pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Aftificial Inteligence in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy
NCT Number: NCT06539104
Acronym: SMARTAI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility|Infertility, Female|Infertility, Male|Infertility Unexplained
Interventions: PROCEDURE: arteficial inteligence evaluation of oocyte and embryo development
Sponsor: Charles University, Czech Republic
Collaborators: Czech Academy of Sciences|Czech Technical University in Prague|General University Hospital, Prague
Sex: ALL
Age: ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-05
Completion Date: 2028-03-31
Locations: General University Hospital in Prague, Prague, 128 08, Czechia|Czech Technical University in Prague, Prague, Czechia|Institute of Physics AS CR, Prague, Czechia|Biocev As Cr, Vestec, Czechia

Summary:
The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.

Primary Outcome Measures: Probability that embryo will have normal caryotype based on time lapse and established by AI, Using an AI based non-invasive method of selecting a high-quality and genetically healthy embryos will undoubtably improve clinical and diagnostic practice and reduce costs in the field of infertility treatment. Both the segmentation and classification training will be based on expert annotations. The approach should lead to a classification accuracy at least 70%., 1 hour
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
NCT Number: NCT06539091
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Epithelial Ovarian Cancer|Efficacy|Safety|Bone Mineral Density|Tolerability
Interventions: DRUG: Fluzoparib|DRUG: Apatinib Mesylate
Sponsor: Anhui Provincial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.

Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.

The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.

Primary Outcome Measures: PFS, Progression-Free Survival (PFS) is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause., 2 year
Secondary Outcome Measures: OS, Overall Survival (OS) was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date., 2 year|DOR, Duration Of Response (DOR) is defined as the time from when a patient reaches first remission (including complete or partial remission) to when the disease re-progresses., 2 year|QoL, Quality of Life Score (QoL) is a score that assesses a patient's overall physical, psychological, social, and environmental well-being through a standardized questionnaire or scale.The scale has a full score of 60, with a very poor score of \<20, a poor score of 21-30, a fair score of 31-40, a better score of 41-50, and a good score of 51-60., 2 year|PFS-2, Progression-Free Survival 2 (PFS-2) defined as the time from patient randomization to completion of secondary therapy after disease re-progression or patient death., 2 year|AE, Adverse events (AE) are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0., 2 year
The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community
NCT Number: NCT06539065
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Virtual Reality
Interventions: DEVICE: VR interactive games
Sponsor: Taipei Medical University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 63
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-02-13
Completion Date: 2023-06-15
Locations: Taipei medical University, Taipei, Taiwan

Summary:
The goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life.

Participants will receive a Twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, While the control group will follow the original iInstructor-led exercise intervention as the course content.

Primary Outcome Measures: Balance ability, The scores of five physical assessments, Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses|Life quality, The score of questionnaire done by all participants, Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses
Periodontal Therapy Effect on the Ratio of TNF-α to IL-10 in Periodontis With/Out DM
NCT Number: NCT06539039
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis Generalized
Interventions: PROCEDURE: non surgical periodontal therapy
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-05-01
Locations: Dentistry, Cairo, Organization Of African Unity St, El-Qobba Bridge, 11566, Egypt

Summary:
Periodontitis is a chronic inflammatory disease affecting the periodontium, characterized by irreversible damage to the gingiva, periodontal ligament, and alveolar bone. It is prevalent among adults, significantly impacting oral health and quality of life. This study investigates the effect of non-surgical periodontal therapy (NSPT) on the levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10) in periodontitis patients with and without diabetes mellitus type II.

Primary Outcome Measures: detect difference in the ratio of tumor necrosis factor-α interleukin-10 in periodontitis patients with and without diabetes, To detect difference in the ratio of the proinflammatory cytokine tumor necrosis factor-α to the anti-inflammatory cytokine interleukin-10 between periodontitis patients with and without type 2 diabetes mellitus before and after non surgical periodontal therapy., 8 weeks
Inferior Vena Cava Collapsibility Index Guide for Preoperative Fluid Therapy in Preeclampsia
NCT Number: NCT06539026
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pre-Eclampsia|Hypotension|Fluid Overload
Interventions: OTHER: fluid therapy, 300 ml of crystalloid Ringer's solution.
Sponsor: Ain Shams University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-28
Completion Date: 2024-12-20
Locations: Ain shams university, Cairo, 11528, Egypt

Summary:
The routine assessment of fluid status depends on clinical evaluation and invasive monitoring. The clinical assessment lacks objectivity and the invasive monitoring carries risks. Point of care ultrasound (POCUS) parameters can be useful as early markers of fluid status and were used in safe fluid assessment in term pregnancy and preeclampsia.

