pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Metabolic Adaptations to High-fat Diet
NCT Number: NCT06537401
Acronym: MetFlexHFD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adiposity|Insulin Sensitivity|Impaired Glucose Tolerance|Metabolic Disturbance
Interventions: BEHAVIORAL: Hypercaloric, High Fat Diet
Sponsor: George Washington University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-12
Completion Date: 2025-12-31

Summary:
The purpose of this study is to understand how the body's response after a meal is influenced by insulin and sugar in the blood. The primary question this study seeks to address is what is the effect of reduced insulin sensitivity on postprandial metabolic flexibility to an oral glucose tolerance test. We will recruit 50 adults (ages 20-45; 50% female) who are otherwise healthy (no known clinical diagnosis) into our non-randomized crossover trial to determine the effect of changes in insulin sensitivity on metabolic response to feeding. Insulin sensitivity will be decreased using a three-day high-fat diet (HFD) with extra calories. Whole-body metabolism will be measured during a standard 75-gram oral glucose tolerance test (OGTT). Metabolic response to feeding (e.g. OGTT) will be compared before and after the HFD and compared with the control diet to understand the effect of decreased insulin sensitivity on the metabolic response to feeding. The role of biological sex as a moderator of the effect of increased insulin resistance on postprandial metabolic flexibility will also be investigated

Primary Outcome Measures: Postprandial Metabolic Flexibility, Mean difference respiratory exchange ratio during an oral glucose tolerance test following a high fat diet, 3 Days
High Frequency Jet Ventilation Versus Conventional Positive Pressure Ventilation for EBUS
NCT Number: NCT06537388
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intermittent Positive-Pressure Ventilation|High-Frequency Jet Ventilation|Ultrasonography, Interventional
Interventions: PROCEDURE: Ventilation type
Sponsor: Erasme University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-05-30
Locations: Hôpital Universitaire de Bruxelles - Hôpital erasme, Brussels, 1070, Belgium

Summary:
Endobronchial ultrasound (EBUS) is frequently used in pneumology for diagnostic procedures like mediastinal biopsies. This procedure is usually done under general anesthesia. Different methods of ventilation are used according to center and physician preferences. In this retrospective study, complications of 2 types of ventilation will be analyzed:

* High frequency jet ventilation (HFJV)
* Conventional intermittent positive pressure ventilation (IPPV) Descriptive statistics will be used to present the data. Both ventilation techniques will be compared after propensity score matching. For HFJV patients from 2019 will be analyzed and for IPPV patients from 2023, as the team changed its practice over time.

Primary Outcome Measures: Hypoxia, defined as an SpO2 \< 90% for more than 1 min, 24 hours|Severe hypoxia, defined as an SpO2 (oxygen saturation by pulse oximetry) \< 85% for more than 1 min, 24 hours|Hemodynamic instability, defined as a systolic arterial blood pressure \< 90/60 mm Hg, 24 hours|Cardiac arrythmia, Any cardiac rhythm other than sinus rhythm, 24 hours|Laryngospasm, Any occurence of laryngospasm, 24 hours|ICU admission, Necessity for admission to the intensive care unit (ICU), 24 hours
Use of Ketamine in Severe Pain Syndromes
NCT Number: NCT06537375
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Intractable|Pain, Chronic|Pain Syndrome|Pain Measurement
Sponsor: Erasme University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-05-01
Locations: Hôpital Universitaire de Bruxelles - Hôpital erasme, Brussels, 1070, Belgium

Summary:
Ketamine has been shown to have a certain efficiency in chronic pain syndromes. However, it is still not clearly known what is its efficiency and how ketamine is used in real world patients. In this retrospective study, all patients treated with ketamine for chronic pain in our hospital will be reviewed. Patients demographics, pain syndromes as well as outcome criteria will be collected to describe the use of ketamine in pain syndromes.

Primary Outcome Measures: Patient satisfaction, A scale (good-medium-no effect) of the efficacity of ketamine on their pain syndrome, 6 month|DN4, Neuropathic pain scale 4, 6 month|VAS, Visual analog scale of the pain intensity, 6 month
Secondary Outcome Measures: Concomitant pain medications, Number of concomitant pain medications used by the patient, 6 month
Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry
NCT Number: NCT06537362
Acronym: COMICUSROM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Morbidity|Lung Function Decreased
Interventions: DEVICE: Mouthpiece with cheek-holder
Sponsor: Politecnico di Milano
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-26
Completion Date: 2024-08
Locations: Allergy and Pneumology Outpatient Clinic, Bergamo, Italy

Summary:
The study aims to evaluate the measurement accuracy of respiratory impedance during oscillometry (or Forced Oscillation Technique - FOT) under the following conditions: 1)The subject's cheeks are manually supported by an expert (Gold Standard method), 2) The subject's cheeks are supported by an integrated cheek support in the mouthpiece.

It is a prospective, randomized, cross-over study on Subjects who will present themselves at the offices of the participating doctors, aged between 5 and 75 years. The primary outcome is to Compare the respiratory impedance measurements under the two measurement conditions. Secondary Objectives are to: i)evaluate the patient's comfort during the measurement with the cheek support and compare this comfort to the gold standard condition; ii) assess the maximum and minimum face dimensions of the recruited subjects that allow for effective and comfortable cheek support; iii) evaluate the type and frequency of measurement errors introduced by the use of the integrated cheek support in the mouthpiece.

Primary Outcome Measures: impedance measurements, Compare the respiratory respiratory resistance (cmH2O\*s/L) and reactance (cmH2O\*s/L) at 5 Hz under the two measurement conditions, within session (about 15 min)
Secondary Outcome Measures: evaluate patient's comfort during the measurement with the cheek support, evaluate the patient's comfort during the measurement with the cheek support and compare this comfort to the gold standard condition as quantified by the questionnaire, within session (about 15 min)|face dimensions allowing for effective and comfortable cheek support, assess the maximum and minimum face dimensions (to lip length and bigonial width) of the recruited subjects that allow for effective and comfortable cheek support as detailed in the Data Analysis section, within session (about 15 min)|evaluate the type and frequency of measurement errors, evaluate the type and frequency of measurement errors introduced by the use of the integrated cheek support in the mouthpiece., within session (about 15 min)
Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors: A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise
NCT Number: NCT06537336
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: DEVICE: QoL|DEVICE: lung function
Sponsor: Hermina Hospitals
Collaborators: Universitas Padjadjaran
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-01
Completion Date: 2023-06-01
Locations: Padjajaran University, Bandung, West Java, 40161, Indonesia

Summary:
Breast cancer survivors frequently experience diminished lung function and decreased quality of life (QoL) following radiation therapy (RT). Additionally, incentive spirometry, which encourages prolonged deep breathing, could potentially amplify lung function and QoL when paired with aerobic exercises. This study investigated the combined effect of aerobic and breathing exercises using incentive spirometry on lung function and QoL in patients with breast cancer after RT.

Primary Outcome Measures: lung function, Lung function tests will be assessed using a spirometry. It measures the value of predicted forced vital capacity (FVC) and forced expiratory volume in one second/forced vital capacity (FEV1/FVC ratio). lower scores are associated with poor lung function, 8 weeks of exercises|quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 (EORTC-QLQ-C30)., The EORTC-QLQ-C30 was designed to assess seven domains of quality of life in cancer patients: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, overall health status, and symptom domains. scores range from 0 to 100, with higher scores indicating better quality of life, 8 weeks of exercises
Femoral Nerve Block, Periarticular Nerve Group (PENG) Block, and Preoperative IV Fentanyl
NCT Number: NCT06537323
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain
Interventions: DRUG: Femoral nerve block with0.25% bupivacaine guided by ultrasound.|DRUG: PENG block with0.25% bupivacaine guided by ultrasound.|DRUG: Preoperative IV fentanyl 100microgram
Sponsor: Aswan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-12-01
Locations: Zaher, Cairo, Egypt

Summary:
The pericapsular nerve group block is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties for postoperative analgesia with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anesthetic within the myofascial plane of the psoas muscle and superior pubic ramus. The indications for total hip arthroplasties often include degenerative hip disease and traumatic hip fractures. These indications for surgery are relatively common in the elderly population and are associated with significant morbidity and mortality.

Primary Outcome Measures: incidence and severity of postoperative pain for 24 hours, Using VAS score, before procedure. vital signs and visual analogue score will be measured to patient. visual analogue score measured 10 min later after block .visual analogue score will be measured at 6 ,12,24 hours after surgery.
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
NCT Number: NCT06537310
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cancer-Neoplasms
Interventions: DRUG: RO7567132 and Atezolizumab|DRUG: RO7567132 and Atezolizumab
Sponsor: Hoffmann-La Roche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2029-06-19

Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is not acceptable to the participant.

Primary Outcome Measures: Percentage of Participants with adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, From 24 to a Maximum of 27 Months.|Percentage of participants with Dose-limiting toxicities (DLTs), From Baseline to 3 Weeks on Study
Secondary Outcome Measures: Maximum concentration (Cmax) derived for RO7567132, up to a maximum of 24 months|Time of maximum concentration (Tmax), up to a maximum of 24 months|Minimum concentration (Cmin), Up to 24 Months|Clearance (CL) or apparent clearance (CL/F), up to a maximum of 24 months|Volume of distribution at steady state (Vss), up to a maximum of 24 months|Area under the curve (AUC) for various time intervals, up to a maximum of 24 months|Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132", Up to 24 months|Objective response rate (ORR), up to a maximum of 24 months|Disease control rate (DCR), up to a maximum of 24 months|Duration of response (DoR), up to a maximum of 24 months|Progression free survival (PFS), Up to a Maximum of 24 Months|Overall survival (OS), Up to a Maximum of 24 Months
Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Leptomeningeal Metastases
NCT Number: NCT06537297
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: Intrathecal Pemetrexed and high-dose Furmonertinib plus bevacizumab
Sponsor: Hunan Province Tumor Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-04-30
Locations: Hunan Cancer Hospital, Changsha, Hunan, 410013, China

Summary:
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs.

Primary Outcome Measures: LM-overall survival, LM-OS was defined as the duration from the start of intrathecal pemetrexed to patient death, Time from first subject dose to study completion, or up to last follow up
Secondary Outcome Measures: Extracranial progression-free survival, Extracranial Progression-Free survival was defined as the duration from the start of intrathecal pemetrexed to the progression of extracranial disease or patient death or last follow up, Time from first dose to the progression of extracranial disease or patient death or last follow up|Clinical response rate, Clinical Response Rate was defined as the ratio of the patient whose neurological symptoms and KPS improved according to the criteria of clinical response, Time from first dose to the improvement of neurological symptoms and KPS score|Adverse events (AEs), Number of participants with adverse events (AEs) according to CTCAE 5.0, From first dose until 28 days after the last dose, up to 24 month
Heart Rate Variability and Inflammatory Bowel Disease
NCT Number: NCT06537258
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Bowel Diseases
Interventions: BEHAVIORAL: Biofeedback Enhanced Treatment
Sponsor: Emory University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01
Completion Date: 2028-10
Locations: Atlanta Metropolitan Area, Atlanta, Georgia, 30303, United States|Children's Healthcare of Atlanta, Atlanta, Georgia, 30322, United States|Center for Advanced Pediatrics, Atlanta, Georgia, 30329, United States

Summary:
The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment. Participants will be randomized to biofeedback enhanced treatment or wait-list control.

Primary Outcome Measures: Changes in psychological distress, A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress., Baseline, 6 weeks post-intervention
Does Application Time Influence the Effect of Massage on Pain and Performance?
NCT Number: NCT06537245
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health, Subjective
Interventions: OTHER: Massage
Sponsor: Universidade Estadual do Norte do Parana
Sex: MALE
Age: ADULT
Enrollment: 11
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-10-23
Completion Date: 2023-11-25
Locations: UNorteParana, Jacarezinho, PR - Paraná, 86400-000, Brazil

Summary:
Introduction: The massage technique is widely used for post-exercise recovery, however, there is still a gap regarding the ideal dosage in relation to the duration of its application. Objective: To analyze the influence of massage when applied at different times on the dominant (DOM) and non dominant (ÑDOM) quadriceps muscles and clinical variables. Methods: Study carried out with 11 men aged 21.5(2.1) years, in a two-week crossover design. Participants performed a jumping protocol followed by manual massage for 5 (G1) or 10 (G2) minutes. Assessments included strength testing, pain scale (VAS), perception of recovery and vital sign measurements up to one hour post-massage. Analysis onducted in SPSS, ANOVA was performed (with Bonferroni test, when necessary), providing effect sizes (p\<0.05).

Primary Outcome Measures: Muscle Strenght., Isokinetic Device., Pre stress protocol and 40 minutes post stress protocol.
Changes in Thoracolumbar Fascia Stiffness and Pain Parameters in Young Patients With Chronic Low Back Pain
NCT Number: NCT06537219
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain|Back Pain|Fascia
Interventions: OTHER: Assessment
Sponsor: Atılım University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-09-15
Locations: Atılım University, Ankara, 06830, Turkey

Summary:
This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.

Primary Outcome Measures: Numerical Pain Scale(NMS, pain assessment, 1 month|Fascia stiffness, thoracolumbar fascia stiffness assessment, 1month|the Pain Sensitivity Scale(PSS), Pain sensitivity assessment, month
Foot Bath on Fever Management in Children (EWWFBFMC)
NCT Number: NCT06537206
Acronym: EWWFBFMC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Caries
Interventions: OTHER: Application Footbath
Sponsor: Atlas University
Collaborators: Koç University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2025-08-30

Summary:
Reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. This study is planned to evaluate the effect of warm water foot baths on vital signs and pain in children and to scientifically examine this effect with a randomized controlled trial.

Primary Outcome Measures: FLACC SCORE, Pain Scale, 0 minute|FLACC SCORE, Pain Scale, 30 minute|FLACC SCORE, Pain Scale, 50 minute
Secondary Outcome Measures: Heart Rate, Heart Rate, 0 minute|Heart Rate, Heart Rate, 30 minute|Heart Rate, Heart Rate, 40 minute|Heart Rate, Heart Rate, 50 minute|Heart Rate, Heart Rate, 60 minute
Other Outcome Measures: Respiration Rate, Respiration Rates, 0 minute|Respiration Rate, Respiration Rates, 30 minute|Respiration Rate, Respiration Rates, 40 minute|Respiration Rate, Respiration Rates, 50 minute|Respiration Rate, Respiration Rates, 60 minute|SpO2, Saturation Level, 0 minute|SpO2, Saturation Level, 30 minute|SpO2, Saturation Level, 40 minute|SpO2, Saturation Level, 50 minute|SpO2, Saturation Level, 60 minute|Fever, Body Temparature, 0 minute|Fever, Body Temparature, 30 minute|Fever, Body Temparature, 40 minute|Fever, Body Temparature, 50 minute|Fever, Body Temparature, 60 minute
Gender-based Differences in the Outcome of the Treatment of Persistent Septic Shock With Hydrocortisone
NCT Number: NCT06537180
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Septic Shock
Sponsor: Alexandria University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 621
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-08-01
Locations: Faculty of Medicine, Alexandria University Hospitals, Alexandria, Egypt

Summary:
The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Primary Outcome Measures: 28-day mortality, The rate of all-cause mortality after enrollment, Day 28
Transcutaneous Electrical Acupoint Stimulation on Blood Pressure
NCT Number: NCT06537167
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: DEVICE: Transcutaneous electrical acupoint stimulation|DEVICE: Sham stimulation
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Shanghai Institute of Hypertension|Shanghai Jiao Tong University School of Biomedical engineering
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-08

Summary:
This study will be conducted in patients with high-normal blood pressure and grade 1 hypertension and will be divided into two phases.

In Phase One, a small group of patients will undergo transcutaneous electrical acupoint stimulation treatment for three consecutive days. Blood pressure changes will be observed before and after each stimulation session, as well as 1 hour, 3 hours, and 5 hours after stimulation, during the night of the treatment day, and the next morning.

Phase Two will be a single-center, single-blind, parallel randomized controlled trial. After screening, patients will be randomly assigned to either the "stimulation" experimental group or the "sham stimulation" control group. For three consecutive days, both groups will receive their respective interventions at the same time each day, and their blood pressure changes will be recorded.

Primary Outcome Measures: Change in office systolic blood pressure between the third day after TEAS treatment and the baseline (before the start of treatment on the first day), At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)
Secondary Outcome Measures: Changes in office systolic blood pressure at other time points before and after treatment, At all other time points (excluding the third day after treatment) and the baseline (before the start of treatment on the first day)|Changes in office diastolic blood pressure at various time points before and after treatment, At each time point before and after treatment and the baseline (before the start of treatment on the first day).|Changes in ambulatory blood pressure before and after treatment, At the third day after the end of treatment and the baseline (before the start of treatment on the first day)|Changes in Hamilton Scale scores before and after treatment, At the third day after the end of treatment and the baseline (before the start of treatment on the first day)
Role of Embolization of Thyroid Arteries as a Treatment for Different Thyroid Disorders
NCT Number: NCT06537141
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Graves Disease|Goiter, Nodular|Goiter Malignant|Goiter Diffuse
Interventions: PROCEDURE: selective embolization of thyroid arteries (SETA)
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2026-07-30

Summary:
To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

Primary Outcome Measures: To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders, Safety measured according to incidence of major and minor complications compared to thyroidectomy., Up to 12 months follow up after embolization|To investigate the efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders, in hyperfunctiong (toxic) disorders Efficacy measured according to thyroid profile levels in certain time interval post procedure, every 3 months time interval and rate of hyper functioning recurrence in comparison to thyroidectomy.

In diffuse or nodular goiter we measure efficacy by percentage of size reduction post procedure in comparison to primary size just before procedure, Up to 12 months follow up after embolization
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
NCT Number: NCT06537128
Acronym: LUNA-A
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder|Autism|Anxiety|Anxiety Disorders|Generalized Anxiety Disorder|Social Anxiety Disorder
Interventions: BEHAVIORAL: LUNA-Adolescent|BEHAVIORAL: Treatment as Usual
Sponsor: Baylor College of Medicine
Sex: ALL
Age: CHILD
Enrollment: 139
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-04
Locations: Baylor College of Medicine, Houston, Texas, 77030, United States

Summary:
Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

Primary Outcome Measures: Pediatric Anxiety Rating Scale modified for ASD (PARS-ASD), Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35. This measure has been modified for autistic youth, Baseline (before treatment), during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
Secondary Outcome Measures: Clinical Global Impression-Improvement (CGI-I), Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse)., during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up|Screen for Child Anxiety Related Disorders (SCARED), Parent and child self-report measure assessing anxiety symptoms including subscales for separation anxiety disorder, generalized anxiety disorder, social anxiety disorder, panic disorder or significant somatic symptoms, and significant school avoidance. A single item is scored on a 3 point Likert scale ranging from 0 (not true or hardly ever true) to 2 (very true or often true)., Baseline (before treatment), post-treatment (on average 12 weeks), 1 month follow up
Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia
NCT Number: NCT06537115
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sarcopenia
Interventions: BEHAVIORAL: exercise|DIETARY_SUPPLEMENT: whey protein powder|DRUG: Eldecalcitol
Sponsor: Zhejiang Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-16
Completion Date: 2027-05-31
Locations: The First People's Hospital of Chun'an County, Hangzhou, Zhejiang, China|Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China|Huzhou Nanxun District People's Hospital, Huzhou, Zhejiang, China|Xianju People's Hospital, Taizhou, Zhejiang, China|Dinghai Central Hospital of Zhoushan City, Zhoushan, Zhejiang, China

Summary:
This clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. Subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. After enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. The experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. The experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. The entire intervention period lasted for 24 weeks. Through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.

