pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Interest of TEG6S® in Reducing Transfusion Needs During Postpartum Haemorrhage
NCT Number: NCT06473233
Acronym: INTEGRAL-HPP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postpartum Hemorrhage
Interventions: DEVICE: TEG6S
Sponsor: Centre Hospitalier Sud Francilien
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2024-12-31
Locations: Centre Hospitalier Sud Francilien, Corbeil-Essonnes, 91106, France

Summary:
The main objective of this study is to evaluate fibrinogen consumption, transfusion need, and other security outcomes in women with postpartum hemorrhage of 1000 mL or more, before and after the implementation of a TEG6S® device at a level III maternity unit (Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France).

Primary Outcome Measures: Fibrinogen consumption, Quantity of fibrinogen administered (in grams), up to 24 hours
Secondary Outcome Measures: Total number of TEG6S®, Total number of TEG6S® carried out over a period of 12 months following its implementation, at 12 months|Estimated blood loss, Estimated total volume of blood loss during PPH, in milliliters, using a graduated bag and weight of blood-soaked materials, up to 24 hours|Calculated blood loss, Estimated total volume of blood loss during PPH, using the following formula = (\[initial Ht - Ht H24\] × total blood volume × 100/35) + compensated blood loss (CBL) ; with: total blood volume in milliliters = basis weight × 65 × 1.4, and CBL in milliliters, corresponding to the number of RBC concentrates transfused (1 RBC corresponds to approximately 500 mL of blood at 35% Ht)., up to 24 hours|Consumption of packed red blood cells (RBC), Number of packed red blood cells used, up to 24 hours|Consumption of fresh frozen plasma (FFP), Number of fresh frozen plasma (FFP) used, up to 24 hours|Invasive haemostatic procedure, Use of surgical and/or radio-interventional hemostasis (Bakri balloon, embolization, arterial ligation, uterine padding, hemostasis hysterectomy), up to 24 hours|Maternal death, Occurrence of maternal death at hospital, until leaving the hospital|ICU admission, Any admission in an intensive care unit, until leaving the hospital|ICU length of stay, Total length of stay in an intensive care unit/critical care (in days), until discharge from the intensive care unit|Total length of stay, Total length of stay in hospital (in days), until discharge from the intensive care unit|Acute anemia, Occurrence of anemia following postpartum hemorrhage, defined by a decrease in hemoglobin level of 4g/dL or more at 24h following delivery, compared to the last hemoglobin level known before delivery, at 24 hours
Evaluation of the Effectiveness of Narrative Nursing
NCT Number: NCT06473220
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease|Narrative|Depression, Anxiety
Interventions: BEHAVIORAL: Narrative nursing
Sponsor: Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2022-10-01
Completion Date: 2023-10-30
Locations: Gulou District, Nanjing, Jiangsu, 210029, China

Summary:
To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).

Primary Outcome Measures: MMSE sore, The simple mental state Intelligence Scale (MMSE) was used to evaluate the mental state of the patients before and after the nursing intervention. The scale was mainly composed of 5 dimensions, namely orientation ability, recall ability, memory ability, attention and calculation ability, and language ability, and contained a total of 30 items. The total score was 0-30 points, the higher the score, the better the mental state of the patients., After 1, 2 and 4 weeks after hospitalization|ESCA score, The self-care ability measurement (ESCA) scale was used to evaluate the practical self-care ability of patients in the two groups before and after nursing intervention. The scale was mainly composed of four dimensions: self-concept, health knowledge mastery level, sense of responsibility, and self-care practical skills, and contained 43 items with a total score of 0-172. It shows that the actual ability of self-care is better., After 1, 2 and 4 weeks after hospitalization|HAMD score, The score consisted of 17 items, including self-awareness, work and interest, gastrointestinal symptoms, weight loss, hypochondriasis, sleep difficulty, etc. The total score \< 7 was considered normal, 7 to 17 divided into possible depression syndrome, \> 17-24 were classified as having depression, and\> 24 were classified as major depression., After 1, 2 and 4 weeks after hospitalization|HAMA score, The score includes two dimensions: spirituality and physicality, with a total of 14 items, including gastrointestinal and digestive symptoms, depressive mood, sensory system symptoms, behavioral manifestations when communicating with others, somatic anxiety, cognitive function, etc. The total score is \> 28, which is classified as severe anxiety, 21 to 28 grades are anxious, 14 to \< 21 is classified as anxiety, 7 to \< 14 scores may have anxiety, and \<7 is considered normal., After 1, 2 and 4 weeks after hospitalization
This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery
NCT Number: NCT06473194
Acronym: laparoscopy
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia Complication|Physiological Parameter
Interventions: PROCEDURE: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum
Sponsor: Mohammed Abdulhameed
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2026-11-01

Summary:
Laparoscopic surgery is widely used now. These benefits included many items, e.g. reducing post-operative pain, cosmetic the result was improved, and the patient also had more satisfaction for the patient and reduced hospital stay. This surgery involved insufflation of gas into the peritoneal cavity, producing pneumoperitoneum, and causing an increase in intra-abdominal pressure. The raised intraabdominal pressure of the pneumoperitoneum, the patient's position alteration, and the absorption of carbon dioxide into the abdomen have a direct effect on causing a change in physiology, especially in the cardiovascular and respiratory systems. These effects, as well as a direct effect of gas insufflation, may have significant effects on the patient especially if the patient has a comorbidity or is elderly.

Primary Outcome Measures: blood pressure., blood pressure in mmHg, pulse rate in beat per minute, during preoperative, 5 minute, intraoperative every five minute with post operative read after one hour|AST and ALT liver enzymes were measured, by blood samples taken intravenously in the perioperative period, in unit/liter, 5 minute pre-operation and 5 minute postoperative|blood sugar, should measured and assessed with different groups, blood sugar in mg/dl, 5 minute during pre-operative and 15 minute post- operative period|end-tidal Co2, measured and compared statistically with other parameter, End-tidal Co2 in CMH2O, perioperatively every 5 minute|pulse rate measured continuously during intra-operative and compared with other hemodynamic parameter, beat per minute (BPM), 5 minute during preoperative, and continue every 5 minute in perioperatively
Secondary Outcome Measures: measurement of body weight, in Kg, measured preoperative period by 5 minute and post-operative during 15 minute
RELATION BETWEEN BODY POSTURE and SHOULDER DYSFUNCTION
NCT Number: NCT06473142
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Subacromial Impingement Syndrome|Frontal Plane Postural
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2024-10-15

Summary:
The purpose of this study will be to investigate if there is any correlation between shoulder dysfunction and the lateral alignment of the spine, scapular dyskinesia, pelvic tilting angle, Shoulder height angle, and trunk side bending (strength and mobility) in the frontal plane in patients with unilateral SIS.

Primary Outcome Measures: Thoracolumbar lateral deviation, will be measured using a scoliometer, 2 MONTHES|Scapular dyskinesia, will be measured using lateral scapular slide test (LSST), 2 monthes|The pelvic tilting angle and shoulder height angle, will be evaluated using Kinovea software, 2 monthes|Trunk side bending ROM, will be evaluated using a bubble inclinometer, 2 Monthes|Trunk side bending strength, will be evaluated using a handheld dynamometer, 2 monthes|Shoulder pain and disability level, will be measured using the Arabic version of shoulder pain and disability index (SPADI), 2 monthes
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
NCT Number: NCT06473103
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Basal Cell Carcinoma
Interventions: DEVICE: Two photon fluorescence microscopy imaging
Sponsor: University of Rochester
Collaborators: Rochester Dermatologic Surgery
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2026-07
Locations: Rochester Dermatologic Surgery, Victor, New York, 14654, United States

Summary:
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.

Primary Outcome Measures: Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology, The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated., Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Secondary Outcome Measures: Overall agreement on margin status, The status of margins (positive/negative) will be compared, Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia
NCT Number: NCT06473064
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Managment of Gynecomastia
Interventions: OTHER: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
Sponsor: Assiut University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-19
Completion Date: 2025-10-19
Locations: Assiut University Hospital, Assiut, 0882, Egypt

Summary:
Gynecomastia is the benign proliferation of male breast tissue caused by an increase in the estrogen/androgen activity ratio. It manifests itself physiologically (adolescence, puberty, and old age) as well as pathologically (androgen insufficiency caused by drugs or disease, testicular tumors, hyperthyroidism, and chronic renal failure).

* In spite of the variety of methods and tools such as (liposuction and circumareolar inframammary inscion ) used in gynecomastia surgery, in gynecomastia the results are satisfactory in grades 1 and 2 while grades 3 and 4 gynecomastia present a surgical challenge.
* As some postoperative frustrating problems still cannot be completely eliminated, the most common of these are a saucer-like deformity (over resection under areola), bleeding, followed by seroma, infection, ischemic necrosis of nipple areola complex residual gynecomastia (under resection), persistence of inframammary fold, contour irregularities, and asymmetries between breasts.
* the objective, in this research, is to demonstrate the The role of Benelli technique in removal of gynecomastia grade 3 and grade 4 in clinical and cosmetic outcomes

Primary Outcome Measures: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia, to evaluate and determine the feasibility and complications of benelli techniques for nipple sparing mastectomy in surgical tratment of grade 3 and 4 gynecomastia and also its cosmetic effect, baseline
Cluster RCT of Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong
NCT Number: NCT06473012
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caregiver Burden|Depressive Symptoms|Quality of Life|Self Efficacy|Resilience
Interventions: BEHAVIORAL: Cognitive Behavioral Therapy for Caregivers of Older Adults|BEHAVIORAL: Control intervention for Caregivers of Older Adults
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-06
Locations: Sau Po Center on Ageing HKU, Hong Kong, Hong Kong

Summary:
The goal of this cluster randomized controlled trial study is to compare the effectiveness of a novel psychosocial intervention based on Cognitive Behavioral Therapy, lifestyle intervention and effective communication skills in caregivers of older adults in Hong Kong. The main question\[s\] it aims to answer are:

What is the impact of the 6-week psychosocial intervention on distress and burden among participants? Participants will participate in a 6-week psychosocial intervention. Researchers will compare the results between the intervention group and the active control group to see if participants in the intervention group have lower distress and burden.

Primary Outcome Measures: Caregiver Risk Screening Tool (RST-22), Risk screening tool 22-item. The Carer Need Screening Tool is a 22-item assessment that evaluates caregivers across 5 key domains of risk:Carers' mental ill health, Caregiving capacity, Lack of support, Carers' health challenges and High care demands., 3 months
Secondary Outcome Measures: Cantonese short version of the Zarit Burden Interview (CZBI), Reduced burden of caregivers, 3 months|The World Health Organization Quality of Life (WHOQoL-BREF), he WHOQOL-BREF is a 28-item instrument developed by the World Health Organization to assess an individual's quality of life across four domains: physical health, psychological health, social relationships, and environment., 3 months|Patient Health Questionnaire (PHQ-9), The PHQ-9 is a self-report instrument used to assess symptoms of depression., 3 months|Connor-Davidson Resilience Scale (CD-RISC-25), The CD-RISC is a 25-item self-administered scale that assesses an individual's level of resilience., 3 months|Self-Care Self-Efficacy Scale (SCSES-10), The SCSES-10 is a measurement tool used to assess an individual's self-efficacy self-care self-efficacy for chronic illness and has been tested in the Hong Kong population., 3 months
Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury
NCT Number: NCT06472999
Acronym: KDIGO-Bundle
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury
Interventions: PROCEDURE: Nephroprotective measures
Sponsor: Universität Münster
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 257
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-09
Locations: University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, Münster, 48149, Germany

Summary:
This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.

Primary Outcome Measures: Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria), 60 hours after onset of moderate/severe AKI
Secondary Outcome Measures: Severity of Acute Kidney Injury, Severity of AKI (worst Acute Kidney Injury (AKI) stage according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with stage 1 being the least and stage 3 being the most severe stage), within 72 hours after diagnosis|Duration of AKI (Acute Kidney Injury), transient AKI (\< 48 hours), persistent AKI (48 hours - 7 days) or acute kidney disease (AKD) (\> 7 days), from onset of AKI until follow-up day 30
Other Outcome Measures: Number of participants with recovery of baseline renal function, recovery of baseline renal function measured by estimated glomerular filtration rate (eGFR) at hospital discharge, hospital discharge (up to 30 days)|Number of Participants with need for renal replacement therapy, defined as whether or not any kind of renal replacement therapy became necessary at any point, within 30 days of AKI onset|Free-days of mechanical ventilation, within 30 days of AKI onset|Length of hospital stay, at hospital discharge (up to 30 days)|Length of Intensive Care Unit stay, at hospital discharge (up to 30 days)|Number of Participants with renal replacement therapy, at day 90|Mortality, at day 90
Relationships Between Physical Activity and Inhibitory Control Among College Students
NCT Number: NCT06472960
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognition
Interventions: BEHAVIORAL: Moderate-intensity cycling|BEHAVIORAL: Vigorous-intensity cycling|BEHAVIORAL: Uninterrupted sitting
Sponsor: Shenzhen University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2025-02-01
Locations: Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University, Shenzhen, Guangdong, China

Summary:
The primary aim of this study is to explore the impact of a 20-minute aerobic exercise on inhibitory control, microvascular diameters, and brain function. The main questions it aims to answer are:

1. Is there a correlation among the level of physical activity, performance in inhibitory control, and the diameter of retinal microvasculature, and do retinal microcirculation parameters mediate this relationship?
2. Does short-term aerobic exercise (moderate and high intensity) improve inhibitory control and physiological markers, such as retinal diameter and frontal brain activation, compared to a sedentary control group?

Primary Outcome Measures: Cognitive function, This primary outcome measure is assessed by the modified dual-task Stroop paradigm., 21 weeks|Retinal Vessel Diameter, Retinal Vessel Diameter is assessed by the fully automated fundus camera., 21 weeks|Brain Connectivity, Brain connectivity is assessed by the NIRSport2 device, 21 weeks
Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.
NCT Number: NCT06472921
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Ischemic Stroke
Interventions: BEHAVIORAL: Butylphthalide treatment initiation time
Sponsor: Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-31

Summary:
This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\&lt;3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.

Primary Outcome Measures: The proportion of participants with an mRS score of 0-2, 90±7 days post-randomization
Secondary Outcome Measures: Proportion of participants with an mRS score of 0-1, 90±7 days post-randomization|Changes in NIHSS scores, at 6±1 days and 12±2 days compared to baseline|Proportion of participants with an improvement of ≥4 points in NIHSS scores, at 6±1 days and 12±2 days|Early neurological deterioration, at 24±2 hours and 6±1 days post-randomization|Proportion of participants with ineffective recanalization, at 90±7 days post-randomization|Proportion of participants with recurrent ischemic stroke, at 90±7 days post-randomization|Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death), at 90±7 days post-randomization|Difference in cerebral infarction volume size, between baseline and 12±2 days post-randomization|Quality of life (EQ-5D) scores, at 90±7 days post-randomization
A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
NCT Number: NCT06472895
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Renal Cell Carcinoma
Interventions: DRUG: AK112 monotherapy
Sponsor: Peking University Cancer Hospital & Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-20
Completion Date: 2027-12-20

Summary:
This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112（ivonescimab）monotherapy as first-line treatment for favourable risk advanced/metastatic renal cell carcinoma (a/m RCC).

Subjects will receive AK112 until disease progression, unacceptable toxic effects, death，a decision by the physician or patient to withdraw from the trial，or AK112 exposure over 2 years.

The study set dose exploration stage and dose expansion stage respectively. Firstly, include a few subjects for observation in dose exploration stage, and select appropriate dose to enter expansion, then continue to include more subjects to further assessment.

Primary Outcome Measures: ORR per RECIST v1.1 assessed by investigators, ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1, Up to 2 years
Secondary Outcome Measures: DCR per RECIST v1.1 as assessed by investigators, DCR is the proportion of subjects with complete response(CR), partial response(PR) and stable disease (SD) based on RECIST v1.1, Up to 2 years|Duration of response (DOR), Duration of response (DOR) assessed according to RECIST v1.1, Up to 2 years|Progression-free survival (PFS), PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first)., 3 years|Overall survival (OS), OS is the time from the first use of a therapeutic drug to death from any cause, 4 years|Treatment-related adverse events, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree, 3 years
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
NCT Number: NCT06472869
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Electronic Cigarette Use|Smoking, Cigarette|Nicotine Dependence
Interventions: OTHER: NJOY ACE e-cigarette
Sponsor: Massachusetts General Hospital
Collaborators: University of Massachusetts, Boston|Dana-Farber Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-08-31
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks).

The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.

Primary Outcome Measures: Study feasibility, Participant enrollment, measured by the proportion of eligible participants following in-person screening who enroll in the study. Retention is measured by weeks of study participation., 4 weeks|Cigarettes per day (CPD) smoked during the period of e-cigarette provision, Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4), 4 weeks
Secondary Outcome Measures: Carbon monoxide (CO) concentration in expired air, Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4), 4 weeks|Urine anabasine concentration, Change in participant's urine anabasine concentration during the period of e-cigarette provision (baseline to week 4), 4 weeks|Urine cotinine concentration, Change in concentration of cotinine (nicotine metabolite) in participant's urine during e-cigarette provision (baseline to week4), 4 weeks|Cigarettes smoked per day after e-cigarette provision ends, Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8), 4 weeks (Weeks 4-8)
Vasomotor Symptom Alleviation Through Acupuncture in Patients With Prostate Cancer
NCT Number: NCT06472856
Acronym: VASA Pro
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostate Cancer
Interventions: PROCEDURE: Acupuncture
Sponsor: University College Cork
Collaborators: Bon Secours Hospital, Cork
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-01
Locations: Bons Secours Hospital, Cork, Ireland

Summary:
A pilot study to assess the acceptability and efficacy of acupuncture in alleviating vasomotor symptoms (hot flushes and night sweats) in Irish patients with prostate cancer receiving androgen deprivation therapy.

Primary Outcome Measures: Feasibility of the intervention, Specially designed questionnaire, Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Secondary Outcome Measures: Changes in symptom interference scores, Changes in the Hot Flash Related Daily Interference Scale (HFRDIS). The scale is measured from 0-10, with lower scores indicating a better outcomes, Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished|Changes in sleep quality, Changes in Pittsburgh Sleep Quality Index (PSQI). Each answer is rated between 0-3, and a higher global score indicates a worse outcome., Completed after 6 weeks of acupuncture sessions and repeated 3 months after acupuncture has finished
Tailoring Upper Limb Exercise Advice for People With Parkinson Disease
NCT Number: NCT06472843
Acronym: ICEBERG
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease|Upper Limb|Aerobic Exercise
Interventions: BEHAVIORAL: Exercise Intervention
Sponsor: University of British Columbia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-09

Summary:
The investigators will explore the impact of hand cycling, on hand function in people with Parkinson's Disease (PD). The study will compare the effects of two different hand cycling approaches-steady-state and interval efforts-on improving hand dexterity in people with PD. Conducted as a clinical trial, it aims to understand if a single session of hand cycling can temporarily enhance hand function and if the nature of the exercise influences the benefit.

