pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
NCT Number: NCT06584006
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hematological Malignancy|Lymphocytopenia
Interventions: DRUG: Combination Therapy Group|DRUG: Monotherapy Group
Sponsor: The First Affiliated Hospital of Xiamen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-02-29
Locations: Zhijuan Lin, Xiamen, Fujian, China

Summary:
To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors

Primary Outcome Measures: Lymphocyte count and its subgroup count, Dynamic changes in lymphocyte count and its subgroup count, Up to 36 months
Secondary Outcome Measures: NK cells, Changes in NK cells, Up to 36 months|Infection, Incidence of infections, Up to 36 months|Treatment interruption, Rate of treatment interruption or delay., Up to 36 months
The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People with Multiple Sclerosis
NCT Number: NCT06583967
Acronym: MS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis (MS)
Sponsor: Soroka University Medical Center
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-01
Completion Date: 2025-06-30

Summary:
The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people with Multiple Sclerosis with moderate severity.

Primary Outcome Measures: Quality of life outcomes, Quality of life to be assessed by using a Short-form 36 health status questionnaire (SF-36). SF-36 consists of 36 questions in total. Each participant will be asked to fill in the questionnaire alone and by reading it themselves., Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
Secondary Outcome Measures: 6 Minute Walk Test (6MWT), Each subject will be asked to perform a 6 min walk and the max distance to be measured,, Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)|Timed Up &amp; Go (TUG), Patients wear their regular footwear and can use a walking aid, if needed. The patient stands up upon therapist\&#39;s command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated, Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)|Berg Balance Scale (BBS), The Berg Balance Scale (BBS) is used to objectively determine a patient\&#39;s ability (or inability) to safely balance during a series of predetermined tasks., Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)|10 Meter Walk Test (10MWT), The 10 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance, Baseline (screening), T1 (Week 6), T2 (Week 12), T3 (Follow-up, 6 weeks post T2)
SUBJECTIVE REFRACTION with LIGHTFIELD TECHNOLOGY
NCT Number: NCT06583954
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Refractive Error Correction
Sponsor: Daniela Nosch
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-15
Completion Date: 2025-06-30

Summary:
The aim of this study is to test whether it is possible in principle to determine defective vision using light field technology. The measurements with this first prototype will be compared with the results of the conventional method for subjective refraction determination and those using a phoropter (Vision R-800 phoropter).

Primary Outcome Measures: precision of determination of refractive error, To explore if this prototype CREAL device based on LightField Technology can determine the refractive error reliably, in comparison to well-established methods such as subjective refraction with a trial frame and with the phoropter Vision-R 800 (Essilor SA)., within one week
Secondary Outcome Measures: repeatability of all three methods for subjective refraction, within one week
Refeeding Syndrome in Critically Ill Children
NCT Number: NCT06583928
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Refeeding Syndrome|Syndrome, Refeeding
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-01

Summary:
Refeeding syndrome (RFS) is the a metabolic disturbance which occurs as a result of reinstitution of nutrition in people who are starved, severely malnourished, or metabolically stressed because of severe illness. When too much food or liquid nutrition supplement is eaten during the initial three to seven days following a malnutrition event, the production of glycogen, fat and protein in cells may cause low serum concentrations of potassium, magnesium and phosphate.\[1\]\[2\]

Primary Outcome Measures: Determine the numbers of patients who developed refeeding syndrome according to ASPEN criteria , those who develop one significant electrolyte disorder (decrease ≥ 10% in phosphorus, potassium, and/or magnesium) within the first, Basline
Dry Needling Vs Transcutaneous Electrical Nerve Stimulation in Management of Myofascial Pain Dysfunction Syndrome
NCT Number: NCT06583915
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myofascial Pain - Dysfunction Syndrome of TMJ
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2025-08-31

Summary:
Myofascial pain dysfunction syndrome (MPDS) is the most common form of temporomandibular disorders. Because of the multifactorial nature of the problem, its management is still not definite. This randomized clinical trial aimed to assess the efficacy of transcutaneous electrical nerve stimulation over dry needling for management of such condition.

Primary Outcome Measures: Pain, Using visual analogue scale (VAS) from (1-10) where 1 is the least pain and 10 is the maximum pain, From enrollment to the end of treatment at 6 months
Secondary Outcome Measures: Muscle stiffness, using Electromyography to measure muscle response or electrical activity in response to a nerve stimulation of the muscle (volt), From enrollment to the end of treatment at 6 months|Limitation in mouth openinig, Measuring muscle opening using digital caliber (Micrometer), From enrollment to the end of treatment at 6 months|Sleeping disorder, Assessing sleeping disorder through Yes or No questionnaire, From enrollment to the end of treatment at 6 months|Anxiety, Assessing anxiety through Yes or No questionnaire, From enrollment to the end of treatment at 6 months|Patient satisfaction, Assessing patient satisfaction through Yes or No questionnaire, From enrollment to the end of treatment at 6 months
Management of Anemia in Patients with EndocaRditis Infectious Candidates for Cardiac Surgery: the AMERICA Study
NCT Number: NCT06583902
Acronym: AMERICA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infective Endocarditis
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-10-30

Summary:
Infective endocarditis (EI) is an extremely serious disease requiring prolonged hospitalisation, complex management by multidisciplinary teams and high healthcare costs. Anemia is also emerging as a virtually constant condition associated with endocarditis, as evidenced by its inclusion in the variables used to calculate risk scores.Anemia associated with infective endocarditis (EI) has a remarkably complex and multifactorial pathogenesis.It is essential to treat anaemia in patients with EI as an integral part of their overall therapy, in what is now called patient blood management. Blood transfusion is not the only approach available to treat this condition. It is essential to correct any deficiencies, whether iron or vitamins. In addition, some patients may benefit from the administration of erythropoiesis-stimulating agents.

Primary Outcome Measures: Assessing improvement in anemia and reduction of transfusion support in the study population, To assess the improvement in anaemia and reduction in transfusion support in the study population compared to a selected control population (patients with endocarditis who underwent surgery in the 24 months prior to PBM implementation)., 18 months
Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
NCT Number: NCT06583876
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Mitral Regurgitation
Interventions: DEVICE: Coriofix System
Sponsor: Bio Refine Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2027-02
Locations: Gottsegen National Cardiovascular Center, Budapest, Hungary|Rabin Medical Center, Petah Tikva, Israel

Summary:
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.

The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive).

Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.

All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.

Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.

Primary Outcome Measures: Coriofix System Safety, Absence of Major Device- or Procedure-Related Serious Adverse Events, 30 days
Secondary Outcome Measures: Coriofix System Safety, Absence of Major Device- or Procedure-Related Serious Adverse Events, 6 and 12 months|Device technical success, Successful system operation with no related emergency surgery or reintervention, Procedure|Treatment success, Reduction of MR grade, 30 days
Parasitic Infections and Ulcerative Colitis: Combining Anti-parasitic and Immunomodulatory Treatments May Achieve Remission
NCT Number: NCT06583863
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis
Interventions: DRUG: Echinacea Extract|DRUG: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]
Sponsor: Benha University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-09-12
Completion Date: 2024-06-12
Locations: Benha faculty of Medicine, Banhā, El Qalyoubia, 13511, Egypt

Summary:
The study aimed to explore the link between parasitic infections and the severity of ulcerative colitis (UC). 120 UC patients were divided into three groups: those without infection, those with Giardia lamblia infection treated with metronidazole, and those with Giardia infection treated with a combination of metronidazole and E. purpurea. The results revealed that patients with Giardia infections exhibited more severe UC symptoms. All groups experienced improved symptoms following treatment, but the combination therapy group demonstrated the most significant improvement. Remission rates were highest in the group without infection and the group receiving combination therapy. Additionally, the study identified E. purpurea therapy and a substantial reduction in SCCAI score as significant predictors of higher remission rates.

Primary Outcome Measures: Proportion of patients reporting at least a 50% increase in the remission rate of parasitic infection (measured by changes in Serum CRP, Fecal calprotectin, and on the Simple Clinical Colitis Activity Index[SCCAI]) in patients with Ulcerative colitis., Patients had parasitic infection showed significantly higher pre-treatment SCCAI score and FCP level than patients free of infection. Post-treatment SCCAI scores of all patients were significantly lower than the pre-treatment scores., 4 weeks
Chronic Neck Pain: Assessing Pain, Mobility, Sleep, and Function
NCT Number: NCT06583850
Acronym: observational
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Neck
Sponsor: Gamze Demircioğlu
Sex: ALL
Age: ADULT
Enrollment: 128
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-05
Completion Date: 2024-09-06

Summary:
The goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. The study focuses on understanding the complex relationships between these factors in individuals with CNP, with the aim of providing insights that could contribute to more effective rehabilitation strategies.

The main questions it aims to answer are:

* How pain, cervical mobility, sleep quality, and functional status differs between individuals with and without chronic neck pain?
* What is the relationship between functional status and cervical mobility and sleep quality in individuals with chronic neck pain?

Primary Outcome Measures: The Neck Disability Index, The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability., Baseline|Pittsburgh Sleep Quality, Five questions on the scale are answered by the participant\&#39;s partner or roommate and are used solely for clinical information..The PSQI has seven components: subjective sleep quality, sleep latency, total sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score is calculated by summing the scores of the seven components, ranging from 0 to 21 points., Baseline|Visual analog scale, A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain., Baseline|Range of motion, Active Cervical Range of Motion Assessment was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane). The same physiotherapist performed all goniometric measurements to eliminate any differences between the measurements that the measurer could cause. The American Association of Orthopaedic Surgeons (AAOS) values were taken as a reference for NEH in the cervical region. Care was taken to ensure that the participant wore comfortable clothes during the measurements. Before starting the measurement, the desired movement was shown to the participant by the physiotherapist., Baseline
Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma
NCT Number: NCT06583837
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma, B-Cell, Marginal Zone
Interventions: DRUG: Orelabrutinib|RADIATION: response-adapted radiation
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-09
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma

Primary Outcome Measures: 1-year event-free survival (EFS), the period from the date of patients sign informed consent to the observed event for any reason, 1 year
Secondary Outcome Measures: 6-months CR rate, the ratio of numbers of patients with complete response to all the participants receiving treatment, up to 6 months|2-year event-free survival (EFS), the period from the date of patients sign informed consent to the observed event for any reason, From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years|2-year progression-free survival (PFS), the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason, From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|2-year overall survival rate, time between the date of patients sign informed consent and the date of death or the date of last follow-up time, From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Throughout the treatment period, up to 1 year|Quality of life questionnaire, evaluate patients' quality of life by questionnaire, Up to 1 year
Remifentanil and Remimazolam to Limit Patient Movement
NCT Number: NCT06583811
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long-Eye Surgeries
Interventions: DRUG: Remifentanil
Sponsor: Egymedicalpedia
Collaborators: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-10
Completion Date: 2025-01-10
Locations: Al-Azhar University hospitals, Cairo, Egypt

Summary:
Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours.

Sedation may be helpful with LA to decrease the experience of discomfort, movement and anxiety, which may in turn positively influence hemodynamic parameters, patient satisfaction, and overall improve surgical safety. Sedatives used in eye surgeries include benzodiazepines, opioids, alpha-adrenoceptor agonists, and propofol.

