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* Is it safe to use intermittent fasting during neoadjuvant chemotherapy? |
* Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy? |
Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes. |
Participants will: |
* Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy. |
* All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing. |
* Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two arm, randomized, controlled study. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participants' cross-sectional skeletal muscle areas will be measured. Measurements will be performed on CT scans obtained within 4-6 weeks of treatment initiation (with a 7-day screening window) by a fellowship-trained, experienced radiologist and imaging specialist in consensus who will be blinded to participant clinical variables and treatment. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Intermittent Fasting name: Neoadjuvant chemotherapy measure: Intermittent fasting compliance as measured by serum glucose laboratory testing measure: Intermittent fasting compliance as measured by ketone laboratory testing measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing measure: Intermittent fasting compliance as measured by insulin laboratory testing measure: Intermittent fasting compliance as measured by serum glucose laboratory testing measure: Intermittent fasting compliance as measured by ketone laboratory testing measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing measure: Intermittent fasting compliance as measured by insulin laboratory testing measure: Intermittent fasting compliance as measured by serum glucose laboratory testing measure: Intermittent fasting compliance as measured by ketone laboratory testing measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing measure: Intermittent fasting compliance as measured by insulin laboratory testing measure: Intermittent fasting compliance as measured by self-reported assessment measure: Intermittent fasting compliance as measured by self-reported assessment measure: Intermittent fasting compliance as measured by food diary measure: Intermittent fasting compliance as measured by food diary measure: Intermittent fasting compliance as measured by food diary measure: Pre body composition measure: Post body composition measure: Chemotherapy related toxicity at Cycle 2 measure: Chemotherapy related toxicity at Cycle 3 measure: Chemotherapy related toxicity at Cycle 4 measure: Chemotherapy related toxicity at post treatment measure: ESAS Score at Enrollment measure: ESAS Score at Cycle 2 measure: ESAS Score at Cycle 3 measure: ESAS Score at Post Treatment measure: SF-125 Score at Baseline measure: SF-125 Score at Cycle 2 measure: SF-125 Score at Cycle 3 measure: SF-125 Score at Post Treatment measure: Pre Quality of Life (QLQ-C30) Score at Baseline measure: Post Quality of Life (QLQ-C30) Score Post Treatment measure: Pre Functional Assessment (FACT-O) Score at Baseline measure: Post Functional Assessment (FACT-O) Score Post Treatment measure: AIM Survey Score at Cycle 2 measure: AIM Survey Score at Cycle 3 measure: AIM Survey Score at Post Treatment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386874 id: BQ7 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-26 date: 2024-04-26 name: [Redacted] hasResults: False |
<|newrecord|> nctId: NCT06386861 id: 24.210.01e briefTitle: Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM). overallStatus: RECRUITING date: 2024-04-14 date: 2024-05-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Boston College class: OTHER briefSummary: the investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino/a, or Latinx. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population. conditions: Adult ALL studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 500 English-speaking Latinx individuals 500 Spanish-speaking Latinx individuals primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Attitudes Toward Genomics and Precision Medicine (English) name: Attitudes Toward Genomics and Precision Medicine (Spanish) measure: Psychometric properties measure: Health literacy/numeracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston College status: RECRUITING city: Chestnut Hill state: Massachusetts zip: 02467 country: United States name: Andrew A Dwyer, FNP-BC, PhD role: CONTACT phone: 617-552-1711 email: [email protected] name: Maria Pineros-Leano, PhD role: SUB_INVESTIGATOR lat: 42.33065 lon: -71.16616 hasResults: False |
<|newrecord|> nctId: NCT06386848 id: 2023PI187 briefTitle: Strategy to Adapt Botulinum Toxin Doses in Dystonia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-01 date: 2024-06-01 date: 2024-04-26 date: 2024-04-26 name: Central Hospital, Nancy, France class: OTHER briefSummary: The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended. |
We we ll study the increase of the dose injected over the time, the side effects... |
The hypothesis is that we inject smaller doses than we could regarding the recommandations conditions: Dystonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Botulinum toxin measure: First dose of botulinum toxin injected, U measure: Effective dose of botulinum toxin measure: Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386835 id: CREC2021.724-T briefTitle: Collagen Paste vs Mucosal Advancement Flap for FIA overallStatus: RECRUITING date: 2024-01-26 date: 2026-03-31 date: 2027-03-31 date: 2024-04-26 date: 2024-04-26 name: Chinese University of Hong Kong class: OTHER briefSummary: The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano. conditions: Fistula-in-ano studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 118 type: ESTIMATED name: Collagen Paste name: Mucosal advancement measure: Clinical healing of Fistula-in-ano measure: 30-day morbidity measure: Quality of life score measure: Postoperative pain score measure: Faecal incontinence rate measure: Hospital readmission rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery, Chinese University of Hong Kong status: RECRUITING city: Shatin state: New Territories country: Hong Kong name: Kaori Futaba role: CONTACT email: [email protected] lat: 22.38333 lon: 114.18333 facility: Prince of Wlaes Hospital status: RECRUITING city: Sha Tin country: Hong Kong name: Kaori Futaba role: CONTACT phone: 35051495 email: [email protected] lat: 22.38333 lon: 114.18333 hasResults: False |
<|newrecord|> nctId: NCT06386822 id: 23-1562H briefTitle: The Development of a System for the Measurement of Tremor overallStatus: RECRUITING date: 2023-08-01 date: 2024-12 date: 2024-12 date: 2024-04-26 date: 2024-04-26 name: The Bionics Institute of Australia class: OTHER briefSummary: The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia). The main questions it aims to answer are: |
* Can individuals with Essential Tremor be distingushed from individuals without tremor using Virtual Reality (VR) |
* Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR |
* Can Essential Tremor be quantified using a measurement system |
* Can Dystonia be quantified using a measurement system. |
Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour. conditions: Tremor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group assignment. Up to 90 participants with Essential Tremor and up to 30 Control participants will be recruited to the study. Both groups will undergo the same intervention. primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: HTC Vive Pro Eye name: HTC Vive Tracker name: Valve Index Controllers name: Biokin measure: To quantify Essential Tremor and dystonia using a measurement system sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Royal Victorian Eye and Ear Hospital status: RECRUITING city: East Melbourne state: Victoria zip: 3002 country: Australia name: Sarah Osborn, BSc role: CONTACT phone: 061396677500 email: [email protected] lat: -37.81667 lon: 144.9879 hasResults: False |
<|newrecord|> nctId: NCT06386809 id: 2024 -25 briefTitle: Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-11-01 date: 2024-04-26 date: 2024-04-26 name: Bandırma Onyedi Eylül University class: OTHER briefSummary: Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions. conditions: Bruxism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: TAVNS name: Exercise program measure: Pain Severity measure: Oral Health Quality of Life measure: Stress Level measure: Sleep Quality measure: Pressure Pain Threshold measure: Muscle Activation Measurement measure: Measurement of heart rate variability/ Autonomic nervous system evaluation sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bandırma Onyedi Eylül University city: Balıkesir country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False |
<|newrecord|> nctId: NCT06386796 id: Asw.U./867/11/23 briefTitle: Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-04-01 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels. conditions: Acute Kidney Injury conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Early detection of acute kidney injury. measure: Diagnosis of acute kidney injury. measure: To grade the severity of AKI. measure: To predict clinical outcome (clinical improvement) measure: To predict clinical outcome (necessity for renal replacement therapy) measure: To predict clinical outcome (death) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Soudy S Hammad role: CONTACT phone: +201014761523 email: [email protected] name: Tarek S Hemaida role: CONTACT phone: 01007363190 email: [email protected] name: mohamed H Abolwafa, MSc role: PRINCIPAL_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False |
<|newrecord|> nctId: NCT06386783 id: Asw.U./823 /7/23 briefTitle: Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anesthesia ; Peritoneal Symptomatic Effects overallStatus: RECRUITING date: 2023-07-01 date: 2024-12-31 date: 2025-07-01 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: To compare whether 5 μg dexmedetomidine with 25 μg fentanyl added to 0.5% hyperbaric bupivacaine as adjuvants in spinal anaesthesia in patients undergoing appendectomy could reduce intraoperative peritoneal related symptoms. conditions: Dexmedetomidine conditions: Fentanyl studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This randomized double blinded study will be conducted at Aswan university hospitals at patients scheduled for emergency appendectomy primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: concealed based on study drugs assigned to each group \& to conduct this double -blinded clinical trials, our study drugs will be prepared by the senior anesthesiologist who won't be involved in further observations of the patients and neither patients nor outcome assessor will be aware of which drugs they will receive. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 148 type: ESTIMATED name: Dexmedetomidine Injection [Precedex] name: Fentanyl HCl measure: intraoperative peritoneal symptoms during appendectomy. measure: Assessment of motor block with Modified Bromage scale measure: Degree of post-operative analgesia measure: Assessment of sensory block by using pin prick method sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Soudy S Hammad, MD role: CONTACT phone: +201014761523 email: [email protected] name: Ahmed M Hagag, MSc role: CONTACT phone: 01141097536 name: Ayman M Eldemrdash, MD role: PRINCIPAL_INVESTIGATOR name: Ahmed A Mahmoud, MD role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False |
<|newrecord|> nctId: NCT06386770 id: Asw.U./742 /2/23 briefTitle: Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block overallStatus: RECRUITING date: 2023-02-01 date: 2024-06-01 date: 2025-12-31 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries. conditions: Erector Spinae Block conditions: Dexmedetomidine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: In our randomized controlled trial, we employed masking (also called blinding) to reduce bias. Participants were unaware of whether they were receiving the intervention or control. Caregivers were instructed not to reveal this information, and outcome assessors who evaluated results were kept separate from intervention delivery. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Dexmedetomidine Injection [Precedex] name: Bupivacaine Hydrochloride name: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) measure: The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics. measure: 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period . measure: Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed measure: Intraoperative hemodynamic parameters blood pressure measure: Minimum alveolar concentration (MAC) requirements sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81511 country: Egypt name: soudy S hammad role: CONTACT phone: +201014761523 email: [email protected] name: tarek S hemaida role: CONTACT phone: 01007363190 email: [email protected] name: Rehab A Mahmoud, MSc role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False |
