rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effect of Teletherapy-supported Training on Nursing Students
Status: Recruiting

Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.

The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.

The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Nursing students between 18 and 60 years of any gender Self-reported chronic neck and back pain in the last six months (more than three months as described by the International Association for the Study of Pain (IASP)). Speak and understand German  Exclusion Criteria:  Surgery in the last year on the spine, cervical, thoracic, or lumbar spine  Currently on sick leave Acute back pain Severe neurological injuries or symptoms Acute trauma to the musculoskeletal system Renal insufficiency, dialysis Severe impairment of the ability to grip with the hand, e.g., rheumatoid arthritis. Severe cardiovascular diseases, e.g. heart failure Severe respiratory diseases, e.g., Chronic Obstructive Pulmonary Disease-COPD Nystagmus Falling tendency/balance disorders Latex allergy, as rubber band may be made of latex Lack of ability to stand, inability to stand safely without the help of a person or object. A spine-specific pain therapy drug treatment within the last three months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression
Status: Not yet recruiting

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question[s] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  married women; age 18-75; fluent in Bengali); Meets criteria on an Economic Vulnerability Index >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale at baseline  Exclusion Criteria:  Inability to provide informed consent; Plans to travel for > 1 month during 24 M period. Inability to participate in the study for any other reason - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Automatic Adjustment for Asynchronies During Mechanical Ventilation
Status: Recruiting

Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >17 years Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp <0.6); obstructive (RCExp >0.9); normal (RCExp 0.6 - 0.9). Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation. Presence of asyncronies in pressure and volume curves tracings of the ventilator. Signed informed content.  Exclusion Criteria:  Pregnant On extracorporeal respiratory support (ECMO or ECCO2R) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Retrospective Evaluation of Effect of Anterior Iliac Block
Status: Recruiting

In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ASA-1, ASA-2 and ASA-3 patients Female/male  Exclusion Criteria:  Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who underwent anterior iliac graft harvesting and were performed anterior iliac block at Kocaeli University Faculty of Medicine between January 2021 and December 2023 will be included in the study. - SamplingMethod: Non-Probability Sample
The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain
Status: Recruiting

Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18-35 years old Being a professional basketball player Clinical diagnosis of lateral ankle sprain in the last 12 months Having a Cumberland Ankle Instability Test score <24 >2.5 cm symmetry between the two extremities in the lunge test Not to participate in any ankle treatment program in the last three months, Being Volunteer  Exclusion Criteria:  History of lower extremity surgery History of disease that may affect sensorimotor function in the lower extremity Musculoskeletal disorders that may affect balance Having any musculoskeletal and orthopedic problems Having a history of previous ankle fracture or ankle surgery Presence of any visual impairment, metabolic, neurological or rheumatological disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care
Status: Not yet recruiting

The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  HISBEANS store employees Age: 18 years old or older possessing a smartphone with internet connection subjects agree to participate in the study  Exclusion Criteria:  Those who have symptoms of psychotic disorder are acutely active or advanced, making clinical intervention difficult Those who has been started or changed their antidepressant medication within the last 1 month or cannot be maintained stably during the intervention period Those who are non-literate Those who have used the Maro app previously Those who couldn't use Maro app in their own smartphone Those who participate in another intervention study Those who have a serious medical condition that prevents them from participating in the intervention and efficacy evaluation Those who is unable to participate fully and cooperatively by the judgment of the researcher - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Virtual Peer Coaching in Manual Wheelchair Skills
Status: Not yet recruiting

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Coaches:  At least 18 years old Non-progressive SCI Able to speak and read English Reside in the community Independently use a manual wheelchair for at least 50% of mobility  Coaches with paraplegia:  - Able to complete all skills targeted by the intervention, except stair ascent, (WST-Q item scores 2) independently.  Coaches with tetraplegia:  - Able to complete all skills targeted by the intervention with or without assistance  Trainees:  At least 18 years old Non-progressive SCI Able to speak and read English Reside in the community Independently use a manual wheelchair for 50% of mobility Access to an Internet-ready device with video capabilities. Access to a spotter for practicing wheelchair skills Desire training for at least 5 of the 16 skills targeted by the training program  Exclusion Criteria:  none - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Preventive Remediation of Stress for Optimal MEdical StudentS
Status: Recruiting

Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.

Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.

Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.

The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024. Having read the information note. Having signed the written consent.  Exclusion Criteria:  No exclusion criteria will be applied. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)
Status: Recruiting

The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-aqcuired pneumonia diagnosed in general practice.

Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.

Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.  Exclusion Criteria:  Need for immediate hospitalisation at the time of diagnosis. Known allergy to beta-lactam antibiotics. Any coinfection necessitating antibiotic treatment. Use of systemic antibiotics, antivirals or mycolytics within the last month. Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer). Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder). Pregnant or lactating. Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Reliability of Range of Movement Measurements in Cerebral Palsy
Status: Recruiting

The aim is to investigate the inter-rater reliability of passive range of motion (pROM) measurement with goniometer of knee extension and ankle dorsiflexion for children with unilateral spastic cerebral palsy (USCP) and secondary to explore to what extent spasticity influences the reliability.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: Children with hemiplegic spastic cerebral palsy -  Exclusion Criteria: Other cerebral palsy diagnoses. Surgery or botulinum toxin treatment within 3 month prior to examination.  - - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Children with with hemiplegic spastic cerebral palsy in the south of Sweden, Skane county. - SamplingMethod: Non-Probability Sample
The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.
Status: Not yet recruiting

The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.

