pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
NCT Number: NCT06574347
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Interventions: DRUG: Vebreltinib|DRUG: Osimertinib|DRUG: PLB1004
Sponsor: Avistone Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2027-07-31
Locations: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China

Summary:
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Primary Outcome Measures: The objective response rate of the tumor (ORR), The incidence of confirmed complete response or partial response., 2 Years
Secondary Outcome Measures: The disease control rate (DCR), The incidence of complete response, partial response and stable disease., 2 Years|Duration of Response (DoR), The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded., 2 Years|Progression-free survival (PFS), Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)., 2 Years|Time to Response (TTR), The period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail)., 2 Years|Incidence of Treatment-Emergent Adverse Events, Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug., 2 Years
Proprioceptive Exercises on Joint Pain and QoL Among Geriatric Patients With Knee Osteoarthritis
NCT Number: NCT06574334
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: PROCEDURE: Proprioceptive exercise
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2023-10-01
Completion Date: 2024-05-31
Locations: Faculty of Nursing, Assiut, Egypt

Summary:
Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Proprioceptive exercise and isometric exercise have been recommended as suitable for reducing joint pain and improvement of quality of life in the geriatric patients.

Primary Outcome Measures: Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis, By using Visual Analog Scales (VAS):, 3 months|Evaluate the effect of proprioceptive exercises on quality of life among geriatric patients with knee osteoarthritis, By using 36 - Item Short-Form Health Survey (SF-36)., 3months
Clinical Evaluation of the Scopio Cell Morphology Technology
NCT Number: NCT06574308
Acronym: Hemascopio
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Cancer
Interventions: DIAGNOSTIC_TEST: Blood cells classification
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, 00168, Italy

Summary:
Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. The aim of the current research will be the comparison between optical microscope reading and automatic pre-classification (AI based)

Primary Outcome Measures: Optical microscope reading and automatic pre-classification, Comparison between optical microscope reading and automatic pre-classification (AI based), 12 months
HTA of NIVATS Based on RWE
NCT Number: NCT06574295
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2025-03-02
Locations: School of Public Health, Fudan University, Shanghai, Shanghai, 200032, China

Summary:
This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time.

The study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE).

By evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.

Primary Outcome Measures: Patient-reported Outcomes, The primary outcome will be assessed using two validated instruments: the Anderson Symptom Inventory (lung cancer-specific module) and the EQ-5D. The Anderson Symptom Inventory will measure symptom severity (e.g., pain, fatigue, nausea, sleep disturbance) and the impact of symptoms on daily functioning, while the EQ-5D will evaluate overall health-related quality of life, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores will provide insight into patients' recovery and well-being following non-intubated video-assisted thoracic surgery (VATS) compared to traditional intubated thoracic surgery., Measured within 3 days post-surgery|Postoperative hospitalization time, The secondary outcome will measure the duration of the postoperative hospital stay. This will be assessed as the number of days from the completion of surgery to the patient's discharge. The goal is to compare the efficiency of recovery between patients undergoing non-intubated video-assisted thoracic surgery (VATS) and those receiving traditional intubated thoracic surgery., Measured in days from surgery completion to hospital discharge.
Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study
NCT Number: NCT06574282
Acronym: COHIRnational
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypophosphatasia
Interventions: DIAGNOSTIC_TEST: Second alkaline phosphatase measurement
Sponsor: University of Bonn
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 720
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-25
Completion Date: 2027-09
Locations: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn, Bonn, North Rhine-Westphali, 53127, Germany

Summary:
Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis

Primary Outcome Measures: Prevalence of hypophosphatasia in adult patients in rheumatology, The primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients presenting with musculoskeletal symptoms in rheumatology., 36 months
Phase 2 Pharmacokinetics Study of TLC590 for Postsurgical Pain Management in Multiple Surgical Models
NCT Number: NCT06574269
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postsurgical Pain Management
Interventions: DRUG: TLC590|DRUG: TLC590|DRUG: TLC590|DRUG: TLC590|DRUG: TLC590|DRUG: Ropivacaine|DRUG: TLC590
Sponsor: Taiwan Liposome Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: First Surgical Hospital, Bellaire, Texas, 77401, United States|Memorial Hermann Village, Houston, Texas, 77043, United States

Summary:
This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures. Researchers aim to determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee (SMC) in a highly vascular surgical model.

The study evaluates TLC590 in bunionectomy, laparoscopy-assisted open ventral hernia repair, breast augmentation, abdominoplasty, and total knee arthroplasty models. Additionally, it determines the relative bioavailability of TLC590 to ropivacaine injection.

Primary Outcome Measures: To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2), 0-168 hours|To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2), 30 days
Investigation of the Effects of Online Education Application on Gynecological Cancer Patients Receiving Chemotherapy
NCT Number: NCT06574256
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gynecological Cancer
Interventions: OTHER: Chemotherapy symptom Management Online Education
Sponsor: Celal Bayar University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-12-01
Completion Date: 2024-06-01
Locations: CelalBayarU, Manisa, 45010, Turkey

Summary:
The aim of the study was to examine the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. It was conducted as a randomized controlled experimental study. The study examined the effect of online nursing education given to patients in the intervention group diagnosed with gynecological cancer and receiving chemotherapy on symptoms, quality of life and patient satisfaction. The control group received routine nursing care.

Primary Outcome Measures: EORT QLQ-C30, EORT QLQ-C30: It consists of three main dimensions and 30 questions, namely general well-being, functional difficulties and symptom control., three monhts|Nightingale symptom assessment scale, Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions, namely physical, social and psychological well-being., three monhts
Secondary Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,, EORT QLQ-C30: It consists of three main dimensions and 30 questions: general well-being, functional difficulties and symptom control. İThe first 28 questions are Likert-type. The other two questions are evaluated as 1: very bad and 7: excellent. Each subscale of the scale is scored between 0-100. High scores from the sub-dimension and general quality of life indicate that the quality of life is high, and high scores from the symptom scale indicate that the symptoms experienced are at a high level., three monhts|Nightingale Symptom Assessment Scale, Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions: physical, social and psychological well-being. This is a Likert-type scale. The total sub-dimension score is calculated by adding the item scores in each sub-dimension and dividing by the number of items. 0-4 points are taken in each subscale of the scale. A high score indicates that the level of being affected by problems caused by the disease/treatment is high., three months|patient satisfaction, score average is taken., one months
Positive Education Through Social Media to Reduce Negative Stereotypes Towards Old Age
NCT Number: NCT06574243
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Ageism
Interventions: BEHAVIORAL: Social media education
Sponsor: Universidad de Zaragoza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 109
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-22
Completion Date: 2023-05-15
Locations: Universidad de Zaragoza, Zaragoza, Zarazgoza, 50009, Spain

Summary:
Introduction and Objectives: To assess the effectiveness of positive psychoeducation regarding aging, disseminated through social media channels, in mitigating negative stereotypes. Additionally, we aim to explore any potential associations between various sociodemographic variables and the prevalence of negative stereotypes towards the elderly.

Methods: This quasi-experimental study involved an experimental group comprising subjects who underwent a 7-day intervention. The study aimed to evaluate any alterations in negative stereotypes towards aging both before and after the intervention. The intervention consisted of daily publication of positive messages about aging on a social media account. Two questionnaires were used: one collecting sociodemographic variables and the Questionnaire for Evaluating Negative Stereotypes towards Aging. Snowball sampling through social media was employed, with 109 subjects completing the study.

