rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Investigation of Adolescents With Nocturnal Bruxism
Status: Recruiting

The aim of this study is to examine the effects of bruxism on mandibular movement capacity, cervical proprioception, posture and quality of life in adolescents diagnosed with nocturnal bruxism (clenching and grinding teeth while sleeping) between the ages of 13-18 and to compare them with healthy adolescents.

Method: A total of 40 adolescents, 20 with nocturnal bruxism and 20 healthy, will be included in the study. Mandibular movement capacity will be evaluated with a caliper and ruler, cervical proprioception with a CROM device, posture with the New York Posture Scale, and quality of life with the PedsQL 13-18 age scale.

Hypotheses:

H1: Nocturnal bruxism reduces the movement capacity of the mandible in adolescents.

H2: Nocturnal bruxism reduces cervical proprioception in adolescents. H3: Posture disorder increases in adolescents with nocturnal bruxism. H4: Nocturnal bruxism affects the level of daily life quality in adolescents.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with nocturnal bruxism, Having received parental consent to participate in the study, Being between the ages of 13 and 18 (including 13,18 years old) Being in good mental state, Being able to understand and follow the locations in the work, Having a Class 1 occlusion.  Exclusion Criteria:  Not consenting to participate in the study and withdrawing from the study, Not being able to cooperate well, Having a history of surgery, Having any physical disability or chronic disease, Having received dental treatment in the last six months, - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: 20 patients with Nocturnal Bruxism and 20 non-Nocturnal Bruxism Adolescence will be included. - SamplingMethod: Non-Probability Sample
The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury
Status: Recruiting

Background: Cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. Recently a new instrument, a stress radiographic device and knee stability test (DYNEELAX), were produced to objectively measure these displacements.

Objective: To assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee.

Material and method: The MRI, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: Patients are diagnoed as ACL/PCL injury or suspect ligament sprain at Kaohsiung veteran general hospital.  Exclusion Criteria: Unable receing MRI exam, any op history of knee or fracture history on the impaired knee. - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Over 20 years old, suspected ligament damage caused by knee contusion - SamplingMethod: Non-Probability Sample
AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
Status: Recruiting

This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery unlimited mouth opening  Exclusion Criteria:  patients with arthritis with limited mouth opening persistent liver dysfunction chronic renal insufficiency body mass index ≧35 kg/m2. past history of malignant hyperthermia or personal or family history diabetes with insulin treatment essential hypertension without controlled - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected. - SamplingMethod: Non-Probability Sample
Transfusion Camp for Medical Students in Rwanda
Status: Not yet recruiting

Transfusion medicine is closely linked with safe surgery. Transfusion Camp is a multidisciplinary educational project aimed at improving transfusion medicine knowledge in physicians. The course has been piloted in Rwanda, showing improvement in participant knowledge and confidence, resulting in its recommended implementation into the medical school curriculum.

This project aims to evaluate a multi-day Transfusion Camp course mandatory for graduating medical students and first-year interns practicing in district hospitals in Rwanda. Its implementation is evaluated through pre- and post-course testing, collecting participants' blood ordering practices following the course, and conducting participant interviews about barriers to safe transfusion medicine in their hospital.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Final year graduating University of Rwanda medical students about to enter their internship year at district hospitals in Rwanda and new interns currently in their first year of their internship at district hospitals in Rwanda.  Exclusion Criteria:  N/A - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.
Status: Not yet recruiting

The investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention, which is a psychotherapeutic technique, for improving insomnia symptoms in adults. Previous research has tested this technique for insomnia and found overall positive results. However, during the last decades very few studies have examined paradoxical intention. Therefore the investigators wish to conduct a pilot study examining the effects in a modern context.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Undergoing three screening phases: a web-based questionnaire, a telephone interview with a structured assessment, and a 7-day sleep diary completion. Screening resulting in diagnosis of insomnia, including co-morbid insomnia. Participant should fulfill the following DSM-5 criteria. (1)Difficulty in sleep Initiation, maintenance, or early morning awakening. (2)Frequency and duration of at least three nights per week and has been present for at least three months.(3) Problems persist despite candidates having had adequate opportunity and circumstances for sleep. (4) The sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. Age above 18 and Swedish resident and language proficient.  Exclusion Criteria:  Excludes candidates with bipolar or psychotic disorders. Suicidal intentions or actions is an exclusion criteria and the applicant will be referred to appropriate services.. Reports of current substance abuse Recent changes in psychopharmacotherapy within the last three months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
Status: Recruiting

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD. Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent. Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome).  Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort.  Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period. Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up. Permission to contact the participant's and her infant's HCPs.  Exclusion Criteria:  If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study. Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 15 Years - MaximumAge: 50 Years - StdAgeList: Child, Adult - StudyPopulation: Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period. - SamplingMethod: Non-Probability Sample
Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.
Status: Recruiting

The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Thai term pregnant women 18-45 year old At least 1 covid vaccination received admission at Vachira Phuket Hospital Labor Room  Exclusion Criteria:  Do not want to participate Unstable or Emergency condition - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments
Status: Recruiting

This study is a prospective interventional study. It will be conducted at a single center with participants who have neuromotor impairments. The primary objective is to assess and measure the clinical and psychosocial effects of a season of power wheelchair soccer among its participants presenting with severe motor impairments due to neuromuscular lesion.

A maximum of twenty participants will be recruited and included in the same group. Data collection will be performed before, during, and after the wheelchair soccer season. The study will span the entire season, starting in November 2023 and ending in June 2024.

Clinical and psychosocial assessments will be conducted every 3 months. Each assessment session will last 2 hours per participant. Before and after the wheelchair soccer season matches, we will evaluate parameters related to the physical load of the sport. These evaluations will last 10 minutes per participant.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a male or female between the ages of 12 and 50. Presenting with severe motor impairments due to neuromotor and/or musculoskeletal impairment. Using a power wheelchair in everyday life. Being part of a power wheelchair soccer team. Committing to participating in the 2023-2024 season of their sport within the team.  Exclusion Criteria:  Practicing another adaptive sport outside of power wheelchair soccer in a regular way (once a week or more). Occasionally practicing power wheelchair soccer (twice a month or less). Presenting with severe cognitive impairments affecting understanding of instructions on how to answer questionnaires and undertake tests.  Presenting with contraindications towards the practice of an adaptive sport such as power wheelchair soccer.  Participating in another study at baseline. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 50 Years - StdAgeList: Child, Adult
Preterm Infant Oral Motor Intervention (PIOMI)
Status: Not yet recruiting

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Gestational age at birth is 28-32 weeks, depending on the mother's last menstrual period, 29-32. can be administered PIOMI per week and can tolerate the transition to oral feeding, Able to tolerate the transition to oral feeding according to the cue-based feeding model, Maintains physiological stabilization (heart rate, oxygen saturation, respiratory rate) during the procedure when oxygen support is provided with room air or nasal cannula or hood. Apgar score of 4 or higher at the 5th minute after birth Not receiving mechanical ventilator support or 48 hours after weaning from mechanical ventilator support Babies with written and verbal permission from their parents will be included in the research.  Exclusion Criteria:  Those with congenital anomalies (cleft lip, cleft palate, gastroschisis, omphalocele, short bowel syndrome and other anomalies) According to the criteria of Jobe and Bancalari (2001), patients with severe bronchopulmonary dysplasia and patent ductus arteriosus (PDA) requiring surgical treatment Babies with gastrointestinal, neurological and genetic diseases (necrotizing enterocolitis, level 3 and 4 intracranial hemorrhage, periventricular 25 leukomalacia, hydrocephalus, down syndrome) will not be included in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 29 Weeks - MaximumAge: 32 Weeks - StdAgeList: Child
Pedometer Coaching to Promote Postoperative Ambulation
Status: Recruiting

The goal of this randomized controlled trial is to evaluate whether remote pedometer follow-up and virtual coaching can improve ambulation after major abdominopelvic surgery, and how this affects key postoperative outcomes.

The main questions it aims to answer are:

Does pedometer-guided ambulation coaching increases ambulation after surgery?
Does pedometer-guided coaching improve satisfaction, quality of recovery, while reducing postoperative complications?

Participants will be asked to install a pedometer app for the purpose of data sharing. Study personnel will compare pedometer follow-up plus text message coaching (intervention) with pedometer follow-up only (control) to investigate whether coaching improves adherence to the postoperative ambulation recommendation, and whether this leads to improvement of the secondary outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult subjects ≥18 years at screening Subjects undergoing major abdominopelvic surgery under general anesthesia, expected to last more than 3 hours from induction of anesthesia to anesthesia stop time. Able to understand the study procedures and voluntarily provide study informed consent Agree to be followed up for the duration of the study period Has access to a smart phone with app compatibility Planned inpatient stay for 1 night or more  Exclusion Criteria:  Subjects undergoing liver surgery or upper gastrointestinal surgery Refusal to install the app/ deleted app before end of the monitor period Subjects who are unable to walk at baseline Medical contraindications for unrestricted ambulation Patients with spinal or lower limb pathology, chronic or poorly controlled pain potentially preventing full postoperative ambulation Neurological impairment precluding unrestricted ambulation Cognitive impairment precluding consent or follow up study activities BMI >40 Patients who require any mobility aid at baseline Subjects discharged to a rehab facility or never discharged from the hospital alive Hospital length of stay > 1 week Patient not cleared by physical therapy for unrestricted ambulation on discharge - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
Status: Not yet recruiting

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV.

The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years Patient receiving any NIV modality for acute respiratory failure of any etiology Admitted to ICU, PACU, step-down unit (surgical or medical), or emergency department  Presence of one or more of the following after optimized NIV treatment (Appendix 1 Table 1):  Agitation (Defined as a Richmond Agitation and Sedation Scale [RASS] score of ≥+2 or a Riker Sedation-Agitation Scale [SAS] score of ≥5) (Appendix 1 Table 2 and Table 3) Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia Other reason that the physician feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded)  Exclusion Criteria:  Bradycardia defined as: a-Persistent bradycardia defined as a heart rate (HR) ≤60bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome Persistent hypotension, defined as a mean arterial pressure (MAP) ≤65mmHg despite volume resuscitation and vasopressors Acute hepatic failure Imminent need for endotracheal intubation Death is deemed imminent and inevitable Patients already on dexmedetomidine at time of enrolment Known allergy to dexmedetomidine Current pregnancy (should not breastfeed until 24 hours from discontinuation of medication) Treating physician refuses enrolment (reasons for refusal will be captured) Previously enrolled in the inDEX trial - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Omission of Axillary Surgery in Breast Cancer Patients
Status: Recruiting

The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities.

We aimed to determine if axillary surgery could be safely tailored in BC patients based on their molecular subtype and nodal burden, without compromising their oncological outcomes. This could in turn reduce the morbidities associated with the axillary surgery,

Total 350 patients will be enrolled. 50 patients with early BC and favourable molecular subtype will be enrolled in a pilot study A (SentiOMIT), whereby SLNB is omitted. For eligible patients who declined study A and other stage I-II patients, with preoperative N0 status, undergoing upfront surgery but did not meet the inclusion criteria of Study A, these patients will be enrolled into study B (SentiMACRO) to undergo SLNB.

In study B, the patients will be categorized based on SLNB into 3 groups with 100 patients in each arm: B1 with pN0, B2- 1-2 metastatic nodes and B3- >/=3 metastatic nodes. In Study B, we aim to investigate if the B2 group (100 patients) can be treated with a less invasive procedure of SLNB alone instead of AC, without affecting oncological outcomes. B1 and B3 are controls.

The outcomes for study A and B include short term outcomes such as morbidity rates, cost and operating time savings. Long term outcomes include recurrence and survival rates. This study will allow individualisation of axillary surgery based on the patient's molecular subtype and nodal burden, to benefit patients' care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  female patients aged >/=55 years old unifocal cancer on imaging breast tumour size based on imaging of </=3cm no evidence of axillary adenopathy on imaging patients with strongly positive ER and PR and negative HER2 on biopsy grade 1-2 tumour on core biopsy patient who opt for mastectomy  Exclusion Criteria:  patients with T3/T4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Female breast cancer - MinimumAge: 21 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.
Status: Recruiting

This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure.

The main question it aims to answer is:

• Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age above 18 years Willingness to provide informed consent for participation in the study Diagnosis of heart failure No previous vaccination against RSV or influenza  Exclusion Criteria:  History of an anaphylactic reaction to vaccination Hypersensitivity to any component of the vaccine Receipt of vaccination against RSV or influenza in the current infectious Active infection Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult