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3. Partograph Overall Design
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A quasi-experimental pre-post study (PartoMa study)
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Setting
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Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.
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Population
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Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.
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Endpoints
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The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.
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Study Time
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Data collection from June 2023 to May 2025.
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Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.
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iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.
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iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.
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Setting
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PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000. conditions: Stillbirth conditions: Obstetric Complication conditions: Maternal Death conditions: Perinatal Death conditions: Perinatal Morbidity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings measure: stillbirth measure: Birth Asphyxia measure: Maternal death measure: Cesarean sections and vacuum extractions measure: Process indicators of quality of intrapartum care measure: Birth attendant's perception of their work condition in the labour and delivery rooms measure: The women's experience of care received during delivery. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Haramaya Hospital status: RECRUITING city: Harar state: Oromia country: Ethiopia name: Roba Ararsa, MD role: CONTACT lat: 9.31387 lon: 42.11815 facility: Hiwot Fana University Hospital status: NOT_YET_RECRUITING city: Harar country: Ethiopia name: Redwan Ahmed, MD role: CONTACT lat: 9.31387 lon: 42.11815 hasResults: False
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<|newrecord|> nctId: NCT06272994 id: 231724 briefTitle: Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin acronym: STOP-Vanc overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2027-12-01 date: 2027-12-31 date: 2024-02-22 date: 2024-04-08 name: Vanderbilt University Medical Center class: OTHER briefSummary: This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be performed as a single center, pragmatic, randomized clinical trial. primaryPurpose: TREATMENT masking: NONE count: 212 type: ESTIMATED name: MRSA Nasal Swab PCR measure: Vancomycin-free hours alive measure: Time Alive off Vancomycin measure: 30-day all-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06272981 id: BWI202308 briefTitle: A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS acronym: PulseSmart overallStatus: RECRUITING date: 2024-02-28 date: 2025-08-29 date: 2025-08-29 date: 2024-02-22 date: 2024-04-26 name: Biosense Webster, Inc. class: INDUSTRY briefSummary: The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 135 type: ESTIMATED name: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation measure: Number of Participants with Primary Adverse Events (PAEs) measure: Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Prince Alfred Hospital status: NOT_YET_RECRUITING city: Camperdown zip: 2050 country: Australia lat: -33.88965 lon: 151.17642 facility: Canberra Heart Rhythm status: RECRUITING city: Garran zip: 2605 country: Australia lat: -35.34206 lon: 149.10846 facility: John Hunter Hospital status: WITHDRAWN city: New Lambton Heights zip: 2305 country: Australia lat: -32.92466 lon: 151.69364 facility: Westmead Hospital status: RECRUITING city: Westmead zip: 2145 country: Australia lat: -33.80383 lon: 150.98768 facility: Southlake Regional Health Centre status: NOT_YET_RECRUITING city: Newmarket state: Ontario zip: L3Y 2P9 country: Canada lat: 44.05011 lon: -79.46631 facility: University of Ottawa Heart Institute status: NOT_YET_RECRUITING city: Ottawa state: Ontario zip: K1Y 4W7 country: Canada lat: 45.41117 lon: -75.69812 facility: Montreal Heart Institute status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H1T 1C8 country: Canada lat: 45.50884 lon: -73.58781 facility: McGill University Health Centre status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H3G 1A4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06272968 id: EA2/252/23 briefTitle: Predicting Cognition After DBS for Parkinson's Disease 2 overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-12-01 date: 2030-12-01 date: 2024-02-22 date: 2024-02-22 name: Charite University, Berlin, Germany class: OTHER briefSummary: The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.
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The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures. conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Neuropsychological Testing measure: Change in cognitive performance after STN-DBS measure: Incidence of postoperative neurocognitive disorder sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin city: Berlin zip: 13351 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06272955 id: H-54417 briefTitle: LONG TERM EFFECTS OF SPINAL CORD STIMULATION acronym: SCS for FOG OL overallStatus: ENROLLING_BY_INVITATION date: 2024-01-04 date: 2025-06-30 date: 2025-06-30 date: 2024-02-22 date: 2024-02-22 name: Nora Vanegas class: OTHER briefSummary: Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.
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The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.
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1. Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
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2. Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Spinal Cord Stimulator (SCS) measure: Safety and Tolerability measure: New Freezing of Gait Questionnaire (NFOG-Q) score measure: Gait and Falls Questionnaire (GFQ) measure: MDS-UPDRS score measure: Timed Up and Go test (TUG) measure: Timed 10-meter walk (T10MW) measure: Mini-Mental State Examination (MMSE) measure: Montreal Cognitive Assessment Scale (MoCA) measure: Beck Depression Inventory (BDI-2) measure: Beck Anxiety Inventory (BAI) measure: Parkinson's Disease Questionnaire - 39 (PDQ39) measure: Non-Motor Symptoms Scale (NMSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor College of Medicine city: Houston state: Texas zip: 77005 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06272942 id: 22722 briefTitle: An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States acronym: SeeMe Tool overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2025-08-30 date: 2025-08-30 date: 2024-02-22 date: 2024-04-23 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.
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ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.
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In observational studies, only observations are made without participants receiving any advice or any changes to health care.
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People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.
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In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.
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They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).
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In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.
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Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.
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The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.
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Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay. conditions: Acute Respiratory Distress Syndrome (ARDS) conditions: Post Intensive Care Syndrome (PICS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 140000 type: ESTIMATED name: An ICU admission and a temporally related ARDS diagnosis measure: Morbidity measure: Post ICU Syndrome-related morbidity measure: Incident morbidity measure: Post ICU Syndrome-related incident morbidity measure: Difference in prevalence rates pre versus post index hospitalization measure: Average total healthcare costs based on healthcare billing data in the one year post index ICU admission measure: Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Whippany state: New Jersey zip: 07981 country: United States lat: 40.82454 lon: -74.4171 hasResults: False
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<|newrecord|> nctId: NCT06272929 id: behcet and vascular briefTitle: Serum Elafin and Vascular Affection in Behcet Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.
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To assess the correlation between serum elafin and vascular affection and their relation with disease activity. conditions: Behcet Disease and Vascular Affection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED name: doppler ultrasound measure: Measuring the level of serum Elafin in patients with BD in comparison to healthy participants. sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272916 id: Effect drugs on headache inCS briefTitle: Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-06 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH. conditions: Post-Dural Puncture Headache studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 630 type: ESTIMATED name: Aminophylline , magnesium sulphate and placebo measure: Effect of the study drugs on the incidence and severity of PDPH sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272903 id: MBRU IRB-2023-228 briefTitle: Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-12 date: 2024-02-22 date: 2024-02-22 name: Mohammed Bin Rashid University of Medicine and Health Sciences class: OTHER briefSummary: The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE). conditions: Effect of Benzocaine on Pain studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: 20% benzocaine, topical anesthetic name: Children's Toothpaste measure: Immediate Pain Levels measure: Patient Satisfaction During Procedure sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Mohammed Bin Rashid University Of Medicine and Health Sciences city: Dubai country: United Arab Emirates name: Iyad Hussein role: CONTACT phone: 971564715509 email: iyad.hussein@mbru.ac.ae name: Simran Kaur Sura role: PRINCIPAL_INVESTIGATOR lat: 25.0657 lon: 55.17128 hasResults: False
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<|newrecord|> nctId: NCT06272890 id: GiresunU briefTitle: THE EFFECT OF MOTIVATIONAL INTERVIEWING ON NURSING STUDENTS WITH SOCIAL ANXIETY overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-22 name: Gazi University class: OTHER briefSummary: Studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. Motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.It also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety. conditions: Motivation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research was planned as a randomized controlled experimental study in a two-center parallel group pretest-posttest design. primaryPurpose: OTHER masking: SINGLE maskingDescription: In order to prevent detection bias in the study, all measurements will be made using an online survey form. In order to prevent reporting bias, the data obtained from the research will be coded as A and B by an independent statistician, transferred to the SPSS program and analyzed. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: motivational interviewing measure: Motivational interviewing has an effect on nursing students' social anxiety. measure: Motivational interviewing has an effect on nursing students' dating violence. measure: Motivational interviewing has an effect on nursing students' self-compassion. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272877 id: 129944-54 briefTitle: Fluidotherapy in Patients With Distal Radius Fractures overallStatus: RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-22 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.
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Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase. conditions: Distal Radius Fractures conditions: Edema Arm conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Investigator and the outcomes assesor will be different persons. Statician will be different person. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Fluidotherapy name: conventional rehabilitation program measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: Wrist joint range of motion measure: Wrist joint range of motion measure: Wrist joint range of motion measure: Circumference (mm) measure: Circumference (mm) measure: Circumference (mm) measure: Gross Grip Strength: measure: Gross Grip Strength: measure: Gross Grip Strength: measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirsehir Research and Training Hospital status: RECRUITING city: Kirsehir state: Kişrsehşr zip: 40100 country: Turkey name: Levent Horoz, Asst Prof role: CONTACT phone: :+90 386 280 39 00 email: dr.leventhoroz@gmail.com lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272864 id: BEGIN study briefTitle: BostonGene and Exigent Genomic INsight Study acronym: BEGIN overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2026-01-08 date: 2028-01-08 date: 2024-02-22 date: 2024-02-22 name: BostonGene class: INDUSTRY name: Exigent briefSummary: The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings. conditions: Breast Cancer conditions: Non-small Cell Lung Cancer conditions: Melanoma conditions: Sarcoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Frequency of actionable findings measure: Test turn-around time measure: Frequency of patients who receive molecularly matched therapy measure: Frequency of patients who receive molecularly matched therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwest Medical Specialities city: Puyallup state: Washington zip: 98373 country: United States name: Sibel Blau, MD role: CONTACT lat: 47.18538 lon: -122.2929 hasResults: False
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<|newrecord|> nctId: NCT06272851 id: Choroidal thickness by OCT briefTitle: Measuring Choroidal Thickness Using Optical Coherence Tomography overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2029-03-30 date: 2029-05-15 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography. conditions: Choroid Disease conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 122 type: ESTIMATED name: optical coherence tomography measure: comparison between choroidal thickness sex: ALL minimumAge: 30 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272838 id: 2023-19/145 briefTitle: Biodex Balance System in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2024-02-28 date: 2024-09-14 date: 2024-10-14 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes Assessor will be different persons whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Biodex balance system name: The conventional balance exercise program measure: Berg Balance Scale measure: Berg Balance Scale measure: Berg Balance Scale measure: Biodex dynamic balance score measure: Biodex dynamic balance score measure: Biodex dynamic balance score measure: The fall efficacy scale measure: The fall efficacy scale measure: The fall efficacy scale measure: Time up and go test measure: Time up and go test measure: Time up and go test measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The Five Times Sit to Stand Test measure: The Five Times Sit to Stand Test measure: The Five Times Sit to Stand Test measure: Beck Depression Inventory measure: Beck Depression Inventory measure: Beck Depression Inventory sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran University Faculty of Medicine status: RECRUITING city: Kırşehir state: City Center zip: 40100 country: Turkey name: Basak Cigdem Karacay, Asist Prof role: CONTACT phone: 0905445094803 email: basak.cigdemkaracay@ahievran.edu.tr name: Basak Cigdem Karacay, Asist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272825 id: 2023-19/140 briefTitle: Virtual Reality in Patients With Knee Osteoarthritis overallStatus: RECRUITING date: 2024-02-28 date: 2024-07-14 date: 2024-08-14 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation. conditions: Knee Osteoarthritis conditions: Pain conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes Assessor will be different persons. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Virtual reality name: conventional rehabilitation measure: Visual Analog Scale measure: Visual Analog Scale measure: Visual Analog Scale measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: Biodex Balance System measure: Biodex Balance System measure: Biodex Balance System measure: Short Form 36 (SF36) measure: Short Form 36 (SF36) measure: Short Form 36 (SF36) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran University Faculty of Medicine status: RECRUITING city: Kırşehir state: City Center zip: 40100 country: Turkey name: Basak Cigdem Karacay, Asist Prof role: CONTACT phone: 0905445094803 email: basak.cigdemkaracay@ahievran.edu.tr name: Basak Cigdem Karacay, Asist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272812 id: IAVI C113 briefTitle: A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-03 date: 2028-03 date: 2024-02-22 date: 2024-02-22 name: International AIDS Vaccine Initiative class: NETWORK name: Biofabri, SLU name: Universidad de Zaragoza briefSummary: A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region. conditions: Tuberculosis (TB) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 4300 type: ESTIMATED name: MTBVAC name: Placebo measure: To evaluate the protective efficacy of of MTBVAC against bacteriologically confirmed pulmonary TB disease, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment as compared to placebo. measure: To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. measure: To evaluate the protective efficacy of MTBVAC candidate vaccine against definite Xpert MTB/RIF Ultra positive pulmonary TB disease diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. measure: To evaluate the protective efficacy of one dose of MTBVAC candidate vaccine against clinical TB, as compared to placebo measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. sex: ALL minimumAge: 14 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06272799 id: RS1480/21 briefTitle: Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study acronym: ATD overallStatus: RECRUITING date: 2022-09-20 date: 2024-09-20 date: 2024-09-20 date: 2024-02-22 date: 2024-02-22 name: Regina Elena Cancer Institute class: OTHER briefSummary: Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 160 type: ESTIMATED name: T-DM1 adjuvant measure: Evaluate the tolerability. measure: Evaluate the effectiveness of treatment. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Patrizia Vici, Doctor role: CONTACT phone: 06-5266.5584 phoneExt: +39 email: patrizia.vici@ifo.it lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06272786 id: 2023-18/128 briefTitle: Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair overallStatus: RECRUITING date: 2024-02-28 date: 2024-09-01 date: 2024-10-01 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications. conditions: Rotator Cuff Tears conditions: Pain conditions: Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and outcome assessor will be different persons. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: conventional physiotherapy program. name: Suprascapular nerve block measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Shoulder joint range of motion (ROM) measure: Shoulder joint range of motion (ROM) measure: Shoulder joint range of motion (ROM) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Modified Constant-Murley Scoring measure: Modified Constant-Murley Scoring measure: Modified Constant-Murley Scoring sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahi Evran University status: RECRUITING city: Kirşehir state: City Centre zip: 40100 country: Turkey name: Basak Cigdem Karacay, Assist Prof role: CONTACT phone: :+90 386 280 39 00 email: basak.cigdemkaracay@ahivran.edu.tr name: Basak Cigdem Karacay, Assist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06272773 id: IRAS Ref: 333663 briefTitle: Forced Oscillation and Breathing Pattern in Asthma overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2025-03 date: 2024-02-22 date: 2024-02-22 name: Karl Sylvester class: OTHER briefSummary: Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.