Primary Outcome Measures: Reduce negative stereotypes towards older people by viewing positive messages on social networks and subsequent analysis using the CENVE questionnaire, We use for this study two Google Forms questionnaires designed for pre- and post-assessment. There are two sections: sociodemographic data Negative Stereotypes towards Old Age Questionnaire (CENVE). The post-intervention evaluation included a new questionon the frequency with which the participant had followed the intervention. The intervention consisted of daily positive messages about aging posted on an Instagram account. The primary objective of this study was to analyze whether positive education about aging disseminated through social media could reduce negative stereotypes towards older adults. We collected data on the participants' engagement with the intervention and measure if the participants had lower scores on CENVE than before the intervention., 7 days
Clinical Observations of Pain and Pruritus Induced by Exposure to Allergic Contact Dermatitis Caused by Macrolides
NCT Number: NCT06574204
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dermatitis, Allergic Contact
Interventions: DRUG: Erythromycin|DRUG: Azithromycin|OTHER: physiological saline
Sponsor: Affiliated Hospital of Nantong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-12-31

Summary:
Clinical side effects of macrolides in addition to the common gastrointestinal reactions, recently it has been found that the incidence of local reactions after injection is relatively high, such as pain and itching and local inflammation. Severe skin reactions include erythema multiforme, acute systemic eruption impetigo, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions with eosinophilia and systemic symptoms. The clinical study is a single-center, randomized, open, single-dose trial design. The clinical study plans to enroll 30 subjects to evaluate the incidence and severity of pain and pruritus after a single skin test in healthy subjects. A total of 30 subjects were randomly divided into 2 groups with 15 cases in each group. Erythromycin or azithromycin skin test will be performed on the left hand, and the same amount of normal saline will be injected into the right hand as the control. This clinical observation experiment helps improve the side effects and promotes upgrading macrolide antibiotics during clinical application.

Primary Outcome Measures: Determine the occurrence of type 1 hypersensitivity reaction, The results are observed within 20 \~ 30 minutes after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus., 20-30 minutes after injection|Determine the occurrence of type 4 hypersensitivity reaction, The results are observed within 48-72 hours after antigen stimulation. The injection site of the drug is compared with normal saline. The subjects observed whether the injection site of the skin had redness, wind mass and redness, and the time of wind mass bulge and disappearance. Participants are surveyed by questionnaire for the presence and extent of pain and pruritus., 48-72 hours after injection
Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet
NCT Number: NCT06574178
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psoriasis
Interventions: BEHAVIORAL: Dietary Counseling
Sponsor: University of California, Davis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-30
Completion Date: 2025-05-01
Locations: University of California, Davis - Dermatology Department, Sacramento, California, 95816, United States

Summary:
Psoriasis is a chronic inflammatory disease that affects the skin and joints in 2-3 % of people in the United States. This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations. With the new EXPLORER PET scanner technology, the investigators are testing to see if the EXPLORER is better than previous PET scanners and improve our ability to assess inflammation in patients.

Also, it is known that the typical Western Diet - high in saturated fats, added sugars, and low in fiber - contributes to obesity and inflammation worldwide. There is evidence in animals that these signs of inflammation are reversible within 4 weeks when changed to a more balanced diet. Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually eat a Western Diet on an EXPLORER PET scan following 6 weeks of a more balanced diet.

Primary Outcome Measures: Inflammation in PET/CT scan, measuring inflammation in PET imaging by calculating the maximum standardized uptake values (SUVmax) in given areas of interest (e.g., joint, blood vessel), in Week 0 and Week 6
Secondary Outcome Measures: Microbiomes Diversity, Measuring changes in stool and skin microbiome both through alpha diversity analysis measured in operational taxonomic units, and through beta diversity analysis using unweighted UniFrac Distance Principal Coordinates Analysis Plots (Shi et al.,2021), in Week 0 and Week 6|Serum Inflammatory Markers, measuring TNF, IL-17A, and CRP levels through ELISA methods in blood samples, in Week 0 and Week 6|Cell Surface Inflammatory Markers, measuring cell surface integrin, L-selectin, CD11b, and CD66b levels by standard flow cytometric methods in blood samples., in Week 0 and Week 6
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
NCT Number: NCT06574152
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Apical Periodontitis|Endodontically Treated Teeth|Endodontic Disease|Apical Cyst|Apical Granuloma|Periradicular Disease|Previous Endodontic Treatment
Interventions: DEVICE: PBM treatment|DEVICE: PBM sham treatment|DEVICE: EMS
Sponsor: The University of Texas Health Science Center, Houston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2025-07-31
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to evaluate the effect of Photobiomodulation (PBM) in postoperative pain after endodontic microsurgery (EMS) in patients from the University of Texas Health Science Center at Houston, School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical releasing incision (VRI) after PBM

Primary Outcome Measures: Change in pain as assessed by a Visual Analogue Scale (VAS), this is scored on a likert scale from 0(no pain), 1-3(mild pain), 4-6( moderate pain to 10(worst pain), preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment).
Secondary Outcome Measures: Change in healing as assessed by the Early Wound Healing Score (EHS)., The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI).

Zero (visible distance between incision margins), 3 (incision margins in contact), or 6(merged incision margins) points were used to evaluate CSR, whereas 0 (bleeding at the incision margins), 1 (presence of fibrin at the incision margins), or 2(absence of fibrin on the incision margins) points were used for CSH and 0 points (redness involving \>50% of the incision length and/or pronounced swelling) 1 point (redness involving \<50% of the incision length) 2 points (absence of redness along the incision length) were used to analyze CSI

The summation of the points of these 3 parameters generated the EHS. The EHS for ideal wound healing was 10 points, while the worst possible score was 0 points, preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment
Evaluation of Unstained
NCT Number: NCT06574139
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Teen Pregnancy Prevention
Interventions: BEHAVIORAL: Unstained|BEHAVIORAL: Like
Sponsor: The Policy & Research Group
Collaborators: Department of Health and Human Services Office of Population Affairs|Mathematica Policy Research, Inc.|Reproductive Health National Training Center|PCI Media
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-09-14
Locations: The Policy & Research Group, New Orleans, Louisiana, 70118, United States

Summary:
The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 19 years old who are at risk for or involved in the juvenile justice system. The primary research questions it aims to answer are:

* Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months?
* Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months?

Researchers will compare participants randomized to receive Unstained (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).

Participants randomized to the treatment group will be offered Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Primary Outcome Measures: Receipt of sexually transmitted infection (STI) testing in the past four months, Participants are asked the following item:

1) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months., Assessed three months after the intervention period has ended (five months post-baseline)|Times having vaginal and anal sex without condoms in the past four months, Participants are asked the following two items:

1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom?
2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months., Assessed nine months after the intervention period has ended (11 months post-baseline)
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
NCT Number: NCT06574113
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Blood Pressure
Interventions: DEVICE: Perin Health Patch
Sponsor: Perin Health Devices
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-31
Locations: Perin Health Devices, Woodland Hills, California, 91364, United States

Summary:
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).

Primary Outcome Measures: Cuffless blood pressure measurement performance, Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2., 3 months
Secondary Outcome Measures: Demographic performance variance, Determine any variations in performance on certain demographic groups, including subjects who are overweight, subjects with dark skin pigmentation, or subjects with comorbidities., 3 months
Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.
NCT Number: NCT06574087
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HPV-Related Carcinoma|HPV Infection
Interventions: DIAGNOSTIC_TEST: hrHPV test and cytology
Sponsor: PCK Marine Hospital in Gdynia
Collaborators: Medical University of Gdansk
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-01-13
Completion Date: 2027-01
Locations: PCK Marine Hospital in Gdynia, Gdynia, Pomorskie, 81-519, Poland

Summary:
The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers/cancers. Moreover, the most appropriate screening test for HSIL(AIN) in this group of patients will be determined. It will be effectuated by performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (HRA) with potential biopsy/excision of suspected lesions and histopathological examination.