<|newrecord|> nctId: NCT06386757 id: Asw.U. 911/3/24 briefTitle: Incidence Of Nasal and Oropharyngeal Bleeding: Video Laryngoscopy Versus Direct Laryngoscopy overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-31 date: 2025-12-31 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension conditions: Maxillofacial Injuries conditions: Nasal Bleeding conditions: Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: These prospective, randomized, controlled clinical trials will be conducted at Aswan University Hospital on 62 patients who are scheduled for maxillofacial surgeries requiring nasal intubation. primaryPurpose: PREVENTION masking: NONE count: 64 type: ESTIMATED name: Combined Video Laryngoscopy (VL) and Bougie name: Combined Direct Laryngoscopy (DL) and Bougie measure: Incidence of nasal and oropharyngeal bleeding measure: Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff measure: Overall rate of first trial success. measure: The use of magill forceps sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Soudy S Hammad, MD role: CONTACT phone: +201014761523 email: [email protected] name: Mohammed E Yahia, MSc role: CONTACT phone: 01125257916 name: Mohammed A Alazhary, MD role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False |
<|newrecord|> nctId: NCT06386744 id: DUS-AUBD-01 briefTitle: Dusquetide for the Treatment of Behcet's Disease overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-02 date: 2025-03 date: 2024-04-26 date: 2024-04-26 name: Soligenix class: INDUSTRY briefSummary: This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks. conditions: Behçet Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Dusquetide measure: Number of Oral Ulcers measure: Number of Genital Ulcers measure: Pain of Oral Ulcers measure: Pain of Genital Ulcers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06386731 id: SYNEO-01 briefTitle: Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice overallStatus: COMPLETED date: 2022-07-05 date: 2022-11-25 date: 2023-04-28 date: 2024-04-26 date: 2024-04-26 name: Goztepe Prof Dr Suleyman Yalcın City Hospital class: OTHER briefSummary: One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy. conditions: Neonatal Jaundice conditions: Phototherapy Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study. primaryPurpose: TREATMENT masking: NONE count: 225 type: ACTUAL name: Intermittent Phototherapy measure: Comparison of the effectiveness of CPT and IPT measure: Comparison of side effect frequency of CPT and IPT sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Göztepe Prof. Dr. Suleyman Yalcin City Hopital city: Kadıköy state: İstanbul zip: 34730 country: Turkey lat: 40.62015 lon: 29.22536 hasResults: False |
<|newrecord|> nctId: NCT06386718 id: USG for ped art can briefTitle: Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients overallStatus: RECRUITING date: 2023-05-15 date: 2024-06-01 date: 2025-05-01 date: 2024-04-26 date: 2024-04-26 name: Ankara University class: OTHER briefSummary: Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients. conditions: Ulnar and Radial Artery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 184 type: ESTIMATED measure: Determining the Diameter and Depth at different angles measure: Comparing Ulnar and Radial Artery Diameters Across Age Groups sex: ALL maximumAge: 10 Years stdAges: CHILD facility: Ankara University School Of Medicine status: RECRUITING city: Ankara zip: 06100 country: Turkey name: Zeynep Altinbas, MD role: CONTACT phone: +905356082156 email: [email protected] name: Ozlem S Can, MD role: PRINCIPAL_INVESTIGATOR name: Zeynep S Altinbas, MD role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06386705 id: TSN084-101CH briefTitle: A Study of TSN084 in Patients With Advanced Malignant Tumors overallStatus: RECRUITING date: 2022-07-20 date: 2025-09-30 date: 2026-03-30 date: 2024-04-26 date: 2024-04-26 name: Tyligand Bioscience (Shanghai) Limited class: INDUSTRY briefSummary: TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China. conditions: Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: TSN084 measure: Dose limiting toxicity (DLT) measure: Incidence of Treatment-Emergent Adverse Events (TEAE) measure: Maximum plasma concentration (Cmax) measure: Time to Cmax (Tmax) measure: Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t) measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease control rate (DCR) measure: Time to response (TTR) measure: Progression free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Jie Wang, MD, PhD role: CONTACT lat: 39.9075 lon: 116.39723 facility: Peking university cancer hospital status: RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Minglei Zhuo, MD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06386692 id: Aarhus111 briefTitle: Community Based Promotion of Physical Activity in Nepal (COBIN-PA) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-26 date: 2024-04-26 name: University of Aarhus class: OTHER briefSummary: Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: FCHVs-led community based educational physical activity intervention measure: Mean moderate to vigorous physical activity sex: ALL minimumAge: 19 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386679 id: R016634005 briefTitle: Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients overallStatus: ENROLLING_BY_INVITATION date: 2023-08-17 date: 2023-11-23 date: 2025-03 date: 2024-04-26 date: 2024-04-26 name: Siriraj Hospital class: OTHER briefSummary: Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Ten elderly patients from both gender diagnosed with knee osteoarthritis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with amniotic fluid mesenchymal stem cells developed for chondrogenic treatment. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: allogenic amniotic fluid mesenchymal stem cell measure: Incidence of abnormal physical examination measure: Incidence of abnormal vital sign measure: Incidence of abnormal laboratory test results measure: Incidence of abnormal ECG parameters measure: The type of Adverse event (AE), numbers of AE and proportion of patients with AE. measure: Pain score measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: Degree of cartilage change sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Siriraj Hospital city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand lat: 13.76266 lon: 100.47798 hasResults: False |
