rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation
Status: Recruiting

Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having a diagnosis of lumbar disc herniation Accepting to participate in the study  Exclusion Criteria:  Concomitant active systemic inflammatory disease, infection and malignancy Having disease that will cause neuropathic pain in the other lower extremity, such as polyneuropathy, multiple sclerosis etc Refusing to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patients aged 18-65 years diagnosed with lumbar disc herniation will be recruited from a PMR outpatient clinic of a state hospital - SamplingMethod: Probability Sample
Long-term Result of DTPA Chelation for Gadolinium Deposition Disease
Status: Not yet recruiting

This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Ca-DTPA (calcium DTPA) and Zn-DTPA (zinc DTPA).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Age 18 or older, 2. Diagnosis of Gadolinium Deposition Disease established by treating MD according to current criteria and confirmed by investigator review of screening questionnaire (dx criteria: presence of at least 3 of 8 symptoms-cognitive disturbance, extremity pain, arthralgia, chest wall pain, skin pain, headache, skin induration, and skin hyperpigmentation; and, had an unprovoked 24-hour Gd urine excretion level exceeding the laboratory norm at least 28 days after the symptom-inducing MRI; 3. has had five or more 2-day chelation treatments with Ca-DTPA/Zn-DTPA; 4. will be at least 2 weeks post the last chelation treatment at the time of completing the patient data-gathering questionnaires. 5. no more than 2 years have elapsed since the last DTPA chelation.  Exclusion Criteria:  1. Not fluent in written and spoken English; 2. having impaired hearing that significantly decreases the person's ability to communicate via telephone; 3. Prisoners; unable to provide informed consent. 4. Participating or having participated in protocols involving a pharmacological treatment of GDD other than DTPA chelation. Note: brief pre- or post-DTPA chelation to prevent GDD symptom flare is not an exclusion criterion.  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients in the U.S. who developed Gadolinium Deposition Disease within 28 days of undergoing a contrast-assisted MRI, in which the contrast agent contained the metal gadolinium, and who retained enough gadolinium to have abnormally high 24-hour urine levels 28 or more days post MRI. Participants must satisfy the Inclusion/Exclusion criteria noted above. - SamplingMethod: Non-Probability Sample
Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability
Status: Not yet recruiting

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.

In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.

Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being over 60 years old. Physical independence in terms of gait and transfers.  Exclusion Criteria:  Having any pathology that prevents the performance of physical activity. Subjects with impaired cognitive abilities. Subjects with tympanic perforation or middle-inner ear pathology. Subjects with pulmonary hypertension, decompensated heart or respiratory failure. Subjects who have undergone lower limb surgery within the past 12 months. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD
Status: Recruiting

Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All patients will have the following criteria:  Age: 50-60 years old All patients will be in mild to moderate of COPD. In accordance with criteria of Global Initiative for Chronic Obstructive Lung Disease (GOLD) (GOLD I-II). BMI: obese class 1 (30-34.9). Sex: male They suffered from mild dyspnea, chronic cough and expectorations, with forced expiratory volume in one second (FEV1sec) from 50% to 80% of predicted value.  Exclusion criteria:  Patients with the following criteria will excluded from the study:  Severe psychiatric or cognitive impairments. Progressive neuromuscular disorders. Decreased level of consciousness. Unstable fracture. pacemaker inserted for fewer than 2 days Deep-venous thrombosis (to minimize risk for pulmonary embolism from being in a prone position. Mean arterial blood pressure of less than 65 mm Hg with or without vasopressors. Tracheal surgery or sternotomy in the last 15 days. Massive haemoptysis. Intracranial pressure of more than 30 mm Hg or cerebral perfusion pressure of less than 60 mm Hg. - HealthyVolunteers: No - Gender: Male - MinimumAge: 50 Years - MaximumAge: 60 Years - StdAgeList: Adult
Using of SGLt2 Inhibitors in Patients With Type 2 DM
Status: Not yet recruiting

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.

- To detect the side-effects of SGLT2i

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (≥18 years) both genders ( male and female) type 2 diabetic patients  Exclusion Criteria:  history of svere hypoglycemia patients with history of weight loss Patients with history of recurrent UTI - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult diabetic type 2patients - SamplingMethod: Non-Probability Sample
Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
Status: Recruiting

The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.

Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pediatric patients from 4 to 18 years old. Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine or Functional Abdominal Pain Not Otherwise Specified) Having the informed consent signed by the parents or legal guardians of the minor.  Exclusion Criteria:  Patients presenting abdominal pain of organic cause. Immunosuppressed patients. Patients with previous hypersensitivity to the study drug.  Elimination Criteria:  Voluntary withdrawal from the study. Patients not adhering to treatment (less than 80%) Patients participating in another study simultaneously. Patients being treated by another doctor simultaneously. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 4 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Status: Not yet recruiting

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria. Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline. Evidence of AD pathology. Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II). Mini Mental Status Examination (MMSE) score ≥ 22 to 30 (inclusive).  Exclusion Criteria  Any evidence of a condition that may affect cognition other than AD. Contraindications to PET imaging. Inability to tolerate or contraindication to magnetic resonance imaging. Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments. Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening. Other protocol-defined Inclusion/Exclusion criteria apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland
Status: Not yet recruiting

The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged ≥18 to ≤ 75 years. Type 2 diabetes diagnosis ≥1 year prior to enrolment. Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment. Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment. Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.  Exclusion Criteria:  Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment. Currently participating in another study that could affect glucose measurements or glucose management. Currently receiving dialysis treatment or receives dialysis during the study. A female participant who is pregnant. A breastfeeding female participant. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
Status: Not yet recruiting

The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged ≥18 to ≤ 75 years. Type 2 diabetes diagnosis ≥1 year prior to enrolment. Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment. Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment. Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.  Exclusion Criteria:  Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment. Currently participating in another study that could affect glucose measurements or glucose management. Currently receiving dialysis treatment or receives dialysis during the study. A female participant who is pregnant. A breastfeeding female participant. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)
Status: Not yet recruiting

The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged: 18 years or older. A participant is willing and able to give informed consent for participation in the study. Patient undergoing revision shoulder or elbow arthroplasty surgery. Previous anatomic total shoulder arthroplasty (TSA), shoulder hemiarthroplasty (HA), reverse total shoulder arthroplasty (RTSA), total elbow arthroplasty (TEA), distal humeral hemiarthroplasty (DHH) and radial head arthroplasty (RHA).  Exclusion Criteria:  Refusal of consent. Antibiotic treatment was not stopped 2 weeks before aspiration or biopsy. Pregnancy. Part of any other trial with similar interventions unless previously agreed on with investigators. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty. - SamplingMethod: Non-Probability Sample
Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students
Status: Recruiting

Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.

The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.

People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  over 18 years of age students at a French school or university using social media agreeing to participate in the study  Exclusion Criteria:  Protected by law Refusing to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: students using social networks - SamplingMethod: Non-Probability Sample
Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes
Status: Not yet recruiting

The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.

Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.

Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged 19 - 64 years old; Diagnosed with type 2 diabetes; An HbA1c >= 7.5%; Not currently meeting the recommended levels of physical activity for optimal health (i.e., 150 minutes of moderate-to-vigorous physical activity and 2+ days/week of resistance training); Average less than 10,000 steps per day over the last seven days; No change in diabetes medications over the last three months.  Exclusion Criteria:  Not diagnosed with type 2 diabetes; Partaking in a self-reported regular exercise regimen, defined as consistent participation in running or jogging activity, attending exercise classes every week, or averaging 10,000 steps per day or more over seven days; Currently performing two days of resistance training per week; Having an injury that would prevent safe participation in the intervention; A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions; A diagnosis of any red blood cell altering condition (i.e., sickle cell anemia, poikilocytosis); Currently living with any cardiovascular disease which would impact the ability to participate in exercise safely; Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 64 Years - StdAgeList: Adult
Effects of SinuSonic on Psychological and Physical Well-Being
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.

The study aims are:

Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;
Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;
Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.

Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years or older; US resident; Currently experiencing symptoms of nasal congestion that have persisted at least 2 weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1 to 10, as included in a question in the Eligibility Screening.  Exclusion Criteria:  Previous use of the SinuSonic device.  Meeting any of the conditions listed under the "Safety and Warnings" for using the SinuSonic device:  Current or history of breathing problems (i.e., asthma, chronic obstructive pulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural effusion, lung cancer, cancer of the throat or upper airway) Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack) Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 101 degrees Pregnant or nursing women - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection
Status: Not yet recruiting

This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged >18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits Unilateral low back/buttocks pain of at least 2 weeks. Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust) Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician. 80% or more relief of index pain within first 5-15 minutes after injection  Exclusion Criteria:  Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation). Those involved in active litigation relevant to their pain. Those unable to read English and complete the assessment instruments. Those unable to attend follow up appointments The patient is incarcerated. History of prior sacroiliac joint fusion Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease) Sacroiliac joint steroid injection within the prior 12 months 2 Positive lumbar medial branch blocks within the past 12 months Radiofrequency ablation of the lumbar spine within the past 12 months Lumbar facet steroid injections within the past 12 months Prior epidural steroid injection within the prior 3 months in any location within the spine. Possible pregnancy or other reason that precludes the use of fluoroscopy. Allergy to steroid, contrast media, or local anesthetics. BMI>40. Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus). Active infection or treatment of infection with antibiotics within the past 7 days. Medical conditions causing significant functional disability (e.g., stroke, decompensated ---COPD, decompensated heart failure) Chronic widespread pain or somatoform disorder (e.g. fibromyalgia). Addictive behavior, severe clinical depression, or psychotic features. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult