pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Efficacy of Allo-HSCT in ND HR-CBF-AML
NCT Number: NCT06458244
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia
Interventions: PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation|DRUG: Chemotherapy
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2028-02
Locations: Ruijin Hospital Affiliated to Shanghai Jiaotong University School Of Medicine, Shanghai, Shanghai, 200025, China

Summary:
For newly diagnosed high-relapse-risk core-binding-factor acute myeloid leukemia participants, the investigators aim to perform allogeneic hematopoietic stem cell transplantation after participants finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk core-binding-factor acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of participants is evaluated.

Primary Outcome Measures: disease-free-survival, disease-free-survival, from data of AML diagnosis until the data of AML relapse, assessed up to 3 years|The relation of CBF-AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation, The relation of CBF-AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation, from data of AML diagnosis until the data of CR-achieved status, assessed up to 3 years
Secondary Outcome Measures: Rate of non-relapse-mortality, the ratio of non-relapse-mortality cases and all the mortality cases, the data of death from any cause, assessed up to 3 years|overall survival, overall survival, from data of AML diagnosed until the data of death from any cause, assessed up to 3 years|adverse events, adverse events related with the indicated regimen, from enrollment to study completion, a maximum of 3 years
Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection (CLABSI) at the Tertiary Care Hospital
NCT Number: NCT06458231
Acronym: Microbiology
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Interventions: DEVICE: Blood Catheters
Sponsor: Port Said University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2025-05-31
Locations: Prof. Refat Sadeq, Port Said, 22223, Egypt|Faculty of Medicine Portsaid Uni, Port Said, Egypt

Summary:
* Review key history and clinical examination findings of cases with CLABSI.
* Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI.
* Determine antibiotic biogram of each organism isolated
* Determine the prevalence of occurrence of Primary or secondary Blood stream infection, causing microorganism, and predisposing factors.

Primary Outcome Measures: • Microbiological diagnosis and Culture sensitivity tests, • Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI., 6 months|Determine antibiotic biogram of each organism isolated, Determine antibiotic biogram of each organism isolated, 6 months
Secondary Outcome Measures: •Determine the prevalence of occurrence of Primary or secondary Blood stream infection, •Determine the prevalence of occurrence of Primary or secondary Blood stream infection, causing microorganism, and predisposing factors., 4 months
Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve in Primary Occipital Neuralgia
NCT Number: NCT06458179
Acronym: PGON-RFA
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Occipital Neuralgia
Interventions: PROCEDURE: Ultrasound-guided proximal greater occipital nerve radiofrequency ablation
Sponsor: Mersin Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2023-04-30
Locations: Mersin Training and Research Hospital, Mersin, Turkey

Summary:
The International Headache Society (IHS) defines occipital neuralgia, as a unilateral or bilateral paroxysmal, shooting, or stabbing pain in the posterior region of the scalp, in the distribution of the greater occipital nerve (GON), lesser occipital nerve (LON), or third occipital nerve (TON). The condition is occasionally accompanied by diminished sensation or dysesthesia in the affected area and is frequently associated with tenderness over the involved nerves. The majority of cases with occipital neuralgia are idiopathic, with no clearly defined anatomical cause. First, conservative treatment approaches including medication and physical therapy are frequently used. When conservative measures fail to alleviate occipital neuralgia, interventional treatments such as local occipital nerve anesthetic and corticosteroid infiltration, botulinum toxin A injection, occipital nerve subcutaneous neurostimulation or occipital nerve radifrequency treatment may be used.

Primary Outcome Measures: NRS, Numerical rating scale (NRS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control., Change from Baseline VAS at 1,3, 6 and 12 months
Secondary Outcome Measures: Headache impact disability index (HIT-6), These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life., Change from Baseline VAS at 1,3, 6 and 12 months
Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery
NCT Number: NCT06458166
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fatigue|Physical Exercise
Interventions: OTHER: Assessment of low frequency fatigue using low frequency eletrical stimulation
Sponsor: University of Maia
Sex: MALE
Age: CHILD, ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-09-30
Locations: University of Maia, Maia, Porto, Portugal

Summary:
Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.

Primary Outcome Measures: Differences in Low frequency fatigue measured using Myocene (eletrical stimulus and force measurement), Assessment using myocene. Muscles are stimulated with low-frequency electrical pulses. The response of the muscle (force or torque) output, is recorded. A decrease in force output compared to baseline levels indicates fatigue., 2 hours before the match; 30 minutes following the match, 24 hours following the match; 48 hours following the match
Cardioneuroablation and Ventricular Proarrhythmia
NCT Number: NCT06458140
Acronym: Roman4
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Syncope, Vasovagal
Interventions: PROCEDURE: Cardioneuroablation
Sponsor: Centre of Postgraduate Medical Education
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2024-12-31
Locations: Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, 04-073, Poland

Summary:
Cardioneuroablation (CNA) is a promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in sinus node acceleration and improved atrio-ventricular conduction, which in turn prevents vagally-mediated reflex asystole. However, lack of parasympathetic protection may potentially be proarrhythmic, especially on the ventricular level. Whether this is a real threat is not known. Therefore, the aim of our study is to assess acute effects of CNA-induced total vagal denervation, measured by extracardiac vagal stimulation, on ECG and electrophysiological parameters as well as vulnerability to ventricular arrhythmias. The study group will consist of 50 consecutive patients undergoing CNA in our institution. Cardioneuroablation will be performed in standard manner. The following parameters will be assessed at baseline and after CNA (directly after CNA, after atropine injected after CNA and after isoproterenol bolus injected at the very end of the procedure): QTc interval, QT dispersion, right ventricular action potential duration, right ventricular effective refractory period and susceptibility to complex ventricular arrhythmias using programmed ventricular stimulation.

Primary Outcome Measures: Inducibility of ventricular arrhythmias, Programmed ventricular stimulation is used to assess vulnerability to ventricular arrhythmia at baseline and after cardioneuroablation, 2 hours
Secondary Outcome Measures: Corrected QT interval, Standard ECG is used to assess corrected QT interval before and after cardioneuroablation, 2 hours|QT interval dispersion, Standard ECG is used to measure QT interval dispersion before and after cardioneuroablation, 2 hours|Right ventricular action potential duration, Intracardiac ECG recorded from the ablation electrode is used to measure right ventricular action potential duration before and after cardioneuroablation, 2 hours|Effective refractory period of the right ventricle, During programmed ventricular pacing using eight-beat drive and one extrastimulus delivered at progressively shortened coupling interval is used to assess effective refractory period of the right ventricle before and after cardioneuroablation, 2 hours
Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease
NCT Number: NCT06458127
Acronym: cGVHDTele-PC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Graft-versus-host Disease|Chronic GVHD|cGVHD
Interventions: OTHER: Tele-palliative care visit
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-03-31
Locations: Massachusetts General Hospital (MGH), Boston, Massachusetts, 02114, United States

Summary:
This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients with moderate to severe chronic graft-versus-host disease.

Primary Outcome Measures: Feasibility of the tele-palliative care intervention as measured by the proportion of eligible patients who are approached and agree to participate, To calculate the feasibility of the intervention using the proportion of eligible patients who are approached and agree to participate, with 95% confidence interval.

The intervention will be deemed feasible if at least 60% of patients with moderate to severe cGVHD agree to participate in the study., Week 12|Feasibility of the tele-palliative care intervention as measured by the proportion of enrolled participants who complete at least two of the three intervention visits, To calculate the feasibility of the intervention using the proportion of enrolled participants who complete at least two of the three intervention visits, with 95% confidence interval.

The intervention will be deemed feasible if at least 70% of participants attend at least two of the three intervention visits., Week 12
Secondary Outcome Measures: Acceptability of the tele-palliative care intervention as measured by the Client Satisfaction Questionnaire, To calculate the acceptability of the intervention using the the proportion of participants who score \>20 on the Client Satisfaction Questionnaire (CSQ-8) with 95% confidence interval.

Total scores of CSQ-8 range from 8 to 32, with the higher score indicating greater satisfaction. The proposed intervention will be deemed acceptable if at least 60% of participants score \>20 on the CSQ-8., Week 12
Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.
NCT Number: NCT06458114
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Caregiver Feeling
Interventions: OTHER: Assessment of caregiver feeling
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-07
Completion Date: 2025-01
Locations: Chu Reims, Reims, 51092, France

Summary:
Introduction :

The birth of a child is usually a happy event that caregivers working in delivery rooms share with families.

Unfortunately, newborns sometimes need palliative care as soon as birth occurs.

In France, neonates who were liveborn under 24+0 weeks amenorrhea (date of last mentrual period) or weighing less than 500 grams) usually have non resuscitation in delivery room \[Ancel 2020\]. Some of them are considered as viable (referring to World Health Organisation definition : either term ≥ 22 + 0 amenorrhea week or birth weight ≥ 500 grams), others as nonviable (term \< 22 AW and birth weight ≤500 grams).

In France, legislative development over last two decades have allowed the emergence of palliative care in delivery room. In a French survey in 2016, 83% of maternities were confronted at least once a year with this situation.

Primary Outcome Measures: Assessment of caregiver feeling, Semi-directional interviews will be carried out with the identification of the main themes during the verbatim transcription (qualitative study)., 1 month
Secondary Outcome Measures: Assessment of stress, Revised Impact of Event Scale (IES-R) \[Weiss, Brunet\] scale, 1 month|Assessment of stress, Revised Impact of Event Scale (IES-R) \[Weiss, Brunet\] scale, 2 months
Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter
NCT Number: NCT06458101
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urolithiasis|Catheter-related Bladder Discomfort
Interventions: PROCEDURE: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter|PROCEDURE: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 172
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-06-30
Locations: Shanghai General Hospital, Shanghai, Shanghai, 200080, China

Summary:
A prospective, multicenter, randomized, controlled clinical trial was conducted to compare the efficacy and safety of non-indwelling catheter and indwelling catheter in relieving postoperative catheter-related complications after ureteroscopic lithotripsy. By comparing the pain score and urination urgency score (PPIUS) of patients after ureteroscopic lithotripsy (including flexible ureteroscopy) lithotripsy to provide a reliable scientific basis for indwelling catheter after ureteroscopic lithotripsy.

Primary Outcome Measures: Pain score, pain scoring will be measured by VAS scale. There are 10 scales, with "0" and "10" at both ends. 0 indicates no pain and 10 represents the most severe pain that is unbearable., 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)|Urinary urgency score, urinary urgency score will be measured by PPIUS scale. 0 No urgency

1. Mild urgency
2. Moderate urgency
3. Severe urgency
4. Urge incontinence, 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
Secondary Outcome Measures: Painful Memory, Painful memory will be measured by SUDS scale. 100: Unbearably upset to the point that you cannot function and may be on the verge of a breakdown 90: Extremely anxious and desperate; helpless and unable to handle it 80: Worried and panicky; losing focus and feeling anxious in your body 70: Discomfort dominates your thoughts and you struggle to function normally 60: Moderate to strong levels of discomfort 50: Upset and uncomfortable; still functional 40: Mild to moderate anxiety and worry 30: Worried or upset; still able to function 20: A little bit sad or distressed 10: No distress; alert and focused 0: Peaceful and complete calm, 1 month after surgery|Operation time, Operation time, The end of operation|blood routine, To calculate the change of haemoglobin, Before surgery and 4 hours after surgery
Advanced Glycation Products and Vascular Complications in Type 1 Diabetes
NCT Number: NCT06458088
Acronym: DIABAGE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Type1diabetes
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-25
Completion Date: 2024-12
Locations: Chu Reims, Reims, 51092, France

Summary:
DIABAGE (Diabetes Advanced Glycation End products) study was conducted between 2015 and 2017. It included 196 type 1 diabetic patients with more than 10 years of diabetes. It revealed a significant association between the occurrence of vascular complications and tissular Advanced Glycation End products (AGEs) as well as with some circulating AGEs. This protocol is a continuation of that initial research.

