pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens
NCT Number: NCT06527586
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia
Interventions: DEVICE: soft contact lens
Sponsor: Yung Sheng Optical Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 131
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-13
Completion Date: 2024-07-31
Locations: National Taiwan University Hospital, Taipei, Taiwan|Tri-Service General Hospital, Taipei, Taiwan|Linkou-Chang Gung Memorial Hospital, Taoyuan, Taiwan

Summary:
This was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Color Contact Lens for vision correction.

Primary Outcome Measures: The effectiveness of corrected visual acuity, The primary effectiveness endpoint of the study was the comparison of the mean change in logMAR visual acuity (VA) of the subject's worse eye, from baseline (Day 1) to the final visit (3-month), between the groups wearing test lenses and control lenses., 3 Months
Secondary Outcome Measures: Effectiveness of corrected visual acuity, The secondary effectiveness endpoint involves comparing the mean difference in LogMAR visual acuity (VA) for each eye-both eyes of each subject-between the test lens and the control lens at one week., 1 Week
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women With Pyelonephritis
NCT Number: NCT06527560
Acronym: CEFURO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pyelonephritis in Pregnancy
Interventions: DRUG: Cefuroxime|DRUG: Cefuroxime Axetil
Sponsor: Hospital de Clinicas de Porto Alegre
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12-31
Locations: HCPA, Porto Alegre, RS, 90035-903, Brazil

Summary:
The goal of this clinical trial is to compare rates of cure in pregnant women with pyelonephritis. The main question aims to answer:

Can we treat pyelonephritis in pregnancy with oral cefuroxime alone?

Pregnant women with pyelonephritis treated with intravenous cefuroxime will be the comparator.

Participants will be asked to accept participation in the study and will be randomly allocated to one of the two arms:

* Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours
* Oral cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours

Primary Outcome Measures: Clinical improvement, No fever, improvement of lower back pain, 3 days|Negative urine culture, No growth of pathogenic bacteria in the urine culture, 21 days
Prevalence of Amyloidosis in Trauma Patients
NCT Number: NCT06527521
Acronym: APTUR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Amyloidosis
Interventions: PROCEDURE: Traumatologic surgery
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 246
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-10
Locations: Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil, Sant Pere De Ribes, Barcelona, 08810, Spain

Summary:
This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.

Primary Outcome Measures: Amyloidosis, Proportion of patients undergoing scheduled orthopedic surgery who are diagnosed with amyloidosis., One month
Construct Validity and Intra-Observer Reliability of the SDQ
NCT Number: NCT06527508
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Interventions: OTHER: Non-Interventional
Sponsor: Bingol University
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-06-15
Locations: Bingöl University, Bingöl, 12000, Turkey

Summary:
The aim of the observational study is to investigate the validity and reliability of a self-report version of the Strength and Difficulties Questionnaire (SDQ) for 11-17 years in children with cerebral palsy (CP). That is, the current study explore if the self-report version of the SDQ would be valid and reliable in children with CP to report their mental health problems themself

Primary Outcome Measures: Change from baseline in mental health on the 3-point Strength and Difficulties Questionnaire (SDQ) at 2 week, The Strength and Difficulties Questionnaire (SDQ) was created by Goodman as a brief screening tool for assessing emotional and behavioral problems in children and adolescents. There are two primary versions of the SDQ, self-report and proxy-report, for different age bands: 2-4, 11-17, 4-17 and over 18 years. The SDQ consists of subscales for emotional problems, conduct problems, hyperactivity-inattention problems, peer problems, and prosocial scales. Each subscale comprises five items, with 'somewhat true' being always scored as 1. On the other hand, the scoring for 'not true' and 'certainly true' varied depending on the item (i.e., 0 or 2)., Baseline and Week 2
Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma
NCT Number: NCT06527495
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: HCC|Hepatocellular Carcinoma
Interventions: DRUG: Sorafenib
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2024-12-01
Locations: NLI, Shibīn Al Kawm, Menoufia, 32511, Egypt

Summary:
The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.

Primary Outcome Measures: Vascular Endothelial Growth Factor A (VEGFA) genotyping, Genetic polymorphism of VEGFA, At Baseline, 3 month, and 6 month after treatment.|Kinase insert domain receptor (KDR) genotyping, Genetic polymorphism of KDR, At Baseline, 3 month, and 6 months after treatment.
Secondary Outcome Measures: Tumor markers, Determination of serum Alpha-Fetoprotein, AFP-L3, At Baseline, 3 month, and 6 month after treatment.|Complete blood culture, Determination of hemoglobin concentration, At Baseline 3 month, and 6 months after treatment.|Kidney function tests, Determination of Serum creatinine concentration, At Baseline 3 month, and 6 months after treatment.|Liver function tests., Determine serum level of ALT and AST, At Baseline 3 month, and 6 months after treatment.|Safety outcome, Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting, hand and foot syndrome), At Baseline, 3 month, and 6 months after treatment.
Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
NCT Number: NCT06527456
Acronym: INDIGO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cervical Cancer
Interventions: OTHER: participation of the general practitioner
Sponsor: Centre Hospitalier Intercommunal Creteil
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 11200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-12
Completion Date: 2026-06

Summary:
In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year.

Since 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65.

This program, managed by the Regional Cancer Screening Coordination Centers (CRCDC), invites women who have not taken a sample within the recommended time frame to consult for screening. However, only 59% of patients participated.

The intervention of the general practitioner, an essential player in prevention, could allow for better awareness.

The objective of the INDIGO study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the DOCCU of patients who are not up to date with their screening.

Primary Outcome Measures: screening participation rate, percentage of patients who had a screening Cervical Sample (cytology or HPV test within a timeframe satisfying the HAS recommendations according to age) among patients eligible for screening aged 25 to 65 years, 12 month
Arterial Stiffness in Patients With Sepsis
NCT Number: NCT06527443
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: the Arterial Stiffness
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-12
Locations: Dina Ali Hamad, Assiut, Egypt

Summary:
To investigate whether arterial stiffness, as defined by measuring Pulse Wave Velocity, could be identified as an independent risk factor for development of acute kidney injury in sepsis.

To compare between the Pulse Wave Velocity and shear wave ultrasound elastography (SWE) as a different methods of evaluation of arterial stiffness in prediction of acute kidney injury in sepsis.

Primary Outcome Measures: Arterial stiffness in prediction of AKI in patients with sepsis, 2 years
Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia
NCT Number: NCT06527430
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Discharge Time|Ambulatory Surgery|Spinal Anesthesia
Interventions: PROCEDURE: 4 mg bupivacaine|PROCEDURE: 6 mg bupivacaine
Sponsor: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2024-12-30
Locations: Ankara Etlik City Hospital, Yenimahalle, Ankara, 06170, Turkey

Summary:
Varicose veins are irreversible and abnormal enlargement of the veins. These veins appear and there are curled swellings under the skin in the feet and legs. Complaints increase when standing and sitting for long periods. For varicose veins in the initial stages, medical treatment methods such as compression socks (elastic socks) and elevating the feet as much as possible can be tried. For widespread varicose veins in more advanced stages, invasive procedures such as sclerotherapy and endovascular ablation are performed. These procedures can be performed under local, spinal or general anesthesia.

Spinal anesthesia; It is a type of neuraxial type of regional anesthesia characterized by injecting local anesthetic drugs into the subarachnoid space alone or together with other drugs, resulting in temporary sensory block, motor block, and sympathetic block. The local anesthetic volume administered during spinal anesthesia may affect the anesthesia levels and discharge times of the patients. For varicose vein surgeries, low-dose local anesthetic is sufficient for spinal anesthesia and can also provide early discharge.

This study will compare the peri-operative effects of different doses of spinal anesthesia in patients undergoing varicose vein surgery.

Primary Outcome Measures: Discharge time, The time (minutes) from the application of spinal anesthesia to the patients' discharge will be recorded as the discharge period., On the operation day
Secondary Outcome Measures: Motor block appearing time, Time (minutes) to complete motor block in the lower extremity after spinal anesthesia, On the operation day|Sensorial block appearing time, Time (minutes) to complete sensorial block in the lower extremity after spinal anesthesia, On the operation day|Motor block disappearing time, Time (minutes) to disappearance of complete motor block in the lower extremity after spinal anesthesia, On the operation day|Sensorial block disappearing time, Time (minutes) to disappearance of sensorial block in the lower extremity after spinal anesthesia, On the operation day
Electromyography-Triggered Electrical Stimulation on Trunk Balance and Muscle Thickness in SCI Patients
NCT Number: NCT06527417
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury Thoracic
Interventions: DEVICE: Neuro Trac Myo Plus Pro|OTHER: Trunk eccentric exercises
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-18
Completion Date: 2024-07-25
Locations: Ankara Bilkent City Hospital, Ankara, Turkey

Summary:
The aim of this study was to investigate the effect of electromyography (EMG) triggered electrical stimulation (ES) applied to multifidus and erector spinae muscles on trunk balance in patients with complete thoracic spinal cord injury (SCI).

The fundamental questions that investigators want to answer are as follows:

* \[question 1\]: "Does multifidus and erector spinae EMG ES improve trunk balance in patients with complete SCI?"
* \[question 2\]: "Does multifidus and erector spinae EMG ES improve muscle thickness in patients with complete SCI?"

Primary Outcome Measures: Trunk control test, The trunk control test is a useful tool in determining the prognosis of independence in activities of daily living and measuring trunk balance in individuals with spinal cord injury. It was applied to all participants before and after treatment. The test consisted of 3 parts; static control, dynamic control and dynamic control with upper extremity activities., Baseline- Week 4|Modified functional reach test, The modified functional reach test is a reliable tool to assess sitting reaching in individuals with SCI and to provide immediate feedback to study personnel. It was applied to both groups before and after treatment., Baseline- Week 4
Secondary Outcome Measures: Erector spinae muscle thickness, Erector spinae muscle thickness was measured with a real-time B-mode ultrasound device (General Electric Co., Wisconsin, USA). Measurements were performed bilaterally in the prone position with an 8-12 MegaHertz linear probe placed parallel to the muscle fibres. Gel was used between the probe and the skin during the measurements. The measurement site was defined as 7 cm lateral to the L3 spinous process of the lumbar erector spina muscle., Baseline- Week 4
Other Outcome Measures: Multifidus muscle thickness, Multifidus muscle thickness was measured with a real-time B-mode ultrasound device (GE, General Electric Co., Wisconsin, USA). Measurements were performed bilaterally in the prone position with an 8-12 MegaHertz linear probe placed parallel to the muscle fibres. Gel was used between the probe and the skin during the measurements. The measurement site was defined as 2 cm lateral to the L4 spinous process of the Multifidus muscle., Baseline- Week 4
Artificial Intelligence in Dental Implant Planning
NCT Number: NCT06527378
Acronym: AIDENT
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Edentulous Alveolar Ridge|Edentulous Mouth|Tooth Loss
Interventions: DIAGNOSTIC_TEST: AI in implant planning
Sponsor: University of Bari Aldo Moro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2024-07-25
Locations: Giuseppe D'Albis, Mola di Bari, Bari, 70042, Italy

Summary:
Artificial intelligence (AI) is revolutionizing the dentistry, offering new opportunities to improve the precision and efficiency of implantology. This study aims to evaluate the current evidence on the use of AI in implant planning assessment

Primary Outcome Measures: Valuation on the diagnosis of anatomical structures, The primary focus is on evaluating the AI tools to evalue the quality and dimensions of the bone and ensuring the safe placement of implants by identifying and preserving critical structures such as nerves and the max-illary sinus., 1 month
Safety and Efficacy of VDPHL01 in Males With AGA
NCT Number: NCT06527365
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Androgenetic Alopecia|AGA|Male Pattern Baldness
Interventions: DRUG: VDPHL01
Sponsor: Veradermics, Inc.
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2025-08-01
Locations: 01, San Diego, California, 92123, United States

Summary:
This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).

AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.

This single center, open-label, study will last about 6 months and includes 7 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6). Male subjects that meet the study eligibility criteria will be administered VDPHL01 twice daily for 6 months.

Primary Outcome Measures: Changes in non-vellus Total Area Hair Count (TAHC), Change from baseline in non-vellus TAHC using digital image analysis at Month 6., Month 6|Subjects Evaluation of Treatment Benefit, Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6., Month 6
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents With Advanced NUT Cancer
NCT Number: NCT06527300
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Patients With Advanced NUT Cancer
Interventions: DRUG: NHWD-870 HCl
Sponsor: Zhejiang Wenda Medical Technology Co., Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-25
Completion Date: 2025-12-30
Locations: Three Gorges Hospital Affiliated to Chongqing University, Chongqing, 404100, China

Summary:
This is a multicenter, open-label, single-arm, phase II study to evaluate the efficacy, safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents with advanced NUT cancer.

Primary Outcome Measures: Objective response rate (ORR), Completed at least four weeks of treatment, the curative effect evaluation of CR, PR and maintain at least 4 weeks, the proportion of the subjects,up to 5 months;
Secondary Outcome Measures: Duration of response (DoR), Completed at least four weeks of treatment,first time participants from CR or PR to onset of disease (PD),up to 5 months;|Disease control rate (DCR), Completed at least four weeks of treatment,tumor curative effect evaluation of CR, PR and SD proportion of subjects,up to 5 months;|Progression-free survival (PFS), From start studying drug therapy to the disease progression or any reason for the first time the time of death,up to 12 months;|time to remission (TTR), From the beginning the study drug therapy to ease for the first time (including patients with CR and PR),up to 5 months.
Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
NCT Number: NCT06527274
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nearsightedness
Interventions: DEVICE: Experimental: Myopic defocus soft lens design (MDSL)|DEVICE: Active Comparator: Single vision soft lens design (SVSL
Sponsor: Université de Montréal
Collaborators: Bausch & Lomb Incorporated
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-25
Completion Date: 2025-03-30
Locations: Universite de Montreal, Montreal, Quebec, H3T1P1, Canada

Summary:
The purpose of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable soft contact lens (MDSL) in a group of healthy young myopic adults (18-35 years; myopia -1.00D to -4.00D; all genders). It will also learn about the acceptance of this visual correction modality compared to regular contact lenses.

The main questions to be answered are:

* To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear.
* To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear.
* To evaluate the visual comfort provided by this MDSL design using a questionnaire.

Researchers will compare the MDSL to a daily disposable single vision soft lens (SVSL) used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal.

Participants will be required to

* Wear both MDSL and SVSL for one week each, in a random order.
* Read letters to measure visual acuity
* Have a deep scan of their retina with an optical coherence tomography (OCT) device
* Rate the comfort and vision provided by both devices using a questionnaire.

Primary Outcome Measures: Measurement of Retinal blood vessel density measured by Triton OCT-A, The TRITON angiographic optical coherence tomograph will be used in this research project. OCT-A is a non-invasive angiography that enables changes in retinal vascularization to be observed. This is achieved by analyzing the movement of erythrocytes in blood vessels using a series of B-scans. Retinal vessel density will be measured at the macular area and at the optic nerve head. (2 scans), Measurement done at baseline and after 1 week of contact lens wear
Other Outcome Measures: Evaluation of the choroidal thickness at the macular area, A 3D scan (OCT- Heidelberg) 6.0mm x 6.0mm will be performed for analysis of choroidal thickness in the different ETDRS quadrants. Choroidal thickness data per quadrant (1-5) will be available in the 6mm CSI analysis (BM-CSI), Measurement done at baseline and after 1 week of contact lens wear
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
NCT Number: NCT06527261
Acronym: eCARE4Stroke
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke
Interventions: OTHER: Real-time electronic data input into REDCap
Sponsor: University of Melbourne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 146
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2026-12
Locations: Austin Health, Melbourne, Victoria, 3084, Australia

Summary:
This is a prospective cohort study to determine the feasibility of accurate, complete, and timely real-time electronic capturing of upper limb motor intervention sessions during usual care. In clinical trials accurate reporting of usual care for people with stroke is scarce, thus understanding the control group compared to the experimental group is poor. The unit of measure in this study is therapy sessions, where a clinician is providing usual care to a patient.

The observed sessions will occur in two Austin Health settings: Acute at Austin Hospital; subacute, across Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital. For each session, patient characteristics, dose and content of upper limb interventions will be electronically captured in REDCap. Additionally, the sessions will be video recorded to allow a second rater to assess feasibility. The secondary aim is to determine if there is an association between the dose and content of upper limb intervention sessions and the contextual factors of stroke patients. Two participant groups will be recruited: Stroke patients and Clinicians (Occupational Therapists and Allied Health Assistants).

Primary Outcome Measures: Feasibility of real-time electronic data input of usual care session dose, A single binary composite primary outcome, where feasibility is defined by 90% of sessions achieving ALL of:

1. Binary outcome of Accuracy: ≤10% difference in dose between electronic data and second-rater data from a video recording of the session as defined by the decision algorithm.
2. Binary outcome of Completeness: ≥90% of the electronic data completed by clinicians as defined by the decision algorithm.
3. Binary outcome of Timeliness: ≤10% of session time is spent completing the electronic record or rated non-burdensome by the clinician as defined by the decision algorithm., Each feasibility session will take up to one hour.
Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
NCT Number: NCT06527235
Acronym: MINUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Meniscus Lesion
Interventions: DRUG: ultrasound-guided betamethasone infiltration of the meniscal wall|DRUG: ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wall
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-01-01

Summary:
The value of corticosteroid infiltration of the meniscus wall in the therapeutic strategy is not clearly defined: the data in the literature on the effectiveness of corticosteroid infiltration are heterogeneous and of low level of proof. We hypothesize that corticosteroid infiltration of the meniscal wall under ultrasound control would be effective for rapid relief of degenerative meniscal pain.

The main objective is to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo, at 1 month, on meniscal pain in the treatment of meniscal pain of degenerative origin in adult.

Primary Outcome Measures: meniscal pain at 1-month follow-up visit, meniscal pain measured using the Visual Analog Scale (VAS) rated from 0 to 10 at 1-month follow-up visit compared to baseline VAS score, month 1
Secondary Outcome Measures: meniscal pain at 3-month follow-up visit, meniscal pain measured using the Visual Analog Scale (VAS) rated from 0 to 10 at 3-month follow-up visit compared to baseline VAS score, month 3|algo-functional scale measured by KOOS score (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) at the 1-month follow-up visit, KOOS score (algo-functional scale) at 1-month follow-up visit compared to baseline KOOS score, month 1|algo-functional scale measured by KOOS score (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) at the 3-month follow-up visit, KOOS score (algo-functional scale) at 3-month follow-up visit compared to baseline KOOS score, month 3|adverse events, the occurrence of adverse events (AEs) and serious AEs (SAEs) up to 3 months of follow-up, month 3|Analgesic response at the 1-month follow-up visit, Analgesic response is defined as a at least 50% reduction in pain (measured using the VAS scale) between the initial visit and the 1-month follow-up visit, month 1
Fibromyalgia and Small Fiber Neuropathy
NCT Number: NCT06527183
Acronym: FIBRO-NEP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Pain Syndrome
Interventions: DIAGNOSTIC_TEST: Skin punch biopsy to demonstrate small fiber neuropathy
Sponsor: Hospital Ambroise Paré Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-04
Completion Date: 2026-01
Locations: Inserm U987, Boulogne-Billancourt, 92100, France|Centre d'Evaluation et de Traitement de la douleur, Paris, 75014, France

Summary:
The primary objective of this study will be to assess the proportion of fibromyalgia patients with diffuse small-fiber neuropathy (i.e. in the upper and lower limbs) and compare this proportion to patients with other chronic pains (nociplastic, nociceptive) and with healthy controls. Our analysis will be based on the demonstration of structural abnormalities of small nerve fibers by means of skin biopsy, but also of functional abnormalities using four validated tests commonly used in this field: quantitative sensory testing (QST), laser evoked potential recordings, Sudoscan and confocal corneal microscopy. It will thus be possible to verify whether or not patients with small fiber neuropathy have a particular clinical profile in terms of pain, physical activity, comorbidities or pain impact.

Primary Outcome Measures: Prevalence of small fiber neuropathy or pathology as assessed with skin punch biopsy in patients with fibromyalgia as compared to patients with other chronic pains and healthy subjects, intraepidermal nerve fiber density, Baseline and at 6 months
Secondary Outcome Measures: Correlation between intraepidermal nerve fiber density and pain or other patient reported outcome measures (quality of life, distress, disability...), Correlation statistics (Spearman Rho), Baseline and at 6 months|Investigate the potential specificity of the results obtained by comparing them with pain patients without fibromyalgia or nerve damage (patients with any nociceptive or nociplastic pain without fibromyalgia) matched for age and gender, Direct group comparisons, Baseline and at 6 months|Monitor the evolution of abnormalities obtained over time (6 months) and correlate them with the evolution of pain and associated symptoms., Comparison of intraepidermal nerve fiber density and other diagnostic measures between baseline and 6 months, 6 months|Determine the sensitivity and diagnostic value of corneal confocal microscopy and laser evoked potentials as compared with skin punch biopsy for exploring nociceptive fibers, Sensitivity and specificy of these tests compared to skin punch biopsy, Baseline and at 6 months|Determine the diagnostic value of the sudoscan and quantified sensory tests compared with other tests for exploring nociceptive fibers in these patients, Sensitivity and specificy of sudoscan and quantitative sensory testing compared to skin punch biopsy, Baseline and at 6 months
Improved Erectile Function After Bariatric Surgery: Role of Testosterone and Other Factors
NCT Number: NCT06527170
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Bariatric Surgery|Erectile Dysfunction
Interventions: PROCEDURE: Sleeve gastrectomy
Sponsor: Jagiellonian University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-05-31
Locations: 2nd Department of General Surgery, Jagiellonian University Medical College, Kraków, Małopolska, 30-688, Poland

Summary:
The prevalence of obesity has risen dramatically worldwide. Beyond its metabolic implications, obesity profoundly impacts sexual health, particularly in males, with erectile dysfunction emerging as a prevalent and distressing comorbidity. Studies show that bariatric surgery alleviates erectile dysfunction. Patients suffering from obesity have lower testosterone levels, which increase after weight-loss surgery. This study aims to investigate the relationship between erectile dysfunction improvement, weight loss and hormonal changes after surgery.

Primary Outcome Measures: The International Index of Erectile Function score, 6 questions from IIEF official questionnare. Each question is score 1-5.

Erectile dysfunction (ED) assessed using a validated tool Patient who scored \<25 points were considered for further analysis. Each patient was categorized into severity: 25-30 no ED, 19-24 mild ED, 13-18 mild to moderate ED, 7-12 moderate ED, 0-6 severe ED.

After follow-up, patients with prior ED (\<25 IIEF) were assigned to three groups: 1 - no improvement, 2 - symptom alleviation (change in severity category), 3 - ED remission, immediately before surgery and one year after
Secondary Outcome Measures: Weight loss results, weight loss (WL) in kg, one year after surgery|percentage of excess weight loss (%EWL), Weight loss results, one year after surgery|percentage of total weight loss (%TWL), Weight loss results, one year after surgery|Testoreone (nmol/l), Laboratory test using blood samples, immediately before surgery and one year after|Sex hormone binding (nmol/l), Laboratory test using blood samples, immediately before surgery and one year after|Estradiol (pmol/l), Laboratory test using blood samples, immediately before surgery and one year after|luteinizing hormone (mIU/ml), Laboratory test using blood samples, immediately before surgery and one year after
Investigations of Reproductive Cancers in Women
NCT Number: NCT06527157
Acronym: PROACTION:
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Uterine Cancer
Sponsor: PinkDx, Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 4500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2026-11-15
Locations: Ob-Gyne Associates of Lake Forest, Ltd, Lake Forest, Illinois, 60045, United States

Summary:
The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.

Primary Outcome Measures: Sensitivity, ability to detect cancer, 12 months
Secondary Outcome Measures: Specificity, ability to identify benign cases, 12 months
Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer
NCT Number: NCT06527131
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Charcot Foot Ulcer
Interventions: DEVICE: pulsed electromagnetic field therapy|DEVICE: Transcutanous electrical nerve stimulation|DRUG: Vancomycin
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-11
Locations: Physical Therapy Cairo University, Giza, Egypt

Summary:
thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months .

control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment

Primary Outcome Measures: rate of bone healing, asses rate of bone healing through plain x-ray after six weeks then after twelve weeks from initiation of treatment, Baseline and three months
Secondary Outcome Measures: ulcrer healing, asses wound surface area through wound surface area Tracing pre treatment ,after six weeks and after twelve weeks from initiation of treatment, baseline and three months
Impact of Sleep Quality on Outcomes After Cardiac Surgery
NCT Number: NCT06527105
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep|Atrial Fibrillation|Delirium, Postoperative|Complications, Postoperative
Sponsor: Amrita Institute of Medical Sciences & Research Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-22
Completion Date: 2025-01-31

Summary:
Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.

The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease

Primary Outcome Measures: Quality of sleep, On the morning after the intervention, patient's sleep quality will be assessed using Richard-Campbell sleep questionnaire (RCSQ). Each point in RCSQ will be scored using a visual analog score, ranging from 0-100. Total score will be calculated and then will be divided by 5., 6 months
Secondary Outcome Measures: Atrial fibrillation, Postoperative atrial fibrillation, 6 months|Delirium, Postoperative Delirium, 6 months|Intensive care unit stay, Duration of intensive care unit stay (in hours to days), 6 months|Vasoactive inotropic score, Vasoactive inotropic score is calculated by multiplying the dose of each vasoactive drug used with 10. (minimum score is 0, while maximum score can go upto 20. Higher the score worse is the outcome, 6 months|Mechanical ventilation, Duration of mechanical ventilation (hours), 6 months
The Effect of VR on Pain, Anxiety And Fear During Venipuncture in Children
NCT Number: NCT06527092
Acronym: VR
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute|Anxiety|Fear
Interventions: DEVICE: Virtual Reality|DEVICE: Bubbles
Sponsor: Ege University
Sex: ALL
Age: CHILD
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-01
Completion Date: 2023-06-30
Locations: Ege University, İzmir, Turkey

Summary:
The use of non-pharmacological applications such as virtual reality,and bubbles are recommended in intravenous interventions. There are very few studies evaluating the effect of non-pharmacological applications in intravenous localization. This study was planned as a randomized controlled trial. The effects of virtual reality and bubble application on pain, fear, anxiety, procedure time and crying time in intravenous insertion were evaluated. Children (105) aged 6-12 years who were treated in a children's hospital and underwent intravenous placement were randomized to virtual reality, bubbles, and control groups. Distraction techniques such as asking questions and talking were used with the children in the control group. Study data were collected using the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale, and Visual Analogue Scales (VAS).

Primary Outcome Measures: Procedurel Pain, Visual Analogue Scale (VAS): Recommended for use in children aged 7 years and over. The child is asked to mark the level of pain felt on a 10 cm ruler in the range from '0 - no pain' to '10 - most severe pain'. The scale can be used either horizontally or vertically., Six month|Anxiety, Child Anxiety Scale-Condition (CAS-D):The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. The score can range from 0 to 10. Turkish validity and reliability have been performed., Six month|Fear, Child Fear Scale:The scale is used to measure the fear level of the child. It is a 0-4 scale consisting of five drawn facial expressions ranging from neutral expression (0=no fear) to frightened face (4=severe fear). Turkish validity and reliability have been performed., Six month
Secondary Outcome Measures: duration of crying, Follow-up form: Children's crying time will be monitored through this form., Six month
Evaluation of Clinical Decision Support in Opioid Tapering
NCT Number: NCT06527079
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Medication Abuse|Harm Reduction|Opioid Use Disorder
Interventions: OTHER: Opioid Tapering Pathway Clinical Decision Support (CDS)
Sponsor: University of Colorado, Denver
Collaborators: National Institutes of Health (NIH)|National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-10

Summary:
The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will evaluate a clinical decision support (CDS) tool in the form of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will have the clinical care pathway available, but will not be reminded of the pathway when tapering a patient. The intervention arm will receive a nudge when prescribing a tapering opioid strategy to a patient to use the clinical care pathway. The rate of opioid tapering in line with CDC guidelines will be examined as well as long-term patient outcomes of opioid overdose or poisoning using existing patient health records. The study period will be approximately 18 months.

