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Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial. conditions: Oesophageal Atresia With Tracheo-Oesophageal Fistula conditions: Tracheomalacia conditions: Oesophageal Atresia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized 1:1 into either the intervention group (PPT-group) or the wait-and-see group (no-PPT). Since the sutures of the PPT remain in place (in the PPT-group), the participants are allocated to one arm for the duration of the study. After the PPT was or was not performed, the participants will follow the same follow-up schedule. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: All participants, parents/caregivers, investigators and treating healthcare personnel, except for the surgical team performing the OA correction, will be blinded to which study arm the participant is assigned. None of the data gathered is affected by the unblinded surgical team since the primary and key secondary outcome measures are evaluated based on pseudonymised video footage. Furthermore, this video footage is assessed by otolaryngologists who are blinded to the patient and study arm. Moreover, the follow-up and documentation of the secondary endpoints are typically performed by the paediatrician and speech- and language therapists (not the paediatric surgeon or otolaryngologist). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: Randomisation between the PPT- and no-PPT-group name: Primary Posterior Tracheopexy name: Preoperative tracheobronchoscopy name: Intraoperative tracheobronchoscopy name: Postoperative tracheobronchoscopy through the endotracheal tube during extubation name: Postoperative tracheobronchoscopy after 2-6 months measure: Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy measure: Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy measure: Difference in symptoms between the PPT-group and no-PPT-group measure: Degree of preoperative TM compared to postoperative TM sex: ALL minimumAge: 34 Weeks stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335849 id: LYB004-CT-AUS-101 briefTitle: A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-05 date: 2024-03-28 date: 2024-03-28 name: Guangzhou Patronus Biotech Co., Ltd. class: INDUSTRY name: Yantai Patronus Biotech Co., Ltd. briefSummary: This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years. conditions: Herpes Zoster studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: LYB004 25µg name: LYB004 50µg name: SHINGRIX measure: Evaluate the reactogenicity of LYB004 vaccine measure: Evaluate the safety and reactogenicity of LYB004 vaccine measure: Evaluate the safety of LYB004 vaccine measure: Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine measure: Evaluate the SAEs and AESIs of LYB004 vaccine measure: Observe the humoral immunity of LYB004 vaccine measure: Observe the cellular immunity of LYB004 vaccine measure: Observe the persistence of humoral immunity of LYB004 vaccine measure: Observe the persistence of cellular immunity of LYB004 vaccine sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nucleus Network Pty Ltd city: Melbourne state: Victoria zip: 3004 country: Australia name: Katherine Gunn role: CONTACT phone: (07) 3707 2781 email: k.gunn@nucleusnetwork.com.au name: Kristof Boot role: CONTACT phone: (07) 3707 2780 email: k.boot@nucleusnetwork.com.au name: Christina Chang, M.D. role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06335836 id: 2024-SR-127 id: 2024-SR-127 type: OTHER domain: Ethics Committee of Nanjing Medical University briefTitle: The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD) overallStatus: RECRUITING date: 2024-03-01 date: 2028-12-30 date: 2028-12-30 date: 2024-03-28 date: 2024-03-28 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD
1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD;
2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation;
3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions;
4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients. conditions: Social Isolation conditions: SCD conditions: Subjective Cognitive Decline conditions: MCI conditions: Mild Cognitive Impairment conditions: AD conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 209 type: ESTIMATED name: social isolation measure: Incidence of Mild Cognitive Impairment (MCI) measure: Incidence of Alzheimer's disease (AD) measure: AVLT-H measure: MoCA measure: WMS-RLM measure: WDS measure: VFT measure: BNT measure: LSNS-6 measure: UCLA measure: GDS measure: PSQI measure: DTC measure: fMRI measure: tau measure: Aβ measure: APOE genotyping measure: TMT-A, TMT-B sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: China, Jiangsu zip: 210000 country: China name: Zhu Yi role: CONTACT phone: +86 137 0516 4030 email: ZhuYi1981@njmu.edu.cn name: Shi Chunxu role: CONTACT phone: +8618625175592 email: scx_0212@outlook.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06335823 id: STUDY20231621 briefTitle: Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2025-08-01 date: 2024-03-28 date: 2024-03-28 name: Jean Marino class: OTHER briefSummary: Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement. conditions: IUD Insertion Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Transcutaneous electrical nerve stimulation (TENS) name: Placebo Transcutaneous electrical nerve stimulation (TENS) measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score measure: Pain during IUD insertion as measured by the VAS score sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University Hospitals city: Cleveland state: Ohio zip: 44106 country: United States name: Jean M Marino, APRN-CNP role: CONTACT phone: 440-720-3250 email: Jean.Marino@UHhospitals.org lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06335810 id: 23-10026599 id: R01DK135949-01 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK135949-01 briefTitle: Reducing Obesity Using Social Ties Program acronym: ROBUST overallStatus: RECRUITING date: 2024-04-05 date: 2026-03 date: 2026-03 date: 2024-03-28 date: 2024-04-17 name: Weill Medical College of Cornell University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Social Network Intervention name: Individual Lifestyle Intervention name: Social Network Member measure: Number of participants who have attended at least 75 percent of the behavioral coaching sessions measure: Number of intervention participants who have at least one social network member engage in the study measure: Number of participants and social network members combined who complete the final study assessment measure: Change in positive communication and problem solving as measured by the McMaster Family Assessment Device (FAD) Questionnaire measure: Change in weight related social norms measure: Change in median Fitbit wear time in minutes measure: Change in total caloric amounts on three-day food record measure: Change in median number of days that the Fitbit is worn sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Urology status: RECRUITING city: Brooklyn state: New York zip: 11217 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.6501 lon: -73.94958 facility: Weill Cornell Internal Medicine Associates status: RECRUITING city: New York state: New York zip: 10021 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.71427 lon: -74.00597 facility: Weill Cornell Primary Care at Lower Manhattan status: RECRUITING city: New York state: New York zip: 10038 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.71427 lon: -74.00597 facility: Weill Cornell Urology status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Jesabely Solano, BS role: CONTACT phone: 646-962-9209 email: jes4037@med.cornell.edu lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06335797 id: IRB00110733 briefTitle: Optimization of Postoperative Bowel Habits overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Wake Forest University Health Sciences class: OTHER briefSummary: Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 88 type: ESTIMATED name: Senna Tab name: Dulcolax Suppositories measure: Time in hours to first bowel movement comparison between the two arms measure: Change in Overall Satisfaction (TSQM) Scores measure: Visual Analog Scale (VAS) Pain Scores measure: Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores measure: Bristol Stool Form Scale (BSFS) Scores sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Christina M Mezes, MD role: CONTACT phone: 336-713-4098 email: cmezes@wakehealth.edu name: Sachin N Vyas, MS, PhD role: CONTACT phone: 336.713.4098 email: svyas@wakehealth.edu lat: 36.09986 lon: -80.24422 hasResults: False
<\|newrecord\|> nctId: NCT06335784 id: 2023-00456 briefTitle: Mental Imagery and Targeted Memory Reactivation in Insomnia overallStatus: RECRUITING date: 2024-04-22 date: 2027-05-31 date: 2027-08-31 date: 2024-03-28 date: 2024-04-23 name: University Hospital, Geneva class: OTHER name: University of Geneva, Switzerland briefSummary: In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).
Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.
Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).
At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night.
The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition. conditions: Insomnia Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Imagery Rescripting (IR) name: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep name: Sleep Hygiene name: Sleep Hygiene + Odor name: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention measure: Insomnia Severity Index (ISI) measure: Pittsburgh sleep quality index (PSQI) measure: Total Sleep Time (TST) measure: Wake After Sleep Onset (WASO) measure: Beck Depression Inventory II (BDI-II) measure: State Trait Anxiety Inventory (STAI) measure: Sleep efficiency (SE) measure: Micro-arousals measure: Temperament and Character Inventory measure: Pre-sleep Arousal Scale (PSAS) measure: Arousal Predisposition Scale (APS) measure: Digit Span Task measure: Psychomotor Vigilance Task (PVT) measure: Declarative word paired-associate learning task measure: Attachment Style Questionnaire (ASQ) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Center for Sleep Medicine status: RECRUITING city: Geneva country: Switzerland name: Lampros Perogamvros role: CONTACT phone: +41223729946 email: Lampros.Perogamvros@hcuge.ch name: Lampros Perogamvros role: PRINCIPAL_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False
<\|newrecord\|> nctId: NCT06335771 id: 2098077 id: R01DK131188 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK131188 briefTitle: Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity acronym: ATM overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-03 date: 2028-03 date: 2024-03-28 date: 2024-03-28 name: Bettina Mittendorfer class: OTHER name: National Institutes of Health (NIH) name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.
Both groups will have:
* screening visit
* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)
* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss. conditions: Obesity conditions: Nonalcoholic Fatty Liver conditions: Diabetes Type 2 conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Dietary consultation weight loss intervention measure: Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. measure: 24-hour plasma glucose concentration measure: Macrophage isolation in adipose tissue biopsy measure: Macrophage isolation in skeletal muscle tissue sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri School of Medicine city: Columbia state: Missouri zip: 65212 country: United States name: Bettina Mittendorfer role: CONTACT phone: 573-822-9377 email: b.mittendorfer@missouri.edu lat: 38.95171 lon: -92.33407 hasResults: False
<\|newrecord\|> nctId: NCT06335758 id: EXC-039-2023-CLR briefTitle: Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication. acronym: RegStud overallStatus: RECRUITING date: 2024-01-15 date: 2025-12-31 date: 2026-01-31 date: 2024-03-28 date: 2024-03-28 name: Dosentrx Ltd. class: INDUSTRY name: US Oncology Research briefSummary: The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.
The study will evaluate and monitor use of ReX in respect of:
* treatment duration
* adverse events
* patient adherence and compliance
* engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen. conditions: Any Solid Oral Medication studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Use of ReX to dispense and monitor solid oral medication therapy. measure: Treatment duration measure: Patient satisfaction measure: Adverse events measure: Patient adherence measure: Patient compliance measure: Patient engagement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHC status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Zachary Beck role: CONTACT lat: 39.12713 lon: -84.51435 hasResults: False
<\|newrecord\|> nctId: NCT06335745 id: 24-066 briefTitle: PediCARE Health Equity Intervention in High-Risk Neuroblastoma overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-04-01 date: 2030-04-01 date: 2024-03-28 date: 2024-03-28 name: Dana-Farber Cancer Institute class: OTHER briefSummary: This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.
The names of the intervention groups in this research study are:
* Usual supportive care
* PediCARE + usual supportive care conditions: Neuroblastoma conditions: High-risk Neuroblastoma conditions: Pediatric Cancer conditions: Disparities conditions: Financial Stress conditions: Poverty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 130 type: ESTIMATED name: PediCARE Intervention measure: Change in Kessler-6 Psychological Distress Scale Score measure: Proportion of Enrolled Participants (Feasibility) measure: Change in Mean Household Material Hardship (HMH) Score sex: ALL minimumAge: 0 Years maximumAge: 17 Years stdAges: CHILD facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Dana Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06335732 id: P.T.REC/012/004394 briefTitle: Prevalenc Of Lumbosacral Radiculopathy Among Physiotherapists Of Pediatric Rehabilitation OF PEDIATRIC REHABILITATION overallStatus: COMPLETED date: 2022-12-05 date: 2023-06-08 date: 2023-08-22 date: 2024-03-28 date: 2024-03-28 name: Kerolous Ishak Shehata class: OTHER briefSummary: Determine the prevalence of lumbosacral radiculopathy among pediatric physiotherapists in the ministry of health in Cairo, Egypt. conditions: Prevalence, Lumbosacral Radiculopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ACTUAL name: Cross section study; single group related measurement design. measure: The Roland-Morris disability scale (RMS) measure: Straight Leg Raising (SLR) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Kerolous Ishak Shehata city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06335719 id: IRB #22-926 briefTitle: Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome overallStatus: RECRUITING date: 2023-03-01 date: 2025-03 date: 2025-06 date: 2024-03-28 date: 2024-03-28 name: The Cleveland Clinic class: OTHER briefSummary: A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery. conditions: Facial Paralysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy.
Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: BES name: Standard of Care surgery measure: To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology. measure: To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Foundation status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Hana Rosen, MD role: CONTACT phone: 216-444-7018 email: rosenh@ccf.org name: John O'Neill, BS role: CONTACT phone: 4405062611 email: oneillj2@ccf.org name: Patrick Byrne, MD role: PRINCIPAL_INVESTIGATOR name: Michael Fritz, MD role: SUB_INVESTIGATOR name: Brandon Hopkins, MD role: SUB_INVESTIGATOR name: Peter Ciolek, MD role: SUB_INVESTIGATOR name: Dane Genther, MD role: SUB_INVESTIGATOR name: Stephen Hadford, MD role: SUB_INVESTIGATOR name: Peng Ding, MD role: SUB_INVESTIGATOR name: Derek Vos, BS role: SUB_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06335706 id: 0596/66 briefTitle: The Influence of Fit of Underpants Worn on Semen Quality overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-28 date: 2024-03-28 name: Chulalongkorn University class: OTHER briefSummary: The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are:
* Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity.
* Determining the prevalence of preferred type of underpants worn by Thai males.
The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample. conditions: Infertility, Male conditions: Semen Analysis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: Fit of underpants worn measure: Semen Volume measure: Total sperm count measure: Sperm concentration measure: Sperm motility measure: Sperm morphology measure: Sperm DNA integrity measure: Preferred type of underpants sex: MALE minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335693 id: CHHHospital briefTitle: Adjuvant Hypofractionated Radiotherapy for Prostate Cancer overallStatus: RECRUITING date: 2024-03-28 date: 2026-02-28 date: 2027-02-28 date: 2024-03-28 date: 2024-03-28 name: Changhai Hospital class: OTHER briefSummary: Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Radiotherapy measure: Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events measure: progression-free survival (PFS) measure: medical expenses measure: quality of life(QoL) measure: overall survival (OS) measure: prostate cancer-specific survival (CSS) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Naval Medical University status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, PhD role: CONTACT phone: 021-31162222 email: huojunzh@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06335680 id: 21-001493 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-03-28 date: 2024-03-28 name: [Redacted] hasResults: False
<\|newrecord\|> nctId: NCT06335667 id: 4565 id: UCI 23-72 type: OTHER domain: UCI CFCCC briefTitle: mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer Objectives overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2030-04 date: 2024-03-28 date: 2024-03-28 name: University of California, Irvine class: OTHER briefSummary: This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC). conditions: Urothelial Bladder Cancer conditions: Muscle-Invasive Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: mpMRI + Diagnostic TURBT measure: Incidence of concordance between VI-RADS score of 4 or 5 (i.e. muscular propria is likely or very likely) on mpMRI and pathologic muscularis propria invasion (i.e. pT2 tumor stage) on diagnostic TURBT. measure: Progression free survival (PFS) with mpMRI compared to diagnostic TURBT measure: Time from intervention that determines invasiveness of bladder tumors (i.e. diagnostic TURBT versus mpMRI) to initiation of cancer-directed therapy measure: Time from initial cystoscopy to intervention that determines invasiveness of bladder tumors (i.e diagnostic TURBT versus mpMRI). measure: Incidence of adverse events with mpMRI versus diagnostic TURBT. measure: Patient Quality of Life with mpMRI versus diagnostic TURBT. measure: Incidence of repeat TURBT. measure: Diagnostic healthcare expenditure with mpMRI versus diagnostic TURBT sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chao Family Comprehensive Cancer Center University of California, Irvine city: Orange state: California zip: 92868 country: United States name: Nataliya Mar, MD role: CONTACT phone: 877-827-8839 email: ucstudy@uci.edu lat: 33.78779 lon: -117.85311 hasResults: False
<\|newrecord\|> nctId: NCT06335654 id: 24K056-001 briefTitle: Real-time Artificial Intelligence-based Endocytoscopic Diagnosis of Colorectal Neoplasms overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-18 name: The First Hospital of Jilin University class: OTHER briefSummary: Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to distinguish neoplastic from non-neoplastic during colonoscopy. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC can demonstrate the atypical of gland structure and cells after staining and display the super-amplified surface microvessels of the lesion under the EC-NBI mode. However, the judgment of endocytoscopic images needs a lot of experience to improve the diagnostic accuracy. Moreover, endoscopists have certain subjective judgments and errors in endocytoscopic diagnosis. There is an artificial intelligence system which has been developed to identify colorectal neoplasms. However, there is still a lack of prospective clinical verification based on Chinese population. In the study, the investigators performed a prospective clinical study to determine the diagnostic accuracy of artificial intelligence system. conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: artificial intelligence system measure: sensitivity measure: specificity measure: accuracy measure: positive predictive value measure: negative predictive value measure: high confidence diagnosis rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: First hospital of Jilin University status: RECRUITING city: Changchun state: Jilin zip: 130021 country: China lat: 43.88 lon: 125.32278 hasResults: False
<\|newrecord\|> nctId: NCT06335641 id: COOLHD24-CAN briefTitle: Head COOLing in iscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety stuDy acronym: COOLHEAD-2-CAN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-28 date: 2024-03-28 name: University of Calgary class: OTHER briefSummary: This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: External active conductive head cooling measure: Adherence to the intervention. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335628 id: RCT: CTG-VCMX briefTitle: Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2029-04 date: 2024-03-28 date: 2024-03-28 name: University of Bern class: OTHER briefSummary: The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed. conditions: Connective Tissue Graft conditions: Volume Collagen Matrix Xenograft studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 38 type: ESTIMATED name: Geistlich Fibro-Gide® measure: Volumetric dimensional changes measure: Clinical: PPD measure: Clinical BoP measure: Clinical: Suppuration measure: Clinical: Mucosa measure: Clinical: ktw measure: Clinical: Mobility measure: Clinical: Thickness measure: Clinical: Contributing factors measure: Patient-reported satisfaction measure: Patient-reported esthetics measure: Patient-reported discomfort measure: Patient-reported pain measure: Prosthetics Survival measure: Prosthetics Sucess measure: Prosthetics Complications measure: Prosthetics PES-WES measure: Prosthetics: Occlusal measure: Prosthetics: Interproximal measure: Radiographics BL measure: Radiographics PP measure: Radiographics distance measure: Radiographics Contacts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bern city: Bern zip: 3010 country: Switzerland name: Martin Schimmel, Prof. role: CONTACT phone: +41316840630 email: martin.schimmel@unibe.ch name: Manrique Fonseca, Dr. med. dent. role: PRINCIPAL_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False
<\|newrecord\|> nctId: NCT06335615 id: FMG-5790_2023 briefTitle: A Brief Acceptance Intervention for Stress to Improve Students' Well-Being overallStatus: COMPLETED date: 2023-11-27 date: 2023-12-19 date: 2023-12-19 date: 2024-03-28 date: 2024-03-28 name: VU University of Amsterdam class: OTHER briefSummary: The goal of this randomized controlled trial is to test a brief psychological intervention that focusses on acceptance of stress in a student population. The main questions it aims to answer are:
* Does this brief acceptance intervention increase the well-being of students in the short term?
