rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips
Status: Recruiting

Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Gastrointestinal lesions that require clips include non-variceal upper gastrointestinal bleeding, post-endoscopic submucosal dissection (ESD) lesions in the gastrointestinal tract, fistulas, diverticula, perforations, and anchoring of self-expanding metal stents. 2. Expected survival greater than 30 days; 3. Written informed consent.  Exclusion Criteria:  1. Patients with diffuse gastrointestinal lesions, such as Crohn's disease and ulcerative colitis; 2. Patients who clearly require surgical intervention; 3. Serious cardio-pulmonary, hepatic or renal disease; 4. Intolerance to endoscopy; 5. Pregnant or lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Meet the inclusion and exclusion criteria. - SamplingMethod: Probability Sample
EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation
Status: Recruiting

The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.

Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.

The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  PEG (recent implantation or already present) Indication for long-term oral anticoagulation  Exclusion Criteria:  Under 18 years of age Life expectancy <30 days Lack of informed consent Contraindication to DOACs - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Status: Not yet recruiting

The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:

How well NORA520 is tolerated and what side effects it may cause
If NORA520 reduces depressive symptoms in subjects with severe PPD
The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits Are an adult female between 18 and 45 years of age, inclusive; Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14; Have a negative pregnancy test at Screening and Day 1 (prior to dosing); Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery Are ≤9 months postpartum at Screening.  Key Exclusion Criteria:  Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder; Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode; Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication; Have a history of suicidal behavior within 2 years; Have a history or current diagnosis of sleep apnea or narcolepsy. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult
Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury
Status: Recruiting

Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.

Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.

Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult men and women, over 30 years of age who have suffered an acquired brain injury. Mild or moderate cognitive impairment as measured by the MEC-Lobo test (score greater than 23/35). Regularly attend some conventional therapy (neuropsychology, physiotherapy or occupational therapy). Agree to participate voluntarily by signing the informed consent form.  Exclusion Criteria:  Present severe cognitive impairment as measured by the MEC-Lobo test (less than 23/35). Present aphasia of comprehension or expression. Present associated neurodegenerative pathology. Present any pathology underlying the acquired brain damage (diabetes, heart disease, COPD, etc.), heart disease, COPD, etc.). Voluntarily refuse to participate in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - StdAgeList: Adult, Older Adult
Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain
Status: Recruiting

The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult individuals (over 18 years old) experiencing chronic musculoskeletal pain (≥ 3 months) able to understand and speak portuguese  Exclusion Criteria:  neurodegenerative diseases cancer pain recent fractures, or surgeries (&lt; 3 months). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
Status: Recruiting

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pediatric subjects between 6 months and 17 years of age Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM) Pediatric subjects where otoscopy would traditionally be indicated Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent  Exclusion Criteria:  The parent or guardian who attends visits does not speak the same language as their physician Pediatric subjects enrolled in another clinical trial Pediatric subjects with: Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat) or any clinically significant illness or condition that, in the opinion of the investigator, would prohibit the subject from participating in the trial Anatomical conditions that would affect their ability to undergo an otoscopy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Months - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Any pediatric patient between 6 months and 17 years of age scheduled for an office visit with ear-related complaints, deemed suitable for otoscopy assessment. - SamplingMethod: Non-Probability Sample
Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women
Status: Not yet recruiting

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Generally healthy iron deficient premenopausal women, with iron deficiency defined as serum ferritin < 30 ug/L and generally healthy as C-reactive protein < 3mg/L (1) Able to provide informed consent Agree not to participate in another clinical trial while enrolled in this trial Agree not to give blood donations during the study Agree not to change current diet (subjects adhering to a vegetarian or vegan diet are allowed to participate) and/or exercise frequency or intensity  Exclusion Criteria:  Anaemia (as determined from the haematocrit and haemoglobin measures) (2) Subjects regularly taking iron specific supplements during or 2 months prior to study commencement (the use of other mineral/vitamin/herbal preparations is allowed but should be recorded) (3) Any uncontrolled serious illness (4) Previously told they have an iron absorption problem Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy active smokers, nicotine use, alcohol (5) or drug (prescription or illegal substances) abuse chronic gastrointestinal disorders Pregnant/lactating women or women trying to conceive Diagnosed depression or mental disorder that is uncontrolled Eating disorders BMI > 35 kg/m2 Allergic to any of the ingredients in active or placebo formula Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion Participants who have participated in any other clinical trial during past 1 month  Footnotes:  A blood test is required prior to enrolment into the study to receive trial product. Participants will be required to attend a local pathology collection centre and have serum ferritin and CRP within the required limits to be considered enrolled in the study and be provided with trial product. Anyone considered to be anaemic will be excluded and directed to their GP. In women, anaemia is defined as any of the following: Haemoglobin < 115 g/L, Haematocrit < 35%. Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study. An uncontrolled illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/ or treatments. Chronic past and/or current alcohol use (>14 alcohol drinks/week). - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Patient Handling Techniques and New Technology for Health Care Workers
Status: Recruiting

Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers. To have a significant impact on injury reduction related to patient handling will require the incorporation of technology. This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling: The Vendlet.

