rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy
Status: Not yet recruiting

Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trial

The goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are:

to assess the patient's satisfaction with each sedation regimen
the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications.

Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and the investigator will not be aware of the treatment administered.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  otosclerosis surgery, ASA ( American Society of Anesthesiologists) status 1-2  Exclusion Criteria:  ASA status 3-4 requiring general anesthesia refusing to participate allergic to study medication - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Morphological Changes of Removable Orthodontic Retainers During the Use
Status: Recruiting

The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  young adult patients: 18-35 years; Caucasian ethnic group; good oral hygiene (evaluated by observing a plaque index < 20% understood as the sum of the indices of the individual dental elements divided by the number of dental elements considered multiplied by 100); patients with normal occlusion Class I occlusion with slight overcrowding and PAR Index less than or equal to 10; patients who have received previous orthodontic treatment, with or without stripping; patients who have received previous orthodontic treatment with < 20 orthodontic aligners; patients who currently use a thermoprinted mask as a restraint, or who do not use any restraint but who would like to receive one.  Exclusion Criteria:  patients with chromosomal defects, specific neuropsychological disorder, epilepsy (1); patients with systemic diseases and comorbidities; bruxist patients; patients with hypertrophy of chewing muscles, occlusal parafunctions or joint disorders; patients with cognitive disabilities with IQ<70; patients undergoing drug therapy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult - StudyPopulation: Undergraduate students - SamplingMethod: Probability Sample
The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy
Status: Recruiting

Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın & Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities.

Translated with DeepL.com (free version)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - To be a 1st, 2nd and 3rd year student of Istanbul University-Cerrahpaşa Faculty of Health Sciences, Department of Midwifery. To get less than 2 points from the "General Health Questionnaire".  Exclusion Criteria:  - Those with an indifferent attachment style, Those with antisocial or narcissistic traits, Those with active suicidal thoughts, People with psychiatric diagnosis and medication, Those with urinary incontinence, Those with severe back pain, Those who have undergone surgical operation within the last 1 year. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult
Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
Status: Not yet recruiting

This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients >= 18 years of age Patients who have qualitative olfactory distortion Etiology of qualitative olfactory distortion is due to upper respiratory infection Quantitative score under the 10th percentile on the SSParoT (HedRang and HedDir) Quantitative score ≥ 8 on the QOD. At least 6 months of parosmia but less than 24 months Patients can have been previously treated with oral and topical steroids but this is not a requirement Patients will receive concurrent olfactory training - the practice of smelling strong odors (standard of care) Be able to read and understand English Be able and willing to provide Informed Consent  Exclusion Criteria:  Patients < 18 years of age, pregnant females, patients who have structural abnormalities on nasal endoscopy or radiographic imaging that would prevent injection into the olfactory cleft Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases or patients who have had olfactory loss > 24 months Patients with bleeding disorders or on blood thinners such as coumadin and plavix - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer
Status: Not yet recruiting

This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Fully understand the study and voluntarily sign the informed consent form; Male or female 18~75 years of age; Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; Life expectancy ≥ 3 months;  Exclusion Criteria:  Participants were deemed unsuitable for participating in the study by the investigator for any reason. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
The Tryptophan Requirement in Healthy Adults
Status: Not yet recruiting

The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.

The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consent provided. Aged 60 to 90 years old. In good general health as evidenced by medical history, physical health and blood draw. Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine. Willingness to participate in the study. BMI <30 kg/m2.  Exclusion Criteria:  Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, taking medications known to affect protein/AA metabolism (e.g. steroids). Inability to tolerate the diet (i.e. allergy). Significant weight loss during the past month or consumption of weight reducing diets. Significant caffeine consumption (>2 cups per day). Significant consumption of alcohol (>1 drink per day i.e. 1 beer or ½ glass of wine). Unwilling to have blood drawn from a venous access or using a ventilated hood indirect calorimeter for the purposes of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women
Status: Not yet recruiting

Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.

Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Agree to participate in the 8-week MBSR training Having completed the Informed Consent Form and volunteering to participate in the study Speaking and understanding Turkish Idiopathic infertile women Primary infertile women YTU treatment has not started Having attempted YTU at most three times before Be able to use ZOOM program  Exclusion Criteria:  - Illiteracy, The woman has a cognitive and auditory problem, Having a chronic disease Not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.) Having participated in any awareness-based training program in the last 1 year  Exclusion Criteria  - Not participating in any session of the 8-session training program, not participating in any of the Pre-test, Post-test-1 and Post-test-2  Being an infertile woman - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Being an infertile woman - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Special Use - Results Surveillance on Long-term Use With Wegovy®
Status: Not yet recruiting

