pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Impact of Airborne Pathogen Inactivation Devices Using UVGI Against Respiratory Diseases Affecting Retirement Home Residents
NCT Number: NCT06569160
Acronym: RESPROTECT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Infections in Old Age
Interventions: DEVICE: UVGI (Ultra-Violet Germicidal Irradiation Device)
Sponsor: Centre Hospitalier Emile Roux
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-10-01
Completion Date: 2026-05
Locations: Centre Hospitalier Emile Roux, Le Puy-en-Velay, France

Summary:
RESPROTECT is a RIPH2 category research, prospective, interventional, multicenter, double-blind, cluster-randomized versus placebo device and cross-over. It's main objective is to compare the cumulative incidence of upper and lower respiratory infections between retirement homes (EHPAD) equipped with active UVGI systems and retirement homes (EHPAD) equipped with inactive systems over two winter periods.

Primary Outcome Measures: Number of symptomatic upper and lower respiratory infections, Number of symptomatic upper and lower respiratory infections collected using monitoring sheets, 14 months (two 7 months period separated by a 5 months wash-out period)
Secondary Outcome Measures: Presence and duration of hospitalization for respiratory infections, Number and duration time of hospitalization for respiratory infections, 14 months (two 7 months period separated by a 5 months wash-out period)|Recovery, recovery with sequelae, death related to respiratory infection., Number of recovery, recovery with sequelae, death related to respiratory infection, 14 months (two 7 months period separated by a 5 months wash-out period)|Respiratory viral and bacterial load in air samples, Collected in 2 common living areas per establishment, every 7 weeks, 14 months (two 7 months period separated by a 5 months wash-out period)|Respiratory viral and bacterial load on sampling of fomites, Collected in 2 common living areas per establishment, every 7 weeks, 14 months (two 7 months period separated by a 5 months wash-out period)|Cost-effectiveness ratio, - The cost-effectiveness ratio will be calculated by estimating the generated/avoided costs per resident without infection., 14 months (two 7 months period separated by a 5 months wash-out period)
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
NCT Number: NCT06569147
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: AL Amyloidosis
Interventions: DRUG: Elranatamab
Sponsor: Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 49
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01

Summary:
This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.

Primary Outcome Measures: To determine RP2D, The recommended phase 2 dose determined in phase 1, up to 26 months|To evaluate objective response rate (ORR), Defined as the proportion of patients with CR, VGPR, or PR, and will be provided as unconfirmed and confirmed ORR at the end of six cycles of treatment. Confirmed responses are those that persist on repeat imaging study at least 28 days after the initial documentation of response., up to 60 months
Secondary Outcome Measures: To assess safety and tolerability of elranatamab in patients with relapse or refractory AL amyloidosis, Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0, up to 72 months|To assess best overall response (BOR), BOR will be analyzed as the number of patients (percentage) with each response, divided by the number of patients treated., up to 72 months|To assess duration of response (DoR), DoR will be analyzed using Kaplan-Meier method and is defined as the time from the first documentation of CR, VGPR, or PR to the first documentation of objective progression or death due to any cause. ., up to 72 months|To assess progression-free survival (PFS), Progression-free Survival (PFS) will be analyzed using Kaplan-Meier method and is defined as the time from Cycle 1 Day 1 to first documentation of objective progression (PD) or death due to any cause, whichever comes first., up to 72 months|To assess overall survival (OS), OS is defined as the time from the date of Cycle 1 Day 1 to date of death due to any cause., up to 72 months|Incidence and severity of cytokine release syndrome (CRS) and immune effector cell- associated neurotoxicity syndrome (ICANS), Number of cases of CRS and ICANs and Grade of CRS and ICANs cases, up to 72 months|Incidence of treatment emergent adverse events, Number of treatment- emergent AEs. An AE is treatment-emergent if the onset occurs on Cycle 1 Day 1 through 90 days after the last dose of investigational product., up to 72 months|To assess major organ deterioration (MOD) progression free survival (PFS) for the duration of the study, PFS is defined as the time from Cycle 1 Day 1 to first documentation of objective progression (PD) or death due to any cause, whichever comes first., up to 72 months
Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest (MIRA29)
NCT Number: NCT06569134
Acronym: MIRA29
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest|Neurologic Dysfunction|Cognitive Impairment
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-24
Completion Date: 2025-01-24
Locations: CHU de Brest, Brest, 29609, France|CH des pays de Morlaix, Morlaix, 29600, France

Summary:
From the informatized prehospital care registry, data will be collected anonymously for all patients' requiring cardiopulmonary resuscitation for an out-of-hospital cardiac arrest within the Norther Finistere sanitary region.

First step of the model derivation will consist in multivariate analysis to extract the most pertinent variates associated with neurological outcome (evaluated using the CPC Score); Second step will consist in the use of artificial intelligence and machine-learning to derive the most discriminant score.

Primary Outcome Measures: Cognitive Outcome, It will be evaluated at the end of the ICU stay using the CPC score; a CPC score equal or below 2 will be considered as a good outcome, while a CPC \> 2 will be considered as a bad outcome, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measures: Death OoH, Death after resuscitation during the prehospital care phase, Before hospital arrival|Death ICU, Death within the ICU care, During ICU stay|Death at Day 28, Death at Day 28, before or after hospital discharge, 28 days after cardiac arrest
CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
NCT Number: NCT06569082
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Graft Failure|Poor Graft Function
Interventions: DEVICE: CD34+ Selected Donor Cell Boost|PROCEDURE: Blood Stem Cell Infusion
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2035-08
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.

Primary Outcome Measures: Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment, ANC engraftment is defined as ANC of ≥ 0.5 × 10\^9/L for three consecutive laboratory values obtained on different days., Day 100 Post-Procedure|Number of Participants with Platelet Engraftment, Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days., Day 100 Post-Procedure
Secondary Outcome Measures: Number of Participants with Grade II-IV Acute GVHD, The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician., Day 100 Post-Procedure|Number of Participants with Moderate to Severe Chronic GVHD, The diagnosis of chronic GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician., Day 365 Post-Procedure
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
NCT Number: NCT06569056
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Interventions: DRUG: HRS-8427|DRUG: Imipenem and Cilastatin Sodium|DRUG: HRS-8427 placebo|DRUG: Imipenem and Cilastatin Sodium placebo
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 578
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-11
Locations: Shanghai Huashan Hospital, Shanghai, Shanghai, 200040, China

Summary:
The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.

Primary Outcome Measures: Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure (TOC), Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)
Secondary Outcome Measures: Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment（EA）、End of Treatment（EOT）and Late Follow-Up (LFU), EA : Day 4、EOT: Day 7 to Day 14、LFU：Day 21 to Day 28|Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU, EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28|Percentage of Participants With Microbiological Eradication at EA 、EOT、TOC and LFU Per Uropathogen, EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28|Percentage of Participants With Clinical Response at EA 、EOT、TOC and LFU, EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28|Percentage of Participants With Clinical Response at EA 、EOT、TOC and LFU Per Uropathogen, EA : Day 4、EOT: Day 7 to Day 14、TOC:Day 14 to Day 21、LFU：Day 21 to Day 28|Number of Participants With Adverse Events, Day 21 to Day 28
Appetite Responses to Breakfast Bar Product
NCT Number: NCT06569043
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Satisfaction, Consumer
Interventions: OTHER: Breakfast Bar
Sponsor: General Mills
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-16
Completion Date: 2024-09-23

Summary:
The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.

Primary Outcome Measures: Visual Analogue Scale for Hunger 0-240 minutes, Visual Analogue Scale for "how hungry are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more hunger. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome., 240 minutes|Visual Analogue Scale for Fullness 0-240 minutes, Visual Analogue Scale for "how full are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more fullness. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome., 240 minutes|Visual Analogue Scale for Satiation 0-240 minutes, Visual Analogue Scale for "how satiated are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satiation. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome., 240 minutes|Visual Analogue Scale for Desire to Eat 0-240 minutes, Visual Analogue Scale for "how strong is your desire to eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more desire to eat. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome., 240 minutes|Visual Analogue Scale for Prospective Consumption 0-240 minutes, Visual Analogue Scale for "how much do you think you can eat right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more prospective consumption. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a lower mm change from baseline indicates a better outcome., 240 minutes|Visual Analogue Scale for Satisfaction 0-240 minutes, Visual Analogue Scale for "how satisfied are you right now?" is scored from 0-100 millimeters (mm), whereby a higher mm indicates more satisfaction. Comparing change from 0 minutes (baseline) to 240 minutes, whereby a higher mm change from baseline indicates a better outcome., 240 minutes
The Effect of Artificial Intelligence Supported and Nurse-Led Online Breastfeeding Counseling
NCT Number: NCT06569017
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Artificial Intelligence|Nursing Caries|Breastfeeding|Breast Feeding, Exclusive
Interventions: OTHER: 1) Artificial intelligence supported working group|OTHER: Online breastfeeding counseling group led by a nurse
Sponsor: Kafkas University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-12-01

Summary:
Breastfeeding is the gold standard in infant nutrition in the first 12 months of life (1). Breastfeeding self-efficacy perception is one of the most important factors affecting mothers\&#39; breastfeeding duration and success in the postpartum period (2,3).Although AI has traditionally been the domain of powerful mainframes and data centers, new approaches have the capacity to put the power of AI directly into the hands of patients (4).Therefore, considering the importance of breastfeeding education and counseling, this study will determine the effect of training and use of a mobile application-supported artificial intelligence tool and nurse-led online breastfeeding counseling on mothers; breastfeeding self-efficacy perception, breastfeeding success, infant feeding attitude and postpartum depression levels. Thus, the effectiveness of the artificial intelligence tool and nurse-led breastfeeding counseling will be compared.

Primary Outcome Measures: mothers' breastfeeding self-efficacy perception, Breastfeeding Self-Efficacy Scale and Latch Breastfeeding Scale and The Iowa Infant Feeding Attitude Scale will be measured., Measurements will be completed by 12 months
Secondary Outcome Measures: mothers' breastfeeding success, Breastfeeding Self-Efficacy Scale and Latch Breastfeeding Scale and The Iowa Infant Feeding Attitude Scale will be measured., Measurements will be completed by 12 months
Other Outcome Measures: mothers' depression level, Edinburgh Postnatal Depression Scale will be masured., Measurements will be completed by 12 months
IR Beam Used Before Peripheral Intravenous Catheter Application on Vein Visibility
NCT Number: NCT06569004
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Questionnaire
Interventions: DEVICE: randomised study, two group (experimental and control)
Sponsor: Karadeniz Technical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2024-09-30
Locations: Şule BIYIK BAYRAM, Trabzon, Ortahisar, 61080, Turkey|Şule, Trabzon, Turkey|Karadeniz Technical University Faculty of Health Sciences, Trabzon, Üniversite, 61080, Turkey

Summary:
The study will be conducted in the Oncology and Cardiovascular Surgery (CVS) services of a university hospital. In the research, 30 patients will constitute the control group and 30 patients will constitute the experimental group. A nurse working in the clinics where the study will be conducted will perform the PIVK procedure, and we will randomly select the control and experimental groups and apply light to the area where the PIVK will be applied to the patients in the experimental groups with a flashlight that emits infrared rays for 10 minutes. The nurse will not be aware of whether the radiation application was made to the patient or not. The veins will be evaluated by the nurse performing PIVK. We will fill out the necessary forms in ANNEX 1 (control group) and APPENDIX 2 (experimental group) while the PIVK procedure is applied. After the procedure is completed, the patient's pain, anxiety and satisfaction level during the procedure will be marked. The data will be entered into the SPSS program and evaluated with statistical tests. According to the results, the effect of IR rays used before PIVK application on the patient's pain, anxiety and satisfaction and on the procedure time spent by the nurse for the application will be determined.

