pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
NCT Number: NCT06495242
Acronym: Pulp cap
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Deep Caries
Interventions: PROCEDURE: Direct pulp capping and partial pulpotomy
Sponsor: King Abdullah University Hospital
Collaborators: Jordan University of Science and Technology
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-25
Completion Date: 2026-12-02
Locations: Faculty of Dentistry, Jordan University of Science and Technology, Irbid, 3030, Jordan

Summary:
This a prospective randomized clinical trial that compare vital pulp therapy procedures in permanent teeth with carious pulp exposure. Patients are recruited from the dental teaching clinics at JUST following preset inclusion criteria. They are subsequently randomly assigned to one of treatment procedures. Clinical and radiographic follow up is performed after 6 months and yearly up to 5 years.

Primary Outcome Measures: Short term clinical outcome, Resolution of clinical symptoms, one week
Secondary Outcome Measures: long term outcome, Maintenance of pulp vitality, 1-5 years
Study of CM310 in Adolescent Subjects With Atopic Dermatis
NCT Number: NCT06495229
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Atopic Dermatitis
Interventions: BIOLOGICAL: CM310
Sponsor: Keymed Biosciences Co.Ltd
Sex: ALL
Age: CHILD, ADULT
Enrollment: 180
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-08-30

Summary:
This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.

Primary Outcome Measures: Adverse events, Incidence of adverse events., up to week 52
Cognition, Flavonoids, Exercise, Gut Microbiome
NCT Number: NCT06495190
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Decline, Mild
Interventions: DIETARY_SUPPLEMENT: Blueberry|BEHAVIORAL: Walking|DIETARY_SUPPLEMENT: Placebo|BEHAVIORAL: Stretching
Sponsor: Appalachian State University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-01
Completion Date: 2028-12-31
Locations: Appalachian State University Human Performance Lab, North Carolina Research Campus, Kannapolis, North Carolina, 28081, United States

Summary:
This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome.

Primary Outcome Measures: Cognition, Cognitive function using the Cambridge Neuropsychological Test Assessment Battery (CANTAB, Cambridge Cognition, Ltd)., Change from pre-study to 6-weeks and 12-weeks
Secondary Outcome Measures: Maximal aerobic capacity, VO2max from a graded treadmill test using a metabolic cart, Change from pre-study to 6-weeks and 12-weeks|Gut microbiome, Alpha and beta diversity from gut microbiome taxa analysis using Whole Genome Shotgun (WGS) sequencing, Change from pre-study to 6-weeks and 12-weeks|Urine blueberry metabolites, Urine gut-derived metabolites (n=24) from targeted LC-MS/MS analysis (concentrations) generated from blueberry ingestion, Change from pre-study to 6-weeks and 12-weeks
European Survey of Cardiovascular Disease Prevention, Diabetes and Chronic Kidney Disease (EUROASPIRE VI)
NCT Number: NCT06495177
Acronym: EUROASPIRE VI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Disease|Acute Coronary Syndrome|Unstable Angina|ST Elevation Myocardial Infarction|Non-ST Elevation Myocardial Infarction
Sponsor: European Society of Cardiology
Collaborators: National Institute for Prevention and Cardiovascular Health, Ireland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-07
Completion Date: 2029-12
Locations: Istanbul University, Cerrahpaşa Cardiology Institute, Istanbul, Turkey

Summary:
The goal of this observational study is to provide a unique European picture of preventive action by cardiologists, other specialists and primary care physicians looking after patients with coronary heart disease (CHD), individuals at high cardiovascular disease risk and all those with hypertension, dyslipidaemia (including familial hypercholesterolaemia), diabetes and dysglycaemia and chronic kidney disease (CKD) and determine whether the European guidelines on cardiovascular disease prevention, hypertension, lipids, diabetes and chronic kidney disease are being followed.

Primary Outcome Measures: Proportions of hospital coronary patients and high risk individuals in primary care achieving European lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention, The management of risk in terms of lifestyle intervention and the use of drug therapies will be evaluated in relation to the lifestyle and therapeutic goals defined in the national and European guidelines on cardiovascular disease prevention., 30 months
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
NCT Number: NCT06495164
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Malignant Neoplasm of Breast
Interventions: DRUG: Palbociclib|DRUG: Aromatase inhibitor|DRUG: Ribociclib|DRUG: Abemaciclib
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5087
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2026-12-31
Locations: Pfizer New York, New York, New York, 10001, United States

Summary:
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies.