Primary Outcome Measures: 9-hole pegboard test, Time to complete the 9-hole pegboard test with the clinically more affected hand., Through study completion, an average of 9 months
Secondary Outcome Measures: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) score, Motor subscale of the movement disorders society revised unified Parkinson Disease Rating Scale, Through study completion, an average of 9 months|Finger tapping speed, Number of alternate finger taps completed in a 30 second period in each hand, Through study completion, an average of 9 months|Perceived exertion, Borg Category Ratio (CR)10 rating of perceived exertion (RPE) scale, Through study completion, an average of 9 months|Positive Affect, Self-reported positive-activated affect (PAA) two-dimensional likert scale, Through study completion, an average of 9 months|Enjoyment, Exercise Enjoyment (Likert scale), Through study completion, an average of 9 months
Prevalence of Monoclonal Gammopathy of Undetermined Significance (MGUS) Among Unique Populations of Black People
NCT Number: NCT06472830
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Monoclonal Gammopathy of Undetermined Significance
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-22
Completion Date: 2029-05
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study is being done to screen for monoclonal gammopathies in people of East African descent. Monoclonal gammopathy is a condition where abnormal proteins are found in the blood, most commonly called monoclonal gammopathy of undetermined significance or MGUS. There is little information on the presence of this condition in people of East African descent. This study is being done to determine how this condition affects this population in order to better treat and/or prevent this condition in the future.

Primary Outcome Measures: Prevalence of MGUS in people of east African descent, Screening for MGUS using mass spectrometry to detect monoclonal proteins among people of east African descent in Minnesota., Up to 10 years
Grounded Theory Study of the Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African Immigrant Men Diagnosed With Prostate Cancer
NCT Number: NCT06472817
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Prostate Carcinoma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-11
Completion Date: 2026-09-11
Locations: Georgia State University, Atlanta, Georgia, 30302-3965, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.

Primary Outcome Measures: Qualitative Interview - identification of themes and constructs, Data will be collected during an in-depth interview and will be analyzed with an inductive, open coding approach, first identifying themes, then constructs that emerge from the data will be categorized and mapped, noting new concepts and constructs. Theme convergence and divergence will be assessed. The interview guide focuses on participants' experiences and health-seeking behaviors regarding prostate cancer prevention, detection, decision-making, treatment, care, and survivorship., Baseline|Immigrant social determinants of health factors that impact Sub-Saharan African Immigrant (SSAI) carcinoma of the prostate (CaP) survivors, From the data generated in Outcome 1 interviews, an interpretive framework or theoretical model for SSAI men will be developed to evaluate and identify factors that contribute to or exacerbate disparities in prostate cancer., Baseline
Insomnia in Patients With Metastatic Lung Cancer
NCT Number: NCT06472804
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-06-19
Completion Date: 2026-06
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.

Primary Outcome Measures: Frequency of clinically significant insomnia, Will be assessed using the Insomnia Severity Index questionnaire (ISI), is a 7-item self-report questionnaire used to gauge the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. ISI score of 15 or greater will be used to categorize clinical insomnia. 0 - 7: no clinically significant insomnia, 8 - 14: subthreshold insomnia, 15 - 21: clinical insomnia (moderate severity), 22 - 28: clinical insomnia (severe)., Baseline
Vaginal Ecosystem and Network in the United States Study
NCT Number: NCT06472765
Acronym: VENUS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bacterial Vaginosis|Candidiasis|Urinary Tract Infections|Genitourinary Syndrome of Menopause|Lichen Sclerosus|Lichen Planus|Vulvodynia|Endometriosis|Ureaplasma Infections|Cancer|Desquamative Inflammatory Vaginitis
Sponsor: Vaginal Biome Science
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 3250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-16
Completion Date: 2026-05-15
Locations: Claris Health, Los Angeles, California, 90064, United States|Healthy Mothers, Healthy Babies Coalition of Hawaii, Honolulu, Hawaii, 96817, United States|Empowered Midwifery and Wellness LLC, Alexandria, Minnesota, 56308, United States|Gary H. Goldman, M.D., New York, New York, 10128, United States|Hormone Wellness, MD, Raleigh, North Carolina, 27612, United States|Camel City Women's Wellness, Winston-Salem, North Carolina, 27101, United States|UH Hospitals, Mayfield Heights, Ohio, 44124, United States|Haven Center for Sexual Medicine & Vulvovaginal Disorders, Tulsa, Oklahoma, 74137, United States|Center of the Health, Corvallis, Oregon, 97330, United States|Heidi Peterson, ND, Portland, Oregon, 97213, United States|Center for Pelvic Medicine, Bryn Mawr, Pennsylvania, 19010, United States|Hello Climax, Virginia Beach, Virginia, 23455, United States

Summary:
The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions. Specifically, the research aims to investigate how imbalances in microbial communities, such as the overgrowth of pathogenic bacteria or the depletion of beneficial ones, are linked to conditions like Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Vaginal Atrophy, and others. By employing PCR testing and the outcomes of next-generation sequencing (NGS) of the microbiome, the study seeks to identify distinct microbial profiles and patterns that are characteristic of each condition. This nuanced understanding is expected to lead to more accurate and early diagnosis, facilitating personalized and effective treatment strategies that go beyond the conventional, often indiscriminate use of antibiotics.

Primary Outcome Measures: Microbiome Analysis, To analyze the vaginal microbiome in patients with diverse vaginal health conditions using next-generation sequencing (NGS) and a 56-panel PCR test to understand microbial diversity and implications for disease management., First (and only) Visit
Secondary Outcome Measures: Registry, Data collection for future research, First (and only) Visit
Neoadjuvant Radiotherapy for High-risk UTUC
NCT Number: NCT06472752
Acronym: LUXUS07
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urothelial Carcinoma of the Renal Pelvis and Ureter
Interventions: RADIATION: Neoadjuvant radiotherapy|COMBINATION_PRODUCT: Neoadjuvant drug therapy
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2029-06-30
Locations: Departmeng of Urology, Peking University First Hospital, Beijing, China

Summary:
The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \[cT2 and above\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.

Primary Outcome Measures: Local tumor response, The criteria for evaluating the efficacy of solid tumours classify the evaluation of the lesion into four scenarios: complete response, partial response, stable disease, progression., 6 months
Secondary Outcome Measures: Disease free survival(DFS), includes local recurrence, metastasis and death, through study completion, an average of 3 year|Adverse effects, Peri-treatment adverse effects and life quality scores, Up to 1 year
Other Outcome Measures: Overall survival(OS), Overall survival, through study completion, an average of 3 year|Local recurrence free survival (LRFS), Includes operational region recurrence and lymph nodes metastasis, through study completion, an average of 3 year|Metastasis free survival (MFS), Distant metastasis, through study completion, an average of 3 year|Bladder recurrence free survival (BRFS), Bladder recurrence free survival, through study completion, an average of 3 year
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy
NCT Number: NCT06472739
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: GM-CSF
Interventions: DRUG: GM-CSF
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-09-15
Completion Date: 2024-11-15
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.

Primary Outcome Measures: The incidence of severe oral mucositis(grade 3+), To evaluate the incidence of severe oral mucositis between the two arms., During radiotherapy, up to 1.5 months.
Secondary Outcome Measures: Acute toxicities, The incidence rates of acute toxicities during treatment, evaluted by CTCAE Version5.0., One month.|The last time of ≥3 grade oral mucositis, The time from first observed ≥3 grade oral mucositis to first observed oral mucositis decrease to less than grade 3, 1 months after radiotherapy|Daily questionaire of oral mucositis (OMDQ), Patients are required to finish daily questionaire of oral mucositis by visual signs, 1 months after radiotherapy|Quality of life(QOL), QOL is calculated by QLQ-C30., 1 months after radiotherapy
Mental Health App for Cancer Survivors Study
NCT Number: NCT06472726
Acronym: MACS
Status: SUSPENDED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Cancer|Head and Neck Cancers|Depression
Interventions: BEHAVIORAL: IONA Mind app
Sponsor: University of Wisconsin, Madison
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-07-31
Locations: University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, 53705, United States

Summary:
The goal of this clinical trial is to adapt a mental health digital app to treat depression among head and neck cancer patients and survivors.

Participants will download and use the digital mental health app for a 6-week period, and will complete related surveys.

Primary Outcome Measures: Feasibility: Screening to enrollment ratio, Recruitment and Retention Tracking Tool will calculate the screening to enrollment ratio., baseline|Feasibility: Measured by Retention rate, The Recruitment and Retention Tracking Tool will calculate the the number of participants who are recruited, dropped out, and complete the intervention., up to 20 weeks|Feasibility: IONA Mind app Utilization in Minutes, Minutes of app usage, up to 20 weeks|Change in Patient Health Questionnaire-9 (PHQ-9), Clinical outcomes will be measured at baseline, weekly for 6 weeks during app utilization, and at post-intervention follow-up conducted at 1- and 3-month post intervention using the PHQ-9. The PHQ-9 is a 9-item scale assessing depression. It is scored on a 0- to 3-point Likert scale where 0=Not at all and 3 = nearly every day. Mean scores are reported for a range from 0-27 where higher scores indicate greater levels of depression, baseline, weekly during intervention from weeks 1 through 6, 1-month post intervention, 3-month post intervention (up to 20 weeks in total)|Satisfaction Measured by System Usability Scale, The System Usability Scale is a 10-item questionnaire assessing participants' satisfaction with the IONA Mind app. It is scored on a 1- to5-point Likert scale where 1= strongly disagree and 5= strongly agree. Mean item scores are reported with a range from 10 to 50 where higher scores indicate greater satisfaction with the app., 2 weeks post-intervention (up to 8 weeks on study)|Qualitative Measure of Acceptability, Ascertained via a qualitative semi-structured interview for a random subsample of 10 - 15 participants after completion of the intervention (1-2 weeks post-intervention). Interview answers with be coded for thematic analysis and reported by participant count., 2 weeks post-intervention (up to 8 weeks on study)
Clinical Study of Mitoxantrone Hydrochloride Liposome Combined With PD-1 Blockade in Recurrent or Metastatic NPC
NCT Number: NCT06472713
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Recurrent or Metastatic Nasopharyngeal Carcinoma
Interventions: DRUG: Mitoxantrone hydrochloride liposome injection
Sponsor: Ming-Yuan Chen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-09-30

Summary:
This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with PD-1 blockade in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1.

Primary Outcome Measures: Objective response rate (ORR), Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment, Through study completion, an average of 2 years
Secondary Outcome Measures: Duration of Response (DOR), Duration of Response (DOR) is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death, Through study completion, an average of 2 years|Disease control rate (DCR), Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents, Through study completion, an average of 2 years|Progression-free survival (PFS), Progression-Free Survival PFS is defined as the time from randomization to progression or death, Through study completion, an average of 2 years|Overall survival (OS), Overall survival (OS) is defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death., Through study completion, an average of 2 years
Endoscopic Extirpation of Benign Breast Tumors Using a Lateral Chest Wall Incision
NCT Number: NCT06472700
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Endoscopic Breast Surgery|Benign Breast Tumors
Interventions: OTHER: No intervention
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 42
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-10-01
Completion Date: 2023-11-30
Locations: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China

Summary:
1. A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast.
2. The feasibility of this surgery, key technical points, and potential complications have been analyzed.

Primary Outcome Measures: Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection, Through outpatient questionnaires and physician-rated photo evaluations, 1-3 months post-surgery.