Primary Outcome Measures: Effect of IR beam used before peripheral intravenous catheter application, question form, 6 mounths
Secondary Outcome Measures: Effect of IR beam on pain, Pain scale, 6 mounths|Effect of IR beam on anxiety, Anxiety scale, 6 mounths|Effect of IR beam on satisfaction, Satisfaction scale, 6 mounths|Effect of IR beam on application, Question form, 6 mounth
The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease.(KS01)
NCT Number: NCT06568991
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Disease (CKD)
Interventions: DIETARY_SUPPLEMENT: Low Protein Rice MATSUBUMAI
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators: TAIWAN KITOKU CO., LTD.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 127
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2015-05-26
Completion Date: 2019-01-11

Summary:
1. To examine nutrient intake change in chronic kidney disease patients consuming " Low Protein Rice MATSUBUMAI "compared to a regular care group at 0,1,3,6 month.
2. To assess nutritional status improved or maintained after low protein rice intervention.
3. To assess whether the patient's renal function improved or maintained after low protein rice intervention.

Primary Outcome Measures: albumin (g/dL), nutritional indicators, baseline, 6 month|nitrogen balance (g/day), nutritional indicators, baseline, 6 month|handgrip strength (kg), nutritional indicators, baseline, 6 month|blood urea nitrogen (mg/dL), residual renal function, baseline, 6 month|creatinine (mg/dL), residual renal function, baseline, 6 month|estimated glomerular filtration rate (eGFR) (mL/min/1.73m2), residual renal function, baseline, 6 month
Secondary Outcome Measures: Body weight (kg), Body composition, baseline, 6 month|muscle mass (kg), Body composition, baseline, 6 month|fat mass (%), Body composition, baseline, 6 month|energy intake (Kcal/day), Nutrient intakes, baseline, 6 month|protein intake (g/day), Nutrient intakes, baseline, 6 month|potassium (mmol/L), electrolytes, baseline, 6 month|phosphorus (mg/dL), electrolytes, baseline, 6 month
Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema
NCT Number: NCT06568978
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Lymphedema of Upper Limb
Interventions: OTHER: Assessments of respiratory parameters
Sponsor: Istanbul University - Cerrahpasa (IUC)
Collaborators: Okan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-20
Completion Date: 2024-08-20
Locations: Gamze Aydın, Tuzla, İstanbul, 34940, Turkey

Summary:
The aim of our study is to assess disease severity, respiratory muscle strength, respiratory functions, pectoralis minor muscle shortening, functionality, and quality of life (QoL) in patients with upper limb lymphedema (ULL), and to compare these findings with healthy controls.The disease severity was assessed using the Stillwell classification system; respiratory muscle strength was measured through maximum inspiratory and expiratory intraoral pressures (MIP, MEP, respectively); respiratory functions were evaluated with a spirometer; pectoralis minor muscle shortening was measured with a tape measure; functionality was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH); and QoL was evaluated with the Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm).

Primary Outcome Measures: MIP and MEP value, assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP)., 9 months|FVC, FVC is used for forced vital capacity which measure by spirometer, 9 months|pectoralis minor muscle length, pectoralis minor muscle length is used for pectoralis muscle shortness, 9 months|DASH questionnaire, Disabilities of the Arm, Shoulder and Hand (DASH) is used for upper extremity functions. Questionnaire score ranged between 0-100. A higher total score indicates decreased functionality., 9 months|LYMQOL-Arm questionnaire, Lymphedema Quality of Life Questionnaire - Arm is used for assess disease related quality of life.The high scores are indicative of poorer QoL. Questionnaire score ranged between 0-100., 9 months
Right Ventricular Function in Patients Taking Carfilzomib
NCT Number: NCT06568952
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pulmonary Hypertension
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-30
Completion Date: 2024-07-30
Locations: Simon VALENTIN, Nancy, 54500, France

Summary:
Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.

Primary Outcome Measures: tricuspid annular plane systolic excursion, measurement of tricuspid annular plane systolic excursion by echocardiography, 6 months after carfilzomib treatment
Adherence of Beta Thalssemia Patients to Oral Chelation Therapy
NCT Number: NCT06568926
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Beta-Thalassemia
Interventions: DIAGNOSTIC_TEST: Serum Ferritin level
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-14
Completion Date: 2025-07-14
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
The β-thalassemias are a group of inherited disorders of hemoglobin (Hb) synthesis characterized by chronic anemia of varying severity. The degree of anemia relies on several genetic and environmental factors and determines the need for regular transfusion therapy. It is now common practice to classify patients as having transfusion dependent β-thalassemia (TDT) or non-transfusion-dependent β-thalassemia (NTDT). Regarding geographical distribution of β-thalassemia, it prevails more in countries on the Mediterranean, South east of Asia and in the east of Europe. In Egypt, it is the most common cause of chronic blood loss: One thousand cases are recorded annually for every 1.5 million live births the disease prevalence is equal to1000 cases per 1.5 million live births (Ghazala et al., 2021).

The only curative treatment for thalassemia currently is a bone marrow transplant. However, it is restricted to only a few patients due to the non-availability of an HLA-matched donor and high cost. Thus, most patients receive regular blood transfusions accompanied by iron chelation therapy (ICT) as the standard of care. The ideal management of a patient with transfusion-dependent thalassemia (TDT) requires a multidisciplinary therapeutic approach. The main iron chelating agents include deferoxamine (DFO), deferiprone (DFP), and deferasirox (DFX). Due to poor oral bioavailibility, DFO is the only chelator that must be administered subcutaneously or intravenously up to once a day; DFP and DFX may be administered orally up to three times a day. The known side effects associated with each chelator include infusion reactions in DFO, gastrointestinal distress, agranulocytosis in DFP, and transaminitis in DFP and DFX.

Primary Outcome Measures: serum ferritin level in beta thalassemia patients adherent to oral chelation therapy, Adherence of Beta Thalssemia Patients to Oral Chelation Therapy, 1 year
The Outcome of the Thrombopoietin Receptor Agonists in Pediatric Patient With Persistent or Chronic ITP Unresonsive to Steroids
NCT Number: NCT06568913
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Persistent or Chronic ITP Not Respnding to Steroids
Interventions: DIAGNOSTIC_TEST: CBC
Sponsor: Sohag University
Collaborators: sohag university hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-14
Completion Date: 2025-07-14
Locations: Sohag University hospitals, Sohag, Egypt

Summary:
Immune thrombocytopenic purpura (ITP) is an autoimmune disease characterized by a low platelet count, purpura, and hemorrhagic episodes caused by antiplatelet autoantibodies. The diagnosis is typically made by excluding the known causes of thrombocytopenia. IgG autoantibodies sensitize the circulating platelets. It leads to the accelerated removal of these cells by antigen-presenting cells (macrophages) of the spleen and sometimes the liver or other components of the monocyte-macrophage system. The bone marrow compensates for platelet destruction by increasing platelet production. ITP most often occurs in healthy children and young adults within a few weeks following a viral infection .

New treatment guidelines have supported a shift from corticosteroids and splenectomy to newer medical treatments that mitigate the thrombocytopenia and avoid splenectomy. The thrombopoietin receptor agonists (TPO-RA), romiplostim, eltrombopag have markedly altered the treatment of ITP.

The thrombopoietin receptor agonists (TPO-Ras) romiplostim and eltrombopag have shown high therapeutic activity In primary ITP.

Romiplostim, a thrombopoiesis-stimulating peptibody, represents a new therapeutic option in adult refractory chronic immune thrombocytopenia (ITP). This study aimed to assess the short-term efficacy and safety of romiplostim in children withChronic ITP.

The most commonly reported drug-related adverse effects include headache, nausea, and hepatobiliary laboratory abnormalities. Long-term safety data in children are limited, and studies in adults have not revealed a clinically significant increased incidence of thrombosis, marrow fibrosis, or cataract formation.

TPO-RA do not need to be continued forever; about a third of patients In the first year and about another third after two years have a remission. Whether TPO-RA affect the ITP pathophysiology and directly cause remission remains unclear. This review provides a personal overview of the diagnosis and treatment of ITP with a focus on the mechanism of action of TPO-RA, their place in the treatment algorithm, unique aspects of their clinical use, adverse effects.

Primary Outcome Measures: Platelets counts in Pediatric Patient With Persistent or Chronic ITP Unresonsive to Steroids on thrombopoietin receptor agonists, The Outcome of the Thrombopoietin Receptor Agonists in Pediatric Patient With Persistent or Chronic ITP Unresonsive to Steroids, 12 months
Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and BoExp in Adult Smokers Over a 12-week Period
NCT Number: NCT06568900
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use
Interventions: OTHER: cigarette smoking|OTHER: tobacco flavored and unflavored pouch|OTHER: unrestricted flavor options pouch
Sponsor: Swedish Match AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-07-31
Completion Date: 2024-08-19
Locations: Rose Research Center, Raleigh, North Carolina, 27617, United States

Summary:
To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.

Primary Outcome Measures: Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine, Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat)., Measured from baseline to week 12
Effectiveness of 5% Dextrose Water Versus Corticosteroid Injection for Pain Management of SJD
NCT Number: NCT06568887
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sacroiliac Joint Dysfunction
Interventions: COMBINATION_PRODUCT: Dextrose Water|COMBINATION_PRODUCT: Corticosteroid Injection
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-10-30
Completion Date: 2024-09-30
Locations: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, Lahore, Punjab, Pakistan

Summary:
The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from lumbar spine sources, such as the zygapophysial joints or intervertebral discs.

Primary Outcome Measures: VAS, The Visual Analog Scale is a subjective measurement tool commonly used in research and clinical settings to assess the intensity or magnitude of various subjective characteristics or attitudes. It typically consists of a 100-mm horizontal or vertical line, with anchor points at each end representing extreme states (e.g., no pain to worst pain imaginable). Participants mark their perceived intensity on the line, and the distance from the starting point is measured to determine the score., 12 Months|ODI, The Oswestry Disability Index is a widely used and well-established questionnaire designed to assess the impact of musculoskeletal conditions on an individual's daily activities and functionality, making it particularly relevant for conditions like piriformis syndrome. The questionnaire consists of ten sections addressing various aspects of daily life, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Participants rate their level of disability in each section on a scale from 0 to 5, with 0 indicating no disability and 5 indicating maximum disability. The scores from each section are then summed and expressed as a percentage, with higher percentages representing greater disability., 12 months
Effect of VR Versus CT in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients
NCT Number: NCT06568874
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Stroke
Interventions: COMBINATION_PRODUCT: Virtual Reality (VR) Therapy|DIAGNOSTIC_TEST: Conservative Treatment
Sponsor: Superior University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-30
Completion Date: 2024-10-30
Locations: Services Hospital,Shadman 1, Lahore, Punjab, Pakistan

Summary:
Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises.

Primary Outcome Measures: Fugl-Meyer Assessment (FMA) for Upper Extremity, The Fugl-Meyer Assessment (FMA) for Upper Extremity is a widely used and validated tool to evaluate motor function, balance, sensation, and joint functioning in individuals who have had a stroke. It specifically assesses the sensorimotor function of the upper extremities.

Scoring:

The upper extremity section of the FMA includes 33 items, each scored on a scale of 0 to 2:

0: Cannot perform

1. Performs partially
2. Performs fully The maximum score for the upper extremity section is 66, indicating optimal function., 12 Months|Stroke Impact Scale (SIS), The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates the impact of stroke on multiple dimensions, including strength, hand function, activities of daily living (ADL), mobility, communication, emotion, memory, thinking, and participation.

Each item is scored on a scale of 1 to 5:

1: Unable to do 5: Not difficult at all Higher scores indicate a lesser impact of stroke on the patient's life., 12 months
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
NCT Number: NCT06568861
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: COVID-19
Interventions: DRUG: ALG-097558
Sponsor: Aligos Therapeutics
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-05
Locations: University of Miami, Miami, Florida, 33136, United States|Orlando Clinical Research Center, Orlando, Florida, 32809, United States

Summary:
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Primary Outcome Measures: Area under the concentration time curve [AUC], Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma, Pre-dose (-0.75 hours) up to Day 8|Time to maximum plasma concentration [Tmax], Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma, Pre-dose (-0.75 hours) up to Day 8|Maximum plasma concentration [Cmax], Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma, Pre-dose (-0.75 hours) up to Day 8|Minimum plasma concentration [Cmin], Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma, Pre-dose (-0.75 hours) up to Day 8|C0 [predose], Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma, Pre-dose (-0.75 hours) up to Day 8|Half-life [t1/2], Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma, Pre-dose (-0.75 hours) up to Day 8
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1, Up to 20 Days
Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients
NCT Number: NCT06568848
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: COMBINATION_PRODUCT: EKKO therapy|DIAGNOSTIC_TEST: Conservative Treatment
Sponsor: Superior University
Sex: ALL
Age: CHILD
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: Little angles home sailkot cantt aziz bhati shaheed road opposit junior aps, Sialkot, Punjab, Pakistan

Summary:
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points.

Primary Outcome Measures: GMFM Scale, improvement in gross motor function, measured using the GMFM scale. The scale evaluates various dimensions such as sitting, rolling, jumping, crawling, kneeling, walking, and running. Assessments will be conducted at three points: pre-evaluation (month 1), mid-evaluation (month 3), and post-evaluation (end of month 6)., 12 Months
Physical Activity, Life Satisfaction and Medication Adherence in Older Adults
NCT Number: NCT06568822
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Physical Activity|Life Satisfaction|Medication Adherence|Older Adults
Interventions: OTHER: Asessment|OTHER: The Physical Activity Scale for the Elderly (PASE)|OTHER: Turkish Version of the Satisfaction with Life Scale (T-SWLS)|OTHER: Modified Morisky Scale (MMS)
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 82
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2024-08-27
Locations: Bezmialem Vakıf University, İstanbul, 34230, Turkey

Summary:
This study will examine the relationships between physical activity, life satisfaction, and medication adherence in elderly individuals with chronic diseases. The research will involve participants aged 65 and above, using the The Physical Activity Scale for the Elderly scale to assess physical activity, the Turkish version of the Satisfaction with Life Scale for life satisfaction, and the Modified Morisky Scale for medication adherence.

Primary Outcome Measures: Physical Activity, The Physical Activity Scale for Elderly (PASE) will be used to assess the physical activity of elderly individuals. The overall PASE score ranges from 0 to 400 or more, with higher scores indicating better physical activity levels., One Month|Life Satisfaction, Turkish version of the Satisfaction with Life Scale (T-SWLS) is a one-dimensional Likert-type scale consisting of 5 questions. The total score of the scale is calculated by adding the scores given to the statements in the scale. The total Turkish version of the SWLS score varies between 5 and 25, and higher scores indicate a better level of life satisfaction., One Month|Medication Adherence, The Modified Morisky Scale (MMS) will be used to examine the patient's compliance with treatment by evaluating the motivation and knowledge levels of individuals with chronic diseases regarding pharmacological treatment during long-term treatment. The total score that can be obtained from the scale varies between 0 and 6., One Month
Timing of Surgery in Pediatric Patients Following Fever Recovery: a Prospective Cohort Study
NCT Number: NCT06568809
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fever
Interventions: OTHER: Time interval between recovery of body temperature and operation
Sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 3053
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-11
Completion Date: 2023-08-30
Locations: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

Summary:
Objectives: The timing of fever recovery may affect the risk of intra-operative hypoxemia in children undergoing elective surgery after SARS-CoV-2 infection. This study aims to determine the optimal timing for surgery by analyzing the occurrence of intra-operative hypoxemia in pediatric patients after they have recovered from a fever.

Methods: This prospective cohort study included 3053 children who had been infected with SARS-CoV-2 and developed fever, and scheduled to a surgery during March 2023 to August 2023, children with temperature recovery time ≥3 month were compared to children with temperature recovery time 0-8weeks. The primary outcome was measured as the incidence of intra-operative hypoxemia in SARS-CoV-2 infected children after their body temperature returned to normal. Logistic regression models were used to calculate the adjusted incidence of hypoxemia rate sratified by time (0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks; ≥3 month) from body temperature recovery to the day of surgery.

Primary Outcome Measures: Pulse oxygen saturation, Record the lowest oxygen saturation of hypoxemia during intubation, extubation and operation., intubation, extubation and operation
Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracorporeal Shoch Wave Therapy of the Patients With Lateral Epicondylitis: a Randomized Controlled Trial
NCT Number: NCT06568796
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lateral Epicondylitis
Interventions: OTHER: randomize controlled study
Sponsor: Ankara Yildirim Beyazıt University
Sex: ALL
Age: ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2024-06-01
Locations: Gülhane Eğitim ve Araştırma Hastanesi, Ankara, 06010, Turkey

Summary:
To compare the effects of Trigger Point Ischaemic Compression Massage (TPICM) and Focused Extracarporeal Shock Wave Therapy (focused ESWT) on pain level, muscle strength, Joint range of motion, functionality and quality of life in patients with lateral epicondylitis (LE) in a randomised controlled trial.

Primary Outcome Measures: grip strenght asessment with jamar hand dynamometer, It will be grip strength assessment with jamar hand dynamometer, baseline-up to 4 weeks|muscle strenght asessment with isocinetic system, It will be elbow flexor and extansor muscle strength asessment with isocinetic system, baseline-up to 4 weeks|range of motion asessment with universal goniometer, It will be elbow range of motion asessment with universal goniometer, baseline-up to 4 weeks|assessment of quality of life with quality of life questionnaire, It will be asessment of quality of life with life questionnaire, baseline-up to 4 weeks|pain level asessment with visual analog scale, It will be asessment of pain level with visual analog scale, baseline-up to 4 weeks|assessment of functionality with functionality questionnaire, It will be asessment of functionality with functionality questionnaire, baseline-up to 4 weeks
Evaluation of Patients With Refractory Dermatomyositis Using [18F] FAPI-74 PET/MRI Imaging
NCT Number: NCT06568783
Acronym: FAPI-74
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Refractory Dermatomyostitis
Interventions: DRUG: [18F]-FAPI-74
Sponsor: Farshad Moradi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-10
Locations: Stanford University, Stanford, California, 94304, United States

Summary:
This study proposes the use of a PET isotope, \[18F\]-Fibroblast Activation Protein Inhibitor-74, for a prospective single-center, single-arm study using MRI imaging for participants with Refractory Dermatomyostitis.

Primary Outcome Measures: Rate of [18F]-FAPI-74 uptake., write the outcome title, how it will be measured., up to 1 hour
Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery
NCT Number: NCT06568770
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Post Operative Pain|Bradycardia|Hypotension|Femur Fracture
Interventions: DRUG: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK|DRUG: PERICAPSULAR NERVE BLOCK
Sponsor: Sahiwal medical college sahiwal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-03-10
Locations: Sahiwal Medical College, Sahiwal, Punjab, 57000, Pakistan

Summary:
To compare the immediate and postoperative analgesic efficacy of S-FICB and PENG block will be the objective. The use of ultrasonography in anesthesia has helped the anesthetist to see the nerve, needle and the distribution of the drug, thereby enhancing the chances of a favorable outcome of the nerve block. Grade A recommendation for an ultrasound guided approach to the peripheral nerve blocks is supported by level Ib evidence for a shortened time for the onset of sensory block, decreased performance time and lower drug doses10.

Although individually both the blocks have been studied, there are only a handful of studies comparing both techniques under ultrasound guidance for making patient positioning for spinal anesthesia easy. And no local data is available comparing these blocks. So, we want to compare the analgesic efficacy of USG PENG block with USG S-FICB block in patients with fracture femur in reducing pain associated with positioning (sitting) for subarachnoid block, duration of analgesia, opioid sparing effect and complications. So that procedure with better analgesic efficacy and less complications will be included in our local guidelines as a part of multimodal analgesia.

Primary Outcome Measures: Ease Of Spinal Positioning, The ease of spinal positioning (EOSP) will be assessed on the scale of 0-3 0 = unable to position

1. = patient had abnormal posturing due to pain and required support for positioning
2. = mild discomfort but does not require support for positioning
3. = optimal condition where the patient was able to position himself without pain, 20 minutes till Performance of spinal anaesthesia
Secondary Outcome Measures: Post op Analgesia, Duration of post op analgesia., from performance of block to first rescue analgesia(in hours)|opioid sparing effect, total opioid consumption in mg/24hrs, 24 hrs
Other Outcome Measures: Post op Nausea Vomiting, Post Op Nausea Vomiting, 24 hrs