pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
The Effect of White Noise and Pacifier Applications on Pain and Crying Time
NCT Number: NCT06535061
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Newborn
Interventions: OTHER: white noise
Sponsor: Sanko University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-03-01
Completion Date: 2022-09-15
Locations: Ebru Karaaslan, Şehitkamil, Gazi̇antep, Turkey

Summary:
The objective of the study was to determine the effect of white noise and pacifier applications on pain and crying time in newborns during painful interventions. The research was planned experimentally. Pacifier application was applied to the newborns, who had undergone surgery, and they formed the control group. White noise and pacifier applications were applied to the newborns, who had undergone surgery, and they formed the experimental group.

Primary Outcome Measures: Neonatal Pain Scale, The factors evaluated in the neonatal pain scale are facial expression, arms, legs, oxygen saturation, arousal status, breathing pattern, crying, and heart rate factors. It can be preferred in post-operative pain and used for procedural pain. It has 8 parameters in total. A maximum of 7 points can be awarded: 0 points = no pain; 1-2 points = mild pain; 3-4 points = moderate pain; \&gt;4 points = severe pain, a day
Secondary Outcome Measures: Neonatal Physiological Evaluation Form, This form included the newborns' fever, heart rate, respiratory rate and saturation, crying time, and NIPS pain scores 5 minutes before painful interventions, during painful interventions, and 5 minutes after painful interventions. A Nimomed Non-Contact Infrared Thermometer was used to measure the temperature of the newborns. The Nihon Kohden Monitor was used to measure the newborn's heart rate and saturation.

A newborn scale was used to weigh the newborn's weight. The sound level (lower limit 200-250 Hz, upper limit 10-16 kHz) was evaluated with a Saunal Meter. The newborns were monitored with the above medical instruments. The crying time of the newborns was recorded with a voice recorder, and discussed on a minute basis. The newborn white noise sound was created by combining hair dryer, vacuum cleaner, wave sound and ultrasound device with heartbeat sound. The newborns in the experimental group listened to it for a total of 15 minutes in 5-minute periods., a day
Impact of Fatty Liver on Hepatitis B Therapy
NCT Number: NCT06535048
Acronym: AV-FLCHB
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fatty Liver Disease|Chronic Hepatitis B|Antiviral Treatment
Interventions: DRUG: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons
Sponsor: Tianjin Second People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2015-01-01
Completion Date: 2024-08-31

Summary:
The primary goal of treating chronic hepatitis B(CHB) is to achieve maximal suppression of HBV replication, thereby reducing hepatocyte inflammation, necrosis, and liver fibrosis. Among various treatment strategies, antiviral therapy plays a crucial role. The prevalence of fatty liver disease (FLD) has continued to increase in recent decades. This study aims to accurately diagnose the pathological state of patients through liver biopsy and conduct a five-year follow-up to explore the impact of FLD on the efficacy of CHB treatment and to identify factors influencing adverse outcomes.

Primary Outcome Measures: Comparison of virological levels in serum, The incidence of negativity for HBV DNA, HBsAg, and HBeAg, defined as serum levels less than 20 IU/mL, 0.05 IU/mL, and 1.0 S/CO, respectively., 5 years|Comparison of liver function improvement, Liver function was assessed by measuring serum ALT, AST, and GGT levels during treatment., 5 years
Secondary Outcome Measures: Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients, Evaluation of the incidence of adverse outcomes such as liver cirrhosis, hepatocellular carcinoma (HCC) under ultrasound, and overall survival in CHB patients with fatty liver compared to those without fatty liver., 5 years|Factors affecting adverse outcomes in patients with chronic hepatitis B, Kaplan-Meier method was used for survival analysis, and the influencing factors of poor prognosis were analyzed., 5 years
Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants
NCT Number: NCT06535035
Acronym: AAPDI
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Pain and Sensation Disorder
Interventions: DEVICE: laser therapy After implant surgery, laser therapy (LLLT) was applied|DEVICE: SHAM
Sponsor: Universidad de Murcia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-01-10
Completion Date: 2024-06-10
Locations: Pia Lopez Jornet, Murcia, 30008, Spain

Summary:
The aim of this study is to evaluate the analgesic and anti-inflammatory effects of photobiomodulation in participants undergoing dental implant placement.

A randomized clinical trial was conducted with 62 participants requiring dental implant placement, divided into two groups of 31 each. Immediately after implant placement, one group received diode laser photobiomodulation, while the SHAM group received sham treatment. Pain and inflammation were assessed at 24 h, 48 h, and 7 days. In addition, Modified Dental Anxiety (MDA) levels were measured and the Oral Health Impact Profile-14 (OHIP-14) questionnaire was used to assess oral health-related quality of life.

Primary Outcome Measures: Pain levels assessed with the visual analogue scale (VAS), A score of 0 indicated no pain while 10 indicated the worst pain possible, 24h-48h,7 days|inflammation evels assessed with the visual analogue scale, A score of 0 indicated no inflammation while 10 indicated the worst inflammation possible, 24h-48h,7 days
Secondary Outcome Measures: Modified Corah Dental Anxiety Scale (MDAS), (0 relaxed, 1 slightly anxious, 2 quite anxious, 3 very anxious or 4 extremely anxious). The total sum was obtained and 4 ranges of fear and anxiety were established (\<9 mild or no anxiety, 9-12 moderate anxiety, 13-14 high anxiety, \>14 phobic anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety)., at day 0 and 7 days|OHIP-14sp, consists of 14 questions related to different dimensions of the patient's quality of life (functional limitation, pain, psychological problems, etc.) higher score worse quality of life, at 0 and at 7 days
DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)
NCT Number: NCT06535022
Acronym: DeliKet
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Delirium|Ketogenic Dieting|Nutrition, Healthy
Interventions: DIETARY_SUPPLEMENT: Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)
Sponsor: University Hospital of Cologne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-03-01

Summary:
Postoperative delirium is a common problem of the critically ill patient and associated with an increased mortality. Intermittent fasting and ketogenesis have been shown to be beneficial for maintaining a circadian rhythm and initiating anti-inflammatory repair mechanisms which could potentially be neuroprotective. However, so far there is little data if cyclic enteral feeding with ketogenic nighttime fasting might be beneficial for reducing the rate of postoperative delirium. The study hypothesis is that equicaloric cyclic enteral feeding (12 hrs) during daytime with ketogenic fasting and exogenous ketone supplementation at nighttime compared to continuous standard enteral nutrition (24 hours) decreases the incidence of postoperative delirium in critically ill patients.

Primary Outcome Measures: Confusion Assessment Method (CAM- ICU), CAM ICU score (lowest score 0, highest score 7)

• Cognitive function (MoCA- and MMST- Score) day 1, 7, 14 / ICU discharge, Day 1-14 after randomization or until ICU discharge|• Montreal Cognitive Assessment (MoCA- Score), • Cognitive function (MoCA- Score) (lowest Score 0, highest Score 30), Day 1-14 after randomization or until ICU- discharge|MMSE (Minimental State Examination), MMSE Score (lowest Score 0, highest Score 30), Day 1-14 after randomization or until ICU discharge
Secondary Outcome Measures: Duration of ventilation, Length of invasive and noninvasive ventilation, From day of randomization until ICU discharge up to 1 month|Length of ICU- and Hospital stay, Length of ICU- and Hospital stay, From day of randomization until hospital discharge up to 6 months|30-day mortality, Mortality at day 30 after ICU admission, From day of randomization up until 30 days
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors
NCT Number: NCT06535009
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor
Interventions: DRUG: ONO-7914|DRUG: ONO-4538
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 204
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-31
Completion Date: 2027-09-30
Locations: Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan

Summary:
This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors

Primary Outcome Measures: Dose Limiting Toxicity, 28 days|Adverse Events as assessed by CTCAE v5.0, Up to 28 days after the completion of treatment period
Secondary Outcome Measures: Plasma concentration of ONO-7914, Up to 21 days after the first treatment|Urine concentration of ONO-7914, Up to 24 hours after the first treatment|Serum concentration of ONO-4538, Up to 28 days after the completion of treatment period
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly
NCT Number: NCT06534996
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Constipation
Interventions: DRUG: SCD-2101
Sponsor: Hong Kong Baptist University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2024-11-30
Locations: Hong Kong Baptist University, Kowloon Tong, Hong Kong

Summary:
This single-arm, open-label pilot clinical trial will test the hypothesis that SCD-2101, a Chinese herbal medicine formula, will have efficacy in alleviating constipation in elderly individuals with functional constipation. All participants (n=14) will receive 2 weeks of intervention and 2 weeks of follow-up.

Primary Outcome Measures: Response rate of Complete Spontaneous Bowel Movements (CSBM), A CSBM responder is defined as a patient who meets the CSBM responder criterion (i.e., a mean increase of CSBM≥1/week compared with CSBM at baseline, in at least 2 out of 4 weeks). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as a SBM that is associated with a sense of complete evacuation. Baseline of weekly CSBM will be the average between Week -2 and Week 0., from baseline to Week 2
Secondary Outcome Measures: Change in the number of Complete Spontaneous Bowel Movements (CSBM) per week compared to baseline, A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as a SBM that is associated with a sense of complete evacuation. Baseline of weekly CSBM will be the average between Week -2 and Week 0., from baseline to Week 2|Change in the number of Spontaneous Bowel Movements (SBM) per week compared to baseline, weekly Spontaneous Bowel Movement (SBM), from baseline to Week 2|Types and severity of adverse reactions after taking the medication, Assessed by number of adverse events or side effects, from baseline to Week 2
Other Outcome Measures: Safety Outcomes: (1) Any adverse reaction symptoms/adverse events occurring after the trial treatment, Assessed by number of adverse events or side effects, from baseline to Week 2|Safety Outcomes: (2) General physical examination items (including heart rate, blood pressure, etc.), Assessed by number of adverse events or side effects, from baseline to Week 2
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
NCT Number: NCT06534957
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Stress
Interventions: OTHER: Online mindfulness-based stress reduction
Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2025-10
Locations: Hospital Zambrano Hellion, San Pedro Garza Garcia, Nuevo Leon, 66278, Mexico

Summary:
The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (MBSR) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.

The main questions it aims to answer are:

* Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
* Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?

Researchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.

Participants will:

* Participate in an online MBSR intervention or no intervention for 6 weeks
* Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up

Primary Outcome Measures: Stress, Measured through the Perceived Stress Scale (PSS). The PSS is a self-report instrument that assesses the level of perceived stress over the past month. It consists of 10 items that are rated using a 5-point Likert scale (0: Never; 1: Almost never; 2: Sometimes; 3: Fairly often; 4: Very often). The total score is obtained by adding the scores of the 10 items, obtaining a total value between 0-40, where higher scores indicate a higher level of perceived stress. A moderate stress level is considered between 20-25 points, and a high stress level is considered when obtaining \>25 points., 11 weeks
Precise Oncology Interventions in Nutrition and Training (OnPoint)
NCT Number: NCT06534918
Acronym: OnPoint
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Prostate Cancer|Colorectal Cancer
Interventions: OTHER: Fitbit|BEHAVIORAL: Nutrition Course|BEHAVIORAL: Physical Activity Program|BEHAVIORAL: Weekly One on One Session with Registered Dietitian|BEHAVIORAL: Weekly One on One Session with an Exercise Physiologist|BEHAVIORAL: Nutrition Prescription|BEHAVIORAL: Physical Activity Prescription
Sponsor: University of Miami
Collaborators: The Applebaum Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 306
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2027-10-01
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.

Primary Outcome Measures: Percentage of Survivors Who Agree to Participate, Percentage of survivors who agree to participate will be reported as ≥ 50%., Up to 8 Weeks|Percentage of Interventions Sessions Completed, Percentage of intervention sessions completed will be reported as ≥ 80%., Up to 8 Weeks|Percentage of Participants Satisfied with the Intervention, Report of 80% satisfaction will be determined as satisfaction with intervention components., Up to 8 Weeks
E-cigarette Switching Older Adults
NCT Number: NCT06534905
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Use|Opioid Use Disorder|Tobacco-Related Disorders
Interventions: OTHER: E-cigarette|BEHAVIORAL: Control/Standard Advice
Sponsor: University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-12
Locations: University of Maryland Addiction Treatment Center (UMATC), Baltimore, Maryland, 21223, United States

Summary:
The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial. The main questions the study aims to answer are:

* Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don't have a plan to quit?
* Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation (control)?
* Does the accuracy of nicotine/tobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education?

Participants will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8, each lasting 30-90 minutes, for a total of approximately 3-4 hours of participation in the study. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning.

Patients will be randomly assigned at baseline (if meeting eligibility criteria) to receive an e-cigarette product (NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).

Primary Outcome Measures: Reduction in cigarettes smoked per day (% change), Measured by self-report during study sessions, up to 8 weeks|Intention to quit smoking in next month, Measured by self-report in response to following question "Do you intend to stop smoking in the next month?", up to 8 weeks
The Effect of Psychosocial Factors on Academic Success in University Students
NCT Number: NCT06534879
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Students|Education
Sponsor: Gazi University
Sex: ALL
Age: ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2024-09-05

Summary:
Psychological well-being is defined as the person fulfilling his/her potential in a completely good mood. It is seen as the result of a life lived well and is an important factor for students to adapt to university life. Psychological well-being includes dimensions such as self-acceptance, establishing positive relationships, autonomy, mastery of the environment, personal development and purpose in life. Students who have just started university have to adapt to a new learning model and the academic pressure on them is also increasing. This period of students' lives is considered to be one of the stages when anxiety is highest and psychological well-being is lowestThe examination of the potential predictive relationship between psychosocial factors and psychological goodness described earlier in a university student, provides a more holistic perspective for potential educators, researchers and health practitioners. Although the literature was examined, although the effects of some of the psychosocial factors on university students, physiotherapy and rehabilitation students have been found to have insufficient studies on the effect of psychosocial factors on academic success.

For this reason, in our study, physiotherapy and rehabilitation students will be evaluated with the level of empathy, self -esteem, social/emotional competence, mental good formation, situational/continuous anxiety (anxiety), motivation, satisfaction and loneliness surveys from life and the relationship between them and the academic achievements of the students will be investigated. .

Primary Outcome Measures: Rosenberg Self-Esteem Scale, The purpose of the 10 item RSE scale is to measure self-esteem. Originally the measure was designed to measure the self-esteem of high school students. However, since its development, the scale has been used with a variety of groups including adults, with norms available for many of those groups., 1 day|Empathy Assessment Scale, EAS is a valid and reliable measurement tool to assess the empathy levels of individuals in three dimensions: Social interaction, cognitive behavior, and emotional identification. EAS can be used to evaluate the empathy levels for research, education, and other interventional purposes., 1 day|State Trait Anxiety Inventory, The STAI is a validated 20 item self report assessment device which includes separate measures of state and trait anxiety. The original STAI form was constructed by Charles D. Spielberger, Richard L. Gorsuch, and Robert E. Lushene in 1964., 1 day|Satisfaction With Life Scale, The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. The scale usually requires only about one minute of a respondent's time, where respondents answer on a Likert scale., 1 day
"Effects of Kinesio Taping in Adjunct to Traditional Physical Therapy on Pain, Range of Motion and Gait Parameters in Patients With Plantar Fasciitis : a Randomized Controlled Trail"
NCT Number: NCT06534866
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Plantar Fascitis
Interventions: OTHER: Traditional Physical Therapy|OTHER: Kinesiotaping
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2025-01-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE EFFECTS OF KINESIO TAPING ON GAIT PARAMETERS IN PATIENTS WITH PLANTAR FASCITIS

