pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Influence of Intermittent Hypoxia on Glycemic Control
NCT Number: NCT06490900
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoxemia
Interventions: BEHAVIORAL: Intermittent hypoxia|BEHAVIORAL: Intermittent normoxia
Sponsor: University of Texas at Austin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-02-05
Completion Date: 2025-06
Locations: The Unviersity of Texas at Austin, Austin, Texas, 78712, United States

Summary:
The aim of this research project is to determine the effect of intermittent hypoxia on glucose uptake in response to an oral glucose tolerance test in healthy individuals, individuals with prediabetes and patients with type 2 diabetes.

Primary Outcome Measures: Change in plasma glucose levels, Plasma glucose levels obtained from a venous catheter during a 2-hour oral glucose tolerance test, Collected at min 0, 30, 60, 90 and 120 minutes of the oral glucose tolerance test
Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)
NCT Number: NCT06490887
Acronym: SUIT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Degenerative Disc Disease
Interventions: OTHER: Use of patient-derived biological samples
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-28
Completion Date: 2025-08
Locations: IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, MI, 20157, Italy|IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione, Palermo, 90127, Italy

Summary:
Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc.

In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. Given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the DDD-related pathways and to screen promising treatments such as MSC-based therapies.

Primary Outcome Measures: Efficacy of MSC-derived secretome, Changes in gene expression in response to the treatment of the spine unit model with MSC-derived secretome. If the MSC-derived secretome is effective, genes upregulated or downregulated by inflammatory stimulation are expected to go back to their basal levels when the inflamed model is treated with MSC-derived secretome., 30 months
Secondary Outcome Measures: Characterization of patient-specific degenerative features, Identification of circulating degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating with tissue degeneration., 30 months|Development of an organotypic spine unit model, Determination of success or failure in the development of spine unit models for each enrolled patient from which cell isolation has been successful., 30 months
Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease
NCT Number: NCT06490861
Acronym: PARPIV23
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: DEVICE: Paragit
Sponsor: Paragit ApS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-12-19
Completion Date: 2024-12-31
Locations: Hospital Beata María Ana, Madrid, Spain

Summary:
This investigation is undertaken to:

* Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
* To assess the safety and tolerability of the device in patients with PD.

Primary Outcome Measures: Tremor, Tremor will be assessed using the device, measured with superficial EMG \[Volts\], and inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied., During the clinical assessment, and for the following 24h.|Bradykinesia, Bradykinesia will be assessed using the device, measured inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied., During the clinical assessment, and for the following 24h.|Rigidity, The device will assess rigidity, measured with superficial EMG \[Volts\], and inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied., During the clinical assessment, and for the following 24h.|Dyskinesia, The device will assess rigidity, measured with superficial EMG \[Volts\], and inertial measurement unit \[m/s2\]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied., During the clinical assessment, and for the following 24h.
Secondary Outcome Measures: Safety, Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality., During the clinical assessment , and for the following 24h.|Usability, The usability of the device will be studied using a questionnaire., During the clinical assessment , and for the following 24h.
Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods
NCT Number: NCT06490848
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Angiography
Interventions: PROCEDURE: Diagnostic cerebral angiography
Sponsor: Mashhad University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-01-01
Completion Date: 2024-12-01
Locations: Mashhad university of medical sciences, Mashhad, Razavi Khorasan, Iran, Islamic Republic of

Summary:
Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

Primary Outcome Measures: technical success, Incidence of sucess of performing the programmed cerebral angiogram through the randomised access without for crossover., during procedure|access success, Incidence of puncture success to insert a sheat in the access point, during procedure
Secondary Outcome Measures: total procedure time, the duration (minutes) between the insertion of sheath and removal of sheath. fluoroscopy time, the need for performing 3D angiography, dose area product (DAP), total radiation dose, successful puncture (successful insertion of radial artery sheath and femoral artery sheath). Procedures that yielded angiograms with acceptable quality through the subclavian artery injection (with an inflated blood pressure cuff on the arm), in cases of failed vertebral artery cannulation, were also considered successful., during procedure|total fluoroscopy time, the duration of fluoroscopy, during procedure|complication, incidence of any procedural-related complication procedure, during procedure or one week after procedure
Other Outcome Measures: Patient Satisfaction, The pain evaluation by the Visual analog score (VAS) by trained nurses and recorded as the scoring system (No pain: 0; Mild:1-3; Moderate:4-7; Severe:8-10)., immediately after procedure, one hour after the procedure
Minimal Clinically Important Difference of the Box and Block Test in Parkinson
NCT Number: NCT06490809
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: OTHER: Physiotherapy
Sponsor: Emre Şenocak
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-10-01
Completion Date: 2025-05-01
Locations: Private Güney Hospital, İstanbul, 34230, Turkey

Summary:
The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.

Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.

Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.

Primary Outcome Measures: Box and Block Test, This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity., Baseline of the study|Box and Block Test, This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity., 6 weeks (5 session days for 6 weeks)|Global Rating of Patient-Perceived Changes (GRP-PC), GRP-PC will used to assess patient-perceived hand dexterity changes after the routine intervention. The patient will first asked, "Has your hand dexterity changed compared to when you did not receive interventions?". If the answer is no, the person will given a score of 0 (i.e. no change). In the case of positive response, the patient will asked, "How much better or worse is your hand dexterity" and the patient response will scored on the following 14-point Likert scale: +7 (very much better), +6 (much better), +5 (better), +4 (relatively better), +3 (somewhat better), +2 (a little better), +1 (very little better), -1 (very little worse), -2 (a little worse), -3 (somewhat worse), -4 (relatively worse), -5 (worse), -6 (much worse), and -7 (very much worse). This form will only be used to classify patients' satisfaction with treatment at the end of the study., 6 weeks (5 session days for 6 weeks)
Secondary Outcome Measures: Demographic Data Form, This form was created by researchers and it consist of personal informations such as gender, education, age, body mass index, dominant and affected extremity, disease duration, using medicine, Baseline of the study
Evolution of Respiratory Function in Lung Transplant Patients With Moderate to Severe Covid-19 Infection
NCT Number: NCT06490744
Acronym: Cov- EvoLuT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: COVID-19 Respiratory Infection
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-04
Completion Date: 2024-12-31
Locations: Service d'Anesthésie Réanimation - CHU de Strasbourg - France, Strasbourg, 67091, France

Summary:
The SARS-Cov-2 infection pandemic has caused a large number of acute respiratory failures and deaths across the world. Certain factors have been identified as associated with a higher risk of developing a severe form and dying. Immunosuppression has been identified as a risk factor for progressing to a severe form.

Lung transplant patients were particularly vulnerable during this period, with a high frequency of respiratory compromise, sometimes progressing towards acute respiratory distress syndrome and, at a later stage, towards fibrotic forms. The impact of the infection on the immunological status of the patient and on the tolerance of the transplant have been little studied. The various treatments implemented during the pandemic have rapidly evolved (immunotherapy, vaccination, convalescent plasma transfusion, etc.) which may have modulated this risk. The evolution of respiratory function may be linked to the respiratory infection itself, or to the severity of respiratory damage during the infection. It is therefore relevant to compare patients with a moderate form of COVID-19 (non-intubated patients) to patients with severe forms, requiring invasive ventilation in intensive care. The evolution of respiratory function after infection has not yet been studied.

Primary Outcome Measures: Retrospective description of the evolution of respiratory function in lung transplant recipients after moderate to severe Covid-19., This retrospective study concerns lung transplant patients who had a Covid-19 infection and were treated at the Strasbourg University Hospital during the period from March 1, 2020 to December 31, 2022., Files analyzed retrospectively cover the period from March 1, 2020 to December 31, 2022.
Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients
NCT Number: NCT06490731
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Haemodynamic Rebound
Interventions: DRUG: Dexmedetomidine|DRUG: Ketamine
Sponsor: New Valley University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2024-08-01
Completion Date: 2026-01-01

Summary:
Inflammatory response and hemodynamic response in patients with intraabdominal sepsis and Effects of Dexmedetomidine versus ketamine on it .

Primary Outcome Measures: blood pressure, Effect of the study drugs as sedative agents on blood pressure in mechanically ventilated septic patients after abdominal exploration for intestinal surgery., 48 hours
Comparing Quality of Recovery Between ESPB and IV Lidocaine After Major Breast Cancer Surgery
NCT Number: NCT06490718
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Neoplasms
Interventions: DRUG: USG ESPB|DRUG: Intravenous Infusion
Sponsor: Chinese University of Hong Kong
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07
Locations: The First Affiliated Hospital, Guangzhou, Guangdong, China|North District Hospital, Sheung Shui, 999077, Hong Kong

Summary:
The erector spinae plane block (ESPB) is gaining popularity as a regional anesthetic technique for major breast cancer surgery. Although there is controversy about its mechanism of action, emerging evidence suggests that clinical analgesia observed after ESPB in breast surgery may be due to rapid and sustained local anesthetic absorption from the injection site. Hence intravenous LA infusion (IVLI) during the perioperative period could offer an effective alternative to invasive ESPB.

Primary Outcome Measures: Quality of Recovery, Quality of Recovery-15: a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery), At 24 hours post surgery|Area under the curve of postoperative pain, Area under the curve of postoperative pain numerical rating score at rest and movement, Over the first 24 hours post surgery
Secondary Outcome Measures: Postoperative opioid consumption, Total postoperative morphine equivalent consumption, At 24 and 48 hour post surgery
The Effect of Blood Flow Restriction Training on Tennis Elbow
NCT Number: NCT06490692
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tennis Elbow|Lateral Epicondylitis|Lateral Epicondylitis, Unspecified Elbow
Interventions: OTHER: Blood Flow Restriction Training|OTHER: Conventional Strength Training
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-29
Completion Date: 2024-11-01
Locations: Beirut Arab University, Beirut, 0000, Lebanon

Summary:
The goal of this randomized controlled clinical trial is to investigate the effects of blood flow restriction training on the parameters surrounding tennis elbow afflicted patients including pain, disability, and grip strength.

The main question this study aims to answer is:

1- Does blood flow restriction training offer significantly better effects on pain, disability, and grip strength when compared to conventional strength training without blood flow restriction in patients afflicted with tennis elbow? Research will compare two groups with tennis elbow where both will perform the same rehabilitation program consisting of conventional physical therapy for tennis elbow as well as a strength training program with the only difference being that one group will undergo blood flow restriction training while the other will not.

Primary Outcome Measures: Hand Grip Strength, The hand grip strength was tested using a Camry Dynamometer, which is a smedly spring type dynamomter, whose reliability and validity in measuring handgrip strength has been reported by available literature., Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
Secondary Outcome Measures: Patient Related Tennis Elbow Evaluation Scale (PRTEES), A scale specifically developed for Lateral Epicondylitis and it was used to determine forearm pain and disability, this scale consists of two parts, namely pain (5 items) and functional activities (10 items), each item has a score from 0 (no pain at all when performing a task) to 10 (the worst pain or unable to perform the task). The total score is the combined score of the 2 parts (OZMEN, KOPARAL, KARATAS... et al 2021), and it is proven that it is a reliable and valid tool for measuring pain and disability in LE patients (Jafarian, Barati, Sadeghi-Demneh 2021), Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).|Numerical Pain Rating Scale (NPRS), A widely used 11-point scale (0-no pain, 10- sever pain) which has been proven to have good test reliability in individuals with chronic pain (Cheatham, Stull, Kobler 2018), Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
(∆PI) to Predict Post-spinal Anesthesia Hypotension
NCT Number: NCT06490666
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spinal Anesthesia Hypotension
Interventions: DEVICE: femoral artery doppler
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2024-10-30
Locations: Cairo University, Cairo, Egypt

Summary:
we aimed to evaluate the change in femoral artery pulsatility index as a predictor to post-spinal anesthesia hypotension

Primary Outcome Measures: change in pulsatility index to predict post spinal anesthesia induced hypotension, to measure PI before and after spinal anesthesia, baseline and immediately after spinal anesthesia
Secondary Outcome Measures: change in resistive index to predict post spinal anesthesia induced hypotension, to measure RI before and after spinal anesthesia, baseline and immediately after spinal anesthesia|change in waveform morphology to predict post spinal hypotension, change of waveform morphology before and after spinal anesthesia, before and immediately after spinal anesthesia
Tranexamic Acid Versus Blood Stopper Treatments in Epistaxis Management
NCT Number: NCT06490653
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Epistaxis Nosebleed
Interventions: DRUG: Blood Stopper (Ankaferd)
Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 186
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-12

Summary:
In this randonmized controlled trial, aim to compare the effectiveness of local administration of tranexamic acid and blood stopper (Ankaferd®) on cessation of bleeding in epistaxis patients.

Primary Outcome Measures: Cessation of bleeding, Primary outcome was definition cessation in bleeding at 10-minutes after performing local drug interventions., 10-minutes after performing local drug interventions.
Secondary Outcome Measures: Re-bleeding, The secondary outcome was a comparison of the re-bleeding rate within 24 hours in the two treatments groups., From cessation of bleeding to re-bleeding within 24-hours.
Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage
NCT Number: NCT06490640
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Spontaneous Subarachnoid Hemorrhage
Interventions: OTHER: Spontaneous subarachnoid haemorrhage survival cohort|OTHER: Spontaneous subarachnoid haemorrhage mortality cohort
Sponsor: Melike Cengiz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 117
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-06-15
Locations: Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey, Antalya, Turkey

Summary:
Spontaneous subarachnoid haemorrhage (SAH) is a serious cerebrovascular disease with high morbidity and mortality.Determining the factors associated with mortality in the ICU follow-up and treatment of patients with spontaneous SAH is very important for clarifying these uncertainties and improving ICU outcomes.In the literature, there are very few studies analysing ICU mortality and mortality-related factors in this patient group.The aim of this study was to determine the demographic/clinical characteristics and factors affecting the mortality of spontaneous SAH patients admitted in the ICU.

Primary Outcome Measures: determine mortality and causes, determine mortality and its causes in patients with spontaneous subarachnoid haemorrhage, 01 January 2019-31 December 2023
Secondary Outcome Measures: factors affecting mortality, evaluate the clinical characteristics and factors affecting mortality in subarachnoid haemorrhage, 01 January 2019-31 December 2023
Use of Sevoflurane to Test Concept of Cognitive Reserve
NCT Number: NCT06490588
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cognitive Reserve|BIS
Interventions: OTHER: sevoflurane
Sponsor: Los Angeles General Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-09

Summary:
Previous pilot study had demonstrated a correlation between cognitive reserve and BIS variability during steady state of anesthesia. This study, we intend to evaluate the association between BIS variability and emergence and recovery time from anesthesia.

Primary Outcome Measures: intraoperative BIS variability, 360 minutes
Secondary Outcome Measures: time to recovery, 120 minutes
Using Nonpharmacological Approaches in Hypertension Prevention and Management
NCT Number: NCT06490575
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Blood Pressure|Hypertension
Interventions: OTHER: Educational Intervention Based on Protection Motivation Theory to Improve Knowledge and Promote Nonpharmacological Approaches to Prevent and Manage Hypertension among Adults
Sponsor: Kansas State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-12-18
Completion Date: 2023-02-20
Locations: Justin Hall, Manhattan, Kansas, 66502, United States

Summary:
The goal of this randomized controlled trial is to test the effectiveness of a four-module nutrition education resource promoting nonpharmacological approaches to prevent and manage hypertension. The main questions it aims to answer are:

* Does the educational intervention increase the knowledge of using nonpharmacological approaches in preventing and managing hypertension among participants?
* Does the educational intervention improve participants' lifestyle behaviors to prevent and manage hypertension? Researchers will compare a four-module educational intervention with a control group (no educational information received until after the study) to see if the educational intervention works to improve knowledge and healthy lifestyle behaviors in preventing and managing hypertension.

Participants will:

* Attend a 30-minute workshop every week for 4 weeks or no workshop at all
* Complete a survey on demographic information, knowledge, lifestyle behaviors, and quality of life at baseline and end of the study
* Complete a dietary 24-hour food recall at baseline, two weeks into the study, and at the end of the study
* Monitor blood pressure levels two times a day for four weeks

Primary Outcome Measures: Demographic and lifestyle pre- and post-survey instrument, The survey includes items on knowledge, risk perceptions, assessment of response efficacy and self-efficacy, intention for behavior change, and lifestyle behaviors., 6 weeks|ASA24 automated self-administered 24-hour food recall, This tool is based upon the validated Automated Multiple-Pass Method (AMPM) to collect dietary data using the 24-hour food recall., 6 weeks
Secondary Outcome Measures: 36-item quality of life, The SF-36 includes one multi-item scale that assesses four major components: general health, mental health, physical health, and social function., 6 weeks
Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
NCT Number: NCT06490562
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Graft-versus-host Disease
Interventions: DRUG: PDCy|DRUG: Non Cy
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2028-12

Summary:
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.

Primary Outcome Measures: Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI., Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI., Until the end of the study
Secondary Outcome Measures: 1-year overall survival rate (OS), 1-year overall survival rate (OS), 1 year after the last patient was enrolled|1-year recurrence rate (CIR), 1-year recurrence rate (CIR), 1 year after the last patient was enrolled|1-year non recurrent mortality rate (NRM), 1-year non recurrent mortality rate (NRM), 1 year after the last patient was enrolled|The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD), The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD), 1 year after the last patient was enrolled|The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups., The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac, 1 year after the last patient was enrolled
An Epidemiological Study to Investigate the Characteristics of RSV Infection in Adult Hematopoietic Cell Transplant Recipients or Hematological Malignancies Patients in Tianjin HI (Hematology Institute)
NCT Number: NCT06490549
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: RSV Infection
Interventions: OTHER: RSV infection observation cohort
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-30
Completion Date: 2025-06-20
Locations: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China

Summary:
This primary objective of this study is to describe the incidence of RSV infection in adult hematopoietic cell transplant recipients OR hematological malignancies patients in Tianjin HI.

Primary Outcome Measures: the incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the study site, infection incidence, 1 year|the Incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the hospital, infection incidence, 1 year
Secondary Outcome Measures: the clinical characteristics of RSV infection, symptoms description and scoring of RSV infection, 1 year|Clinical outcome and relevant risk factor of RSV infection, Clinical outcome and relevant risk factor of RSV infection, 1 year|Virological characteristics of RSV infection from D1 through D28, D42 or even longer, Clinical outcome and relevant risk factor of RSV infection, 1 year
Prognostic Significance of Mutation Type and Chromosome Fragility in Fanconi Anemia
NCT Number: NCT06490510
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fanconi Anemia
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 227
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-16
Completion Date: 2024-06-18
Locations: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau, Barcelona, 08041, Spain

Summary:
The goal of this observational study is to analyze the data included in the Spanish Registry of Patients with Fanconi anemia to better understand the natural history of the disease, identify genetic risk and prognostic factors, and identify potential therapeutic strategies.

Primary Outcome Measures: Description of the clinical evolution of the patient, Study the clinical evolution of patients with Fanconi anemia, 1 month
Expectations and Needs of a Glioblastoma Caregiver
NCT Number: NCT06490497
Acronym: GLOIOS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Glioblastoma
Interventions: OTHER: Interview
Sponsor: Hopital Nord Franche-Comte
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-26
Completion Date: 2024-06-20
Locations: Hôpital Nord Franche-Comté, Trévenans, 90400, France

Summary:
Cancers of the central nervous system have a poor prognosis. Glioblastoma is most common glial tumor of the central nervous system. The presence of a tumour in the brain determines the particular and specific nature of care for these patients and their families. Symptoms affect daily life and the balance of the family sphere.It's easy to imagine a difficult and disturbed family's daily routine.

Caregivers find themselves in great distress but can still benefit from support to lighten the domestic burden, and financial burden, thanks to the various recommendations of successive Cancer Plans. In fact, support for patients and their families during the illness and after is one of the key points of the programs in place. The aim of this research will be to provide food for thought in order to improve the support provided to family and friends.

Primary Outcome Measures: Difficulties and specific needs of a caregiver, Identify the difficulties and specific needs of a caregiver in the particular context of a person with glioblastoma., Day 1
Femom System Compared to the Standard of Care CTG
NCT Number: NCT06490471
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Related
Sponsor: Biorithm Pte Ltd
Sex: FEMALE
Age: ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-07

Summary:
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation \> 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces.

Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.

Primary Outcome Measures: FHR, The 95% confidence limits for the 95% limits of agreement (LoA) for FHR are within

-10 and 10 bpm, From 32 weeks gestation to labour|MHR, The 95% confidence limits for the 95% limits of agreement (LoA) for MHR are within

-8 and 8 bpm, From 32 weeks gestation to labour|PPA, The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO)., From 32 weeks gestation to labour
Secondary Outcome Measures: Femom NST vs NST, To test concordance in clinical interpretability of femom NST traces and the standard of care CTG traces., From 32 weeks gestation to labour
Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery
NCT Number: NCT06490458
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Bypass Graft Surgery(CABG)
Interventions: COMBINATION_PRODUCT: Balance Training
Sponsor: Cairo University
Collaborators: National Heart Institute, Egypt
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-12-10
Locations: National heart institute, Giza, 11262, Egypt

Summary:
Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.

Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.

Primary Outcome Measures: Berg balance scale(BBS), (0 indicating the lowest level ,4 indicating the highest level ) data about balance from BBS index., 7 Days
Secondary Outcome Measures: sit to stand test(SST)in seconds, represent functional capacity (duration of 5 times sit to stand), 1st day and 7th day|length of hospital stay (in Days), number of days spent in hospital, from 1st day|SF36 Questionnaire( scores), Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, 3rd day
Pattern of Cardiac Arrhythmia in Patients With MASLD
NCT Number: NCT06490432
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrhythmia|Metabolic Dysfunction Associated Steatotic Liver Disease
Interventions: DEVICE: Transient elastography
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-26
Completion Date: 2025-10-20
Locations: Sohag University Hospital, Sohag, So, Egypt

Summary:
Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients

Primary Outcome Measures: Cardiac arrhythmia and MASLD patients, Study metabolic dysfunction -assocatied steatotic liver disease, 1 year|Cardiac arrhythmia, Study pattern of cardiac arrhythmia, 1 year
Effect of Ultrasound Cavitation Versus Electrolipolysis on Obese Infertile Women With Polycystic Ovarian Syndrome
NCT Number: NCT06490419
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome
Interventions: DEVICE: Electrolipolysis|DEVICE: ultrasound cavitation
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2024-12-10

Summary:
This study aims to determine the difference between the effect of ultrasound cavitation and electrolipolysis on obese infertile women with polycystic ovarian syndrome.

Primary Outcome Measures: Weight, height and BMI measurements, Weight/ height scale will be used to measure the weight and height of all females in both groups to calculate their BMI before and after treatment according to the following equation BMI = weight/height2 (kg/ m2), within 3 months|Waist hip Ratio, To accurately measure central obesity, waist/hip ratio will be measured by tape measurement. Waist circumference will be measured at the narrowest portion of the torso approximately midway between the lower costal margin and the iliac crest. The hip circumference will be measured over the widest portion of the gluteal and greater trochanteric region then the ratio between them will be calculated. Reference of female measurements for central obesity will be a waist circumference of \>88 cm and a waist-hip ratio \>0.85., within 3 months|LH/ FSH Ratio, ELISA kites will be used for assessing serum luteinizing hormone (LH) and follicular stimulating hormone (FSH) to calculate LH/ FSH ratio. Blood samples will be drawn from antecubital vein of each patient before and after treatment. It will be centrifuged within 2 hours after withdrawal. Serum will be stared at -20°C and assayed for LH/ FSH Ratio. They will be measured in the third day of the menstrual cycle but will be measured in the luteal phase, within 3 months|Ovulation rate, Abdominal ultrasongraphy will be used to assess ovarian volume before and after treatment for measuring ovulation rate. A minimum of 12 follicles with a diameter of 2 to 9 mm in each ovary, as well as a rising ovarian volume with a minimum size of 10 mm, are the criteria required for an ultrasound diagnosis of defective ovulation, within 3 months
Communication Practices to Develop the Health Literacy Competencies in Nursing Students
NCT Number: NCT06490406
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Literacy|Competence|Nursing Students
Interventions: BEHAVIORAL: Multimodal intervention (communication and education simulations) for EG1
Sponsor: University of Cadiz
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-01-01
Completion Date: 2020-06-30
Locations: Faculty of Nursing, University of Cadiz, Algeciras, Cadiz, 11207, Spain

Summary:
Communication is a key health literacy educational competency in the professional training of health providers. However, students often have difficulty in applying theoretical communication models to the reality of clinical practice. Multimodal interventions based on simulation models emerge as an essential element to overcome this gap. During the simulation training, students must be aware of their communication errors and the needs that patients share in a clinical interaction.

The aim is to evaluate the effectiveness of multimodal training, which incorporates a systematic feedback guide about the student's clinical interview simulation performance, as a training complement to classical education to improve health literacy competencies and clear communication practices in health sciences students.

A randomized controlled trial will be conducted on 82 second-year nursing students recruited from the University of Cadiz. The experimental and control groups will receive the same communication multimodal training except for the inclusion of feedback on key aspects of communication for health literacy, which the experimental groups only used. Students will be assessed through clinical interview simulations by external observers. Bivariate and inferential statistical analyses will be carried out.

Primary Outcome Measures: Clinical relationship during the healthcare process, Clinical relationship developed between a healthcare professional and a patient was measured through CICAA scale (pre-test, post-test 1, and post-test 2).

The CICAA scale is a measure instrument designed to assess the clinical relationship (CR) developed between a health professional and a patient. It can be used to evaluate global or partial aspects of CR, is based on an external evaluation through observation of the interaction and can be used for teaching purposes. For all 29 items (scored 0, 1, 2), the minimum score is 0, and the maximum score is 58. The higher the score, the better the communication skills in the consultation., 5 months
The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
NCT Number: NCT06490393
Acronym: IMSUP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Health-related Quality of Life
Interventions: OTHER: Questionnaires
Sponsor: St. Claraspital AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-17
Completion Date: 2027-07-01
Locations: St Clara Research Ltd, Basel, Basel-Stadt, 4058, Switzerland

Summary:
Effect of supervision on scoring and completion on Quality of Life Questionnaire

Primary Outcome Measures: EORTC QLQ-C30, To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers., 2024-2026|EORTC QLQ-SH22, To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers., 2024-2026|Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital, To study the impact of Health Care Professional supervision on scoring patterns on financially- and sexuality related questions by cancer patients receiving systemic antineoplastic therapy, compared to self-administered electronic completion at home. The null-hypothesis is tested that the method of administration does not influence patients' answers., 2024-2026
Secondary Outcome Measures: Incidence of reported sexual problems, 2024-2026|Patient preference, Reported patient preference of mode of reporting (electronically vs supervised), 2024-2026|Time, Time used by the Health care professional per completion mode, 2024-2026
HRD Status Reference Standard Based on WGS
NCT Number: NCT06490380
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer
Interventions: DRUG: PARPi
Sponsor: Lei Li
Collaborators: National Institutes for Food and Drug Control, China|Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-30
Completion Date: 2024-06-21
Locations: Lei Li, Beijing, Beijing, 100730, China

Summary:
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.

Primary Outcome Measures: Progression-free survival, Time from first dose of PARPi to disease progression or death, whichever occurs first., Up to 42 months
Secondary Outcome Measures: Overall survival, Time from first dose of PARPi to death., Up to 48 months
Effectiveness of the Use of Lightback in Conventional Football Training.
NCT Number: NCT06490354
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Injury; Hip
Interventions: DEVICE: Lightback group|OTHER: Conventional treatment
Sponsor: Universidad Católica de Ávila
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-04-01
Locations: Universidad Católica de Ávila, Ávila, 05005, Spain

Summary:
Lightback is a patented device that allows instrumental stretching of the gluteal muscles. Football players overload this musculature and this type of device is effective and the cost/benefit ratio is high.

The intention is to carry out a randomised clinical trial to carry out a study on athletes to see the differences between a group of football players with their normal training and a group of football players with their normal training and the application of lightback beforehand.

The variables studied will be sprint speed in 20 and 40m, vertical jump height, hamstring muscle injuries throughout the season, triceps sural injuries throughout the season, internal and external hip ROM, dorsal flexion ankle ROM.

Primary Outcome Measures: Range of motion, Measurement of hip joint range and ankle dorsiflexion measured with goniometer, 5 weeks
Secondary Outcome Measures: Sprint, Measurement of speed over 20 and 40 metres using approved devices, 5 weeks|Vertical jump height, Measurement of height (metres) using approved devices, 5 weeks
GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma
NCT Number: NCT06490341
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Nasopharyngeal Carcinoma
Interventions: DRUG: GP Regimen, Nimotuzumab, Sintilimab
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2027-07-20

Summary:
The goal of this clinical trial is to learn if the regimen of gemcitabine, cisplatin combined with nimotuzumab and sintilimab works to treat locally advanced nasopharyngeal carcinoma before chemoradiotherapy. It will also learn about the safety of the regimen. The main questions it aims to answer are:

* Does the regimen increase the number of participants who has a significant tumor shrinkage?
* What medical problems do participants have when taking the regimen? Researchers will evaluate the safety and efficacy of the regimen.

Participants will:

* Take the regimen every 21 days, for twice.
* Visit the clinic weekly for drug administration, checkups and tests.
* Keep a diary of their symptoms.

Primary Outcome Measures: ORR, objective response rate, 3 months
Secondary Outcome Measures: mPFS, median progression-free survival, 1 year|mOS, median overall survival, 2 years|PFS rate, 3-year progression-free survival rate, 3 years|OS rate, 3-year overall survival rate, 3 years|Adverse events, EGFR and PD-L1 expression, MRD, and others, 1 year|Radiographic down-staging, stage change according to radiography, 3 months