Primary Outcome Measures: post-spinal hypotension, post-spinal and early intraoperative (0-10 min) hypotension (MAP \< 65 mmHg and/or ≥ 20% of decrease from baseline.

Measured by occurrence or not of hypotension. Method of aggregation will be according to the distribution of data if normal mean and SD will be used.

post-spinal and early intraoperative (0-10 min) hypotension (MAP \< 65 mmHg and/or ≥ 20% of decrease from baseline.

Measured by occurrence or not of hypotension. Method of aggregation will be according to the distribution of data if normal mean and SD will be used.

of post-spinal early intraoperative (0-10 min) hypotension (MAP \< 65 mmHg and/or ≥ 20% of decrease from baseline.

Measured by occurrence or not of hypotension. Method of aggregation will be according to the distribution of data if normal mean and SD will be used early post spinal decrease of mean arterial blood pressure (MAP \< 65mmhg ) or decrease to more than 20 % change from the baseline., 15 min after spinal
Secondary Outcome Measures: occurrence of complication, occurrence of any complications as pulmonary edema, needs for intraoperative vasopressors and postoperative base deficits., within half an hour post-spinal technique
Efficacy of Remifentanil in Preventing Emergence Agitation
NCT Number: NCT06539013
Acronym: agitation
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emergence Agitation
Interventions: DRUG: Remifentanil|DRUG: N2O|DRUG: Fentanyl
Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2024-10-01
Locations: Health Sciences University Gazi Yaşargil Training and Research Hospital, Diyarbakır, Kayapınar, 21070, Turkey

Summary:
The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.

Primary Outcome Measures: Richmond Agitation-Sedation Scale (RASS), * 4 Combative, violent, danger to staff
* 3 Pulls or removes tube(s) or catheters; aggressive
* 2 Frequent non-purposeful movement, fights ventilator
* 1 Anxious, apprehensive, but not aggressive 0 Alert and calm

  * 1 Awakens to voice (eye opening/contact) \> 10 seconds
  * 2 Light sedation; briefly awakens to voice (eye opening/contant) \< 10 seconds
  * 3 Moderate sedation; movement or eye opening. No eye contact
  * 4 Deep sedation; no response to voice, but movement or eye opening to physical stimulation
  * 5 Unarousable; no response to voice or physical stimulation, Postoperative care unit 1.second_5. second_15.second
Secondary Outcome Measures: mean arterial pressure, mmHg, Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min|Heart rate, beats/min, Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Anesthetic Management in Patients Undergoing Epicardial Ablation
NCT Number: NCT06538987
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ventricular Tachycardia
Interventions: PROCEDURE: percutaneous epicardial ablation
Sponsor: Eskisehir Osmangazi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2024-10-30
Locations: University of Eskisehir Osmangazi, Eski̇şehi̇r, Odunpazarı, 26040, Turkey

Summary:
The study is a retrospective study and is descriptive in nature. In this study, the investigators aimed to emphasize the importance of anesthesia management by cardiac risk assessment of patients undergoing epicardial ablation under general anesthesia and analysis of complications that developed during the procedure.

Primary Outcome Measures: sex, male %, 2 years|age, years, 2 years|weight, kilograms, 2 years|height, meters, 2 years|Hypertension, yes or no, 2 years|Diabetes mellitus, yes or no, 2 years|Coronary artery disease, yes or no, 2 years|Chronic obstructive pulmonary disease, yes or no, 2 years|Chronic kidney disease, yes or no, 2 years|Systolic pulmonary artery pressure, mmHg, 2 years|Left ventricular ejection, 2 years|PAAINESD (Acute hemodynamic decompensation risk assessment, ranging from 0 to 35 points, 35 point is the worst) score, score 0-35, 2 years|ASA ( American Society of Anesthesiologists (ASA) physical status classification ranging from I to IV, score I-IV, 2 years|Hemoglobin, g/dl, 2 years|glomerular filtration rate (eGFR), ml/dak/1,73m2, 2 years|Total procedural time, minutes, 2 years|Fluoroscopy time, minutes, 2 years|Ablation time, minutes, 2 years
Secondary Outcome Measures: Transient ischemic attack after procedure, yes or no, 2 years|Exitus during the follow-up, yes or no, 2 years|cause of death, End-Stage heart failure, VT storm, 2 years
SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma
NCT Number: NCT06538935
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma|SBRT|Immune Checkpoint Blockade|Tyrosine Kinase Inhibitor
Interventions: DRUG: adbelimumab|PROCEDURE: SBRT|DRUG: apatinib
Sponsor: Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2027-12

Summary:
This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.

Primary Outcome Measures: Pathological complete response Rate (Perioperative cohort), No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors, 4 months|Objective Response (Conversion cohort), It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR., 12 months
Secondary Outcome Measures: Event-free survival, Refers to the time from the start of the group to the occurrence of any event, 5 year|Major pathologic response, It is defined as residual tumors less than 10% after neo-adjuvant therapy, 4 months|Overall survival, It is defined as the time from randomization to death from any cause during the course of the study, 5 year|Safety as measured by the rate of AEs, Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs), 1 month
Developing a Digital Intervention to Prevent Risky Health Behaviors
NCT Number: NCT06538922
Acronym: PATT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Substance Use
Interventions: BEHAVIORAL: Single Session Family Intervention
Sponsor: University of Vermont
Sex: ALL
Age: CHILD
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-29
Completion Date: 2025-03
Locations: University of Vermont, Burlington, Vermont, 05401, United States

Summary:
The project will launch the development of Parents and Teens Together (PATT), a dyadic digital parent-teen prevention intervention, for families of young teens experimenting or at high risk for experimenting with substance use (SU) that can provide personalized support for learning and practicing evidence-based family skills. This scalable intervention will combine a blended, virtual and health coach-led, single-session intervention (SSI) for evidence-based family skills with an mHealth app delivering a just-in-time adaptive intervention (JITAI) to support the use of family skills in daily life. As a first step in the iterative design of PATT, this project will test the acceptability, feasibility and costs of the SSI and engage in a participatory design process to finalize the plan for an initial JITAI prototype. For young teens experimenting or at risk for experimenting with SU and their parents, ready access to a scalable prevention program that closely mirrors and extends the in-time support provided in behavioral family therapy is essential for SUD prevention.

Primary Outcome Measures: Acceptability of the single session intervention, Acceptability will be assessed by examining (1) single item mean scores and overall mean scores on the Program Feedback Scale, a scale used to evaluate acceptability and perceptions of SSIs, across participants. Higher scores indicated greater acceptability, range 1-5., 2 hours (end of single session intervention)|Feasibility of the single session intervention, Feasibility will be assessed by examining the percent of full session completers., 2 hours (end of single session intervention)|Parenting self-efficacy, average within-parent changes in key aspects of self-efficacy for parenting related to emotion and communication and evidence-based family practice with means on 10 items from the Self-Efficacy for Parenting Adolescents Scale; range 0 to 100; higher scores greater self-efficacy., 3 Hours (before and after the single session)
Steps Against the Burden of Parkinson's Disease - StepuP
NCT Number: NCT06538909
Acronym: StepuP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: DEVICE: VR
Sponsor: Tel-Aviv Sourasky Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-12

Summary:
The goals of our StepuP project are:

1. To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD;
2. To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
3. To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
4. To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.

Primary Outcome Measures: motion capture, Kinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz., 13 months|describe brain activity by EEG cap, EEG recordings will be made using a 64-channel or 128 channel EEG cap, 13 months|describe muscles activity by EMG electrodes, Bipolar EMG electrodes will be placed on the leg muscles. EMG data will be recorded at a sample frequency available for each system around 2000 Hz., 13 months
Secondary Outcome Measures: clinical trial TUG, standard time-up-and-go test, 13 months|clinical trial walk test, 2-minute walk test, 13 months|clinical trial MiniBESTest, balance and fall risk, 13 months|mGES questionnaire, modified gait efficacy scale, 13 months|FES-i questionnaire, Short falls efficacy scale international FES-i, 13 months|FACIT-F questionnaire, fatigue, 13 months|EQ-5D questionnaire, health-related quality of life, 13 months|Frailty questionnaire, Frailty index for physical activity, 13 months|Fall questionnaires, Fall events (occurrence and frequency) and fall related injuries. (twelve-month retrospective during T0 and during the duration of the trail, 13 months|MDS-UPDRS test, MDS-UPDRS, 13 months|NFOGQ questionnaires, NFOGQ, 13 months|aids questionnaires, Use of mobility aids, 13 months|cognition questionnaires, MoCA and trail making test for cognition, 13 months|Demographics questionnaire ( descriptive measures), General descriptive measures : Year of birth, gender, height, weight, shoe size, education, employment, living arrangement, smoking history and alcohol consumption., 13 months|Fracture history questionnaire, Fracture history (number and type of fracture, twelve-month retrospective of T0), 13 months
Phase II Study of Tislelizumab Combined With Nab-Paclitaxel as First Line Treatment for Patients of Triple-negative Breast Cancer(TNBC) With Bone Metastasis
NCT Number: NCT06538896
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Triple-negative Breast Cancer|Bone Metastases
Interventions: DRUG: Tislelizumab + Nab-Paclitaxel|OTHER: Bone Targeted Agents
Sponsor: Zhejiang Cancer Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-05
Locations: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310000, China

Summary:
The goal of this clinical trial is to learn if Tislelizumab Combined with Nab-Paclitaxel works to treat patients of TNBC with bone metastasis as first line treatment. It will also learn about the safety of the combination. The main questions it aims to answer are:

How effective is the combination therapy of tislelizumab and nab-paclitaxel in treating advanced first-line triple-negative breast cancer with bone metastasis? And is it safe?

Participants will:

* Receive the treatment as follows: Tislelizumab, 200mg, intravenous, every 3 weeks; nab-paclitaxel, 125mg/m2 on day 1 and day 8, followed by once every three weeks; bone targeted therapy selected by investigator.
* Visit the clinic once every 3 weeks for checkups and tests
* Keep a diary of their symptoms and the number of times they use a rescue inhaler

Primary Outcome Measures: Objective Response Rate(ORR), Objective Response Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1), Up to approximately 33 months
Secondary Outcome Measures: Progression-Free Survival (PFS), Progression-Free Survival by investigator assessment (in accordance with RECIST 1.1), The time from date of randomization to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 33 months|Overall Survival (OS), Overall Survival (OS), The time from date of enrollment to the date of death due to any cause up to approximately 33 months|Skeletal Related Events(SRE), Time from the date of first medication to the first occurrence of pathological fractures, bone surgery, bone radiotherapy, or spinal cord compression caused by tumor bone metastasis, up to 33 months
CEB-01 in Locally Resectable Pancreatic Cancer
NCT Number: NCT06538857
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Carcinoma
Interventions: PROCEDURE: Standard surgery|DRUG: CEB-01
Sponsor: CEBIOTEX
Collaborators: MFAR
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2028-09
Locations: H.U. Virgen del Rocío, Sevilla, Spain

Summary:
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the pancreatic cancer tumor, CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of pancreatic cancer after surgery, while keeping a tolerable toxicity profile.

The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in patients with locally resectable pancreatic cancer