Primary Outcome Measures: Pain Intensity, Pain is assessed by using numeric main rating scale comparing pre and post pain intensity. This is 11- point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme, 2 weeks|Range of Motion at ankle joint, Goniometer will be used to measure the pre and post treatment ranges of dorsiflexion and plantar flexion of ankle in supine and sitting positions., 2 weeks|Cadence (steps/min), Will asses gait parameters through 30 meters walk test. steps counted x 60 / time (s), 2 weeks|Cycle time (s), Will asses gait parameters through 30 meters walk test. time (s) x 2/steps counted, 2 weeks|Gait speed, Will asses gait parameters through 30 meters walk test. Distance (m) /time (s), 2 weeks|Stride length(m), Will asses gait parameters through 30 meters walk test. speed (m/s) x cycle time (s), 2 weeks
Comparison of Post Facilitation Stretch Versus Reciprocal Inhibition in Quadratus Lumborum Syndrome: a Randomized Controlled Trial
NCT Number: NCT06534853
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Quadratus Lumborum Syndrome
Interventions: OTHER: Post Facilitation Stretch|OTHER: Reciprocal Inhibition|OTHER: Conventional Physical Therapy
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2025-01-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
This study is a randomised control trial and the purpose of this study is to determine the effects Post facilitation stretch versus reciprocal inhibition on pain, lumbar range of motion, apparent leg length discrepancy and lumbar lordotic angle in Quadratus Lumborum Syndrome.

Primary Outcome Measures: Pain intensity, Pain is assessed by using numeric main rating scale comparing pre and post pain intensity. This is 11- point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme, 2 weeks|Lumbar Range of Motion (ROM), It will measured using inclinometer, 2 weeks|Leg Length Discrepancy (LLD), Measure the distance between the anterior superior iliac spine (ASIS) and the medial malleolus.This method, referred to as the "direct" clinical method for measuring LLD, provides the apparent leg length discrepancy., 2 weeks|Lumbar Lordotic Angle, It will be measured using Flexible Ruler, 2 weeks
Evaluation of Pulmonary Complications in Liver Transplantation Patients Based on Machine Learning
NCT Number: NCT06534840
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Transplantation
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-12-15
Locations: West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China

Summary:
The main objective of this study is to develop a machine learning model that predicts moderate-severe prediction model of pulmonary complications in liver transplantation patients within 14 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes.

Primary Outcome Measures: Prediction of postoperative moderate-to-severe pulmonary complications, IA total of 72 variables are expected to be included, using 6 types of machine learning methods, including decision tree (DT), logistic regression (LR), random forest (, RF), support vector machine (SVM), extreme gradient lift (XGBoost), and gradient lift decision tree (GBDT) to build a moderate postoperative prediction model, August 2024-December 2024
Development and Application of an Artificial Intelligence-driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis
NCT Number: NCT06534814
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: The Primary Focus of This Study is on Gastric Cancer
Interventions: DIAGNOSTIC_TEST: AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)
Sponsor: Hebei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2030-07-30
Locations: Department of General Surgery, Shijiazhuang, Hebei, 050011, China

Summary:
The clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis" aims to enhance the detection and treatment of gastric cancer through the utilization of cutting-edge artificial intelligence (AI) technology. This study will develop an AI-driven model designed to accurately identify lymph node metastasis in patients with gastric cancer, which is crucial for staging the disease and planning effective treatment strategies.

