pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
NCT Number: NCT06520358
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Brain Injury
Interventions: OTHER: Acute Intermittent Hypoxia (AIH)|BEHAVIORAL: Task specific Airway Protection Training|OTHER: Sham AIH
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07-30
Locations: University of Florida, Jacksonville, Florida, 32209, United States

Summary:
Acute intermittent hypoxia (AIH) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. Animal and human studies show that AIH improves motor function after neural injury, particularly when paired with task-specific training. Using a double blind cross-over study we will test whether AIH and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (TBI).

Primary Outcome Measures: Duration of laryngeal vestibule closure (dLVC), Time in (msec) the laryngeal vestibule stays closed during a swallow, Pre-intervention, 1 day after intervention block and 1-week post intervention|Time to laryngeal vestibule closure (Time-to-LVC), Time in (msec) it takes to close the laryngeal vestibule after swallow initiation, Pre-intervention, 1 day after intervention block and 1-week post intervention
Secondary Outcome Measures: Penetration-Aspiration Scale Scores, The penetration-aspiration scale (PAS) will be used to assess penetration or aspiration; the PAS is an 8-point scale that ranges from 1 (no penetration/aspiration) to 8 (aspiration with no cough response)., Pre-intervention, 1 day after intervention block and 1-week post intervention
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT-GLOBAL)
NCT Number: NCT06520345
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: DRUG: 177Lu-TLX591|DRUG: Enzalutamide|DRUG: Abiraterone|DRUG: Docetaxel
Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 430
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2030-12

Summary:
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Primary Outcome Measures: Radiographic Progression-free Survival, time from randomization to disease progression confirmed by central independent radiology review according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (which incorporates Response Evaluation Criteria in Solid Tumors, RECIST 1.1, for soft tissue lesions), or death (whichever occurs first), 337days
Secondary Outcome Measures: Overall Survival, Defined as the time from randomization, until death from any cause., 5 years|Objective Response Rate (ORR), Tumor response in terms of PCWG3 criteria (which incorporates RECIST 1.1 for soft tissue lesions)., 337days|Time to a first symptomatic skeletal event (SSE), Time to a first SSE, defined as the use of external beam radiation to relieve bone pain, or occurrence of a new symptomatic pathological fracture (vertebral or non-vertebral), or occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention., 337days
Comparative Evaluation of the Clinical Efficacy of Short Implants With Standard-Length Implants - a Randomised Controlled Trial
NCT Number: NCT06520332
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implant
Interventions: PROCEDURE: Dental Implant Surgery - short implant group (less than or equal to 6mm)|PROCEDURE: Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08
Locations: Krishnadevaraya college of dental sciences, Bangalore, Karantaka, 562157, India

Summary:
Periodontal disease , especially in its advanced stages , is one of the main cause for tooth loss .Tooth replacement options include dental implants , fixed partial denture , removable partial denture and complete dentures . Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Although conventional implants cannot be placed in every site due to resorption of the alveolar socket after extraction. Thus short implants can be used as an alternative . Hence, this study aims at comparing the clinical efficacy of short implants with standard length implants placed in native or augmented bone in patients with a history of periodontitis.

Primary Outcome Measures: The primary outcome that will be assessed is implant survival rate., The primary objective of this randomised controlled clinical trial will be to compare the survival rate of short implants (≤ 6 mm ) and standard-length implants (≥ 10 mm) in patients with a history of periodontitis; through clinical and radiographic analysis., 6 months
Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma
NCT Number: NCT06520319
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Medullary Thyroid Carcinoma
Interventions: DRUG: 68Ga-MGS5
Sponsor: First Affiliated Hospital of Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-06-21
Completion Date: 2025-07
Locations: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350005, China

Summary:
Cholecystokinin-2 (CCK2) receptor is overexpressed in more than 90% of MTC cases, and preclinical studies have shown that 68Ga-MGS5 (targeting CCK2) has good stability in vivo and is promising for diagnosis and staging of MTC. This prospective study will compare the diagnostic effects of 68Ga-MGS5 and 68Ga-DOTATATE on MTC primary foci, lymph node metastasis, and distant metastasis, and explore the effect of 68Ga-MGS5 PET/CT on the clinical staging (TNM staging) of MTC.

Primary Outcome Measures: SUVmax and SUVpeak, Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan., through study completion, an average of 2 years
Secondary Outcome Measures: immunohistochemistry, Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored., through study completion, an average of 2 years
A Study of Ropivacaine Combined With Different Concentrations of Methylene Blue Fascia Iliaca Block in Postoperative Analgesia, Cognition, and Hip Function Recovery in Patients Undergoing Hip Arthroplasty
NCT Number: NCT06520306
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Femoral Neck Disease
Interventions: DRUG: Ropivacaine combined with methylene blue for iliac fascia block
Sponsor: Wang wanxia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-03-15
Completion Date: 2024-08-31
Locations: Zhang Yang, Taizhou, China

Summary:
Total hip arthroplasty (THA) is a commonly used treatment for hip lesions, but it is often accompanied by persistent pain after surgery, which obviously affects the quality of life of patients, so perfect postoperative analgesia is particularly important for the rapid recovery of patients. Peripheral nerve blocks are often used as postoperative analgesia for THA, and fascia iliaca compartment block (FICB) is the preferred nerve block for THA due to its good postoperative analgesic effect and fewer postoperative adverse reactions. However, the effect of nerve block with ropivacaine alone is short, and the postoperative analgesia time is limited, which seriously affects the patient\&#39;s surgical recovery. Therefore, prolonging the postoperative analgesic time is an urgent problem to be solved by FICB, and some scholars recommend the combined use of local anesthetic adjuvants to prolong the block time, which is an effective and safe method. In this study, a long-acting analgesic drug, methylene blue, was selected as an adjuvant for ropivacaine for FICB, but there was no unified clinical standard for the postoperative analgesic concentration of methylene blue.

Primary Outcome Measures: visual analogue scale（VAS）, Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and "0" and "10" at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain, The first, third, and seventh days after the surgery|Mini-Mental State Examination (MMSE), An examination tool to assess cognitive status, Seventh day after surgery|Harris Hip Scoring System, Harris (1969) proposed a scoring system to evaluate the functional status and postoperative efficacy of patients with artificial hip arthroplasty, On the seventh day after surgery
Secondary Outcome Measures: Number of postoperative salvage analgesia, From the end of the surgery to the seventh day after the surgery|Walking distance for the first time getting out of bed, From the end of the surgery to the seventh day after the surgery|Number of exercises to get out of bed within 7 days of surgery, From the end of the surgery to the seventh day after the surgery
Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults
NCT Number: NCT06520293
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Adults
Interventions: OTHER: Sweet Beverage
Sponsor: Amai Proteins
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2025-02

Summary:
The study aims to evaluate, for the first time, the post-prandial effects of a single oral administration of Serendipity Berry Sweet Protein sweelin® compared to glucose and stevia, as a commercial sweetener, in healthy adults. The study design is a single center, randomized, crossover study.

Each subject will receive a single oral dose of sweelin® compared with an equivalently sweet dose of glucose and stevia dissolved in a water beverage with flavor.

The advantage of a crossover design is that it will allow to compare the blood glucose and insulin levels of each subject to his baseline in every test beverage, and to remove the inter-subject variability. The post-prandial effects will be monitored with multiple blood sampling up to 120 minutes post dosing.

Primary Outcome Measures: Blood glucose incremental area under the curve (iAUC), To monitor blood glucose incremental area under the curve (iAUC) response of sweelin® in healthy adult subjects, following a single oral administration, in comparison to glucose and stevia., 120 minutes after single oral dose administration
Secondary Outcome Measures: Insulin incremental area under the curve (iAUC), To monitor blood insulin incremental area under the curve (iAUC) response of sweelin®, following a single oral administration, in comparison to glucose and stevia., 120 minutes after single oral dose administration
Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture
NCT Number: NCT06520280
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complete Denture
Interventions: OTHER: polyamide and 3D printed complete denture
Sponsor: Ibrahim Mohamed Ali Ibrahim Abd Elrahman
Sex: MALE
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-02-13
Completion Date: 2025-06
Locations: Faculty of Dental Medicine, Cairo, Naser City, Egypt

Summary:
The objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion.

Primary Outcome Measures: retention, Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval., 6 months
Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia
NCT Number: NCT06520267
Acronym: BPH
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Bacteriuria in Symptomatic Benign Prostate Hyperplasia|Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia|Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia
Interventions: DRUG: Antibiotic therapy
Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 131
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-01
Completion Date: 2021-08-15
Locations: BP Koirala Institute of Health Sciences, Dharān Bāzār, Koshi, 56700, Nepal

Summary:
The goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.

Primary Outcome Measures: Identification of common pathogens and Antibiotic susceptibility testing, Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic patients with BPH., 4 weeks
Secondary Outcome Measures: Severity of LUTS in patients with symptomatic BPH, The study assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy., 4 weeks
The Effectiveness of Massage Therapy in Patients With Shoulder Pain
NCT Number: NCT06520254
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain
Interventions: OTHER: Massage therapy
Sponsor: Wroclaw University of Health and Sport Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-09-01
Completion Date: 2020-03-20
Locations: Wroclaw University of Health and Sport Sciences, Wrocław, Poland

Summary:
The goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in SP.

The main questions it aims to answer are:

1. Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
2. Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?

Researchers will compare a dedicated massage protocol to a control group to see if the massage protocol works to treat shoulder pain.

Participants in the massage group will:

Take part in 6 massage sessions (twice a week for 3 weeks) in the

Participants in the control group will:

Take part in 2 massage sessions (after the first and second assessment)

Primary Outcome Measures: Change in the pain threshold of the shoulder after therapy compared to baseline, Measuring device: The Wagner FPXTM Algometer produced by The Wagner Instruments, Greenwich CT, USA, Change = (Value after therapy - baseline), 1) baseline, 2) 3 weeks after the first massage session massage session|Change in the The University of California at Los Angeles Shoulder Score after therapy compared to baseline, Measuring device: UCLA scale (The University of California at Los Angeles Shoulder Score) , Change = (Value after therapy - baseline), 1) baseline, 2) 3 weeks after the first massage session massage session
Secondary Outcome Measures: Change in the Visual analog scale score after therapy compared to baseline, Measuring device: VAS scale - Visual analog scale - a continuous scale comprised of a horizontal line, 100 mm in length, anchored by "no pain" (score of 0) and "worst imaginable pain" score of 10, Change = (Value after therapy - baseline), 1) baseline, 2) 3 weeks after the first massage session massage session|Change in ROM after therapy compared to baseline, Measuring device: a goniometr, Change = (Value after therapy - baseline), 1) baseline, 2) 3 weeks after the first massage session massage session
The Effect of Stress, Anxiety, and Depression Experienced by Pregnant Women on Sleep Bruxism and Oral Health
NCT Number: NCT06520241
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Bruxism, Adult|Stress|Depression|Anxiety|Pregnancy Related|Oral Disease
Interventions: OTHER: Pregnant
Sponsor: Trakya University
Sex: FEMALE
Age: ADULT
Enrollment: 321
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2023-11-30
Locations: Bartın University, Bartin, 78100, Turkey

Summary:
Background The oral health of pregnant women affects not only the systemic health of the mother but also the birth outcome of the fetus. Therefore, oral health management of pregnant women is important for both maternal and fetal health.

Objectives The study aimed to examine the effects of stress, anxiety, and depression experienced by pregnant women on sleep bruxism and oral health.

Methodology This cross-sectional study was conducted between September and November 2023 on 321 pregnant women who volunteered to participate in the study by posting on social media forum pages via the web. Data were collected using the Personal Information Form, Depression-Anxiety-Stress Scale (DASS-21), and Oral Health Impact Scale (OHIP-14-TR). Descriptive statistical methods, the Kruskal-Wallis test, Mann-Whitney-U test, and Spearman correlation test were used to analyze the data.

Primary Outcome Measures: Depression-Anxiety-Stress Scale, Sarıçam (2018) adapted the scale developed by Lovibond and Lovibond (1995) into Turkish. In the scale consisting of depression, anxiety, and stress sub-dimensions, each sub-dimension consists of seven items. Scale items are scored from 0 to 3 (0=never and 3=always). Scores between 0 and 21 can be obtained from the scale sub-factors. Higher scores indicate higher levels of depression, anxiety, and stress., 1 day (collected once)|Oral Health Impact Scale, Oral Health Impact Scale (OHIP-14) with an internal consistency coefficient (Cronbach alpha) of 0.74, which was conducted by Başol et al. in 2014 for Turkish validity and reliability. The scale consists of 14 items with a 5-point Likert response scale (never-0; rarely-1; sometimes-2; often-3; very often-4) and seven subscales, each consisting of two items: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The total score obtained from the scale is obtained by summing the scores given to each item, and the total scale score range varies between 0 and 56., 1 day (collected once)
The Purpose of This Study is to Reveal the Influence of Active Video Games on Children's Motor Coordination
NCT Number: NCT06520228
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: The Study Demonstrated the Effect of Active Video Games on Motor Coordination in Children Over a 12-week Intervention
Interventions: BEHAVIORAL: Active video games|BEHAVIORAL: Traditional sports games
Sponsor: Universiti Putra Malaysia
Sex: ALL
Age: CHILD
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-08
Completion Date: 2024-07-12
Locations: Lu Chenxi, Zhengzhou, Henan, 450000, China

Summary:
The goal of the study was to understand the effects of active video games on motor coordination in children. The main questions it aims to answer are:

The effect of positive video games on children's motor ability.

Researchers will compare traditional physical activities to see if active video games are effective in improving motor coordination in children.

Participants will:

Play active video games twice a week for 12 weeks Data were collected during the first and twelfth weeks

Primary Outcome Measures: baseline, The subjects (control group and experimental group) will be pre-tested during the first week of the experiment. The motor coordination ability of the subject was obtained. Motor coordination was measured using the Motor Assessment Battery for Children - Second Edition (MABC-2)., The first week of the experiment.
Secondary Outcome Measures: post test1, The subjects (control group and experimental group) will be tested after the 12th week of the experiment. The motor coordination ability of the subject was obtained. Motor coordination was measured using the Motor Assessment Battery for Children - Second Edition (MABC-2)., The 12th week of the experiment.
Correlation Hand Grip Strength and Walking Distance in Elderly
NCT Number: NCT06520215
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Revascularization
Sponsor: Universitas Padjadjaran
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2024-10-17

Summary:
Elderly patient post coronary revascularization assessed hand grip strength and changes in six minute walking distance

Primary Outcome Measures: Correlation Between Hand Grip Strength and Walking Distance in Elderly Patients, Elderly patient post coronary revascularization assessed hand grip strength (measured with hand dynamometer) and changes in six minute walking distance (measured in meter), 6 weeks
RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
NCT Number: NCT06520202
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Sjogren's Syndrome With Dry Eye
Interventions: DRUG: rhPRG4 (450 µg/mL)|DRUG: Vehicle
Sponsor: Lubris Bio Pty Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12

Summary:
A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or vehicle (Crossover group). At 90 minutes, Crossover group subjects will be administered rhPRG4, then evaluated 5 \& 30 minutes after rhPRG4 instillation (95 \& 120 minutes from baseline). All subjects will self-report for the remainder of the day at 4 hours and 8 hours post dose.

Primary Outcome Measures: • To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at 90 minutes, 90 minutes|• To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events, 90 minutes
Secondary Outcome Measures: • To assess the efficacy of rhPRG4 using the average VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia and total VAS, at 5 minutes, 30 minutes, 90 minutes, 4 & 8 hours|• To assess the efficacy of rhPRG4 using the minimum inter-eye non-invasive tear film breakup time (TBUT): min(OU), 30 minutes, 90 minutes|• To assess the efficacy of rhPRG4 using maximum inter-eye tear osmolarity: max(OU), 30 minutes, 90 minutes|• To assess the efficacy of rhPRG4 using a patient questionnaire, 90 minutes|• To assess the safety of rhPRG4 by observation of the Best Corrected Visual Acuity (BCVA), 90 minutes|• To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE), 90 minutes
Value of F-18 FDG PET/CT for the Prediction of EGFR Mutation in Lung Cancer Patients
NCT Number: NCT06520189
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: DEVICE: F-18 FDGPET/CT
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-10-01

Summary:
To detect value of F-18FDG PET/CT as a non-invasive method for the prediction of EGFR mutations in lung cancer patients.

Primary Outcome Measures: • Assessment of semi-quantitative F-18 FDG PET/CT as a non-invasive method for prediction of EGFR mutations in lung cancer patients., detection value of F-18 FDG PET/CT for the prediction of EGFR mutation in lung cancer patients., baseline
Secondary Outcome Measures: • Assessment of the relationship between degree of the tracer uptake and pathology of the lesion., correlate between degree of the tracer uptake and pathology of the lesion, baseline
Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.
NCT Number: NCT06520150
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chest Pain|Pain, Procedural|Pain, Postoperative|Analgesia|Regional Anesthesia Morbidity|Anesthesia, Local|ICD
Interventions: PROCEDURE: Regional anaesthetic combined fascial plane block|DRUG: Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution
Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SCREENING
Start Date: 2024-06-16
Completion Date: 2025-12-01
Locations: 4th Military Clinical Hospital with Polyclinic, Wrocław, Dolnośląskie, 50-981, Poland

Summary:
Our study consists of a combination of regional blockade ('local' anesthesia) of the anterior and lateral chest wall in the form of a thin needle prick and the supply of local anesthetic drugs to the area of the relevant chest wall structures to exclude all stimuli, including pain from the operative site. A short-acting analgesic and sedative drug will be administered intravenously throughout the procedure - in a dose that allows the required contact between the patient and the anesthetist. If necessary, the dose of the drug may be increased to maintain pain comfort throughout the procedure.

The anesthetic team will be with the patient throughout the procedure to ensure comfort and safety.

Primary Outcome Measures: NRS, numerical pain scale 0-10 points, Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure|VAS, visual analogue scale 0-10 points, Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure|QoR - 15, post-operative quality of life and improvement scale 0-150 points, Administered to the patient before surgery and 24 hours after surgery|RASS, Richmond arousal/sedation scale) (-5 \<-\>+5) points, Checked at regular 15 minute intervals during the procedure|GCS, Glasgow level of consciousness score scales 3-15 points, Checked at regular 15 minute intervals during the procedure|EOA, Effectiveness of Anaesthesia) -scale (-3 do +3) points, Checked immediately after the procedure (last suture)
Secondary Outcome Measures: SpO2, hemoglobin oxygen saturation 50-99%, Monitored every 5 minutes during the procedure|NIBP, non-invasive blood pressure measurement of 0-200 millimeters of the mercury column (mmHg), Monitored every 5 minutes during the procedure|HR, heart rate, Monitored every 5 minutes during the procedure
Other Outcome Measures: BMI, Body mass index 15-45, Before performing procedure|bioimpedance, volume od lipids 30-80%, beforeperforming procedure
Third Molars Extraction and Periodontal Disease
NCT Number: NCT06520137
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Periodontal Diseases
Interventions: PROCEDURE: Tooth extraction
Sponsor: Azienda Ospedaliera Universitaria Senese
Sex: ALL
Age: ADULT
Enrollment: 126
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-27
Completion Date: 2026-09-15
Locations: University of Siena, Siena, Italy/SI, 53100, Italy

Summary:
The aim of the study is to evaluate the changes in periodontal conditions on the distal aspect of the second maxillary molar after the extraction of the maxillary wisdom tooth. As secondary outcome patient- related and tooth-related factors will be analysed to evaluate their effects on the periodontal varibales during time.

Primary Outcome Measures: Probing Pockeet Depth (PPD), Distance between the free gingival margin and the apical location of the probe's tip., Baseline, 1 month, 6 months, 12 months, 24 months|Bone Level (BL), Distance between the bone crest and the cemento-enamel junction (CEJ), Baseline, 1 month, 6 months, 12 months, 24 months
Secondary Outcome Measures: Type of impaction, According to Archer's classification it is possible to have seven types of impaction: mesio-angular, disto-angular, bucco-angular, linguo-angular, horizontal, vertical, inverted., Baseline|Clinical Attachment Level (CAL), Distance between the cemento-enamel junction and the apical location of the probe's tip, Baseline, 1 month, 6 months, 12 months, 24 months|Recession (REC), Distance between the free gingival margine and the cemento-enamel junction (CEJ), Baseline, 1 month, 6 months, 12 months, 24 months|Keratinized Tissue (KT), Distance between the muco-gingival line and the free gingival margin, Baseline, 1 month, 6 months, 12 months, 24 months
Stellest Lens Wear in Adult Progressing Myopes
NCT Number: NCT06520124
Acronym: SWAP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia, Progressive
Interventions: DEVICE: Essilor® Stellest® spectacle lens|DEVICE: Single-vision spectacle lens
Sponsor: University of Ulster
Collaborators: Essilor International
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-04
Locations: Ulster University, Coleraine, County Londonderry, BT52 1SA, United Kingdom

Summary:
It is expected that myopia progression stabilises in the late teenage years, however, some studies report that myopia progression continues through early adulthood in as many as one third of myopes. Similarly, there are reports of myopia commencing in early adulthood. Although the rate of progression is slower than that occurring in childhood, between 20-35% of adults aged between 20-30 years were reported to progress by at least -1.00D over a five year period. Given that every dioptre increase in myopia results in an increased overall lifetime risk of serious ocular pathology, it seems opportune to investigate whether myopia management treatments designed to slow myopia progression in childhood could be beneficial for progressing adult myopes. The proposed study will conduct a prospective, randomised, paired-eye, trial with cross-over to evaluate the efficacy of Essilor Stellest myopia management spectacle lenses on the progression of myopia in adults aged between 18-40 years. The outcomes from the trial will provide novel evidence regarding the utility of these lenses in an adult population.

Primary Outcome Measures: Change in axial length (mm), Change in axial length (mm) of the eye wearing the Stellest lens compared to the control eye wearing standard single vision lenses., 2 years|Change in cycloplegic autorefraction (D), Change in cycloplegic autorefraction (D) of the eye wearing the Stellest lens compared to the control eye wearing standard single vision lenses., 2 years
Secondary Outcome Measures: Acceptability to adult patients of Stellest lenses prescribed for both eyes, assessed using the Stellest adult tolerability questionnaire., Acceptability to adult patients of the Stellest lens when prescribed for both eyes following the 2-year trial period., 1 month
Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
NCT Number: NCT06520085
Acronym: TRAPP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Osteoarthritis
Interventions: OTHER: interactive mHealth application for patients undergoing RSA
Sponsor: VieCuri Medical Centre
Collaborators: Anna ziekenhuis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: VieCuri Medisch Centrum, Venlo, Limburg, 5912BL, Netherlands

Summary:
Background: Mobile health (mHealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. Providing patients with timely and interactive information through mHealth is hypothesized to positively influence recovery after reverse shoulder arthroplasty (RSA).

Aim: The aim of this study is to determine the effectiveness of interactive and personalized information and rehabilitation protocol with a mobile application compared to generic information and generic rehabilitation protocol (standard care) on postoperative recovery in patients undergoing primary RSA.

Methods and analysis: A multicentre randomised controlled trial will be conducted in two Dutch hospitals. In total 170 patients undergoing elective, primary RSA will be included. Participants will be randomly allocated to one of the two groups on a 1:1 ratio. The intervention group will receive interactive postoperative information on a daily basis. The control group will receive standard care. The primary outcome is defined as functional recovery measured using the Oxford Shoulder Score (OSS) at 6 weeks. Secondary outcomes are: pain, physical functioning, quality of life, length of stay, complications, treatment satisfaction and app use. The between group difference will be analysed using linear mixed-effects regression.

Primary Outcome Measures: Postoperative shoulder functioning, Shoulder functioning measured with the Oxford Shoulder Score, bssix weeks, three months and 1 year
Secondary Outcome Measures: Shoulder pain, Shoulder pain measured using the Numeric Rating Scale, baseline, daily during the first 6 weeks, 3 months and 1 year|Shoulder disability, shoulder disability measured using the Disability of the Arm, Shoulder and Hand, baseline, six weeks, three months and 1 year|Range of Motion of the Shoulder, Range of Motion of the Shoulder measured with the goniometer, baseline, six weeks, three months and 1 year|Satisfaction with the Application, Satisfaction with the Application measured with a five-point likert scale, six weeks, three months and 1 year|Readmission rate, Readmission rate related to RSA, 1 year|Complication rate, Complication rate related to RSA, 1 year
Mobile Apps for Preschool Parents (MAPP) Study
NCT Number: NCT06520072
Acronym: MAPP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Childhood|Nutrition, Healthy|Physical Inactivity|Sleep, Inadequate
Interventions: BEHAVIORAL: Children Eating Well (CHEW) mobile app|BEHAVIORAL: Beanstalk mobile app
Sponsor: Pamela Hull
Collaborators: United States Department of Agriculture (USDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2024-12
Locations: University of Kentucky, Lexington, Kentucky, 40536, United States

Summary:
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the effectiveness of two mobile applications for parents of preschool aged children: 1) an app focused on child and family nutrition and wellness, and 2) an app focused on parents reading to their children.

Primary Outcome Measures: Healthy Kids childhood obesity risk score, Using the 19-item Healthy Kids scale, each item is coded from 1 to 5, with 1 being the least healthful and 5 being the most healthful. To calculate the childhood obesity risk score, all 19 items are summed together, ranging from 19 to 95, with higher values reflecting a more healthful, or positive, outcome., 2 months
Secondary Outcome Measures: Child intake of sugar-sweetened beverages (Healthy Kids items), Child intake of sugar-sweetened beverages (Healthy Kids items), 2 months|Child intake of fruits and vegetables (Healthy Kids items), Child intake of fruits and vegetables (Healthy Kids items), 2 months|Child intake of energy dense food/beverages (Healthy Kids items), Child intake of energy dense food/beverages (Healthy Kids items), 2 months|Child intake of dairy/calcium (Healthy Kids items), Child intake of dairy/calcium (Healthy Kids items), 2 months|Child physical activity and sedentary behavior (Healthy Kids items), Child physical activity and sedentary behavior (Healthy Kids items), 2 months|Sleep: Child bedtime (Healthy Kids item), Child bedtime (Healthy Kids item), 2 months|Family meals: Eating meals with child (Healthy Kids item), Eating meals with child (Healthy Kids item), 2 months|Child dietary intake (Healthy Kids items), Child dietary intake (Healthy Kids items), 2 months|Diet quality: Variety of child vegetable intake (My Veggies questionnaire), Variety of child vegetable intake (My Veggies questionnaire), 2 months|My Child at Mealtime questionnaire, My Child at Mealtime questionnaire measures food-related parenting styles., 2 months|Home Inventory Describing Eating and Activity (Home-IDEA2, food section), Home Inventory Describing Eating and Activity (Home-IDEA2, food section) measures home food environment., 2 months|Frequency of reading to child, Frequency of reading to child, 2 months|Length of time reading to child, Length of time reading to child, 2 months
Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma
NCT Number: NCT06520059
Acronym: OASIS-PRP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Knee Osteoarthritis
Interventions: COMBINATION_PRODUCT: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration
Sponsor: Universidade do Porto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-10-31
Locations: Faculdade de Medicina da Universidade do Porto, Porto, 4200 - 319, Portugal|Faculdade de Medicina da Universidade do Porto, Porto, 4200-319, Portugal

Summary:
This is a prospective cohort clinical study. Due to logistic constraints at the sites of implementation, a randomized allocation will not be feasible (private clinic). Patients will be selected with the aim of matching for important confounders (sex and age) the grade of knee OA will be restricted to advance stages.

Primary Outcome Measures: PROM - Knee related Qol, Knee injury and Osteoarthritis Outcome Score (KOOS) - absolute value from the score (units). Min-Max (0-100) higher scores indicate better outcomes and a higher quality of life related to the knee, baseline, and at follow-up of 3 months, 6 months and 12 months|PROM - PAIN, Visual analogic Score - PAIN (VAS) -absolute value from the score (units). Min-Max (0-10) higher scores indicate worse outcomes, baseline, and at follow-up of 3 months, 6 months and 12 months
Secondary Outcome Measures: bone marrow edema -MRI, first scored dichotomous (yes/no), 1 month prior to the injection; 1 month to one year after intervention|bone marrow edema -MRI, BME will be classified using the criteria defined in the Whole-Organ Magnetic Resonance Imaging Score (WORMS). Range 0-3 Higher scores mean more medular edema., 1 month prior to the injection; 1 month to one year after intervention
Motor Control Prevention Strategies in Basketball Players
NCT Number: NCT06520046
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Sprains|Motor Disorders
Interventions: OTHER: Experimental Group|OTHER: Control Group
Sponsor: University of Salamanca
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2025-06-30

Summary:
Ankle sprains have always been considered as isolated injury entities, in which the passive ankle stabilisation system suffered an elongation due to trauma. Today, this concept of an isolated injury has evolved into a more holistic concept, interrelated with various components from different sources.

Primary Outcome Measures: Range of motion, Measurements of the articular range of the ankle joint, At the beginning and at 9 months|Musculature Strength, Measurement of the strength of the musculature of the back of the leg by means of isokinetic tests, At the beginning and at 9 months|Presence of Myofascial trigger points, Diagnostic criteria established by Travell and Simons, the presence or absence of active or latent myofascial trigger points will be assessed., At the beginning and at 9 months|Speed of contraction of the musculature, By means of the isokinetic tests and the aforementioned exploratory curves, the speed of contraction of the musculature of the back of the leg and foot will be evaluated, At the beginning and at 9 months
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction
NCT Number: NCT06520007
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Meibomian Gland Dysfunction|Blepharitis|Doxycycline Adverse Reaction
Interventions: DRUG: Doxycyclin
Sponsor: University of Milan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2024-05-01
Locations: ASST Santi Paolo e Carlo - Ospedale San Paolo, Milano, MI, 20142, Italy

Summary:
The goal of this observational study (spontaneous, non-randomised, prospective cohort, phase IV) is to compare the efficacy and safety of two different oral doxycycline treatment protocols (LCP - Low dose continuous protocol \& FPP - Full dose pulsed protocol) for meibomian gland dysfunction (MGD) in patients with refractory MGD (OSDI \> 13 after at least 2 months treatment with warm compresses and lacrimal substitutes - first-line therapy). Systemic doxycycline doesn't have a standardized treatment protocol and this is why those patients are treated as in normal clinical practice. The main questions it aims to answer are:

Which treatment protocol has a greater impact on patient symptoms during the follow-up (OSDI score reduction)? Which treatment protocol has a greater impact on patient signs during the follow-up (TBUT and corneal staining variations)? Which treatment protocol is safer (in terms of adverse events rate)?

Participants will be visited every 3 months (V0-V1-V2-V3) with signs and symptoms assessment (TBUT, corneal staining, OSDI score) after being treated for 3 months with the assigned doxycycline treatment protocol (LCP or FPP).

Primary Outcome Measures: OSDI score, Ocular Surface Disease Index, Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Secondary Outcome Measures: TBUT, Tear break-up time, Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)|Corneal staining, Oxford scale has been use to assess corneal staining, Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)|Adverse events, Number of dropouts due to drug toxicity, From baseline up to the 3rd month
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
NCT Number: NCT06519994
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Human Immunodeficiency Virus|Human Papillomavirus|Cervical Precancer
Interventions: DRUG: Artesunate vaginal inserts|DRUG: Placebo vaginal inserts
Sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)|Kenya Medical Research Institute|Maseno University School of Medicine, Kenya
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-11-30
Locations: Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building, Kisumu, 614-40100, Kenya

Summary:
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH).

The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.

Primary Outcome Measures: Clearance of type-specific HPV genotype(s), The number and proportion of women in each study arm who demonstrate clearance of the specific HPV genotype, or genotypes (if multiple) between baseline and six months will be reported., 24 weeks
Secondary Outcome Measures: Adherence, Adherence will be evaluated based on the number and proportion of women confirmed self-administration of at least 80% (12 of 15) vaginal inserts., Week 6|Acceptability measured by acceptability questionnaire, Acceptability will be evaluated based on a close-ended structured acceptability questionnaire. The responses will be on a Likert score, between 1-5, and higher scores represent better accepted., Week 6
Other Outcome Measures: Uptake, Number of screen-eligible participants who agree to enroll in the study., Baseline|Accrual rate, Number of participants that enrolled in the trial divided by time from the first enrollment to the last enrollment in months., 24 weeks|Retention rate, Retention rate: Number of women in each study arm retained in the study., 24 weeks