Primary Outcome Measures: muscle mass, The DXA equipment is used to detect the muscle mass., up to 24 weeks
Secondary Outcome Measures: Grip strength, Using a spring dynamometer, stand upright with the elbow joint fully extended, and use the muscle strength of the dominant hand to record the maximum reading (in kg) from three trials., up to 24 weeks|6-meter walking speed, Record the time required to walk 6 meters from the starting point at a normal speed without decelerating, and use the average result of 3 trials as the recorded walking speed (in m/s)., up to 24 weeks|incidence of adverse reactions, The number of patients with adverse events within a unit time / the total number of patients in the experimental or control group during the same period \* 100%., up to 24 weeks
Unilateral vs Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate Resistant Cases of Polycystic Ovarian Syndrome
NCT Number: NCT06537102
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Laparoscopic|Ovarian Drilling|Clomiphene Citrate|Polycystic Ovarian Syndrome|Unilateral|Bilateral
Interventions: OTHER: Unilateral laparoscopic ovarian drilling|OTHER: Bilateral laparoscopic ovarian drilling
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-01
Completion Date: 2023-06-01
Locations: Sahar Saeed Ahmed Elhalfawy, Tanta, ElGharbia, 31527, Egypt

Summary:
The aim of the current study is to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in clomiphene citrate resistant cases of polycystic ovarian syndrome in terms of clinical response (regularity of the cycle), change in biochemical parameters, ovulation rate over six months, pregnancy rate within six months.

Primary Outcome Measures: Restoration of ovulation, Restoration of ovulation was measured before operation and for 6 month after operation ., 6 month after operation.
Secondary Outcome Measures: Folliculometry, Folliculometry was measured before operation and for 6 month after operation ., 6 month after operation.|Follicle-stimulating hormone (FSH), Follicle-stimulating hormone (FSH) was measured before operation and for 6 month after operation ., 6 month after operation.|Luteinizing hormone (LH), Luteinizing hormone (LH) was measured before operation and for 6 month after operation ., 6 month after operation.|Anti-müllerian hormone(AMH), Anti-müllerian hormone(AMH) was measured before operation and for 6 month after operation ., 6 month after operation.|Pregnancy rate, Pregnancy rate was measured before operation and for 6 month after operation ., 6 month after operation.
Comparative Study Between Using WHO Labour Care Guide & Modified WHO Partograph
NCT Number: NCT06537089
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Labor Onset and Length Abnormalities|37 or More Completed Weeks of Gestation|First Birth
Sponsor: Hend Mahmoud Abdelghany
Sex: FEMALE
Age: ADULT
Enrollment: 230
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-10-01
Locations: kasr Al Aini, Faculty of Medicine, Cairo University, Cairo, Old Cairo, 11562, Egypt

Summary:
This randomized clinical trial is based on comparing the efficiency of modified WHO partographs vs. the new WHO labour care guide in monitoring and assessing the outcome of labour.

