pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
NCT Number: NCT06528158
Acronym: EMA-FRaM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anorexia Nervosa
Interventions: OTHER: sibling group
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: CHILD, ADULT
Enrollment: 24
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-31

Summary:
Anorexia nervosa (AN) is a complex mental disease with a huge impact on the patient's siblings life and well-being. Based on literature, group interventions for siblings of children suffering from a chronic disease could provide an effective support. A few have been studied, and even fewer exist for siblings of children with AN.

Primary Outcome Measures: Group ACCEPTABILITY, assess the clinical setting " sibling group "'s acceptability among siblings of teenagers engaged in health care for AN. This will be assessed through the acceptability scale Abbreviated Acceptability Rating Profile (AARP) after attending group sessions.

In the questionnaire, there are 8 questions. For each, a scale of 1 to 6, with 1 being "not agreeing at all with the question" and 6 being "completely agree". Maximum score = 48 the higher the score, the better the acceptability of the group is felt by participants., after attending group sessions, maximum 3 months after baseline
Secondary Outcome Measures: Impact of the groups on quality of life, THE PEDIATRIC QUALITY OF LIFE INVENTORY VERSION 4 (PEDSQLTM4.0) (MODULE GENERIC CORE SCALE) The PedsQL is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18.

The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules.

The PedsQL 4.0 Generic Core Scales consist of 23 items A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is us, baseline|impact of the groups on quality of life, THE PEDIATRIC QUALITY OF LIFE INVENTORY VERSION 4 (PEDSQLTM4.0) (MODULE GENERIC CORE SCALE) The PedsQL is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18.

The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules.

The PedsQL 4.0 Generic Core Scales consist of 23 items A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is us, after attending group sessions, maximum 3 months after baseline
Long Covid (Individuals With Ongoing COVID-19 Symptoms) Ongoing Effects
NCT Number: NCT06528145
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Patients Who Have Had COVID-19 Infection and Whose Symptoms Persist
Interventions: OTHER: Evalation
Sponsor: Ziya Yildiz
Collaborators: Suleyman Demirel University|Pamukkale University
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-25
Completion Date: 2023-02-20
Locations: Süleyman Demirel Univesity, Isparta, 32000, Turkey

Summary:
Persistent Covid-19 symptoms, known as long Covid, can impact healthcare provision. This study aimed to assess how symptoms persisting six months after Covid-19 affect quality of life and functional capacity.

Primary Outcome Measures: Functional capacity, physical function, physical role difficulties, emotional role difficulties, pain and general health, Functional capacity was affected more in the group whose symptoms persisted than in the group whose symptoms did not persist (p\<0.05). Some of the SF-36 sub-parameters (physical function, physical role difficulties, emotional role difficulties, pain and general health) were found to be sig-nificantly more affected in participants with persistent symptoms (p\<0.05)., 1 year
The Combined Usage of Clinical Physical Finding in Management of COVID 19 Patients
NCT Number: NCT06528119
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COVID-19 Pandemic
Interventions: OTHER: COVID 19 pandemic
Sponsor: St. Martin De Porress Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-30
Completion Date: 2024-07-20
Locations: St. Martin De Porres Hospital, Tainan, 60069, Taiwan

Summary:
Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients. In response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.

Primary Outcome Measures: COVID 19 pandemic, Assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients., March 2020 and September 2022
Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
NCT Number: NCT06528106
Acronym: REPeAL
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Penicillin Allergy
Sponsor: Royal Cornwall Hospitals Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2025-06
Locations: Royal Cornwall Hospital, Truro, Cornwall, TR1 3LJ, United Kingdom

Summary:
To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.

Primary Outcome Measures: The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled., 1 year
A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy
NCT Number: NCT06528093
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pancreatic Ductal Adenocarcinoma
Interventions: DRUG: BI 765883|DRUG: gemcitabine|DRUG: nab-paclitaxel
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2027-03-01

Summary:
This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists.

The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy. Another purpose is to check whether BI 765883 helps people with advanced pancreatic cancer. In this study, BI 765883 is given to humans for the first time.

Participants receive either BI 765883 alone or BI 765883 in combination with chemotherapy. Participants can stay in the study as long as they benefit from treatment and can tolerate it. At study visits, doctors collect information on any health problems of the participants and check the severity of participants' cancer.

Primary Outcome Measures: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period, phase Ia, Up to 28 days (2 treatment cycles)|Confirmed objective response (OR), phase Ib, Up to 350 days (25 treatment cycles)
Secondary Outcome Measures: Objective response (OR), phase Ia, Up to 350 days (25 treatment cycles)|Recommended dose for expansion (RDE) for BI 765883 in combination with gemcitabine and nab-paclitaxel, phase Ia, Up to 28 days (2 treatment cycles)|Frequency and severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE), phase Ia and phase Ib, Up to 350 days (25 treatment cycles)|Maximum measured concentration of the analyte in serum (Cmax), phase Ia and phase Ib, Up to 350 days (25 treatment cycles)|Area under the serum concentration time curve of the analyte (AUC0-t), phase Ia and phase Ib, Up to 350 days (25 treatment cycles)|Progression-free survival (PFS), phase Ib, Up to 350 days (25 treatment cycles)|Duration of response (DOR), phase Ib, Up to 350 days (25 treatment cycles)
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection
NCT Number: NCT06528054
Acronym: TENTACLE-Colon
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Treatment|Anastomotic Leakage|Resection|Colon Cancer
Interventions: OTHER: Development of a model for predicting 90-day mortality and to compare various treatment strategies for anastomotic leakage
Sponsor: Radboud University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-03

Summary:
This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:

1. To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.
2. To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.

Primary Outcome Measures: 90-day mortality, mortality correlated with anastomotic leakage, 90 days after colon cancer resection|90-day Clavien-Dindo grade IV - V complications, This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V), 90 days after colon cancer resection
Secondary Outcome Measures: Time from colon cancer resection to diagnosis of anastomotic leakage, at least one year follow up|Time from colon cancer resection to primary treatment of anastomotic leakage, at least one year follow up|Length of hospital/intensive care unit stay, at least one year follow up|Mortality, 30-day, 90-day and one-year after colon cancer resection|Stoma presence (and if so, type of stoma), At least one year after colon cancer resection, preferably last date of follow up|Disease status, At least one year after colon cancer resection, preferably at last date of follow up|Number of radiologic and surgical reinterventions, One year after colon cancer resection
Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes
NCT Number: NCT06528028
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Anti-Infective Agent
Interventions: DRUG: CAZ/AVI|DRUG: CAZ/AVI
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-30
Locations: Intensive Care Unit, Drum Tower Hospital, Nanjing, Jiangsu, 210009, China

Summary:
Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.

Primary Outcome Measures: Clinical effective rate, According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%., 14 days
Secondary Outcome Measures: Bacterial removal, Defined as clearance or change of existing bacteria within two weeks of medication., 14 days|28-d mortality, Defined as whether a patient died at 28-d after follow-up.28-d Mortality rate = Number of deaths/group size x 100%., 28 days|PK/PD compliance rate, PK/PD compliance rate = number of qualified persons/number of groups × 100%., 14 days
Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan
NCT Number: NCT06528002
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Continous Blood Glucose Monitoring|Calculation of Body Mass Index|Measurment of Blood Pressure
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-06-15
Locations: Sohag Faculty of Medicine, Sohag, Egypt

Summary:
All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan. However, many Muslim patients insist on fasting in spite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting.

Primary Outcome Measures: effect of hyprid method of insulin in type 2 diabetic patients during fasting in ramadan, This is a study aiming to assess the safety and efficacy of our hybrid method compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting. and this done by measurement of blood glucose level 7 times daily to detect control of blood glucose during fasting in ramadan .then will measure fasting and postprandial blood glucose level after ramadan, 4 weeks after ramadan
Prophylactic Antibiotic in Subtalar Fusion Surgery
NCT Number: NCT06527989
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Surgical Site Infection
Interventions: DRUG: Ceftriaxone 2000 mg
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-11-01

Summary:
Assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days

Primary Outcome Measures: assessment of incidence rate of surgical site infection, surgical site infection are further classified as either superficial or deep. Superficial infections involve only the skin and subcutaneous tissue, whereas deep infections involve deep tissue spaces or organs, baseline
Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block
NCT Number: NCT06527976
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain
Interventions: DRUG: Dexmedetomidine|DRUG: Dexamethasone
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-02-15
Completion Date: 2024-01-01
Locations: Assiut university, Assiut, 71111, Egypt

Summary:
Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.

Primary Outcome Measures: visual analogue scale score, scale of 11 points. zero=no pain, 10 = worest pain ever, 24 hours postoperative
Secondary Outcome Measures: analgesia duration, pain free duration after block, 24 hours postoperative|opioid consumption, amount of opioid consumed postoperative, 24 hours postoperative
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
NCT Number: NCT06527963
Acronym: Dragon
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arteriovenous Fistula|Angioplasty, Balloon|Hemodialysis Access Failure
Interventions: PROCEDURE: Endovascular therapy
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China|Renji Hospital, Shanghai, Shanghai, China

Summary:
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are:

1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons?
2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?

Primary Outcome Measures: Number of Participants with Clinically-driven Target Lesion Re-intervened, Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled.require reintervention after surgery, including: 1) clinically driven target lesions reintervention; 2) target lesion thrombosis; 3) surgery to remove the target lesion; 4) AVF waste caused by the target lesion can't treatment again., 1-month#3-month#6-month#12-month
Secondary Outcome Measures: Number of Participants with Target Lesion Primary Patency, Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the need for any additional revascularization procedure during the follow-up period., 1-month#3-month#6-month#12-month|Number of Participants with Target Lesion Assisted Primary Patency, Target lesion assisted primary patency refers to the treated lesion site remaining patent (open) during the follow-up period, but requiring an additional revascularization procedure, such as percutaneous transluminal angioplasty, to maintain patency of the target lesion., 1-month#3-month#6-month#12-month
Anterior Mandibular Region for Immediate Implant Placement
NCT Number: NCT06527950
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dental Implants
Interventions: OTHER: no intervention
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 103
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-05

Summary:
Immediate implant placement has been proven to be a successful treatment modality, it is however considered a technique sensitive procedure, which mandates careful planning on basis of the recommended guidelines and thorough site assessment. The anatomical characteristics play a major role in the treatment planning, to determine that enough alveolar bone housing is available to accommodate the implant in the correct prosthetic-driven position and to avoid complications that may be caused by injury of the adjacent anatomical structures. There is scarcity in the literature regarding data on the anatomical features of the mandibular anterior zone in relevance to immediate implant planning. Analysis of the anatomical landmarks of the mandibular anterior region to determine the thickness of the labial and lingual alveolar bony plates, in addition to the bony socket configuration along with the labio-lingual socket dimension and relate them to immediate implant treatment planning

Primary Outcome Measures: Labial bone thickness, Linear measurements on CBCT measured in mm, 1 year
Secondary Outcome Measures: Lingual bone thickness, Linear measurements on CBCT measured in mm, 1 year
Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome (OAS)
NCT Number: NCT06527937
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Allergic Reaction
Interventions: DRUG: DESF|DRUG: Epinephrine Injection
Sponsor: Aquestive Therapeutics
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2024-11
Locations: Frontage Clinical Services, Inc., Secaucus, New Jersey, 07094, United States

Summary:
An open-label study to assess the pharmacokinetics (PK) of epinephrine administered as single and repeat doses of DESF in healthy adults with oral allergy syndrome (OAS). Subjects undergo an oromucosal allergen challenge prior to administration of DESF according to randomization into two cohorts. There are three treatment periods evaluating single and repeat doses of study drug, DESF after an allergen challenge (Treatment Period 1), intramuscular (IM) injection without allergen challenge (Treatment Period 2), and DESF without allergen challenge (Treatment Period 3).

Primary Outcome Measures: Cmax, Baseline Corrected Maximum Epinephrine Plasma Concentration occurring at Tmax (Time to reach maximum concentration), 0 to 240 minutes post-dose|AUC0-10, Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 10 minutes, 0 to 10 minutes|AUC0-20, Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 20 minutes, 0 to 20 minutes|AUC0-30, Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 30 minutes, 0 to 30 minutes|AUC0-45, Baseline Corrected Plasma Epinephrine Concentration-Time Curve from Time Zero to 45 minutes, 0 to 45 minutes
A Randomized Study on Sagittal Angle Differences in Lower Limbs Between Normal Individuals and Osteoarthritis Patients
NCT Number: NCT06527924
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: OA|TKA|EOS
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100037, China

Summary:
With China gradually entering an aging society, the proportion of the elderly population is gradually increasing, and the number of patients with knee disease is also increasing year by year. Total knee arthroplasty is one of the effective methods for the treatment of joint disease, which can effectively relieve knee pain, restore function and improve the quality of life. The goal of total knee arthroplasty is to relieve pain, restore function and obtain a long service life. Whether total knee arthroplasty can obtain good alignment is very important for the postoperative recovery of patients. The alignment of lower limb sagittal position is of great significance for evaluating whether the crowd is straightened or not, and can also evaluate and guide the TKA in sagittal position. At present, there are few studies on the sagittal position of the lower limb, and there is no clear definition of whether the lower limb is extended in the sagittal position. At the same time, there is no clear method to evaluate whether the lower limb is extended in the sagittal position in normal people and patients with OA. Therefore, it is urgent to develop a classification standard for the sagittal extension of the lower limb, which can be used in clinical evaluation and TKA operation evaluation. This study will be carried out in the first medical center of the Chinese PLA General Hospital, and a total of about 400 people are expected to be enrolled.

Primary Outcome Measures: Sagittal plane femur lateral, tibia lateral modified mechanical axis angle., From admission to discharge, up to 1 week|Angle formed by the line connecting the center of the femoral head, the center of the ankle joint, and the hinge point of the knee joint., From admission to discharge, up to 1 week|Sagittal plane femoral anterior arch angle., From admission to discharge, up to 1 week|Sagittal posterior slope angle of the tibial plateau., From admission to discharge, up to 1 week|Coronal Hip-Knee-Ankle Angle (HKA), From admission to discharge, up to 1 week|Lateral Distal Femoral Angle (LDFA), From admission to discharge, up to 1 week|Medial Proximal Tibial Angle (MPTA), From admission to discharge, up to 1 week
Secondary Outcome Measures: Basic demographic profile of the patient, From admission to discharge, up to 1 week
A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic TKA and Manual TKA
NCT Number: NCT06527911
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arthroplasty|Replacement|Knee|Osteoarthritis|Robotic Surgical Procedures
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100037, China

Summary:
As China transitions into an aging society, the proportion of the elderly population is escalating, with a corresponding rise in the number of patients with knee joint diseases. Total knee arthroplasty stands as an effective treatment for joint disorders, effectively reducing knee pain, restoring functionality, and enhancing quality of life. The objectives of total knee arthroplasty are to relieve pain, restore function, and ensure a long-lasting implant. In recent years, technological advancements have integrated robotic assistance into total knee arthroplasty (TKA), aiding surgeons in planning and executing more accurate surgical plans, significantly enhancing precision and post-operative outcomes. However, the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb, and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures, necessitating adjustments by surgeons based on their experience. Consequently, there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment. Additionally, the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue, and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA, necessitating further comparative analysis to draw definitive conclusions. This study will be carried out at the People's Liberation Army General Hospital, with an anticipated enrollment of approximately 100 participants.

Primary Outcome Measures: The extension angle displayed by the Mako robot at the conclusion of the Mako-assisted Total Knee Arthroplasty (TKA) procedure, From admission to discharge, up to 1 week|Sagittal plane femoral anterior arch angle, From admission to discharge, up to 1 week|Preoperative and postoperative coronal hip-knee-ankle (HKA) angles, lateral distal femoral angle (LDFA), and medial proximal tibial angle (MPTA) in Mako robot-assisted TKA and manual TKA, From admission to discharge, up to 1 week|Preoperative and postoperative sagittal measurement of the tibial plateau posterior slope angle; postoperative femoral prosthesis head-down angle, From admission to discharge, up to 1 week
Secondary Outcome Measures: Basic demographic profile of the patient, From admission to discharge, up to 1 week
Hypofractionated Radiotherapy Combined With Immunotherapy for Limited-stage Small-cell Lung Cancer
NCT Number: NCT06527898
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Small-cell Lung Cancer
Interventions: DRUG: hypofractionated radiotherapy with immunotherapy
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-07-31
Locations: Anhui Provicial Hospital, Hefei, Anhui, 230011, China

Summary:
Concurrent chemoradiotherapy has long been the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. With the introduction of immune checkpoint inhibitors, ADRIATIC study concluded that consolidative Durvalumab after concurrent chemoradiotherapy could achieve a far longer median overall survival of 55.9 months compared with 33.4 months for concurrent chemoradiotherapy. Recently, several studies have demonstrated the safety and efficacy of hypofractionated radiotherapy (3 to 4 Gy) for limited-stage small-cell lung cancer. Hypofractionated radiotherapy processes the advantage of short treatment duration compared with conventional fractionated radiotherapy, which may allow the early participation of immunotherapy. Therefore, we suppose that whether hypofractionated radiotherapy combined with immunotherapy could improve the survival of limited-stage of small-cell lung cancer.

Primary Outcome Measures: progression-free survival, progression-free survival, 1 to 2 years
Secondary Outcome Measures: 2-year progression-free survival rate, 2-year progression-free survival rate, 2 year|2-year overall survival rate, 2-year overall survival rate, 2 year
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
NCT Number: NCT06527872
Acronym: OBSErve-LN
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lupus Nephritis
Interventions: OTHER: None (Observational study)
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2029-03-29

Summary:
The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.

Primary Outcome Measures: Number of participants maintaining renal function (less than equal to [<=]30 percentage [%] decline in estimated glomerular filtration rate [eGFR] from the initiation of belimumab) and not requiring renal replacement therapy, At Month 24
Secondary Outcome Measures: Number of participants achieving Modified Partial Renal Response (<=20% decline eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% decline eGFR and <=0.5 uPCR), At Months 24, and 60|Number of participants maintaining renal function (<=30% decline in eGFR from the initiation of belimumab) and not requiring renal replacement therapy (in those that remain adherent to belimumab) at Month 24, At Month 24|Change in the daily dose of steroid (in milligrams per day) from the initiation of belimumab, Baseline (Day 1) to Month 60|Estimated Glomerular Filtration Rate (eGFR) slope over time, Up to Month 60|Time to achieving eGFR 30% and 40% reduction, Up to Month 60|Time to initiating renal replacement therapy, Up to Month 60|Number of participants maintaining renal function (<=30% decline in eGFR from the initiation of belimumab) and not requiring renal replacement therapy, At Month 60
Correlation Between Levothyroxine and Blood Th17/Treg in Pregnant Women With Normal-high TSH and Positive TPOAb
NCT Number: NCT06527859
Status: TERMINATED
Study Type: OBSERVATIONAL
Conditions: Pregnancy Related|Thyroid Stimulating; Hormone, C
Interventions: DRUG: Levothyroxin
Sponsor: Third Affiliated Hospital of Zhengzhou University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-06
Completion Date: 2024-06-05
Locations: The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

Summary:
The purpose of this clinical trial is to understand the impact of different doses of levothyroxine on the immune inflammatory response in pregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy. It aims to answer the main questions:

Are there differences in immune inflammation between normal pregnant women and those in the disease group? Can different doses of levothyroxine improve the Th17/Treg ratio and cytokine levels in the disease group? Researchers first compared the differences between normal pregnant women and those in the disease group, and then administered two different doses of levothyroxine to the disease group to observe whether different doses of levothyroxine can improve the immune inflammation in this group.

pregnant women in the disease group will: Take the same dose of levothyroxine (25/50ug) every day Return for a follow-up visit after 4 weeks of medication

Primary Outcome Measures: Th17/Treg, Ratio of Th17 to Treg percentages in peripheral blood., 4 weeks
Secondary Outcome Measures: cytokines, inflammatory factor, Concentrations of IL-2, 4, 6, 10, TNF-α, and hsCRP in peripheral blood., 4 weeks
Other Outcome Measures: lipids, Small intestinal bacterial overgrowth, Concentrations ofTC, TG, LDL, HDL, FFA, ApoA, and ApoB in peripheral blood., 4 weeks
Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
NCT Number: NCT06527846
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Disease, Chronic
Interventions: DRUG: JARDIANCE®
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2027-05-31

Summary:
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.

Primary Outcome Measures: Incidence of Adverse Drug Reactions (ADRs), Up to 52 weeks
Secondary Outcome Measures: Kidney disease progression, Kidney disease progression defined as incidence of end stage kidney disease (ESKD), a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73 m\^2, renal death, or a sustained decline of ≥40% in eGFR from baseline).

ESKD is defined as the initiation of maintenance dialysis or receipt of a kidney transplant., Up to 52 weeks|Incidence of cardiovascular death, Up to 52 weeks|Incidence of all cause death, Up to 52 weeks|Incidence of hospitalization for heart failure, Up to 52 weeks|Change from baseline in eGFR to the last observation on treatment, at baseline, at last observation on treatment (Up to 52 weeks)
Procedure-Specific Approach To Minimize Fistulaization of The Perianal Abscess Cavity After Surgical Drainage
NCT Number: NCT06527833
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Perianal Fistula
Interventions: PROCEDURE: Non Packing of perianal abscess cavity after drainage|PROCEDURE: Packing of perianal abscess cavity after drainage
Sponsor: Suez Canal University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 154
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-10
Completion Date: 2025-01-31
Locations: Suez Canal University Hospital, Ismailia, 41511, Egypt

Summary:
Perianal abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Symptoms include perianal pain, back pain, fever, and more. The main treatment is incision and drainage, but packing during drainage can reduce fistula incidence, though it is associated with pain and cost. Research comparing outcomes with and without packing is limited.

Primary Outcome Measures: Perianal fistula formation, To Compare the incidence of fistulous tract formation in patients drained with non-packing vs. packing approach., 6 months|Recurrence of perianal abscess, To Compare the incidence of abscess recurrence formation in patients drained with non-packing vs. packing groups ., 6 months
A Study of PD5K3 in Healthy Adult Volunteers
NCT Number: NCT06527781
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lymphoblastic Leukemia, Acute|Lymphoblastic Lymphoma
Interventions: DRUG: PD5K3|DRUG: Placebo|DRUG: Pegaspargase
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-27
Completion Date: 2024-05-20
Locations: The First Affiliated Hospital of Soochow University, Suzhou, Jiangshu, 215006, China

Summary:
The main aim of this clinical trial is to assess the safety of PD5K3 in patients aged 18 to 65 years. The main questions it aims to answer are:

* Is PD5K3 safe in adult? Researchers will compare PD5K3 to an active comparator pegaspargase to see if PD5K3 is safe and active in human.

Participants will

* Receive a single dose injection of PD5K3, pegaspargase or placebo according to weight,
* Visit the clinic for assessment.

Primary Outcome Measures: Treatment-related Adverse Events, To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration., up to 49 days
Secondary Outcome Measures: The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t), Pharmacokinetic parameter, up to 49 days|Maximum plasma concentration (Cmax), Pharmacokinetic parameter, up to 49 days|The half-life (t1/2), Pharmacokinetic parameter, up to 49 days|Compare the plasma asparaginase activity between the PD5K3 and pegaspargase groups, Plasma asparaginase activities are determined by a validated enzymatic spectrophotometric assay, and the results are reported in IU/mL. In the assay, asparaginase hydrolyzes asparagine to generate aspartic acid, which can be detected colorimetrically using a coupled enzymatic reaction., up to 49 days|Compare the plasma asparagine concentration between the PD5K3 and pegaspargase groups, Plasma asparagine concentration as a pharmacodynamic parameter, up to 49 days
Body Composition, Frailty, and Function in Rehabilitation
NCT Number: NCT06527742
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frailty|Stroke|Debility Due to Disease
Sponsor: Changi General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 345
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-06

Summary:
The investigators are investigating if body composition measures - in particular muscle mass, body fat, and something called the phase angle - are able to reliably predict functional outcomes for patients who are in an acute hospital for inpatient rehabilitation. The investigators also want to see if age and frailty affect these relationships.

Patients undergoing inpatient rehabilitation in our hospital will be monitored through a variety of frailty-specific tools, including strength and speed. The investigators will use a device called a body composition monitor (BCM) to record their body composition measurements. These will then be compared against their usual rehabilitation outcomes.

The investigators believe that there is a correlation between these measures and a patient's functional outcomes.

Primary Outcome Measures: M-FIM, Motor component of the Functional Independence Measure, Baseline at recruitment, and upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later
Secondary Outcome Measures: M-FIM effectiveness, M-FIM effectiveness is a derivative of the M-FIM value which has been corrected for the ceiling effect that the M-FIM value sometimes encounters in patients with higher baseline FIM scores.

This is a single outcome value with a single unit of measure., Upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later|Grip strength, Handgrip strength measured in kg, Baseline at recruitment, and upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later
An International Prospective, Observational, Multi-centre Study on the Duration of Pre-operative Liquid Fasting
NCT Number: NCT06527703
Acronym: THIRST
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus|Hypertension|Ischaemic Heart Disease|Comorbidities and Coexisting Conditions|Fasting|Fasting, Time Restricted
Interventions: OTHER: no intervention
Sponsor: Mater Dei Hospital, Malta
Collaborators: Puerta de Hierro University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-23
Completion Date: 2024-10-23

Summary:
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients.

Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.

Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability.

The investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.

Primary Outcome Measures: The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time., Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate.

After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake., Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024
Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer
NCT Number: NCT06527690
Acronym: REPRESENTATION
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer|Castrate Resistant Prostate Cancer|Homologous Recombination Deficiency
Interventions: DRUG: Niraparib/Abirate rone acetate fixed-dose combination|DRUG: Prednisone
Sponsor: Latin American Cooperative Oncology Group
Collaborators: Janssen, LP
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-29
Completion Date: 2029-02-28

Summary:
This is an open-label, multicenter, interventional study in racially self-identified black or ethnically self-identified hispanic and racially self-identified white or native American participants with metastatic castration-resistant prostate cancer whose tumors demonstrate molecular alterations compatible with homologous repair deficiency.

Primary Outcome Measures: 12-month radiographic Progression-Free Survival (rPFS), Assessed by modified RECIST v1.1 and PCWG3 criteria, and defined as time from enrollment until progression of soft tissue lesions measured by CT or MRI as defined in RECIST 1.1, progression of bone lesions observed by bone scan and based on PCWG3, or death from any cause., 12 months
Effects of Ultrasound-guided Genicular Nerve Block in Knee Osteoarthritis Patients on Proprioception and Static Balance
NCT Number: NCT06527651
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis|Osteoarthritis, Knee|Proprioceptive Disorders|Balance; Distorted
Interventions: DRUG: Genicular blocks (dexamethazone and lidocaine)
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-07-14
Locations: Ankara Bilkent City Hospital, Ankara, Turkey

Summary:
Genicular nerve block (GNB) is a novel and promising interventional method for pain in knee osteoarthritis (KOA). However ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. These proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. This study aims to evaluate Pproprioception and static balance after ultrasound-guided GNB in patients with knee osteoarthritis.

Primary Outcome Measures: Visual analog scale (VAS), Ten-cm VAS was used as a self-report measure for knee joint pain. Turkish Validity and Reliability of scale was published. 0 indicates no pain and 10 indicates unbearable pain. As it approaches 10, the pain becomes more severe., 24 hours|HUR SmartBalance®: HUR SmartBalance®, provides both balance assessments and rehabilitative training programs. Training programs are used in vertigo rehabilitation, balance training in mild gait disorders and fall prevention in elderly. Balance scores allow assessments and comparison in terms of static balance, proprioception disturbance, visual dependency and vestibular dominant proprioception . It consists of Balance Trainer, Support Rail, SmartBalance Software, Touchscreen Computer and Foam surface, 24 hours