Primary Outcome Measures: HPV in the anal cancer, The presence of HPV in the anal cancer, Just before surgery
Improving Help-seeking for Depression Care in Nepal
NCT Number: NCT06574074
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Help-Seeking Behavior|Depression
Interventions: BEHAVIORAL: Gain-Life (Give informAtIoN to transform Life)
Sponsor: Transcultural Psychosocial Organization Nepal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 286
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-15
Completion Date: 2024-11-30
Locations: Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu, Bagmati, 44600, Nepal

Summary:
Depression is a serious public health concern worldwide due to its high prevalence rate and significant emotional and financial burden on individuals, their families, and society. There is a substantial gap between the number of people in need of treatment for depression and those who actually receive it. The recent World Health Organization (WHO) World Mental Health Survey revealed that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries did not receive any treatment in the past 12 months. This study aims to evaluate a community-based intervention to address demand-side barriers by improving mental health literacy, dispelling myths and misconceptions about depression, changing negative attitudes towards depression care, and promoting help-seeking behavior.

Primary Outcome Measures: Change in help-seeking behaviour for depression care, The primary outcome of this study is "change in help-seeking behavior for depression care, defined by the proportion of participants who receive treatment from a health provider"., In one month
Secondary Outcome Measures: Treatment adherence for depression, The secondary outcome of the study is "treatment adherence for depression defined by the proportion of people who continue treatment for three months"., In three month|Change in knowledge, attitude and perception, The secondary outcome of this study is to measure changes in knowledge, attitudes, and perceptions related to depression using a questionnaire developed based on the intervention content. The results will be presented based on the number of correct responses (yes and no) for each item of each scale separately.The secondary outcome of this study is to measure changes in knowledge, attitudes, and perceptions related to depression using a questionnaire developed based on the intervention content. The results will be presented based on the number of correct responses (yes and no) for each item of each scale separately. Number of greater "Yes" response indicates greater knowledge in depression, and positive attitude in help-seeking., In three months|Change in symptom severity of depression, The secondary outcome of the study is change in symptom severity of depression assessed by patient health questionnaire (PHQ-9). The total score of PHQ9 can range from 0 to 27, with higher scores indicating greater severity of depression, In three month
Evaluation of the Benefits of Sublingual AIT (PRACTIS)
NCT Number: NCT06574061
Acronym: PRACTIS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Allergic Rhinitis
Sponsor: Stallergenes Greer
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1635
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-08-29
Completion Date: 2021-10-14
Locations: Stallergenes Greer, Antony, 92160, France

Summary:
The objective of the study was to evaluate in routine practice the benefits of sublingual allergen immunotherapy (SLIT) for allergic patients with allergic rhinitis (AR), with or without asthma, according to various methods of use (treatment regimen: formulation type, dose, duration, initiation) and type of allergen (grass pollen, tree pollen, herbaceous pollen, house dust mites, animal dander, moulds and poly-reactive types).

Primary Outcome Measures: PBQ (Patient Benefit Questionnaire), The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients., V1 / V2 (6, 9 or 12 months after treatment initiation)
Secondary Outcome Measures: PNQ (Patient Need Questionnaire), The Patient Need Questionnaire (PNQ) was used to evaluate the expectations of patients regarding the prescription or new treatment(s) prescribed by the observing physicians., V1 (at study inclusion)|PBI Patient Benefit Index, The overall PBI score was calculated using the PNQ questionnaire at V1 (treatment expectations) and the PBQ questionnaire at V2 (treatment benefits).

PBI is an index of the benefits perceived by patients with the AIT received. It considers patient expectations prior to AIT treatment and the perceived benefits after treatment.

