rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Association Of Serum Vitamin D Level With Isthmic Spondylolysis
Status: Not yet recruiting

The aim of this study is to compare vitamin D level between young adults with isthmic spondylolysis and a matched healthy control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients: Adults aged 20 - 45 years with symptomatic isthmic spondylolysis Controls: Matched population without spondylolysis indicated for plain x-ray and CT lumbo-sacral spine. These will be recruited mainly from the Trauma Unit. This will not add any non-indicated radiation exposure to healthy individuals  Exclusion Criteria:  Traumatic spondylolysis Pregnant women Significant co-morbidities (renal or hepatic diseases, malignancy, malabsorption syndrome, musculoskeletal diseases, steroid therapy) Metabolic diseases affecting vitamin D and Calcium metabolism (e.g. hyperparathyroidism) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: Detailed history taking (including dietary calcium and vitamin D intakes, Exposure to sun, and Clothing habits)  Clinical examination Imaging: plain x-ray and CT scan Laboratory: Free serum calcium, alkaline phosphatase and 25-OH vitamin D - SamplingMethod: Non-Probability Sample
Behavioral Activation for the Treatment of Depression in Older Adults
Status: Not yet recruiting

Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.

250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants should fulfill criteria for current major depressive episode or sub-threshold depressive episode. Eligible participants should be 65 years or older, should be fluent in spoken and written Swedish to understand the treatment materials, have access to telephone, and be interested in participating in the trial.  Exclusion Criteria:  Severe depression, elevated suicide risk, current substance use disorder, current or previous manic or hypomanic episodes, current psychotic disorder, and current diagnosis of minor or major neurocognitive disorder or suspected neurocognitive disorder with < 24 points on the Mini Mental State Examination number 3, MMSE-NR3. ongoing psychotherapy - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Status: Not yet recruiting

To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult males and females aged 19 years or older on the day of informed consent Subjects requiring continuous treatment or receiving treatment with NSAIDs Subjects with at least one of following peptic ulcer risk factors at the time of Screening Subjects who have provided voluntary informed consent for the study participation after the study is explained  Exclusion Criteria:  Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results. Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder Subjects with confirmed history of malignancy within 5 years prior to Screening Positive human immunodeficiency virus (HIV) antigen/antibody at Screening - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Impact Of Nutritional Education Program In Hemodialysis Patients
Status: Not yet recruiting

The study aims to improve the health status of chronic renal failure patients on hemodialysis using nutritional education program on quality of life anserum d electrolytes level by application of physical and clinical evaluation and some biochemical analysis before and after a specified nutritional program

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  hemodialysis patients whatever diabetic or hypertensive underweight patients  Exclusion Criteria:  patients diagnosed CKD not on hemodialysis treatment patients with malignancy patients refuse to participate patients age over than 60 years or below 18 patients with malignancy patients refuse to participate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels
Status: Recruiting

The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients>18 year-old and at least one of the following  Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment  Exclusion Criteria:  Patients already treated with an SGLT-2 inhibitor Patients with Hb<11gr/dl or>16gr/dl Patients with history of inherited or acquired hemoglobin disease Patients with history of hemolytic anemia Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome Patients treated within the last 6 months for anemia due to iron, B12 or folate deficiency Patients with history of major hemorrhage or major operation leading to RBC transfusion within the last 3 months. Patients planning major operation or revascularization procedure within the 12 following weeks Patients treated with erythropoietin Patients with Chronic Kidney Disease and GFR<30ml/min/1.73m2 Pregnancy Women of childbearing age not receiving appropriate contraception measures - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients>18 year-old and at least one of the following  Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment - SamplingMethod: Probability Sample
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Status: Recruiting

Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years Undergoing transfemoral TAVI with any commercially available transcatheter heart valve Suitable radial and secondary femoral access  Exclusion Criteria:  Primary arterial access via surgical cut-down Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist Previously failed attempt to access bilateral radial arteries. Patient on hemodialysis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparison of RA TKA Systems: MAKO vs VELYS
Status: Not yet recruiting

The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:

Will the patient reported outcomes differ between the two groups?
Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance). Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor. Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol. Individuals who are male or non-pregnant female age 18-80 years at time of device implantation. Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.  Exclusion Criteria:  Patient has a Body Mass Index (BMI) > 40. Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator. Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency. Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's). Subject is a woman who is pregnant or lactating. Patient has a contralateral amputation. Patient's affected knee has a flexion contracture greater than 15 degrees. Patient has history of post operative arthrofibrosis. Patient's affected knee has a partial knee arthroplasty. Patient has undergone contralateral TKA within the last three months. Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims. Patient who is bedridden per the discretion of the investigator. Patient has a medical condition with less than 2 years of life expectancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Massage and Percussion Therapy on Muscle and Performance Parameters
Status: Recruiting

DOMS, muscle viscoelastic properties, quadriceps strength and vertical jump performance will be evaluated in physically active individuals before the exercise and after the exercise and intervention which is either Swedish massage or Percussion therapy

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants willing to provide informed consent to participate in the study. Healthy adults aged between 18 and 30 years. No history of musculoskeletal injuries within the past six months. No known cardiovascular or respiratory conditions that may affect exercise performance. Participants with no previous experience with either massage or percussion therapy. International Physical Activity Questionnaire - Short Form questionnaire score above 3000  Exclusion Criteria:  Any medical condition or history of medical conditions that could affect muscle function or recovery (e.g., chronic pain conditions, autoimmune disorders). Individuals taking medications that could influence muscle performance or recovery. Any current injuries or pain that may interfere with the ability to perform exercises or receive interventions. Known allergies to massage oils or lotions or individuals with skin conditions that may be exacerbated by massage or percussion therapy. Participants unwilling or unable to comply with the study protocol. Inability to understand the study requirements. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
A Research Study of a New Medicine (NNC0650-0013) in Healthy Men
Status: Recruiting

This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male. Age 18-55 years (both inclusive) at the time of signing the informed consent. Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.  Exclusion Criteria:  Any disorder, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer
Status: Recruiting

This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The subjects voluntarily joined this study and signed an informed consent form Locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as HER-2 negative (cT2-4N+M0 Phase II-III) The primary lesion can be surgically removed, and the patient is willing to receive surgical treatment There are measurable solid tumors (efficacy evaluation standard: RECIST 1.1) Tumor evaluation should be conducted through CT scanning or MRI within 28 days before treatment ECOG score 0-1 Life expectancy ≥ 12 months.  Exclusion Criteria:  Preoperative imaging examination indicates distant or peritoneal metastasis in patients Subjects with any known active autoimmune disease Serious cardiovascular disease The serum of the subjects tested positive for HIV Active hepatitis B (HbsAg positive and HBV-DNA ≥ 10 ^ 3copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time) Known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy Have a history of alcohol, drug, or substance abuse Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees
Status: Recruiting

This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.

All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  40 to 55 years of age. Residual femoral length from ischial tuberosity to the end of the limb with distal soft tissue compressed (15-35 cm) Unilateral trans-femoral traumatic amputation with single-axis mechanical knees, axial foot (single axis). Able to walk without the use of any assistive device; subjects must have obtained a score of > 5 for Houghton Scale to indicate active use of prosthesis and > 41 for Berg Balance Scale (BBS). Medicare level 3 (community) ambulatory or above. Ability to descend stairs and hills without caregiver and assistive devices. Be able to independently provide informed consent. Be willing to comply with study procedures.  Exclusion Criteria:  Reduced somatosensory sensibility of the non-affected limb, ulceration or pain at the stump the amputation was of vascular origin Poor fittings of prosthesis Visual or vestibular impairment (vertigo or dizziness) Lower limb musculoskeletal injury and other neurological deficits - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 55 Years - StdAgeList: Adult
Effect of Rhythmic Gymnastics Training in Children With Down Syndrome
Status: Recruiting

Some of the clinical characteristics of people with Down syndrome (DS) are orthopedic, cardiovascular, neuromuscular, visual, cognitive and perceptual disorders, which directly affect the quality of their movements. Children with DS often have a sedentary lifestyle or low levels of physical activity which exacerbates problems related to obesity and overall physical health. Therefore, the practice of physical exercise in this type of population is essential to improve their health-related physical fitness. The aim of this study was to analyze the influence of an adapted rhythmic gymnastics training program on body composition, tendon architecture and stiffness, and physical capacity in children with DS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Disabiluty: mild to moderate  Exclusion Criteria:  Any contraindication to exercise Severe or profound intellectual disability Musculoskeletal disorders that prevented completion of the tests - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 20 Years - StdAgeList: Child, Adult
Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach
Status: Not yet recruiting

This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Physician-diagnosed spinal cord injury Neuropathic pain for at least 3-months, as diagnosed by a physician Pain not attributable to any other conditions Aged 18-75 years  Exclusion Criteria:  Prior history of transcranial magnetic stimulation (TMS) therapy Any TMS-related contraindications, for example: pacemaker, metallic implant, other medical conditions such as structural brain disease, previous seizure, psychiatric disorders (excluding depression and anxiety), suicide attempt in the past 6 months, liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and pregnancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety
Status: Recruiting

To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18-45 years old; American society of Aneshesiologists（ASA）physical status classification system is grade I-III; Elective surgery is proposed BMI of 19-30 kg/m2; Patients who agreed to enroll in this study voluntarily  Exclusion Criteria:  Those who are known to be allergic to the drug ingredients in this study and their allergic constitution; Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs; History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities; Respiratory insufficiency, respiratory failure; BMI<18 kg/m2 or BMI>30kg/m2; Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks; Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7 Any circumstances deemed unsuitable for inclusion by the researcher for any reason. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult