rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Tissue Therapy of Transsphincteric Anal Fistula
Status: Not yet recruiting

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

Eligibility:
- EligibilityCriteria: Inclusion criterion:  Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:  able to communicate with Danish language able to provide informed consent having address in the region of southern Denmark during the study  Exclusion criteria:  Signs of suppuration/cavitation around the fistula Simple or low anal fistula, which can be treated by simple surgical incision Ano-vaginal and recto-vaginal fistula The presence of more than one fistula tract, more than two external orifices or more than one internal orifice Inflammatory Bowel Disease Immunosuppression (due to clinical condition or medical therapy) Malignancy within 5 years Previous radiotherapy of the abdomen and pelvis BMI under 18.5 Allergy against the antibiotics: Penicillin and streptomycin. Coagulopathy Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test) Verified syphilis, HIV, or hepatitis on screening test - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease
Status: Recruiting

The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question[s] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical complaint related to Peyronie's disease; At any stage of the disease (acute or chronic).  Exclusion Criteria:  Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant; Metallic implants over or under the area to be treated. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
Status: Not yet recruiting

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Healthy adult male or female aged 25 to 55 inclusive Normal resting ECG Normal hematologic and hepatic function Normal renal function  Key Exclusion Criteria:  Vital sign abnormalities Positive urine drug screen at screening and / or Day -1 Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 55 Years - StdAgeList: Adult
A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
Status: Not yet recruiting

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men ≥18 years of age Clinical suspicion of prostate cancer and indicated for prostate biopsy Serum Prostate-specific antigen (PSA) < 20 ng/mL Digital rectal examination ≤ cT2 (organ-confined cancer) Able to provide written informed consent MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5  Exclusion Criteria:  Prior prostate biopsy in the 2 years before screening visit Prior diagnosis of prostate cancer Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted) Patient refusal for biopsy - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder
Status: Not yet recruiting

The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women with genito-pelvic pain disorder associated to penetration.  Exclusion Criteria:  Participants with chronic degenerative disease, cognitive impairment, genital agenesis, with a history of vaginal cancer or genital radiotherapy, with the use of pelvic or lumbosacral prostheses, cardiac pacemakers, pregnant women, infections in the genital or systemic region, or who are undergoing some type of treatment for genito-pelvic pain disorder, unstable relationship with the same partner, partner with sexual complaints. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Hippotherapy in Patients With Schizophrenia
Status: Not yet recruiting

This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with schizophrenia, Being at an age of older than 18 years, Being registered with and treated at the Community Mental Health Center, Being at remission period (a stable condition) at the time of enrollment and throughout the study. Being able to provide written informed consent and comprehend the instruments.  Exclusion Criteria:  The participants who suffer from other comorbid psychiatric disorders (depression, personality disorder, substance addiction, etc.), The participants who are not willing to sign the consent. The participants who have physical health problems that would prevent horseback-riding. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Effect of ESPB on Intraoperative Remifentanil Consumption
Status: Recruiting

In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.

General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.

As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 to 65 years old ASA physical status I-II-III BMI 18 to 40 kg/m2 Elective LDH surgery  Exclusion Criteria:  Patient refusing the procedure Patients who have previously undergone spinal surgery Chronic opioid or analgesic use Patients who will operate under emergency conditions Patients who will not undergo LDH surgery - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers
Status: Not yet recruiting

The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  parent who identifies as Alaska Native (AN) parental consent enrolled in preschool in one of the12 participating Head Start programs present at school for health screenings  Exclusion Criteria:  lack of parental consent does not have a parent who is AN - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 5 Years - StdAgeList: Child
End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children
Status: Not yet recruiting

Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children.

During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are.

The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged 3 - 11 years undergoing non- or minimally-stimulating elective procedures, defined as anesthesia without skin incision or painful manipulation (e.g., non-invasive imaging, auditory brainstem response testing), middle ear surgery, surgery with effective local or regional anesthesia before surgical incision (e.g dental procedures with local anesthetic infiltration, urology with regional block). American Society of Anesthesiologists (ASA) physical status I and II TIVA technique appropriate throughout induction and maintenance of anesthesia Controlled ventilation via endotracheal tube Anticipated surgical time ≥ 90 minutes: to allow time for anesthetic induction and subsequent testing and washout periods at all three EtCO2 levels.  Exclusion Criteria:  Need for inhalational induction of anesthesia Sedative premedication Use of ketamine intraoperatively Unable to place BIS electrodes due to surgical site or other contraindications (e.g., MRI) Allergy to study drugs (propofol, remifentanil, lidocaine) Depression of conscious level for any reason BMI <5th or >95th centile for age History of obstructive or central sleep apnea Known or suspected raised intracranial pressure Recent or historical traumatic brain injury - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 11 Years - StdAgeList: Child
Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study
Status: Not yet recruiting

Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years American Society of Anesthesiologists' (ASA) physical status I-III Patients scheduled for non-elective non-cardiac surgery.  Exclusion Criteria:  Abnormal anatomy of the upper gastro-intestinal tract (including hiatus hernia, gastric tumors, and previous surgeries of the upper gastrointestinal tract). Extrinsic gastric compression obtained from the medical history or during the actual ultrasound examination. Pregnancy. Attending anesthesiologist refusal to include the patient for participation in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity
Status: Not yet recruiting

It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;

Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,
It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.

In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.

Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.

Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Female/male young adult between the ages of 18-30 December, Who volunteered to participate in the study, Without a known disease Volunteers who do not have psychological, cognitive and emotional problems  Exclusion Criteria:  Cigarette and alcohol users People with severe cardiopulmonary disorders People with postural disorders (such as scoliosis,kyphosis...) Unstable angina, has it been recently, pulmonary embolism People with obesity/diabetes Mental or cognitive impairment that will affect mental cooperation People with severe nausea, vomiting attacks People with dyspnea People with orthopedic disorders that will affect exercise performance - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy.
Status: Recruiting

The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with DNP with score ≥ 2.5 on Michigan neuropathy screening instrument of both genders. Age between 40 to 65 years. Patients having the minimum history of diabetes is 7 years. History of mild to moderate neuropathy . The patients ability to do resistance and aerobic exercises.  Exclusion Criteria:  History of taking anti-inflammatory drugs. History of recent surgical operations of joints in lower extremities. Patients suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy. Patients having any disability, fracture, or dislocation of at least six months before the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Effects of Virtual Reality Training Versus Motor Imagery in Children With Cerebral Palsy
Status: Recruiting

Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children of 7-12 years. CP children of both genders. Children with Mini Mental Scale score >24. Children with Gross motor function classification system (GMFCS) level I and II.  Able to follow and accept verbal instruction.  Exclusion Criteria:  History of any Visual and Hearing Impairments. Virtual game phobia. History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs.  Children with history of severe cardiopulmonary disease, History of epilepsy History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 12 Years - StdAgeList: Child