The trial will involve a multidisciplinary team of oncologists, radiologists, data scientists, and AI experts who will collaborate to create a robust and precise identification system. Participants will undergo standard diagnostic procedures, and the AI model will analyze imaging and pathological data to predict lymph node involvement.

By comparing the AI model's predictions with traditional diagnostic methods, the study seeks to validate the model's accuracy and efficiency. This approach is expected to improve early detection rates, reduce diagnostic errors, and ultimately lead to better clinical outcomes for patients with gastric cancer. The successful implementation of this AI-driven model could revolutionize the current standards of care and serve as a blueprint for integrating AI technologies in other cancer diagnoses and treatments.

Primary Outcome Measures: Identification of metastatic lymph nodes, A prediction model based on artificial intelligence technology was constructed to accurately identify metastatic perigastric lymph nodes before surgery., 2025-12-31
Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment
NCT Number: NCT06534801
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oxycodone|Thoracoscopic Lobectomy|Acute Postoperative Pain
Interventions: DRUG: Oxycodone will be administered intravenously in the group 1
Sponsor: Jianbo Wu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-04-01

Summary:
The goal of this clinical trial is to measure the median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy. This clinical trial was divided into two groups based on age, Group I (Age \< 65 years old) and Group II (Age ≥65 years old). We used the sequential allocation designed by Dixon. The initial oxycodone dose was set to 0.1 mg/kg.A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point was included as the first case for ED50 estimation in each group.The study was conducted until 7 crossover points were collected

Primary Outcome Measures: The median effective dose, The median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy, 3 minutes after remoal of the endotracheal tube, 30minutes after remoal of the endotracheal tube
Effects of Reciprocal Inhibition Versus Post Facilitation Muscle Energy Technique Along With Conventional Physical Therapy in Patients With Piriformis Syndrome: a Randomized Controlled Trial
NCT Number: NCT06534788
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Piriformis Syndrome
Interventions: OTHER: Reciprocal Inhibition MET|OTHER: Post-facilitation MET|OTHER: Conventional physical therapy
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-31
Completion Date: 2025-01-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
This study is a randomized controlled trial and the purpose of this study is to compare the effects of reciprocal inhibition versus post facilitation muscle energy technique along with conventional physical therapy in patients with piriformis syndrome in terms of pain, range of motion at hip joint and functional disability.

Primary Outcome Measures: Pain Intensity, The pre and post pain intensity will be measured using Numeric Pain Rating Scale (NPRS) comprising of 11 points from 0 - 10 where 0 indicates "no pain" while 10 is "maximally felt pain"., 2 weeks|Hip range of motion, Goniometer will be used to measure the pre and post treatment ranges of internal rotation, external rotation, abduction and adduction at hip joint in supine and sitting positions., 2 weeks|Functional Disability, Lower Extremity Functional Scale comprising of 20 questions regarding lower extremity function will be used. The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function., 2 weeks
Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
NCT Number: NCT06534762
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: NSCLC|SCLC|Colorectal Cancer|Pancreas Cancer|TNBC - Triple-Negative Breast Cancer|DLBCL - Diffuse Large B Cell Lymphoma|Squamous Cell Carcinoma of Head and Neck
Interventions: BIOLOGICAL: Mirabegron
Sponsor: Zhejiang Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2028-07-01
Locations: Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Summary:
This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg/day, and the dose used in this study is 100mg/day, which is larger than the clinical commonly used dose. The main adverse reactions of this product are urinary tract infection and rapid heartbeat. In the clinical study, we will focus on the urine routine and heart-related adverse events of the subjects, and deal with the adverse events in time.

Subjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued.