<|newrecord|> nctId: NCT06386666 id: RLRL-CTP briefTitle: A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-04-29 date: 2025-07-15 date: 2024-04-26 date: 2024-04-26 name: Suzhou Kerui Medical Technology Co., Ltd class: OTHER briefSummary: The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal. conditions: Intervertebral Disc Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 135 type: ESTIMATED name: Disposable fibrous ring sutures measure: Success rate of suture measure: Annulus fibril cleft decreased in value measure: Reduced proportion of annular fibril cleft measure: Intraoperative blood loss measure: Suture time measure: Treatment success rate measure: VAS pain score (lower back, bilateral lower limbs) measure: SF-12 rating measure: ODI index measure: Recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386653 id: [123I]I-DARPIN-Ec1 briefTitle: Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 overallStatus: ENROLLING_BY_INVITATION date: 2024-05-14 date: 2024-12-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Tomsk National Research Medical Center of the Russian Academy of Sciences class: OTHER name: Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences name: Uppsala University briefSummary: The study should evaluate the biological distribution of \[123I\]I-DARPIN-Ec1 in patients with lung and ovarian cancer |
The primary objective are: |
1. To assess the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals. |
2. To evaluate dosimetry of \[123I\]I-DARPIN-Ec1 . |
3. To study the safety and tolerability of the drug \[123I\]I-DARPIN-Ec1 after a single injection in a diagnostic dosage. |
The secondary objective are: |
1. To compare the obtained \[123I\]I-DARPIN-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in lung and ovarian cancer patients. conditions: Lung Cancer conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: Diagnostic Test: whole body study and SPECT with [123I]I-DARPIN-Ec1 measure: Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%) measure: SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts) measure: SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts) measure: Tumor-to-background ratio (SPECT) measure: Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections. measure: Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections. measure: Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections measure: Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TomskNRMC city: Tomsk country: Russian Federation lat: 56.49771 lon: 84.97437 hasResults: False |
<|newrecord|> nctId: NCT06386640 id: 0784 briefTitle: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure acronym: FIT-HF overallStatus: RECRUITING date: 2023-01-27 date: 2025-04-30 date: 2025-04-30 date: 2024-04-26 date: 2024-04-26 name: University of Leicester class: OTHER briefSummary: Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach conditions: Chronic Heart Failure conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Intervention Development measure: Phase I: Qualitative evaluation with stakeholders to identify gaps in current HF care pathway leading to unmet healthcare needs in older people living with frailty and CHF measure: Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF measure: Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration measure: Phase III: Change in physical function as assessed by the SPPB upon completion of 12-week intervention and at 6 month follow up (this may alter depending on findings from Phase II) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital status: RECRUITING city: Leicester country: United Kingdom name: Shirley Sze role: CONTACT email: [email protected] lat: 52.6386 lon: -1.13169 hasResults: False |
<|newrecord|> nctId: NCT06386627 id: Skoltech-CNBR3 id: 21-75-30024 type: OTHER_GRANT domain: Russian Science Foundation briefTitle: Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients. overallStatus: COMPLETED date: 2023-07-01 date: 2024-03-15 date: 2024-03-15 date: 2024-04-26 date: 2024-04-26 name: Skolkovo Institute of Science and Technology class: OTHER name: Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia briefSummary: The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. We recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, we also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections. conditions: Stroke studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ACTUAL name: Stimulus response task name: Transcranial magnetic stimulation measure: Atypical shape of lateralized readiness potential measure: Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skolkovo Institute of Science and Technology (Skoltech) city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 hasResults: False |
<|newrecord|> nctId: NCT06386614 id: BDNF briefTitle: Effects of TDCS of the Frontal Lobe on Cognitive Function and BDNF in PSCI overallStatus: RECRUITING date: 2023-01-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-26 date: 2024-04-26 name: The Second Affiliated Hospital of Dalian Medical University class: OTHER briefSummary: The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are: |
* \[Search for effective treatments of cognitive impairment after stroke\] |
* \[explore the relationship between BDNF level and cognitive function\] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Routine treatment name: Transcranial Direct Current Stimulation measure: BDNF measure: Cognitive function level measure: Executive function level measure: Memory function level sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University status: COMPLETED city: DaLian state: Liaoning zip: 116021 country: China lat: 38.91222 lon: 121.60222 facility: Lily status: RECRUITING city: Dalian state: Liaoning zip: 116021 country: China name: Yang Tu role: CONTACT phone: 18875214238 email: [email protected] lat: 38.91222 lon: 121.60222 hasResults: False |
<|newrecord|> nctId: NCT06386601 id: 2024-15804 briefTitle: Surgical Ergonomics Education During Minimally Invasive Gynecologic Skills Training acronym: SEE MIGS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-26 date: 2024-04-26 name: Montefiore Medical Center class: OTHER briefSummary: The goal of this pilot study is to learn if a class and hands-on-practice of ergonomic body positions - or specific ways to move the body while working to prevent injury - is valuable to training obstetrics and gynecology doctors. The main questions the study team aims to answer are: |
* Will these lessons successfully teach the participants how to move bodies at work in a way that will prevent injury? |
* Will the participants feel that learning and practicing such lessons helps to avoid injury while at work? |
Researchers will compare training obstetrics and gynecology doctors that attend a class on ergonomics and have guided hands-on-practice of ergonomic body positions with training obstetrics and gynecology doctors that attend the class only to see if the first group learns and remembers how to move their bodies safely while working. All participants will attend a class that teaches basic ergonomic lessons before they are divided into two groups. Group 1 will practice common surgery skills on a model while being videotaped by an artificial intelligence application. The application will make a report on unsafe positions a participant does while practicing surgical skills. The Group 1 participant will then go over the report with one of the study supervisors to talk about ways that the participant can move safely while practicing the skills. The participant will then practice the skills one more time while being videotaped. The study supervisors will then compare the two reports to see if the participant improved. |
Group 2 will also practice common surgery skills on a model while being videotaped. Group 2 participants will not get to see the report that the application generates or speak with the study supervisors about ways to move safely while practicing the skills. |
There will be a follow up after two months to see if participants remembered what was learned during the class and during the hands-on practice lesson. All participants will again be videotaped. The study supervisors will compare the videos and reports from the last class to the most recent ones to see if the participants learned and remember how to move safely while working. |
Participants in both groups will take a quiz about the lessons learned in the class before and after the class to determine what had been learned from the lesson. A survey about how useful and helpful the class was and hands-on practice sessions were will also be completed. conditions: Work-related Injury conditions: Work Related Upper Limb Disorder conditions: Surgery conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified into junior residents (1st and 2nd year) and senior residents (3rd and 4th year) and then randomized to the intervention group or control group. primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Ergonomics Knowledge name: Ergonomics Feedback/Guided Practice measure: Number of participants that would recommend incorporating surgical ergonomics lecture/module as a permanent part of the didactic curriculum. measure: Number of participants that would recommend incorporating surgical ergonomics hands-on skills session with feedback and guided practice on surgical ergonomics as a permanent part of the didactic curriculum. measure: Change from baseline in surgical ergonomic knowledge score over two sessions measure: Change from baseline in surgical ergonomic practice based on rapid upper limb assessment (RULA) score over two sessions measure: Change from baseline in surgical ergonomic practice based on rapid entire body assessment (REBA) score over two sessions measure: Change from baseline in surgical ergonomic practice based on revised hand strain index (RHSI) score over two sessions measure: Number of participants that reported an increase in knowledge following surgical ergonomics lecture/module and/or skills practice. measure: Number of participants that reported an increase in practice following surgical ergonomics lecture/module and/or skills practice. measure: Number of participants that reported that surgical ergonomics education is valuable following surgical ergonomics lecture/module and/or skills practice measure: Number of participants with a change in pain scores following surgical ergonomics lecture/module and skills practice sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center city: Bronx state: New York zip: 10467 country: United States name: Alexandria Connor, MD role: CONTACT phone: 859-512-4053 email: [email protected] lat: 40.84985 lon: -73.86641 hasResults: False |
<|newrecord|> nctId: NCT06386588 id: 2024P000610 briefTitle: The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-30 date: 2027-12-31 date: 2024-04-26 date: 2024-04-26 name: Massachusetts General Hospital class: OTHER briefSummary: In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan. conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Closed loop auditory stimulation during sleep measure: Changes in sleep physiology measure: Changes in functional connectivity of the hippocampus and thalamus measure: Changes in hippocampal activation during motor sequence task (MST) measure: Changes in hippocampal microstructural integrity measure: Greater gains in typing speed over rest breaks during MST training (micro-offline gains) measure: Sleep dependent memory consolidation (SDMC) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Massachusetts General Hospital city: Charlestown state: Massachusetts zip: 02129 country: United States name: Dara Manoach, PhD role: CONTACT phone: 617-724-6148 email: [email protected] name: Lindsey Jones, MS role: CONTACT phone: 617-702-2368 email: [email protected] name: Dara Manoach, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 hasResults: False |
<|newrecord|> nctId: NCT06386575 id: suprainguinal briefTitle: Suprainguinal Fascia Iliaca Block in Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-26 date: 2024-04-29 name: Konya City Hospital class: OTHER briefSummary: Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia. conditions: Analgesia conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Suprainguinal fascia iliaca block will be applied to the patients at the end of the surgery. primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: control group; Patients who received physiological saline name: suprainguinal fascia block; Patients receiving local anesthetic measure: quality of recovery-15T sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386562 id: 2023-07489-01 briefTitle: Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-06-30 date: 2024-06-30 date: 2024-04-26 date: 2024-04-26 name: Karolinska Institutet class: OTHER briefSummary: The goal of this pilot randomized controlled trial is to learn about effects and experiences of an internet-based parenting program for parents of children and adolescents with behavioral problems (e.g., aggressive or defiant behavior). |
The main questions the study aims to answer are: |
* What are the preliminary effects of the internet-based parenting program? |
* What is the level of parents' engagement in the parenting program? |
* How do parents perceive the program? |
