ASAT \>2 × normal values)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Up Until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid luekemia (AML), which has low complete response and poor survival. According to different guildlines, clinical trial is the first choice for the treatment of rrAML. High expression of BCL-2 and hypermethylation are very important factors for drug resistance in AML. Lots of studies have reported combination of BCL-2 inhibitor with hypomethylating agents (HMA) showed a promising efficacy in elder or unfit patients with newly diagnosed AML, however, presented not that exciting curing effect in rrAML. It is known that overexpression of MCL-1 and BCL-XL is the main reason for leukemia cells being resistant to BCL2 inhibitors. Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells, there might be a synergic effect for combination of BCL-2 inhibitors with HHT, which has been proven in the treatment of lymphoma. Yet, there is not a report for the use of this combination in AML. In this single arm multi-centers prospective study, adult patients with rrAML are included and treated with BCL-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with azacitidine (AZA) at a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days, and then the eficacy and safety of HVA regimens as salvage treatment in rrAML are assessed.


Eligibility Criteria:
Inclusion Criteria:

Patients with rrAML Patients with the age of 18-65 years old

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Bacterial Composition and Immune Responses in the Nose and Oropharynx During Influenza Infection

This study will serve to determine how influenza infection alters the bacterial colonization patterns in the nasal and oropharyngeal compartments, and whether the immune response correlate with these alterations. The investigators will be determining bacterial composition and immune responses in the nose and oropharynx during influenza infection.

Specific Aims

Therefore, the overall aims of this study are as follows:

1. To identify baseline composition and kinetic changes in the nasal and oropharyngeal microflora and immune responses after administering intranasal live attenuated influenza virus (i.e., FluMist® vaccine) or saline mist to healthy subjects;
2. To identify nasal and oropharyngeal microbial composition and local immune responses during influenza infections and after resolution of infection, and correlate these changes with clinical outcomes.

Randomization and Post-Randomization Visits After undergoing the nasal swabs and nasopharyngeal washes, and nasal epithelial brushing, healthy volunteers will be randomly assigned to receive either saline nasal spray (placebo) or FluMist® nasal influenza vaccine (live attenuated influenza vaccine, or LAIV). They will return 1-2 weeks and 4-6 weeks later to repeat the nasal swabs and nasopharyngeal washes, and nasal epithelial brushings done at the Enrollment Visit.

Samples will be processed to isolate 16s bacterial RNA and host RNA. 16s rRNA will be analyzed by 16S sequencing for to determine the composition of the bacterial microbiome pre and post LAIV or saline (placebo) administration. Host immune responses will be assessed based upon microarray analysis of host RNA pre and post LAIV or saline administration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers:
* Healthy subjects between the ages of 18 and 65. Approximately half of the subjects will be female and approximately half will be male.
* Must be eligible to receive live-attenuated nasal version of the influenza vaccine.
* Must be able to provide signed and dated informed consent.
* Healthy subjects willing and able to provide oropharyngeal and nasal cavity specimens

Exclusion Criteria:

* Immunosuppressive conditions or medications
* chronic systemic medical illness
* infections or antibiotic use within the past 60 days
Impar VS Coccygeal Block in the Treatment of Coccidine

The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.

Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Coccygeal pain

Exclusion Criteria:

* Malignite
* Infection
* Pregnancy
The Different Analgesic Potency of Volatile Anesthetics at Equi-MAC

The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.

Volatile anesthetics vary in their relative hypnotic potencies. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetics produced different EEG-derived indices such as bispectral index. However, there was no controlled study that demonstrates the difference of analgesic potency. The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing arthroscopic shoulder surgery
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients who have not received interscalene approach brachial plexus block (refusal or failure)
* pregnant women
Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome

This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>3 months
* Intestinal failure patients
* Silicone catheter for the administration of parenteral nutrition

Exclusion Criteria:

* Age \< 3 months
* Weight \< 5 kg
* Documented allergy to ethanol
* Evidence of tunnel site infection
* Patients receiving continuous renal replacement therapy
* Concomitant use of metronidazole
Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening

Sonographically, cervical length measurement is widely used in obstetrics. Studies have revealed that early detection of short cervix can be a predictor of predicting preterm labor. Transvaginal ultrasonography has been shown as a reference method for the recognition of the short cervix, as well as it may be useful in the transabdominal evaluation in the studies conducted. In addition to the advantages of transvaginal evaluation, it is time consuming and disadvantages of some women during anxiety and discomfort during this procedure. Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal. The aim of this study is to investigate the value of the cervical length measured by transabdominal route, which is a more acceptable method for pregnant women, in predicting preterm birth.

Births that occur before 37th gestational week are an important cause of perinatal morbidity and mortality. Preterm birth accounts for about 12% of all births. Early screening and correct management of pregnant women at risk of preterm birth is essential in reducing perinatal mortality and morbidity associated with prematurity. But the precise prediction and prevention of preterm birth is still an important research topic.

Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal.The aim of this study was to investigate the value of the cervical length measured by transabdominal route, which is a more acceptable method for pregnant women, in predicting preterm birth.

Eligibility Criteria:
Inclusion Criteria:

-Pregnant women who gave birth in our clinic and have a 2nd trimester cervical length measurement

Exclusion Criteria:

* uterin anomaly
* multiple pregnancy cases with a history of cervical surgery
* termination of pregnancy due to fetal or maternal reasons
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 to 65 years old
* Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
* At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
* Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
* Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Exclusion Criteria:

* Symptomatic regional or structural rheumatic disease
* Diagnosed neuropathic pain syndrome
* Receiving treatment with neurostimulating devices
* Significant psychopathology
* History of chronic alcohol or drug abuse within 6 months prior to Screening
* Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening
* Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
* Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
* Other medical conditions that could compromise the subject's ability to participate in the study