Primary Outcome Measures: Association between baseline AGE values and incident cases of vascular complications., * Occurrence of a cardiovascular event.
* Appearance or aggravation of ophthalmological involvement.
* Appearance or worsening of diabetic nephropathy.
* Appearance of diabetic neuropathy., At inclusion
Secondary Outcome Measures: The correlation between the tissue AGE deltas (defined by the difference between the AGEs at 5 years and the initial AGEs) and the cumulative HbA1c over the 5 years., Tissular AGEs at initial inclusion and after follow-up, At inclusion|The association between baseline AGE values and the occurrence of macrovascular damage., * Cardiovascular event as defined in the primary endpoint.
* Or medically treated arterial injury (coronary stenosis objectified on medically treated coronary angiography, SPI \< 0.9 without revascularization, stenosis or occlusion objectified on lower extremity arterial Doppler and carotid stenosis \> 60% without endarterectomy).
* Tissular and plasmatic AGEs., At inclusion
Intervention to Improve Communication and Medication Adherence in Lupus
NCT Number: NCT06458075
Acronym: CO-LEAD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Systemic Lupus Erythematosus
Interventions: BEHAVIORAL: CO-LEAD
Sponsor: Duke University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 480
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-30
Completion Date: 2028-12
Locations: Duke University, Durham, North Carolina, 27710, United States

Summary:
CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE).

The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following:

1. clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers.
2. use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.

Primary Outcome Measures: Frequency of adherence discussions, Proportion of SLE patient visits in which a nonjudgmental, patient-centered adherence discussion took place as determined by analysis of clinic visit audio recordings, During intervention period (up to 2 years)
Secondary Outcome Measures: Quality of patient-clinician communication determined by audio recordings, Audio recordings of clinic visits which will be analyzed using a validated coding scheme, During intervention period (up to 2 years)|Quality of patient-clinician communication determined by surveys, The Interpersonal Processes of Care survey will be used, During intervention period (up to 2 years)|Change in SLE medication adherence, Determined by pharmacy refill data. Proportion of days covered (PDC) will be calculated as total days of supply dispensed., Baseline and post-intervention (up to 6 months)
Pocket Colposcopy Using CARE Algorithm
NCT Number: NCT06458062
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Cancer|HPV Infection
Interventions: DEVICE: Pocket Colposcope
Sponsor: Duke University
Collaborators: Kenya Medical Research Institute|National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1054
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-02-01
Completion Date: 2027-06
Locations: Kenya Medical Research Institute, Nairobi, Kenya

Summary:
The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at 4-6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Primary Outcome Measures: Sensitivity of the Pocket CARE in detecting pre-cancer, Sensitivity will be reported as a percentage, Day of imaging (Day 1)|Specificity of the Pocket CARE in detecting pre-cancer, Specificity will be reported as a percentage, Day of imaging (Day 1)|Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer, PPV will be reported as a percentage, Day of imaging (Day 1)
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
NCT Number: NCT06458036
Acronym: RAISE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Differentiated Thyroid Cancer|Pediatric Cancer|Cancer|Cancer, Thyroid
Interventions: DRUG: Selpercatinib Monotherapy|RADIATION: 131I Therapy
Sponsor: Children's Hospital of Philadelphia
Collaborators: Eli Lilly and Company|United States Department of Defense
Sex: ALL
Age: CHILD, ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2031-08-01

Summary:
Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

Primary Outcome Measures: Number of patients with complete overall, pulmonary, structural, and biochemical response., Determine the overall, pulmonary, structural, and biochemical response rate to selpercatinib in patients with RET fusion differentiated thyroid cancer treated with 6 months of selpercatinib prior to 131I therapy, 18 months|Number of patients who survive without progression of disease after 5 years following protocol treatment., Determine the progression free survival to the combination of selpercatinib followed 6 months later 131I therapy from the initiation of selpercatinib therapy, 5 years|Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy., Determine the proportion of patients for whom oncogene-specific, targeted therapy increases tumor RAI-avidity., 6 months|The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5., Determine the safety of the combination of selpercatinib given for 6-months followed by 131I therapy in patients with RET fusion differentiated thyroid cancer, 12 months
TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age
NCT Number: NCT06458023
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery
Interventions: DEVICE: TetraGraph (TM) NMT Monitor
Sponsor: Joseph D. Tobias
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-11
Completion Date: 2025-12-31
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States

Summary:
The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age and when feasible to compare it to standard TOF monitoring using a qualitative monitor.

Primary Outcome Measures: EMG changes, Changes in the amplitude of the evoked response of the muscles., During the surgery
Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH)
NCT Number: NCT06458010
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Familial Hypercholesterolemia
Interventions: DRUG: YOLT-101
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-24
Completion Date: 2026-02-25
Locations: Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China

Summary:
This study is a single arm, open, single dose escalation trial aimed at evaluating the safety and tolerability of YOLT-101 administration in patients with familial hypercholesterolemia; Determination of YOLT-101 OBD; Preliminary evaluation of the effects of single administration of YOLT-101 on plasma lipid and lipoprotein levels.

Note: OBD is defined as the dosage at which plasma PCSK9 protein levels decrease between 60% and 95% from baseline on the 28th day after YOLT-101 administration. OBD ≤ Maximum Tolerable Dose (MTD).

In this study, the longest screening period for the main study was 42 days, the treatment day was Day 1 (D1), and the safe follow-up period was up to 52 weeks after medication. In the main study, when OBD occurs, additional subjects will be added to the dose group (specific number of cases will be negotiated between the cooperating organization and investigators) for further validation. In addition, subjects in the first dose group can voluntarily receive a second drug administration of OBD level.

After the completion of the main study, participants will undergo long-term follow-up. According to the Technical Guidelines for Long term Follow up Clinical Research of Gene Therapy Products (Trial) released by CDE, a long-term follow-up until 15 years after the medicine administration is required .

Primary Outcome Measures: safety evaluation of YOLT-101, The safety of YOLT-101 evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs)., through week 52
Secondary Outcome Measures: pharmacokinetics of YOLT-101, The Peak Plasma Concentration (Cmax) of YOLT-101. 0.5 predose,2,12,24,48,72,144,312,648hours., through Day 28|pharmacodynamics, The effect of YOLT-101 on serum levels of LDL-C, through week 52|pharmacodynamics, The effect of YOLT-101 on plasma levels of PCSK9, through week 52|pharmacokinetics of YOLT-101, Area under the plasma concentration versus time curve (AUC); 0.5 predose,2,12,24,48,72,144,312,648hours., through Day 28|pharmacokinetics of YOLT-101, Tmax;, through Day 28|pharmacokinetics of YOLT-101, T1/2, through Day 28
A Study of PHN-010 in Patients With Advanced Solid Tumors
NCT Number: NCT06457997
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lung Cancer|Colon Cancer|Endometrial Cancer|Ovarian Cancer|Cervical Cancer|Advanced Solid Tumor|Advanced Cancer
Interventions: DRUG: PHN-010
Sponsor: Pheon Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 273
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-07
Locations: Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States|NEXT - San Antonio, San Antonio, Texas, 78229, United States|NEXT - Virginia, Fairfax, Virginia, 22031, United States

Summary:
This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Primary Outcome Measures: Incidence of dose limiting toxicities (Phase 1a), 18 months|Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a), 18 months|Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b), 18 months|Overall response rate (ORR) (Phase 1b), 36 months
Secondary Outcome Measures: Best overall response (BOR) (Phase 1a and 1b), 36 months|Disease control rate (DCR) (Phase 1a and 1b), 36 months|Progression free survival (PFS) (Phase 1a and 1b), 36 months|Time to response (TTR) (Phase 1a and 1b), 36 months|Overall survival (OS) (Phase 1a and 1b), 36 months|Cancer antigen 125 (CA-125) response (Phase 1a and 1b), 36 months|Time to CA-125 response (Phase 1a and 1b), 36 months|Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b), 36 months|Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b), 36 months|Pharmacokinetics, Cmax of free payload (Phase 1a and 1b), 36 months|Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b), 36 months|Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b), 36 months|Pharmacokinetics, Tmax of free payload (Phase 1a and 1b), 36 months|Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b), 36 months|Pharmacokinetics, AUC of total antibody (Phase 1a and 1b), 36 months|Pharmacokinetics, AUC of total free payload (Phase 1a and 1b), 36 months|Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b), 36 months|Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b), 36 months|Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b), 36 months|Concentration of anti-drug antibodies (Phase 1a and 1b), 36 months|Type, incidence and severity of AEs and SAEs (Phase 1b), 18 months
Effects of Selenium Towards Type 2 Diabetes
NCT Number: NCT06457984
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: DIETARY_SUPPLEMENT: Selenium nutritional supplementation
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2025-05-07
Locations: Yu Kang, Beijing, Beijing, 100730, China

Summary:
According to the prevalence of non-communicable chronic diseases and aging population characteristics, this study is exploring the coexist effects combined with various dimensions: nutritional functions, metabolic homeostasis, inflammation and immunity by the selenium supplementation among type 2 diabetes, which based on insulin resistance, beta-cell function disorders, and body metabolic homeostasis disorders of the mechanism of type 2 diabetes by lifecycle so that could provide with a totally new and safe nutritional method for type 2 diabetes prevention and diagnosis.

Primary Outcome Measures: Drugs of reduce glucose or stop using the antidiabetics., Dose or types of antidiabetics drugs would reduce., 12 weeks
Secondary Outcome Measures: GPX activity, Level of GPX-1 activity would decrease alone with the supplementation of selenium, 12 weeks|Situation of glucose, Level of glucose would decrease alone with the supplementation of selenium, 12 weeks|Nutrition status of selenium, Content of selenium in serum would increase alone with the supplementation of selenium, 12 weeks|Status of immunity, Level of immunity indicator serum iron would increase along with the supplementation of selenium, 12 weeks
Anovo Surgical System in Ventral Hernia
NCT Number: NCT06457971
Acronym: CLEVER
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventral Hernia
Interventions: DEVICE: Robotic Ventral Hernia Repair
Sponsor: Momentis Surgical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-14
Completion Date: 2024-06-23
Locations: Imelda Hospital, Bonheiden, Belgium|Hadassah Medical Center, Jerusalem, Israel

Summary:
The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.

Primary Outcome Measures: Rate of Conversion, The primary endpoint is rate of conversion to open surgery or multiport laparoscopic approach. As this is a clinical assessment, no pre-determined success criteria have been set., Intra-Operative
Secondary Outcome Measures: IntraOperative Procedural Outcomes - AE and SADE, IntraOperative Adverse and Serious Adverse Events, Intra-Operative|IntraOperative Procedural Outcomes - Device/Procedure AE, IntraOperative device related and / or procedure related Adverse Event, Intra-Operative|IntraOperative Procedural Outcomes - Time, IntraOperative Operative Time, Intra-Operative|Post Operative Procedural Outcomes - AE and SADE, Post operative procedural outcomes such as Adverse and Serious Adverse Events and Series Adverse Device Effects, Through study completion, an average of 4 weeks.|Post Operative Procedural Outcomes - Wound Seroma, Post operative procedural outcomes such as post operative wound seroma, Through study completion, an average of 4 weeks.|Post Operative Procedural Outcomes - SSI, Post operative procedural outcomes such as surgical site infection, Through study completion, an average of 4 weeks.|Post Operative Procedural Outcomes - Length of Stay, Post operative procedural outcomes such as length of hospital stay, Through hospital discharge, up to approximately 3 days|Procedure Completion, Rate of procedure completion with the device, Intra-Operative|Console Time, Length of time the surgeon is actively using the surgeon console to control the robotic device, Intra-Operative|Docking Time, Length of time spent docking the robotic device, described as when the robotic instrument arms are inserted through the cannula., Intra-Operative|Draping Time, Length of time spent draping the robotic device, Intra-Operative
Effect of Sevoflurane and Desflurane on Heme Oxygenase-1 Expression in Elective Cholecystectomy
NCT Number: NCT06457958
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cholecystitis, Chronic
Interventions: DRUG: Sevoflurane Group|DRUG: Desflurane Group
Sponsor: Kocaeli City Hospital
Collaborators: The Scientific and Technological Research Council of Turkey
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-11-01
Completion Date: 2025-01-31
Locations: Kocaeli City Hospital, Kocaeli, Izmit, 41100, Turkey

Summary:
General anesthesia is routinely administered to patients who undergo elective cholecystectomy. The most commonly used inhalation agents during general anesthesia are sevoflurane and desflurane. Participants who will undergo elective cholecystectomy surgery and meet the eligibility criteria will be randomized. Participants will be divided into two groups. One group will receive sevoflurane, and the other group will receive desflurane. Preoperative and postoperative blood samples will be taken from the participants. After the sample collection process is completed, the ELISA method will be used for measuring blood heme oxygenase-1 protein levels, and the PCR technique will be used for measuring blood heme oxygenase-1 mRNA gene expression. The increase in amounts between the two groups will be compared. This study aims to demonstrate the effects of the most commonly used inhalation agents on the levels of heme oxygenase-1 enzyme, which has been shown to be an important enzyme in cellular protection mechanisms, as well as on mRNA gene expression, and to determine which agent may be more effective in preventing cellular damage at the molecular level.

Primary Outcome Measures: Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels, The aim of this study is to compare the effects of sevoflurane and desflurane, commonly used inhalation anesthetics in routine anesthesia practice, on blood heme oxygenase-1 gene and protein levels., Postoperative at hour 1
Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.
NCT Number: NCT06457932
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Anxiety State
Interventions: BEHAVIORAL: Heart rate variability biofeedback training|BEHAVIORAL: Guided meditation
Sponsor: University of Seville
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2025-02-01

Summary:
The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.

Primary Outcome Measures: Stress, Measured using the Percieved Stress Scale (PSS)., T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up|Anxiety State, Measured using the State-Trait Anxiety Inventory (STAI)., T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Secondary Outcome Measures: Heart Rate Variability (HRV), Measured using the Polar H10 band and Elite HRV app., T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up|Academic Performance, Semester grade averages compared between groups., T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up|Adherence, Tracked using an online calendar., Daily during the 8 week intervention
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
NCT Number: NCT06457919
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: Tinengotinib|DRUG: abiraterone acetate|DRUG: Prednisone or Enzalutamide|DRUG: Tinengotinib
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: TransThera Sciences
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2027-06
Locations: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States|Columbia University, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States|Duke University, Durham, North Carolina, 27710, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States

Summary:
The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).

