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2. Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner. conditions: Breast Cancer conditions: Benign Breast Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Breast scan using the Z-scanner name: Breast scan using the Z-scanner measure: Measurement of complex permittivity of breast tissue components measure: Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion) measure: Repeatability of the Z-scanner measure: Reproducibility of the Z-scanner sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Lesley Honeyfield role: CONTACT name: Adrian Lim role: PRINCIPAL_INVESTIGATOR name: Deborah Cunningham role: SUB_INVESTIGATOR name: Sylvie Flais role: SUB_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06264921 id: NKT3447-101 briefTitle: A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-02-23 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-04-12 name: NiKang Therapeutics, Inc. class: INDUSTRY briefSummary: The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D). conditions: Solid Tumor conditions: Solid Tumor, Adult conditions: Advanced Solid Tumor conditions: Metastatic Tumor conditions: Ovarian Cancer conditions: Ovarian Neoplasms conditions: Ovarian Carcinoma conditions: Metastatic Ovarian Carcinoma conditions: Endometrial Cancer conditions: Endometrial Neoplasms conditions: Endometrial Diseases conditions: Metastatic Endometrial Cancer conditions: Metastatic Endometrial Carcinoma conditions: Advanced Endometrial Carcinoma conditions: Advanced Ovarian Carcinoma conditions: Gastric Cancer conditions: Advanced Gastric Carcinoma conditions: Metastatic Gastric Cancer conditions: Metastatic Gastric Carcinoma conditions: Small-cell Lung Cancer conditions: Small Cell Lung Carcinoma conditions: Triple Negative Breast Cancer conditions: Triple Negative Breast Neoplasms conditions: Platinum-resistant Ovarian Cancer conditions: Platinum-refractory Ovarian Carcinoma conditions: CCNE1 Amplification conditions: Hormone Receptor Negative Breast Carcinoma conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: Progesterone-receptor-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose Escalation and Dose Expansion primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomized for the Expansion Phase count: 90 type: ESTIMATED name: NKT3447 measure: Number of Participants with Dose Limiting Toxicity (DLT) events measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Duration of Response (DOR) measure: Disease control rate measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Number of Participants with Adverse Events measure: Maximum observed plasma concentration (Cmax) of NKT3447 measure: Time to maximum observed plasma concentration of NKT3447 (Tmax) measure: Observed trough concentration of NKT3447 (Ctrough) measure: Area under the plasma concentration-time curve (AUC0-t) of NKT3447 measure: Apparent clearance (CL/F) measure: Apparent volume of distribution (V/F) measure: Half-life (t1/2) measure: Accumulation ratio (AR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarah Cannon Research Institute at HealthONE status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Kelly Mozzetta role: CONTACT name: Gerald Falchook, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: AdventHealth Cancer Institute status: RECRUITING city: Celebration state: Florida zip: 34747 country: United States name: Heather Osorio role: CONTACT email: Heather.Osorio@AdventHealth.com name: Karolina Kilowski, DO role: PRINCIPAL_INVESTIGATOR lat: 28.32529 lon: -81.53313 facility: The Gabrail Pharmacology Phase 1 Research Center status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States name: Carrie Smith role: CONTACT email: csmith@gabrailcancercenter.com name: Nashat Y Gabrail, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79895 lon: -81.37845 facility: Texas Oncology-Austin Midtown NEXT Oncology status: RECRUITING city: Austin state: Texas zip: 78758 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com name: Andrae Vandross, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: START Mountain Region status: RECRUITING city: West Valley City state: Utah zip: 84119 country: United States name: Marie Asay role: CONTACT phone: 801-907-4770 email: marie.asay@startthecure.com name: Justin A Call, MD role: PRINCIPAL_INVESTIGATOR lat: 40.69161 lon: -112.00105 hasResults: False
<\|newrecord\|> nctId: NCT06264908 id: 20240125-010-000 briefTitle: An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis acronym: OASIS-H overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2028-04 date: 2024-02-20 date: 2024-02-20 name: Dr Iris Tang Yan Ki class: OTHER name: Hospital Authority, Hong Kong briefSummary: The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).

This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.

Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups. conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients will be randomized into early intervention and routine clinical care (control) group. Patients in control group will crossover to receive the intervention at week 26. primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Integrated self-management programme measure: Change in Pain visual analogue scale (VAS) measure: Change in pain Visual Analogue Scale (VAS) measure: Change in Functional index hand osteoarthritis (FIHOA) measure: Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score measure: Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 measure: Change in Short-form 36 items health survey measure: Change in hand grip strength measure: Change in hand dexterity measurement measure: Radiographic changes measure: Adverse events measure: Use of rescue pain medication sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264895 id: Trinity College Dublin 211202 briefTitle: Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction. acronym: LEAP-W overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-07-31 date: 2024-07-31 date: 2024-02-20 date: 2024-02-20 name: University of Dublin, Trinity College class: OTHER briefSummary: Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.

Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun \& Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.

Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population. conditions: Social Exclusion conditions: Chronic Disease conditions: Physical Disability conditions: Addiction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single -arm longitudinal cohort study primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Exercise measure: Recruitment measure: Retention measure: Adverse events measure: Hand grip dynamometry measure: Limb circumference measure: 10 Metre Walk Test measure: 2 Minute Walk Test measure: The Chair Stand Test measure: Single Leg Stance Test measure: Numerical Rating Scale (NRS) measure: Clinical Frailty Scale (CFS) measure: SHARE-Frailty Instrument (FI) measure: Mini Nutritional Assessment (MNA) measure: Short Form-12 V2 sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264882 id: 23-1518 id: U54AG062319 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG062319 briefTitle: Cardiometabolic Consequences of the Loss of Ovarian Function acronym: LILAC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-05-31 date: 2028-08-31 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: National Institute on Aging (NIA) briefSummary: The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen. conditions: Menopause conditions: Estrogen Deficiency conditions: Aging conditions: Adiposity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Degarelix name: Transdermal Estradiol Patch name: Transdermal Placebo Patch measure: Brachial artery flow mediated dilation (FMD) measure: Visceral fat area (VFA) measure: Subcutaneous fat area measure: Tryptophan-Kynurenine metabolites measure: Body composition - mass measure: Body composition - bone measure: Oxidized LDL measure: Total antioxidant status measure: Pro-inflammatory cytokines measure: Blood lipids and lipoproteins measure: Blood glucose measure: Insulin measure: Adipokines measure: Physical activity levels measure: Endothelial cell protein measures measure: Ex vivo serum exposure studies measure: Cerebrovascular function measure: Arterial Stiffness measure: Carotid artery stiffness measure: Blood pressure measure: Self reported sleep quality measure: Cognitive function sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False
<\|newrecord\|> nctId: NCT06264869 id: 141123 briefTitle: Interdental Guided Creeping Technique overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-11 date: 2024-11 date: 2024-02-20 date: 2024-02-20 name: October 6 University class: OTHER briefSummary: The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft. conditions: Interdental Papilla Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) name: Interdental guided creeping technique (IGCT) and collagen membrane (CM) measure: Black triangle height measure: Percentage of interdental papillary fill measure: Papillary gain, black triangle reduction measure: Papillary height, attached gingiva width measure: Pocket depth, clinical attachment level, keratinized tissue thickness measure: Plaque index measure: Gingival index measure: Duration of surgery measure: Patient Reported Outcome measure: Patient Reported Outcome sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264856 id: 202210096RIND briefTitle: Bronchoscopy for Thoracic Trauma Patients overallStatus: SUSPENDED date: 2024-12-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: National Taiwan University Hospital class: OTHER briefSummary: The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes. conditions: Chest Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: bronchoscopic sputum suction name: negative pressure aspiration suction measure: Rate of pneumonia measure: Intensive Care Unit admission interval measure: admission interval measure: tracheostomy rate measure: intubation rate sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Traumatology, National Taiwain University Hospital city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch city: Taipei zip: 100; 300; 640; 280 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06264843 id: 724 briefTitle: Peripheral Bypass Trial for Completion Control acronym: PATENT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2027-12 date: 2024-02-20 date: 2024-02-20 name: Medistim ASA class: INDUSTRY briefSummary: The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Medistim MiraQ system with TTFM and L15 HFUS probes measure: Primary graft patency rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264830 id: 202307103DIPC briefTitle: 3D Visualization System in Highly Myopic Cataract Operation acronym: 3D-HiMCO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-04-16 name: National Taiwan University Hospital class: OTHER name: Alcon Research briefSummary: This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes. conditions: Cataract conditions: High Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Alcon-NGENUITY®(NG)-system name: Standard cataract operation measure: Number of times of Microscopic focus adjustment, measured by counting from the video recordings measure: Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope measure: Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope measure: Total operation time measure: Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion) measure: Number of Participants with intraoperative complication measure: Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment) measure: Number of Participants with post-operative complication measure: Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan name: Tzyy-Chang Ho, MD role: CONTACT phone: 886-2-23123456 phoneExt: 62579 email: hotc@ntuh.gov.tw name: Cheng-Yung Lee, MD role: CONTACT phone: 886-2-23123456 phoneExt: 65190 email: G05875@hch.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06264817 id: EC 48 LyberT briefTitle: Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema. acronym: LyberT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-04-15 date: 2024-02-20 date: 2024-02-20 name: Thuasne class: INDUSTRY briefSummary: This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema conditions: Lymphedema of Upper Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, multi-center, interventional, controlled-randomized, single blinded study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: For the same patient, all measurements will be performed as far as possible by the same health professional who doesn't have the knowledge of patient's group. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: MOBIDERM Autofit Armsleeve name: Compressive bandaging measure: Volume excess variation measure: Resource consumption measure: Resource consumption measure: Resource consumption measure: Lymphedema related Quality of life (QoL) measure: Doctors' opinion on improving the patient's health condition measure: Patient's opinion on Global Impression of Change measure: Satisfaction about the device measure: The safety measure: Compliance to treatment measure: General quality of life (QoL) measure: Skin elasticity measure: Ttissue induration sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pinar BORMAN city: Ankara country: Turkey name: Pinar BORMAN role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06264804 id: [2023] No. 86 briefTitle: Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery overallStatus: RECRUITING date: 2024-02-16 date: 2024-07-01 date: 2024-12-01 date: 2024-02-20 date: 2024-04-02 name: Yifeng Yu class: OTHER briefSummary: The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. conditions: Refractive Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: Identify risk factors for progressive suction loss sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Yuyifeng status: RECRUITING city: Nanchang state: Jiangxi zip: 330008 country: China name: yifeng Yu, Doctorate role: CONTACT phone: +8613979180258 email: 171018170@qq.com lat: 28.68396 lon: 115.85306 hasResults: False
<\|newrecord\|> nctId: NCT06264791 id: STUDY00018516 id: K99AA030591 type: NIH link: https://reporter.nih.gov/quickSearch/K99AA030591 briefTitle: Stress-motivated Alcohol Use as a Value-based Decision-making Process overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-20 date: 2024-02-20 name: University of Washington class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are:

* Does psychological stress affect the decision to consume (more) alcohol?
* How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations). conditions: Psychological Stress conditions: Alcohol Intoxication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 160 type: ESTIMATED name: Stress name: Alcohol measure: Proportion of choices for alcoholic over non-alcoholic drinks. sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98105 country: United States name: Jonas Dora, PhD role: CONTACT phone: 206-741-6330 email: jdora@uw.edu lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06264778 id: 2023013 briefTitle: Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-01 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Shandong University class: OTHER briefSummary: This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients. conditions: Ameloblastoma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a single-arm study that does not involve randomization or blinding, nor does it establish a parallel control group and uses external control. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dabrafenib measure: objective response rate measure: Relapse-free survival sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264765 id: 22-12-23 briefTitle: Scalp Block -Craniotomi acronym: scalp block overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.

In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended. conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized double blinding primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blind patients and postoperative follow-ups will not know which group the patient is in the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 62 type: ESTIMATED name: scalp block name: Incisional infiltration measure: opioid consumption measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferdi Gülaştı status: RECRUITING city: Aydın zip: 09020 country: Turkey name: Ferdi Gülaştı role: CONTACT email: ferdigulasti@gmail.com lat: 37.84501 lon: 27.83963 hasResults: False
<\|newrecord\|> nctId: NCT06264752 id: STUDY20120008 id: R01DK121730 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK121730 briefTitle: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury acronym: MEnD-AKI overallStatus: ENROLLING_BY_INVITATION date: 2024-02-15 date: 2026-01 date: 2026-04 date: 2024-02-20 date: 2024-02-20 name: University of Pittsburgh class: OTHER name: University of Florida name: University of Pittsburgh Medical Center name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. Researchers will randomize 39 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Statisticians performing the analysis will be blinded to the treatment allocation.

The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention. whoMasked: OUTCOMES_ASSESSOR count: 625 type: ESTIMATED name: Level A name: Level B name: Passive Alert measure: Major Adverse Kidney Events within 30 days of randomization (MAKE30) measure: Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge measure: AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3 measure: Nephrotoxic burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Altoona city: Altoona state: Pennsylvania zip: 16601 country: United States lat: 40.51868 lon: -78.39474 facility: UPMC Horizon city: Farrell state: Pennsylvania zip: 16121 country: United States lat: 41.21228 lon: -80.49674 facility: UPMC McKeesport city: McKeesport state: Pennsylvania zip: 15132 country: United States lat: 40.34785 lon: -79.86422 facility: UPMC Jameson city: New Castle state: Pennsylvania zip: 16105 country: United States lat: 41.00367 lon: -80.34701 facility: UPMC Magee city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Presbyterian/Montefiore city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Shadyside city: Pittsburgh state: Pennsylvania zip: 15232 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Williamsport city: Williamsport state: Pennsylvania zip: 17701 country: United States lat: 41.24119 lon: -77.00108 hasResults: False
<\|newrecord\|> nctId: NCT06264739 id: 22-12-23/2 briefTitle: Erector Spinae Block -Dexmedetomidine acronym: esp -dex overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.

Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain. conditions: Postoperative Acute Pain conditions: Opioid Consumption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized double blinding primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blindness patients and those who follow up after surgery will not know which group is in the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 74 type: ESTIMATED name: esp Dexmedetomidine (dekstomid) name: esp remifentanyl (ultiva) measure: opioid consumption measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferdi Gülaştı status: RECRUITING city: Aydın zip: 09020 country: Turkey name: Ferdi Gülaştı role: CONTACT email: ferdigulasti@gmail.com lat: 37.84501 lon: 27.83963 hasResults: False
<\|newrecord\|> nctId: NCT06264726 id: 23-0254 id: R01HL150909 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL150909 briefTitle: CommunityRx-Cardiovascular Disease acronym: CRx-CVD overallStatus: RECRUITING date: 2024-03-12 date: 2025-03-12 date: 2025-03-12 date: 2024-02-20 date: 2024-04-12 name: University of North Carolina, Chapel Hill class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:

• What is the effectiveness of community resource information on patient self-efficacy to use community resources?

Participants will be given:

* A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
* Access to a community resource navigator for support with using the HealtheRx upon request
* 2 text messages with reminders about the HealtheRx and access to the community resource navigator conditions: Cardiovascular Diseases conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 325 type: ESTIMATED name: HealtheRx measure: Change in participant self-efficacy for finding community resources measure: Change in participant knowledge of community resources measure: Change in participant utilization of community resources sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: OIC Family Medical Center - Fairview status: RECRUITING city: Rocky Mount state: North Carolina zip: 27801 country: United States name: Jesslyn Pope role: CONTACT email: jpope@oicone.org lat: 35.93821 lon: -77.79053 facility: OIC Family Medical Center - Happy Hill status: RECRUITING city: Rocky Mount state: North Carolina zip: 27804 country: United States name: Jesslyn Pope role: CONTACT email: jpope@oicone.org lat: 35.93821 lon: -77.79053 hasResults: False
<\|newrecord\|> nctId: NCT06264713 id: CE/2023_041 briefTitle: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback acronym: IRENE overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2025-12-01 date: 2024-02-20 date: 2024-02-22 name: I.R.C.C.S. Fondazione Santa Lucia class: OTHER briefSummary: The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests. conditions: Neglect, Hemispatial conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Clinical Trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blind randomisation. The patients and their families/caregivers are blinded with respect to the group allocation. The assessors are not informed about the group allocation for the entire period of the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Immersive Virtual Reality name: Sham Immersive Virtual Reality measure: Changes in the Behavioural Inattention Test measure: Changes in the Copying drawings with or without programming elements measure: Changes in the Barrage Test measure: Changes in the Wundt Justrow area illusion test measure: Changes in the Kessler Foundation Neglect Assessment Process measure: Changes in the Stroke Specific Quality of Life Scale measure: Changes in the Fugl-Meyer Assessment scale measure: Changes in reaction time e time of fixation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Santa Lucia Foundation status: RECRUITING city: Rome state: Lazio zip: 00142 country: Italy name: Valeria Verna, MSc role: CONTACT phone: 0651501907 name: Valeria Verna, MSc role: PRINCIPAL_INVESTIGATOR name: Marco Tramontano, PhD role: SUB_INVESTIGATOR name: Alex Martino Cinnera, PhD role: SUB_INVESTIGATOR name: Viviana Betti, PhD role: SUB_INVESTIGATOR name: Matteo Marucci, PhD role: SUB_INVESTIGATOR name: Luisa Magnotti, BSc role: SUB_INVESTIGATOR name: Alessandro Matano, MSc role: SUB_INVESTIGATOR name: Aurora Tavernese, MSc role: SUB_INVESTIGATOR name: Paolucci Stefano, MD role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06264700 id: STUDY00003303 id: R44HL169085 type: NIH link: https://reporter.nih.gov/quickSearch/R44HL169085 briefTitle: Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness acronym: ADHERE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Nationwide Children's Hospital class: OTHER name: Ann & Robert H Lurie Children's Hospital of Chicago name: Hasbro Children's Hospital name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.

Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After completing a one to three-month run-in period, participants will be randomized to receive six months of either VDOT or attention control. All participants will then complete six months of ongoing monitoring during which VDOT patients will receive intermittent communication to encourage adherence and both groups will continue to use their electronic adherence monitors. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigators will be blinded to prevent the possibility of any differential treatment that could affect the ability of the study team to evaluate the impact of VDOT on hydroxyurea adherence. As such, a statistician will create a randomization model and study staff will facilitate communication with participants as well as between participants and the VDOT team. whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Video Directly Observed Therapy (VDOT) name: Health Reminder Tip Alerts measure: Retention Rate measure: Sustained Engagement measure: Electronic Adherence measure: Pediatric SCD Medication Self-Management Questionnaire measure: Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations measure: Laboratory Studies (i.e. MCV, HbF) measure: Treatment Satisfaction measure: Participant Satisfaction sex: ALL minimumAge: 11 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lurie Children's Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Sherif Badawy, MD role: CONTACT phone: 312-227-4836 email: sbadawy@luriechildrens.org lat: 41.85003 lon: -87.65005 facility: Hasbro Children's Hospital city: Providence state: Rhode Island zip: 02903 country: United States name: Patrick McGann, MD, PhD role: CONTACT phone: 617-519-9555 email: patrick_mcgann@brown.edu lat: 41.82399 lon: -71.41283 hasResults: False
<\|newrecord\|> nctId: NCT06264687 id: HepcidinIVIron briefTitle: Hepcidin After Intravenous Iron Treatment overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Pierre-Alexandre Krayenbühl class: OTHER briefSummary: The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration. conditions: Iron Deficiency (Without Anemia) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: Serum Hepcidin Change sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264674 id: CLI-05993AB6-03 id: 2023-503333-22-00 type: OTHER domain: EMA CTIS briefTitle: Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos) acronym: TRECOS overallStatus: RECRUITING date: 2023-11-27 date: 2024-08-25 date: 2025-09-18 date: 2024-02-20 date: 2024-02-20 name: Chiesi Farmaceutici S.p.A. class: INDUSTRY briefSummary: The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 790 type: ESTIMATED name: CHF5993 200/6/12.5 μg pMDI HFA-152a name: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a measure: Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1) measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period measure: Percentage of days without intake of rescue medication. measure: Change in the average daily use of rescue medication. measure: Change on the average daily asthma symptoms. measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs). measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital status: RECRUITING city: Manchester zip: M23 9QZ country: United Kingdom name: Dave Singh, MD role: CONTACT lat: 53.48095 lon: -2.23743 hasResults: False
<\|newrecord\|> nctId: NCT06264661 id: HJM 006/22-R briefTitle: Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia overallStatus: COMPLETED date: 2022-08-08 date: 2022-09-30 date: 2022-11-30 date: 2024-02-20 date: 2024-02-20 name: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás class: OTHER briefSummary: Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried outwith validated instruments for Mexican population and gene expression was evaluated by real-time PCR. primaryPurpose: TREATMENT masking: NONE count: 23 type: ACTUAL name: Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia measure: Sleep quality measure: Glycosylated hemoglobin measure: Quality of life measure: Insomnia measure: Gene expression analysis of CLOCK measure: Gene expression analysis of BMAL1 measure: Gene expression analysis of PER1 measure: Gene expression analysis of PER2 sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás city: Cdmx state: México zip: 11360 country: Mexico hasResults: False
<\|newrecord\|> nctId: NCT06264648 id: AIBU-FTR-OOP-04 briefTitle: Investigation of Palpation Pressure Sensitivity overallStatus: COMPLETED date: 2023-05-03 date: 2023-06-16 date: 2023-10-20 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again. conditions: Sensitivity Training Groups studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups of physiotherapists with different fields of experience were attended to study. primaryPurpose: OTHER masking: NONE count: 63 type: ACTUAL name: Pressure sensitivity education measure: Measurement Palpation Pressure with Digital Scale measure: Measurement Palpation Pressure with Digital Scale sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University city: Bolu zip: 14300 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False
<\|newrecord\|> nctId: NCT06264635 id: HS26227 briefTitle: Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-20 date: 2024-03-08 name: University of Manitoba class: OTHER briefSummary: There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Platelet-Rich-Plasma name: Saline measure: International Index of Erectile Function (IIEF) measure: Adverse Events sex: MALE minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Men's Health Clinic city: Winnipeg state: Manitoba zip: R3K 1M3 country: Canada name: Premal Patel, MD role: CONTACT phone: 2042214476 email: ppatel5@hsc.mb.ca name: Jainik Shah, BFSc role: CONTACT phone: 6477721737 email: shahj4@myumanitoba.ca lat: 49.8844 lon: -97.14704 hasResults: False
<\|newrecord\|> nctId: NCT06264622 id: CEIC-2996 briefTitle: ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension acronym: GARDOSE overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Universitat de Lleida class: OTHER name: Pharmactive Biotech Products S.L.U briefSummary: The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:

* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
* If the changes in lipid profile are in a dose-response manner

Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Low dose name: High dose name: Placebo measure: Blood Pressure measure: Blood Lipid Profile sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Lleida status: RECRUITING city: Lleida zip: 25198 country: Spain name: Jose Serrano, PhD role: CONTACT phone: 973702408 email: josecarlos.serrano@udl.cat name: Manuel Portero, PhD role: CONTACT phone: 973702408 email: manuel.portero@udl.cat lat: 41.61674 lon: 0.62218 hasResults: False
<\|newrecord\|> nctId: NCT06264609 id: 91026 briefTitle: Precision Medicine Approach for Osteoporosis - Follow Up Study overallStatus: ENROLLING_BY_INVITATION date: 2024-02-01 date: 2029-12-31 date: 2029-12-31 date: 2024-02-20 date: 2024-02-20 name: Hartmut Malluche, MD class: OTHER briefSummary: Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.

Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.

Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment. conditions: Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Alendronate name: Teriparatide name: Alendronate measure: Percent change in bone loss measure: Percent change in Bone Mass Density at the hip measure: Trabecular bone score (TBS) sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky city: Lexington state: Kentucky zip: 40536 country: United States lat: 37.98869 lon: -84.47772 hasResults: False
<\|newrecord\|> nctId: NCT06264596 id: 2310-72 briefTitle: Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: The Guthrie Clinic class: OTHER briefSummary: The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery. conditions: Intraoperative Bleeding studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Concealed irrigation bags whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: Epinephrine name: Normal Saline irrigation fluid measure: visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale measure: surgeon's discomfort related to bleeding, measured by visual numeric rating scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Robert Packer Hospital city: Sayre state: Pennsylvania zip: 18840 country: United States name: Wonyong Lee, MD role: CONTACT phone: 570-887-4882 email: Wonyong.Lee@guthrie.org name: Wonyong Lee role: PRINCIPAL_INVESTIGATOR lat: 41.97896 lon: -76.5155 hasResults: False
<\|newrecord\|> nctId: NCT06264583 id: IN-DE-980-6998 briefTitle: HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Bonn class: OTHER name: Swiss HIV Cohort Study name: ICONA Cohort name: Amsterdam UMC name: Royal Free Hospital NHS Foundation Trust name: King's College London name: University Hospital of Cologne name: Goethe University name: Heinrich-Heine University, Duesseldorf name: University Hospital, Essen name: ICH Hamburg name: Praxiszentrum Hohenstaufenring Köln name: Sorbonne University name: Henri Mondor University Hospital name: Hospital Universitario Infanta Leonor name: Hospital General Universitario Gregorio Marañon name: GEPCOI (Portuguese Group of Coinfection) briefSummary: The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.

1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.

1. Evaluation of former screening of HDV by assessing existing data at study sites.
2. Determination of the HDV prevalence in European PLWH and HBV coinfection.
2. Setting up a database of all PLWH with HBV/HDV coinfection

1. Analysis of transmission risk factors for HDV coinfection
2. Asses the rate of HDV positive patients with ongoing HDV replication.
3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results. conditions: Hepatitis D studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8000 type: ESTIMATED name: HDV screening measure: HDV prevalence in HIV/HBV coinfection measure: Degree of liver disease in pateints with HIV/HBV/HDV triple infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn city: Bonn state: NRW zip: 53127 country: Germany name: Jürgen Rockstroh role: CONTACT phone: +491716575969 email: juergen.rockstroh@ukbonn.de lat: 50.73438 lon: 7.09549 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-31 uploadDate: 2024-02-09T03:56 filename: Prot_000.pdf size: 798649 hasResults: False
<\|newrecord\|> nctId: NCT06264570 id: SW007 briefTitle: Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels. acronym: PERBIO-HC overallStatus: RECRUITING date: 2023-10-23 date: 2024-05-15 date: 2024-11-30 date: 2024-02-20 date: 2024-03-13 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results. conditions: Hyperhomocysteinemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 111 type: ESTIMATED name: B-TMG supplementation name: B-SAM supplementation name: B-TMG placebo name: B-SAM placebo measure: Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l. measure: change in the level of very low density lipoproteins measure: change of anxiety when using dietary supplements accessed by the Spielberg scale measure: change of depression when using dietary supplements by the Becks scale measure: occurrence of major cardiovascular events during follow-up sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies status: RECRUITING city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation name: Andrei AV Ponomarenko, MD role: CONTACT phone: +79628316017 email: dayshadoff@gmail.com name: Elena EI Krykova role: CONTACT phone: +79133825952 email: krukova_ei@cnmt.ru name: Eugene EA Pokushalov, PhD role: PRINCIPAL_INVESTIGATOR name: Andrei AV Ponomarenko, MD role: SUB_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False
<\|newrecord\|> nctId: NCT06264557 id: RW-MCI-01 id: ROWAN type: OTHER domain: ROWAN briefTitle: Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment acronym: SB-DEX overallStatus: RECRUITING date: 2024-01-17 date: 2024-05-31 date: 2025-05-01 date: 2024-02-20 date: 2024-02-20 name: Rowan class: INDUSTRY briefSummary: Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment conditions: Mild Cognitive Impairment conditions: MCI studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: SB-100 name: Educational book measure: K-RBANS measure: K-RBANS measure: K-MMSE-2 measure: CDR-SB measure: K-IADL measure: PRMQ measure: GDS-15 measure: QOL-AD measure: ADAS-Cog14 sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hanyang University Guri Hospital status: RECRUITING city: Guri-si state: Gyeonggi-do zip: 11923 country: Korea, Republic of name: Hojin Choi, PI role: CONTACT lat: 37.5986 lon: 127.1394 facility: Inje University Haeundae Paik Hospital status: RECRUITING city: Busan country: Korea, Republic of name: Jinse Park, PI role: CONTACT lat: 35.10278 lon: 129.04028 facility: Inha University Hospital status: RECRUITING city: Incheon zip: 22332 country: Korea, Republic of name: Hyewon Yoon, PI role: CONTACT lat: 37.45646 lon: 126.70515 facility: Gachon University Gil Medical Center status: RECRUITING city: Incheon country: Korea, Republic of name: Kee Hyung Park, PI role: CONTACT lat: 37.45646 lon: 126.70515 facility: Chonnam National University Hospital status: RECRUITING city: Kwangju country: Korea, Republic of name: Soo Hyun Cho, PI role: CONTACT lat: 36.9122 lon: 127.1279 facility: Ewha Womans University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Ji Young Yun, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Hanyang University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Jin Seok Park, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Koera University Guro Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Chi Kyung Kim, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Chan Nyoung Leee, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: The Catholic University of Korea, Seoul St. Mary's Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Dong Woo Kang, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Ajou University Hospital status: RECRUITING city: Suwon country: Korea, Republic of name: Sun Min Lee, PI role: CONTACT lat: 37.29111 lon: 127.00889 facility: The Catholic University of Korea, St. Vincent's Hospital status: RECRUITING city: Suwon country: Korea, Republic of name: Yoo Hyun Um, PI role: CONTACT lat: 37.29111 lon: 127.00889 hasResults: False
<\|newrecord\|> nctId: NCT06264544 id: SW006 briefTitle: Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism acronym: ZEST-PREP overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-10-15 date: 2024-12-30 date: 2024-02-20 date: 2024-02-20 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach. conditions: Thyrotoxicosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: zinc, selenium, and L-tyrosine in SEPP1 name: Placebo measure: Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism measure: Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism measure: Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism measure: Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism measure: Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism measure: TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation lat: 55.0415 lon: 82.9346 hasResults: False
<\|newrecord\|> nctId: NCT06264531 id: JDS_2023_12 briefTitle: Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations acronym: BevacizuMAV overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-06 date: 2024-02-20 date: 2024-02-22 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. The management of brain AVMs is complex and requires a multidisciplinary approach in an expert center. Available therapies include endovascular embolization, neurosurgical resection and/or radiosurgery. These procedures carry a risk of neurological complications, and are reserved for small AVMs located at a distance from highly functional cerebral structures. To date, no drug therapy is recommended if interventional treatment is not possible.

Several studies on resected brain AVM tissue have demonstrated that these malformations are the site of significant evolutionary inflammatory and neo-angiogenesis processes. Other studies have specifically shown that VEGF (vascular endothelial growth factor) levels are increased in AVMs. More recently, a pre-clinical study showed that anti-angiogenic treatment with Bevacizumab reduced vascular proliferation within AVMs in mice. Finally, a Phase II clinical trial in patients with Rendu-Osler disease (a genetic vascular disorder characterized by recurrent epistaxis, cutaneous telangiectasia and the presence of visceral AVMs) showed a clinical benefit of IV Bevacizumab on the symptomatology of these vascular malformations, with a reduction in the risk of hemorrhage and the extent of hepatic arteriovenous shunts. A randomized Phase III trial is currently underway (NCT03227263) to assess the efficacy of IV Bevacizumab in Rendu-Osler disease.

The aim of our study is to assess the efficacy of IV Bevacizumab on the disabling symptoms associated with symptomatic brain AVMs. conditions: Cerebral AV Malformation studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Bevacizumab name: Placebo measure: Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06264518 id: 56168915 briefTitle: An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-02-20 date: 2024-02-20 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data. conditions: Traumatic Brain Injury studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Number of patients who decide to enroll in a traumatic brain injury clinical trial measure: Rate of patients who remain in traumatic brain injury clinical trial to trial completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-09 uploadDate: 2024-02-09T11:16 filename: ICF_000.pdf size: 79118 hasResults: False
<\|newrecord\|> nctId: NCT06264505 id: 55955210 briefTitle: Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-02-20 date: 2024-02-28 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.

The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion. conditions: Soft Tissue Sarcoma studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients in soft tissue sarcoma clinical research measure: Number of soft tissue sarcoma study participants who maintain involvement until study finish sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-09 uploadDate: 2024-02-09T10:34 filename: ICF_000.pdf size: 80606 hasResults: False
<\|newrecord\|> nctId: NCT06264492 id: 55777205 briefTitle: Delving Into Participation Trends of Scleroderma Clinical Trials overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-02-20 date: 2024-02-28 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.

The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma. conditions: Scleroderma studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients in clinical research for scleroderma measure: Number of scleroderma study participants who stay committed until clinical study wraps up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-09 uploadDate: 2024-02-09T10:51 filename: ICF_000.pdf size: 71611 hasResults: False
<\|newrecord\|> nctId: NCT06264479 id: PEAR-TREE2 briefTitle: Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2 acronym: PEAR-TREE2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-09-30 date: 2029-03-31 date: 2024-02-20 date: 2024-04-02 name: Ourotech, Inc. class: INDUSTRY name: Royal Free Hospital NHS Foundation Trust name: Cambridge University Hospitals NHS Trust name: East & North Herts NHS Trust name: Imperial College Healthcare NHS Trust briefSummary: Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.

This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.

The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival). conditions: Kidney Cancer conditions: Renal Cell Cancer Metastatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biopsy measure: Objective Response Rate correlation accuracy (sensitivity & specificity) measure: Complete Response rate correlation accuracy (sensitivity & specificity) measure: Deep Response rate correlation accuracy (sensitivity & specificity) measure: Durable Response rate correlation accuracy (sensitivity & specificity) measure: PFS prediction accuracy measure: Culture success rate measure: Hazard ratio by biomarker group measure: OS prediction accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Addenbrooke's Hospital city: Cambridge state: Cambridgeshire zip: CB2 0QQ country: United Kingdom name: Kate Fife role: CONTACT lat: 52.2 lon: 0.11667 facility: Mount Vernon Cancer Centre city: London zip: HA6 2RN country: United Kingdom name: Anand Sharma role: CONTACT lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London zip: W6 8RF country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Royal Free NHS Foundation Trust city: London country: United Kingdom name: Ekaterini Boleti, MD PhD MRCP role: CONTACT phone: 020 7830 2396 phoneExt: 34476 lat: 51.50853 lon: -0.12574 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-28 uploadDate: 2023-07-28T07:18 filename: Prot_SAP_000.pdf size: 424039 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-28 uploadDate: 2023-07-28T07:19 filename: ICF_001.pdf size: 197013 hasResults: False
<\|newrecord\|> nctId: NCT06264466 id: IECED-010112023 briefTitle: Safety and Efficacy of a Novel Flexible Bipolar in POEM overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2025-01-15 date: 2024-02-20 date: 2024-02-20 name: Instituto Ecuatoriano de Enfermedades Digestivas class: OTHER briefSummary: Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM.

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