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A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University. |
Population of study: |
192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 192 type: ACTUAL name: Misoprostol measure: The amount of blood loss measure: Changes in hematocrit values in both groups after delivery measure: Changes in Hemoglobin level measured by gm/dl in both groups after delivery measure: Incidence of side effects of study medications sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Faculty of medicine, Kasr Alainy city: Cairo state: Al Manyal zip: 11956 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06364085 id: DBS2024 briefTitle: Enhancing Epilepsy Management With Precision Deep Brain Stimulation acronym: EPI-BOOST overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-06 date: 2024-04-15 date: 2024-04-15 name: Nova Scotia Health Authority class: OTHER briefSummary: The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study. conditions: Epilepsy, Drug Resistant studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Neuromodulation programming measure: Seizure reduction measure: Change in disease score on Patient Weighted Quality Of Life In Epilepsy measure: Change in depression score on Neurological Disorders Depression Inventory in Epilepsy measure: Change in anxiety score on Anxiety General Anxiety Disorder-7 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth Health Science Centre city: Halifax state: Nova Scotia zip: B3H 3A7 country: Canada name: Lutz Weise role: CONTACT lat: 44.64533 lon: -63.57239 hasResults: False |
<|newrecord|> nctId: NCT06364072 id: PDC 01-0202 id: 2023-504023-63-00 type: CTIS briefTitle: Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-09-20 date: 2024-04-15 date: 2024-04-15 name: Cessatech A/S class: INDUSTRY briefSummary: The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children. conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: CT001 measure: To assess the safety and tolerability measure: To evaluate the analgesic effect measure: To assess medication errors sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06364059 id: aSDH-TT briefTitle: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-11 date: 2024-04-15 date: 2024-04-15 name: Charles University, Czech Republic class: OTHER name: Military University Hospital, Prague briefSummary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. conditions: Acute Subdural Hematoma conditions: Acquired Brain Injury studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Decompressive craniectomy with evacuation of subdural hematoma measure: Level of consciousness at time of injury measure: Initial size of subdural hematoma measure: Initial midline shift measure: Chronic use of anti-clotting medication measure: Trauma severity analyzed using Injury Severity Score (ISS). measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC). measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months. measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months. measure: Number of revisions. measure: Time from injury to surgery. measure: Time of operation. measure: The need for reversal of the effects of anticoagulants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military University Hospital Prague city: Praha zip: 16209 country: Czechia name: Michal Soták, M.D., Ph.D. role: CONTACT phone: +420973202999 email: [email protected] name: Tomáš Tyll, M.D., Ph.D. role: CONTACT phone: +420973202999 email: [email protected] name: Tomáš Tyll, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False |
<|newrecord|> nctId: NCT06364046 id: ZJLS-KLDMIR-22006 briefTitle: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: The Central Hospital of Lishui City class: OTHER briefSummary: This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice. conditions: Carcinoma conditions: Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Drug-eluting beads bronchial arterial chemoembolization name: Serplulimab name: Intravenous chemotherapy measure: Objective response rate measure: Progression Free Survival measure: Overall Survival measure: Time to tumor untreatable progression measure: Disease Control Rate measure: Duration of Overall Response measure: Tumor biomarkers measure: Tumor biomarkers measure: Tumor biomarkers measure: Tumor biomarkers measure: Eastern Cooperative Oncology Group Score measure: Recurrence rate of hemoptysis measure: Quality of life Questionare-Core score measure: The incidence of adverse events and serious adverse events measure: Pain assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lishui central hospital city: Lishui state: Zhejiang zip: 323000 country: China lat: 28.46042 lon: 119.91029 hasResults: False |
<|newrecord|> nctId: NCT06364033 id: CLL2624 briefTitle: Biological and Clinical Efficacy of Shingrix in Patients With CLL overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-11 date: 2028-10 date: 2024-04-15 date: 2024-04-15 name: Gruppo Italiano Malattie EMatologiche dell'Adulto class: OTHER briefSummary: This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma conditions: CLL-like MBL conditions: Varicella-zoster Virus Reactivation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 312 type: ESTIMATED name: serologic response evaluation measure: Serologic response evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC Ematologia ASST dei Sette Laghi city: Varese country: Italy name: Marta Coscia role: CONTACT lat: 45.82058 lon: 8.82511 hasResults: False |