Primary Outcome Measures: Frequency of Adverse Events (AEs) (Safety), Frequency of adverse events reported classified by type and severity according to the most updated version of the Common Terminology Criteria for Adverse Events (CTCAE)., Through study completion, average 3 years|Frequency of surgical complications after pancreatic surgery, Frequency of surgical complications according to the International Patient Safety Goals (IPSG)., Through study completion, after surgery average 3 years
Secondary Outcome Measures: Local recurrence-free survival (LRFS), Time from surgery until the progression of the disease in the area of implanted CEB-01, Through study completion, average 3 years|Progression-free survival (PFS), Time from surgery to objective tumour progression or death from any cause, Through study completion, average 3 years|Overall survival (OS), Time from surgery to death from any cause, Through study completion, average 3 years|Maximum concentration (Cmax) of SN-38, The highest concentration of SN-38 in the peripheral blood samples taken at sequential timepoints, During 60 days|Time of maximum plasma concentration (Tmax) of SN-38, Time from the surgery to the momento with the highest concentration of SN-38 in the peripheral blood samples taken at sequential timepoints, During 60 days|Terminal half-life (t1/2) of SN-38, The time required for the plasma concentration of SN-38 to fall by 50% from the Cmax, During 60 days|Area under the concentration-time curve (AUC0-inf) of SN-38, Represents the total SN-38 exposure in the peripheral blood across time, During 60 days
Dentists' Knowledge, Attitude and Practice Regarding Minimally Invasive Dentistry a Cross Sectional Comparative Study Between Two Governorates in Egypt
NCT Number: NCT06538805
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Attitude Towards Minimal Invasive Dentistry
Interventions: OTHER: Minimal invasive management of dental caries
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 808
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-01

Summary:
Some of the published researches indicate that many practicing dentists have not used the MID concepts yet in their clinics. They still use the surgical model of treatment despite the paradigm shift to the medical model. Spreading the knowledge and education about MID concepts will help in preserving more teeth structures which will be reflected on the efforts to promote the oral health in the Egyptian community. Thus the purpose of thiscross sectional study is to evaluate dentists' knowledge, attitudes, and practices regarding MID in both Cairo and Benisuef governorates.

The aim of this study is to gauge, assess and compare the knowledge, attitudes, and impact on clinical practices of dentists in Cairo and Beni-Suef governorates in Egypt regarding minimally invasive dentistry concepts.

Primary Outcome Measures: Awareness of the minimal invasive dentistry among practicing dentists in Cairo and Beni-suef, Validated Questionnaire used in the study by (Oliveira, 2011), Data will be collected online over a 3-month duration
Secondary Outcome Measures: Comparison of knowledge, attitudes and practices between dentists from Cairo and Beni-suef regarding minimally invasive dentistry, Validated Questionnaire used in the study by (Oliveira, 2011), Data will be collected online over a 3-month duration
Proprioception, Muscle Strength and Kinesiophobia After Anterior Cruciate Ligament Reconstruction
NCT Number: NCT06538792
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anterior Cruciate Ligament Reconstruction
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12
Locations: Bezmialem Vakif University, Istanbul, Turkey

Summary:
Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Primary Outcome Measures: Kinesiophobia, The Tampa Kinesiophobia Scale consists of seventeen items. Scores obtained from the scale range from 17 to 68, with higher scores indicating greater severity of kinesiophobia., Baseline|Joint position sense, Measurement of knee joint position sense by the active and passive repositioning technique with isokinetic dynamometer at 30˚ and 60˚.The deviation from the target angle is recorded in degrees. A high deviation from the target angle indicates a deficiency in proprioceptive sense., Baseline|Muscle strength, Assessment for knee extensor and flexor muscles with isokinetic dynamometer at 60 º/sec and 180º/sec angular velocity. The peak torque value (Nm), which is measured by the device and indicates the maximum force the subject can reach, will be used in the assessment., Baseline|Dynamic stability, The single leg dynamic stability test by the Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability, while higher scores indicate a lower ability to maintain postural stability., Baseline
Secondary Outcome Measures: Return to sports after ACL injury, The ACL Return to Sports after Injury (ACL-RSI) scale is a 12-item scale, scored from 0 to 10, that evaluates psychological readiness for return to sports after ACL injury. High scores indicate positive psychological readiness., Baseline
Sonographic Examination of Median Nerve Variations
NCT Number: NCT06538779
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carpal Tunnel Syndrome
Interventions: DIAGNOSTIC_TEST: elastography,usg
Sponsor: Yunus Burak Bayır
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 129
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
The aim of the study is to evaluate the prevalence of bifid median nerve in patients diagnosed with carpal tunnel syndrome (CTS) and whether it has a higher prevalence in CTS patients than in asymptomatic individuals, and to evaluate the characteristics of the bifid median nerve found and whether median nerve variations are predisposing factors in the development of CTS.