Eligibility:
- EligibilityCriteria: Inclusion criteria  Gastric or Gastroesophageal junction Siewert type III adenocarcinomas  Clinical T3-4a-stages  Any differentiation grade Any histological subtype  Clinical T2-stage  a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells  Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy. Any clinical nodal-stage clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted) Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 Age 18 - 80 years Undergoing robotic or laparoscopic D2 gastrectomy Able and willing to provide written informed consent and to comply with the clinical study protocol Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception.  Exclusion criteria  Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds. Renal impairment, defined as glomerular filtration rate (GFR) < 40 ml/min (Cockcroft-Gault Equation). Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4. An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL). An inadequate haematological function, defined as absolute neutrophil count (ANC) <1.5 x 109/l and platelets <100 x 109/l. Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Evaluation of ARi With OpSens SavvyWire
Status: Recruiting

The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE Age > 18 years Able and willing to give informed consent.  Exclusion Criteria:  Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely Subject is considered part of a vulnerable population. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention - SamplingMethod: Non-Probability Sample
Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)
Status: Recruiting

This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth Planned for dental implant and fixed prosthesis Aged 20 and above but under the age of 65 with good physical health and good oral hygiene Able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment. Available for follow-up after implant placement.  Exclusion Criteria:  (i) Heavy smokers (>10 cigarettes/day) (ii) receiving bisphosphonates (iii) undergoing radiotherapy (iv) uncontrolled medical conditions (v) Alcoholism (vi) Pregnancy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Personalized Medication Software for BCL-2 Inhibitor in AML Patients Using Machine Learning and Genomics
Status: Not yet recruiting

Severe neutropenia caused by venetoclax,a B-cell lymphoma-2(BCL-2) inhibitor, is the main cause of venetoclax tapering, drug discontinuation, and treatment delay. This study combines machine learning and genomics, hoping to develop models to predict venetoclax dose in Acute myeloid leukemia(AML) patients and compare the efficacy and safety differences of model-guided individualized medication regimen with current conventional regimen. According to the demographic information, the drug information, the drug concentration of the target patients, the laboratory examination, the single nucleotide polymorphism(SNP) information and the adverse reactions of the AML patients, and the model was constructed through machine learning.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old, regardless of gender; Diagnosed as an AML patient according to the Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non Acute Promyelocytic Leukemia) in China (2021 Edition) and receiving treatment with venetoclax; Before receiving venetoclax treatment, absolute neutrophil count (ANC) ≥ 1.0 ×10 ^9/L, white blood cell count (WBC) ≥ 2.0 ×10 ^9/L, platelet count (PLT) ≥ 50 ×10 ^9/L, and hemoglobin (HB) ≥ 90g /L; Before receiving venetoclax treatment, liver and kidney function were normal (aspartate aminotransferase ≤ 3 times the upper limit of normal (ULN), alanine aminotransferase ≤ 3.0 x ULN, bilirubin ≤ 1.5 x ULN, urea nitrogen:3.2-7.1 mmol/L, glomerular filtration rate (eGFR) ≥ 60ml/min; Sign an informed consent form.  Exclusion Criteria:  Age<18 years old; Non AML patients; Patients who plan to use a treatment regimen without venetoclax; Patients with poor medication adherence; Liver and kidney function damage before medication; Before medication, ANC<1.0 x 10 ^9/L or WBC<2.0 x 10 ^9/L or PLT<50 x 10 ^9/L or HB<90g /L; Pregnant and lactating women; Cases deemed unsuitable for inclusion by researchers - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This study aims to include 200 patients with AML who were treated with venetoclax. A database of venetoclax medication for AML patients will be constructed based on demographic information, medication information, laboratory test information, blood drug concentration, SNPs, and drug-related adverse reactions. Randomly divide the data into training and testing sets in a 7:3 ratio, and construct the model through machine learning. - SamplingMethod: Non-Probability Sample
Klinefelter Syndrome and Testosterone Treatment in Puberty
Status: Not yet recruiting

The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).

The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.

Participants will be randomized to two years treatment with testosterone or placebo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  47,XXY Klinefelter syndrome Age 10-14 years at inclusion Luteinizing Hormone > +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay Free Testosterone<+2 standard deviations Signed consent from parents  Exclusion Criteria:  Previous or ongoing T treatment except for TRT because of micropenis Contraindications to testosterone treatment known hypersensitivity to testosterone or to any other constituent of the gel known or suspected prostatic cancer or breast carcinoma Participation in any other clinical trial - HealthyVolunteers: No - Gender: Male - MinimumAge: 10 Years - MaximumAge: 14 Years - StdAgeList: Child