The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems (SAMS) bed to reduce the physical load on healthcare providers performing patient handling tasks. This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market. The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities.

The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device. This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - One-month history of no pain or injury in the low back or shoulder region.  Exclusion Criteria:  - Participant received a training on proper patient handling techniques. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 17 Years - MaximumAge: 40 Years - StdAgeList: Child, Adult
Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery
Status: Recruiting

In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  American Society of Anesthesiologists (ASA) classification I-III Scheduled for cardiac surgery with elective median sternotomy under general anesthesia  Exclusion Criteria:  a personal or family history of malignant hyperthermia, opioid sensitivity, alcohol or drug addiction, liver or kidney disease, skin infection in the area to be blocked, thoracic deformity, patients who are allergic to their medications, patients who do not agree to participate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)
Status: Not yet recruiting

The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.

The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients admitted for acute heart failure and ≥ 1 clinical sign of volume overload (edema, ascites, or pleural effusion). NTproBNP levels >1000 pg/mL or BNP >250 ng/mL on admission. Under treatment with furosemide and iSGLT2 according to European guidelines and indication of association of another diuretic due to residual congestion data defined by ADVOR SCORE>1.  Exclusion Criteria:  Systolic blood pressure <90 mmHg or mean arterial pressure < 65 mmHg. Maintenance treatment with acetazolamide/ Treatment with acetazolamide in the month prior to inclusion in the study. Anticipated need for intravenous inotropes, vasopressors or nitroprusside during the study. Contraindication to ISGLT2. Type 1 diabetes mellitus GFR < 20 ml/min/m2 or renal replacement therapy/ultrafiltration at any time prior to the study. Anticipated exposure to nephrotoxic agents, such as iodinated contrast during admission. Concurrent diagnosis of acute coronary syndrome. History of congenital heart disease requiring surgical correction. History of cardiac transplantation and/or ventricular assist device. Pregnant or breastfeeding patients. Inability to adequately collect diuresis. Serum potassium less than 3.5 mEq/L. Venous pH <7.30 Severe aortic stenosis or obstructive hypertrophic cardiomyopathy. Sulfonamide allergy, liver cirrhosis, renal lithiasis. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients admitted for heart failure with persistent findings of residual congestion who meet the inclusion criteria and none of the exclusion criteria. - SamplingMethod: Non-Probability Sample
A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
Status: Recruiting

This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women of any age with diagnosis of any type of breast cancer  Breast cancer on unilateral or bilateral side Surgical intervention for treatment of breast cancer  Exclusion Criteria:  Previous shoulder injury or known shoulder limitation on affected side - HealthyVolunteers: No - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Women who have undergone surgical intervention for treatment of breast cancer. - SamplingMethod: Non-Probability Sample
Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Distention
Status: Not yet recruiting

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 18 to 70 years. Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.  Exclusion Criteria:  Patients who are pregnant or lactating. Patients have history of gastrointestinal malignancy or gastrointestinal surgery. Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance. Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system. Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks. Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week. Patients who are unwilling or incapable to provide informed consents. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Abdominal distension patients in the outpatient department at Qilu Hospital of Shandong University. - SamplingMethod: Probability Sample
Delirium Treatment With Transcranial Electrical Stimulation
Status: Not yet recruiting

The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.

To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.

Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age over 50 years. Diagnosis of postoperative delirium that started within the first three days after surgery. Richmond Agitation and Sedation Scale (RASS) score of -2 to +2. Delirium duration of at least two days prior to study inclusion, based delirium assessments and/or descriptions in the medical and/or nursing files. Known causes underlying delirium are being treated adequately, as assessed by the treating physician.  Exclusion Criteria:  Inability to conduct delirium assessment (e.g. coma, deaf, blind) or inability to speak Dutch or English. A moribund state. Alcohol/substance abuse withdrawal as precipitating factor for delirium. Diagnosis of dementia, based on medical record review and/or a score of ≥4.5 on the short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)  One or more contra-indications for tACS:  History of serious head trauma or brain surgery; Large or ferromagnetic metal parts in the head (except for a dental wire); Implanted cardiac pacemaker or neurostimulator; Skin diseases or inflammations ; Epilepsy. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult