pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
NCT Number: NCT06500910
Acronym: EXCELSIOR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preterm Birth
Interventions: OTHER: Physical Exercise
Sponsor: Henner Hanssen
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-12
Completion Date: 2025-12-31
Locations: Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie, Basel, Basel Stadt, 4052, Switzerland

Summary:
EXCELSIOR is a randomized controlled trial to investigate the effect of physical exercise on cardiovascular health in prematurely born children. Participants will be randomly allocated to either an intervention group or a control group. The intervention will receive a child-friendly physical exercise program and the control group will receive age appropriate lifestyle- and exercise recommendations.

Primary Outcome Measures: Central Retinal Arteriolar Equivalent (CRAE), Diameter of the retinal arterioles, 10 weeks
VEST Device to Enhance Safein Vein Patency
NCT Number: NCT06500897
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Bypass
Interventions: DEVICE: VEST
Sponsor: Cardiochirurgia E.H.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 385
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-02
Completion Date: 2024-07-08
Locations: Medical University of Vienna, Vienna, Austria|Cardiochirurgia European Hospital, Rome, 00152, Italy|Mauriziano Hospital, Turin, Italy

Summary:
Purpose - Bypass grafting is the gold standard for severe coronary disease, yet most repeat revascularizations target previously grafted territories. External stenting of saphenous vein grafts, the most frequently used bypass conduit, has been shown to minimize disease markers. This study evaluates clinical outcomes of external stenting in real world routine practice.

Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients. All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial and/or venous grafts. One or more venous grafts were externally stented. Choice of conduits, use of cardiopulmonary bypass, and vein harvesting technique were performed according to the routine practice of each surgeon.

All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects.

Primary Outcome Measures: Re-rivascularization, Number of PCI or re-CABG performed, stratified by target site, Up to 7 years|MACCE, Major adverse cardiac and cerebrovascular events, Up to 7 years
Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.
NCT Number: NCT06500871
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Teeth With Acute Irreverseble Pulpitis
Interventions: DRUG: Diclofenac Potassium
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07

Summary:
This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth

Primary Outcome Measures: Efficacy of local anesthesia, using Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain\<55 mm). if \>55 defined as failure, intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Secondary Outcome Measures: Intensity of intraoperative pain, using Heft parker Visual analogue scale score ranges from on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (\< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (\> 54 mm and \< 114 mm), Severe pain (≥ 114 mm)., intraoperative ( access cavity preparation & instrumentation ) during root canal treatment|Post-operative pain, using Heft parker Visual analogue scale on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (\< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (\> 54 mm and \< 114 mm), Severe pain (≥ 114 mm)., 6, 12, 24 and 48 hours post-operatively|Number of needed analgesic tablets in case of intolerable pain, by counting, Up to 2 days post operatively
Assessment of Marginal and Internal Fit of High Performance Polymer PEEK Endocrown Using Two Preparation Designs
NCT Number: NCT06500845
Acronym: PEEK
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endodontically Treated Molar|Marginal Fit|Internal Fit
Interventions: OTHER: Bevel marginal design endocrown for endodontically treated teeth|OTHER: Butt marginal design endocrown for endodontically treated teeth
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-09
Completion Date: 2025-05-01
Locations: Cairo University, Cairo, Egypt

Summary:
First, Participants in this study will be recruited according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for endodontically treated molar for receiving high performance polymer endocrown. Checking and verification for the restoration (trying) and assessment of marginal and internal fit by replica technique. Then final cementation of endocrown.

Primary Outcome Measures: Marginal fit, stereomicroscope by Micrometer, 2 weeks
Secondary Outcome Measures: Internal fit, stereomicroscope by Micrometer, 2 weeks
Defensive Dentistry Practices and Dentists (DDP)
NCT Number: NCT06500832
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Defensive Medicine
Interventions: OTHER: Survey-based Data Collection Tool
Sponsor: Istanbul Aydın University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 410
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2023-07-30
Locations: Istanbul Aydin University, Istanbul, Kucukcekmece, 34295, Turkey

Summary:
Medical malpractice claims have been on the rise in recent years due to the growing patient rights movement. This term is defined as an injury caused by a healthcare professional's failure to follow standard practice during treatment, a lack of skill, or failure to provide treatment. Defensive dentistry is on the rise as violence and malpractice claims increase. Defensive dental practices (DDP) refer to minimize legal responsibility of the clinician primarily rather than looking out for the patient's benefit. This study aims to evaluate the knowledge, awareness and attitudes of dentists in terms of DDP.