Primary Outcome Measures: Visual Analog Scale(VAS), The VAS used for pain assessment consists of a line drawn in the form of a ruler,and numbers from 0 to 10(with 0 as ''no pain'' and 10 as ''unbearable pain'') were asked to score., This evaluation will be made and recorded at the beginning
Secondary Outcome Measures: Boston Carpal Tunnel Questionnaire, symptom severity and functional status scale, This evaluation will be made and recorded at the beginning.|Dynamometer, Hand grip strength measurement test, This evaluation will be made and recorded at the beginning.|Ultrasound, Median nerve cross-sectional area measurement at the pisiform level., This evaluation will be made and recorded at the beginning.|Real-time elastography., Median nerve stiffness will be evaluated by real-time strain/sheer elastography., This evaluation will be made and recorded at the beginning.
Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health
NCT Number: NCT06538753
Acronym: Feydarjan
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pregnancy Complications|Herbal Medicine Adverse Reaction
Sponsor: Centre Hospitalier de Cayenne
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 332
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-21
Completion Date: 2023-07-07
Locations: Centre Hospitalier de Cayenne, Cayenne, 97300, French Guiana

Summary:
This is a descriptive, observational, cross-sectional study among women who have given birth in one of French Guiana's maternity hospitals to determine if the use of silver leaf is frequent and could have an impact on pregancy outcomes. This Fey darjan project is an ancillary study of the Nutri Pou Ti'Moun 1 project

Primary Outcome Measures: Prevalence of silver leaf decoction use, To estimate the prevalence of silver leaf decoction use among women who gave birth in one of the French Guiana maternity hospitals assessed by a questionnaire, At inclusion
Secondary Outcome Measures: Description of pregnancy outcomes, To describe pregnancy outcomes of women using SLDs in the prenatal period in relation to perinatal indicators in French Guiana (gestational diabetis, hypertension, pre-eclampsia/eclampsia, foetal weight abnormalities ), documented from medical file, At inclusion|Description of immediate post-partum outcomes, To describe immediate post-partum outcomes of women using SLDs in the prenatal period in relation to perinatal indicators in French Guiana (vaginal delivery, C-section, post-partum bleeding, foetal cardio rhythm abnormalities...), documented from medical file, At inclusion|Description of delivery pain management method, To describe the delivery pain management method of women using SLDs in prenatal period in relation to women not using SLDs (no delivery pain management method, epidural, spinal analgesia, general anaesthetic) documented from medical file, At inclusion|Use and representations of women using SLDs, To describe how women use SLDs during delivery assessed by a questionnaire, At inclusion|Health professionals comprehensions on SLDs use during delivery, To describe the comprehensions of health professionals on SLDs use during delivery assessed by a questionnaire, At inclusion
Effect of ALA on Retrolingual Collapse in Patients With Multilevel Obstructive OSA
NCT Number: NCT06538701
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: PROCEDURE: Anterolateral advancement pharyngoplasty
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
To determine the effect of Anterolateral advancement pharyngoplasty on retrolingual collapse in patients with multilevel OSA, and thus if multistage surgery is required.

Primary Outcome Measures: determine the changes in apnea-hypopnea index (AHI) in multilevel OSA patients with Anterolateral advancement pharyngoplasty, we assess pre- and post-operative polysomnogram to detect if there is changes in AHI (per hour of sleep), Baseline|determine the changes in diameter of retrolingual airway in multilevel OSA patients with Anterolateral advancement pharyngoplasty ., we assess pre- and post-operative cephalometry to detect if there is changes in diameter of retrolingual airway (in mm)., Baseline
Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar
NCT Number: NCT06538688
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inferior Alveolar Nerve Injuries
Interventions: PROCEDURE: Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction
Sponsor: Alexandria University
Sex: ALL
Age: ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-12-17
Completion Date: 2024-07-20
Locations: Alexandria university, Alexandria, Egypt|Faculty of Dentistry, Alexandria University, Alexandria, Egypt|Faculty of Dentistry, Alexandria, Egypt

