hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06306872 id: ABSK-011-102 briefTitle: A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules overallStatus: RECRUITING date: 2024-02-23 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Abbisko Therapeutics Co, Ltd class: INDUSTRY briefSummary: The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned 1:1 to arms A (Sequence A) or arms B (Sequence B) to receive a single dose of ABSK-011 orally in two separate doses, spaced at least 4 days apart. Among them, subjects in sequence A will be given ABSK-011 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) and ABSK-011 200 mg (100 mg capsule \*2) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and the first day of cycle 2 (C2D1), respectively. Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule \*2) and ABSK-011 old formulation 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) on an empty stomach in the morning of Cycle 1 day (C1D1) and cycle 2 day (C2D1), respectively. primaryPurpose: OTHER masking: NONE count: 73 type: ESTIMATED name: Sequence A ABSK-011 name: Sequence B ABSK-011 measure: Cmax measure: AUC measure: tmax measure: AEs measure: SAEs SAEs measure: t1/2 measure: Vz/F measure: CL/F CL/F sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Affiliated Hospital of Jiangnan University status: RECRUITING city: Wuxi state: Jiangsu zip: 214062 country: China name: Yiqing Zhao role: CONTACT phone: 13358100007 email: 13358100007@126.com lat: 31.56887 lon: 120.28857 hasResults: False
nctId: NCT06306859 id: SIKIDI 2024 briefTitle: Development of Health Monitoring System on Patient's Well Being in Dialysis Context acronym: SIKIDI overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Universitas Muhammadiyah Yogyakarta class: OTHER name: Ministry of Education Culture, Research and Technology briefSummary: One of the goals in the Sustainable Development Goals (SDGs) is the availability of a healthy and prosperous life for all ages. This goal mentions health priorities i.e. non-communicable diseases. Chronic kidney failure (CRF) is one of the non-communicable diseases that is the main cause of death and disability both in the world and in Indonesia. The prevalence of CRF in Indonesia is 0.5% with 83.2% of patients being of productive age and the highest number of CRF patients in North Kalimantan, Southeast Sulawesi, DKI Jakarta and Yogyakarta. Monitoring and evaluation of patients with CRF is currently mostly carried out conventionally not using health technology that is integrated with hospital information systems. This study aims to design and provide a health information system for patients with CRF, hereinafter referred to as SIKIDI, which integrates mobile-health applications used independently by patients with existing information systems in hospitals. conditions: Quality of Life conditions: Self Efficacy conditions: Chronic Kidney Diseases conditions: M-health studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group will be given access to m-health to monitor and education provision for about four weeks primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The sample will be divided based on the schedule of hemodialysis. Intervention group will be chosen from Monday-Thursday. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Using m-health for monitoring and education provision name: Standard care measure: Quality of Life that will be measured using KDQOL before and after intervention measure: Self-efficacy that will be measured using CKD SE before and after sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RS PKU Muhammadiyah Bantul city: Bantul state: Yogy zip: 55183 country: Indonesia name: Indra Prasetyantori, Master role: CONTACT lat: -7.88806 lon: 110.32889 hasResults: False
nctId: NCT06306846 id: 11235794 briefTitle: Neoadjuvant SBRT in Localized Advanced HNSCC overallStatus: RECRUITING date: 2023-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Jiang Feng class: OTHER briefSummary: The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC. conditions: Head and Neck Squamous Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: SBRT+immunochemotherpy name: Immunochemotherapy name: cetuximab+immunochemotharpy measure: major pathology response (MPR) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Feng Jiang, MD role: CONTACT phone: 0086-571-88128202 email: jiangfeng@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06306833 id: CLBP-sEMG-14022024 briefTitle: The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain overallStatus: RECRUITING date: 2023-10-01 date: 2024-05 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: Amaila Fazal [afazal] class: OTHER name: University of Karachi briefSummary: The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run. conditions: Chronic Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Surface Electromyography (sEMG) Biofeedback measure: Pain Intensity and interference measure: Lower back pain related Disability measure: Quality of Life with chronic low back pain measure: Pain and Disability-related Anxiety measure: Substance P measure: Cortisol measure: Beta Endorphins sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Psychophysiology Lab, University of Karachi status: RECRUITING city: Karachi state: Sindh zip: 75270 country: Pakistan name: Shamoon Naushad, PhD role: CONTACT phone: 03333549258 lat: 24.8608 lon: 67.0104 hasResults: False
nctId: NCT06306820 id: 36264MS257/7/2023 briefTitle: Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery overallStatus: RECRUITING date: 2024-03-12 date: 2024-08-01 date: 2024-08-01 date: 2024-03-12 date: 2024-03-13 name: Tanta University class: OTHER briefSummary: The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries. conditions: Ultrasound Guided Recruitment Manauvere conditions: End Expiratory Pressure conditions: Pediatric Patients conditions: Laparoscopic Abdominal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Fixed PEEP name: Ultrasound-guided lung recruitment name: Individualized PEEP measure: Intraoperative oxygenation measure: Lung ultrasound scores measure: Mean arterial blood pressure (MAP) measure: Heart rate measure: Postoperative pulmonary complication sex: ALL minimumAge: 3 Years maximumAge: 8 Years stdAges: CHILD facility: Tanta University status: RECRUITING city: Tanta state: El-Gharbia zip: 31527 country: Egypt name: Reham M Rezk, MBBCH role: CONTACT phone: 00201013193723 email: rehamrezk95@gmail.com name: Soher M Soliman, MD role: SUB_INVESTIGATOR name: Shaimaa F Abdelkader, MD role: SUB_INVESTIGATOR name: Shaimaa E Shaban, MD role: SUB_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
nctId: NCT06306807 id: AtlasUmkaya02 briefTitle: Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Text Neck Syndrome overallStatus: COMPLETED date: 2023-12-31 date: 2024-03-14 date: 2024-03-15 date: 2024-03-12 date: 2024-03-15 name: Atlas University class: OTHER briefSummary: Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment. conditions: Neck Muscle Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications name: PNF exercise program measure: Pain intensity measure: Cervical range of motion measure: Neck flexor-extensor muscle endurance test measure: Posture measure: Disability sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Atlas University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06306794 id: 2011-KAEK-25 2023/12-26 briefTitle: Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-12 date: 2024-03-12 name: Nurgül Tekin class: OTHER briefSummary: The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.
It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.
PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.
During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention. conditions: Pain conditions: Premature Baby 26 to 32 Weeks conditions: Premature Baby 33 to 36 Weeks conditions: Aspiration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: crochet octopus measure: pain in the during endotracheal aspiration measure: comfort in the during endotracheal aspiration sex: ALL minimumAge: 1 Day maximumAge: 5 Days stdAges: CHILD hasResults: False
nctId: NCT06306781 id: HI-IM-002 briefTitle: A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2026-07-30 date: 2026-12-30 date: 2024-03-12 date: 2024-03-12 name: RenJi Hospital class: OTHER briefSummary: This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis. conditions: Decompensated Cirrhosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: HCL001 cell (homologous allogeneic hepatocytes) injection measure: Types and incidence of treatment-related adverse events. measure: Dose-Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Child-Pugh grading. measure: Number of participants with abnormal laboratory tests results measure: The percentage of participants with improved liver conditions (including changes in portal vein diam sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06306768 id: STU00219979 briefTitle: Remote Therapeutic Monitoring Exercise Tracking overallStatus: RECRUITING date: 2024-04-01 date: 2028-03 date: 2028-03 date: 2024-03-12 date: 2024-04-16 name: Shirley Ryan AbilityLab class: OTHER briefSummary: The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform. conditions: Parkinson Disease conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: Activity Monitoring measure: Physical Activity Metric 1 measure: Physical Activity Metric 2 measure: Exercise Self Efficacy measure: Quality of Life from PROMIS 10-b measure: Quality of Life from PROMIS-29 sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shirley Ryan AbilityLab status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Hannah Redd, DPT role: CONTACT email: hredd@sralab.org name: Kristen Hohl, DPT role: CONTACT email: khohl@sralab.org lat: 41.85003 lon: -87.65005 hasResults: False
nctId: NCT06306755 id: 2021YFC2500405 briefTitle: Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer acronym: ERSS-EGC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2034-12 date: 2024-03-12 date: 2024-04-16 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China.
In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment.
Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups. conditions: Esophageal Cancer conditions: Gastric Cancer conditions: Precision Screening conditions: Sequential Screening conditions: Risk Stratification studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 21000 type: ESTIMATED name: Risk Assessment and Individualized Surveillance name: Universal screening measure: Detection rate of upper gastrointestinal (esophageal/gastric) malignant lesions measure: Rate of early-stage upper gastrointestinal (esophageal/gastric) malignant lesions measure: Detection rate of upper gastrointestinal (esophageal/gastric) premalignant lesions measure: Response rate of endoscopic examination measure: Total screening costs measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) malignant lesions measure: Unit cost per detected early-stage upper gastrointestinal (esophageal/gastric) malignant lesions measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) premalignant lesions measure: Satisfaction with the risk-based sequential screening modality measure: Rate of timely treatment measure: UGIC-specific mortality measure: All-cause mortality measure: Quality of life Scale Score sex: ALL minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of genetics, Peking University Cancer Hospital & Institute city: Beijing state: Beijing zip: 100142 country: China name: Zhonghu He role: CONTACT email: zhonghuhe@bjcancer.org name: Zhonghu He, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06306742 id: ct9874 briefTitle: Open-label Placebo in Manual Therapy overallStatus: RECRUITING date: 2024-02-26 date: 2025-12 date: 2026-06 date: 2024-03-12 date: 2024-03-12 name: Studio Osteopatico Busto Arsizio class: OTHER briefSummary: to investigate the effects of placebo in patients affected by low-back pain. conditions: Low Back Pain, Recurrent studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Open-label placebo name: Osteopathic manipulative treatment measure: Change in Numeric Rating Scale measure: Adverse effects measure: Change in measures of Von Frey filaments measure: Changes in algometer measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CTFO status: RECRUITING city: Saronno state: Varese zip: 21047 country: Italy name: CFTO role: CONTACT phone: +39 02 96701013 email: cfto@aimoedu.it lat: 45.62513 lon: 9.03517 hasResults: False