The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) The decision to initiate treatment with commercially available Wegovy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study Male or female, no age limitation  Diagnosis of obesity disease; with either hypertension, dyslipidaemia or type 2 diabetes, insufficiently controlled with diet and exercise therapies, and should meet either of:  Body mass index (BMI)* greater than or equal to 27 kilograms per meter square (kg/m^2) with two or more obesity-related comorbidities**, or BMI* greater than or equal to 35 kg/m^2  Participant who has never been exposed to Semaglutide or who started treatment with Wegovy® within the past 4 weeks at registration  BMI calculation will be based on height and body weight recorded in the enrolment form of electronic case report form (eCRF) at enrolment.  Definition of obesity-related comorbidities are in accordance with Japan Student Services Organization (JASSO) guideline 3: (1) impaired glucose tolerance, (2) dyslipidaemia, (3) hypertension, (4) hyper-uricemia/gout, (5) coronary artery disease, (6) cerebral infarction, (7) non-alcoholic fatty liver disease, (8) menstrual disorder/infertility, (9) obstructive sleep apnoea syndrome/obesity-hypoventilation syndrome, (10) locomotory disease or (11) obesity-related kidney disease.  Exclusion Criteria:  Previous participation in this study. Participation is defined as having given informed consent in this study Treatment with any investigational drug within 30 days prior to baseline (Visit 1) Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation A history of hypersensitivity to any ingredients of this drug Diabetic ketoacidosis, diabetic coma, pre-coma or type 1 diabetes mellitus [The treatment with insulin is mandatory. It is not appropriate to use this drug] In emergency cases such as severe infections and surgery in patients with type 2 diabetes [It is desirable to control blood glucose with insulin; therefore, administration of this drug is not appropriate] Pregnant or possibly pregnant female Female who plans to become pregnant within 2 months - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants are patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan. - SamplingMethod: Non-Probability Sample
Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.
Status: Not yet recruiting

This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.

The study will last for about 26 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or Female of Taiwanese patients, age above or equal to 12 years who are under Saxenda® treatment or are scheduled to treat with Saxenda® according to approved label in Taiwan based on the clinical judgment of their treating physician. Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® . The decision to initiate treatment or to have started with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician independently from the decision to join this study. Informed consent obtained before collection of clinical data for this study. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.  Exclusion Criteria:  Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients Previous participation in this study. Participation is defined as having given informed consent in this study. Treatment with any investigational drug within 30 days prior to initiation of Saxenda® treatment. Female patient who is pregnant, breast-feeding, or intends to become pregnant. Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants are patients with obesity treated with Saxenda® for weight management in routine clinical practice in Taiwan - SamplingMethod: Non-Probability Sample
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Status: Not yet recruiting

The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Bilateral equally intense axial low back pain Pain duration of ≥ 6 months Three-day average NRS scores of ≥ 3/10 Age greater than 18 years Failure of conservative treatment, including nonsteroidal anti-inflammatory medications and physical therapy Positive response to a series of two bilateral diagnostic lumbar medial branch nerve blocks (≥ 80% pain relief). This is the current standard of care.  Exclusion Criteria:  Radicular pain below the knee Systemic infection or localized infection at the anticipated introducer entry site Pregnancy Allergy to Lidocaine Bleeding dyscrasias Patients unable to give informed consent History of lumbar spine surgery at the affected levels History of previous bilateral lumbar RFA of medial branches within the past six months. Significant comorbid somatization or widespread pain with central sensitization Secondary gain identified due to ongoing legal proceedings or worker's compensation Cognitive impairment Any pre-existing condition at the discretion of the provider that may confound interpretation of results - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency
Status: Recruiting

Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.

The primary and secondary outcomes will be collected.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informed consent was obtained from patients or their legal representatives for participation in this study Patients 18 years of age or older, under 70 years of age, chronic intestinal failure/insufficiency Serum 25(OH)D level < 30.0 ng/ml Vital signs are stable  Exclusion Criteria:  Those who did not meet the inclusion criteria, or who were deemed unfit by their physician to participate in this study Primary hypothyroidism or parathyroidism Patients suffering from allergic diseases, are allergic, have a history of drug sensitivity similar to the structure of the study drug Patients with primary diabetes Patients with mental illness, inability to cooperate or consciousness disorders Patients with contraindications of experimental drugs Patients with a suspected or confirmed history of substance abuse Immune deficiency, use of immunosuppressants and hormones Pregnant and lactating women Have taken any vitamin D supplements in the last 6 months Have taken any medication in the last 6 months that affects vitamin D metabolism (e.g., phenytoin, phenobarbital, rifampicin) Patients who participated in a drug trial (including the drug in the trial) within 3 months before the trial Sponsors or investigators directly involved in the trial or their family members The researcher believes that there is any reason not to be accepted - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Online Physical Activity Tracking in Patients With Multiple Sclerosis
Status: Not yet recruiting

This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ->18 years old  Being diagnosed with multiple sclerosis according to McDonald's diagnostic criteria, owning a smartphone and using the WhatsApp application, Having regular internet access Not participating in a regular physical activity program in the last 6 months, Expanded Disability Status Scale<6  Exclusion Criteria:  Having an attack during work, Any orthopedic or neurological disorder that affects compliance with the physical activity program, Not having independent mobility ability - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Online Episiotomy Simulation Training for Midwifery Students
Status: Not yet recruiting

Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.

Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Wanting to participate in the study voluntarily Having taken the normal birth and postpartum period course Not having any previous episiotomy experience  Exclusion Criteria:  Student wants to leave the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - StdAgeList: Child, Adult, Older Adult