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FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.
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However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.
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Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.
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We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 65 type: ESTIMATED name: Forced Oscillation Test measure: Change in airway resistance at 5 Hertz (Hz) and 19Hz sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06272760 id: 2024-02-060 briefTitle: Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2026-02-28 date: 2024-02-22 date: 2024-02-22 name: Samsung Medical Center class: OTHER briefSummary: The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single blinding whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Home-based hand-arm bimanual intensive training (Tele-HABIT) name: Hand-arm bimanual intensive training (In-clinic-HABIT) measure: Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0). measure: Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0). measure: Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0). measure: Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0). measure: Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0). measure: Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0). measure: Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0). sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06272747 id: XH-S003-I-101 briefTitle: A Phase I Study of XH-S003 in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-07-30 date: 2024-10-30 date: 2024-02-22 date: 2024-02-22 name: S-Infinity Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S003 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S003. conditions: Healthy Adults studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: XH-S003 name: Placebo measure: Number of participants with adverse events (AEs) measure: Number of participants with adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Friendship Hospital,Capital Medical University city: Beijing country: China name: Ruihua Dong, MD role: CONTACT phone: 010-63139033 email: Ruihua_Dong_RW@163.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06272734 id: RCV-0007 briefTitle: Reprieve System Pilot Study overallStatus: RECRUITING date: 2024-01-23 date: 2024-12-31 date: 2025-01-31 date: 2024-02-22 date: 2024-02-22 name: Reprieve Cardiovascular, Inc class: INDUSTRY briefSummary: The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Reprieve System measure: Functional Device Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tbilisi Heart and Vascular Clinic status: RECRUITING city: Tbilisi zip: 0159 country: Georgia name: Tamaz Shaburishvili, MD role: CONTACT phone: +995 322 479300 email: tamaz_shaburishvili@yahoo.com lat: 41.69411 lon: 44.83368 hasResults: False
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<|newrecord|> nctId: NCT06272721 id: 6272 briefTitle: Hypothyroidism in Pregnancy and Neuropsychological Development in Children acronym: OHPLDO overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2024-04-30 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development.
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Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes.
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Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool.
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This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention. conditions: Thyroid Dysfunction conditions: Pregnancy Related conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 104 type: ESTIMATED name: Griffiths Scale measure: total development quotient measured using the Griffiths scale sex: ALL minimumAge: 2 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: ALFREDO PONTECORVI role: CONTACT phone: +390630155701 email: alfredo.pontecorvi@policlinicogemelli.it name: ALFREDO PONTECORVI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06272708 id: IIT-2023-0356 briefTitle: Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients overallStatus: RECRUITING date: 2024-01-29 date: 2024-02-29 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: RenJi Hospital class: OTHER briefSummary: Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.
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Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.
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Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer. conditions: Thromboelastography conditions: Hemodialysis conditions: Anticoagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: thromboelastography parameter R value measure: thromboelastography parameter K value measure: thromboelastography parameter Angle measure: thromboelastography parameter MA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Yunyue Guo role: CONTACT phone: 0086-021-68383312 email: guoyunyue@renji.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06272695 id: R477-203 briefTitle: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-15 date: 2025-06-15 date: 2024-02-22 date: 2024-04-10 name: REMD Biotherapeutics, Inc. class: INDUSTRY briefSummary: This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.
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