pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Turkish Validity and Reliability of the Expanded Rehabilitation Complexity Scale
NCT Number: NCT06573359
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke
Interventions: OTHER: questionnaire
Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sex: ALL
Age: CHILD
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-24
Completion Date: 2024-11-07
Locations: Istanbul Physical Medicine Rehabilitation Research and Training Hospital, Istanbul, Bahçelievler, Turkey

Summary:
The RCS is a tool that can assess the need for complex rehabilitation and objectively indicate that a patient may have difficulty functioning well at home or in the community if their medical needs are still high. Among rehabilitation patients, there are still patients with complex needs, even though they have maximized rehabilitation potential. Moreover, RCS can also be useful in highlighting cases of patients becoming seriously ill during the rehabilitation process due to an acute illness such as sepsis, which significantly limits treatment time. This information can be emphasized using RCS data when requesting extended or increased rehabilitation support.

Primary Outcome Measures: Turkish validation and reliability of the Rehabilitation Complexity Scale (RCS-E), The validity of the scale was validated by analyzing the correlations between the rcs-e-tr score obtained at admission (both for each partial item and the total score) and other suitability indicators used in Turkey (FIM Motor and Barthel) using Spearman's rank correlation coefficient r (rho). Additionally, to check the ability of rcs-e-tr to capture case complexity, it will be correlated with other scores usually recorded in our rehabilitation services on admission, using Spearman's rank correlation coefficient r(rho). Files will be viewed simultaneously and independently in a blinded manner by three researchers to assess the reproducibility of the scale., 1 week for test retest interrater and intrarater evaluation. 2 months for the study
Cervical Stabilization Exercises on Bruxism and Sleep Quality
NCT Number: NCT06573346
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bruxism|Sleep Quality|Cervical Stabilization Exercise
Interventions: OTHER: Cervical spinal stabilization exercise
Sponsor: Hacettepe University
Collaborators: Necmettin Erbakan University
Sex: FEMALE
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2024-12-30

Summary:
Bruxism and temporomandibular joint dysfunction are common conditions today. The applications in the treatment of these disorders are limited. When the literature is examined, it has been determined that cervical stabilization exercises, which are frequently applied in physical therapy clinics for neck problems, have not been applied to bruxism before. For this reason, in this study, we will examine the effects of cervical stabilization exercises targeting deep cervical muscles on bruxism.

Primary Outcome Measures: Muscle Activation Evaluation, Participants' Masseter, Temporal and Trapezius muscle activation will be evaluated with Superficial Electromyography. (Number of Participants estimated 28 individuals), At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment|Tongue Pressure Evaluation, Tongue pressure will be done by oral muscle measurement. (Number of Participants estimated 28 individuals), At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment|Evaluation of Sleep Quality, Since bruxism affects the sleep quality of patients, the Pittsburg Sleep Quality Index will be used to evaluate sleep quality. (Number of Participants estimated 28 individuals), At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Secondary Outcome Measures: Mouth Opening Evaluation, The amount of mouth opening will be evaluated by adding the vertical coverage amounts of the lower and upper incisors to the distance between the incisal edges of the lower and upper incisors at maximum mouth opening, using a ruler, for pre-treatment, post-treatment and 1 month later follow-up purposes. (Number of Participants estimated 28 individuals), At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment|Tongue Range of Motion Ratio Assessment, In the functional tongue tie classification published by Ferrés-Amat et al., the mouth opening with tongue tip to maxillary incisive papillae at roof of mouth (MOTTIP) and the maximum interincisal mouth opening (MIO) ratio (MOTTIP/MIO ratio is defined as "Tongue range of motion ratio - TRMR") will be used to measure functional tongue limitation. In this classification system, it is stated as Grade 1: tongue range of motion ratio \>% 80, Grade 2: 50-80, Grade 3: \<% 50, Grade 4: \<% 25. (Number of Participants estimated 28 individuals), At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
NCT Number: NCT06573333
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Serum Calcium Concentration
Interventions: PROCEDURE: Umblical Cord Clamping
Sponsor: College of Physicians and Surgeons Pakistan
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2024-09-30
Locations: Pak Emirates Military Hospital, Rawalpindi, Punjab, 45000, Pakistan

Summary:
Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management.

Objective: The objective is to determine the effects of early and delayed cord on serum calcium level in neonates Study Design: Randomized Controlled Trial

Primary Outcome Measures: Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates, Serum Calcium Levels, at 6 hours of life
Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine
NCT Number: NCT06573320
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Clozapine|Exercise
Interventions: OTHER: physical exercise
Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-14
Completion Date: 2024-08-31
Locations: Kartal Dr Lütfi Kırdar Şehir Hastanesi, İstanbul, Turkey

Summary:
This prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with Clozapine.

Primary Outcome Measures: Montreal Cognitive Assessment (MOCA), OCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment., 12 weeks|Positive and Negative Syndrome Scale (PANSS), To evaluate clinical symptoms, both the exercise and control groups will be assessed by using the Positive and Negative Syndrome Scale (PANSS), 12 weeks
Hematological Dynamic Scores for Predicting Survival and Treatment Response for Advanced Gastric Cancer After Neoadjuvant Therapy
NCT Number: NCT06573307
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Sponsor: Chang-Ming Huang, Prof.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 442
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2024-08-26
Locations: Department of Gastric Surgery， Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Summary:
HMDLS, based on hematological markers, could effectively distinguish the long-term efficacy of AGC patients after NAT. The predictive performance of nomogram-HMDLS was better than ypTNM stage, achieving better prognostic stratification and tumor treatment response prediction.

Primary Outcome Measures: 3-year OS, Overall survival, death, survival with tumor, 3-year OS or 36 months|3-year DFS, Disease-free survival, death,recurrence, 3 years DFS or 36 months|Tumor Regression Grade, a grade system evaluates the pathological response based on the degree of tumor tissue regression after NAT., 3 years or 36 months
Da-vinci sp Versus xi Thyroid Surgery
NCT Number: NCT06573268
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Thyroid Cancer|Thyroid Nodule
Interventions: DEVICE: robot surgery device
Sponsor: Inha University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-01
Completion Date: 2024-08-01
Locations: Inha University Hospital, Incheon, 22332, Korea, Republic of

Summary:
One year comparative analysis between SPRA\* versus BABA\*\* thyroid surgery. \* SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery

\*\* BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery

Primary Outcome Measures: Total operation time (minutes), Time for spending total surgery, on the surgery day (1 day)
Secondary Outcome Measures: Hospital stay days after surgery, Hospital admission days after surgery, after the surgery day (up to 2 weeks)
Assessment of Cardiopulmonary Fitness in Healthy Adults
NCT Number: NCT06573255
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy
Interventions: OTHER: Healthy group
Sponsor: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-18
Completion Date: 2025-03
Locations: Hacettepe University, Ankara, Turkey

Summary:
This project was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.

Primary Outcome Measures: Cardiorespiratory Fitness, In this parameter, which is assessed by cardiopulmonary exercise testing, the oxygen consumption measured during the test and the workload achieved in the test will be taken into consideration., This test takes 15 to 20 minutes.
Secondary Outcome Measures: Respiratory Function Test, The pulmonary function test is a test that assesses respiratory function by performing certain manoeuvres., This test takes 3 to 5 minutes.|Respiratory Muscle Strength Test, Inspiratory and expiratory muscle strengths will be measured separately by breathing manoeuvres., This test takes 3 to 5 minutes.|Physical Activity, Physical activity level will be measured with International Physical Activity Questionnaire., This questionnaire takes 1 minute.
Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020
NCT Number: NCT06573216
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure
Interventions: DEVICE: Wrist Ambulatory Blood Pressure Monitor
Sponsor: Huawei Device Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-24
Completion Date: 2024-06-04
Locations: Bin Peng, Chenzhou, Hunan, 423000, China

Summary:
The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.

Primary Outcome Measures: Blood pressure mean deviation and standard deviation- evaluation criterion 1, The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255).

Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg., 30 minutes|Blood pressure mean deviation and standard deviation- evaluation criterion 2, The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85).

Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceed the maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020., 30 minutes|The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring, The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020, specifically in section 5.2.4.1.2a).

The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg., 30 minutes
Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
NCT Number: NCT06573203
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep|Infant，Newborn|Vital Signs
Interventions: DEVICE: Non-contact heart rate and respiratory rate monitoring system|DEVICE: Mindray ECG monitor|DEVICE: aEEG|OTHER: Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Collaborators: Jiaxing Yuanbeibei Technology Co. LTD|Children's Hospital, Zhejiang University School of Medicine
Sex: ALL
Age: CHILD
Enrollment: 70
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-21
Completion Date: 2026-12-31

Summary:
In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.

Primary Outcome Measures: Sleep-wake state, Sleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements., 10minutes after the meal, 5minutes each time, two times in total|Number of sleep cycles, The number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG., The hospital stay lasted 6 hours|Proportion of quiet sleep, non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the quiet sleep time for 6 hours, and then the proportion of quiet sleep was calculated., The hospital stay lasted 6 hours|Proportion of active sleep, non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the active sleep time for 6 hours, and then the proportion of active sleep was calculated., The hospital stay lasted 6 hours
Secondary Outcome Measures: Heart rate, Heart rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average heart rate was calculated., The hospital stay lasted 6 hours|Respiratory rate, Respiratory rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average respiratory rate was calculated., The hospital stay lasted 6 hours
Selinexor, Anti-PD-1 Antibody and P-GemOx Regimen in R/R NKTCL
NCT Number: NCT06573151
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma
Interventions: DRUG: Selinexor, anti-PD-1 antibody and P-GemOx
Sponsor: Ruijin Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-07-01

Summary:
A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody and P-GemOx in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma.

Primary Outcome Measures: Best CRR, CRR defined according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy., through study completion, an average of 1 year]
Selinexor, Anti-PD-1 Antibody Plus Golidocitinib in R/R NKTCL
NCT Number: NCT06573138
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma, Extranodal NK-T-Cell
Interventions: DRUG: Selinexor, anti-PD-1 antibody plus Golidocitinib
Sponsor: Ruijin Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-07-01

Summary:
A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody plus Golidocitinib in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma.

Primary Outcome Measures: Best CRR, CRR defined according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy., through study completion, an average of 1 year
Central Venous Catheter-Related Thrombosis in Critically Ill Patients
NCT Number: NCT06573112
Acronym: CVC-RT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Catheter Related Complication
Interventions: DIAGNOSTIC_TEST: ultrasound assessment for catheter-related thrombosis.
Sponsor: Sultan Qaboos University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 315
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-21
Completion Date: 2025-07-20
Locations: Sultan Qaboos University Hospital, Muscat, 123, Oman

Summary:
This project aims to identify catheter-related thrombosis (CRT) and determine its incidence, associated factors, and outcomes. The eligible patients will undergo daily ultrasound just distal to the central venous catheter insertion site for CRT. A staff radiologist will review all positive cases. These cases will be monitored by daily ultrasound examination till three days after the removal of the catheter or till the patient stays in the intensive care unit (ICU). The patient demographics, ICU treatment details, and outcomes will be noted. The data will be then analyzed. A preventive strategy will be prepared and disseminated to the department personnel to improve the quality of care.

Primary Outcome Measures: Incidence of Catheter-related thrombosis (CRT), Incidence of CRT in critically ill patients, one year approximately
Secondary Outcome Measures: Rate of cases developing ischemic complications, Rate of new onset of myocardial infarction (diagnosis by electrocardiogram \[ECG\] + troponin), stroke, gut ischemia, spleen, liver, and kidney infarction (diagnosis by computerized tomography \[CT\] scan), one year approximately|Presence of factors associated with the development of CRT, Association of presence of various factors with the development of CRT (measured by uni- and multivariate regression analysis) like demographics (age\>60 years, gender), co-morbidities (diabetes, hypertension, heart disease, chronic obstructive pulmonary disease, stroke, kidney failure, lymphoma/leukemia, sickle cell disease), treatment modalities (medications: antibiotics, thrombogenic medications, hyper-osmolar medications; derangement in lab values like thrombocytosis, polycythemia, plasma albumin level \[g/dl\] above or below normal range, presence/absence of deep vein thrombosis prophylaxis; ventilation days more than 7 days) extracorporeal therapies (presence/absence of dialysis, plasmapheresis, and extracorporeal membrane oxygenation), and catheter-related factors like catheter-vein diameter ratio more than 33% and number of catheter days more than 10 days, one year approximately|Mortality at 28 and 90 days, Mortality at 28 and 90 days till hospital discharge, one year approximately|Length of stay in ICU, Length of stay in ICU for each episode of ICU admission, one year approximately
A Real-World Study on Extranodal Lymphoma
NCT Number: NCT06573099
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Extranodal Lymphoma|Diffuse Large B Cell Lymphoma
Interventions: OTHER: No interventions need to be specified for this study
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2029-09-01

Summary:
The aim of this study is to prospectively collect clinical information on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population.

Primary Outcome Measures: Progression Free Survival (PFS), Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause., Baseline up to data cut-off (up to approximately 1 year)
Secondary Outcome Measures: Overall Survival (OS), Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause., Baseline up to data cut-off (up to approximately 1 year)
Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS
NCT Number: NCT06573060
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type 2 Diabetes Mellitus|Coronary Heart Disease
Interventions: DEVICE: Continuous glucose monitoring
Sponsor: Second Affiliated Hospital of Nanchang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-05
Completion Date: 2025-09-30
Locations: The Second Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, 330000, China

Summary:
Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.

Primary Outcome Measures: Major adverse cardiovascular events, Composite Major Adverse Cardiovascular Events (MACE), 2023.7-2025.10
Secondary Outcome Measures: cardiovascular mortality, Deaths due to heart and/or vascular disease. According to the World Health Organisation (WHO) classification, cardiovascular diseases include a wide range of diseases such as coronary heart disease, myocardial infarction, stroke and hypertension., 2023.7-2025.10|ACS Recurrence, Refers to the recurrence of a new ACS event after an episode of ACS. Depending on the signs and symptoms, patients can be classified as having STEMI, NSTEMI, or unstable angina., 2023.7-2025.10|Angina requiring revascularisation, Presence of indications for coronary revascularisation, 2023.7-2025.10|Acute decompensated heart failure requiring hospitalisation, Clinical syndrome caused by acute imbalance of oxygen supply and demand due to impaired cardiac function, manifested by dyspnoea, pulmonary oedema and peripheral oedema. The patient's condition is severe enough to require hospitalisation., 2023.7-2025.10|Strokes requiring hospitalisation, An acute disease with sudden defects in brain function, such as sudden motor, sensory, speech, and vision disorders. The patient's condition is serious enough to require hospitalisation for treatment and observation., 2023.7-2025.10
Thoracic KT on Pulmonary Function Ichildren With Pneumonia
NCT Number: NCT06573047
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumonia Childhood
Interventions: OTHER: kinesotape|BEHAVIORAL: Chest physiotherapy exercises
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12

Summary:
The purpose of study is to investigate the effect of thoracic kinesio-tape on Pulmonary Function ( VC - FVC - FEV1 - FEV1/ FVC ratio - PEF ) ,Time to clinical resolution and respiratory rate and arterial oxygen saturation in children with pneumonia

Primary Outcome Measures: pulmonary function, assesment of pulmonary function (VC-FVC-FEV1-FEV1/FVC ratio-PEF) will carried out by using digital spirometer (ZAN 100 flow handy II, ZAN, Oberthulba, Germany), baseline- 15min for each participant
Fluorescent Cholangiography in Acute Cholecystitis
NCT Number: NCT06573021
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Cholecystitis
Interventions: DRUG: Near-infrared fluorescent cholangiography
Sponsor: University Hospital of Ferrara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 81
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-05-31
Locations: Unità Operativa Qualità, Accreditamento, Ricerca organizzativa, Ferrara, 44123, Italy

Summary:
Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis.

Primary Outcome Measures: Efficacy of near-infrared fluorescent cholangiography in emergency cholecystectomy, The primary aim was to analyze the correct visualization by fluorescence of extrahepatic bile ducts (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct, and any accessory or aberrant ducts) before and after Calot's dissection in different grades of severity of acute cholecystitis according to the AAST classification, particularly distinguishing non-gangrenous forms (grade I) from gangrenous and complicated forms (grades II-V)., From start of surgery to the end of Calot's triangle dissection
Secondary Outcome Measures: Conversion rate in emergency cholecystectomy by fluorescence, Conversion rate (from laparoscopy to open approach), perioperatively|The bail-out procedures rate in emergency cholecystectomy by fluorescence, Bail-out procedures during surgery, such as subtotal cholecystectomy, antegrade cholecystectomy, perioperatively|The rate of bile duct injuries in emergency cholecystectomy by fluorescence, Iatrogenic bile duct injuries, perioperatively|The duration of surgery in emergency cholecystectomy by fluorescence, Total surgery duration (minutes), perioperatively|Analysis of post-operative complications in emergency cholecystectomy by fluorescence, Postoperative complications according to Clavien-Dindo classification, up to 30 days|The length of stay in emergency cholecystectomy by fluorescence, Length of hospital stay, perioperatively
Thoracic Fluid Content During Stabilization and Therapeutic De-escalation in Septic Shock
NCT Number: NCT06572995
Acronym: TFC-SEPSIS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis|Septic Shock|Hemodynamic Instability|Fluid Overload
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2025-06-01
Locations: Chu Brest, Brest, 29200, France|Hegp - Aphp, Paris, 75015, France

Summary:
In ICU, fluid challenge represents one of the cornerstones of hemodynamic care. However, fluid overload due to an excessive and/or inappropriate fluid administration could be associated with morbidity or mortality. Unfortunately, there is currently no continuous non-invasive devices to monitor fluid content at bedside. Bio reactance is a non-invasive, rapid and continuous technology developed in order to measure body fluid compartment. Monitoring devices functioning with such technology are promising to evaluate fluid overload in ICU.

Primary Outcome Measures: Changes in daily body weight, Evaluation of correlation between daily body weight and thoracic fluid content, Daily, during the first 10 days|Changes in extra vascular lung water, Evaluation of correlation between extra vascular lung water and thoracic fluid content, Daily, during the first 10 days|Changes in daily fluid balance, Evaluation of correlation between fluid balance and thoracic fluid content, Daily, during the first 10 days
Secondary Outcome Measures: Length of ICU stay, Number of day from admission to ICU leaving, during ICU stay (up to 10 days)|Length of hospital stay, Number of day from admission to hospital leaving, during hospital stay (up to 10 days)|Ventilator free days at Day 28, Number of day alive without mechanical from ICU admission to Day 28, Day 28|Mortality at Day 28, Survival (Yes/No), Day 28|Short Form-12, Quality of life will measured by Short-Form 12 questionnaire. This validated scale contains sub-scale which explore eight domains: physical activities, social activities, usual role in activities, pain, mental health, emotional problem, vitality, general health perceptions. A higher Short Form-12 score is associated with a better quality of life, a lower Short Form-12 score is associated with a lower quality of life. The minimum score is 10 and the maximum is 60., 3 months|Percentage of patients who return at home, Evaluation of rehabilitation with the proportion of patients able to return at home, 3 months|Percentage of patients who have professional activities, Evaluation of rehabilitation with the proportion of patients able to return at professional activities, 3 months
Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
NCT Number: NCT06572982
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: Azacitidine
Sponsor: Hikma Pharmaceuticals LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-05

Summary:
Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number: HIK-AZA-2023-01

Primary Outcome Measures: Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug, Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug, Up to 12 months
Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
NCT Number: NCT06572956
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc
Interventions: BIOLOGICAL: CAR-T/CAR-NK cell injection
Sponsor: The Second Hospital of Shandong University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-21
Completion Date: 2025-03-01
Locations: Shandong Province, Jinan, Shandong, 250000, China

Summary:
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc

Primary Outcome Measures: ORR, Proportion of patients with PR or CR., 2024.11|PFS, The time from the start of a randomized clinical trial until tumorigenesis (any aspect) progresses or death from any cause., 2024.11
Serum FSH Monitoring for Identification of an Optimal Range During Ovarian Stimulation
NCT Number: NCT06572930
Acronym: FSH
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Stimulation
Interventions: DRUG: Gonal-f (gonadotropin)
Sponsor: ART Fertility Clinics LLC
Sex: FEMALE
Age: ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-25
Completion Date: 2025-10-01
Locations: ART Fertility Clinics, Abu Dhabi, 60202, United Arab Emirates

Summary:
This study examines if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict oocyte yield and progesterone levels, considering factors like age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH. The aim is to find a minimum FSH level that ensures optimal ovarian response and enables tailored FSH dosages for better outcomes.

Primary Outcome Measures: Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays., serum FSH levels during ovarian stimulation, 1 year
Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
NCT Number: NCT06572904
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Temporomandibular Joint Internal Derangement
Interventions: DRUG: Tenoxicam Injectable Product|DRUG: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-20
Completion Date: 2024-11-20
Locations: Mansoura university, Mansoura, 35511, Egypt

Summary:
To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction.

Primary Outcome Measures: Intracapsular Pain and pain during movement, Pain intensity will be measured by VAS score. Zero score for no pain and 10 score for worst pain experienced, at 1 week, 4, 12, and 24 weeks|Clicking sound, Clicking sound will be assessed as to its presence = 1 or absence =0., at 1 week, 4, 12, and 24 weeks|Maximum inter-incisal opening (MIO), Maximum inter-incisal opening (MIO): was measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors., at 1 week, 4, 12, and 24 weeks
Secondary Outcome Measures: Magnetic Resonance Imaging (MRI) evaluation, Magnetic resonance imaging (MRI) (open and closed) will be done for all patients to diagnose the patients with internal derangement with reduction The MRI protocol included bilateral sagittal oblique proton-density images of the right and left sides in both the closed-mouth (maximum intercuspation) and maximum mouth opening positions., will be done at 24 weeks postoperatively
Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients
NCT Number: NCT06572891
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Satisfaction
Interventions: OTHER: Maxillary obturator|OTHER: Implant supported obturator
Sponsor: Mansoura University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-07
Completion Date: 2024-07-20
Locations: Faculty of dentistry, mansoura university, Mansoura, Dakahlia, 35511, Egypt

Summary:
This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.

Primary Outcome Measures: Patient Satisfaction, Patient Satisfaction Based on Visual Analog Scale (VAS), 6 months
Secondary Outcome Measures: Oral health impact profile for edentulous patient (OHIP-EDENT), - Oral health impact profile for edentulous patient (OHIP-EDENT), 6 months|- Obturator Functioning Scale, - Obturator Functioning Scale, 6 months
Identifying Parents in Child Welfare Services Who Need Mental Health Support: Depression and Anxiety Symptoms
NCT Number: NCT06572865
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Illness|Depression|Anxiety
Interventions: OTHER: Screening for depression and anxiety
Sponsor: Karolinska Institutet
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 290
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-30

Summary:
The main aim of this study is to examine the occurrence of mental health symptoms among parents referred to the Swedish child welfare services for child maltreatment and other family related risks. Additionally, to examine any variables associated with parents' level of depression and anxiety.

Parents will respond to questionnaires administered by social workers. The level of depression and anxiety will be descriptively and statistically compared to clinical and normative samples. Additionally, statistical analyses will examine variables associated with parents' mental health symptoms.

Primary Outcome Measures: The Patient Health Questionnaire, The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression., At inclusion, each participant will be assessed one time only.|The GAD-7, The 7-item GAD-7 will measure symptoms of anxiety. Items are scored 0-3, resulting in a total score of 0-21. Higher scores indicate more symptoms of anxiety., At inclusion, each participant will be assessed one time only.
Secondary Outcome Measures: Parents' background, Parent will respond to a few questions about their background when responding to the screening questionnaire., At inclusion, each participant will be assessed one time only.|Characteristics of the contact with child welfare services, In parents' questionnaires, previous contact with child welfare services will be noted and the reason to the child welfare report., At inclusion, each participant will be assessed one time only.|Parents' contact with mental health services, In the screening questionnaire, parents will be asked whether they are currently or have previously been in contact with healthcare services for their mental health., At inclusion, each participant will be assessed one time only.
Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
NCT Number: NCT06572839
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Interventions: OTHER: Amnio-Maxx
Sponsor: Capsicure, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2025-09-30

Summary:
This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

Primary Outcome Measures: Wound Closure Assessment Verified with Independent Adjudication, To demonstrate increased healing rates of chronic wounds (diabetic foot ulcers), unresponsive to standard therapy., 12 weeks|Percentage Area Reduction verified with Independent Adjudication, To demonstrate increased healing rates of chronic wounds (diabetic foot ulcers), unresponsive to standard therapy., 12 weeks
Secondary Outcome Measures: Reduction of Subjects Pain Levels, Subject pain assessed through the Numeric Pain Rating Scale on a weekly basis throughout the study, 12 weeks|Reduction in Adverse Events, Reduction in Adverse Events estimated from the observed data through physician reporting, 12 weeks
Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)
NCT Number: NCT06572826
Acronym: ENIGMA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiogenic Shock
Interventions: OTHER: Cardiac Rehabilitation intervention
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Collaborators: Ospedale Civile Ss. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy|Azienda Ospedaliera Brotzu|Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona|ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2026-08-31

Summary:
This is a prospective and retrospective multicentre study conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health (PNRR-MCNT2-2023-12377767). Using the Altshock registry, the largest multicentre Cardiogenic Shock (CS) registry in Italy, which currently has registered more than 1,000 CS patients across Italy, we will recruit patients to: (1) provide a granular assessment of post-acute phase programmes, patients' functional disability, return to work and quality of life, including specific reference to gender; (2) implement specific pathways of care in the post-acute phase; (3) provide a multidimensional assessment, thus validating an innovative model in comparison with the traditional pathway, defining the potential benefits to and impact on economic efficiency and the general sustainability of this therapeutic trajectory.

Primary Outcome Measures: All-cause of death, Incidence of all-cause death, 1 Year|Readmission in hospital for any cause, Incidence of readmission, 1 Year
Secondary Outcome Measures: Severity of critical illness polyneuropathy, Assessment using clinical evaluation (using the Medical Research Council Scale for Muscle Strength), with electromyography and nerve conduction if required, 6-months|Disease-specific PROM, The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a specialized tool designed to assess the health-related quality of life in patients with heart failure. It measures the physical, social, and emotional impacts of heart failure, providing insights into the effectiveness of treatments and guiding clinical decisions., 6-Months|Chronic-condition PROM, standardized by the Food and Drug Administration and the Oxford Patient-Reported Outcomes Group's Long-Term Conditions Questionnaire, 6-months|PREMS: patient's opinion regarding their clinical service., Patients will be questioned about the clinical service received. The items explored will be coordination and integration of care; information, communication, and education; physical comfort; emotional support; welcoming and involvement of family and friends; transition and continuity; and access to care. Patients will define every item in terms of low quality, moderate quality and high quality., 6-months
Bortezomib Combined With PD-1 mAb and mFOLFIRINOX for Metastatic Pancreatic Cancer
NCT Number: NCT06572813
Acronym: CISPD-7
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Pancreas Cancer
Interventions: DRUG: Bortezomib Injection|DRUG: Sintilimab|DRUG: mFOLFIRINOX
Sponsor: Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 63
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-03

Summary:
This is an single-center, prospective, open-label clinical trial, to explore the safty and efficacy of combination of Bortezomib, Sindilizumab, and mFOLFIRINOX Chemotherapy (oxaliplatin, fluorouracil, irinotecan, leucovorin) in metastatic pancreatic cancer

Primary Outcome Measures: Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0，including Complete Blood Count, liver function, renal function lab test and other blood test will be evaluated by using CTCAE 5.0 during study., Up to 2 years.|Phase 2: Objective reponse rate (ORR), The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase 2, Up to 2 years
Secondary Outcome Measures: Disease control rate (DCR), The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during phase 2, Up to 2 years|Duration of remission （DoR）, The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during phase 2, Up to 2 years|Progression-free survival （PFS）, The time from enrolled to disease pregression or death from any cause during phase 2, Up to 2 years|Overall survival (OS), The time from enrolled to death from any cause during phase 2, Up to 2 years
Family Centered Services in Cerebral Palsy
NCT Number: NCT06572787
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Sponsor: Hacettepe University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-20
Completion Date: 2024-05-27

Summary:
To examine the family-centered service characteristics of physiotherapy and rehabilitation services received by children with cerebral palsy (CP) and to investigate the affecting factors.

Primary Outcome Measures: Measure of Processus of Care, Measure of Processus of Care-20 (MPOC-20) survey was administered to assess parents' perceptions of the family-centered features of physiotherapy and rehabilitation services. The appropriate answers to the questions in the survey are marked with a number from 1 (strongly disagree) to 7 (strongly agree). A value of zero (0) indicated not personally relevant., 3 months
Secondary Outcome Measures: Impact on Family Scale, The Impact on Family of Scale (IPFAM) scale was used to determine impact of the child with CP on parents. IPFAM consists of 33 items in total. The family's level of involvement is measured under 5 headings.The scale has a Likert-type evaluation ranging from 1 to 4. A low score from the survey indicates a high level of family involvement, 3 months|Nottingham Health Profile, The Nottingham Health Profile (NHP) was used to measure parents' health-related quality of life. NHP is a scale used to assess quality of life. This profile was developed to measure the physical, emotional and social health status of individuals. The questionnaire consists of 7 subsections and a total of 45 items. The maximum score that can be obtained from the questionnaire is 607. High scores indicate low quality of life and low scores indicate high quality of life, 3 months