A PBI ≥1 is considered as indicating a relevant benefit of the AIT treatment for the patient, Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation)
Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
NCT Number: NCT06574048
Acronym: COHOST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Carbon Monoxide Poisoning|Carbon Monoxide Intoxication|Carbon Monoxide Encephalopathy|Carbon Monoxide-induced Parkinsonism
Interventions: DRUG: saline placebo|DRUG: Dexamethasone
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2028-01
Locations: Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower, Omaha, Nebraska, 68105, United States

Summary:
Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

Primary Outcome Measures: Montreal Cognitive Assessment (MoCA), The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. The MoCA will be given in person while inpatient and via phone after discharge. Scored 0-30 Normal Cognitive performance 26 and above Mild impairment 18-25 Moderate impairment 10-17 Severe impairment 0-9, Prior to hospital discharge after HBO therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.
Secondary Outcome Measures: Memory, Emotion, and Neurologic Symptoms, Post-treatment phone followup, 6 weeks and 12 weeks post-treatment
Better Options for Chronic Cancer Pain
NCT Number: NCT06574009
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain|Cancer Survivor|Opioid Dependence
Interventions: BEHAVIORAL: Multimodal pain care|DRUG: Medication optimization|DEVICE: Buprenorphine rotation|OTHER: Opioid tapering
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 294
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-04-01
Completion Date: 2029-12-31
Locations: Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, 46202-2884, United States|VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, 48105-2303, United States

Summary:
This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.

Primary Outcome Measures: Opioid dose reduction + Pain response (binary: yes/no), Our primary outcome is a composite variable which combines one objective outcome (opioid dose reduction) and one subjective outcome (pain interference) to reflect two outcomes of equal importance to Veterans. Veterans will be considered as achieving this outcome if they experience 20% reduction in opioid daily dose (in MEDD) from baseline and no worsening of pain interference by more than 1 point on the Pain Enjoyment of Life and General Activity (PEG) score., 9 months
Secondary Outcome Measures: Opioid dose, total daily opioid dose will be measured in MEDD and based upon prescription tracking records and adjusted based upon self-report in the patient's diary., 9 months|Pain interference, Pain interference will be measured using PROMIS Pain Interference 6b measure, 9 months|Pain intensity, Pain intensity will be measured using a 0-10 Numeric Rating Scale, 9 months
Comparison of the Effects of Dexmedetomidine and Lidocaine on Blood Pressure and Heart Rate Response
NCT Number: NCT06573957
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: General Anesthesia
Interventions: DRUG: Dexmedetomidine|DRUG: Lidocain
Sponsor: Universitas Padjadjaran
Sex: ALL
Age: ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-29
Completion Date: 2024-08-14
Locations: RSUP Dr. Hasan Sadikin, Bandung, West Java, 40161, Indonesia

Summary:
Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. These spikes in blood pressure and heart rate can be tolerated by healthy individuals, but for patients with cerebrovascular and cardiovascular risk factors, they can be extremely dangerous and even life-threatening. Various techniques and drug choices can be employed to prevent the hemodynamic surges associated with endotracheal intubation, including the use of anesthetic drugs from the α2-adrenergic agonist and amide classes. One of the α2-adrenergic agonists commonly used to prevent hemodynamic surges during endotracheal intubation is dexmedetomidine, while one of the amide drugs frequently used for this purpose is lidocaine.

Primary Outcome Measures: Systolic blood pressure, Right after endotracheal intubation until 5 minutes after endotracheal intubation|Diastolic blood pressure, Right after endotracheal intubation until 5 minutes after endotracheal intubation|Heart rate, Right after endotracheal intubation until 5 minutes after endotracheal intubation
IUS Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
NCT Number: NCT06573944
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn's Disease|Upadacitinib|Intestinal Ultrasound|Predictors
Sponsor: The Third Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-16
Completion Date: 2025-09-30
Locations: The Third Xiangya Hospital of Central South University, Hunan, Hunan, 410000, China

Summary:
Crohn's disease (CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood, and can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. Currently, the main therapeutic drugs for CD include aminosalicylic acid preparations, glucocorticoids, immunosuppressants, and biological agents. With the development of medical technology, small molecule preparations have begun to be applied to moderate-to-severe Crohn's disease.

Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor. A large real-world study showed that in refractory moderate-to-severe CD, upadacitinib showed a clinical response rate of 76.5% and a clinical remission rate of 70.6% at 8 weeks of treatment.

Intestinal ultrasound (IUS) is a noninvasive, reproducible, convenient, and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making process.The 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD. There are no validated indicators to predict the efficacy of upatinib treatment in patients with moderate-to-severe CD in the currently available studies.

Currently, there are no national or international studies in which intestinal ultrasound predicts the efficacy of upatinib therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.

Primary Outcome Measures: Bowel wall thickness (BWT), BWT is measured by intestinal ultrasound. BWT≤3mm means that CD is in quiescent, #3mm means CD is active, follow-up time of about 54 weeks
Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty
NCT Number: NCT06573931
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbar Erector Spinae Plane Block|Fascia Iliaca Block|Lumbar Plexus Block|Analgesia|Total Hip Arthroplasty
Interventions: OTHER: Lumbar Erector Spinae Plane Block|OTHER: Fascia Iliaca Block|OTHER: Lumbar Plexus Block
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2025-03-01
Locations: Tanta University, Tanta, El-Gharbia, 31527, Egypt

Summary:
This study aims to compare lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery.

Primary Outcome Measures: Time to the 1st rescue analgesia, Time to the first request for the rescue analgesia (time from end of block to first dose of morphine administrated) will be recorded., 24 hours postoperatively
Secondary Outcome Measures: Total morphine consumption in the 1st 24h, Rescue analgesia will be provided by patient-controlled analgesia (PCA) with intravenous morphine (no basal rate; bolus 1 mg, lockout 10 minutes, maximum dose 20 mg in 4 h), which will be started if the numeric rating scale (NRS)\> 3. NRS will be assessed at PACU, 4, 8, 16, and 24 h postoperatively., 24 hours postoperatively|Degree of pain, Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at PACU, 4, 8, 16, and 24 h postoperatively., 24 hours postoperatively|Incidence of adverse events, Incidence of adverse events such as Bradycardia, hypotension, postoperative nausea and vomiting (PONV), or any other complication will be recorded., 24 hours postoperatively
EMG-Assessed Paratonia: A New Approach to Response Inhibition
NCT Number: NCT06573918
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIAGNOSTIC_TEST: EMG-based assessment of paratonia
Sponsor: Universita degli Studi di Genova
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-18
Completion Date: 2024-07-23
Locations: Università degli Studi di Genova, Genova, 16122, Italy

Summary:
Paratonia is the inability to relax muscles during the assessment of muscle tone in the absence of spasticity and parkinsonian rigidity. It can be evaluated qualitatively using clinical scales and objectively through surface electromyography (EMG-assessed paratonia). It is widely accepted that paratonia represents a manifestation of impaired motor response inhibition due to frontal lobe dysfunction.

Traditionally, motor response inhibition has been assessed using experimental protocols such as go/no-go and stop-signal tasks. Research has shown that athletes, particularly those engaged in open-skill sports, demonstrate superior motor response inhibition compared to sedentary individuals. Even amateur athletes exhibit better motor response inhibition than sedentary individuals, though to a lesser extent than professional athletes.

Given that the etiology of paratonia involves a defect in motor response inhibition, it is hypothesized that EMG-assessed paratonia could become a novel approach for evaluating motor response inhibition. The present study was designed to validate this hypothesis. Specifically, we first tested whether EMG-assessed paratonia in healthy subjects can reveal a well-known aspect of motor response inhibition, namely its correlation with the level of physical activity.

Primary Outcome Measures: Neuromuscular excitation of the Biceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension, Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle, Throughout the duration of the evaluation, which lasts about 120 seconds|Neuromuscular excitation of the Triceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension, Amplitude of electromyography value (Root Mean Square in microvolt) measured for Triceps Brachii muscle, Throughout the duration of the evaluation, which lasts about 120 seconds