Primary Outcome Measures: RP2D, Evaluate DLT occurrence to confirm safety and RP2D, From the start of study treatment through the DLT window (28 days)|Objective Response Rate (ORR), by local investigator's assessment per PCWG3-modified RECIST v1.1 in participants with baseline measurable disease OR rate of PSA decline of ≥ 50% from baseline in patients with a baseline PSA of 2.0 ng/mL or above, up to 6months
Secondary Outcome Measures: Time to Radiographic Response (phase II), Time to radiographic response by local investigator's assessment per PCWG3-modified RECIST v1.1 in participants with baseline measurable disease (CR) or Partial Response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST v1.1 in patients with baseline measurable disease, From start of study treatment until 6 months post study treatment start
SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC
NCT Number: NCT06457906
Acronym: SHARP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Small-cell Lung Cancer|Brain Metastases|SRS|Stereotactic Radiotherapy|Whole Brain Radiotherpay|Hippocampal-avoidance
Interventions: COMBINATION_PRODUCT: Experimental group (SRS/SRT/Hypo-RT)|RADIATION: Controled group (HA-WBRT)
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 340
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2028-02-28
Locations: Nan Bi, Beijing, Beijing, 100021, China

Summary:
This phase III trial compares the effect of stereotactic radiosurgery and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain.

Primary Outcome Measures: Cognitive function scores, HVLT-R total recall score at 6 months after radiotherapy, At 6 months after radiotherapy.|Meadian OS time, The time that half of enrolled patients died., Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
Secondary Outcome Measures: Cognitive function scores, The MoCA score at 3 ,6,9,12 months after radiotherapy, Measured at months 3, 6, 9, 12months after radiotherapy|Scores of quality of life, The EORTC QLQ-C30 score at 3,6,9,12 months after radiotherapy, Measured at months 3, 6, 9, 12months after radiotherapy|The time of neurological progression free survival, The time that ≥3 points reduced of HVLT-R total recall score or MoCA score after radiotherapy, Measured at months 3, 6, 9, 12months after radiotherapy|The time of intracranial overall progression free survival, The time that half of enrolled patients had intracranial relapse, Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy|The time of overall progression free survival, The time that half of enrolled patients had relapse, Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy|The rate and grade of treatment related toxicity, All adverse events of enrolled patients after radiotherapy evaluated by CTCAE 5.0, Measured at months 3, 6, 9, 12, 15,18, 21, 24, 30, 36,42,48,60 months after radiotherapy
THE EFFECT OF THE EDUCATION PROGRAM BASED ON THE HEALTH BELIEF MODEL ON THE PHYSICAL ACTIVITY BELIEFS AND BEHAVIOR OF FIRST YEAR STUDENTS OF THE FACULTY OF NURSING
NCT Number: NCT06457893
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: THE HEALTH BELIEF MODEL ON THE PHYSICAL ACTIVITY BELIEFS
Interventions: OTHER: The health belief model-based exercise training program and health belief model-based education
Sponsor: Aydin Adnan Menderes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 121
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-12-19
Completion Date: 2023-07-31
Locations: Aydin Adnan Menderes University, Aydin, 09010, Turkey

Summary:
The aim of the study is to examine the effect of the Health Belief Model-Based Education Program on the Physical Activity Beliefs and Behaviors of First Year Students of the Faculty of Nursing using a randomized controlled experimental research method.

Primary Outcome Measures: Health Belief Model Scale Scores, Checking change in the exercise health belief model scale scores of the control group students ., 6 months
PENG Block vs FNB + ONB in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia
NCT Number: NCT06457880
Acronym: PENG/FNB+ONB
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Fractures|Pain, Postoperative|Coagulopathy|Comorbidities and Coexisting Conditions
Interventions: PROCEDURE: PENG BLOCK|PROCEDURE: Femoral Nerve Block|PROCEDURE: Obturator Nerve Block
Sponsor: Campus Bio-Medico University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-06-01
Locations: Campus Bio Medico, Roma, 00128, Italy

Summary:
The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.

Primary Outcome Measures: preoperative pain, Preoperative pain score expressed by numerical rating scale 0-10, 30 minutes|Pain following regional anesthesia, Preoperative pain score following regional anesthesia execution expressed by numerical rating scale 0-10, 30 minutes|Postoperative pain, Postoperative pain score expressed by a numerical rating scale 0-10, 24 hours
Secondary Outcome Measures: Morphine milligrams (mg) consumption, needed opioid rescue therapy, 24 hours