hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06388941 id: CLNP023R12201 briefTitle: Iptacopan in Patients With ANCA Associated Vasculitis overallStatus: NOT_YET_RECRUITING date: 2024-08-28 date: 2027-08-27 date: 2027-09-22 date: 2024-04-29 date: 2024-04-29 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL. conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Iptacopan name: Placebo name: Rituximab measure: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. measure: B cell counts measure: Total IgG levels measure: Complete remission at week 24 measure: Time to reach BVAS=0 measure: Time to major relapse measure: Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks measure: Cumulative dose of glucocorticoid (GC) measure: Glucocorticoid toxicity index over 48 weeks measure: 36-Item short form survey (SF-36) measure: Patient's Global Assessment (PtGA) measure: Physician's global assessment (PhGA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06388928 id: P.T.REC/012/004596 briefTitle: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists overallStatus: COMPLETED date: 2023-07-09 date: 2023-12-26 date: 2023-12-26 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.
- Is there any effect of the menstrual cycle on the manual dexterity of female dentists? conditions: Menstrual Cycle conditions: Manual Dexterity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 45 type: ACTUAL measure: Manual dexterity assessment sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: Horus University city: Damietta country: Egypt lat: 31.41648 lon: 31.81332 hasResults: False
nctId: NCT06388915 id: K2202403004 briefTitle: A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion overallStatus: COMPLETED date: 2024-03-12 date: 2024-03-20 date: 2024-03-23 date: 2024-04-29 date: 2024-04-29 name: Weikang Chen class: OTHER briefSummary: Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries. conditions: Pelvic Fracture conditions: Morel-Lavallee Lesion studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Site of MLL measure: Site of injury and Classification of pelvic fracture measure: Time to treatment measure: Drainage volume sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Provincial Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False
nctId: NCT06388902 id: BR115-101 briefTitle: A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-08 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: BioRay Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.
Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study. conditions: Advanced Solid Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: BR115 for injection measure: Treatment-emergent Adverse Events Following Treatment With BR115 measure: Objective Response Rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of response (DOR). measure: Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) measure: Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) measure: The anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Rui Xu, MD role: CONTACT phone: 86-20-87343468 email: ruihxu@163.com lat: 23.11667 lon: 113.25 hasResults: False
nctId: NCT06388889 id: AR-DEX-22-04 briefTitle: Phase III Long-Term Extension Study With Dexpramipexole acronym: EXHALE-5 overallStatus: ENROLLING_BY_INVITATION date: 2024-05-08 date: 2027-06-01 date: 2027-06-01 date: 2024-04-29 date: 2024-04-29 name: Areteia Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3. conditions: Eosinophilic Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1600 type: ESTIMATED name: Dexpramipexole Dihydrochloride measure: Number and Percentage of Participants with a Treatment Emergent Adverse Event measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight measure: Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters measure: Severe Asthma Exacerbations measure: Change in Asthma Control Questionnaire-6 (ACQ-6) measure: Change in absolute eosinophil counts (AEC) sex: ALL minimumAge: 12 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site 20001-004 city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 hasResults: False
nctId: NCT06388876 id: AnkaraYBUbk briefTitle: The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes overallStatus: COMPLETED date: 2023-04-01 date: 2023-06-15 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Yildirim Beyazıt University class: OTHER name: TÜBİTAK briefSummary: Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye. conditions: Earthquake conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: there are 2 groups; exercise and control primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Exercise name: lifestyle advice measure: Post-traumatic Stress Disorder Short Scale measure: Pittsburgh Sleep Quality Index sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Ankara Yildirim Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