<|newrecord|> nctId: NCT06364020 id: APHP230067 briefTitle: Assessment of Risk Factors in Patients With Non-carious Cervical Lesions acronym: LACIS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies. conditions: Anxiety conditions: Stress conditions: Non-carious Cervical Lesions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: To investigate the association between anxiety/stress and the presence of NCCL. measure: To investigate the association between bruxism and the presence of NCCL. measure: To investigate the association between eating disorders and the presence of NCCL. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hôpital Rothschild - Service Odontologie city: Paris zip: 75012 country: France name: Caroline Mocquot, MCU-PH role: CONTACT phone: +33622971627 email: [email protected] name: Maria Clotilde Carra, Professor role: CONTACT phone: +33630746555 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06364007 id: SLiu0401 briefTitle: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC overallStatus: RECRUITING date: 2024-03-03 date: 2025-12-31 date: 2026-03-31 date: 2024-04-12 date: 2024-04-12 name: Sulai Liu class: OTHER briefSummary: The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: HAIC+STRIDE+Len measure: ORR measure: PFS measure: OS measure: DCR measure: AE sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University) status: RECRUITING city: Changsha state: Hunan country: China name: Chuang Peng, PhD role: CONTACT phone: 15200850489 email: [email protected] lat: 28.19874 lon: 112.97087 hasResults: False |
<|newrecord|> nctId: NCT06363994 id: ICP-CL-00128 briefTitle: A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2034-12-25 date: 2035-12-25 date: 2024-04-12 date: 2024-04-12 name: InnoCare Pharma Inc. class: INDUSTRY briefSummary: Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL) conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 490 type: ESTIMATED name: Orelabrutinib name: Bendamustine Injection name: Rituximab name: Orelabrutinib Placebo measure: Dose-limiting toxicity (DLT) measure: Progression-free Survival (PFS) for Arm A vs. Arm C sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06363981 id: JagiellonianU72 briefTitle: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-04 date: 2024-04-12 date: 2024-04-15 name: Jakub Antczak class: OTHER name: Andrzej Frycz Modrzewski Krakow University briefSummary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression. conditions: Unipolar Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active rTMS over the left DLPFC and over the left DMPFC name: Active rTMS over the left DLPFC name: Sham rTMS measure: Beck Depression Inventory 2 measure: Froward digit span measure: Language part of Addenbrooke's Cognitive Examination measure: Dimensional Anhedonia Rating Scale measure: Athens Insomnia Scale measure: Pittsburgh Sleep Quality Index measure: Epworth Sleepiness Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Education of Research and Development Center, Babinski Clinical Hospital city: Cracovia zip: 30393 country: Poland name: Wojciech Korzeniowski, MD role: CONTACT phone: +48 12 652 42 00 email: [email protected] name: Jakub Antczak, MD role: CONTACT phone: +48 12 25 50 email: [email protected] lat: 50.06143 lon: 19.93658 hasResults: False |
<|newrecord|> nctId: NCT06363968 id: 1743326 briefTitle: Biomarkers in the Retina for Prognosticating Mental Health Treatments acronym: BRIGHT overallStatus: RECRUITING date: 2024-02-12 date: 2025-09-01 date: 2030-09-01 date: 2024-04-12 date: 2024-04-12 name: VA Puget Sound Health Care System class: FED briefSummary: Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study |
Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are: |
1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD? |
2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment? |
Participants will be asked to: |
* Undergo ERG recordings before and after a single dose of sertraline. |
* Provide relevant clinical information related to PTSD symptoms and treatment history. |
Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording. conditions: PTSD conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 50 type: ESTIMATED name: RETeval measure: ERG b-wave amplitude response to SSRI measure: Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score measure: Total PTSD Checklist for DSM-5 (PCL-5) sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Puget Sound Health Care System status: RECRUITING city: Seattle state: Washington zip: 98108 country: United States name: Rebecca C Hendrickson, MD, PhD role: CONTACT phone: 206-277-5054 email: [email protected] name: Katharine J Liang, MD, PHD role: SUB_INVESTIGATOR name: Rebecca C Hendrickson, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06363955 id: INTM-PMCF-UNIMOUTH id: 750/13.02.2023 type: OTHER domain: National and Kapodistrian University of Athens briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief overallStatus: COMPLETED date: 2023-04-25 date: 2024-04-01 date: 2024-04-01 date: 2024-04-12 date: 2024-04-26 name: National and Kapodistrian University of Athens class: OTHER name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. briefSummary: The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures). |
Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical. |
Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed. conditions: Wound Heal conditions: Oral Dryness conditions: Postoperative Pain conditions: Sjogren's Syndrome conditions: Biopsy Wound conditions: Mouth; Wound conditions: Mouth Dryness conditions: Dental Plaque conditions: Gingival Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide mouthwash or placebo mouthwash, made by the same manufacturer. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: Hydrogen Carbamide/Peroxide Mouthwash name: Placebo mouthwash measure: Assessment of wound healing based on the modified Landry Healing Index on day 14 measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14 measure: Assessment of wound healing based on the modified Landry Healing Index on day 7 measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14 measure: Wound healing based on the incision/wound length measure: Subjective oral dryness symptoms (8-item VAS questionnaire) measure: Observed (objective) signs of oral dryness measure: Change in Unstimulated Saliva Flow Rate measure: Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index measure: Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index measure: Oral Health Related Quality of Life measure: Assessment of swelling in the biopsy area measure: Adverse Events measure: Participant's comments and satisfaction regarding the provided treatment/use of the products measure: Compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens city: Athens state: Attiki zip: 11527 country: Greece lat: 37.97945 lon: 23.71622 hasResults: False |
<|newrecord|> nctId: NCT06363942 id: 2024-5973 briefTitle: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2026-04-15 date: 2024-04-12 date: 2024-04-12 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not. conditions: Fall Injury conditions: Frailty conditions: Old Age; Atrophy conditions: Age-Related Atrophy conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: SAFE program (exercise intervention) measure: Objective 1 measure: Objective 2 measure: Objective 4 sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Royal Victoria Hospital - Glen site city: Montréal state: Quebec zip: H4A 3J1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06363929 id: 341-23 briefTitle: Continuous Glucose Monitoring in Neonatal Hyperinsulinism overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-01 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: MemorialCare Health System class: OTHER name: DexCom, Inc. briefSummary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly. conditions: Hyperinsulinism conditions: Hypoglycemia Neonatal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Dexcom G6 continuous glucose monitor measure: Mean absolute relative difference (MARD) measure: Mean absolute difference (MAD) sex: ALL minimumAge: 24 Hours maximumAge: 3 Months stdAges: CHILD facility: Miller Children's Hospital status: RECRUITING city: Long Beach state: California zip: 90806 country: United States name: Erin Okawa role: CONTACT phone: 310-825-6244 email: [email protected] lat: 33.76696 lon: -118.18923 hasResults: False |
<|newrecord|> nctId: NCT06363916 id: 2023-A00335-40 briefTitle: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System acronym: SEECLOOP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Medtrum France class: INDUSTRY name: Axonal-Biostatem briefSummary: The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study. |
The main question it aims to answer is : |
• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ? |
Participants will be : |
* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system |
* Randomized to the Open Loop or Closed Loop group |
* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status |
Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: Insulin Management System in Manual mode of operation name: Insulin Management System in Automatic mode of operation measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups measure: Evolution of TIR measure: Evolution of coefficient of glycemic variation measure: Superiority in Glycated Haemoglobin (HbA1c) improvement measure: Evolution of Time spent Above Range (TAR) measure: Evolution of Time spent Below Range (TBR) measure: Body Mass Index change measure: Glucose sensor measurement change measure: Percentage of patients with TIR > 70% measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1% measure: Evolution of glucose management indicator (GMI) measure: Evolution of dosage of insulin measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop) measure: Evolution of Self-administered