Primary Outcome Measures: DDPS Score, Total DDPS score of a participant is determined by assigning points as "completely disagreed" (1 point), "disagreed" (2 points), "neither disagreed nor agreed" (3 points), "agreed" (4 points), "completely agreed" (5 points). The total scores are categorized considering the cut-off values as very poor (23-12), poor (35-24), good (47-36), very good (60-48) to determine the level of participants' attitudes towards DDP., 1hour
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
NCT Number: NCT06500819
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Neuroblastoma|Sarcoma|Osteosarcoma
Interventions: DRUG: B7-H3CART Dose (Intravenous)
Sponsor: Stanford University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 41
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2029-07
Locations: Stanford University, Palo Alto, California, 94304, United States

Summary:
The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.

Primary Outcome Measures: Feasibility of manufacturing autologous T cells, Feasibility of manufacturing autologous T cells transduced with Ef1a-CAR276 lentiviral vector expressing B7-H3 Chimeric Antigen Receptor (B7-H3-CART), using the Miltenyi CliniMACS Prodigy® system with dasatinib and protamine sulfate., 2 years|Safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of a single dose of intravenous B7-H3CART, Assess the safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of a single dose of intravenous B7-H3CART in children and young adults with relapsed and refractory solid tumors (i.e. soft tissue sarcoma, osteosarcoma, Ewing sarcoma, Wilms tumor, neuroblastoma) using the proposed dose escalation schedule., 2 years
Secondary Outcome Measures: Clinical response in children and young adults, Assess clinical response in children and young adults with relapsed and refractory solid tumors treated with IV B7-H3CART., 2 years|Safety of B7-H3CART at the MTD/RP2D, Assess the safety of B7-H3CART at the MTD/RP2D in children and young adults with relapsed and refractory solid tumors treated with IV B7-H3CART., 2 years
Experiment to Assess Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Prostate Cancer Patients
NCT Number: NCT06500741
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: OTHER: No Intervention
Sponsor: Astellas Pharma Global Development, Inc.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 342
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2024-11-30

Summary:
The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).

Primary Outcome Measures: Patients' Preference weights for different treatment attributes, Preference data will be collected via online survey questionnaires designed using DCE method., Up to 1 day|Patients' Overall Preference for a specific treatment profile (NHT +/- ADT or ADT monotherapy), Preference data will be collected via online survey questionnaires designed using DCE method., Up to 1 day
Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma
NCT Number: NCT06500715
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Febrile Neutropenia|Sarcoma|Doxorubicin Adverse Reaction|Hospitalization-Associated Infection
Interventions: DEVICE: Acupuncture
Sponsor: Shaare Zedek Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2025-01
Completion Date: 2027-06
Locations: Shaare Zedek Medical Center, Jerusalem, 91031, Israel

Summary:
Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (\>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.

Primary Outcome Measures: Incidence of chemotherapy-induced febrile neutropenia-related hospitalization, 3 weeks|Duration of chemotherapy-induced febrile neutropenia-related hospitalization, 3 weeks
Secondary Outcome Measures: Relative Dose Intensity of Chemotherapy Regimen, Actual vs. planned dosage and interval between cycles, 3 weeks|G-CSF-related muscle and bone pain, Patient-reported outcome measures, 3 wseks|Quality of life-related outcomes: Quantitative Assessment, Patient-reported outcome measures, 3 weeks|Quality of life-related outcomes: Qualitative Assessment, MYCaW narratives, 3 weeks|Adverse effects of study intervention, Patient medical files, 3 weeks
A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
NCT Number: NCT06500702
Acronym: RESULT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Focal Segmental Glomerulosclerosis|Glomerulonephritis Minimal Lesion
Interventions: DRUG: frexalimab|DRUG: SAR442970|DRUG: rilzabrutinib|DRUG: placebo
Sponsor: Sanofi
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-04
Completion Date: 2028-02-16

Summary:
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).

The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.

Study details for each participant include:

The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Primary Outcome Measures: Percent reduction in urine protein to creatinine ratio (UPCR), From baseline to Week 12
Secondary Outcome Measures: Percentage of participants achieving FSGS partial remission endpoint, Defined as UPCR ≤1.5 g/g and \>40 % reduction of UPCR from baseline, At Week 12|Percentage of participants achieving CR, Defined as UPCR ≤0.3 g/g, At Week 12|Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study, TEAEs, including clinically significant changes in vital signs, electrocardiogram \[ECG\], and laboratory evaluation, Treatment emergent period, up to Week 48|Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970, Up to Week 48|Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970, Up to Week 48
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
NCT Number: NCT06500676
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: KRAS G12D Mutations|Advanced Solid Tumors
Interventions: DRUG: GFH375
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 290
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2028-12-31
Locations: Shanghai Chest Hospital, Shanhai, Shanghai, 201210, China

Summary:
This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.

Primary Outcome Measures: Phase Ia:The incidence and severity of AEs and SAEs, The incidence and severity of AEs and SAEs, 24 months|Phase Ia:The incidence of DLT events, The incidence of DLT events, 21 days|Phase Ib:The incidence and severity of AEs and SAEs, The incidence and severity of AEs and SAEs, 24 months|Phase II:Overall response rate (ORR), Aassessed by investigators according to RECIST 1.1, 24 months
Secondary Outcome Measures: Plasma concentrations, Plasma concentrations and PK parameters of GFH375, up to 21 days|Efficacy endpoints, Duration of response (DoR), 24 months|Efficacy endpoints, Disease control rate (DCR), 24 months|Efficacy endpoints, Progression free survival (PFS), 24 months|Efficacy endpoints, Overall survival (OS), 24 months
Studying Thyroid Function of Haemodialysis Patients in Upper Egypt (Two Centers Study).
NCT Number: NCT06500663
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Haemodialysis Patients
Interventions: OTHER: haemodialysis
Sponsor: Sahar Ezeldeen Hussein Ali
Collaborators: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-12-30

Summary:
1. The study aims to investigate the prevalence of thyroid dysfunction in haemodialysis patients and study the association of thyroid hormone concentration with health status of those patients
2. Study the effects of frequent haemodialysis on thyroid function

Primary Outcome Measures: 1. Prevalence of Hypothyroidism: The primary outcome measure could be the prevalence of hypothyroidism in patients with end-stage renal disease (ESRD) undergoing frequent hemodialysis, 2. Changes in Thyroid Hormone Levels: Another primary outcome measure could be the changes in serum TSH, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations in patients undergoing frequent hemodialysis., 1 year
Secondary Outcome Measures: 1. Correlation of TSH Concentrations with Age: A secondary outcome measure could be the correlation of TSH concentrations with age., 2. Association of Thyroid Hormone Levels with Health Status: the association of circulating thyroid hormone levels with parameters of self-reported health status, and physical and cognitive performance.

3. Effects of Increased Dialysis Frequency on Thyroid Indices: The effects of increased dialysis frequency on thyroid indices in patients receiving haemodialysis without overt hyper/hypothyroidism or thyroid hormone treatment., 1 year
Comparative Efficacy of Escitalopram Monotherapy and Escitalopram in Adjuvant With Pizotifen in Depressive Disorder
NCT Number: NCT06500624
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: DRUG: Pizotifen
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-09-30
Locations: Riphah International University, Rawalpindi, Punjab, 00666, Pakistan

Summary:
To compare the efficacy of escitalopram monotherapy and combination with pizotifen in patients of major depressive disorder(MDD).The levels of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) at base level and during follow-up.

Primary Outcome Measures: Improvement in the severity of the depressive disorder, To find a difference in the clinical improvement of depressive symptoms in combination, by using Patient Health Questionnaire, PHQ-9, which is a self administered scale, in combination with pizotifen., 4 weeks
Combined Effects Of Sensory Integration And Vestibular Exercises On Post-Stroke Patients
NCT Number: NCT06500611
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Stroke
Interventions: OTHER: Sensory Integration and Vestibular Exercise with Routine Physical Therapy|OTHER: Vestibular Exercise with Routine Physical Therapy
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-10-30

Summary:
The aim of this study is to determine the combined effects of sensory integration and vestibular exercise on dizziness, fall risk and quality of life.

Primary Outcome Measures: Combined Effects Of Sensory Integration And Vestibular Exercises On Post-Stroke Patients, DHI assesses Dizziness Consists 25 items three answers yes sometimes no. Highest disability 100 ,lowest one be 0.The SS-QOL, disease-specific consist 49 items 12 domains, social role (five questions), mobility (six questions), energy (three questions), language (five questions), self-care (five questions), mood (five questions), personality (three questions), thinking (three questions), upper extremity function (five questions), family role (three questions), vision (three questions),work/productivity (three questions). Each item ranked five-point level one means completely agreed while level five means completely disagree. Total score ranges from 49 to 245.Time up and go test Duration of ≥13.5 s associate increased fall risk with vestibular dysfunction. STRATIFY tool comprises five items risk factors past history falling, patient agitation, visual impairment, incontinence, transfer and mobility score range from 0 to 5 points and risk of falling is a score ≥ 2 points., 6 weeks
Compassionate Use of Evinacumab
NCT Number: NCT06500598
Status: AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Pediatric Homozygous Familial Hypercholesterolemia (HoFH)|Severe Hypertriglyceridemia (HTG)|Dysbetalipoproteinemia (DBL)
Interventions: DRUG: Evinacumab
Sponsor: Regeneron Pharmaceuticals
Age: CHILD, ADULT, OLDER_ADULT

Summary:
Provide compassionate use of evinacumab
Effects of Mill's Manipulation Along With Muscle Energy Technique in Lateral Epicondylitis
NCT Number: NCT06500585
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lateral Epicondylitis
Interventions: OTHER: Mill's Manipulation|OTHER: Mill's Manipulation and Muscle Energy Technique
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-31
Completion Date: 2024-06-30
Locations: Ghosia Medical Centre, Rawalpindi, Punjab, Pakistan

Summary:
The effects of Muscle Energy Technique intervention have been investigated in recent studies in Lateral Epicondylitis. Some studies have been conducted about mills manipulation and Muscle Energy Technique but according to the literature review there is no study exist to determine the effects of Mill's Manipulation along with Muscle Energy Technique in Lateral epicondylitis. Because of this reason, further research required to find out the effects of Mill's Manipulation along with Muscle Energy Technique in pain, Range of motion and disability in lateral epicondylitis. So the aim of the study is to determine whether these techniques are effective and should be incorporated frequently in a clinical setting in relation to the conventional therapy. This study will help the clinician for the identification of the better and quick treatment regime which will have no adverse effects and risks and making them more effective, efficient for the patient with lateral epicondylitis.

Primary Outcome Measures: NPRS, The numeric pain rating scale (NPRS) measure the subjective intensity of pain. NPRS is an eleven point scale from 0 to 10 is the most commonly used version which has good test-retest reliability ( r= .79-.96). The NPRS is a reliable and valid pain assessment scale in LE., 2 weeks|Goniometer, Universal goniometer is use to measure wrist ROM in flexion , extension, radial deviation, ulnar deviation, forearm pronation and forearm supination.The intraclass correlation coefficients (ICC) ranged from 0.945 to 0.973 which are classified for the goniometer measurements., 2 weeks|PRFEQ, The PRTEE, formerly known as the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) PAIN subscale: (0 = no pain, 10 = worst imaginable) Pain - 5 items 2) FUNCTION subscale: (0 = no difficulty, 10 = unable to do) Specific activities - 6 items , Usual activities - 4 items . Test-retest reliability of Korea version PRTEE was good total ICC= .962 (CI=.922-,982). Therefore, it is a useful measure to evaluate the conditions of patients with lateral epicondylitis., 2 weeks
Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm
NCT Number: NCT06500572
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intercostobrachial Nerve Block|Serratus Plane Block|Supraclavicular Plexus Block|Arteriovenous Fistula
Interventions: OTHER: Landmark Guided Intercostobrachial Nerve Block|OTHER: Ultrasound Guided Intercostobrachial Nerve Block|OTHER: Serratus Plane Block
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-13
Completion Date: 2024-12-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm.

Primary Outcome Measures: Percent of patients who needed local anesthetic supplementation, Number of patients who needed local anesthetic supplementation will be recorded., Intraoperatively
Secondary Outcome Measures: Total amount of morphine consumption, Rescue analgesia of morphine will be given as 3 mg bolus if the visual analog scale (VAS) \> 3 to be repeated after 30 min if pain persists until the VAS \< 4. VAS will be assessed at 0, 2, 4, 8, 12 and 24 h postoperatively., 24 hours postoperatively|Patient satisfaction, Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)., 24 hours postoperatively
Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction
NCT Number: NCT06500559
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fenestration|Dehiscence
Interventions: PROCEDURE: PRP injection|PROCEDURE: Combined decortication and PRP injection
Sponsor: Tanta University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2024-12
Locations: Tanta University, Tanta, 6624033, Egypt

Summary:
Alveolar bone loss and fenestration are the most prevalent bone defects that often result in root exposure, gingival recession, and potential treatment relapse or failure. These issues present complications in orthodontic therapy. Hence, reducing the length of orthodontic therapy and minimizing the occurrence of these serious complications are highly important for orthodontic patients, particularly adults. platelet-rich plasma (PRP) injection and decortication are two promising methods for accelerated tooth movements. Thus, The aim of this study is to evaluate alveolar bone dehiscence and fenestrations after canine retraction, using alveolar decortication and PRP injection as two methods for accelerating tooth movements.

Primary Outcome Measures: Alveolar bone dehiscence, Pre- and post- retraction CBCTs will be obtained from patients. Linear measurement (mm) for dehiscence (LM-D) will be defined as the distance between the alveolar crest to the cementoenamel junction of each root (critical point will be set at 2 mm), 4 months|Alveolar bone fenestration, Pre- and post- retraction CBCTs will be obtained from patients. Linear measurement (mm) for fenestration (LM-F) will be recorded when the defect involved only the apical one-third of a root (critical point will be set at 2.2 mm), 4 months
The Effect of Different Adhesion Strategies on the Clinical Success
NCT Number: NCT06500546
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Poor Aesthetic of Existing Restoration of Tooth|Dental Restoration Failure of Marginal Integrity|Unacceptable Morphology of Tooth Restoration|Secondary Caries
Interventions: PROCEDURE: Treatment of cervical lesions
Sponsor: Istanbul University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 41
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-01

Summary:
The study will involve 41 people who regularly seek treatment at clinics. Participants must be in generally good health and be older than eighteen. must have at least 20 teeth in an occlusion and maintain appropriate dental hygiene. They have to be treated for a minimum of four non-cancerous cervical lesions in their mouths.Four non-carious cervical lesions from patients will be separated into four groups, and adhesive material will be applied to the lesions in each group using different procedures. Evaluation will be performed based on World Dental Federation (FDI) criteria after initial, ½, 1, 2, 3, 4, and 5 years.

Primary Outcome Measures: retention rate of restorations, survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence), Restorations will be evaluated 1 week, 6 months, 12 months and 24 months after finishing.
Secondary Outcome Measures: retention rate of restorations, survival of restorations discoloration, color match, translucency, esthetic anatomic form), functional (fracture and retention, marginal adaptation), and biologic criteria (postoperative sensitivity). and vitality, caries recurrence), Restorations will be evaluated 36 months, 48 months and 60 months after finishing.
Resistive Exercise and Stretching in Women With Dysmenorrhea
NCT Number: NCT06500520
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dysmenorrhea Primary
Interventions: OTHER: Resisted Exercise group|OTHER: Stretching Exercise group
Sponsor: Karabuk University
Sex: FEMALE
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-02-10
Locations: Karabük University, Karabük, 78000, Turkey

Summary:
This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. A comprehensive comparison of the effects of especially resistant exercises and stretching exercises on menstrual pain is based on limited findings in the literature. Therefore, this study aims to make a significant contribution to clinical practice by evaluating the effectiveness and feasibility of these exercise types.

Primary Outcome Measures: Visual Analog Scale, Lower abdomen, leg and low back pain were evaluated with the Visual Analog Scale, At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).|Menstrual symptoms questionnaire, menstrual symptoms were evaluated with the Menstrual Symptoms Questionnaire, At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).|Pittsburgh Sleep Quality Index, sleep quality was evaluated with the Pittsburgh Sleep Quality Index, At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).|Health-Related Quality of Life Assessment (SF 36 Short Form), Quality of life was evaluated with the Health-Related Quality of Life Assessment (SF 36 Short Form), At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).|Functional and Emotional Dysmenorrhea Questionnaire, functional and emotional status was evaluated with the Functional and Emotional Dysmenorrhea Questionnaire, At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
NCT Number: NCT06500507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Interventions: DRUG: QLS4131 Injection
Sponsor: Qilu Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2027-01-31
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, 300020, China

Summary:
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.

Primary Outcome Measures: Recommended Phase 2 Dose (RP2D), Determination of the recommended phase 2 dose (RP2D) of QLS41315 injection in patient with relapsed or refractory multiple myeloma, Approximately 2 years|Incidence of adverse events（AEs）, Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)., Up to 2 years
Secondary Outcome Measures: Overall Response Rate (ORR), ORR assessed by the IMWG response criteria, Up to 2 years
To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment
NCT Number: NCT06500494
Acronym: VINOREAL
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Advanced Breast Cancer
Interventions: DRUG: Vinorelbine Tartrate Oral
Sponsor: Pierre Fabre Medicament
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 368
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-12

Summary:
This study looks at how well oral vinorelbine works in treating advanced breast cancer. It looks at women who have already had this treatment or are currently having it.

Primary Outcome Measures: PFS rate in both cohorts., PFS is defined as the time between vinorelbine-based treatment initiation and the first occurrence of progression or death from any cause, with censoring of patients who are lost to follow-up, 2-years follow-up
PillSense for Suspected Upper Gastrointestinal Bleeding
NCT Number: NCT06500468
Acronym: BLEED
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bleeding Ugi
Interventions: DEVICE: PillSense System
Sponsor: Tan Tock Seng Hospital
Collaborators: EnteraSense Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2026-01

Summary:
This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display to detect the presence of bleeding in the upper digestive tract within 10 minutes.

Primary Outcome Measures: Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit, To compare the percentage of patients who are safely discharged from ED visit with the usage of PillSense, compared to standard treatment., 1.5 years
Secondary Outcome Measures: Risk of clinical rebleeding after a negative PillSense reading, To measure the number of patients who have clinical re-bleeding in both arms., 1.5 years|Discharge rate of patients who can be triaged home using PillSense , compared to conventional clinical scoring system like Glasgow Blatchford Score (GBS)., To compare what is the percentage of patients who can be discharged safely using PillSense vs Glasgow Blatchford Score alone. The Glasgow Blatchford Score (GBS) is a risk assessment tool to help triage patients presenting with upper gastrointestinal bleeding, if they can be discharged safely from emergency department for outpatient care. The score may range from 0 to 23 and higher scores are associated with higher risks of complications related to gastrointestinal bleeding. Conventional studies recommend that such patients can be safely discharged if the score is 0., 1.5 years|Number of inpatient beds saved from this arrangement, To review the beds and potential cost savings from the hospital from the reduction of admissions, 1.5 years|Risk of patient morbidity after a negative PillSense reading, To quantify and specify any patient morbidity after a negative PillSense reading., 1.5 years|Risk of patient mortality after a negative PillSense reading, To quantify and specify any mortality after a negative PillSense reading., 1.5 years
A Study to Assess NEU-111 in Healthy Participants
NCT Number: NCT06500442
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: NEU-111|DRUG: Placebo
Sponsor: Neuron23 Inc.
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-02

Summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), of orally administered NEU-111 in healthy subjects.

Primary Outcome Measures: Evaluate the safety and tolerability of single and multiple oral doses of NEU-111 in healthy subjects, Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), Up to 10 days of dosing
Secondary Outcome Measures: PK Parameter, The maximum concentration (Cmax) at steady state in plasma, Up to 10 days of dosing|PK Parameter, The area under the concentration-time curve from zero to infinity (AUC0-inf) in plasma, Up to 10 days of dosing|PK Parameter, The time to reach maximum concentration (tmax) in plasma, Up to 10 days of dosing|PK Parameter, Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC\[0-last\]) in plasma, Up to 10 days of dosing|PK Parameter, Apparent terminal elimination half-life (t1/2) in plasma, Up to 10 days of dosing|PK Parameter, The terminal elimination rate constant (λZ) with the respective half-life (t½) in plasma, Up to 10 days of dosing|PK Parameter, The oral clearance (CL/F), Up to 10 days of dosing|PK Parameter, The volume of distribution (Vd/F), Up to 10 days of dosing|PK Parameter, The area under the concentration-time curve over a dosing interval (AUC0-τ) in plasma (multiple dosing only), Up to 10 days of dosing
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist
NCT Number: NCT06500429
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Overweight and Obesity|Healthy
Interventions: DRUG: NG101|DRUG: Placebo|DRUG: Semaglutide Injectable Product
Sponsor: Neurogastrx, Inc.
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-24
Completion Date: 2024-10-02
Locations: Celerion, Tempe, Arizona, 85283, United States

Summary:
Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg BID) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a GLP-1 agonist (semaglutide). Participants will remain at the clinical research unit for the duration of the treatment period.

The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo, when also administered along with a GLP-1 agonist, in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity. Adverse event information will be collected. GI-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.

Primary Outcome Measures: Duration of GI-related adverse events, Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection, 96 hours following GLP-1 agonist injection|Severity of GI-related adverse events, Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection, 96 hours following GLP-1 agonist injection
Secondary Outcome Measures: Number of TEAEs of GI-related adverse events, Number of TEAEs of GI-related adverse events following GLP-1 agonist injection, 96 hours following GLP-1 agonist injection
Visual Outcomes of Tecnis Symfony Opti-Blue EDOF Intraocular Lens (IOL)
NCT Number: NCT06500416
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract
Interventions: DEVICE: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL
Sponsor: Coastal Eye Surgeons PLLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-01
Locations: Coastal eye surgeons, Greenwich, Connecticut, 06830, United States

Summary:
Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.

Primary Outcome Measures: Binocular uncorrected visual acuity at distance, Mean binocular uncorrected visual acuity at distance, 3 months|Binocular uncorrected visual acuity at intermediate, Mean binocular uncorrected visual acuity at intermediate, 3 months|Binocular uncorrected visual acuity at near, Mean binocular uncorrected visual acuity at near, 3 months
Other Outcome Measures: Monocular uncorrected visual acuity at distance, Mean monocular uncorrected visual acuity at distance, 3 months|Monocular corrected visual acuity at distance, Mean monocular corrected visual acuity at distance, 3 months|Monocular uncorrected visual acuity at intermediate, Mean monocular uncorrected visual acuity at intermediate, 3 months|Monocular distance-corrected visual acuity at intermediate, Mean monocular distance corrected visual acuity at intermediate, 3 months|Monocular uncorrected visual acuity at near, Mean monocular uncorrected visual acuity at near, 3 months|Monocular distance-corrected visual acuity at near, Mean monocular distance corrected visual acuity at near, 3 months|Binocular corrected visual acuity at distance, Mean binocular corrected visual acuity at distance, 3 months|Binocular distance-corrected visual acuity at intermediate, Mean binocular distance-corrected visual acuity at intermediate, 3 months|Binocular distance-corrected visual acuity at near, Mean binocular distance-corrected visual acuity at near, 3 months
Non-invasive Tools for PSVD Diagnosis
NCT Number: NCT06500403
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-Cirrhotic Portal Hypertension|Porto-Sinusoidal Vascular Diseases
Interventions: DIAGNOSTIC_TEST: liver and stiffness measurement
Sponsor: Nanfang Hospital, Southern Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-28
Completion Date: 2029-12-31
Locations: Nanfang hospital, Southern Medical Uiversity, Guangzhou, Guangdong, 510080, China

Summary:
Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.

Primary Outcome Measures: Searching for valid non-invasive tools for the diagnosis of PSVD, The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively, 2 years
Secondary Outcome Measures: Patients developed portal-hypertension-related complications, clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc., 3 years|Patients died, All-cause death, 3 years|Patients underwent liver transplantation, Patients underwent liver transplantation during follow up, 3 years|Patients reached the final follow-up time, Patients had accepted 3-year follow up, 3 years