Primary Outcome Measures: ORR, Overall objective tumor response rate, 3 years|DLT, Dose-limiting toxicity, 3 years
Secondary Outcome Measures: DCR, Disease control rate, 3 years|DOR, duration of response, 3 years|TTR, Median time to remission, 3 years|OS, overall survival, 3 years|PFS, Progression free Survial, 3 years
Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates
NCT Number: NCT06534749
Acronym: CAKUT
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary Tract Anomalies|Kidney; Anomaly
Interventions: DEVICE: ultrasound
Sponsor: Tanta University
Sex: ALL
Age: CHILD
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-28
Completion Date: 2024-10
Locations: Sara Mabrouk Mohamed Elghoul, Tanta, Tanta, Qism 1, 31511, Egypt

Summary:
This cross sectional study will be conducted to investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital.

Primary Outcome Measures: Incidence of CAKUT in neonates, investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital., one year
Effects of Scapular Stabilization Exercises Combined With Post Facilitation Stretch in Patients With Upper Cross Syndrome: A Randomized Control Trial
NCT Number: NCT06534736
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Upper Cross Syndrome
Interventions: PROCEDURE: Electrotherapy and physical agents|PROCEDURE: Post Facilitation Stretch|PROCEDURE: Scapular Stabilization Exercise
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
Upper Cross Syndrome is characterized by the postural deviation of head , neck , shoulders and altered muscular muscular activation which included weakness of rhomboids , middle and lower trapezius and serratus anterior and tightness of upper trapezius , pectorallis and levator scapulae . It is a combinaton of scapular dyskinesia , forward head posture , rounded shoulder and thoracic kyphosis.This study aims to assess the enduring effects scapular stabilization exercises along with post facilitation stretch on Upper Cross Syndrome with the goal of preventing its reoccurrence over time, If there are improved results by the combination of both treatments than any of them alone , then it can used in combination for better results on patients

Primary Outcome Measures: pain intensity, Measured with Numeric Pain Rating Scale, 4 weeks|Neck Disability, Neck disability index is used for assessing self-rated disability in neck pain patients, 4 weeks|Cervical Range of Motion, Goniometer will be used to measure Cervical Range of Motion, 4 weeks
Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty
NCT Number: NCT06534697
Acronym: FIB-PAIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hip Osteoarthritis
Interventions: DRUG: Naropin, 0.2% Injectable Solution in Sodium chloride|DRUG: Naropin, 0.2% Injectable Solution in dextrose 5%|DRUG: Dextrose 10 % in Water
Sponsor: Foisor Orthopedics Clinical Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2025-02-28

Summary:
This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:

·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?

The secondary questions are:

* What is the length of stay in hospital for each group?
* What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.

Primary Outcome Measures: The total morphine consumption, The total morphine consumption is measured in mg, 24 hours postoperatively
Secondary Outcome Measures: The risk of fall, The percent of the number of falls reported to the number of the patients for each arm, Up to 1 week|Length of stay in hospital, The duration between admision and discharge of the hospital, Up to 1 week
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
NCT Number: NCT06534684
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression, Unipolar|Depression Moderate
Interventions: DEVICE: Intermittent Theta Burst Stimulation
Sponsor: University Hospital of North Norway
Collaborators: UiT The Arctic University of Norway
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-12
Completion Date: 2029-02-12
Locations: University Hospital North Norway, Tromsø, 9038, Norway

Summary:
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.

Primary Outcome Measures: Data from magnetic resonance imaging - white matter integrity, Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of cerebral white matter integrity quantified by fractional anisotropy measured by diffusion tensor imaging (DTI) obtained from magnetic resonance imaging (MRI)., Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days|Data from magnetic resonance imaging - cortical thickness, Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of thickness in cerebral gray matter thickness quantified by T1-weighted magnetic resonance imaging (MRI)., Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days|Data from magnetic resonance imaging - cerebral activity, Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in cerebral activity quantified by blood-oxygen-level-dependent (BOLD) responses measured by functional resonance imaging (fMRI)., Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Secondary Outcome Measures: Performance on a N-back cognitive test, Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in behavioral performance on a cognitive task measuring working memory and executive performance when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation., Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days
Diltiazem in Jervell and Lange-Nielsen Syndrome
NCT Number: NCT06534671
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Jervell and Lange Nielsen Syndrome
Interventions: DRUG: diltiazem
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States

Summary:
This study will test the effect of diltiazem, a calcium channel blocking drug, on the QT interval in patients with Jervell and Lange-Nielsen syndrome. This will be a single IV dose and acute effects (within minutes) will be observed.