Questionnaires scores measure: Evolution of Diabetes Treatment Satisfaction score measure: Safety Events measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores sex: ALL minimumAge: 7 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Angers city: Angers country: France name: Regis COUTANT role: CONTACT name: Regis COUTANT role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: CHU Besançon city: Besançon country: France name: Sophie BOROT role: CONTACT name: Sophie BOROT role: PRINCIPAL_INVESTIGATOR lat: 47.24878 lon: 6.01815 facility: CHU Bordeaux city: Bordeaux country: France lat: 44.84044 lon: -0.5805 facility: CHU Caen city: Caen country: France name: Michael JOUBERT role: CONTACT name: Michael JOUBERT role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: Centre Hospitalier Sud-Francilien city: Corbeil-Essonnes country: France name: Freddy PENFORNIS role: CONTACT name: Freddy PENFORNIS role: PRINCIPAL_INVESTIGATOR name: Thanh-Lan DANG DUY role: PRINCIPAL_INVESTIGATOR lat: 48.60603 lon: 2.48757 facility: Centre Hospitalier de Gonesse city: Gonesse country: France name: Jennifer ALLAIN role: CONTACT name: Jennifer ALLAIN role: PRINCIPAL_INVESTIGATOR lat: 48.98693 lon: 2.44892 facility: Centre Hospitalier Saint-Louis city: La Rochelle country: France name: Didier GOUET role: CONTACT name: Didier GOUET role: PRINCIPAL_INVESTIGATOR lat: 46.16667 lon: -1.15 facility: Hôpital Hôtel-Dieu city: Le Creusot country: France name: Sylvaine CLAVEL role: CONTACT name: Sylvaine CLAVEL role: PRINCIPAL_INVESTIGATOR lat: 46.80714 lon: 4.41632 facility: Hospices Civils de Lyon city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Hôpital Européen city: Marseille country: France name: Denis RACCAH role: CONTACT name: Denis RACCAH role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Hôpital La Timone city: Marseille country: France name: Rachel REYNAUD role: CONTACT name: Rachel REYNAUD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier country: France name: Fabienne DALLA VALE role: CONTACT name: Fabienne DALLA VALE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: CHU Nantes city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Hôpital Lariboisière city: Paris country: France name: Jean-Pierre RIVELINE role: CONTACT name: Jean-Pierre RIVELINE role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Necker city: Paris country: France name: Jacques BELTRAND role: CONTACT name: Jacques BELTRAND role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Robert Debré city: Paris country: France name: Elise BISMUTH role: CONTACT name: Elise BISMUTH role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Rangueil city: Toulouse country: France name: Vincent MELKI role: CONTACT name: Vincent MELKI role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False |
<|newrecord|> nctId: NCT06363903 id: 2022-MMC-051 briefTitle: ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation overallStatus: RECRUITING date: 2022-05-09 date: 2024-05 date: 2025-05 date: 2024-04-12 date: 2024-04-12 name: Maxima Medical Center class: OTHER name: Amsterdam UMC name: Maastricht University Medical Center briefSummary: In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics. conditions: Autoimmunity conditions: Inguinal Hernia conditions: Stress Urinary Incontinence conditions: Pelvic Organ Prolapse conditions: Implant Complication conditions: Systemic Autoimmune Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: mesh allergy test name: blood tests name: Mesh removal measure: Positive diagnostic tests measure: Autoimmune complaints and objective findings in immunologic blood test measure: Autoimmune complaints and objective findings in mesh allergy test (MAT) measure: Mesh removal and subjective complaints measure: Mesh histopathology measure: Patient demographics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Centre status: ACTIVE_NOT_RECRUITING city: Maastricht state: Limburg zip: 6229HX country: Netherlands lat: 50.84833 lon: 5.68889 facility: Maxima Medical Centre status: RECRUITING city: Veldhoven state: Noord-Brabant zip: 5504DB country: Netherlands name: Willem AR Zwaans, MD PhD role: CONTACT phone: +31408888550 email: [email protected] name: Maurits JC Gielen, MD role: SUB_INVESTIGATOR lat: 51.41833 lon: 5.40278 facility: Amsterdam UMC status: NOT_YET_RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: Prof. Dr. J.P. Roovers role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06363890 id: TD02 briefTitle: Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia acronym: AusTD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-01 date: 2025-12-01 date: 2024-04-12 date: 2024-04-12 name: Lumen Bioscience, Inc. class: INDUSTRY briefSummary: The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population. conditions: Travelers Diarrhea studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: TAQMan Array Card measure: Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06363877 id: 5220078 briefTitle: Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2025-11 date: 2024-04-12 date: 2024-04-12 name: Loma Linda University class: OTHER briefSummary: This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 1100 type: ESTIMATED name: Povidone-Iodine name: Normal Saline measure: Surgical Site Infection measure: Readmission measure: Return to the Operating Room measure: Ileus measure: Small Bowel Obstruction sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University Health city: Loma Linda state: California zip: 92354 country: United States name: Martin G Rosenthal, MD role: CONTACT email: [email protected] name: Martin Rosenthal, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed H El-Farra, MD role: SUB_INVESTIGATOR lat: 34.04835 lon: -117.26115 hasResults: False |
<|newrecord|> nctId: NCT06363864 id: LL-IRB-2401 briefTitle: Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2029-10-31 date: 2029-10-31 date: 2024-04-12 date: 2024-04-12 name: Leeuwenhoek Laboratories Co. Ltd. class: INDUSTRY briefSummary: The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future. conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED measure: Concentration changes of small molecules in blood. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06363851 id: Kylo-11-I-C01 briefTitle: Single-ascending Dose Study of Kylo-11 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-05-31 date: 2025-11-30 date: 2024-04-12 date: 2024-04-12 name: Kylonova (Xiamen) Biopharma co., LTD. class: INDUSTRY briefSummary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Kylo-11 name: Placebo measure: Incidence of adverse events measure: Incidence of adverse events measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) measure: PK parameter of time of maximum observed concentration (Tmax) measure: PK parameter of area under the concentration time curve (AUC) measure: Change in serum Lp(a) over time measure: Percent change in serum Lp(a) over time sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False |
<|newrecord|> nctId: NCT06363838 id: ordu eah briefTitle: Evaluation of Neuromuscular Morphometry of the Vaginal Wall overallStatus: COMPLETED date: 2019-12-01 date: 2020-06-25 date: 2020-06-30 date: 2024-04-12 date: 2024-04-12 name: Gaziosmanpasa Research and Education Hospital class: OTHER_GOV name: T.C. ORDU ÜNİVERSİTESİ briefSummary: In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group. conditions: Pelvic Organ Prolapse studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 62 type: ACTUAL measure: epithelial thickness measure: smooth muscle density sex: FEMALE minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hakan Timur city: Ordu country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False |
<|newrecord|> nctId: NCT06363825 id: MRCTA,ECFAH Of FMU[2024]373 briefTitle: A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-04-12 date: 2026-04-11 date: 2027-05-11 date: 2024-04-12 date: 2024-04-17 name: Fujian Medical University class: OTHER briefSummary: To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: camrelizumab measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Tumor progression time (TTP) measure: Overall survival (OS) measure: AE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Chen status: RECRUITING city: Fuzhou country: China name: Yiping Chen role: CONTACT phone: 13805066904 lat: 26.06139 lon: 119.30611 hasResults: False |
<|newrecord|> nctId: NCT06363812 id: The POST briefTitle: Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology overallStatus: ACTIVE_NOT_RECRUITING date: 2018-03-08 date: 2021-05-15 date: 2024-12-31 date: 2024-04-12 date: 2024-04-15 name: Fondazione Sandro Pitigliani class: OTHER name: Genomic Health®, Inc. name: Istituto Toscano Tumori briefSummary: In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 258 type: ACTUAL measure: the proportion of tumor samples with a useful OncotypeDx measure: the proportion of patients in which the result of the test has induced a modification in the initial treatment plan measure: the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of Prato city: Prato zip: 59100 country: Italy lat: 43.8805 lon: 11.09699 hasResults: False |
<|newrecord|> nctId: NCT06363799 id: OST1_010 briefTitle: Osteopathic Protocol for Insomnia in College Students overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-29 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: 4th ventricle compression technique and diaphragmatic breathing name: Sham Technique measure: Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score sex: ALL minimumAge: 18 Years maximumAge: 28 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06363786 id: GOOSEBERRY briefTitle: Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-09-30 date: 2024-04-12 date: 2024-04-12 name: Essity Hygiene and Health AB class: INDUSTRY briefSummary: The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed. conditions: Incontinence-associated Dermatitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameteres and skin mictrobiome is measured on day 3. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Test patches measure: Changes in skin microbiome as measured by molecular sequencing measure: Changes in skin microbiome diversity as measured by qPCR measure: Skin surface pH measure: Change in Trans Epidermal Water loss measure: Change in skin hydration measure: Change in Skin water profile measure: Presence of low pH formula on the skin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essity Study Site city: Gothenburg zip: SE40503 country: Sweden name: Fredrik Agholme, PhD role: CONTACT phone: +46730323634 email: [email protected] name: Ulrika Husmark, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False |
