pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Counseling Intervention on Severe Nomophobia Among Health Care Providers
NCT Number: NCT06550557
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Specific Phobia, Other
Interventions: BEHAVIORAL: counselling sessions
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-01-28
Completion Date: 2024-08-01
Locations: Faculty of Medicine- Cairo University, Cairo, 11562, Egypt

Summary:
Assess the effect of a counseling intervention adopted from heath belief model merged with multiple smart phone-based action cues on the level of nomophobia among participants with severe nomophobia Assess the effect of a counseling intervention adopted from heath belief model merged with multiple smart phone-based action cues on the level of nomophobia among participants with severe nomophobia

Primary Outcome Measures: Study the effect of the counseling program on severe nomophobia score among participants in the intervention group., apply the counseling program and reassess the nomophobia level post-intervention by using the nomophobia questionnaire developed by Yildirim \& Correia (2015). With a total of twenty statements on the questionnaire, responses were recorded on a 7-point Likert scale, with 7 representing strongly agree and 1 representing strongly disagree. The lack of nomophobia corresponded to a score of 20. Mild nomophobia was indicated by questionnaire scores ranging from 21 ≤ to \< 60. On the other hand, scores between 60 and less than 100 suggested a moderate level of nomophobia, while scores between 100 and 140 indicated a severe level of nomophobia, 18 months|Compare the level of nomophobia between intervention and control group post intervention., apply the counseling program and comparing the nomophobia score with the control group post intervention at same time frame, by using the nomophobia questionnaire developed by (Yildirim \& Correia, 2015) where severe nomophobes are those with a score above 100, comparing the post counseling sessions score between the intervention or the control group whether there was a significant decline in the nomophobia score., 24 months
Secondary Outcome Measures: correlation between nomophobia scores, self-esteem scores and mental health scores, pre and post intervention nomophobia scores using the nomophobia questionnaire were correlated to the self-esteem scores using state self esteem questionnaire with r value expressed to show whether the correlation is positive or negative and it's strength.

as well the nomophobia scores using nomophobia questionnaire were correlated to the mental health scores using the mental health inventory questionnaire, where positive r indicates positive correlation and negative r indicates an inverse correlation, the strength of the correlation is determined by the value of r., 18 months
Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD
NCT Number: NCT06550544
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Contraceptive Device; Complications
Interventions: PROCEDURE: Office hysteroscopy|PROCEDURE: Ultrasound guided
Sponsor: Cairo University
Collaborators: Bedaya Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2025-02-21
Locations: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university, Cairo, Egypt

Summary:
The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.

Primary Outcome Measures: Intensity of pain, Measured after the procedure using a 10 cm Visual analogue scale ( where 0 indicates no pain') and 10 indicates a 'pain as bad as it could possibly be'), Immediately after the procedure
Secondary Outcome Measures: Success of IUD extraction, Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs), Immediately after the procedure
Impact of Human Papillomavirus Carriage on IVF/ICSI Results (HPV AMP)
NCT Number: NCT06550531
Acronym: HPV-AMP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Human Papilloma Virus|Infertility, Female
Sponsor: University Hospital, Brest
Sex: FEMALE
Age: ADULT
Enrollment: 618
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-02-04
Completion Date: 2026-02-04
Locations: CHRU de Brest, Brest, 29609, France

Summary:
The prevalence of the papilloma virus in the general population is 12%. This virus is known to impair male fertility but its impact on female infertility remains uncertain. This is a public health problem since there is a vaccination protocol. Demonstrating the impact of the human papillomavirus on fertility would be an argument in favor of vaccination.

Primary Outcome Measures: clinical pregnancy rate after fresh eSET by HPV status, A clinical pregancy is the visualisation of a gestational sac inside the uterus after 6 weeks of gestation, 1 year
Secondary Outcome Measures: IVF issues, oocytes number, embryos number, fecondation rate, implantation rate, 1 year|Positive HPV rate, number of women who have a positive HPV test before IVF procedure, 1 year
Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.
NCT Number: NCT06550518
Acronym: EPITAX
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Advanced Small Cell Lung Carcinoma
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-05-04
Completion Date: 2021-12-12
Locations: CHRU de Brest, Brest, 29609, France|Hôpital de Landerneau, Landerneau, 29800, France|CHIC, Quimper, 29000, France

Summary:
Initial chemosensitivity is known concerning SCLC but relapse is almost systematic, especially at a metastatic stage. Brain metastasis are identified around 40 to 50% during the evolution of the disease. Concerning the efficacy of epirubicin combined with paclitaxel from the second-line treatment, data is lacking more particularly about specific response on brain metastasis.

In this retrospective multicentric observational study in real life conditions, we try to evaluate systemic and specific cerebral efficacy and safety of a regimen combining epirubicin and paclitaxel in patients treated between 2010 and 2020 for a small cell lung carcinoma from the second-line treatment.

Primary Outcome Measures: Progression-free survival, Time from epirubicin-paclitaxel regimen initiation to disease progression (according to Response Evaluation Criteria In Solid Tumors v1.1) or death from any cause, through study completion, an average of 1 year
Secondary Outcome Measures: Overall survival, Time from epirubicin-paclitaxel regimen initiation to death from any cause, 1 year|Objective response rate, Complete response or partial response (according to Response Evaluation Criteria In Solid Tumors v1.1), 1 year|Disease control rate, Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1), 1 year|Intracranial control rate, Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1), 1 year|Toxicities, According to Common Toxicity Criteria for Adverse Events version 5.0., 1 year
Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.
NCT Number: NCT06550505
Acronym: ELASTICC
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cardiac Surgery
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-03-20
Completion Date: 2022-03-23
Locations: CHRU BREST, Hôpital de la Cavale Blanche, Brest, 29200, France

Summary:
Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

Primary Outcome Measures: fresh frozen plasma transfusion, Proportion of patients transfused with fresh frozen plasma 48 hours after the surgery., 48 hours
Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter
NCT Number: NCT06550492
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Procedure, Unspecified
Interventions: DEVICE: smoke filtering electrocautery device|OTHER: double mask
Sponsor: Ataturk University
Sex: ALL
Age: ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-02-28
Locations: Atatürk University Health Application and Research Centre, Erzurum, Yakutiye, 25200, Turkey

Summary:
This study was conducted to determine and compare the effectiveness of the smoke filtering electrocautery device used to reduce the negative effects of surgical smoke and the use of a double layer mask.

Primary Outcome Measures: Application Registration Form, This form includes laboratory findings such as COHb, MetHb, PaO2, PaCO2, pH, HCO3, SpO2, Hg that may be affected in the person exposed to surgical smoke. In the study, it was examined whether exposure to surgical smoke affected these values., 1 day|Questionnaire on Reported Health Problems, The questionnaire form, which was created by the researcher by reviewing the literature on the subject, includes 45 health problems that may occur in the short term as a result of exposure to surgical smoke and a scale related to the frequency of experiencing these problems. in the questionnaire, the every day option shows the maximum value, the never option shows the minimum value, 1-2 day
Comparison of Three Types of Distal Arteriovenous Fistulas: SBAVF, RCAVF, and RCAVF With Venous Branch Patch.
NCT Number: NCT06550479
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dialysis; Complications|Vascular Access Complication
Interventions: PROCEDURE: AVF
Sponsor: Wroclaw Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2030-07-31
Locations: Department of Nephrology and Transplantation Medicine, Wrocław, 50-556, Poland

Summary:
This study aims to determine which type of distal arteriovenous fistula (SBAVF, RCAVF, and RCAVF with venous branch patch) is most clinically favorable.

The recommendations and scientific evidence do not suggest which option should be chosen initially.

The investigators expect that results will show which type of the anastomosis should be preferred.

Primary Outcome Measures: Primary patency:, The interval between VA creation and the first re-intervention (intervention free VA survival) for VA dysfunction or thrombosis, the time of measurement of patency or the time of its abandonment, 12 months|Assisted primary patency:, The interval between VA creation and the first occlusion (thrombosis free VA survival) or measurement of patency including operative/endovascular interventions to maintain the VA., 36 months|Secondary patency, The interval between VA creation and the abandonment of this VA (i.e. thrombosis) after one or more interventions or the time of measurement of patency including achievement of a censored event (death, change of HD modality, loss of follow-up)., 36 months
Secondary Outcome Measures: Mature VA, A fistula was considered mature when the blood flow exceeded 500 ml/min and the diameter of the cephalic vein exceeded 5 mm., 6 weeks
The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers
NCT Number: NCT06550466
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteopenia or Osteoporosis
Interventions: OTHER: Breakfast only|OTHER: FAST|OTHER: FED
Sponsor: Sheffield Hallam University
Collaborators: Anglia Ruskin University|University of Sheffield|Manchester Metropolitan University|Sheffield Teaching Hospitals NHS Foundation Trust
Sex: MALE
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-06

Summary:
Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease.