* By which mechanisms does this effect occur?
* What are moderating factors of this effect?
Half of the participants follow a one-hour intervention, which includes
* psychoeducation and metaphors about stress and how acceptance can help to deal with it
* experiential exercises
* mindfulness meditation
* mindfulness homework practice
Students that receive the intervention will be compared to students that merely received psychoeducation about stress and acceptance to see if the intervention lead to larger increases in well-being. conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 116 type: ACTUAL name: Brief Acceptance Intervention name: Psychoeducation measure: Psychological Well-Being measure: State Anxiety measure: Study Stress measure: Interoceptive awareness measure: Psychological Flexibility sex: ALL minimumAge: 17 Years maximumAge: 29 Years stdAges: CHILD stdAges: ADULT facility: University of Amsterdam city: Amsterdam state: Noord-Holland zip: 1018 WS country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06335602 id: 202301283A3 briefTitle: TCM for Post-operative Edema overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-09-30 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Chang Gung Memorial Hospital class: OTHER briefSummary: There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.
Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine. conditions: Anterior Cruciate Ligament Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: LASER acupuncture measure: Leg girth measurement measure: VAS measure: WOMAC measure: Tegner score sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335589 id: CDX 24-002 briefTitle: Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2026-12-31 date: 2026-12-31 date: 2024-03-28 date: 2024-03-28 name: VA Office of Research and Development class: FED briefSummary: Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment). conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Massed PTSD treatment (e.g., cognitive processing therapy \[CPT\] or prolonged exposure \[PE\] therapy delivered at least 3 times per week) will be compared to CPT \& PE delivered as usual, which is usually once per week. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical interviewers who assess primary outcomes will not be informed of participant's randomization assignment. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: EBP-Massed name: EBP-TAU measure: Treatment completion measure: Acceptability of Intervention (AIM) measure: Client Satisfaction Questionnaire-8 (CSQ-8) measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Severity Score measure: Session attendance measure: Patient Health Questionnaire-9 (PHQ-9) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Brief Inventory of Psychosocial Functioning (BIPF) measure: Brief Inventory of Psychosocial Functioning (BIPF) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Durham VA Medical Center, Durham, NC city: Durham state: North Carolina zip: 27705-3875 country: United States name: Stephanie Y Wells, PhD MS BA role: CONTACT phone: 919-286-0411 phoneExt: 134053 email: stephanie.wells2@va.gov name: Laurel B Koss, MS OTR role: CONTACT phone: (919) 286-0411 phoneExt: 775648 email: laurel.koss@va.gov name: Stephanie Y Wells, PhD MS BA role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06335576 id: ZSGCproteomics briefTitle: Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical Application overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-10-31 date: 2026-12-31 date: 2024-03-28 date: 2024-03-28 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: This study is a prospective, single-center, observational study aimed at detecting the status of serum protein profiles at key time points in gastric cancer patients receiving neoadjuvant therapy for advanced disease, and constructing a serum protein model for evaluating the efficacy of neoadjuvant therapy for gastric cancer. Subjects will receive neoadjuvant therapy (treatment regimen determined by the primary physician, limited to systemic therapy, with options including immune checkpoint inhibitor-based regimens and non-immune checkpoint inhibitor-based regimens). After four cycles of treatment, the efficacy will be assessed. Patients eligible for R0 resection will undergo D2 radical surgery regardless of tumor regression, while those ineligible for R0 resection will enter the palliative treatment phase (Note: Subjects are all patients who require neoadjuvant therapy even if they do not participate in this clinical study). Patients will receive regular follow-up evaluations for metastasis/recurrence and survival until tumor recurrence/progression or the last known date of patient survival (Note: Regular follow-up in this study follows the frequency of routine clinical follow-ups). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is pathological response rate (based on Becker tumor regression grading, with residual tumor less than 50% considered effective preoperative treatment).
Peripheral venous blood samples will be collected before the start of neoadjuvant therapy (blood sampling point 1 - baseline) and before surgery after neoadjuvant therapy (blood sampling point 2 - post-treatment). Approximately 3 ml of blood will be collected each time, and about 1.5 ml of serum will be obtained after processing. Serum protein profiling will be conducted to assess the expression of protein profiles at these treatment time points. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ESTIMATED name: This study is a single-arm and observational study with no intervention. measure: C-index measure: Sensitivity and specificity of model sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335563 id: STAR009 briefTitle: Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules overallStatus: RECRUITING date: 2024-03-14 date: 2024-12-01 date: 2024-12-01 date: 2024-03-28 date: 2024-04-12 name: Shanghai Pulmonary Hospital, Shanghai, China class: OTHER briefSummary: This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules. conditions: Pulmonary Nodule studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group primaryPurpose: TREATMENT masking: NONE maskingDescription: no masking count: 166 type: ESTIMATED name: AR glasses-assisted pulmonary nodule puncture localization name: CT-guided pulmonary nodule puncture localization measure: Accuracy of puncture localization of pulmonary nodules measure: Success rate of puncture localization of pulmonary nodules measure: Adjust the number of needle punctures measure: Operating time measure: Radiation dose sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Shenghao Huang role: CONTACT email: huangshplus5@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06335550 id: 2021/2680 briefTitle: Surgical and Patient Reported Outcomes in Robotic Mastectomy overallStatus: COMPLETED date: 2022-11-24 date: 2023-12-31 date: 2024-03-01 date: 2024-03-28 date: 2024-03-28 name: Changi General Hospital class: OTHER briefSummary: Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.
In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.
To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.
The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 29 type: ACTUAL name: Robotic mastectomy measure: Surgical Outcomes - Operative parameters measure: Surgical Outcomes - Length of stay (days) measure: Surgical Outcomes- 30-days morbidity/complications measure: Oncologic outcomes measure: Learning curve sex: FEMALE minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-05 uploadDate: 2024-03-08T05:13 filename: Prot_SAP_000.pdf size: 785756 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-05-03 uploadDate: 2024-03-08T05:19 filename: ICF_001.pdf size: 704077 hasResults: False
<\|newrecord\|> nctId: NCT06335537 id: 2405 briefTitle: Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2026-02 date: 2024-03-28 date: 2024-04-24 name: University of California, Irvine class: OTHER briefSummary: The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels. conditions: Uric Acid Stones studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The following study will be a randomized cross-over trial evaluating the effects of baking soda and Urocit-K on 24-hour urinary parameters in hypocitrituric calcium oxalate and uric acid stone formers. All participants that consent to participate in the study will undergo the same tests.
Participants will begin a 2-week washout period of Urocit-K as their standard of care. After completion of the washout period subjects will be randomized to take either Urocit-K or Baking Soda for 4 weeks. After participants undergo a secondary 2-week washout period, then they are assigned to medication not taken in the first study period for 4 weeks. primaryPurpose: TREATMENT masking: NONE maskingDescription: This is an unblinded study. count: 100 type: ESTIMATED name: Potassium citrate name: Sodium bicarbonate measure: Change in 24-hour Urinary pH measure: Change in 24-hour Urinary Citrate measure: Change in Supersaturation of Calcium Oxalate measure: Change in Supersaturation of Uric acid sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Irvine Medical Center city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 hasResults: False
<\|newrecord\|> nctId: NCT06335524 id: IRB-300012718 briefTitle: Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-08 date: 2028-08 date: 2024-03-28 date: 2024-03-28 name: University of Alabama at Birmingham class: OTHER briefSummary: This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age. conditions: Child Development conditions: Infant Development conditions: Infant, Premature, Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 188 type: ESTIMATED name: Finger puppet name: Bookworm reading intervention training and routine EDI care. measure: ASQ-3 scores measure: ASQ-3 scores measure: ASQ scores below -2SD measure: ASQ scores below -2SD measure: ASQ scores below -1SD measure: ASQ scores below -1SD measure: ASQ-SE2 scores measure: ASQ-SE2 scores measure: Severe neurodevelopmental impairment measure: Moderate or severe neurodevelopmental impairment measure: Cognitive Composite Score on BSID-IV measure: Language Composite Score on BSID-IV measure: Motor Composite Score on BSID-IV measure: Edinburgh Postnatal Depression Scale measure: MCHAT score sex: ALL minimumAge: 1 Day maximumAge: 17 Weeks stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06335511 id: 631-2021-OSS-AUSLBO briefTitle: Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study acronym: ARCHIMEDE overallStatus: RECRUITING date: 2022-10-10 date: 2025-02-28 date: 2025-02-28 date: 2024-03-28 date: 2024-03-28 name: Azienda Usl di Bologna class: OTHER_GOV briefSummary: Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis. conditions: Lumbar Spinal Stenosis conditions: Degenerative Lumbar Spinal Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: microsurgical decompression name: decompression and instrumented fusion measure: Short Form 12 measure: Short Form 12 measure: Short Form 12 measure: Short Form 12 measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Oswestry Disability Index measure: Oswestry Disability Index measure: Oswestry Disability Index measure: Oswestry Disability Index measure: EuroQol-5D measure: EuroQol-5D measure: EuroQol-5D measure: EuroQol-5D measure: Postural Balance measure: Postural Balance measure: Postural Balance measure: Postural Balance measure: Locomotor performance measure: Locomotor performance measure: Locomotor performance measure: Locomotor performance measure: Spinal mobility measure: Spinal mobility measure: Spinal mobility measure: Spinal mobility measure: Evaluation of costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Ortopedico Rizzolo status: RECRUITING city: Bologna zip: 40136 country: Italy name: Giovanni Barbanti Brodano, Dr. role: CONTACT phone: +390516366971 email: giovanni.barbantibrodano@ior.it lat: 44.49381 lon: 11.33875 facility: IRCCS Istituto delle Scienze Neurologiche di Bologna status: RECRUITING city: Bologna zip: 40139 country: Italy name: Alfredo Conti, Prof. role: CONTACT phone: 3382131017 email: alfredo.conti2@unibo.it lat: 44.49381 lon: 11.33875 hasResults: False
<\|newrecord\|> nctId: NCT06335498 id: 130-0008P briefTitle: Further Study of AFGen1 Clinical Performance acronym: CS3 overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-02 date: 2024-04-12 date: 2024-04-19 date: 2024-03-28 date: 2024-04-12 name: TriVirum, Inc. class: INDUSTRY briefSummary: AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants. conditions: Atrial Fibrillation conditions: Afib conditions: ECG studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: ECG co-measurement name: Periodic ECG triggered measurement measure: Bland-Altman Comparison measure: Qualitative Evaluation measure: Adhesive performance sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1808 49Th St Ct NW city: Gig Harbor state: Washington zip: 98335 country: United States lat: 47.32926 lon: -122.58013 hasResults: False
<\|newrecord\|> nctId: NCT06335485 id: 2020- P123456 briefTitle: Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery overallStatus: COMPLETED date: 2021-04-01 date: 2022-09-29 date: 2022-09-29 date: 2024-03-28 date: 2024-03-28 name: Brigham and Women's Hospital class: OTHER briefSummary: This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery. conditions: Back Pain conditions: Cognitive Behavioral Therapy conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients are randomized to either the intervention group or general group, for the intervention group patients will be randomly assigned to attend 4 weekly online virtual CBT sessions that will provide information on stress and pain reduction techniques before surgery, and 2 sessions following patient surgery. primaryPurpose: PREVENTION masking: NONE count: 32 type: ACTUAL name: Cognitive Behavioral Therapy measure: Numeric Pain Rating measure: Pain Medication Usage measure: Activity Tracking (Digital Phenotyping) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06335472 id: Three nerves radiofrequency briefTitle: Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-03 date: 2027-03-05 date: 2024-03-28 date: 2024-03-28 name: Assiut University class: OTHER briefSummary: comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up. conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Ultrasound-guided effect of three nerves pulsed radiofrequency versus supra-scapular nerve pulsed radiofrequency both combined with hydro-dissection in reducing the intensity of pain in adhesive capsulitis primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: pain control and range of motion in adhesive capsulitis whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 3 nerves pulsed radiofrequency with hydrodissection name: suprascapular nerve pulsed radiofrequency with hydrodissection measure: The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score. sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut university Hospital city: Assiut country: Egypt name: safaa noaman, assistant lecturer role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06335459 id: Epidemiology of bunion briefTitle: Epidemiology of Bunion and Risk Factors overallStatus: NOT_YET_RECRUITING date: 2024-07-24 date: 2025-04-05 date: 2025-06-01 date: 2024-03-28 date: 2024-03-28 name: Assiut University class: OTHER briefSummary: Analysis of the collected data to determine:
* Prevalence.
* Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus conditions: Hallux Valgus and Bunion studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED name: epidemiology measure: History taken and well clinical examination and AP Foot standing position of 2000 randomly case with determination of Hallux Valgus angles knowing if It's Hallux Valgus or not calculating The prevalence sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335446 id: 011040- AT validation phase id: PG/16/10/32016 type: OTHER_GRANT domain: British Heart Foundation briefTitle: Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation overallStatus: COMPLETED date: 2016-10 date: 2019-10 date: 2019-10 date: 2024-03-28 date: 2024-03-28 name: Barts & The London NHS Trust class: OTHER briefSummary: Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.
STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT. conditions: Atrial Tachycardia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: Novel mapping algorithm measure: STAR maps compared to conventional maps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barts Heart Centre city: London zip: EC1A 7BE country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06335433 id: RM_30_06_22b briefTitle: Isometric Handgrip Training Frequency and Blood Pressure in People With Hypertension overallStatus: RECRUITING date: 2024-03-20 date: 2026-03 date: 2026-03 date: 2024-03-28 date: 2024-03-28 name: Swansea University class: OTHER briefSummary: Hypertension is the most important cause of cardiovascular disease (CVD), stroke, and premature death (WHO, 2021). It is estimated by The World Health Organisation in 2021 that 1.4 billion individuals across the globe have high blood pressure, with only 14% of people actively managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Physical activity is one possible strategy: in previous research, several different types of physical activity have been shown to have beneficial effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of physical activity (150 mins of moderate intensity physical activity per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort, exertion, and physical discomfort (Korkiakangas et al 2009). Thus, there is a need to identify alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021, Toohey et al, 2018).
Low intensity isometric hand grip exercise training (IET) has been shown to result in large decreases in resting blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IET has almost universally involved performing 4 x 2 IET holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). There are very few studies that have investigated the effect of changing different protocol parameters on changes in blood pressure and vascular health, and the minimal effective dose of IET is unknown. Defining the minimal effective dose of different types of exercise may help overcome key barriers to exercise by lowering the required time commitment, reducing perceived effort/exertion, and promoting more positive affective responses. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IET will reduce the efficacy for improving blood pressure.
Therefore, the primary objective of this study is to determine if reducing the frequency of isometric handgrip training from four times a week to two times a week will affect the improvements in resting blood pressure and vascular health in people with hypertension. A secondary objective is to investigate the acute affective and perceptual responses to sessions of IET and the effect of training on these acute affective/perceptual responses. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled trial primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Exercise Training (Isometric Handgrip Exercise) measure: Office measured supine and seated systolic, diastolic and mean arterial pressure measure: Office measured central systolic, diastolic and mean arterial pressure measure: 24-h mean ambulatory systolic, diastolic, and mean arterial pressure measure: Daytime ambulatory systolic, diastolic, and mean arterial pressure measure: Sleeping ambulatory systolic, diastolic and mean arterial pressure measure: Carotid-Femoral Pulse Wave Velocity measure: Affective Valence (Feeling Scale) measure: Ratings of perceived exertion sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swansea University status: RECRUITING city: Swansea state: Wales zip: SA18EN country: United Kingdom name: Richard Metcalfe, PhD role: CONTACT phone: 01792205678 phoneExt: 4779 email: r.s.metcalfe@swansea.ac.uk lat: 51.62079 lon: -3.94323 hasResults: False
<\|newrecord\|> nctId: NCT06335420 id: 324-2023-GB briefTitle: Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps acronym: Px7 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-09 date: 2024-03-28 date: 2024-03-28 name: Odense University Hospital class: OTHER name: Karolinska Institutet name: Umeå University name: Uppsala University Hospital name: Sahlgrenska University Hospital, Sweden name: Svendborg Hospital briefSummary: The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.
The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?
Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.
Researchers will compare the group with ingestion of FaOH/FaDOH rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients. conditions: Colorectal Cancer Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Carrot juice from Yellowstone carrots cultivars name: Placebo juice measure: Number and size of polyps found at the one-year follow up colonoscopy measure: Polyp number and size in relation to carrot consumption measurement measure: Compliance rate (Juice consumption level) measure: Side effects measure: Acceptability of treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery, Odense University Hospital city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06335407 id: AS210006-A08 id: W81XWH-21-2-0026 type: OTHER_GRANT domain: DoDCongressionally Directed Medical Research Program briefTitle: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-09-30 date: 2025-10-29 date: 2024-03-28 date: 2024-03-28 name: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance class: OTHER name: United States Department of Defense name: Congressionally Directed Medical Research Programs name: VA Connecticut Healthcare System name: BioXcel Therapeutics Inc name: Yale University name: RTI International briefSummary: The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. conditions: Alcohol Use Disorder (AUD) conditions: Post Traumatic Stress Disorder (PTSD) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Participants will receive 40µg on days 1-2. On days 3 and 4, participants will receive 40µg twice per day. On days 5 and 6 participants will receive 40µg in the morning and 80µg in the evening. If dosing is tolerated, per clinical judgement, participants will begin to receive 80µg twice per day on days 7-28. primaryPurpose: OTHER masking: NONE maskingDescription: no one will be masked count: 10 type: ESTIMATED name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg name: Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg measure: Change in Blood Pressure (Systolic and Diastolic) from baseline (pre-treatment) through day 28. measure: Change in anxiety (measured via the State Trait Anxiety Inventory - STAI-6) from baseline (pre-treatment) through day 28. measure: Number and Proportion of Adverse Events measure: Change in PTSD symptoms (measured via the PTSD Checklist for Diagnostic and Statistical Manual (DSM-5) - Posttraumatic Stress Disorder Checklist (PCL-5) from baseline (pre-treatment) through day 28. measure: Change in alcoholic consumption (measured via the Timeline Follow-Back Method - TLFB) from baseline (pre-treatment) through day 28. measure: Change in compulsive drinking (measured via the Obsessive Compulsive Drinking Scale - OCDS) from baseline (pre-treatment) through day 28. measure: Change in mood (measured by the Differential Emotions Scale - DES-R) from baseline (pre-treatment) through day 28. measure: Change in depression (measured by the Patient Health Questionnaire-9 - PHQ-9) from baseline (pre-treatment) through day 28. measure: Change in affective states (measured by the Positive and Negative Affect Scale - PANAS) from baseline (pre-treatment) through day 28. measure: Change in overall functioning (measured by the Veteran's RAND 12-item Health Survey - VR-12) from baseline (pre-treatment) through day 28. measure: Change in cognitive functioning (measured by the Hopkins Verbal Learning Test Revised - HVLT-R) from baseline (pre-treatment) through day 28. measure: Change in sleep (measured by the Insomnia Severity Index - ISI)) from baseline (pre-treatment) through day 28. measure: Change in mental status (measured by the Mini Mental State Examination - MMSE) from baseline (pre-treatment) through day 28. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Connecticut Healthcare System city: West Haven state: Connecticut zip: 06516 country: United States name: Jenelle Newcomb, BA role: CONTACT phone: 203-932-5711 phoneExt: 12874 email: jenelle.leblanc@yale.edu name: Ismene Petrakis, MD role: CONTACT phone: (203) 932-5711 phoneExt: 12244 email: ismene.petrakis@yale.edu name: Ismene Petrakis, MD role: PRINCIPAL_INVESTIGATOR name: John Krystal, MD role: SUB_INVESTIGATOR lat: 41.27065 lon: -72.94705 hasResults: False
<\|newrecord\|> nctId: NCT06335394 id: NVD003-CLN01 briefTitle: Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion overallStatus: ACTIVE_NOT_RECRUITING date: 2018-08-02 date: 2022-04-27 date: 2028-05-15 date: 2024-03-28 date: 2024-03-28 name: Novadip Biosciences class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion. conditions: Recalcitrant Lower Limb Nonunion studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 11 type: ACTUAL name: NVD003 measure: Safety - Adverse Events measure: Safety - Abnormalities of vital signs measure: Safety - Abnormalities of vital signs measure: Safety - Abnormalities of physical examination measure: Safety - Abnormalities of physical examination measure: Safety - Abnormalities of physical examination measure: Safety - Abnormalities of laboratories measure: Safety - Abnormalities of laboratories measure: Safety - Abnormalities of laboratories measure: Healing efficacy: plain X-ray measure: Healing efficacy: CT-scan measure: Healing efficacy: average time from Investigational Medicinal Product grafting surgery till first observation of plain X-ray and CT-scan confirmed fracture healing measure: Healing efficacy: investigator assessed clinical healing measure: Healing efficacy: average time from IMP grafting surgery to Investigator assessed clinical healing measure: Grafting Surgery parameters measure: Grafting Surgery parameters measure: Complications: rate of subsequent surgical interventions measure: Quality of Life: pain evaluation measure: Quality of Life: questionnaire EuroQol-5 Dimensions measure: Quality of Life: overall treatment effect measure: General Pre-graft implantation safety: all SAEs, AESI and PRAE measure: All SAEs during the extended safety follow-up period sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Interregional Edith Cavel (CHIREC) - Clinique Ste Anne-St Remi city: Anderlecht zip: 1070 country: Belgium lat: 50.83619 lon: 4.31454 facility: Algemeen Ziekenhuis (AZ) Sint-Jan Brugge - Oostende AV - Campus Sint-Jan city: Brugge zip: 8000 country: Belgium lat: 51.20892 lon: 3.22424 facility: Centre Hospitalier Universitaire CHU/UVC Brugmann (Site Horta) city: Brussel zip: 1020 country: Belgium lat: 50.85045 lon: 4.34878 facility: Grand Hôpital De Charleroi city: Charleroi country: Belgium lat: 50.41136 lon: 4.44448 facility: Ziekenhuis Oost-Limburg (ZOL) city: Genk zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg city: Leuven zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 facility: CHU Ambroise Paré city: Mons zip: 7000 country: Belgium lat: 50.45413 lon: 3.95229 facility: Centre Hospitalier Regional De Namur city: Namur zip: 5000 country: Belgium lat: 50.4669 lon: 4.86746 facility: Centre Hospitalier de Luxembourg city: Luxembourg zip: 1210 country: Luxembourg lat: 49.61167 lon: 6.13 facility: University Hospital Basel city: Basel country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False
<\|newrecord\|> nctId: NCT06335381 id: 24-0131 id: 1R01NR021134-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01NR021134-01 briefTitle: MOMs Chat and Care Study acronym: MOMs-CC overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-06-30 date: 2024-03-28 date: 2024-04-01 name: Northwell Health class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities. conditions: Severe Maternal Morbidity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to one of two groups in parallel for the duration of the study. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The Principal Investigator and Biostatistician will be masked. whoMasked: INVESTIGATOR count: 674 type: ESTIMATED name: Northwell Pregnancy & Peds Chats name: Prenatal Telehealth Visits name: Postpartum Telehealth Visits name: Home Blood Pressure Monitor name: Fitbit measure: Severe maternal morbidity (SMM) measure: Preeclampsia measure: Informational Support measure: Emotional Support measure: Tangible Support measure: Minutes of Physical Activity measure: Barriers to Exercise sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Northwell Health city: Manhasset state: New York zip: 11030 country: United States name: Stephanie L Fitzpatrick, PhD role: CONTACT lat: 40.79788 lon: -73.69957 hasResults: False
<\|newrecord\|> nctId: NCT06335368 id: 201512178RINC briefTitle: Assessment of Nutritional and Growth Status in Rett Syndrome Patients overallStatus: COMPLETED date: 2016-03-09 date: 2016-05-23 date: 2020-10-26 date: 2024-03-28 date: 2024-03-28 name: National Taiwan University Hospital class: OTHER briefSummary: Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan. conditions: Rett Syndrome conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 70 type: ACTUAL name: Nutrition and Growth Status measure: gender, age , disease history checklist measure: Change in Body height measure: Change in Body weight measure: Change in knee height measure: Change in arms height measure: Change in waist measure: Change in hip circumferences sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335355 id: SHR-1316-307 briefTitle: A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-10 date: 2030-10 date: 2024-03-28 date: 2024-03-28 name: Shanghai Shengdi Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations conditions: Non-squamous Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 401 type: ESTIMATED name: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin name: Camrelizumab + Pemetrexed + Carboplatin name: Adebrelimab + Pemetrexed + Carboplatin measure: Investigator-assessed Objective Response Rate (Phase One) measure: Overall Survival (Phase Two) measure: The incidence and severity of Adverse Events (AEs) (Phases One and Two) measure: Duration of Response (DoR) based on Investigator Assessment (Phases One and Two) measure: Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two) measure: Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two) measure: Overall Survival (OS) (Phase One) measure: Objective Response Rate (ORR) based on Investigator Assessment (Phase Two) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Tumor Hospital of Shandong First Medical University city: Jinan state: Shandong zip: 250117 country: China name: Jinming Yu role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06335342 id: IEO 0726 briefTitle: Radiotherapy Treatments for Neoplasms in the Head and Neck Region overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: The aim of this study is the evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of radiotherapy treatments in the head and neck region.
Eligible patients undergoing radiotherapy for primary or secondary neoplasms localized in the head and neck anatomical region. conditions: Head and Neck Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 4050 type: ESTIMATED measure: Overall Survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06335329 id: Pro00133616 briefTitle: Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-03-28 date: 2024-04-02 name: Medical University of South Carolina class: OTHER briefSummary: Vaping has emerged as a prominent public health crisis in recent years. In 2023, the National Youth Tobacco Survey found that more than 2.1 million adolescents endorse vaping, with 25% of those endorsing daily use. Many adolescents also perceive vapes as safer than cigarettes, and more acceptable to use both indoors and outdoors compared to cigarettes. Vapes are available in numerous device and delivery systems, with the psychoactive agent commonly including nicotine or cannabis, although these can be of a wide variety of concentrations and formulations. They may be ultra-compact and allow for ease of concealment. In addition, they are produced in a variety of appealing flavorings such as candy, desserts, and fruits. Other constituents include the liquids and aerosolized components of the vaping cartridges, including formaldehyde, acetone, glycerol, propylene glycol, acetaldehyde, and heavy metals. Many of the flavoring concentrates, as well as the vaporized solvents, have not been evaluated for long term safety. One of these additives, vitamin E acetate, present in primarily illicit vaping devices, rose to national attention in 2019 for a suspected link to the dramatic increase in vaping/e-cigarette associated lung injury (EVALI) cases, with over 60 confirmed deaths since that time.
To our knowledge, there are no studies evaluating the lung ultrasound findings of asymptomatic vapers. However, there is data to suggest that vaping can lead to pulmonary toxicity in in-vitro and animal models, including increased inflammatory cytokines, hyperreactivity, and oxidative stress. In addition, studies found the risk of bronchitic symptoms is twice as likely in current adolescent vapers, compared to those who have never vaped before. Given the potential pulmonary toxicity of vaping, as well as the increased percentage of adolescent vaping activity in recent years, investigators aim to evaluate baseline lung ultrasound findings in adolescents who vape. Concurrently, investigators will assess if observing their lung ultrasound findings can alter their attitudes and behaviors towards vaping. Prior adult studies have found that showing patients' their atherosclerosis plaque increased the motivation to quit and cessation rates. Additionally, data in pregnant patients found real-time ultrasound feedback of smoking effects on the fetus lead to near abstinence in light smokers. Given the frequent use of point-of-care ultrasound in the emergency department, investigators hope to assess an innovative intervention for cessation. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: All participants will be randomized on a 1:1 ratio to be able to see and discuss their ultrasound results, or remain blinded to them. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Discussion of point-of-care ultrasound lung findings measure: Lung Ultrasound Findings measure: Behavioral Changes sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29412 country: United States name: Kaitlyn Boggs, MD role: CONTACT lat: 32.77657 lon: -79.93092 hasResults: False
<\|newrecord\|> nctId: NCT06335316 id: wallenburg sym briefTitle: Effect of Stellate Nerve Block in Dysphagia overallStatus: COMPLETED date: 2022-01-01 date: 2023-05-04 date: 2023-05-28 date: 2024-03-28 date: 2024-03-28 name: Copka Sonpashan class: OTHER_GOV briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ACTUAL name: Injection name: Lidocaine Hydrochloride name: Comprehensive therapy name: placebo measure: Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: penetration-aspiration scale measure: The Swallowing Quality of Life Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huimin Hos. city: Pengfu country: Taiwan lat: 24.98333 lon: 121.41667 hasResults: False
<\|newrecord\|> nctId: NCT06335303 id: 1462-0004 id: 2023-508395-11-00 type: OTHER domain: CTIS id: U1111-1302-4283 type: OTHER domain: WHO briefTitle: A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) overallStatus: NOT_YET_RECRUITING date: 2024-06-20 date: 2026-04-30 date: 2026-06-30 date: 2024-03-28 date: 2024-03-28 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.
Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.
At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Idiopathic Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: BI 1819479 name: Placebo matching BI 1819479 measure: Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year] measure: Absolute change from baseline in FVC at Week 24 [in milliLiter] sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335290 id: IEO 725 briefTitle: Radiotherapy Treatments for the Treatment of Thoracic District Tumors overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of thoracic radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the thoracic anatomical region. conditions: Thoracic Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 13200 type: ESTIMATED measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06335277 id: IEO 0727 briefTitle: Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant. conditions: Leukemia conditions: Leukemia, Chronic conditions: Leukemia, Acute conditions: Lymphoma conditions: Aplastic Anemia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Overall Survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06335264 id: 2024-9987 briefTitle: Screening for Heart Failure Using a Multimodal Wearable Device acronym: WEAR-HF overallStatus: RECRUITING date: 2024-01-15 date: 2024-07 date: 2024-12 date: 2024-03-28 date: 2024-03-28 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER name: HOP-Child Technologies Inc briefSummary: The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: Watch HOP measure: Presence or absence of heart failure measure: left ventricular ejection fraction (LVEF) measure: Natriuretic peptide (NT-proBNP) level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: McGill University Health Centre status: RECRUITING city: Montreal state: Quebec zip: H4A 3J1 country: Canada name: Abhinav Sharma, MD role: CONTACT phone: 514 934-1934 email: dreamcvlab@muhc.mcgill.ca name: Abhinav Sharma, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06335251 id: IEO 0728 briefTitle: Radiotherapy Treatments for Neoplasms of the Limbs overallStatus: RECRUITING date: 2018-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: European Institute of Oncology class: OTHER briefSummary: In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included conditions: Bone Neoplasms conditions: Bone Metastases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Overall survival measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Barbara Alicja Jereczek role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

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