Primary Outcome Measures: Eye Movement, Incidence of patients who are not moving their Eyes during long eye surgery, from 0 hours to 4 hours after the procedure
Validity and Reliability of the Virtual Reality-Based 9-Hole Peg Test in Stroke Patients
NCT Number: NCT06583772
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke
Interventions: DIAGNOSTIC_TEST: VR-based 9-hole peg test
Sponsor: Ankara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-22
Completion Date: 2025-03-24
Locations: Ankara University School of Medicine Department of Physical Medicine and Rehabilitation, Ankara, 06620, Turkey

Summary:
The goal of this observational study is to demonstrate diagnostic value of a VR-based 9-hole peg test (9HPT) for the evaluation of manual dexterity in stroke patients.

The main questions it aims to answer are:

* Is the VR-based 9HPT a reliable and valid diagnostic tool to evaluate manual dexterity in stroke patients when compared to the physical version of it.
* Does the VR-based 9HPT differ between the dominant and non-dominant hand in healthy individuals?

Primary Outcome Measures: Test-retest reliability of the VR-based 9-hole peg test, Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds. The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed. In this application, patients will first practice 2 times and then be tested. The test will be repeated 3 times and the average value will be recorded in seconds. The test will be repeated in the same way after 7 days. To determine the reliability of the test, an intra-class correlation coefficient-ICC will be calculated., Baseline and 7 days
Secondary Outcome Measures: Internal consistency of the VR-based 9-hole test, Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds. The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed. In this application, patients will first practice 2 times and then be tested. The test will be repeated 3 times and the average value will be recorded in seconds. To determine the internal consistency of the test, Cronbach's alpha coefficient will be calculated., Baseline|Construct validity of the VR-based 9-hole test, Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds. The volunteers will first undergo a physical 9-hole peg test. After the physical test is completed, the VR-based 9-hole peg test will be performed. The criterion validity of the test will be calculated by its agreement with the physical 9-hole peg test (Spearman's rank correlation)., Baseline|To determine the normative values of the virtual reality-based 9-hole peg test in healthy individuals and to reveal whether there is a difference between dominant and non-dominant hand., In age- and gender-matched healthy volunteers, the VR-based 9-hole peg test test will be performed on both the dominant and non-dominant hand. Scoring is based on the time taken to complete the VR based 9-hole peg test activity, recorded in seconds., Baseline
EVALUATION OF PREFABRICATED CAD/CAM PEEK CROWNS USED IN PRIMARY MOLARS: A RANDOMISED CONTROLLED CLINICAL TRIAL
NCT Number: NCT06583759
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Full Coverage Treatment
Interventions: PROCEDURE: Full coverage Crowns
Sponsor: Alexandria University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-10
Completion Date: 2025-04-10
Locations: Faculty of Dentistry, Alexandria University, Alexandria, Egypt|Faculty of Dentistry, Alexandria, Egypt

Summary:
Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically.

Primary Outcome Measures: Clinical Evaluation of the crown using Modified Ryge Criteria, Day 0, 1 week , 3 months, 6 months , 12 months
Bangkok Noi District Electronic Health Database With Socioeconomic Factors From Bangkok Noi Model Project (BANMOP)
NCT Number: NCT06583694
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Conditions Influencing Health Status|Health Knowledge, Attitudes, Practice|Health-Related Behavior
Interventions: BEHAVIORAL: Health promotion campaigns to correct the health problems
Sponsor: Siriraj Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 21286
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-05
Completion Date: 2020-10-30

Summary:
Bangkoknoi Model Project (BANMOP) is guided by context-specific health databases to promote the sustainable health and well-being of people living in the Bangkoknoi district. The BANMOP is a prospective cohort project that emphasizes community engagement via electronic databases. Data were collected from households in Bangkoknoi district. Convenience sampling was used and the data were collected via mobile application and a web-based platform, and by face-to-face interviews with well-trained volunteers who were mainly health professionals. The data were categorized by age groups: 0-5, 6-14, 15-21, 22-59, \>60 years old, included both individuals and families in five categories: health, environment \& disaster, economics, social, and safety.

