pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis
NCT Number: NCT06563765
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: CKD|Renal Fibrosis
Interventions: OTHER: FAP-targeting PET/CT imaging will be performed on the enrolled patients.
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-10
Completion Date: 2026-05-10
Locations: Peking University First Hospital, Beijing, Beijing, China

Summary:
Chronic kidney disease (CKD) is an irreversible change of kidney function and structure caused by many reasons. The main threat of CKD to human health is progressive renal function decline. Delaying the progression of chronic kidney disease to end-stage renal failure is an important clinical need, and renal fibrosis is a common pathway for the progression of chronic kidney disease to end-stage renal failure. The evaluation of renal fibrosis is of great value for the course and prognosis of patients with chronic kidney disease. However, pathological detection has the disadvantages of trauma, false negative, and cannot be implemented repeatedly. At present, there is a lack of effective non-invasive, dynamic, real-time monitoring and evaluation means. A commercially available FAP-targeted imaging agent, FAPI-04, has been used for PET/CT imaging of systemic fibrosis lesions with high uptake background in normal kidneys. Although it can show severe renal fibrosis, it is not conducive to the detection rate of patients with mild-moderate fibrosis who need more accurate evaluation. The new targeted FAP imaging agent successfully constructed by our research group has proved that it can show the degree of renal fibrosis at the living level and has correlation. Therefore, this study intends to carry out a series of clinical studies on the imaging of renal fibrosis with new targeted FAP probes, evaluate the specificity and sensitivity of the new targeted FAP probes in the diagnosis of renal fibrosis, and ultimately provide a new method for clinical dynamic, non-invasive assessment and monitoring of the degree and progression of renal fibrosis.

Primary Outcome Measures: Pathological type, pathological type (e.g., sclerosing IgA nephropathy), 1 week after enrollment|Pathological MESTC score, MESTC score (0-2), 1 week after enrollment|serum creatinine (μmol/L), laboratory results, 1 month before enrollment and 1 month after enrollment|24-hour urinary protein (g/24h), laboratory results, 1 month before enrollment and 1 month after enrollment
Study on the Application of Shock Wave Technique After Rotator Cuff Operation
NCT Number: NCT06563739
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rotator Cuff Tear
Interventions: PROCEDURE: Divergent low energy shock wave|PROCEDURE: Divergent low energy shock wave|PROCEDURE: Divergent medium and low energy shock wave|PROCEDURE: Divergent medium and low energy shock wave|PROCEDURE: Focused low energy shock wave|PROCEDURE: Divergent medium energy shock wave|PROCEDURE: Divergent medium energy shock wave|PROCEDURE: Non-exposed group
Sponsor: Peking University Third Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-05
Completion Date: 2024-12-30
Locations: PekingUTH, Beijing, Beijing, China

Summary:
This study is a prospective cohort study and is a single-center clinical trial. The subjects of this study were patients who underwent rotator cuff repair in the Department of Sports Medicine and the Department of Rehabilitation in the Third Hospital of Beijing Medical University. The sample size of this study is about 2600 cases. We will collect the results of shoulder joint function score, quality of life score, pain score and MRI examination of all participants at baseline. Meanwhile, epidemiological data and related clinical characteristics of patients will be collected at the time of enrollment. All the collected data information was entered into the computer for statistical analysis, and the prognosis of patients under different programs was evaluated.

Primary Outcome Measures: pain VAS score, pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain., 6 weeks, 3 months, and 6 months after surgery|ASES score, The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints., 6 weeks, 3 months, and 6 months after surgery
Secondary Outcome Measures: Active shoulder ranges of motion, internal rotation at the side, and external and internal rotation at 90° of abduction, 6 weeks, 3 months, and 6 months after surgery
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy Subjects
NCT Number: NCT06563713
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Oligozoospermia|Asthenozoospermia
Interventions: DRUG: STSP-0902 injection|DRUG: Placebo
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sex: MALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-02
Locations: Peking University Third Hospital, Beijing, Beijing, 100191, China

Summary:
This is a Phase 1a, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902.

Primary Outcome Measures: Number of treatment-related adverse events as assessed by CTCAE 5.0, To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects, 28 days
Secondary Outcome Measures: Maximum Concentration (Cmax), To evaluate the pharmacokinetics (PK) of STSP-0902, Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days|Area under the plasma concentration-time curve (AUC0-t), To evaluate the pharmacokinetics (PK) of STSP-0902, Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days|Area under the curve from time 0 extrapolated to infinite time (AUC0-∞), To evaluate the pharmacokinetics (PK) of STSP-0902, Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days|Time to peak Concentration (Tmax), To evaluate the pharmacokinetics (PK) of STSP-0902, Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days|Elimination Phase Half-life (t1/2), To evaluate the pharmacokinetics (PK) of STSP-0902, Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days|apparent oral clearance (CL/F), To evaluate the pharmacokinetics (PK) of STSP-0902, Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days|Anti-drug antibody(ADA), To evaluate the immunogenicity of STSP-0902, Pre-dose; after dose: 336 hours, 28 days
BEYOND DISCO Lens for Myopia Progression Trial
NCT Number: NCT06563700
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia, Progressive
Interventions: OTHER: spectacle lens|OTHER: single vision lens
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sex: ALL
Age: CHILD
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2027-07-31
Locations: Shanghai Eye Disease Prevention and Treatment Center, Shanghai, China

Summary:
This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with ZEISS BD micro-structured spectacles compared to ZEISS Single-Vision spectacles. A total of 300 children will be recruited where 50 participants each are randomised to wear one of 5 test ZEISS BD spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.

Primary Outcome Measures: myopia progression, change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group, 12 monthly
Secondary Outcome Measures: axial elongation, change in axial length from baseline for each of the groups of BD test lenses and the single vision control group, 12 monthly|Subjective responses and compliance, Subjective visual responses of wearing spectacles and compliance using questionair for each groups, 12 monthly
Continuous Glucose Monitoring in HIE
NCT Number: NCT06563687
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoxic Ischemic Encephalopathy of Newborn|Hyperglycemia|Hypoglycemia
Interventions: DEVICE: Dexcom ONE+
Sponsor: University of Campania "Luigi Vanvitelli"
Sex: ALL
Age: CHILD
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2026-12-01
Locations: A.O.S.G. Moscati, Avellino, 83100, Italy|Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli, Naples, 80131, Italy|University of Campania Luigi Vanvitelli, Napoli, 80100, Italy

Summary:
The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges.

Randomized controlled trial recruiting neonates (Birth weight \>1.8kg, Gestation\>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.

Primary Outcome Measures: In range - time, Proportion of time that the sensor glucose values are in the target range (50 to 180 mg/dL) compared between the study groups, 72 hours after birth
Secondary Outcome Measures: Hypoglycemia, Percentage of time below 50 mg/dl, 72 hours after birth|Hyperglycemia, Percentage of time above 180 mg/dl, 72 hours after birth|Glycemic variability, Evaluation of glycemic variability, 72 hours after birth|Adverse events associated to insertion of CGM, % of infants with adverse events secondary to CGM placement or wear, up to 10 days after birth
The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction
NCT Number: NCT06563648
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain|Satisfaction, Patient
Interventions: OTHER: shotblocker|OTHER: local cold application|OTHER: ShotBlocker placebo group
Sponsor: Bornova No. 25 Mevlana Family Health Center
Collaborators: Ataturk Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2022-01-01
Completion Date: 2024-04-30
Locations: Ege university nursing faculty, Izmir, Bornova, 35360, Turkey

Summary:
The research was conducted as a single-blind, randomized controlled, experimental study to determine the effect of ShotBlocker and local cold application on pain and patient satisfaction in subcutaneous heparin injection.

Primary Outcome Measures: Visual analog scale, The VAS is used to assess the severity of acute pain. It is mostly a horizontal or vertical line 100 mm long, starting with "no pain" and ending with "unbearable pain". It is used to convert some values that cannot be measured numerically to a numerically usable form, At the first minute after the injection, the patients were evaluated about the pain they felt during the injection by a different reseacher.
Secondary Outcome Measures: Visual patient satisfaction scale, The visual patient satisfaction scale combines the characteristics of the well-known VAS. At one end of the scale is the phrase "I am not satisfied at all", and at the other end is the phrase "I am very satisfied". It is mostly a horizontal or vertical line 100 mm long., At the first minute after the injection, the patients were evaluated their satisfaction with the injection by a different reseacher.
Frequency of Tuberculosis in Psoriasis Patients
NCT Number: NCT06563635
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Psoriasis Vulgaris|Tuberculosis
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 719
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2023-07-31
Locations: Bezmialem Vakif University Hospital, Istanbul, Turkey

Summary:
Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center.

Primary Outcome Measures: tuberculosis rate, number of patients with tuberculosis infection after receiving TNF inhibitor therapy, patients from June 2007 to January 2023, up to 15 years
Pericapsular Nerve Group Block Versus Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery
NCT Number: NCT06563622
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Postoperative
Interventions: PROCEDURE: Pericapsular Nerves Group Block|PROCEDURE: Caudal Epidural Block
Sponsor: Benha University
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-10
Completion Date: 2024-10-10
Locations: Samar Rafik Mohamed Amin, Banhā, Qalubia, 13511, Egypt

Summary:
Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Regional blocks such as caudal Block (CB) and pericapsular nerve group (PENG) block in adjuvant with general anaesthesia are alternative perioperative analgesic techniques that lead to lesser side effects, including motor weakness, postoperative nausea and vomiting with decreased opioid consumption.

Primary Outcome Measures: pain score with FLACC, (Face, Legs, Activity, Cry, and Consolability scale to assess pain in young children. Each category is scored on a 0-2 scale which results in a total score between 0 (lowest pain) and 10 (worst pain)., 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
Secondary Outcome Measures: The duration of the block, from immediately after the block administration until the first postoperative rescue analgesia., immediately after the intervention, up to 24 hours postoperative|the Time to first postoperative rescue analgesia, it will be administered if the FLACC score is ≥ 4/10., 24 hours postoperative|Total rescue analgesia consumption, total dose of pethidine administrated as rescue opioid, 24 hours postoperative|The incidence of postoperative adverse effects, including nausea , vomiting , localized hematoma, bradycardia, hypo-tension, and Pruritis., 24 hours postoperative|Parents satisfaction score, using a 5- point Likert score (0 = very dissatisfied, 1=dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied), 24 hours postoperative
Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy
NCT Number: NCT06563557
Acronym: ERASME ULB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Esophagectomy|Epidural; Anesthesia|Paravertebral Anesthesia|Hemodynamic Instability
Interventions: OTHER: Hemodynamic changes between epidural and paravertebral during esophagectomy
Sponsor: Erasme University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2026-12-12

Summary:
In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.

Primary Outcome Measures: Consumption of norepinephrine and fluids during procedure, norepinephrine mcg/kg/hr, 6 hours
Secondary Outcome Measures: Postoperative complications, Medical complications: Pneumonia, atrial fibrillation, thromboembolic event Surgical complications : Wound dehiscence, anastomotic leakage, chylothorax, recurrent laryngeal nerve injury, 6 months
FCV vs VCV in Obstructive and Asthmatic Patients
NCT Number: NCT06563544
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Pulmonary Disease|Mechanical Ventilation Pressure High|Asthma COPD
Interventions: DEVICE: FCV
Sponsor: Erasmus Medical Center
Collaborators: Maasstad Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2027-10
Locations: Erasmus Medical Center, Rotterdam, Zuid-Holland, 3015 GD, Netherlands|Maasstad Hospital, Rotterdam, Zuid-Holland, 3079DZ, Netherlands

Summary:
The goal of this physiological pilot study with a randomized crossover design is to study the effect of Flow-controlled ventilation (FCV) on the minute volume compared to Volume-controlled ventilation (VCV) in intubated patients with an exacerbation of their asthma or COPD.

Our hypothesis is that FCV will results in a lower minute volume compared to VCV in this patient category.

Patients will be randomized between two ventilation sequences, namely 90 minutes of FCV followed by 90 minutes of VCV or vice versa.

Primary Outcome Measures: MV, Minute Volume, 90 minutes
Secondary Outcome Measures: EILV, End-inspiratory lung volume, 90 minutes|Vei, Volume end-inspiratory, 90 minutes|MP, Mechanical Power (J/min), 90 minutes|Dissipated energy, 30 and 90 minutes|Airway pressures, (peak airway pressure, plateau pressure, mean airway pressure, PEEP, intrinsic PEEP, driving pressure, 30 and 90 minutes|Transpulmonary pressures, (end-expiratory transpulmonary pressure, end-inspiratory transpulmonary pressure, transpulmonary driving pressure, 30 and 90 minutes|RVDI, Regional ventilation delay index, 30 and 90 minutes|GI, Global Inhomogeneity index, 30 and 90 minutes|Gas exchange, Arterial blood gas values, ventilatory ratio, 30 and 90 minutes|Hemodynamic parameters, Pulse rate and mean blood pressure, 30 and 90 minutes
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?
NCT Number: NCT06563531
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arthroplasty Complications
Interventions: PROCEDURE: Pharmacological thromboprophylaxis and elastic compression|PROCEDURE: Pharmacological thromboprophylaxis without elastic compression
Sponsor: Clinique Pasteur Lanroze
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1274
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2026-07-15
Locations: Clinique Pasteur Lanroze, Brest, 29000, France

Summary:
Venous thrombosis and pulmonary embolism are considered serious and potentially preventable complications of hip and knee replacement surgery. The risks of thrombosis must be weighed against the risks associated with preventive measures, both mechanical and pharmacological. Modern medicine is now questioning the use of elastic restraints in surgery. Several studies have investigated the benefits of using restraints to prevent thromboembolic events. These studies have shown no additional benefit from the use of compression stockings in thromboembolism prevention. To the best of our knowledge, no orthopedic study has investigated the non-inferiority of pharmacological treatment compared with elastic compression devices, specifically in knee and hip surgery. The aim of this multicenter, prospective, randomized study is to investigate whether pharmacological prophylaxis alone is non-inferior to pharmacological and mechanical prophylaxis (using restraints) of peripheral venous thrombosis or pulmonary embolism up to 90 days after prosthetic surgery.

Primary Outcome Measures: incidence of venous thromboembolic events, Evaluation of venous thromboembolic events (symptomatic deep vein thrombosis, fatal or non-fatal pulmonary embolism)., day 1 ; day 21 ; day 90
Secondary Outcome Measures: Quality of life evaluation, Quality of life will be evaluated by EQ-5D-5L questionnaire : 5 questions with a Likert scale from 0 (no symptoms) to 4 (extreme symptoms), with a final result from 0 to 20., day 1 ; day 21 ; day 90
Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.
NCT Number: NCT06563518
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gingivitis|Plaque
Interventions: DRUG: Meridol|DRUG: Colgate Cavity Protection
Sponsor: Colgate Palmolive
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-18
Completion Date: 2022-07-10
Locations: Mahidol University, Ratchathewi, Bangkok, 10400, Thailand

Summary:
The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.

Primary Outcome Measures: Gingivitis Assessment, A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror., baseline, 3 months and 6 months|Plaque Assessment, A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror, baseline, 3 months and 6 months
A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
NCT Number: NCT06563505
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma
Interventions: DRUG: Mosunetuzumab|DRUG: Zanubrutinib
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2028-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
NCT Number: NCT06563479
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: HPV-Related Squamous Cell Carcinoma
Interventions: DIAGNOSTIC_TEST: FMISO-PET Scan|COMBINATION_PRODUCT: Chemoradiation|COMBINATION_PRODUCT: Chemoradiation|OTHER: Assessments
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 291
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2027-08
Locations: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States

Summary:
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following:

* Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy
* How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.

Primary Outcome Measures: overall survival, The measurement of survival will be evaluated as a time from randomization to events endpoint (i.e., death due to any cause) so that censored data are allowed. To assess the overall survival rate, Kaplan-Meier estimates will be calculated and reported., 2 years
Reliability of Internal Jugular Ultrasound : an Observational Transversal Study (AIJV)
NCT Number: NCT06563427
Acronym: AIJV
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Diagnosis|Vascular Diseases
Sponsor: Maggiore Bellaria Hospital, Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-07-30
Locations: Nicola Parenti, Bologna, 40125, Italy

Summary:
This is an observational transversal study without intervention on the inter-rater reliability of four ultrasound measures of Internal Jugular Veins.

Aims are : 1) to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images, registered in several acoustic views of neck of patients admitted in Internal Medicine Dept of five Italian Hospitals ; 2)to measure the differences between ultrasound measurements in different acoustic views .

The reliability will be tested by recording Ultrasound measures on images registered using an Utrasound protocol on 100 patients.

Primary Outcome Measures: inter-rater reliability, the variability in the recording of ultrasound measurements among sonographers from differente centers, From 1st march 2024 to 30th July 2024
Secondary Outcome Measures: statistical significance of differences of ultarsound measurements, differences of ultrasound measurements among different acoustic views, From 1st march 2024 to 30th July 2024
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)
NCT Number: NCT06563414
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Epidermolysis Bullosa Dystrophica|Epidermolysis Bullosa Dystrophica, Recessive|Epidermolysis Bullosa Dystrophica Dominans
Sponsor: Krystal Biotech, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-02
Completion Date: 2025-01
Locations: Krystal Biotech, Pittsburgh, Pennsylvania, 15203, United States

Summary:
This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB). Corneal abrasion symptomology, frequency, and outcomes will be evaluated for up to 6 months.

Primary Outcome Measures: Corneal abrasion frequency, Frequency of corneal abrasions, Baseline through 6 months
Secondary Outcome Measures: Epidermolysis Bullosa Eye Disease Index Symptom Score, Symptom score for Epidermolysis Bullosa related eye problems, 0 to 30 (higher score indicates worse symptoms), Baseline through 6 months
Mortality and Cardiovascular Diseases in Adult-onset Type 1 Diabetes
NCT Number: NCT06563401
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 1 Diabetes|Type 2 Diabetes
Interventions: OTHER: prognosis of adult-onset t1d
Sponsor: Karolinska Institutet
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-04-01
Locations: Karolinska institute, Stockholm, 17177, Sweden

Summary:
Scarce evidence is available for prognosis in adult-onset type 1 diabetes (T1D). The aim of this study is to investigate the risk of all-cause mortality, cause-specific mortality, and incident CVD in adult-onset T1D, as compared to type 2 diabetes with comparable age at diagnosis and population controls. We will explore potential modifiable factors including lifestyle and clinical characteristics that contribute to T1D prognosis. In addition, we will estimate the life expectancy associated with different age at T1D diagnosis as compared to population controls. This study will be based on people with diabetes recorded in Swedish National Diabetes Registers, with linkages to other nationwide registers to retrieve data on lifestyle factors, biomarkers, treatment and outcome information.

Primary Outcome Measures: mortality and vascular outcomes, all-cause mortality, cause-specific mortality, and MACE, 2001-2022
Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
NCT Number: NCT06563388
Acronym: ID-COMET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Oligometastasis|Lung Cancer|Colo-rectal Cancer|Prostate Cancer
Interventions: PROCEDURE: Stereotactic Ablative Radiotherapy|OTHER: Best Practice
Sponsor: Roswell Park Cancer Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2032-10-01

Summary:
This protocol is comprised of three unblinded, randomized, single-center studies to evaluate the impact of immediate versus three-month delayed comprehensive ablative treatment on survival in newly diagnosed metastatic patients with lung (Trial 1), colorectal (Trial 2), and prostate (Trial 3) cancers

Primary Outcome Measures: Overall Survival - Trial 1 and 2, Calculated from the time of randomization until death, UP to 5 years|Androgen DeprivationTherapy (ADT)-free survival - Trial 3, The time from radomization until receipt of ADT, death due to any cause, end of study or last follow up., Up to 5 years
Secondary Outcome Measures: Change in Quality of Life, Quality of life will be assessed using The EORTC Core Quality of Life questionnaire (EORTC-QLC30). This questionnaire measures cancer patients' physical, psychological and social functions. This 30 item questionnaire ranges from 1 (not at all ) to 4 (Very much) except for the global health status/quality-of-life scale, which has response options ranging from (1) "very poor" to (7) "excellent", Up to 5 years after radiation treatment|Physician determined Radiation related toxicity, To document toxicity in patients using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5 for each organ treated, 5 years
Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
NCT Number: NCT06563375
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor
Interventions: DRUG: NP-101
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2030-09-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation in Intracranial Surgery
NCT Number: NCT06563297
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Procedural Pain
Interventions: DRUG: Alfentanil
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-13
Completion Date: 2024-12-31
Locations: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan

Summary:
Forty patients were enrolled, and all patients used total intravenous anesthesia (alfentanil-propofol based TIVA) as anesthesia induction and maintenance. According to our experience, patients who underwent intracranial surgery for skull pin fixation used alfentanil 100 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by EEG, maintaining a value of 40-60), first start with alfentanil 100 ng/ml, and use the up and down method as adjust 25 ng/ml of concentration of alfentanil each time. An SPI higher than 80 and hyperdynamics (the increased HR and MBP up 20% of baseline or HR\>100bpm and ABP\>180/100mmHg) indicates insufficient analgesia, therefore increase it by 25 ng/ml at the next patient; an SPI lower than 80 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR\<50bpm and ABP\<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 25 ng/ml during skull pin fixation. If the analgesia is inadequate, increase alfentanil concentration will be prescribed. On the other hand, if analgesia is adequate, however hyperdynamics was noted, beta blocker or calcium channel blocker will be prescribed. If hypotension (ABP\<90/50 mmHg) or bradycardia (HR\<50 bpm) occur, we first stop alfentanil infusion and treated with ephedrine or atropine, respectively.

Data collection: HR, MBP, SPI, BIS, systolic pressure variation (SPV), pulse pressure variation (PPV) , concentrations of propofol and alfentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.

Primary Outcome Measures: 50% effect concentration of alfentanil, 50% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation., peri-fixation period|95% effect concentration of alfentanil, 95% effect concentration of alfentanil will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation., peri-fixation period
HealthcAre sUppoRt fOr Remote HIV pAtients
NCT Number: NCT06563284
Acronym: AURORA
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: HIV Infections
Interventions: OTHER: AURORA Mobile App
Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-20
Completion Date: 2024-03-30
Locations: SC Malattie Infettive, Alessandria, Piedmont, 15121, Italy

Summary:
Adherence to antiretroviral therapy (ART) is crucial for treatment success in HIV+ patients. This study proposes the use of a smartphone application, specifically developed for this project, to monitor ART adherence and assess quality of life among HIV+ patients. The aim is to optimize long-term disease management through the early identification of comorbidities and clinical complications

Primary Outcome Measures: Effective use of the mobile application, Frequency of interaction with the mobile application, 6 months
Secondary Outcome Measures: Adherence to therapy, Frequency of click in the mobile application, Everyday, through study completion (6 months)|EuroQol five-dimensional questionnaire, Quality of life assessment questionnaire, Twice, at baseline and after 4 months|Pittsburgh Sleep Quality index, Quality of sleep assessment questionnaire, Twice, at baseline and after 4 months|Generalized Anxiety Disorder 7, Questionnaire for assessment of generalized anxiety state, Twice, at baseline and after 4 months
Approach to Ankle Sprains in the Emergency Department
NCT Number: NCT06563271
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Ankle Sprains
Interventions: DRUG: Dexketoprofen Trometamol 50 Mg/mL Solution for Injection|DRUG: Ibuprofen 100 MG/ML Solution for Injection|DRUG: Paracetamol 10 Mg/mL Solution for Injection|DRUG: isotonic saline
Sponsor: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-06-01
Locations: Ankara Etlik City Hospital, Ankara, Yenimahalle, 38000, Turkey

Summary:
The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).

Primary Outcome Measures: To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains., Numeric Rang Scale (NRS) will be used to assess effects on pain. NRS: This scale uses 11 numbers from 0 to 10 to measure pain intensity, where 0 represents "No pain" and 10 represents "Worst (unbearable) pain.", *Patient's pain level, NRS Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment|To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains., Wong-Baker FACES pain rating scale (WBS) will be used to assess effects on pain.

WBS: This scale uses a series of faces ranging from a smiling face representing "No pain" to a crying face representing "Worst pain" to visually express the intensity of pain., *Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment|To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains., A standard handheld goniometer will be used to calculate Range of Motion (ROM) measurements. The aim is to determine the effects of multimodal treatment methods routinely applied in emergency services on pain and range of motion and to reveal their superiority over each other, if any. (Normal ROM values: 20° for dorsiflexion, 45° for plantar flexion), - 0 minute ROM before treatment - 60 minute ROM after treatment
Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis
NCT Number: NCT06563258
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: DEVICE: Biodex Balance Training|DEVICE: A vibration device|OTHER: traditional exercises
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-03-30
Locations: Mti University, Cairo, Egypt

Summary:
This study will be conducted to answer the research question:

Are there differences between the effect of Biodex balance training and Whole-body vibration training on Knee osteoarthritis?

Primary Outcome Measures: Pain intensity, Pain intensity will be measured by visual analogue scale (VAS)., one month|static balance, static balance will be measured by Postural stability test by Biodex balance SD., one month|Dynamic balance, Dynamic balance will be measured by Limit of stability Test by biodex balance SD., one month|.Functional abilities, Functional abilities will be measured by Arabic- language version of knee injury and osteoarthritis outcome score physical function short form (KOOS-PS)., one month
Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
NCT Number: NCT06563245
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Classical Hodgkin Lymphoma|Child|Adolescent|Young Adult|Metabolic Response|Survival|Treatment|Brentuximab Vedotin|PET Scan
Interventions: DRUG: Brentuximab Vedotin for Injection|RADIATION: response-adapted radiation|DRUG: Doxorubicin|DRUG: Etoposide|DRUG: Prednisone|DRUG: Cyclophosphamide|DRUG: Dacarbazine|DRUG: Tislelizumab Injection|DRUG: Bedamustine
Sponsor: Children's Cancer Group, China
Collaborators: Shanghai Children's Medical Center|Najing Children's Hospital|West China Second University Hospital|Qilu Hospital of Shandong University|Tianjin Medical University Cancer Institute and Hospital|Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology|Xiangya Hospital of Central South University|The First Affiliated Hospital of Zhengzhou University|Second Affiliated Hospital of Anhui Medical University|Children's Hospital of Hebei Province|Children's Hospital of Henan Province|Sun Yat-Sen Memorial Hospital Zhongshan University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 96
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-15
Completion Date: 2039-11-15

Summary:
Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.

Primary Outcome Measures: Early complete metabolic response rate for the entire group, Early complete metabolic response rate after 2 cycle of Bv-AEPC based on PET/CT result for the entire group, 5 years|Late complete metabolic response rate in intermediate/high risk group, Late complete metabolic response rate based on PET/CT results for patients who did not achieve early complete metabolic response after 2 or 3 cycles of Bv-Dac-AEPC, 5 years|Complete metabolic response rate in intermediate/high risk group after modified Check Mate 744 regimens, Complete metabolic response rate based on PET/CT results for patients who receive a modified Check Mate 744 regimen, 5 years|Overall survival rate for the entire group and each risk group, the overall survival rate for all the patients enrolled, 5 years
22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions
NCT Number: NCT06563232
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Neoplasms|Mediastinal Neoplasms|Abdominal Neoplasm, Excluding Pancreas Neoplasm
Interventions: DEVICE: FNA group|DEVICE: Adapt FNB group
Sponsor: Huazhong University of Science and Technology
Collaborators: Peking Union Medical College Hospital|Fudan University|Qilu Hospital of Shandong University|Chongqing University Cancer Hospital|The First Affiliated Hospital of Zhengzhou University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 656
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2026-02-01
Locations: Tongji Hospital, Tongji Medical College, HUST, Wuhan, Hubei, 430030, China

Summary:
The investigators conduct a multicenter randomized controlled study to evaluate the diagnostic value and safety of 22G Adapt Aspiration puncture needle for histopathology of solid lesions.

Primary Outcome Measures: The histological diagnostic yields, The investigators' primary outcome measure is to compare the histological diagnostic yields of 22G Adapt Aspiration FNB and FNA puncture needle (22G EchoTip Ultra Echo-3-22) to the solid pancreatic or nonpancreatic lesions compared to conventional FNA puncture needle(22G EchoTip Ultra Echo-3-22) for pancreatic and non-pancreatic solid lesions., up to 15 months
Secondary Outcome Measures: the histological acquisition yields, Comparing the histological acquisition yields of 22G Adapt Aspiration (EUS-FNB) and Echo-3-22 (EUS-FNA) for solid space-occupying lesions., up to 15 months|the diagnostic yields of the first pass and the number of subsequent passes, Comparing the diagnostic yields of the first puncture needle and subsequent puncture needles of 22G Adapt Aspiration (EUS-FNB) and Echo-3-22 (EUS-FNA) for solid space-occupying lesions(EUS-FNA) for the number of first and subsequent puncture needles for solid space occupying lesions., up to 15 months|the cytological diagnosis yields, Comparing the cytological diagnostic yields of 22G Adapt Aspiration (EUS-FNB) and Echo-3-22 (EUS-FNA) for solid space-occupying lesions., up to 15 months|the complication yields, Comparing the complication rates during and after puncture between 22G Adapt Aspiration (EUS-FNB) and Echo-3-22., up to 15 months