rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Status: Not yet recruiting

The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient candidated to undergo unilateral cementless primary total hip arthroplasty with Jump System Traser® cup or Jump System HAX-Pore® cup by Permedica Orthopaedics (study sponsor). Patient with primary or secondary hip osteoarthritis; Patient who has given informed consent;  Exclusion Criteria:  Male patients younger than 40 years or older than 85 years; Female patients younger than 50 years or older than 85 years; Childbearing; Patients not indicated for receiving the investigational devices; Patients not indicated for receiving cementless metaphyseal short femoral stems by Permedica Orthopaedics as the "Exacta RS" or "Exacta S" brand; Patients with rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (grade III-IV according to Crowe classification), Perthes disease, Paget disease, femoral neck fracture, pelvic fracture or sequelae of previous surgical procedures or trauma to the ipsilateral hip; Patients with bone disorders; Patients with diabetes; Patients under PTH (parathyroid hormone), corticosteroid, or osteoporosis pharmacological therapy; Patients with disabling disease in the contralateral limb; Patients with BMI > 30 or < 18; Patients not willing to follow the study protocol; Patients incapable to understand the study protocol; Patients addicted to alcohol or drugs; Patients already enrolled in other clinical investigations; - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
The Oral Symptom Assessment Scale in Older Patients With Frailty
Status: Recruiting

Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.

This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.

This study will take place in Our Lady's Hospice & Care Services, Harold's Cross and St James' Hospital over six months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Age ≥ 65 years old Clinical Frailty Score ≥ 5 No known history of dementia The attending clinician should have no concerns about a participant's capacity to consent for this research  Exclusion Criteria:  Inability to provide informed consent Inability to complete the questionnaire Abbreviated Mental Test Score -4 (AMT4) <4 - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult - StudyPopulation: Participants will be patients aged 65 years and older with a Clinical Frailty Score (CFS) ≥5 (as determined by the multi-disciplinary clinical team). - SamplingMethod: Non-Probability Sample
Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain.
Status: Not yet recruiting

Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1.Meet the above Chinese and Western medicine diagnostic criteria; 2.18 years old ≤ age ≤ 70 years old, gender is not limited; 3.The duration of the disease is more than 3 months, no other treatment has been received in the last month, and the VAS score is ≥4 at the time of participating in the treatment; 4.Voluntarily cooperate with the examination and treatment, and sign the Informed Consent Form.  Exclusion Criteria:  Those with severe cardiac, hepatic and renal insufficiency and those with bleeding tendency; Previous history of lumbar spine surgery, spinal cauda equina tumor, lumbar spondylolisthesis, lumbar spinal stenosis, scoliosis deformity, tumors and other diseases caused by low back pain; Women who are in the period of pregnancy or breastfeeding should not perform acupuncture treatment; Those who have needle-sickness, blood-sickness and so on; Those who have cognitive impairment and cannot complete the relevant scale assessment independently or under the guidance of the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
Status: Recruiting

The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All polyps included in the Paris Classification (Polypoid (0-I): Sessile type (Is), Pedunculated type (Ip), Non-polypoid (0-II, III): Raised type (IIa), Flat type (IIb), Depressed type (IIc), Excavated type (III)) Lesions located from the anal margin to about 20 cm. Extent of at least 2 cm² (polyps 2 cm in diameter or areas of ERM or ESD 2 x 2 cm). Well or moderately differentiated tumours. T1: Tumours confined to the mucosa (Tis) and submucosa (T1). No positive lymph nodes. No lymphatic, vascular or perineural invasion.  Exclusion Criteria:  Are considered vulnerable subjects. They suffer from hematological diseases with altered coagulation of their own or pharmacologically induced coagulation disorders (the use of acetylsalicylic acid (ASA) in doses of 150 mg/day is permitted). Have rectal lesions that lie above the pectineal line or extend into the anal canal. Local or distant metastasis. Have a score of more than 2 points on the Wexner faecal incontinence scale. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
Status: Not yet recruiting

Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies?

Primary Outcomes:

To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.
To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks.

Secondary Outcomes:

1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of Anorexia Nervosa (AN) Female participants Age 15-30 years old inclusive at time of enrollment Ability of parent or legal guardian to provide informed consent if participant is under 18 years old. Ability of patients ages 15-17 to give assent to the study. Completion of the signed HIPAA authorization form by a parent or legal guardian or by participants (18 years of age).  Exclusion Criteria:  Pregnancy Known history of traumatic brain injury that required medical care Non-English speaking (based on standardized neuropsychological testing and questionnaires) Claustrophobic Brain Implants Pacemakers Hearing or visual impairment Any biomedical or metal implants in any part of the body (excluding orthopedic implants) - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Must be female/ biologically female - MinimumAge: 15 Years - MaximumAge: 30 Years - StdAgeList: Child, Adult
Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
Status: Recruiting