Families will be randomized to a version of an internet-based parenting program with support provided from family guides (psychologists) through chat messages in the program, or to the same internet-based parenting program with additional phone/digital support-meetings. Parents will answer quantitative measurements questions before, during, and after treatment. Parents will also be asked to participate in a qualitative interview after the program. Both within and between group comparisons will be conducted to see if there are trends within each arm and differences between the two types of support. conditions: Child Behavior Problem conditions: Disruptive Behavior conditions: Oppositional Defiant Disorder conditions: Conduct Problems conditions: Parent-Child Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program name: Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program with additional parental support measure: Mean change from baseline in behavior problems on the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale). measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale: Impact scale measure: Mean change from baseline in child wellbeing on the KIDSCREEN-10 measure: Mean change from baseline in child wellbeing on the Strengths and Difficulties Questionnaire measure: Mean change from baseline in emotion regulation on the Difficulties in Emotion Regulation Scale measure: Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale measure: Mean change in family warmth measure: Mean change in family conflicts measure: Mean change in parental satisfaction with the week measure: Parental experiences of the internet-based parenting program explored through qualitative interviews measure: Parental experiences of each module in the internet-based parenting program measure: Parental experiences of the whole internet-based parenting program measure: Parental use of the internet-based parenting program: homework tasks, exercises measure: Parental use of the internet-based parenting program: time spent working with the program measure: Parental use of the internet-based parenting program: drop out rate measure: Background information measure: Working alone or with partner in the parenting program sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06386549 id: HSEARS20220424001 briefTitle: Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial overallStatus: RECRUITING date: 2022-11-14 date: 2024-10-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: LIAO Peng class: OTHER briefSummary: The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are: |
* Is tele-rehabilitation better for improving the quality and outcomes of care for burn children? |
* Is tele-rehabilitation more effective in improving scar management in children with burns injuries? |
* Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries? conditions: Burns conditions: Tele-rehabilitation conditions: Scar conditions: Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: tele-rehabilitation measure: The scars of children with burns measure: The quality and outcomes of care for burn children measure: psychological stress of caregvers sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Hongkong Poly Uiniversity status: RECRUITING city: Hong Kong country: China name: Fu Jinfeng role: CONTACT phone: +8613987695500 email: [email protected] lat: 22.39407 lon: 114.13737 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-05-31 uploadDate: 2024-04-17T21:22 filename: ICF_000.pdf size: 59989 hasResults: False |
<|newrecord|> nctId: NCT06386536 id: 2023-1796 briefTitle: Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs. overallStatus: RECRUITING date: 2024-01-15 date: 2024-05 date: 2024-05 date: 2024-04-26 date: 2024-04-26 name: Sylvie Nadeau class: OTHER briefSummary: This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype. |
The study also aims to assess the feasibility and acceptability of the training programs and to document their preliminary effects on physical health, perceived well-being, and quality of life. Ten participants will take part in five personalized training sessions with the intelligent bike and five standard training sessions with a traditional stationary bike. conditions: Aging conditions: Mobility Limitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A single-subject reversal study design (A-B) will be used. During the A and B phases, the participants will undergo training with either the VI-TRIVEL or a conventional stationary bike. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Intelligent stationary bike name: Conventional stationary bilke measure: Walking ability and functional capacity measure: Leg strength and endurance measure: Well-being measure: Quality of life sex: ALL minimumAge: 50 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: L'Institut de réadaptation Gingras-Lindsay-de-Montréal status: RECRUITING city: Montréal state: Quebec zip: H3S 2J4 country: Canada name: Sylvie Nadeau, PhD role: CONTACT phone: 5143436111 phoneExt: 12253 email: [email protected] name: Roua Walha, PhD role: CONTACT phone: 8199195095 email: [email protected] name: Sylvie Nadeau, PhD role: PRINCIPAL_INVESTIGATOR name: Roua Walha, PhD role: SUB_INVESTIGATOR name: Julie Soulard, PhD role: SUB_INVESTIGATOR name: Cyril Duclos, PhD role: SUB_INVESTIGATOR name: Nicolas Berryman, PhD role: SUB_INVESTIGATOR name: Elaine Deguise, PhD role: SUB_INVESTIGATOR name: Claudine Auger, PhD role: SUB_INVESTIGATOR name: Dahlia Kairy, PhD role: SUB_INVESTIGATOR name: David Labbé, PhD role: SUB_INVESTIGATOR name: Rachid Aissaoui, PhD role: SUB_INVESTIGATOR name: Gabriel Moisan, PhD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06386523 id: 23-AOI-03 briefTitle: Standardization of a New Psychophysical Olfactory Test, TODA2 acronym: TODA-STAR overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-05-23 date: 2025-11-15 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder: |
Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st conditions: Patients Without an Olfactory Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 112 type: ESTIMATED name: Passage of olfactory tests measure: Passage of olfactory tests: measure: Passage of olfactory tests: measure: Passage of olfactory tests: measure: Identify confounding factors, i.e. factors that can influence the results of the olfactory test measure: Identify confounding factors, i.e. factors that can influence the results of the olfactory test sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386510 id: 2025-5517 briefTitle: Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke acronym: CN-NINM overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2027-05-01 date: 2027-07-01 date: 2024-04-26 date: 2024-04-29 name: Université de Sherbrooke class: OTHER briefSummary: Following a stroke, persistent residual muscle weakness in the upper limb (UL) drastically impacts the individuals' quality of life and level of independence. Training interventions are recommended to promote UL motor recovery, and recent studies have shown that training must be tailored to each individual's recovery potential to maximise training gains. Complementary to training interventions, non-invasive brain stimulation devices (NIBS) can help support the provision of post-stroke care by modulating brain excitability and enhancing recovery. Among NIBS, cranial nerve non-invasive neuromodulation (CN-NINM) is gaining increasing attention in rehabilitation since it can directly and non-invasively stimulate the tongue's cranial nerves. The impulses generated can then reach the motor cortex, induce neuroplastic changes and support recovery. Promising results in various neurological populations have been observed, but in stroke, the efficacy of CN-NINM at improving arm motor recovery and brain plasticity is yet to be determined. This is what the present project intends to address, using a stratified randomized controlled trial, where participants in the chronic phase of a stroke will take part in a 4-week individualized training program of their affected UL in combination with real or sham CN-NINM. Before and after the intervention, participants will undergo clinical and neurophysiological evaluations to thoroughly evaluate CN-NINM-induced changes in UL motor function and associated neuroplastic changes. The proposed study will allow an in-depth evaluation of the effects of CN-NINM for an eventual implementation in clinics and at home to support optimal post-stroke recovery. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentered stratified randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Strength training name: Cranial nerve non-invasive neuromodulation measure: Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale measure: Change in UL functional performance on the Wolf Motor Function Test measure: Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres. measure: Change in participants' subjective real life functional UL performance on the Motor Activity Log measure: Change in active and passive range of motion at both UL in shoulder flexion, elbow flexion and wrist extension measure: Change in resting motor threshold of the affected and unaffected FDI sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital city: Laval state: Quebec zip: H7V 1R2 country: Canada name: Marie-Helene Boudrias, PhD role: CONTACT phone: 514-398-5457 email: [email protected] name: Marie-Helene Boudrias, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.56995 lon: -73.692 facility: Centre de recherche sur le vieillissement city: Sherbrooke state: Quebec zip: J1H 4C4 country: Canada name: Marie-Helene Milot, PhD role: CONTACT phone: 819-780-2220 phoneExt: 45277 email: [email protected] name: Maureen Ahiatsi, MsC role: CONTACT phone: 819-780-2220 phoneExt: 45691 email: [email protected] lat: 45.40008 lon: -71.89908 facility: CIRRIS city: Québec zip: G1M2S8 country: Canada name: Andréanne Blanchette, PhD role: CONTACT phone: 418-529-9141 phoneExt: 46896 email: [email protected] name: Andréanne Blanchette, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False |
<|newrecord|> nctId: NCT06386497 id: 2023-D0100 briefTitle: Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease acronym: Somnomat Casa overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09-30 date: 2025-12-31 date: 2024-04-26 date: 2024-04-26 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: ETH Zurich briefSummary: This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: Nocturnal translational vestibular stimulation measure: Evaluation of acceptability and feasibility measure: Evaluation of acceptability and feasibility measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Epworth Sleepiness Scale (ESS) measure: Epworth Sleepiness Scale (ESS) measure: Epworth Sleepiness Scale (ESS) measure: Epworth Sleepiness Scale (ESS) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Patients' Global Impression of Severity Scale (PGIS) measure: Patients' Global Impression of Change Scale (PGICS) measure: Patients' Global Impression of Change Scale (PGICS) measure: Patients' Global Impression of Change Scale (PGICS) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Insel Gruppe AG, University Hospital Bern city: Bern zip: 3010 country: Switzerland lat: 46.94809 lon: 7.44744 facility: ETH Zurich, Sensory-Motor Systems Lab, IRIS city: Zürich zip: 8092 country: Switzerland name: Robert Riener, Prof. role: CONTACT phone: 44 632 66 79 phoneExt: +41 email: [email protected] lat: 47.36667 lon: 8.54999 hasResults: False |
<|newrecord|> nctId: NCT06386484 id: 2019-05463 briefTitle: Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout overallStatus: RECRUITING date: 2021-11-02 date: 2025-01-01 date: 2025-01-30 date: 2024-04-26 date: 2024-04-26 name: Region Skane class: OTHER briefSummary: Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight. conditions: Repetitive Head Impact conditions: Selective Head and Neck Cooling studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The PolarCap System consists of a high-powered portable cooling system, designed to reduce brain temperature by controlled cooling of the scalp and neck with a circulating coolant (PolarCap Coolant, PolarCool AB, Lund, Sweden). The coolant is maintained at 0°C and flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap for isolation. primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PolarCap System measure: Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight. measure: Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5). sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden status: RECRUITING city: Lund state: Skane zip: 22100 country: Sweden name: Ali Al-husseini, MD, Medical doctor, PhD stud role: CONTACT phone: +46707267261 email: [email protected] name: Ali Al-husseini role: SUB_INVESTIGATOR lat: 55.70584 lon: 13.19321 hasResults: False |
<|newrecord|> nctId: NCT06386471 id: 24093 briefTitle: Personalized GI Motility Responses to Diet overallStatus: RECRUITING date: 2024-03-07 date: 2024-06-12 date: 2025-06-02 date: 2024-04-26 date: 2024-04-26 name: University of Illinois at Urbana-Champaign class: OTHER briefSummary: The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol. |
Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses. conditions: Nutritional and Metabolic Diseases conditions: Gastrointestinal Dysfunction conditions: Cardiovascular Diseases conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, controlled, crossover primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Appearance, flavor, and texture of whole grain vs refined bread could not be masked count: 50 type: ESTIMATED name: Whole grain rye bread name: Refined grain rye bread measure: Gastrointestinal Pressure (mmHg) measure: Luminal pH (pH units) measure: Temperature (degrees celcius) measure: Gastrointestinal Transit Time (hours:minutes) measure: Blood Glucose measure: Triglycerides measure: Total Cholesterol measure: HDL cholesterol measure: LDL cholesterol measure: Lipopolysaccharide Binding Protein measure: Microbiome measure: Metabolomics sex: ALL minimumAge: 21 Years maximumAge: 63 Years stdAges: ADULT facility: University of Illinois at Urbana-Champaign status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Brett R Loman, PhD, RD role: CONTACT name: Brett R Loman, PhD, RD role: PRINCIPAL_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False |
<|newrecord|> nctId: NCT06386458 id: AT-01 briefTitle: Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access overallStatus: COMPLETED date: 2022-07-08 date: 2023-05-09 date: 2023-05-11 date: 2024-04-26 date: 2024-04-26 name: Hangzhou NOYA MedTech Co. Ltm. class: INDUSTRY briefSummary: This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups. conditions: Heart Diseases conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 177 type: ACTUAL name: AThrough radiofrequency transseptal puncture system name: Traditional mechanical transseptal puncture needle measure: Transseptal puncture success rate. measure: Initial transseptal puncture success rate. measure: Time required to successfully complete the transseptal puncture. measure: Number of attempts needed to successfully complete the transseptal puncture. measure: Ratio of atrial septal puncture failures that cross over to the opposite group. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The 7th People's Hospital of Zhengzhou city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital with Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China lat: 32.06167 lon: 118.77778 facility: Tianjin Chest Hospital city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Ningbo University city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 hasResults: False |
<|newrecord|> nctId: NCT06386445 id: XJTU1AF-CRF-2023-XK013 briefTitle: Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications. conditions: Stem Cell Transplant Complications conditions: Acute Graft Versus Host Disease conditions: Acute Kidney Injury conditions: Major Adverse Cardiac Events studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Serum metabolomics sequencing measure: acute graft versus host disease measure: acute kidney injury measure: major adverse cardiac events sex: ALL minimumAge: 0 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386432 id: RG1124189 id: NCI-2024-02453 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: RG1124189 type: OTHER domain: Fred Hutch/University of Washington Cancer Consortium id: U54CA132381 type: NIH link: https://reporter.nih.gov/quickSearch/U54CA132381 briefTitle: EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-26 date: 2024-04-26 name: Fred Hutchinson Cancer Center class: OTHER name: National Cancer Institute (NCI) name: National Cancer Institute Center to Reduce Cancer Health Disparities name: New Mexico State University briefSummary: This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking. conditions: Cigarette Smoking-Related Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Any outcome evaluator who has contact with participants will remain blinded to treatment group assignment until the final set of questions regarding acceptability of specific program components is asked. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Smartphone App-delivered Smoking Cessation Intervention name: Smartphone App-delivered Smoking Cessation Intervention name: Health Promotion and Education name: Health Promotion and Education name: Biospecimen Collection name: Questionnaire Administration measure: Participant satisfaction measure: Number of logins to the assigned application measure: Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products measure: Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products measure: Self-reported 30-day PPA from all nicotine/tobacco products measure: Biochemically confirmed 30-day PPA from all nicotine/tobacco products measure: Self-reported 7-day PPA from cigarette smoking measure: Self-reported 30-day PPA from cigarette smoking measure: Change in Contemplation Ladder scores measure: Change in acceptance of tobacco-use triggers measure: Change in values-guided action sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Fred Hutch/University of Washington Cancer Consortium city: Seattle state: Washington zip: 98109 country: United States name: Jaimee Heffner role: CONTACT phone: 206-667-7314 email: [email protected] name: Jaimee Heffner role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False |
<|newrecord|> nctId: NCT06386419 id: CKJX839A1IN03 briefTitle: A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-08-08 date: 2025-08-30 date: 2024-04-26 date: 2024-04-26 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium. conditions: Primary Hypercholesterolemia conditions: Mixed Dyslipidemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: open label assignment primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: inclisiran measure: Incidence and type of treatment-emergent adverse events (TEAEs) measure: Mean change in LDL-C from baseline to Day 300. measure: Proportion of the participants with ≥50% LDL-C reduction on Day 300 measure: Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk measure: Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06386406 id: ORL-ORT-040 briefTitle: This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain acronym: TAP overallStatus: RECRUITING date: 2024-04-23 date: 2026-03-31 date: 2026-03-31 date: 2024-04-26 date: 2024-04-26 name: Ente Ospedaliero Cantonale, Bellinzona class: OTHER briefSummary: Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year. |
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