Primary Outcome Measures: health conditions, survey questionnaires on individual and household health condition, 4.5 years from 1st of October 2015 to the 31st of March 2020
Secondary Outcome Measures: Health-related conditions, survey questionnaires on individual and household health-related condition including environment \& disaster, economics, social, and safety, 4.5 years from 1st of October 2015 to the 31st of March 2020
Shape of the Sagittal Curvatures of the Spine in Youthful Female Volleyball Players
NCT Number: NCT06583681
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Sponsor: University of Rzeszow
Sex: FEMALE
Age: CHILD
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-11-15
Completion Date: 2024-01-15

Summary:
The goal of this study is to assess the formation of the sagittal curvatures of the spine in healthy girls practicing volleyball versus their untrained peers.

Research questions:

1. Is there a differentiation in values of thoracic kyphosis, lumbar lordosis angles, and compensation ratio among girls practicing volleyball and their untrained peers?
2. Does practicing volleyball determine the frequency of correctness in the lumbosacral inclination, the shape of the curvature of the thoracic kyphosis and lumbar lordosis?
3. Does practicing volleyball determine the frequency of types and subtypes of body posture?

Primary Outcome Measures: Number of participants who experienced abnormalities resulting from sports training according to inclinometer assessment, through study completion, an average of 1 year
Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer
NCT Number: NCT06583655
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Invasive
Sponsor: Ruijin Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 205
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-06-30

Summary:
Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Since the publication of IBCSG23-01, ACOSOG Z0011 and AMAROS study, these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNB+ALND followed by adjuvant radiotherapy. Therefore, an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy. However, they also pose new challenges for adjuvant radiotherapy decisions. In the Z0011 study, patients were required to receive breast tangent field radiotherapy. In the AMAROS study, axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area, but the study results showed a local recurrence rate of only 1.19% at 5 years in the axillary radiotherapy group. Consequently, there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients. In contrast, results from the EORTC-22922 and MA-20 studies, which included patients undergoing axillary lymph node dissection, showed that adjuvant radiotherapy to the entire lymphatic drainage area, including the internal mammary region, reduced the risk of disease-free survival and breast cancer-specific mortality. Therefore, the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial, with a lack of high-level evidence to support it.

Primary Outcome Measures: Percentage of patients with arm lymphedema, Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy, 2 year
Secondary Outcome Measures: Disease free survival, Number of patients with an oncological event (local, regional and distant recurrence free survival), 5 years|Overall survival, Number of patient alive after 5 years of follow up, 5-year
Antimicrobial Therapeutic Drug Monitoring During Lung Transplant Perioperative Phase
NCT Number: NCT06583642
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Transplant Infection|Pneumonia, Bacterial|Antibiotic Resistant Strain
Sponsor: Policlinico Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-03-01
Locations: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico, Milan, 20122, Italy

Summary:
Background: Post-LUTX pneumonia represents a leading cause of death along the first month after LUTX. Donor-derived transmission of pathogenic species occurs up to 25% of recipients receiving a graft with a positive BAL culture, despite in-vitro adequate antimicrobial prophylaxis.

Hypothesis: LUTX recipients are either exposed to suboptimal antimicrobial doses or antimicrobial penetration into the lug parenchyma is altered either due to surgery (absence of bronchial anastomoses) or to the hyperinflammatory state.

Methods: LUTX recipients admitted to the intensive care unit at the Fondazione IRCCS Ca' Granda Policlinico Hospital. According to the institutional perioperative prophylaxis protocol and the donor/recipient ecology the most frequent antimicrobial molecules administered will be: cefepime, vancomycin, and meropenem. Antimicrobial pharmacokinetics will be investigated at three timepoints. Plasma levels of the ongoing antimicrobial molecule will be assessed at ICU admission, on postoperative day 1 and on postoperative day 3. Bronchoalveolar lavage (BAL) samples for the measurement of BAL antimicrobial levels will be collected during the BAL performed for clinical indication on postoperative day 1 and on postoperative day 3.