Summary:
The goal of this clinical trial is to investigate the usage of maxillary miniscrew and cross-arch elastics for the orthodontic traction of the impacted mandibular third molar in close proximity to the inferior alveolar nerve to decrease the chance of nerve injury

Primary Outcome Measures: Radiographically, By measuring the amount of extrusion of the impacted tooth gained in millimetres Using CBCT, 6months
Secondary Outcome Measures: Clinical neurosensory assessment, By using pinprick test in which ;A sharp dental probe was applied to the skin over chin region, lip and mucosa in a quick pricking movement and pain perception of the patient was assessed. Each area was tested three times bilaterally.the scale ranged from 0-2, where 0= no sensation, 1= decreased sensation and 2= normal sensation., 6months|clinical brush stroke directional test, using a micro brush tip which was moved in horizontal and/or vertical directions on the chin area ten times and asked the patient to reproduce the movements the scale ranged from 0-2, where 0= no sensation, 1= decreased sensation and 2= normal sensation., 6months|Clinical Two-point discrimination test, By using probes of caliper device which were drawn across the skin at constant pressure and patient was asked whether one or two points were felt, the minimum separation distance was felt by the patient was termed two point discrimination threshold.scoring from 0-2 in which; 0=\>15mm, 1=8-15, 2= \<8 ., 6months
Process and Outcome Evaluation of Different Psychotherapies
NCT Number: NCT06538675
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Mental Illness|Psychiatric Disorder|Mental Disorder
Interventions: OTHER: Psychotherapy
Sponsor: University of Salzburg
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2035-12
Locations: Paris-Lodron-University Salzburg, Salzburg, 5020, Austria

Summary:
In this study, adult patients and therapists at the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg will complete questionnaires throughout the course of psychotherapy in order to evaluate the course and outcome of psychotherapy.

Primary Outcome Measures: Hopkins Symptom Checklist Short Form (HSCL-11), 11 items, Likert scale: 4-point scale; 1 (not at all) to 4 (very much), Minimum value: 11, Maximum value: 44, Higher scores indicate more mental health problems., through study completion, an average of 1 year
Secondary Outcome Measures: Patient Health Questionnaire-8 (PHQ-8), 8 items, Likert scale: 4-point; 0 (not at all) to 3 (nearly every day), Minimun value: 0, Maximum value: 24, Higher scores indicate more depressive symptoms, Score ≥ 10 indicate depression., through study completion, an average of 1 year|Generalizied Anxiety Disorder Scale-7 (GAD-7), 7 items, Likert scale: 4-point; 0 (not at all) to 3 (nearly every day), Minimun value: 0, Maximum value: 21, Higher scores indicate more anxiety symptoms, Score ≥ 10 indicate anxiety., through study completion, an average of 1 year|Patient Health Questionnaire-4 (PHQ-4), 4 items, Likert scale: 4-point; 0 (not at all) to 3 (nearly every day), Minimun value: 0, Maximum value: 12, Higher scores indicate more depressive and anxiety symptoms, Score ≥3 for first 2 questions indicates depression, Score ≥ 3 for last 2 questions indicates anxiety., through study completion, an average of 1 year|Positive Mental Health scale (PMH), 9 items, Likert skala: 4-point; 0 (do not agree) to 3 (agree), Minimun value: 0, Maximum value: 27, Higher scores indicate higher positive mental health., through study completion, an average of 1 year|Society for Psychotherapy Research Item on Mental Health, 1 item, Likert scale: 5-point; 0 (very bad) to 4 (very good), Minimum value: 0, Maximum value: 4, Higher scores indicate better mental health., through study completion, an average of 1 year
Effect of Statins on Crohn's Disease
NCT Number: NCT06538649
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Crohn's Ileocolitis|Crohn Disease
Interventions: DRUG: Rosuvastatin|OTHER: Placebo
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2028-09-01

Summary:
Can statin use reduce the formation of Crohn's strictures?

Primary Outcome Measures: Rutgeerts score, at post surgery surveillance colonoscopy, 6-12 months post surgery
Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer
NCT Number: NCT06538623
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pancreatic Neoplasms|Neoplasm Metastasis|Hepatic Metastasis of Pancreatic Cancer
Interventions: DRUG: Liposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin|DRUG: Tegodor
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-23
Completion Date: 2025-12-31
Locations: Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 2000010, China

Summary:
The study explores the efficacy and safety of oxaliplatin combined with irinotecan liposome injection II via hepatic arterial infusion (HAIC) followed by sequential treatment with 5-FU/LV (HAIC) or oral administration of S-1 in patients with liver metastasis from pancreatic cancer after the failure of first-line treatment with the AG regimen. This research aims to accumulate more clinical evidence and treatment options for second-line therapy in metastatic pancreatic cancer.

Primary Outcome Measures: OS, Overall Survival, From enrollment to the death from any cause, assessed up to 18 months
Secondary Outcome Measures: ORR, Objective Response Rate (according to RECIST 1.1 criteria), From enrollment to tumor response or date of death from any cause, whichever came first, assessed up to 18 months|PFS, Progression Free Survival, From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months
The 5-FU Holter Study
NCT Number: NCT06538610
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Malignancy
Interventions: DEVICE: Holter monitor
Sponsor: University of Auckland, New Zealand
Collaborators: Gut Cancer Foundation|Auckland City Hospital|The Heart Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2026-01

Summary:
To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy

Primary Outcome Measures: Recruitment rate, The percentage of participants who were contacted and joined the study will be reported., Up to 1 year|Acceptability rate, The percentage of participants who joined the study and wore the Holter monitor for the required study duration., Up to 1 year|Completion rate, The percentage of participants who joined the study and completed all study assessments, Up to 1 year|Overall time required to recruit to the target sample size, The overall time in weeks required to recruit participants for the feasibility study will be reported., Up to 1 year|Clinician experience of recruitment, Clinician Survey administered at end of study recruitment to measure clinicians' perceived ease of recruitment (5-point Likert scale 1=Difficult to 5=Very easy), After 1 year|Clinician experience of barriers to recruitment, Clinician Survey administered at end of study recruitment to measure clinicians' perceived barriers to recruitment (open ended questions), After 1 year|Clinician experience of software module (Pathfinder SL) to measure ST segments using Holter monitoring while receiving infusional 5-FU chemotherapy, Clinician Survey administered at the end of study recruitment to measure clinicians' perceived quality of Holter monitor recordings (5-point Likert scale 1=Poor to 5=Excellent), After 1 year|FBAL (fluoro-beta-alanine) Excretion rate, Cumulative urine sample collected over 3 hours, 3 hours|FBAL (fluoro-beta-alanine) Area under the Curve (AUC), Blood samples collected prechemo and 20 mins, 1 hour, 3 hours, 0, 20 minutes, 1 hour, 3 hours|FBAL (fluoro-beta-alanine) Clearance (CL), Blood samples collected prechemo and 20 mins, 1 hour, 3 hours, 0, 20 minutes, 1 hour, 3 hours
Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
NCT Number: NCT06538584
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Enhanced Recovery After Surgery in a Pediatric Population
Interventions: DRUG: Caffeine citrate 10mg/kg|DRUG: 0.9% Sodium Citrate
Sponsor: University of Chicago
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2027-12-31
Locations: University of Chicago Medical Center, Chicago, Illinois, 60637, United States

Summary:
Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. With this Dex sedation protocol, these pediatric patients usually take an average of 45 minutes (30-60 minutes) to wake and become alert and up to 2 hours to be discharged.

Without reversal agents, emergence times from Dex sedation are slow. The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput, thus increasing the cost of care. Patient safety and satisfaction suffer as a result. The children wake feeling tired and sluggish. The children don't feel back to normal for an extended period of time, which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. In humans, it has been found that caffeine at 7.5 mg/kg (15 mg caffeine citrate equivalent to 7.5 mg caffeine base) sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers.

The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging (MRI) procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria.

Primary Outcome Measures: Improve rate of wakefulness post surgery, Subject post-surgery wakefulness recovery with caffeine based on a modified Aldrete score, Up to 2 hours
Secondary Outcome Measures: Time needed to be able to return to tasks performance with purpose, Eyes open, normal response to verbal stimulation, crying/complaining, taking PO (if applicable), Up to 2 hours