<|newrecord|> nctId: NCT06363773 id: RESTO-IMMUNO id: 2023-A02451-44 type: OTHER domain: ANSM briefTitle: A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer. acronym: RESTO-IMMUNO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2026-06 date: 2024-04-12 date: 2024-04-17 name: Elsan class: OTHER briefSummary: This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression. |
In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications. |
The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases. conditions: Metastatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot, exploratory, prospective, monocentric study primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Stereotactic Radiotherapy measure: Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy. measure: Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Duration until new systemic treatment start. measure: Incidence of Adverse Events (safety) measure: Progression-Free Survival measure: Overall Survival measure: Objective Response Rate according to iRECIST criteria on the irradiated lesion only. measure: Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only. measure: Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect). measure: Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect). measure: Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect). measure: Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Clinical city: Soyaux state: Charente zip: 16800 country: France lat: 45.65 lon: 0.2 hasResults: False |
<|newrecord|> nctId: NCT06363760 id: EDIT-301-LTFU-001 briefTitle: A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301 overallStatus: NOT_YET_RECRUITING date: 2024-06-04 date: 2040-08 date: 2040-08 date: 2024-04-12 date: 2024-04-12 name: Editas Medicine, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301. conditions: Sickle Cell Disease conditions: Transfusion-dependent Beta-Thalassemia conditions: Hemoglobinopathies studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: Safety and efficacy assessments measure: Adverse events of special interest (AESI) measure: Adverse events of interest (AEI) measure: All-cause mortality measure: Adverse events (AEs) related to EDIT-301 measure: Serious adverse events (SAEs) measure: Proportion of SCD participants with severe vaso-occlusive events (sVOEs) over time post-EDIT-301 infusion measure: Proportion of SCD participants with vaso-occlusive events (VOEs) over time post-EDIT-301 infusion measure: Frequency of SCD-related transfusions over time post-EDIT-301 infusion for SCD participants measure: Proportion of TDT participants with sustained transfusion independence (TI) over time measure: Proportion of TDT participants with sustained transfusion reduction (TR) over time measure: Frequency of TDT-related transfusions over time post-EDIT-301 infusion for TDT participants measure: SCD and TDT: Percent of peripheral red blood cells (RBCs) containing HbF (F-cells) over time measure: SCD and TDT: Total hemoglobin (Hb) concentration (g/dL) over time measure: SCD and TDT: Proportion of alleles with intended genetic modification present in peripheral blood nucleated cells and bone marrow derived CD34+ over time measure: Average HbF (pg) per RBC over time for SCD participants measure: Complete Blood Count (CBC) red cell indices assay over time for SCD participants measure: Average HbF (pg) per F-cell over time for SCD participants measure: HbF and HbS concentration (g/dL) over time for SCD participants measure: The level of HbF production determined by fractionation of different forms of Hb (including but not limited to HbA, HbA2, HbC, HbD, HbE, and HbS) over time for SCD participants. measure: Percentage of HbF over total non-transfused total Hb (non-transfused total Hb refers to the total g/dL of all Hb variants, excluding HbA) over time for TDT participants. measure: HbF concentration (g/dL) over time for TDT participants measure: Iron overload of TDT participants measure: Proportion of TDT participants receiving iron chelation therapy over time. sex: ALL minimumAge: 12 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06363747 id: 123456 briefTitle: The Medically Reproducing Bariatric Surgery (MRB) II Study overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-06-03 date: 2025-06-03 date: 2024-04-12 date: 2024-04-15 name: Durham VA Medical Center class: FED name: Société des Produits Nestlé (SPN) briefSummary: Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB. |