The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later.

Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study:

* HR+/HER2- MBC
* First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.

Primary Outcome Measures: Overall Survival (OS), From start of index line of therapy to death, February 2015 - December 2022 or data cutoff
Secondary Outcome Measures: Real Progression Free Survival (rwPFS), From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff|Progression Free Survival 2, from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff|Real-World Tumor Response (rwTR), From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff|Duration of treatment, from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff|Time to chemotherapy, from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff
Other Outcome Measures: Early discontinuation, from index treatment initiation to discontinuation between February 2015 - December 2022 or data cutoff|Dose adjustment, from index treatment initiation to initial dose change, February 2015 - December 2022 or data cutoff
Endometriosis and Complement System
NCT Number: NCT06495151
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Endometriosis|Complement System|Alternative Complement Pathway
Interventions: DIAGNOSTIC_TEST: Mannose-binding lectin-associated serine protease-3 (MASP-3) Level|DIAGNOSTIC_TEST: Adipsin Level|DIAGNOSTIC_TEST: Properdin Level|DIAGNOSTIC_TEST: Complement Factor H (CFH) Level|DIAGNOSTIC_TEST: Cancer Antigen 125 (CA-125) Level
Sponsor: Ankara City Hospital Bilkent
Sex: FEMALE
Age: ADULT
Enrollment: 58
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-10
Completion Date: 2022-10-07
Locations: Ankara Bilkent City Hospital, Ankara, 06100, Turkey

Summary:
Endometriosis is a chronic gynecological condition affecting nearly 10% of women of reproductive age. A definitive diagnosis of endometriosis requires laparoscopy. Studies aim to identify novel biomarkers to aid in the development of effective noninvasive diagnostic methods. Despite several theories, the full understanding of the etiopathogenesis remains elusive. A distorted immune response is thought to play a crucial role in the pathophysiology of endometriosis. This study aimed to evaluate whether the levels of alternative complement molecules change in the blood serum and peritoneal fluid of endometriosis patients compared to healthy subjects.

Primary Outcome Measures: Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 level, Nanogram/milliliter, day 1|Serum and peritoneal fluid adipsin level, Nanogram/milliliter, day 1|Serum and peritoneal fluid properdin level, Nanogram/milliliter, day 1|Serum and peritoneal fluid complement factor H level, Nanogram/milliliter, day 1
Secondary Outcome Measures: Serum cancer antigen 125 level, Unit/milliliter, day 1
Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
NCT Number: NCT06495112
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ocular Surface Disease
Interventions: OTHER: Soft contact lens with lathe cut technique Lathe|DIAGNOSTIC_TEST: Soft contact lens with cast molding technique
Sponsor: Superior University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 69
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-09-30
Locations: The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society, Lahore, Punjab, Pakistan

Summary:
"Comparison between Lathe Cut versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity" investigates the impact of two different manufacturing methods on the health and integrity of the ocular surface.

Primary Outcome Measures: Corneal epithelial integrity, This involves assessing the health and integrity of the outermost layer of the cornea, which can be done through optical coherence tomography (OCT), 12 Months|Ocular surface symptoms, Utilizing standardized questionnaires or scales to assess symptoms such as dryness, discomfort, or irritation experienced by the subjects wearing the different types of soft contact lenses., 12 months
Effect of Core Stability Exercises and Russian Electrical Stimulation in Non-specific Low Back Pain
NCT Number: NCT06495099
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: OTHER: Russian electrical stimulation
Sponsor: Deraya University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-10
Completion Date: 2024-07-31
Locations: Deraya university, Minya, 05673, Egypt

Summary:
Brief Summary: Low back pain (LBP) is an important public health problem due to the increasing world population and aging. In chronic LBP, exercise therapy is among the first-line treatments. Core stabilization exercises (CSE), one of the motor control exercises, focus on the activation and control of the deep spinal muscles. Recently, some studies have shown that Russian electrical stimulation alone or combined with exercise can provide contraction in deep stabilizer muscles and significantly reduce pain in patients with LBP

Primary Outcome Measures: Pain scoring, pain measured by VAS tool, 0 the least pain while 10 the highest one, 6 weeks|Quality of life by using Oswestry Disability Index (OID), questioner, Score from 0 to 19% indicate minimal disability- 20 to 39% represent moderate disability- 40 to 59% represent severe disability- 60 to 79% represent crippled disability- and scores from 80 to 100% represents patients that are confined to bed, 6 weeks
Secondary Outcome Measures: Muscle thickness assessment, Ultrasonography, 6 weeks|Stability and mobility of spine, Spinal mouse assessment spinal vertebrate from 7th cervical vertebrae to 3rd sacral vertebrae, 6 weeks
HFNC vs. NIV in Acute COPD Exacerbations
NCT Number: NCT06495086
Acronym: HFNCstdy
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD Exacerbations|Acute Hypercapnic Respiratory Failure|Respiratory Failure
Interventions: DEVICE: NIV|DEVICE: HFNC-30|DEVICE: HFNC-50
Sponsor: Haseki Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 137
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-05-01
Locations: Haseki Training and Research Hospital, Istanbul, Fatih, 34265, Turkey

Summary:
The investigators investigated the efficacy and safety of High Flow Nasal Cannula (HFNC) at different flow rates compared to non-invasive ventilation (NIV) in patients presenting to the emergency department (ED) with acute exacerbations of Chronic obstructive pulmonary disease (COPD) who did not respond adequately to bronchodilator therapy and continued to exhibit hypercapnic respiratory failure. Specifically, the investigators tested the hypothesis that HFNC would be more effective at reducing partial pressure of carbon dioxide (PaCO2) levels and hospital stay duration and would be associated with greater patient comfort than NIV.

Primary Outcome Measures: Changes in pH in arterial blood gas before vs. after treatment, The investigators assessed the changes in pH before treatments vs. 30, 60, and 120 minutes after treatments., at 30, 60, and 120 minutes relative to baseline|Changes in PaCO2 in arterial blood gas before vs. after treatment, The investigators assessed the changes in PaCO2 before treatments vs. 30, 60, and 120 minutes after treatments., at 30, 60, and 120 minutes relative to baseline|Changes in lactate in arterial blood gas before vs. after treatment, The investigators assessed the changes in lactate before treatments vs. 30, 60, and 120 minutes after treatments., at 30, 60, and 120 minutes relative to baseline|Changes in bicarbonate in arterial blood gas before vs. after treatment, The investigators assessed the changes in bicarbonate before treatments vs. 30, 60, and 120 minutes after treatments., at 30, 60, and 120 minutes relative to baseline
Secondary Outcome Measures: Assessing the need for rescue treatment and treatment-related complications, The investigators assessed the need for invasive respiratory support and also evaluated treatment-related complications., 120 minutes after initial treatment
Determining the MCIDfor the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or TIA
NCT Number: NCT06495073
Acronym: CONSIDER
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke|TIA
Interventions: OTHER: PROMIS-10 and TOPICS-SF
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sex: ALL
Age: OLDER_ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-20
Completion Date: 2024-12-31
Locations: OLVG, locatie West, Amsterdam, Noord-Holland, 1061 AE, Netherlands|Amsterdam UMC, locatie AMC, Amsterdam, Noord-Holland, 1105AZ, Netherlands

Summary:
Patient-related outcome measures (PROMs) play a crucial role in assessing patient outcomes in healthcare. Two of these PROMs are the TOPICS-Short Form (TOPICS-SF) and PROMIS Global Health-10 (PROMIS-10). We aim to determine the MCID for the TOPICS-SF and PROMIS-10 in older people that suffered an ischemic stroke or Transient Ischemic Attack (TIA), using an anchor-based method, to determine the clinical significance of differences in patients' scores.

Primary Outcome Measures: MCID of the PROMIS-10, The MCID of the PROMIS-10 will be calculated using an achor-based approach, 4 weeks|MCID of the TOPICS-SF, The MCID of the TOPICS-SF will be calculated using an achor-based approach, 4 weeks
Secondary Outcome Measures: MCID of the mental health score of the PROMIS-10, Since the PROMIS-10 provides subscales for mental and for physical health, as well as a global measure of the health related quality of life, we will try to calculate the MCID for the mental health subscale, 4 weeks|MCID of the physical health score of the PROMIS-10, Since the PROMIS-10 provides subscales for mental and for physical health, as well as a global measure of the health related quality of life, we will try to calculate the MCID for the physical health subscale, 4 weeks
Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema
NCT Number: NCT06495034
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: DEVICE: airwave compression therapy|OTHER: standard care: health education and routine functional exercise
Sponsor: Shantou Central Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-07-01
Completion Date: 2026-06-30
Locations: Shantou Central Hospital, Shantou, Guangdong, 510000, China

Summary:
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).

Primary Outcome Measures: Incidence of lymphedema, Incidence of lymphedema of ipsilateral upper limb, 18 months
Secondary Outcome Measures: Symptoms, Questionnaire. The level of subjective symptoms( pain, heaviness, paresthesia) at each time point was recorded with a 0-3 four-point scale questionnaire. 0-3 indicated no symptoms, mild, moderate, and severe, respectively., 18 months|Quality of life assessment, FACT-B (V4.0), 18 months
How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.
NCT Number: NCT06495021
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumonia|Sinusitis|Bronchitis|Respiratory Disease|Respiratory Tract Infections
Interventions: PROCEDURE: Lymphatic Pump Osteopathic Manipulative Therapy
Sponsor: Geisinger Clinic
Sex: ALL
Age: OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: Geisinger 65-Forward, Buckhorn, Bloomsburg, Pennsylvania, 17815, United States

Summary:
This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.

Primary Outcome Measures: To address the magnitude in which lymphatic pump OMT improves respiratory illness symptom severity and overall sickness duration when combined with standard care treatment., Survey given to patients will provide feedback to capture their symptom severity at the time of diagnosis and 5 days post-diagnosis, Through study completion of up to one year.
AK104 and Low-dose Radiation in Recurrent/Metastatic HNSCC After Failure of First-line Systemic Therapy
NCT Number: NCT06494995
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: Cadonilimab|RADIATION: Low-dose radiotherapy|RADIATION: SBRT|DRUG: Capecitabine
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-07-01
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
Currently, there is a lack of high-quality clinical evidence for subsequent treatment options for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) after first-line treatment, especially for subsequent treatment after first-line therapy combined with PD-1 inhibitors. Increasing evidence suggests that low-dose radiation (LDRT) can reshape the tumor microenvironment.Cadonilimab is a bispecific antibody that specifically binds to CTLA-4 and PD-1 proteins in the human body.

Considering that low-dose radiotherapy and cadonilimab both have immunomodulatory effects, this study intends to select recurrent metastatic HNSCC patients who have failed first-line and above treatment to explore the safety and efficacy of cadonilimab combined with low-dose radiotherapy.

Primary Outcome Measures: Objective Response Rate, Objective Response Rate (ORR), as assessed by investigators according to RECIST 1.1 criteria. For patients who have received radiotherapy for all lesions, the ORR assessment should be based on the lesions that received SBRT and low-dose radiotherapy. For patients with lesions that did not receive radiotherapy, the ORR assessment should be based on the lesions that received SBRT, low-dose radiotherapy, and those that did not receive radiotherapy, Up to two years
Secondary Outcome Measures: Adverse effect, Adverse effects (AE) as evaluated by CTCAE 5.0, Up to two years|Disease Control Rate, Disease Control Rate (DCR), as assessed by investigators according to RECIST 1.1 criteria, Up to two years|Duration of Response, Duration of Response (DoR), as assessed by investigators according to RECIST 1.1 criteria, Up to two years|Progression-free survival, Progression-free survival (PFS): from the start of enrollment to the first recorded date of objective tumor progression or death from any cause, whichever occurs first., Up to two years|Overall survival, Overall survival (OS): the time from enrollment to death due to any cause., Up to two years
Intraocular Pressure in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardiopulmonary Bypass
NCT Number: NCT06494969
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Intraocular Pressure|Anesthesia
Interventions: DEVICE: Intraocular pressure measurement
Sponsor: Antalya Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-09-01
Completion Date: 2022-01-28
Locations: Health Science University, Antalya Training and Research Hospital, Antalya, Muratpasa, 071**, Turkey

Summary:
The aim of the study to compare the effects of sevoflurane-based anesthesia and propofol-based total intravenous anesthesia on intraocular pressure (IOP) during coronary artery bypass graft surgery (CABG) with cardiopulmonary bypass (CPB).

The primary endpoint was to examine the effects of propofol-based total intravenous anesthesia (TIVA) and sevoflurane-based anesthesia methods on IOP during CABG operation. Secondary endpoints included a comparison of hemodynamic variables, blood gas values, intensive care, and hospital stay.

Primary Outcome Measures: Intraocular pressure during coronary artery bypass graft surgery with cardiopulmonary bypass, Examine the effects of propofol based total intravenous anesthesia and sevoflurane-based anesthesia methods on intraocular pressure during coronary artery bypass graft surgery operation, Through study completion, an average of 6 months
To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease
NCT Number: NCT06494956
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease Dementia
Interventions: PROCEDURE: Implant device
Sponsor: Jiangsu CED Medtech Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-07-31

Summary:
To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

Primary Outcome Measures: Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary, Subjects fill in diary cards, 7 months|Subjects fill in a diary card after device implantation, Subjects fill in diary cards, 6 months|Drug dosage evaluation, Subjects fill in diary cards, 7 months|Charging performance evaluation, Subjects fill in diary cards, 6 months
Induction IBI110 and Sintilimab With Chemotherapy In LA HNSCC
NCT Number: NCT06494943
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Head and Neck Cancer|Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: Sintilimab|DRUG: IBI110|DRUG: Paclitaxel|DRUG: Cis Platinum|PROCEDURE: Surgery|RADIATION: Adjuvant radiation
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2028-12-31
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
This study aims to investigate the efficacy and safety of combining IBI110 and sintilimab with the TP regimen for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Primary Outcome Measures: Adverse Events related to treatment, Adverse Events related to treatment of sintilimab, IBI110, paclitaxel and cisplatin, per Common Terminology Criteria for Adverse Events (CTCAE) v5.0., Up to 4 months
Secondary Outcome Measures: Pathologic complete response rate, Pathologic complete response rate, Up to 3 months, post-surgery|Objective response rate, Objective response rate of primary tumor and metastatic lymph nodes, per RECIST 1.1 criteria, Up to 2 months, prior to surgery|Progression-free survival rate, Progression-free survival rate, Up to 2 years|Overall survival rate, Overall survival rate, Up to 2 years|Quality of life asessment, Quality of life evaluation, based on EORTC QLQ-H\&N35 criteria, Up to 2 months, prior to surgery
Other Outcome Measures: Tumor Mutation Burden, A measurement of mutations carried by tumor cells. It is a predictive biomarker being studied to evaluate its association with response to the study therapy, which may help to plan the best treatment. Tumors that have a high number of mutations appear to be more likely to respond to certain types of immunotherapy., Up to 2 months, prior to surgery
Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles
NCT Number: NCT06494917
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colonic Inertia|Dyschezia|Constipation
Interventions: OTHER: pelvic floor exercises|OTHER: Pelvic floor exercises and manual therapy techniques
Sponsor: Istanbul Arel University
Sex: FEMALE
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2024-09
Locations: Cizre Dr Selahattin Cizrelioglu State Hospital, Şırnak, 732000, Turkey

Summary:
The goal of this clinical trial is to Investigation of the effect of manual therapy and pelvic floor exercises on pelvic floor muscle in women with constipation. The main question\[s\] it aims to answer are:

* In addition to pelvic floor exercises, manual therapy applied to the pelvic floor muscles has no impact on constipation.
* In addition to pelvic floor exercises, manual therapy applied to the pelvic floor muscles has an impact on constipation.