Absolute plasma and BAL antimicrobial levels will be assessed. The ratio of BAL to plasma dosage of antimicrobial will be assessed to evaluate antimicrobial penetration within the target tissue. Correlation between both plasma and BAL antimicrobial dosage and recipients' postoperative fluid balance, body weight, vasopressor requirement, renal function will be performed.

Primary Outcome Measures: Plasma Antimicrobial Concentration, Dosage of plasma levels of Cefepime or Meropenem or Vancomycin, ICU admission after LuTX; 12 hours after LuTX; 72 hours after LuTX|Bronchoalveolar Antimicrobial Concentration, Dosage of bronchoalveolar levels of Cefepime or Meropenem or Vancomycin, ICU admission after LuTX; 12 hours after LuTX; 72 hours after LuTX|Antimicrobial lung tissue penetration, Ratio of bronchoalveolar to plasma concentration of Cefepime or Meropenem or Vancomycin, ICU admission after LuTX; 12 hours after LuTX; 72 hours after LuTX
The Prognostic Value of Anion Gap in Predicting Mortality Among Patients With Acute Pulmonary Embolism
NCT Number: NCT06583616
Acronym: PRAGUE-PE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Pulmonary Embolism (PE)
Interventions: DIAGNOSTIC_TEST: Anion Gap
Sponsor: Universitas Diponegoro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-09-30
Locations: Dr. Kariadi Central General Hospital, Semarang, Central Of Java, Indonesia

Summary:
This study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism.

Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (CT scan). The data consist of demographic data, clinical presentation, laboratory, and CT scan were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.

Primary Outcome Measures: In-hospital mortality, During hospitalization, up to 1 weeks
Identifying Barriers to Implementing Sensory Strategies in the Classroom Setting
NCT Number: NCT06583603
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sensory Disorder
Sponsor: Bay Path University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 365
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-06
Completion Date: 2024-11-01

Summary:
The goal of this clinical trial is to determine barriers to implementing sensory strategies in the classroom setting as well as potential supports needed in teachers and paraprofessionals 18 years and older who are actively working in the classroom setting. The main questions it aims to answer are:

1. What are common themes that limit classroom staff from implementing sensory strategies within the classroom setting?
2. What support do classroom staff need from an occupational therapist to feel confident in implementing sensory strategies within their classroom?

Participants will be asked to participate in a 17-item electronic survey via Google Forms. They will be asked to provide informed consent prior to participating.

Primary Outcome Measures: Barriers to implementing sensory strategies in the classroom setting, Survey will be dispersed via email and Facebook groups. Survey will be on google docs., 13 weeks
Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
NCT Number: NCT06583590
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Erectile Dysfunction With Diabetes Mellitus
Interventions: DRUG: Botulinum toxin A|DRUG: Tadalafil 5mg
Sponsor: Aswan University Hospital
Collaborators: Aswan University|Cairo University Hospitals
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-01
Locations: Aswan University-Faculty of Medicine, New-Aswan City, Aswan Governorate, 81528, Egypt

Summary:
Study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ICI) of Botulinum toxin A plus oral tadalafil in controlled diabetic men with refractory Erectile Dysfunction.

Primary Outcome Measures: Treatment., The primary outcome is to assess the effect of single intra-cavernosal injection of 100 unit of botulinum-A toxin plus daily intake of 5mg oral tadalafil in 32 adult diabetic patients with erectile dysfunction to detect its effect on on the erectile function status by reporting changes in IIEF and penile doppler parameters., 3 months
Secondary Outcome Measures: Secondary adverse events of the drug., The second outcome is to assess the safety of the drug injection by reporting any secondary adverse events during or after injection such as mild pain, discomfort, edema, hematoma formation or chance of infection or psychological effects., 3months
The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer
NCT Number: NCT06583564
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer Stage III
Sponsor: Shanghai Tong Ren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-27
Completion Date: 2025-03-31