This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ALS diagnosed by a neurology and chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS  Exclusion Criteria:  impaired cognition to give informed consent to participation contraindication to NIV therapy another severe disease with a prognosis of less than one year ventilation via an artificial airway, tracheostomy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Sleep Position Pattern Recording
Status: Not yet recruiting

The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Assigned female at birth Currently pregnant Admission to MUMC Antenatal Clinic with anticipation of being admitted for greater than 24 hours Able and willing to provide informed consent to participate  Exclusion Criteria:  Unestablished gestational dating (based on first-trimester ultrasound) Known maternal cardiac or pulmonary disorder Known sleep disorders (i.e., sleep apnea, periodic limb movement disorder, etc.) Known fetal chromosomal or structural abnormalities Known highly sensitive skin/skin sensitivities to textile electrodes - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: This study will enroll pregnant women. - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Pregnant women admitted in the antenatal in-patient clinic at McMaster University Medical Centre for greater than 24 hours. - SamplingMethod: Probability Sample
Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients
Status: Recruiting

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years Both genders Elective pulmonary endarterectomy surgery Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.  Exclusion Criteria:  Reoperation for any reason  • Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients in the preoperative period of elective pulmonary endarterectomy susrgery. - SamplingMethod: Probability Sample
Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial
Status: Recruiting

The goal of this randomised trial is to learn about the role of AI in clinical coding practice. The main question it aims to answer is:

Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding? Participants will be asked to code clinical texts both while they use our CAC system and while they do not.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  participant has coded clinical texts before, preferably ICD-10 coding is a healthcare professional, eg. clinician, nurse, professional coders can understand Swedish  Exclusion Criteria:  participants outside Norway and Sweden - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia
Status: Recruiting

Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).

Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.

This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.

The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with oesophageal atresia (type III according to Ladd's classification); Patients who underwent their first operation for oesophageal atresia in the period 2011-2021 Signature of written informed consent and consent to the study and privacy.  Exclusion Criteria:  Not signature of written informed consent and consent to the study and privacy. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 13 Years - StdAgeList: Child - StudyPopulation: Patients with oesophageal atresia (type III according to Ladd's classification). - SamplingMethod: Non-Probability Sample
The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates
Status: Recruiting

This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.

Interventional research with two parallel groups and no control group

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.  Exclusion Criteria:  ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 1 Hour - MaximumAge: 72 Hours - StdAgeList: Child
Personalized Transcranial Direct Current Stimulation in Stroke Recovery
Status: Not yet recruiting

The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4). Age more than 18, Male or Female, All racial and ethnic groups Entry into the study >3 months post onset Modified Ashworth Scale Score <3 in the involved upper extremity Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand Able to follow 2 step commands  Exclusion Criteria:  Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions). Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.) Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age,epilepsy or others). Patients with unstable cardiac arrhythmia. Pregnancy Patients with metallic implants in the head, patients with pacemakers, patients with craniotomies, including burr holes who cannot be safely stimulated Patients with seizures Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families
Status: Recruiting

It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Form 1 students able to speak Cantonese and read Chinese, and from low-income families (with a half-median monthly household income or the recipients of Comprehensive Social Security Assistance)  Exclusion Criteria:  Children with identified cognitive or learning problems, chronic illness, or physical disabilities - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 14 Years - StdAgeList: Child
Sleep as a Mechanism of Change in Alcohol Use
Status: Not yet recruiting

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  report heavy drinking in a typical week in the past month meet DSM-5 criteria for Alcohol Use Disorder meet DSM-5 and research diagnostic criteria for Insomnia Disorder  Exclusion Criteria:  ≥50 years unable to provide informed consent report contraindications for CBT-I (mania or seizure disorder) moderate to severe sleep apnea that is untreated have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan) are already receiving behavioral treatment for insomnia or alcohol use - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 49 Years - StdAgeList: Adult
Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
Status: Not yet recruiting

The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 and ≤75 years of age body mass index ≥18.5 and ≤45 kg/m2 Weight stable (i.e., ≤3% change) ≤150 min of structured exercise/week for at least 2 months before entering the study Blood glucose: < 126 mg/dl fasted, < 200 mg/dl with 2 hour oral glucose tolerance testing Hemoglobin A1C (HbA1C) ≤6.5% Dyslipidemia triglycerides ≥125 mg/dL No chronic kidney disease Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed No intolerance or allergies to study diet ingredients No excessive alcohol or tobacco consumption  Exclusion Criteria:  <18 and >75 years of age body mass index <18.5 or >45 kg/m2 history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for <5 years, dementia, chronic kidney disease) allergies or intolerances to meal ingredients, vegans or vegetarians use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc) take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements) engaged in regular structured exercise >150 min per week alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances pregnant women persons who use tobacco prisoners the inability to grant voluntary informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: convenience population of volunteers in mid-Missouri region - SamplingMethod: Non-Probability Sample