Participants will apply pelvic floor exercises and manual therapy techniques. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Primary Outcome Measures: Constipation Quality of Life questionnaire, evaluates constipation through daily individual health assessment and functioning. The highest score that can be obtained from the scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as scores on the scale increase., will be evaluated at the first session and at the end of session 6
Secondary Outcome Measures: Constipation Severity Scale, scale that is calculated as a sum of a 5-point ordinal frequency ratings for the six Rome III (IV) functional constipation questions. The lowest score is 0 and the highest is 73. A high score on the scale indicates that the symptoms are at a severe level., will be evaluated at the first session and at the end of session 6
Other Outcome Measures: Bristol stool chart, Bristol stool chart is a medical aid designed to classify faeces into seven groups., will be evaluated at the first session and at the end of session 6|Rome IV Criteria, categorizes disorders of chronic constipation into four subtypes: (a) functional constipation, (b) irritable bowel syndrome with constipation, (c) opioid-induced constipation, and (d) functional defecation disorders, including inadequate defecatory propulsion and dyssynergic defecation, will be evaluated at the first session and at the end of session 6|bowel diary, a record you keep of when and how much faeces (poo) you passed or leaked during the day and overnight., During the 6-week study
Standard Versus High Dose ED-Initiated Buprenorphine Induction
NCT Number: NCT06494904
Acronym: ED-ENVISION
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Opioid Use Disorder
Interventions: DRUG: Buprenorphine
Sponsor: Yale University
Collaborators: National Drug Abuse Treatment Clinical Trials Network|The Emmes Company, LLC|National Institute on Drug Abuse (NIDA)|Alameda Health System
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-10
Locations: Highland Hospital, Oakland, California, 94602, United States|San Leandro Hospital, San Leandro, California, 94578, United States|Maine Medical Center, Portland, Maine, 04102, United States|Cooper University Hospital, Camden, New Jersey, 08103, United States|University of Utah Hospital, Salt Lake City, Utah, 84132, United States

Summary:
This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Primary Outcome Measures: Engagement in Treatment (10), The proportion of patients in each of the two study arms participating in OUD treatment within 10 days after the study randomization, Within 10 days after study randomization
Secondary Outcome Measures: Craving, The maximum intensity of opioid cravings during the preceding 24 hours assessed daily for 10 days post randomization using a numerical rating scale (0 to 10)., Measured daily for 10 days post randomization|Withdrawal, The maximum intensity of opioid withdrawal symptoms during the preceding 24 hours assessed daily for 10 days post randomization using a numerical rating scale (0 to 10)., Measured daily for 10 days post randomization|Substance Use, The number of days with illicit opioid and other substance use based on self-reported data obtained daily during the first 10 days post randomization, Measured daily for 10 days post randomization|Engagement in Treatment (30), The proportion of patients in each of the two study arms participating in OUD treatment, Within 30 days after randomization
Motivation for IV Alcohol Self-Administration in Humans
NCT Number: NCT06494891
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alcohol Use Disorder
Interventions: DRUG: Intravenous Alcohol
Sponsor: University of California, Los Angeles
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-01-16
Completion Date: 2027-06-30
Locations: University of California, Los Angeles, Los Angeles, California, 90095, United States

Summary:
The goal of this translational study is to understand different reasons why people between the ages of 21 and 65 with alcohol use disorder are motivated to self-administer alcohol. The main questions it aims to answer are:

* How does a person's desire for a reward affect their motivation to self-administer alcohol?
* How does a person's emotions affect their motivation to self-administer alcohol?
* How does a person's cognitive functioning affect their motivation to self-administer alcohol?

Participants will be asked to complete questionnaires about their mood, habits, and functioning and will complete an IV alcohol administration that will include pressing a button to receive additional doses of IV alcohol.