Summary:
Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

Primary Outcome Measures: Disease-free survival (DFS) rate, the rate of of no recurrence or metastasis after 3 years from radical surgery, From radical surgery to the end of follow-up ,up to 36 months
Secondary Outcome Measures: the number of harvested lymph nodes, the number of harvested lymph nodes of radical surgery, From radical surgery to the end of perioperative period at 1 month|Postoperative complications, Postoperative complications ICG-related complications, surgery-related complications, and systemic complications. Postoperative complications were graded according to the Clavien-Dindo system, From radical surgery to the end of perioperative period at 1 month|Overall survival rate, the rate of 3 years overall survival after radical surgery, From radical surgery to the end of follow-up ,up to 36 months
Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia
NCT Number: NCT06583551
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myalgia|Bruxism|Quality of Life
Interventions: DRUG: Botulinum toxin|PROCEDURE: Dry needling|DRUG: Myorel|PROCEDURE: Manual therapy
Sponsor: Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-01-03
Completion Date: 2021-09-01
Locations: University of Health Sciences, Istanbul, Turkey

Summary:
Eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: Botulinum toxin (BTX); Dry needling (DN); Pharmacological therapy (PT) and Manual therapy (MT). All treatments were carried out by the same maxillofacial surgeon. An informed consent form was obtained from all participants.

Primary Outcome Measures: Pain in at rest and at chewing, Average pain was measured by a scale, named Visual analogue scale., 12 weeks|MMO, Maximum painless mouth opening (in millimeters) was measured by a special ruler., 12 weeks|OHRQoL questionnaire, Oral-health-related quality of life, 12 weeks
An Online Rehabilitation Programme for People with SCI
NCT Number: NCT06583538
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries|Physical Inactivity|Spinal Cord Injury, Acute
Sponsor: Glasgow Caledonian University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-22
Completion Date: 2024-12

Summary:
The goal of this feasibility study is to explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with Spinal Cord Injury during the transition from hospital to home.

The main question\[s\] it aims to answer are:

* What is the feasibility of an online rehabilitation programme to support physical activity adherence in people with spinal cord injury following discharge into the community?
* How effective is an online rehabilitation programme to enhance functional capacity, physical activity and quality of life in people with spinal cord injury following discharge into the community?

Participants will be given a personalised online rehabilitation programme to complete two times a week. It will consist of a warm up two exercise components (cardiorespiratory fitness and muscle strength) and a cool down.

Primary Outcome Measures: Adherence, Adherence will be monitored remotely by the number of online diary entries per participant., 12 weeks|Acceptability, Acceptability will be captured by the structured online video interview., 12 weeks|Participant recruitment and retention, Measured by assessing participant eligibility (number of those approached and those who meet the inclusion criteria), recruitment rate per month and retention of recruited participants, 12 weeks
Secondary Outcome Measures: Self-report Physical Activity Scale for individuals with Physical Disabilities (PASIPD), Captures information about leisure, household and work-related activity over the preceding 7 days., Baseline, Week 2, Week 6 and week 12|6-minute wheelchair test (6minWCT) OR 6-minute walk test (6MinWT), Assesses functional capacity and endurance, Baseline and week 6|Muscle Strength in kg, Via manual muscle dynamometer, Baseline and week 6|Borg Rate of Perceived Exertion (RPE) Scale, Collected after 6 minute test. 6-20 point self-reported scale based on rate of perceived exertion with 6 being minimum and 20 being maximum., Baseline and week 6|Walking Index for Spinal Cord Injury (WISCI II), Assesses improvement in walking ability, Baseline and week 6|Spinal Cord Independence Measure Self Report (SCIM III SR), Performance in activities of daily living and mobility questionnaire, Baseline, Week 2, Week 6 and week 12|World Health Organisation Quality of Life-Bref Scale (WHOQoL-Bref), Quality of life questionnaire measures 4 domains: physical, psychological, social and environmental health. Higher score indicates greater quality of life., Baseline, Week 2, Week 6 and week 12
The Effectiveness of Integrated Interactive Digital Health Application and Telemonitoring in Patients With Heart Failure and Reduced Ejection Fraction
NCT Number: NCT06583473
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Health Behavior
Interventions: BEHAVIORAL: Interactive digital health application
Sponsor: Hsiao Fu-Chih
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2026-03-31

Summary:
Patient Source: Patients discharged from the cardiology ward with heart failure.

