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<|newrecord|> nctId: NCT06365268 id: APHP231139 briefTitle: Perinatal Thoraco-abdomino-pelvic Tumors Study acronym: CONTRAST overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-09 date: 2024-04-15 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Congenital tumors are a rare diagnosis in the fetus and newborn. They differ from those of children and adults in terms of the nature, location and evolution of the tumor. |
Indeed, some histologically benign tumors may have lethal potential in utero (e.g. sacrococcygeal teratomas) or even undergo malignant transformation if left untreated. In contrast, other tumors that are malignant by histological criteria may have a very good prognosis, regressing spontaneously within the first year of life (e.g. neuroblastoma). |
Despite advances in imaging, benign and malignant solid tumors remain a major diagnostic and prognostic challenge in the antenatal context. |
The management of congenital tumors requires multidisciplinary expertise, taking into account the perinatal context, which poses specific problems, particularly in terms of therapeutic aspects, but also the frequent existence of associated malformations and/or genetic predisposition syndromes. |
This study focuses on solid tumors of the thoraco-abdomino-pelvic region, the main objective being to investigate the correlation between antenatal clinical and radiological analysis and confirmed postnatal diagnosis of congenital solid truncal tumors, as well as the developmental spectrum in which they fit. conditions: Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Collection of data from the patient's medical file measure: Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors measure: Description of the developmental spectrum of solid congenital truncal tumors measure: Characteristics and location of the tumor on pre- and post-natal imaging measure: Ile-de-France epidemiology of perinatal tumors measure: Evolution of solid congenital truncal tumors measure: Associated genetic abnormalities and malformations measure: Intercurrent obstetric events and obstetric outcomes based on the diagnoses made measure: Development of a management algorithm based on prenatal findings sex: ALL maximumAge: 3 Months stdAges: CHILD facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Sabine SARNACKI, MD, PhD role: CONTACT phone: 1 44 49 41 94 phoneExt: +33 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06365255 id: 2022-A01453-40 briefTitle: National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes acronym: EPISTRESS2 overallStatus: COMPLETED date: 2023-01-17 date: 2024-02-28 date: 2024-02-28 date: 2024-04-15 date: 2024-04-17 name: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète class: OTHER briefSummary: The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres. |
In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres. conditions: Diabetes Type 1 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1344 type: ACTUAL name: questionnaires measure: The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps. measure: Identify sub-populations of patients who feel stressed measure: Establish and categorise the different stress factors measure: Establishing a relationship between personality type and the impact of stress measure: Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Angers University Hospital city: Angers zip: 49100 country: France lat: 47.46667 lon: -0.55 facility: Avignon Hospital city: Avignon zip: 84000 country: France lat: 43.94834 lon: 4.80892 facility: St André Hospital city: Bordeaux zip: 33076 country: France lat: 44.84044 lon: -0.5805 facility: Brest University Hospital city: Brest zip: 29200 country: France lat: 48.3903 lon: -4.48628 facility: Dijon University Hospital city: Dijon zip: 21079 country: France lat: 47.31667 lon: 5.01667 facility: CERITD city: Evry zip: 91058 country: France lat: 48.63333 lon: 2.45 facility: Grenoble University Hospital city: Grenoble zip: 38043 country: France lat: 45.16667 lon: 5.71667 facility: Lille University Hospital city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: APHM- La Conception Hospital city: Marseille zip: 13000 country: France lat: 43.29551 lon: 5.38958 facility: Private practice in endocrinology and metabolic diseases city: Mérignac zip: 33700 country: France lat: 44.83248 lon: -0.63381 facility: Srasbourg University Hospital city: Strasbourg zip: 67091 country: France lat: 48.58392 lon: 7.74553 hasResults: False |
<|newrecord|> nctId: NCT06365242 id: DOACS1_2024 briefTitle: Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study. acronym: DOACS_1 overallStatus: COMPLETED date: 2020-07-23 date: 2021-07-27 date: 2022-12-23 date: 2024-04-15 date: 2024-04-15 name: University of Pisa class: OTHER briefSummary: Evaluation of DOACs treatment on post-extraction bleeding conditions: Post Operative Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 49 type: ACTUAL measure: Peri-operative hemorrhage measure: Post-operative bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale city: Pisa zip: 56126 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False |
<|newrecord|> nctId: NCT06365229 id: 2022-P2-336-02 briefTitle: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS). conditions: Lumbar Spinal Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Oswestry Disability Index (ODI) measure: Magnetic resonance imaging (MRI) measure: Computed tomography (CT) scans measure: Creatine kinase (CK) measure: Erythrocyte sedimentation rate (ESR) measure: Surgical complication measure: VAS (visual analogue scale) for leg pain measure: VAS (visual analogue scale) for lower back pain measure: Japanese Orthopaedic Association (JOA) score measure: Modified MacNab criteria measure: Operation time measure: Blood loss measure: Postoperative hospital stays measure: Age measure: Gender measure: Body mass index (BMI) measure: Medical comorbidity measure: Smoking status measure: Alcohol status measure: Symptoms duration measure: Physical examination finding measure: Previous spinal surgery measure: Affected level measure: Stenosis grade measure: Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06365216 id: AXO-CLI-210c-03 id: 2023-508895-13-00 type: CTIS briefTitle: ALS Phase II Study of NX210c acronym: SEALS overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-15 date: 2024-04-15 name: Axoltis Pharma class: INDUSTRY name: ACT4ALS network briefSummary: This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS). conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, randomized, placebo-controlled, multicentric, phase II study in adult patients with ALS to assess efficacy, safety, tolerability and pharmacokinetics of multiple intravenous infusions of NX210c. |
Two doses of NX210c (5 mg/kg and 10 mg/Kg) will be investigated, along with a placebo group which will serve as a reference. Patients will be randomized to one of 3 arms in an allocation ratio of 3:3:2. |
Patients will participate up to approximately 20 weeks: up to 30 days for screening, 26 days of treatment and 3 months of follow-up. Lumbar punctures will assess cerebrospinal fluid (CSF) NfL and other key CSF biomarkers related to ALS and drug mechanism of action. Blood sampling will be drawn for safety, PK and biomarkers testing. Urine will equally be collected for biomarkers. A comprehensive assessment of the disease, including the ALS Functional Rating Scale (ALSFRS-R) will be performed. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: NX210c name: Placebo measure: The effect of NX210c on blood neurofilament light chain (NfL) or on a blood and cerebrospinal fluid (CSF) biomarker of BBB integrity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Lyon HCL city: Bron zip: 69500 country: France name: Emilien Bernard, MD role: CONTACT phone: 0033 (0)4 72 35 72 18 email: [email protected] lat: 45.73333 lon: 4.91667 hasResults: False |
<|newrecord|> nctId: NCT06365203 id: Through knee amputation briefTitle: Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-04-15 date: 2024-04-15 name: Assiut University class: OTHER briefSummary: The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation conditions: Amputation of Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Through knee amputation name: Above knee Amputation measure: Wound healing rate measure: Incidence of infection measure: Function of the limb Rehabilitation Quality of life measure: Mortality rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365190 id: AHMU-PD-rTMS briefTitle: Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2020-04-06 date: 2024-07-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-16 name: Anhui Medical University class: OTHER briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD. conditions: Transcranial Magnetic Stimulation conditions: Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 47 type: ACTUAL name: transcranial magnetic stimulation name: Pharmacotherapy（antiparkinsonian drugs） measure: Unified Parkinson's Disease Rating Scale III scores measure: Hoehn-Yahr(H-Y) stage measure: Levodopa equivalent dose sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cognitive Neuropsychology Lab Anhui Medical University city: Hefei state: Anhui zip: 230022 country: China lat: 31.86389 lon: 117.28083 hasResults: False |
<|newrecord|> nctId: NCT06365177 id: 29BRC22.0243 briefTitle: Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation acronym: TELETEST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-15 date: 2024-04-19 name: University Hospital, Brest class: OTHER briefSummary: This study concerns elderly person aged more than 65 years with autonomous mobility. |
It is a multicentric randomized trial in two arms : |
Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation |
Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient. conditions: Rehabilitation conditions: Elderly Person conditions: Teleconsultation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cross-sectional interventional multicenter study primaryPurpose: OTHER masking: NONE count: 108 type: ESTIMATED name: Physical consultation name: Teleconsultation measure: Five Time Sit To Stand test completion time in teleconsultation measure: Five Time Sit To Stand test completion time in face-to-face consultation measure: Satisfaction questionnaire measure: Five Time Sit To Stand test completion time in teleconsultation measure: Five Time Sit To Stand test completion time in face-to-face consultation measure: Presence or absence of falls measure: Number of falls sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06365164 id: 38RC23.0354 briefTitle: Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex acronym: PREMATACT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-11 date: 2024-04-15 date: 2024-04-15 name: University Hospital, Grenoble class: OTHER name: Faculty of Psychology and Educational Sciences,University of Geneva briefSummary: The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness. |
The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness. |
The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn. conditions: Premature conditions: Development, Child conditions: Rooting Reflex studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 19 type: ESTIMATED name: Tactile stimulation measure: The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening. measure: The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn. sex: ALL minimumAge: 28 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: University Hospital Grenoble city: Grenoble state: Isere zip: 38 000 country: France lat: 45.16667 lon: 5.71667 hasResults: False |
<|newrecord|> nctId: NCT06365151 id: TMDs fibromyalgia briefTitle: An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia overallStatus: RECRUITING date: 2024-04-05 date: 2025-04-05 date: 2026-04-05 date: 2024-04-15 date: 2024-04-15 name: Universitat de Lleida class: OTHER briefSummary: Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders. conditions: Fibromyalgia conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 114 type: ESTIMATED name: Osteopathic manual therapy name: Sham osteopathic manual therapy measure: catastrophizing measure: functional limitation measure: functional status, disability and pain measure: pain and tinnitus measure: myofascial trigger points measure: Range of motion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Osteopatia i Fisioteràpia Cornellà status: RECRUITING city: Cornella de Llobregat state: Barcelona zip: 08940 country: Spain name: Llanos de la Iglesia, MsC role: CONTACT phone: +34679536992 email: [email protected] lat: 41.35 lon: 2.08333 hasResults: False |
<|newrecord|> nctId: NCT06365138 id: Aortic Rupture briefTitle: Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms overallStatus: RECRUITING date: 2024-01-01 date: 2029-12-01 date: 2030-12-01 date: 2024-04-15 date: 2024-04-15 name: University Hospital Augsburg class: OTHER name: Epidemiology, Medical Faculty, University Augsburg briefSummary: It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture. conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Bahaviour at the time of an aortic aneurysm rupture measure: Occupation at the time of the aortic aneurysm rupture sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Augsburg status: RECRUITING city: Augsburg zip: 86156 country: Germany name: Tobias Warm, MD role: CONTACT phone: +49821400161068 email: [email protected] lat: 48.37154 lon: 10.89851 hasResults: False |
<|newrecord|> nctId: NCT06365125 id: 7313E briefTitle: College Student Daily Life and Alcohol Use Study overallStatus: RECRUITING date: 2024-03-22 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-15 name: Boston University Charles River Campus class: OTHER briefSummary: Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups. conditions: Drinking, College conditions: Drinking Heavy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 129 type: ESTIMATED name: eCHECKUP TO GO name: Text messaging boosters measure: Heavy drinking episodes measure: Alcohol-related negative consequences sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Boston University Charles River Campus status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Bonnie Rowland, MA role: CONTACT phone: 617-906-6645 email: [email protected] name: Tibor Palfai, PhD role: CONTACT email: [email protected] name: Bonnie Rowland, MA role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06365112 id: R21154 briefTitle: Endoscopic Acetabulum Surgery overallStatus: RECRUITING date: 2024-04 date: 2026-01 date: 2028-01 date: 2024-04-15 date: 2024-04-24 name: Tampere University Hospital class: OTHER briefSummary: Try to develop an endoscopic surgical technique to treat acetabulum fractures conditions: Acetabulum Fracture studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 13 type: ESTIMATED name: Endoscopy assisted measure: Number of patients with major complications measure: Number of patients with minor complications measure: Operation time measure: Patient satisfaction using EQ5D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University hospital status: RECRUITING city: Tampere zip: 33521 country: Finland name: Piia Suomalainen role: CONTACT lat: 61.49911 lon: 23.78712 hasResults: False |
<|newrecord|> nctId: NCT06365099 id: STUDY00000896_Exp2 briefTitle: Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke overallStatus: RECRUITING date: 2024-02-02 date: 2026-03-31 date: 2026-03-31 date: 2024-04-15 date: 2024-04-15 name: University of Texas at Austin class: OTHER name: Emory University briefSummary: Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and promote poststroke hand motor recovery. To maximize the effects of such interventions, they must be delivered during brain activity patterns during which TMS best activates the residual CST and enhances its neural transmission. This approach is termed brain state-dependent TMS. The investigators have recently developed a machine learning framework that identifies personalized brain activity patterns reflecting strong CST activation in neurotypical adults. In this study, the investigators will apply this framework to the poststroke brain for the first time. They will also evaluate relationships between this framework's ability to detect strong and weak CST activation states and measures of CST pathway integrity. |
Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep. On Day 1, participants will provide their informed consent. The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed. Afterwards, participants will complete eligibility screening and clinical assessment of upper extremity motor impairment, motor function, and disability using the Upper Extremity Fugl-Meyer Assessment, the Wolf Motor Function Test, and the Modified Rankin Scale. Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle. Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles. During this procedure, single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output. If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous, that participant will be considered to have residual CST connections and will be eligible for the full study. If no muscle twitch is observed, the participant will not be eligible for the full study. Afterwards, recording electrodes will be removed and the participant will leave the laboratory. |
On Day 2, participants will return to the laboratory. The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap. The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles. After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle, the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open. Stimulation will be delivered at an intensity that is 20% greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time. Afterwards, all electrodes will be removed, participation will be complete, and participants will leave the laboratory. |
The investigators will recruit a total of 20 chronic stroke survivors for this study. conditions: Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Single-pulse TMS measure: Personalized classifier performance measure: Corticospinal tract-lesion overlap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin status: RECRUITING city: Austin state: Texas zip: 78712 country: United States name: Sara Hussain role: CONTACT phone: 512-232-2686 email: [email protected] lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-10 uploadDate: 2024-04-05T17:22 filename: ICF_000.pdf size: 462079 hasResults: False |
<|newrecord|> nctId: NCT06365086 id: STUDY00000608 briefTitle: Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-27 date: 2025-01-01 date: 2025-01-01 date: 2024-04-15 date: 2024-04-15 name: University of Texas at Austin class: OTHER name: Emory University briefSummary: Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and enhance recovery of paretic hand function after stroke. To maximize the therapeutic effects of such interventions, they must be delivered during poststroke brain activity patterns during which TMS best activates the residual corticospinal tract and enhances neural transmission within it (i.e., brain state-dependent TMS). In this study, the investigators will test the feasibility of real-time, personalized brain state-dependent TMS in neurotypical adults. |
Participants will visit the laboratory for one day of testing. Upon arrival, participants will provide their informed consent; afterwards, they will complete eligibility screening. The investigators will then place recording electrodes on the scalp using a swim-type cap and on the left first dorsal interosseous, abductor pollicis brevis, and extensor digitorum communis muscles. After determining the location at which TMS best elicits muscle twitches in the left first dorsal interosseous, the investigators will determine the lowest possible intensity at which TMS elicits muscle twitches at least half of the time in this muscle. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while the participant rests quietly with their eyes open; stimulation will be delivered at an intensity that is 20% greater than the lowest possible intensity at which TMS elicits muscle twitches at least half of the time. Afterwards, the investigators will use the muscle and brain activity recordings acquired during these 6 blocks to build a personalized mathematical model that identifies which patterns of brain activity correspond to the largest TMS-evoked muscle twitches. The investigators will then use this model to detect the occurrence of these brain activity patterns in real-time; when these patterns are detected, single TMS pulses will be delivered. Afterwards, all recording electrodes will be removed, participation will be complete, and participants will leave the laboratory. |
The investigators will recruit a total of 16 neurotypical adults for this study. conditions: Neurotypical Adults studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER interventionModelDescription: Participants will receive single-pulse TMS during personalized brain activity patterns reflecting either strong or weak corticospinal tract activation primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ESTIMATED name: Personalized brain state-dependent single-pulse TMS measure: Motor-evoked potential (MEP) amplitudes elicited from the left first dorsal interosseous muscle during personalized strong and weak CST states measure: State-targeting accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin city: Austin state: Texas zip: 78712 country: United States lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-04 uploadDate: 2024-04-05T16:56 filename: ICF_000.pdf size: 305303 hasResults: False |
<|newrecord|> nctId: NCT06365073 id: TJIRB20231276 briefTitle: A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax overallStatus: RECRUITING date: 2024-03-13 date: 2024-08-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Qin Ning class: OTHER briefSummary: This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge. conditions: Anthrax studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED measure: mortality rates of severe anthrax measure: incidence of complications measure: Peripheral blood biomarkers associated with 28-day and 90-day mortality measure: the improvement in 28-day and 90-day mortality with treatment for severe anthrax sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Qin Ning, PHD,MD role: CONTACT phone: +8602783662391 email: [email protected] name: Qin Ning, PHD,MD role: PRINCIPAL_INVESTIGATOR name: Tao Chen, PHD,MD role: SUB_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06365060 id: 00003143 id: R01CA279808 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA279808 briefTitle: Screening for AL Amyloidosis in Smoldering Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-02-27 date: 2029-02-27 date: 2024-04-15 date: 2024-04-15 name: Tufts Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm. conditions: Smoldering Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study. measure: Validating an NGS assay that identifies IGLV genes in clonal plasma cells sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama Hospital city: Birmingham state: Alabama zip: 35233 country: United States name: Susan Bal, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Cedars-Sinai Medical Center city: Los Angeles state: California zip: 90048 country: United States name: Robert Vescio, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of California, Irvine city: Orange state: California zip: 92868 country: United States name: Lisa Lee, MD role: PRINCIPAL_INVESTIGATOR lat: 33.78779 lon: -117.85311 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Tom Martin, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Cleveland Clinic Florida, Weston Hospital city: Weston state: Florida zip: 33331 country: United States name: Chakra Chaulagain, MD role: PRINCIPAL_INVESTIGATOR lat: 26.10037 lon: -80.39977 facility: Tufts Medical Center city: Boston state: Massachusetts zip: 02111 country: United States name: Denis Toskic, BS role: CONTACT phone: 617-636-5907 email: [email protected] name: Raymond Comenzo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Giada Bianchi, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Columbia University Medical Center city: New York state: New York zip: 10032 country: United States name: Suzanne Lentzsch, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States name: Heather Landau, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Atrium Health Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Cindy Varga, MD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 facility: UNC Lineberger Comprehensive Cancer Center city: Durham state: North Carolina zip: 27705 country: United States name: Sascha Tuchman, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: UT Southwestern, Harold C. Simmons Comprehensive Cancer Center city: Dallas state: Texas zip: 75390 country: United States name: Gurbakhash Kaur, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: University of Utah, Huntsman Cancer Hospital city: Salt Lake City state: Utah zip: 84112 country: United States name: Amandeep Godara, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: VCU Medical Center city: Richmond state: Virginia zip: 23219 country: United States name: Hashim Mann, MD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False |
<|newrecord|> nctId: NCT06365047 id: STUDY00004926 briefTitle: Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2027-06-01 date: 2024-04-15 date: 2024-04-23 name: Tufts University class: OTHER name: Colgate Palmolive briefSummary: This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product. conditions: Xerostomia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: 8% Arginine toothpaste name: 1000 ppm F toothpaste measure: Salivary pH Impact measure: Measuring the change in the oral microbiome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts University School of Dental Medicine city: Boston state: Massachusetts zip: 02111 country: United States lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06365034 id: YKLL-KY-2024（024） briefTitle: Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-01-31 date: 2024-04-15 date: 2024-04-15 name: Qianfoshan Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). conditions: Carcinoma, Hepatocellular studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 92 type: ESTIMATED measure: Pathologic response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Qianfoshan Hospital status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jing Liang, Dr role: CONTACT phone: +8618663761275 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False |