This study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone's response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.

Primary Outcome Measures: C-terminal telopeptide of type-1 collagen (CTX-1), The primary endpoint of this study is the change of the bone resorption biomarker C-terminal telopeptide of type-1 collagen (CTX-1) expression, Between pre-exercise and 2 hours following the exercise timepoints
Secondary Outcome Measures: Procollagen type 1 N-terminal propeptide (P1NP), The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression, Between pre-exercise and 2 hours following the exercise timepoints|Cortisol, Markerof physiological and psychological stress is assessed and because of its promotion of bone resorption, Between pre-exercise and 2 hours following the exercise timepoints|Insulin, The change of concentration in fasted and fed states is assessed, Between pre-exercise and 2 hours following the exercise timepoints|Glucose, The change of concentration in fasted and fed states is assessed, Between pre-exercise and 2 hours following the exercise timepoints
Safety and Efficacy of Pembrolizumab in Combination With Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer
NCT Number: NCT06550453
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Locally Advanced Colorectal Cancer
Interventions: DRUG: Pabolizumab+ bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine)
Sponsor: yangjianjun
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2026-01-15
Locations: the First Affliated Hospital (Xijing Hospital),the First Affiliated Hospital of Air Force Military Medical University, Xi'an, Shaanxi, 710032, China

Summary:
To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer.

Methods and analysis: A prospective, open-label, single-arm, phase 2 clinical study protocol will enroll a total of 20 patients. The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer (LACRC) patients. Initially, 9 patients will be recruited in the Simon I phase, and if more than 1 patient achieves a pathological complete response (pCR), the study will proceed to the II phase. Recruit up to 20 patients in Phase II, and if more than 4 patients achieve pCR, the trial will be considered successful. All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine). The primary efficacy endpoint is the pathological complete response (pCR) of the cancer following neoadjuvant therapy. Secondary efficacy endpoints include major pathological response (MPR), objective response rate (ORR), and assessment of adverse events (AEs).

Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital (Xijing Hospital)(KY20232402-F-1)

Primary Outcome Measures: Pathological complete response rate (pCR), Pathological complete reand the postoperative pathological findings were statistically completse rate (pCR rate): The pathological status of the primary site was determined in the surgical patient Proportion of patients with complete response:, 12 months
Secondary Outcome Measures: Objective response rate (ORR) in the neoadjuvant phase, Obiective response rate (ORR) at the neadjuvant stage: proportion of subjects who achieved partiaand complete response on radiographic assessment (RECIST v1.l) after the end of neoadjuvanttherapy;, 36 months|Major pathological response rate (MPR), Major pathological response rate (MPR rate): The pathological status of the primary site wadetermined in the patients undergoing surgery, and the proportion of patients with residuatumor cells \<10% by pathological detection in postoperative specimens was counted, 36 months|Adverse event rate (AE), Safety: all adverse events, serious adverse events;, 36 months
The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants
NCT Number: NCT06550440
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Very Low Birth Weight Infant
Interventions: BEHAVIORAL: family integrated care
Sponsor: Children's Hospital of Fudan University
Sex: ALL
Age: CHILD
Enrollment: 1255
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-02-01
Completion Date: 2024-05-01
Locations: Children's Hospital of Fudan University, Shanghai, Shanghai, 200032, China

Summary:
To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.

Primary Outcome Measures: total duration of family integrated care, Trained NICU staffs effectively educate parents as part of the NICU team so that they can proactively provide active care for the baby, rather than passive caregivers. Parents are primarily involved in care such as bottle feeding, diaper changing, skin-to-skin contact and so on.We calculate total duration of family integrated care in hours., From the day admitted into the NICU until day on discharge，an average of 2 months.
Secondary Outcome Measures: Birth weight, birth weight in grams, assessed at birth.|Small for gestational age, birth weight\<10th percentile of the neonatal growth curve for infants of the same sex and gestational age, assessed at birth.|Necrotizing enterocolitis, diagnosed according to the Bella classification, From the day admitted into the NICU until day on discharge, an average of 2 months.|gestational age, gestational age at weeks, assessed at birth.
Other Outcome Measures: Bronchopulmonary dysplasia, oxygen is required at 36 weeks of corrected gestational age or at discharge, From the day admitted into the NICU until day on discharge，an average of 2 months.|Retinopathy of prematurity, diagnosed according to the International Classification of Retinopathy of Prematurity, From the day admitted into the NICU until day on discharge, an average of 2 months.|Intraventricular hemorrhage, the diagnosis is based on Paplie's classification, From the day admitted into the NICU until day on discharge，an average of 2 months.|Late-onset sepsis, sepsis occurs \>72h after birth, From the day admitted into the NICU until day on discharge, an average of 2 months.
Early Assessment of Lymphoma Treatment Response Using Phased Variant Analysis With Next-Generation Sequencing
NCT Number: NCT06550427
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lymphoma, B-Cell
Interventions: DIAGNOSTIC_TEST: ctDNA analyzed by phased variant
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-02
Completion Date: 2026-07-31
Locations: National Taiwan University Hospital, Taipei, Taiwan

Summary:
Lymphoma is a prevalent lymphoid malignancy globally and in Taiwan. Large B-cell lymphoma (LBCL) is the most common subtype of aggressive B-cell lymphoma. LBCL's aggressive nature manifests through extranodal involvement, severe symptoms, and relative refractoriness to therapies, leading to a 5-year overall survival rate of 60-70% across developed countries and poorer outcomes in high-risk patients with primary refractory disease. Chemoimmunotherapy remains the primary treatment for LBCL, requiring comprehensive assessment through clinical and imaging examinations, biomarkers, and molecular testing. Currently, computed tomography (CT) and positron emission tomography (PET) scans are the standard modalities for treatment response evaluation, though their radioactive nature calls for the development of safer alternatives. Circulating tumor DNA (ctDNA) analysis has emerged as a promising field, providing insights into tumor molecular characteristics, clinical status, and treatment response by analyzing DNA fragments released from tumor cells into the bloodstream. Dynamic monitoring of ctDNA during treatment can effectively gauge therapeutic efficacy-decreasing ctDNA concentrations suggest successful treatment, while increasing levels may indicate treatment failure or tumor recurrence. The detection of ctDNA has been much improved through advances in next-generation sequencing (NGS) technologies, particularly taking advantage of analyzing phased variants, consecutive gene mutations on the same chromosome, enhances the sensitivity and specificity.

Primary Outcome Measures: Correlation between ctDNA analyzed by phased variant and early outcome of lymphoma, The primary endpoint of this observational cohort study is to investigate the correlation between ctDNA analyzed by phased variant and the early outcome of aggressive B cell lymphoma, From the date of enrollment, up to 24 months or date of death from any cause.
Dexmedetomidine As An Adjuvant To Bupivacaine 0.1% in Labor Analgesia
NCT Number: NCT06550414
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Analgesia|Labor Pain
Interventions: DRUG: Dexmedetomidine|DRUG: Bupivacain
Sponsor: Services Institute of Medical Sciences, Pakistan
Sex: FEMALE
Age: ADULT
Enrollment: 165
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2022-11-01
Completion Date: 2023-05-01
Locations: Hameed Lateef Hospital, Lahore, Punjab, 042, Pakistan

Summary:
Females who have experienced normal labor for child birth have claimed it to be most difficult and distressing moments of their life due to excruciating and unbearable pain. Provision of effective and satisfactory labor analgesia to the parturient helps in achieving greater degree of well-being for both mother and child. Several medical and non-medical pain relief methods are used since ages for pain relief during childbirth.

Epidural anesthesia and intravenous opioids (pethidine) are most commonly offered to the mothers for relieving labor pain. So far, Epidural is considered gold standard in attaining maternal satisfaction for pain free deliveries. lt can be modified for individual parturient in order to achieve highest level of comfort and pain relief. To attain better and prolonged analgesia several additives have been used with local anesthetists and their effects are studied. Epidural opioids are conventionally being used as adjuvants, however associated side effects (nausea, vomiting, and pruritus) may limit their use. An alpha 2 adrenoceptor agonist, dexmedetomidine, has been effectively used and studied in labor epidurals and provided better analgesia without significant side effects. Hamed Lateef Hospital is one of the largest tertiary care private setup offering painless deliveries in Lahore.

It is need of the hour to modify and improve our clinical practice in order to achieve highest level of patient satisfaction and provision of best possible maternal and fetal outcome. This study is proposed to investigate and elaborate the effect of adding dexmedetomidine to bupivacaine in labor epidurals and to study possible side-effects associated with its use.

Primary Outcome Measures: onset of analgesia, time noted for onset of analgesia in both groups, Patient observed for 45 minutes after drug delivery and time required to achieve a VAS of 3 or less than 3 is noted down.
A Study of the BREAST-Q REACT Tool for People Having Breast Surgery
NCT Number: NCT06550401
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Conserving Surgery|Mastectomy With Reconstruction
Interventions: OTHER: BREAST-Q Physical Well-Being|OTHER: QuickDASH
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-09
Completion Date: 2026-08
Locations: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Commack (All Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, 11553, United States

Summary:
The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.

Primary Outcome Measures: feasibility of recruitment, assessed by frequency data from initial eligibility screening to enrollment, up to 3 months
Secondary Outcome Measures: feasibility of protocol delivery, by evaluating survey completion rates and proportion of patients who are being referred to medical interventions., up to 3 months
Subjective Sleep Quality of Patients With Chronic Insomnia
NCT Number: NCT06550388
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insomnia Chronic
Interventions: BEHAVIORAL: Nutritional Education|BEHAVIORAL: Physical Activity
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-08-15
Locations: Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States

Summary:
The purpose of this study is to assess subjective sleep quality, diet quality, physical activity in patients with chronic insomnia before and after a brief lifestyle intervention during a traditional course of Cognitive Behavioral Therapy for Insomnia (CBT-I)

Primary Outcome Measures: Change in sleep quality measured by the Pittsburgh Sleep Quality Index, Measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance., Baseline, 84 days
Secondary Outcome Measures: Change in insomnia measured by the Insomnia Severity Index, Self-reported insomnia severity index questionnaire score, using a total score, scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe), Baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days
Clinical Outcomes With Bilateral Implantation of Odyssey IOLs
NCT Number: NCT06550375
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cataract
Interventions: DEVICE: TECNIS Odyssey IOL
Sponsor: Mann Eye Institute
Collaborators: Sengi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Mann Eye Institute, Houston, Texas, 76134-2099, United States

Summary:
This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.

Primary Outcome Measures: Visual Acuity at Distance (6m) logMAR, Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected, 3 months postoperative|Visual Acuity at Intermediate (66cm) logMAR, Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected, 3 months postoperative|Visual Acuity at Near (40cm) logMAR, Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected, 3 months postoperative|Visual Acuity at Near (33cm) logMAR, Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected, 3 months postoperative
Secondary Outcome Measures: Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare, The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Lower scores for the symptom questions indicate lower frequency and both of visual disturbances., 3 months postoperative
Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA
NCT Number: NCT06550362
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Iron Deficiency, Anaemia in Children
Interventions: DRUG: iron sulfate
Sponsor: Loma Linda University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-02

Summary:
Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. This study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of IDA in pediatric patients.

Primary Outcome Measures: Hemoglobin stabilization, standard per age, 3 months|Serum ferritin stabilization, standard per age, 3 months
Secondary Outcome Measures: Hepcidin level, observation of hepcidin levels under clinic conditions, 3 months
ScanNav Anatomy PNB Data Collection Study 2024
NCT Number: NCT06550349
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Data Collection
Interventions: OTHER: N/A - non-interventional study
Sponsor: IntelligentUltrasound Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-27
Completion Date: 2024-08-28
Locations: Hodge House, Cardiff, CF10 1DY, United Kingdom

Summary:
Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

Primary Outcome Measures: Training and/or validation data (in the form of recorded ultrasound scans), Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist ultrasound-guided regional anaesthesia., 6 months
A Clinical Study Assessing the Efficacy of Chidamide for CD30-positive Peripheral T-cell Lymphoma (PTCL).
NCT Number: NCT06550336
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Peripheral T Cell Lymphoma
Interventions: DRUG: Chidamide
Sponsor: The First Hospital of Jilin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2027-12-30
Locations: The First Bethune Hospital of Jilin University, Changchun, Jilin, 130021, China

Summary:
* Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone (CHP)treatment, excluding ALK+ anaplastic large-cell lymphoma (ALCL).
* Design: The study is a prospective, single-center, open-label clinical trial.
* Treatment:Eligible patients will receive Chidamide tablets at a dosage of 20 mg (4 tablets) twice weekly. Treatment cycles are 4 weeks long and will continue until disease progression, unacceptable toxicity, patient withdrawal, investigator decision to discontinue, loss to follow-up, death, or study termination.
* Endpoints:The primary endpoint is the 2-year progression-free survival (PFS). Secondary endpoints include the overall response rate (ORR), overall survival (OS), and safety indicators.
* Rationale:The study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients.

Primary Outcome Measures: 2-year progression-free survival (PFS) rate, PFS was defined as the time between diagnosis and the first date of relapse or all-cause death, whichever occurred first., 24months
Secondary Outcome Measures: overall survival (OS), OS was defined as the time after the date of diagnosis until all-cause death., 48months
Effect of Virtual Reality Application on Pain, Anxiety and Comfort During Chest Tube Removal Procedure
NCT Number: NCT06550323
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chest Tube Removal
Interventions: DEVICE: Group using virtual reality glasses
Sponsor: Hale Rumeysa Seçer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-03-20
Completion Date: 2024-08-30
Locations: Ataturk University, Erzurum, Turkey

Summary:
Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. The chest tubes, which remain in place for a long time, fuse with the endothelium lying in the chest cavity. For this reason, the adhesions formed with the fusion cause very severe acute pain in the patient with the pulling force applied during removal.The high level of pain of the person will cause an increase in the level of anxiety and a decrease in the level of comfort. The anxiety experienced by the patients will also reduce the tolerance to pain.It has been observed that the use of virtual reality in the field of health significantly reduces the level of pain and anxiety during medical procedures, shortens wound healing and hospital stay, and increases compliance with treatment.In the literature, no studies were found in which the effects of virtual reality application on pain, anxiety and comfort were evaluated in patients whose chest tube was removed.Thereforee, this study was conducted to evaluate the effect of virtual reality application against all these negative situations.

Primary Outcome Measures: visual analog scale, To evaluate pain severity, pain results are evaluated by scoring between 0-10. While 0 indicates "No pain", 10 indicates "Unbearable pain".

The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result, 5 month|State-Trait Anxiety Inventory Scale, It is a 4-point Likert-type scale with 40 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. anxiety level will be determined., 5 month|comfort scale, It is a scale ranging from 0 to 10 points. While 0 points indicate 'most comfortable', 10 points indicate 'most uncomfortable'.

The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result, 5 month|verbal pain scale, 0 points indicate "No pain", 1 point indicates "Mild pain", 2 points indicate "Moderate pain" and 3 points indicate "Severe pain"., 5 month
Small Nerve Fiber Activity in Patients With Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing
NCT Number: NCT06550284
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carpal Tunnel Syndrome
Interventions: OTHER: Physical Therapy
Sponsor: Brooke Army Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-07

Summary:
The diagnosis of carpal tunnel syndrome (CTS) is typically based on clinical findings and confirmatory electrodiagnostic testing. However, electrodiagnostic testing can only assess large A-alpha and A-beta nerve fibers. Quantitative sensory testing (QST) is a series of tests used to assess small nerve fiber changes in the A-delta, c-fibers, and A-beta nerve fibers as well. Previous studies have used QST to assess small nerve fiber changes related to carpal tunnel syndrome and found changes compared to controls. This study will utilize a course of standard physical therapy care and assess for any changes to small nerve fiber activity and how those changes may or may not relate to patient outcomes.

Primary Outcome Measures: Quantitative Sensory Testing (QST), QST is a test method that measures sensory thresholds for temperature sensations, touch, vibration, and pain and is described in section 10.1. All thermal testing (CDT, WDT, CPT, and HPT) will be performed via the TSA 2 Thermosensory Stimulator., From enrollment until the end of the study at 12 weeks
Secondary Outcome Measures: Boston Carpal Tunnel Questionnaire (BCTQ), The BCTQ is a self-based outcome scale measured with 2-parts, the symptom severity scale and functional status scale. Both scales are likert scales 1-5., From enrollment until the end of the study at 12 weeks|Numeric Pain Rating Scale (NPRS), he NPRS is an 11-point scale ('0' indicating no pain, and '10' worst imaginable pain) that will be used to assess pain intensity. This will be measured as the mean of three pain ratings: best pain rating over 24 hours, worst pain rating over 24 hours, and current pain rating., From enrollment until the end of the study at 12 weeks
The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals
NCT Number: NCT06550271
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Aging
Interventions: DRUG: Rapamycin
Sponsor: AgelessRx
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-25
Completion Date: 2023-12-15
Locations: AgelessRx, Ann Arbor, Michigan, 48104, United States

Summary:
This study collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).

Primary Outcome Measures: define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels)., 8 months
Study of Infants' Social Cognition Using the Lookit Platform
NCT Number: NCT06550245
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infant Development
Interventions: OTHER: Infants observing familiar and unfamiliar racial groups
Sponsor: University of California Santa Cruz
Sex: ALL
Age: CHILD
Enrollment: 82
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-23
Completion Date: 2025-09
Locations: Social Science 2 Building, Santa Cruz, California, 95064, United States

Summary:
Examine infants' attention to racial ingroup and outgroup faces and collect information about racial diversity in infants' social environment from social networks to neighborhoods.

Evaluate infants' social wariness toward racial ingroup and outgroup strangers, collect information about racial diversity in infants' social environment from social networks to neighborhoods, and collect temperament measures.

Primary Outcome Measures: Mu event related desynchronization, EEG oscillation in alpha power over central regions, Through study completion, an average of 10 years.|Frontal theta synchronization, EEG oscillation in theta power over frontal regions, Through study completion, an average of 10 years.|Frontal alpha asymmetry, left and right hemispheric difference in EEG oscillation in alpha power in the frontal regions, Through study completion, an average of 10 years.
IV PAPAVERINE Prior to Propess for Labor Induction
NCT Number: NCT06550232
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Induced Vaginal Delivery
Interventions: DRUG: Papaverine|OTHER: placebo
Sponsor: Western Galilee Hospital-Nahariya
Sex: FEMALE
Age: ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-11
Completion Date: 2026-08-11

Summary:
We aim to evaluate the effect of administering papaverine prior to PGE2 (propess) insertion on changes in Bishop-scores and on the induction-to-delivery interval.

Primary Outcome Measures: Delta Bishop score, The bishop score pre- and post-catheter-balloon expulsion, 24 hours|visual analogue scale score, The procedure related pain was assessed using a 10-point visual analogue scale, 24 hours
Secondary Outcome Measures: PGE2 insertion-to-delivery interval, time interval from PGE2 insertion to delivery of the newborn, hours
Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound
NCT Number: NCT06550219
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preterm|Ventilator Lung; Newborn
Interventions: DEVICE: Nasal humidified heated high flow cannula (NHHHC)|DEVICE: Nasal intermittent positive pressure ventilation (NIPPV)|DEVICE: Nasal continuous positive airway pressure NCPAP|DEVICE: lung ultrasound
Sponsor: Alexandria University
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2025-11-01
Locations: Alexandria university, Elshattbi hospital, Alexandria, 0354, Egypt

Summary:
This study aims to evaluate the effect of non-invasive ventilation (nIPPV)

, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates \<37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay

Primary Outcome Measures: Duration of non-Invasive ventilation (NIV), Describe the days of non-invasive ventilation , described in days number., First two weeks of life.
Secondary Outcome Measures: Oxygen saturation index (OSI)., Mean airway pressure (MAP)X Fraction of inspired oxygen (FIO2) X SPO2 ( oxygen saturation) The score of OSI is recorded twice per day for first seven days., first one weeks of life.
The Malleability of Social Group Understanding in Infancy and Early Childhood
NCT Number: NCT06550206
Acronym: ISW
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Social Behavior
Interventions: BEHAVIORAL: Children's stranger wariness response to strangers
Sponsor: University of California Santa Cruz
Collaborators: New York University|University of Maryland, College Park
Sex: ALL
Age: CHILD
Enrollment: 262
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2025-09
Locations: Social Science 2 Building, Santa Cruz, California, 95064, United States

Summary:
The study will assess if interacting with different-race people causes shifts in children's race-based social preferences and inferences, associations, and social relationships about social structures compared to interacting with same-race people.

Primary Outcome Measures: Social Wariness, children's social wariness as assessed by the time that the child first vocalized, touched the stranger, and the duration of time that the child stayed near their parent in seconds standardized and averaged to create a composite score., Through study completion, an average of 10 years|Social Preference, Social preference will be coded by observing toddler behavior and assigning the following codes: 1 = did not take the toy from either stranger, 2 = took toy from familiar race stranger, 3 = took toy from unfamiliar race stranger, 4 = took toy or played with both strangers simultaneously., Through study completion, an average of 10 years