Intervention Group: Prior to discharge, patients will be provided with and instructed on how to use the "Intelligent Interactive Personal Management System for Heart Failure" as well as a "Bluetooth-enabled blood pressure monitor and scale for remote data transmission."

Control Group: Patients will receive standard medical care.

Assessment Method: The Health-Related Quality of Life Questionnaire (EQ-5D), Kansas City Cardiomyopathy Questionnaire (KCCQ-12), and Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) will be completed before discharge, and at 1 month, 6 months, and 12 months post-discharge. The average time to complete the questionnaires is 10-15 minutes. Additionally, cardiovascular events and readmission rates will be tracked and analyzed over a 1-year period.

Primary Outcome Measures: Heart failure re-hospitalization rate, The rate of heart failure re-hospitalization, 1 Year|Kansas City Cardiomyopathy Questionnaire, The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated, disease-specific instrument designed to quantify the health status of patients with heart failure. It assesses the physical, social, and emotional impacts of heart failure, providing a comprehensive understanding of the patient's condition., 1 Year|EQ-5D, The EQ-5D is a standardized instrument developed by the EuroQol Group for measuring general health-related quality of life. It is widely used in clinical and economic evaluations of healthcare as well as in population health surveys., 1 Year|FACIT-Sp-12, he Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) is a 12-item scale designed to measure spiritual well-being in individuals with chronic illnesses. It is a subset of the broader FACIT-Sp, which evaluates various dimensions of spiritual health., 1 Year
Systematic Intervention to Improve Sexual Dysfunction
NCT Number: NCT06583460
Acronym: SISTER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female|Localized Cancer
Sponsor: Center Eugene Marquis
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-15
Completion Date: 2028-01-15

Summary:
The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.

Primary Outcome Measures: Sexual satisfaction, Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22)., Measured at baseline and at 18 months following initiation of treatment and surgical.
Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus
NCT Number: NCT06583434
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Flexible Flatfoot
Interventions: BEHAVIORAL: core-lower extremity Pilates Training Group|OTHER: Non-Training Group
Sponsor: Hyun Ju Kim
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2024-03-30
Locations: Busan University of Foreign Studies, Busan, 46234, Korea, Republic of

Summary:
The goal of this clinical trial was to determine if stabilization-based Pilates exercises could improve gait and balance in women with flexible flatfoot.

The main questions it aimed to answer were:

Did Pilates training improve gait parameters in women with flexible flatfoot? Did Pilates training reduce balance instability in these participants?

Researchers compared the Pilates training group to a non-training group. The results showed significant improvements in gait and balance for those who participated in the Pilates training.

Participants:

Completed twice-weekly Pilates sessions for 8 weeks. Underwent pre- and post-intervention assessments of gait and balance.

Primary Outcome Measures: Improvement in step time, Step time was measured in seconds using a 3D motion capture system., Baseline and after 8 weeks|Improvement in stride time, Stride time was measured in seconds using a 3D motion capture system., Baseline and after 8 weeks|Improvement in walking speed, Walking speed was measured in meters per second using a 3D motion capture system., Baseline and after 8 weeks|Improvement in cadence, Cadence was measured in steps per minute using a 3D motion capture system., Baseline and after 8 weeks|Improvement in foot off, Foot off was measured as a percentage of the gate cycle using a 3D motion capture system., Baseline and after 8 weeks|Improvement in balance stability, Balance was assessed using a single-leg stance test, measuring the center of pressure(COP) sway in both anterior-posterior (AP) and medial-lateral (ML) directions., Baseline and after 8 weeks