Primary Outcome Measures: Rate of primary caesarean section, number of women will undergo Caesarean section after monitoring, whether by Modified WHO partograph or a labour care Guide, First and second stage of labour
Secondary Outcome Measures: Duration of active phase of first stage of labour, First stage of labour|Duration of second stage of labour, Second stage of labour|need for oxytocin use, First stage of labour
Safety and Efficacy of AR1005 in Patients With Lewy Body Disease
NCT Number: NCT06537076
Acronym: AR1005
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lewy Body Dementia
Interventions: DRUG: AR1005|DRUG: Placebo|DRUG: Rivastigmine 3 mg
Sponsor: Yonsei University
Collaborators: Samjin Pharmaceutical Co., Ltd.|AriBio Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-12
Locations: Severance Hospital, Seoul, 03722, Korea, Republic of

Summary:
This study is a phase 2a, single-center, double-blind and randomized clinical trial that evaluates the safety and efficacy of AR1005 administration in 60 patients with cognitive impairment due to Lewy body disease. The study evaluates whether the administration of AR1005 in patients with cognitive impairment due to Lewy body disease has the effect of improving cognitive function, behavioral psychological symptoms, cognitive fluctuations, movement, brain waves and brain activity.

Primary Outcome Measures: Clinical Dementia Rating-Sum Of Boxes (CDR-SOB) at Week 20, The CDR-SOB score ranges from 0 to 18, with 0 indicating no dementia symptoms and 18 indicating severe dementia. Higher scores on the CDR-SOB reflect a worse outcome, as they indicate more severe dementia symptoms., 20 Weeks
Secondary Outcome Measures: Change in K-MMSE over 20 weeks, Change in Korean-Mini Mental State Examination (K-MMSE) over 20 weeks, 20 Weeks
Detection of G-quadruplex DNA Methylation in Cancer
NCT Number: NCT06537063
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|DNA G-quadruplex|Methylation|Cell-free DNA
Interventions: OTHER: G4 DNAm test
Sponsor: Zhongnan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-30
Completion Date: 2024-12-30
Locations: Hubei Locations, Wuhan, Hubei, 430071, China

Summary:
This study aims to evaluate the early diagnosis value of G-quadruplex DNA methylation in patients with cancer.

Primary Outcome Measures: G-quadruplex DNAm score, Detection of DNAm around G-quadruplex loci in cell-free DNA from blood., 2024.04.30-2024.09.30
A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects
NCT Number: NCT06537050
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Parkinson's Disease
Interventions: DRUG: JX2105|DRUG: Placebo
Sponsor: Zhejiang Jingxin Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-03
Locations: Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing, 100015, China

Summary:
The purpose of the study is to evaluate the safety, tolerability after administration of single dose or multiple doses, and the pharmacokinetics (PK) of single and multiple doses of JX2105 in healthy study participants.

Primary Outcome Measures: TEAE/SAE, The number, frequency and incidence of TEAE/SAE; The number, frequency and incidence of drug-related TEAE/SAE;, Day1 to Day 10
Secondary Outcome Measures: Cmax, Peak concentrations (Cmax) of JX2105 and metabolites detected after administration; Area under the drug concentration-time curve (AUC0-last) from 0h to the last sample collection time t where the concentration of JX2105 and metabolites can be accurately determined;, Day1 to Day 10|AUC0-∞, Area under the drug concentration-time curve of JX2105 and metabolites from 0 to infinity (AUC0-∞), Day1 to Day 10|Tmax, Peak time of JX2105 and its metabolites, Day1 to Day 10|t1/2z, End phase elimination half-life, Day1 to Day 10|λz, End-phase elimination rate constant, Day1 to Day 10|Vz/F, Apparent volume of distribution, Day1 to Day 10|CLz/F, Apparent clearance, Day1 to Day 10|MRT0-last、 MRT0-∞, Mean residence time, Day1 to Day 10
Exploring the Association of Imaging and Tumor Microenvironment in Urologic Cancer Using Radiogenomic Approach（Radiogenomics-Urinary）
NCT Number: NCT06537037
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urologic Cancer
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-08
Locations: Union Hospital，Tongji Medical College，Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

Summary:
This is the prospective, observational cohort study (Radiogenomics-Urinary), which aims to explore the relationship between the imaging information of urologic cancer patients, tumor microenvironment and the prognosis of urologic cancer patients.

Primary Outcome Measures: Correlation analysis of sequencing results and body composition, Conducting correlation analysis between body composition and results of multi-omics sequencing., 0.5 year|Correlation analysis of sequencing results and tumor radiomic features, Conducting correlation analysis between radiomic features and results of multi-omics sequencing., 0.5 year
Secondary Outcome Measures: Constructing tumor microenvironment prediction model, Constructing radiomic model to predict tumor microenvironment. The indicator is the area under the curve (AUC) of the prediction model, 2 years|Constructing a multi-dimensional prognostic prediction model, A high-dimensional model was constructed to predict the prognosis of patients through multi-omics sequencing data, body composition, and tumor radiomic features. The indicator is the area under the curve (AUC) of the prediction model., 3 years
Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
NCT Number: NCT06537024
Acronym: ReplPHF
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Proximal Humeral Fracture
Interventions: PROCEDURE: RTSA
Sponsor: University Hospital Muenster
Collaborators: Universität Münster
Sex: ALL
Age: OLDER_ADULT
Enrollment: 32953
Study Design: Observational Model: |Time Perspective: p
Start Date: 2011-01-01
Completion Date: 2022-12-31

Summary:
The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.

Primary Outcome Measures: 30-day mortality, Death from any cause during the first 30-days after surgery., 30 days|Overall survival (OS), Time from discharge of index hospitalization to death of any case., up to 12 years|Major adverse events during index case, See above, only events during hospitalization, through hospital stay, an average of 16 days|Major adverse events after discharge, Time from discharge of index hospitalization to MAE as defined above, up to 12 years|Thromboembolic events during index, See above, only events during hospitalization, through hospital stay, an average of 16 days|Thromboembolic events (or death) after discharge, Time from discharge of index hospitalization to a thromboembolic event or death of any case., up to 12 years|Surgical complications during index case, See above, only events during hospitalization, through hospital stay, an average of 16 days|Surgical complications after discharge, Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event., up to 12 years
Secondary Outcome Measures: Implant-associated complication during index, See above, only events during hospitalization, through hospital stay, an average of 16 days|Non-Implant-associated complication during index, See above, only events during hospitalization, through hospital stay, an average of 16 days|Minor outpatient complications after discharge, Time from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event., up to 12 years
AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06537011
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: AK112
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-07-30

Summary:
This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them.

Primary Outcome Measures: EFS, The time between the onset of treatment till disease progression, discontinuation of treatment for any reason, or death, 2 years
Secondary Outcome Measures: pCR, The percentage of tumor tissue that has completely disappeared on pathological examination after treatment, 3 cycles of treatment(1.5months)|OS, The time between the onset of treatment till death, 2 years|MPR, The percentage of active tumor components decreasing below a certain threshold, 3 cycles of treatment(1.5months)
Exploring the Association of Imaging and Tumor Microenvironment in Liver Cancer Using Radiogenomic Approach（Radiogenomics-Liver）
NCT Number: NCT06536998
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Cancer
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-08
Locations: Union Hospital，Tongji Medical College，Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

Summary:
This is the prospective, observational cohort study (Radiogenomics-Liver), which aims to explore the relationship between the imaging information of liver cancer patients, tumor microenvironment and the prognosis of liver cancer patients.

Primary Outcome Measures: Correlation analysis of sequencing results and body composition, Conducting correlation analysis between body composition and results of multi-omics sequencing, 0.5 year|Correlation analysis of sequencing results and tumor radiomic features, Conducting correlation analysis between radiomic features and results of multi-omics sequencing, 0.5 year
Secondary Outcome Measures: Constructing tumor microenvironment prediction model, Constructing radiomic model to predict tumor microenvironment. The indicator is the area under the curve (AUC) of the prediction model, 2 years|Constructing a multi-dimensional prognostic prediction model, A high-dimensional model was constructed to predict the prognosis of patients through multi-omics sequencing data, body composition, and tumor radiomic features. The indicator is the area under the curve (AUC) of the prediction model, 3 years