Primary Outcome Measures: QT interval, QT interval (on 12-lead ECG) in ms, Baseline
STOP-stroke: STroke Outcome Prediction in the Acute Treatment Setting
NCT Number: NCT06534645
Acronym: STOP-STroke
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke Outcome Prediction Supported by Deep Learning Algorithm
Sponsor: University of Zurich
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-30

Summary:
The STOP-stroke project aims at improving prediction of outcome early after stroke. In order to achieve this, we need to understand reasons (important variables) for prediction in a real clinical prognostication process.

We aim to:

1. Test the predictive performance of stroke neurologists for outcome prediction (NIHSS at 24 hours and 3 months and mRS at 3 months after stroke onset) prospectively and in a real clinical setting, and to explore the most important baseline variables in their prognostication process.
2. Test the prediction performance of our DL models when being provided with structured clinical and/or imaging information from the same patients as the neurologists; and to discover most relevant features of the input data.
3. Use the information gained from our experiments for improving our DL algorithm. This will include an error analysis on the missclassifications of models and neurologists to understand the pitfalls of both approaches. We anticipate to develop a robust, reliable and clinically feasible application ready for testing in a prospective, observational trial.

Primary Outcome Measures: actual stroke related disability, actual stroke related disability assessed by the mRS at 3 months as well as the NIHSS (stroke severity) after 24 hours and 3 months after acute ischemic stroke (AIS), assessed 90 days after stroke onset
Secondary Outcome Measures: predicted stroke related disability, predicted mRS scores of the treating neurologists on the stroke unit one side and the predicted mRS by the DL model on the other, 90 days after stroke onset
Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants
NCT Number: NCT06534632
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prematurity
Interventions: OTHER: Mother's colostrum|OTHER: Placebo
Sponsor: General Organization for Teaching Hospitals and Institutes
Sex: ALL
Age: CHILD
Enrollment: 65
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2022-11-01
Completion Date: 2023-11-01
Locations: Mataria Teaching Hospital, Cairo, Egypt

Summary:
This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.

Primary Outcome Measures: Number of infants with late-onset sepsis in each group, Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age, Up to 40 weeks corrected gestational age
Secondary Outcome Measures: Mortality, Number of deaths in each group, Up to 40 weeks corrected gestational age
Additional Effects of Joint Mobilization in Addition to Rocabado Exercises on Alleviating Trismus Following Third Molar Extraction
NCT Number: NCT06534619
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trismus
Interventions: PROCEDURE: Electrotherapy|PROCEDURE: Rocabado exercises|PROCEDURE: Maitland oscillatory mobilizations
Sponsor: Foundation University Islamabad
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, Punjab, 46000, Pakistan

Summary:
Without appropriate early intervention, prolonged trismus can lead to lasting complications like reduced jaw mobility or temporomandibular joint disorders.Therefore joint mobilization will impact on trismus, that will offer valuable insights into how these interventions will affect inflammation, muscle function and overall healing process within TMJ besides rocabado exercises that involves a series of movements and stretches targeting the muscles and joints involved in chewing,swallowing and speaking and minimizing muscle tension and opening the mouth, preventing further deterioration of jaw function and improving overall quality of life of individuals. If found effective, this will be added to the literature for the treatment of trismus after third molar extraction.

Primary Outcome Measures: Pain intensity, pain will be measured using Numeric pain rating scale, 1 week|Range of motion, A Vernier caliper will be used to measure maximal incisal opening (MIO) ≤ 35 mm (ROM), 1 week|Functional Performance, Gothenburg Trismus Questionnaire will be used for assessing functional performance or trismus-related quality of life., 1 week