<|newrecord|> nctId: NCT06365021 id: 88887.687583/2022-00 briefTitle: ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder overallStatus: RECRUITING date: 2024-05 date: 2025-08 date: 2026-08 date: 2024-04-15 date: 2024-04-15 name: Beny Lafer class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following questions will be investigated: |
* The efficacy of ACT in reducing depressive symptoms in patients with BD. |
* The efficacy of ACT in improving the quality of life in patients with BD. |
* The efficacy of ACT in improving functionality in patients with BD. |
* The efficacy of ACT in improving sleep quality in patients with BD. |
* The efficacy of ACT in improving psychological flexibility in patients with BD |
Participants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance and Commitment Therapy, in addition to their regular pharmacological treatment. |
Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment. |
Scales and assessments will be used to measure study outcomes on 3 different time-points: pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the additional 12 week follow-up period. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment. |
Results will be compared among both groups to assess the effectiveness of Acceptance and Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar disorder. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Acceptance and Commitment Therapy name: Bipolar Disorder Psychoeducation Therapy measure: Montgomery-Asberg Depression Scale measure: Young Mania Rating Scale measure: Functional Assessment Staging Tool measure: World Health Organization Quality of Life Brief Scale measure: Pittsburgh Sleep Quality Index measure: Psychological Flexibility Questionnaire measure: Generalized Anxiety Disorder 7-item Scale measure: Medication Recommendation Tracking Form measure: Regulatory Satisfaction Alertness Timing Efficiency Duration measure: Adhesion and Satisfaction Questionnaire measure: Life Events Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tatiana Cohab Khafif status: RECRUITING city: São Paulo state: SP zip: 01231010 country: Brazil name: Tatiana Khafif, Master's degree role: CONTACT phone: +5511983389643 email: [email protected] lat: -23.5475 lon: -46.63611 hasResults: False |
<|newrecord|> nctId: NCT06365008 id: SYSKY-2024-210-01 briefTitle: Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer overallStatus: RECRUITING date: 2024-04-08 date: 2027-04-08 date: 2027-09-30 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the salvage therapy for patients diagnosed with unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is progression-free survival (PFS). The investigators estimated that 40 patients were necessary. Secondary endpoints include overall survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. conditions: Unresectable/Metastatic Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sintilimab+irinotecan+leucovorin folinate+fluorouracil measure: Progression-free survival measure: Overall survival measure: Objective response rate measure: Disease control rate measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Qiong Yang, Doctor role: CONTACT phone: 13632341201 email: [email protected] name: Yajing Liu, Doctor role: CONTACT phone: 13631327315 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06364995 id: JKEUPM-2023-1364 briefTitle: Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance overallStatus: RECRUITING date: 2024-01-10 date: 2024-06-28 date: 2024-07-05 date: 2024-04-15 date: 2024-04-16 name: Universiti Putra Malaysia class: OTHER briefSummary: Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Volleyball offers a blend of aerobic and anaerobic exercises, developing muscle strength, bone density, cardiovascular health, and fine-tuning the nervous system. It is effective in improving physical attributes such as strength, speed, agility, endurance, and coordination, which are crucial for holistic student development and success in the standardized PE entrance examinations for senior high school. |
Recent trends have highlighted a decline in physical fitness among youth, as evidenced by rising obesity rates and increasing failure rates in fitness assessments. To counteract this, the Ministry of Education of the People's Republic of China 2021 has initiated a shift towards "specialised physical education," integrating health knowledge with basic and specialised motor skills training. This innovative educational model hopes to improve student physical fitness across educational tiers. |
Therefore, this study chose volleyball specialised physical education as an intervention to study the effect of physical fitness and The PE entrance examination for senior high school performance of middle school students. conditions: Physical Fitness conditions: Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this experiment, the experimental group used the intervention of specialised physical education teaching of volleyball. However, the control group only conducted traditional physical education teaching content primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Volleyball name: Traditional Physical Education measure: Effects of physical fitness of middle school students measure: Effects on middle school students' PE entrance examination for senior high school test performance sex: ALL minimumAge: 13 Years maximumAge: 15 Years stdAges: CHILD facility: Yimou MAO status: RECRUITING city: Chengdu state: Sichuan zip: 610044 country: China name: Yimou MAO, PHD role: CONTACT email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06364982 id: PER-ECL-2023-05 briefTitle: Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances. conditions: Peri-implant Mucositis conditions: Peri-Implantitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED name: Two contiguous dental implants placed with less ≤ 3mm from each other. name: Two contiguous dental implants placed with > 3mm from each other. measure: Prevalence of peri-implant diseases. measure: FMPI measure: FMBI measure: mPI measure: mBI measure: SoP measure: PPD measure: MR measure: KM measure: Implant location measure: Implant position measure: Implant type measure: Implant brand measure: Implant roughness measure: Implant diameter measure: Implant length measure: Apico-coronal position of the implant measure: Inter-implant distances (IID) measure: Implant placement protocol measure: Bone grafting procedures (BGP) at implant placement measure: Implant-supported restorations measure: Cleansability of the prosthesis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clínica Universitaria de Odontologia city: Sant Cugat Del Vallès state: Barcelona zip: 08195 country: Spain lat: 41.47063 lon: 2.08611 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-10 uploadDate: 2024-04-10T16:21 filename: Prot_SAP_000.pdf size: 82991 hasResults: False |
<|newrecord|> nctId: NCT06364969 id: 2021-06-02 briefTitle: Investigation of the Pruritogens of Liver-related Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-08-01 date: 2025-08-01 date: 2024-04-15 date: 2024-04-16 name: Peking University class: OTHER briefSummary: This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch. conditions: Cholestasis conditions: Intrahepatic Cholestasis of Pregnancy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Itch intensity measure: Flare areas sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Peking University city: Beijing state: Beijing zip: 100000 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: [email protected] name: Yulong Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06364956 id: SYSKY-2024-124-02 briefTitle: Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2026-06 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was conducted. |
This study will adopt a 3+3 design and include two predefined dose groups of palbociclib: 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) . |
This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Tislelizumab combined with two predefined dose groups of palbociclib name: RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial. measure: Phase I: the safety dose of the combination of Tislelizumab and palbociclib measure: Phase II: Pathological complete response rate(pCR) measure: Pathological Downstaging(pDS) measure: Event-free survival (EFS) measure: overall survival (OS) measure: Safety and AE measure: Biomarker Endpoint Analyses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Fan Wu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-sen Memorial Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China name: Wenlong Zhong, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Junxin Chen, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Yun Luo, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Ebai Xu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Zheng Liu, Ph.D role: CONTACT lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Yu Xie, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital, Central South University status: RECRUITING city: Changsha state: Hunan country: China name: Xiongbing Zu, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 hasResults: False |
<|newrecord|> nctId: NCT06364943 id: 202400020B0 briefTitle: Tear Ferning Test for Dry Eye Diagnosis overallStatus: RECRUITING date: 2024-04-05 date: 2025-01-05 date: 2025-04-04 date: 2024-04-15 date: 2024-04-15 name: Chung Shan Medical University class: OTHER briefSummary: Application of tear ferning test for clinical dry eye diagnosis conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: with/without dry eye syndrome measure: Schirmer's test measure: Tear film breakup time measure: Ocular surface health evaluate measure: Ocular surface disease index measure: Intraocular pressure sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jen-Ai Hospital status: RECRUITING city: Taichung, zip: 412 country: Taiwan name: SHU-YAN PENG, Master role: CONTACT phone: 886-933-854862 lat: 24.1469 lon: 120.6839 hasResults: False |
<|newrecord|> nctId: NCT06364930 id: SGLT2i_HBV Study briefTitle: SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus overallStatus: RECRUITING date: 2024-03-26 date: 2030-10-31 date: 2031-03-30 date: 2024-04-15 date: 2024-04-15 name: Chinese University of Hong Kong class: OTHER briefSummary: This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo). conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 412 type: ESTIMATED name: Dapagliflozin 10mg Tab name: Placebo 10mg Tab measure: The primary endpoint is liver complications measure: Cardiovascular complications measure: change in liver stiffness measurement measure: change anthropometric parameters measure: change anthropometric parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Angel ML Chim, MSc role: CONTACT phone: 26324205 email: [email protected] name: Grace LH Wong, MD role: CONTACT phone: +85235053538 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False |
<|newrecord|> nctId: NCT06364917 id: IRB-300012781 (UAB2432) briefTitle: DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2027-01-30 date: 2027-06 date: 2024-04-15 date: 2024-04-26 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Pembrolizumab name: Carboplatin name: Paclitaxel name: Pemetrexed name: Nivolumab name: Ipilimumab measure: Rate of Molecular Response in Patients with PD-L1 Negative Advanced NSCLC Treated with Dual vs. Single ICB Plus CT Regimens measure: Efficacy Evaluation measure: Correlation Analysis measure: Progression-Free Survival (PFS) measure: Median Overall Survival (OS) measure: Tolerability Assessment sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Margaret Thomas, MPH role: CONTACT email: [email protected] name: Aakash Desai, MD role: PRINCIPAL_INVESTIGATOR name: Maya Khalil, MD role: SUB_INVESTIGATOR name: Yanish Boumber, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False |
<|newrecord|> nctId: NCT06364904 id: SYSKY-2024-123-02 briefTitle: An Phase III Study, Multicenter，Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2029-04-15 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib name: Tislelizumab, Cisplatin, Gemcitabine measure: Progression-Free Survival(PFS) measure: Incidence of Grade 3/4 Neutropenia measure: ORR measure: overall survival (OS) measure: Safety and AE measure: Disease Control Rate(DCR) measure: During Of Response(DOR) measure: Biomarker Endpoint Analyses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong country: China name: Fan Wu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-sen Memorial Hospital city: Guangzhou state: Guangdong country: China name: Wenlong Zhong, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: Junxin Chen, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: Yun Luo, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong country: China name: Ebai Xu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei country: China name: Zheng Liu, Ph.D role: CONTACT lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital city: Changsha state: Hunan country: China name: Yu Xie, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital, Central South University city: Changsha state: Hunan country: China name: Xiongbing Zu, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 hasResults: False |
<|newrecord|> nctId: NCT06364891 id: VMMC NEXUS briefTitle: Assessing the Impact of a Digital VMMC Platform acronym: VMMC NEXUS overallStatus: RECRUITING date: 2023-10-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: University of Alabama at Birmingham class: OTHER name: Centre for Infectious Disease Research in Zambia briefSummary: VMMC has been identified as a crucial intervention by UNAIDS to achieve the 2030 global target of a 90% reduction in new HIV infections compared with 2010 levels. CIDRZ, a key partner to the Ministry of Health, has worked with DesireLine to develop a mobile application that supports mobilisers to segment potential clients and provide them with targeted messaging based on their segmentation type. The hypothesis of our proposed study is that targeted interventions addressing the barriers for each of the seven segments, assisted by the Digital Mobilization Tool, will better meet the needs of potential clients and therefore improve uptake of VMMC services, specifically among the three most-resistant segments. |
The objective of this study is to evaluate the effect of a segment-targeted mobilization intervention supported by the VMMC NEXUS Digital Mobilization Tool on the uptake of VMMC services at 30 intervention sites, compared with 30 control sites. |
The research questions are: |
1. What is the effect of segment-targeted mobilization interventions designed to address the specific psycho-behavioral barriers each of the seven segments face, supported by the VMMC NEXUS Digital Mobilization Tool, on the overall numbers of men receiving VMMC in each site? |
2. What is the effect of the same on the numbers of men by segment receiving VMMC in each site? |
3. What is the effect of the same on the numbers of men by age receiving VMMC in each site? |
Secondary goals will be the following, to the extent possible: |
* Assess the incremental cost of the intervention, including by MC |
* Assess and document process learnings from the intervention |
* Develop a workplan to enable national and regional scale-up of the mobilization model and NEXUS Digital Mobilization Tool if demonstrated as effective conditions: Voluntary Medical Male Circumcision studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomised control study primaryPurpose: OTHER masking: NONE count: 2000 type: ESTIMATED name: VMMC NEXUS Digital application measure: Total number of VMMC's conducted in intervention vs control measure: Total number of VMMC's by segment measure: Total number of VMMC's by age measure: Costing measure: Process evaluation measure: Develop a workplan and handbook to allow for the intervention to be scaled up elsewhere. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ministry of Health facilities status: RECRUITING city: Lusaka zip: 10101 country: Zambia name: Carolyn Moore role: CONTACT phone: 0966841034 email: [email protected] lat: -15.40669 lon: 28.28713 hasResults: False |
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