Primary Outcome Measures: Percentage of encounters tapering within CDC guidelines, The number of encounters where a provider's actions are in line with CDC tapering guidelines divided by the total number of opioid tapering prescriptions, 18 months
Secondary Outcome Measures: Clinical decision support (CDS) acceptance rate, The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway, 18 months|Subsequent opioid overdose/poisoning rates, The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following an opioid tapering prescription, 6 months after taper encounter|Health care utilization, The number of emergency department and clinic visits, 6 months after taper encounter
Digital Obturators in Maxillectomy Cases
NCT Number: NCT06527053
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Device Malfunction
Interventions: DEVICE: obturator
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2021-12-21
Completion Date: 2024-01-07
Locations: Eman Nasr, Tanta, Gharbeya, Egypt

Summary:
Using Digital approach to treat patients with maxillofacial defects without surgical intervention

Primary Outcome Measures: Evaluation of hypernasality in speech, physiologic parameter, one month|Evaluation of masseter muscle muscle, physiologic parameter, three months|Evaluation of Patient Quality of Life, questionnaire, six months|Evaluation of retention, descriptive by KP scale, 1 day (at time of device insertion)|Obturator misfit, descriptive by Digital software, 1 day (at time of device delivery)
Clinical Decision Support for Safety of Opioid Transitions
NCT Number: NCT06527040
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Medication Abuse|Harm Reduction
Interventions: OTHER: Opioid Transitions Clinical Decision Support (CDS)
Sponsor: University of Colorado, Denver
Collaborators: National Institutes of Health (NIH)|National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-10

Summary:
The objective of this study is to evaluate the impact of clinical decision support (CDS) alert to notify providers when the opioid prescription being written will result in the patient transitioning into a new phase of opioid therapy. The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends providers reassess patient pain as well as the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and when patients transition from subacute to chronic opioid treatment (3 months). This study will evaluate a clinical decision support tool identifying patients who will be transitioning between phases as a result of an opioid prescription and suggest a review of patient pain and goals. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will not be notified that the prescription transitions the patient to a new phase but will have access to the same patient pain scales and information. The intervention arm will receive a notification of the transition and suggest review of patient needs and encourage documentation. Opioid transition orders and outcomes of patients will be examined based on medical records data collected during routine care.

Primary Outcome Measures: Percentage of encounters with an opioid transitioning prescription, The number of primary care encounters where an opioid prescription transitions a patient to a different phase of care (by phase) divided by the total number of opioid prescriptions, 18 months
Secondary Outcome Measures: Clinical decision support (CDS) acceptance rate, The number of times providers accepted the Clinical decision support (CDS) tool and documented a review of patient pain and goals, 18 months|Subsequent opioid overdose/poisoning rates, The number of patients who reached the threshold of chronic opioid use, had a diagnosis of opioid overdose/poisoning or a new diagnosis of opioid use disorder, Six months after an encounter where the opioid use disorder is identified|Opioid prescription abandonment, The proportion of opioid prescriptions initiated (triggering the CDS) and an opioid was not signed by the provider, indicating a change in clinical decision to prescribe an opioid, 18 months|Number of patients with long term opioid use, Count of patients receiving \>90 day supply of opioids, Six months after an encounter where the opioid use disorder is identified
Pulsed Radiofrequency to the Suprascapular Nerve
NCT Number: NCT06527014
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Chronic|Shoulder Pain
Interventions: PROCEDURE: Pulse Radiofrequency to the suprascapular nerve
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2024-01-01
Locations: Ankara Bİlkent City Hospital, Ankara, 00650, Turkey

Summary:
Regardless of the etiology, chronic shoulder pain is a distressing condition that affects daily life and is among the first common reasons for musculoskeletal system problems when admitting to clinics. Pulsed radiofrequency (pRF) treatment to the suprascapular nerve (SSN) is a promising interventional procedure, that is thought to be effective in case of chronic shoulder pain. However, conventional physical therapy program is preferred more often and found more applicable. The aim of current study is to compare the effectiveness of two treatment procedures.

Primary Outcome Measures: Numarical Rating Scale, Numerical rating scale (NRS): It is a rating scale for self reported pain. 0 , means there is no pain and 10, represents the most pain experienced in life time., partcipants were evaluated at baseline and 1st month follow-up|QuickDASH, It is self-reported questionnaire related to pain and disfunction. Abilities and symptoms are asked about last week. All questions are rated 0-5. Higher scores are related more disability for upper extremity., partcipants were evaluated at baseline and 1st month follow-up