Primary Outcome Measures: Incentive Salience, Craving, and Self-Administration, Scores on the incentive salience factor of the ANA will correlate with craving during the challenge and self-administration during the progressive ratio., 10 hours|Negative Emotionality, Negative Mood, and Self-Administration, Scores on the negative emotionality factor of the ANA will correlate with relief from negative mood during the challenge and self-administration during the progressive ratio., 10 hours|Executive Dysfunction, Loss of Control, and Self-Administration, Scores on the executive dysfunction factor of the ANA will correlate with loss of control during the challenge and self-administration during the progressive ratio., 10 hours
The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
NCT Number: NCT06494878
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Venous Thromboembolism|Postpartum Period|Aspirin|Low Molecular Weight Heparin
Interventions: DRUG: Aspirin|DRUG: Low-molecular-weight heparin
Sponsor: University of Calgary
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 8805
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2030-12
Locations: Foothills Medical Centre, Calgary, Alberta, T2N 2T9, Canada|The Ottawa Hospital - General Campus, Ottawa, Ontario, K1H 8L6, Canada|Mount Sinai Hospital, Toronto, Ontario, M5G 1Z5, Canada

Summary:
The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE: blood clots in the legs or lungs) for postpartum individuals with VTE risk factors.

Primary Outcome Measures: Symptomatic VTE, Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism, 6 weeks
Secondary Outcome Measures: Late symptomatic VTE, Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism, 90 days|Superficial vein thrombosis, A non-compressible vein segment on ultrasound that involves the superficial veins in the lower or upper extremity, At 6 weeks and at 90 days|Distal deep vein thrombosis, A non-compressible vein segment on ultrasound involving the deep veins that is distal to the popliteal vein in the lower extremity, or distal to the axillary vein in the upper extremity, At 6 weeks and at 90 days|Single subsegmental pulmonary embolism (SSPE), Intraluminal filling defect that involves one subsegmental artery only, At 6 weeks and at 90 days|Major bleeding, Based on the ISTH definition, At 6 weeks and at 90 days|Clinically relevant non-major bleeding, Based on the ISTH definition, At 6 weeks and at 90 days|Wound hematoma requiring intervention, Requiring intervention such as hematoma evacuation or wound packing, At 6 weeks and at 90 days|Symptomatic arterial thromboembolism, Ischemic stroke/transient ischemic attack, myocardial infarction, or peripheral arterial embolism, At 6 weeks and at 90 days|Postpartum preeclampsia, New preeclampsia presenting in the postpartum period, At 6 weeks and at 90 days|Heparin-induced thrombocytopenia, According to a priori categories of definite or possible HIT., At 6 weeks and at 90 days|All-cause mortality, At 6 weeks and at 90 days
" Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"
NCT Number: NCT06494865
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: DEVICE: MRI device
Sponsor: Sohag University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-12-01

Summary:
Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer.

Primary Outcome Measures: Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology., evaluation of the lesion with MRI DWI and histopathology for detect rate of false posive results, 6 months
Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy
NCT Number: NCT06494852
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cow's Milk Protein Allergy|Rta
Interventions: DIAGNOSTIC_TEST: investigations
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-03
Completion Date: 2024-01-03
Locations: Sohag, Sohag, Egypt

Summary:
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.

Primary Outcome Measures: investigate association of Renal tubular acidosis in cow milk protein allergy patients, Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction, 6 months
Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy
NCT Number: NCT06494839
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tonsillitis
Interventions: PROCEDURE: Bipolar electrocautery tonsillectomy technique|PROCEDURE: Cold steel dissection technique
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: CHILD
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-04-30
Locations: Sir Ganga Ram Hospital, Lahore, Punjab, 54000, Pakistan

Summary:
It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.

Primary Outcome Measures: Operative time, Operative time was measured from the anterior pillar incision to the removal of the mouth gag., 1 hour|Blood loss, Intraoperative blood loss was measured by reading the levels given in the suction bottle at the end of surgery. The weight of dry gauze was subtracted from the wet, considering 1g=1ml., up to 24 hours|Postoperative pain, Postoperative pain was measured at regular intervals (6-hourly till 24 hours) using the Wong-Baker faces pain rating scale.12 The Wong-Baker faces pain rating scale graded pain as mild (1-3), moderate (4-6), or severe (\>6)., 24 hours
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
NCT Number: NCT06494826
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease
Interventions: OTHER: colonoscopy procedure
Sponsor: Weizmann Institute of Science
Collaborators: HaEmek Medical Center, Israel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2027-05
Locations: Emek medical center, Afula, Israel

Summary:
In this study, the investigators will explore our protein-based platform assessing commensals potentially contributing to features of CD, while assessing the global composition and abundance of AMPs expressed in the GI tract under specific CD-relevant clinical contexts. This would enable us to (a) identify new commensals contributing to features of CD spectrum and various sub-types; (b) uncover the mechanistic basis of dysbiosis in CD (c) utilize the pipeline to develop new theranostic for disease exacerbation, complication and treatment responses; and (d) potentially enable future exploitation of novel AMP combinations, and their respective antimicrobial capacity to counteract dysbiosis in CD.

Uncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers, mechanistically determine causative drivers of CD, and potentially facilitate the development of novel therapeutic interventions.

Primary Outcome Measures: Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract, Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy, 1 week
Added Value of PET/CT in Lung Cancer
NCT Number: NCT06494800
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: DIAGNOSTIC_TEST: True cut needle biobsy
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-12-01

Summary:
Assess the value of PET/CT in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer.

Primary Outcome Measures: Accuracy of PET CT in diagnosis of lung cancer, using the qualitative and quantitative measuring including the SUV max value in detection of the malignant potentiality of the pulmonary nodule or mass comparing it with the pathological result, 1 Year|Value of PET CT in staging of lung cancer, using the PET CT in TNM staging with better detection of pleural , mediastinal extension /involvement, the value and accuracy of PET in detecting the potential malignancy of the mediastinal lymph nodes even the subcentemetric lymph nodes not adequately assessed by the usual CT., 1 Year|predicting the pathological subtype of lung cancer using the morphological and PET CT of pathologically proved lung masses, assessing the morphology of the lung mass including density, solid, subsolid and soft nodule.

site of the nodule/mass peripheral or centrally located. presence of cavitation or cystic changes. presence of speculated or irregular margin. measuring the SUV max and comparing it with the pathology of each mass/nodule., 1 Year|Differentiating between the primary mass and associated consolidation if present, using the PET CT (mainly the qualitative assessment) in differentiating the primary mass from the associated consolidation-atelectasis around, 1 Year
Secondary Outcome Measures: assessment of the pleural thickening/effusion associated with the primary mass, assessing the qualitative and quantitative assessing the pleural thickening if found for differentiating the pleural involvement from the inflammatory pleural thickening, 1 Year|presence of enlarged axillary Lns, assessing the activity of enlarged axillary Lns by measuring the SUV value, 1 Year|assessing the Vocal cord paralysis in the pan-coast tumor, using the morphological assessment of the lower CT neck scans and the adduction of the vocal cord and the atrophic changes of the Muscle and loss of vocal cord physiological activity., 1 Year
A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma
NCT Number: NCT06494787
Acronym: SOC-2320
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Soft Tissue Sarcoma
Interventions: COMBINATION_PRODUCT: Aliya Pulse Electric Field sysem and pembrolizumab
Sponsor: Sarcoma Oncology Research Center, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-31

Summary:
The is a phase 2 that will evaluate the efficacy and safety of the Aliya PEF ablation system combined with pembrolizumab, an immune checkpoint inhibitor.in advanced soft tissue sarcoma. Twenty subjects will be treated.

Primary Outcome Measures: Progression free survival, Progression free survival at 6 months, 24 months
Secondary Outcome Measures: Objective response, • Objective response rate by RECIST v1.1 and iRECIST via CT scan or MRI after every 6-weeks, 24 months|Overall survival, Overall survival at 6, 9, 12, 24 months, 24 months
A Study to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body of Healthy Japanese Men
NCT Number: NCT06494774
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: BI 1815368|DRUG: Placebo matching BI 1815368
Sponsor: Boehringer Ingelheim
Sex: MALE
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2024-11-20
Locations: SOUSEIKAI Sumida Hospital, Tokyo, Sumida-ku, 130-0004, Japan

Summary:
The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.

Primary Outcome Measures: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator, Up to 26 days
Secondary Outcome Measures: SRD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), Single-rising dose (SRD), Up to 6 days|SRD part: Maximum measured concentration of the analyte in plasma (Cmax), Single-rising dose (SRD), Up to 6 days|MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss), Multiple dose (MD), Up to 19 days|MD part: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss), Multiple dose (MD), Up to 19 days|MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss), Multiple dose (MD), Up to 19 days