The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB. conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control--\[GLP-1 agonist +/- DM2 meds + medical management + nutritional/behavioral counseling\] Experimental---\[Optifast + GLP-1 agonist + medical management + nutritional/behavioral counseling\] primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Very Low Calorie Diet measure: Glycemic Control measure: Weight lost measure: Medication Intensity measure: Health Related Quality of Life measure: Symptom Item Checklist sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Greenville VA Health Care Center city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 hasResults: False |
<|newrecord|> nctId: NCT06363734 id: DAL20240409 briefTitle: Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial overallStatus: RECRUITING date: 2024-04-09 date: 2025-12-15 date: 2026-12-31 date: 2024-04-12 date: 2024-04-16 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI. conditions: Non-small Cell Lung Cancer conditions: EGFR Activating Mutation conditions: Cell Cycle Deregulation conditions: EGFR-TKI Resistant Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Osimertinib plus Dalpiciclib measure: Objective Response Rate (ORR) measure: disease control rate (DCR) measure: Duration of Response (DoR) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300060 country: China name: Peng Chen, M.D. role: CONTACT phone: +86-22-23340123 phoneExt: 3201 email: [email protected] name: Peng Chen, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06363721 id: DFH00125 briefTitle: A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health overallStatus: RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Designs for Health class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices. |
A 12-week pilot study will be conducted to achieve the purpose of this study. The research team hypothesizes that PerioPull™ will improve a variety of validated markers of dental health that are commonly used in clinical practice. conditions: Oral Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist. All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice. All study outcomes are described in detail in an ensuing section. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 18 type: ESTIMATED name: PerioPull™ measure: Plaque Index measure: Gingival Index measure: Pocket Depth measure: Intraoral Photos measure: MyPerioPath® sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Julian Center for Comprehensive Dentistry status: RECRUITING city: Ellicott City state: Maryland zip: 21042 country: United States name: Eugene Sambataro, DDS role: CONTACT phone: 410-834-0796 email: [email protected] name: Eugene Sambataro, DDS role: PRINCIPAL_INVESTIGATOR name: Chris D'Adamo, PhD role: SUB_INVESTIGATOR name: Michael Jurgelewicz, DC role: SUB_INVESTIGATOR name: David Brady, ND, DC role: SUB_INVESTIGATOR lat: 39.26733 lon: -76.79831 hasResults: False |
<|newrecord|> nctId: NCT06363708 id: 2024050 briefTitle: Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Zhongnan Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer. conditions: Endometrial Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Tislelizumab name: Paclitaxel name: Carboplatin measure: R0 resection rate (R0 %) measure: Pathological complete response rate (pCR%） measure: Objective Response Rate (ORR%) measure: Progression free survival (PFS) measure: Recurrence free survival (RFS) measure: Overall survival (OS) measure: Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0 sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Central Hospital of Wuhan city: Wuhan state: Hubei zip: 430014 country: China name: Xun Tian, MD,PhD role: CONTACT phone: 15327205656 email: [email protected] lat: 30.58333 lon: 114.26667 facility: Zhongnan Hospital of Wuhan University city: Wuhan state: Hubei zip: 430062 country: China name: Zheng Hu, MD,PhD role: CONTACT phone: 13632120686 email: [email protected] lat: 30.58333 lon: 114.26667 facility: Hubei maternal and child health care hospital city: Wuhan state: Hubei zip: 430070 country: China name: QuanFu Ma, MD,PhD role: CONTACT phone: 13728133014 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False |
<|newrecord|> nctId: NCT06363695 id: 131-22 id: 1R01HD112043-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HD112043-01 briefTitle: Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya overallStatus: RECRUITING date: 2024-03-14 date: 2028-01 date: 2028-05 date: 2024-04-12 date: 2024-04-12 name: Pacific University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Africa Mental Health Research and Training Foundation name: Georgia State University briefSummary: The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are: |
* Will SafeCare Kenya improve child and parent outcomes? |
* Is virtual delivery as effective as in-person delivery of SafeCare Kenya? |
* Is SafeCare Kenya feasible to deliver by community health volunteers? |
Mothers will: |
* Complete study assessments at three timepoints: baseline, 6 months and 18 months |
* Mothers in the SafeCare Kenya group will receive the program from their community health volunteer |
Researchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life. conditions: Child Maltreatment conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 369 type: ESTIMATED name: SafeCare Kenya name: Care as Usual by Community Health Volunteers measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months measure: Change from Baseline in scores on Parenting Stress Index at 6 months measure: Change from Baseline in scores on Parenting Stress Index at 18 months measure: Change from Baseline in score on Childhood injuries at 6 months measure: Change from Baseline in score on Childhood injuries at 18 months measure: Change from Baseline in score on Child Quality of Life at 6 months measure: Change from Baseline in score on Child Quality of Life at 18 months measure: Change from Baseline in score on Parent Quality of Life at 6 months measure: Change from Baseline in score on Parent Quality of Life at 18 months measure: Client satisfaction measure: Provider fidelity measure: Parent Interview measure: Provider Interview measure: Trainer Interview measure: Stakeholder Interview measure: Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Africa Mental Health Research and Training Foundation status: RECRUITING city: Nairobi country: Kenya name: Victoria Mutiso, PhD role: CONTACT phone: (254) 202 651 360 email: [email protected] name: Christine Musyimi, PhD role: CONTACT phone: (254) 202 651 360 email: [email protected] name: David Ndetei, MD role: PRINCIPAL_INVESTIGATOR lat: -1.28333 lon: 36.81667 hasResults: False |
<|newrecord|> nctId: NCT06363682 id: 2023PI225 briefTitle: Interventional Reference Levels (IRL) in Digestive Endoscopy acronym: EndoscopX overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-11 date: 2024-06-11 date: 2024-04-12 date: 2024-04-12 name: Central Hospital, Nancy, France class: OTHER briefSummary: Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure. |
Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. |
Secondary objective(s) : |
* Application of regulatory texts |
* Assessment of patient radiation protection |
* Radiation protection assessment for workers conditions: Each Endoscopic Intervention Using X-rays studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: ERCP name: endoscopic ultrasound name: gastroscopy name: Colonoscopy name: placement of a nasojejunal tube measure: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. measure: Application of regulatory texts measure: Assessment of patient radiation protection measure: Radiation protection assessment for workers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital University of Nancy city: Nancy state: Meurthe-et-Moselle zip: 54000 country: France name: MUNIER W Munier Wendy role: CONTACT phone: +3383155457 email: [email protected] name: CHEVAUX JB Doctor CHEVAUX Jean-Baptiste, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 hasResults: False |
<|newrecord|> nctId: NCT06363669 id: 1_CAF_AWF briefTitle: Effects of Caffeine-based Supplement on Physical Performance overallStatus: COMPLETED date: 2018-01-15 date: 2024-03-30 date: 2024-03-30 date: 2024-04-12 date: 2024-04-12 name: University School of Physical Education, Krakow, Poland class: OTHER briefSummary: The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men conditions: Muscle Power studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 12 type: ACTUAL name: multi-ingredient pre-workout dietary supplement (caffeine-based) measure: anaerobic power measure: aerobic power sex: MALE minimumAge: 19 Years maximumAge: 30 Years stdAges: ADULT facility: University School of Physical Education in Cracow city: Krakow zip: 31-571 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False |
<|newrecord|> nctId: NCT06363656 id: 76455623.5.0000.0068 briefTitle: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol acronym: SLEEP-EX2 overallStatus: RECRUITING date: 2024-02-15 date: 2024-05-28 date: 2024-07-30 date: 2024-04-12 date: 2024-04-26 name: University of Sao Paulo General Hospital class: OTHER name: Samsung Eletrônica da Amazônia Ltda name: Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP briefSummary: The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality. |
The main question it aims to answer is: |
- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep? conditions: Insomnia conditions: Sleep Initiation and Maintenance Disorders conditions: Health Status conditions: Wearable Electronic Devices conditions: Sleep studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 158 type: ESTIMATED name: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires measure: Concordance between the smartwatch application and clinical assessment sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo status: RECRUITING city: São Paulo zip: 05403-900 country: Brazil name: ARO-InCor Academic Research Organization Office role: CONTACT phone: +55 11 2661-5795 email: [email protected] name: Daniel Queiroz, PhD role: CONTACT phone: +55 11 9-4138-5473 email: [email protected] name: Geraldo Lorenzi Filho, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False |
<|newrecord|> nctId: NCT06363643 id: Prehab01 briefTitle: Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-26 date: 2024-07-26 date: 2024-04-12 date: 2024-04-12 name: University of Pavia class: OTHER briefSummary: Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity. |
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