nctId: NCT06388863 id: B2024-002 briefTitle: Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-29 date: 2024-04-29 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Healthy donor-derived FMT capsule name: Placebo capsule measure: Response rate of constipation in Parkinson's Disease (PD) measure: Change from baseline PD symptoms at week 5, week 13 and week 24 measure: Change from baseline anxiety at week 5, week 13 and week 24 measure: Change from baseline depression at week 5, week 13 and week 24 measure: Change from baseline quality of life at week 5, week 13 and week 24 measure: Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24 measure: Change from baseline fecal microbiota at week 5, week 13 and week 24 measure: Change from baseline fecal metabolites at week 5, week 13 and week 24 sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road city: Shanghai state: Shanghai zip: 200032 country: China name: Shengdi Wu role: CONTACT phone: (86)13817923359 email: wu.shengdi@zs-hospital.sh.cn name: Shengdi Wu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06388850 id: 5U01CE003393-03 type: NIH link: https://reporter.nih.gov/quickSearch/5U01CE003393-03 briefTitle: Evaluation of HRP Among Pre-K Through 5th Grade overallStatus: ENROLLING_BY_INVITATION date: 2023-03-23 date: 2025-09-30 date: 2025-09-30 date: 2024-04-29 date: 2024-04-29 name: Northeastern University class: OTHER briefSummary: This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data. conditions: Child Sexual Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops. primaryPurpose: PREVENTION masking: NONE count: 16 type: ESTIMATED name: Healthy Relationships Project measure: Reports of child sexual abuse measure: The Parental Knowledge Scale (PKS) measure: The Parental Discussions about Sex Abuse Scale (PDSAS) measure: The adapted Parenting Self Agency (PSAM) measure: The Parent Knowledge Questionnaire (PKQ) measure: HRP evaluation measure: The CSA Myths Scale measure: The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA) sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Safe Shores city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False
nctId: NCT06388837 id: RECO6U/20- 2021 briefTitle: Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone overallStatus: COMPLETED date: 2021-02-20 date: 2023-03-01 date: 2023-03-01 date: 2024-04-29 date: 2024-04-29 name: October 6 University class: OTHER briefSummary: The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft conditions: Symphysis Onlay Bone Graft conditions: Platelet Rich Fibrin conditions: Xenograft conditions: Horizontal Alveolar Ridge Augmentation conditions: Esthetic Zone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12 type: ACTUAL name: Injectable Platelet Rich Fibrin name: Xenograft measure: Alveolar ridge width measure: Bone density sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
nctId: NCT06388824 id: GWang028 briefTitle: The Effect of Esketamine on Sleep Disturbance overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-09-30 date: 2024-10-10 date: 2024-04-29 date: 2024-04-29 name: Tianjin Medical University General Hospital class: OTHER briefSummary: To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: normal saline name: Esketamine measure: The incidence of sleep disturbance on the first night after surgery measure: The incidence of sleep disturbance on the second and third postoperative nights measure: The incidence of sleep disturbance on the seventh postoperative nights measure: Postoperative anxiety measure: Postoperative depression measure: Pain intensity measure: Adverse event measure: preoperative hemoglobin concentration measure: Human Chorionic Gonadotropin level measure: The incidence of sleep disturbance on the day before surgery measure: The incidence of sleep disturbance before surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University General Hospital city: Tianjin zip: 300052 country: China lat: 39.14222 lon: 117.17667 hasResults: False
nctId: NCT06388811 id: 2023/1162 briefTitle: Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-29 date: 2024-04-29 name: Istanbul University class: OTHER briefSummary: The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression.
Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet.
For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation). conditions: Early Knee Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 220 type: ESTIMATED name: Early Osteoarthritis Questionnaire measure: Numeric Rating Scale measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06388798 id: Ankara Etlik city hospital briefTitle: Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic overallStatus: COMPLETED date: 2023-05-30 date: 2023-07-30 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Summary:
Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA). conditions: Nursing Education conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 78 type: ACTUAL name: Education measure: Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group. measure: Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation sex: ALL minimumAge: 23 Years maximumAge: 45 Years stdAges: ADULT facility: Ankara Etlik City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-05-05 uploadDate: 2024-03-04T06:15 filename: Prot_SAP_ICF_000.pdf size: 163176 hasResults: False
nctId: NCT06388785 id: TAK-003-5001 briefTitle: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia acronym: PRIME-Q overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-09-01 date: 2027-09-01 date: 2024-04-29 date: 2024-04-29 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.
No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate. conditions: Dengue Fever studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: No Intervention measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP) sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universiti Putra Malaysia city: Serdang state: Selangor zip: 43400 country: Malaysia name: Study Contact role: CONTACT phone: +603-9769 1000 email: zamberi@upm.edu.my name: Zamberi Sekawi, Dr role: PRINCIPAL_INVESTIGATOR facility: Universiti Malaya city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 50603 country: Malaysia name: Study Contact role: CONTACT phone: +60379493641 email: sfaridah@ummc.edu.my name: Sharifah Faridah binti Syed Omar, Dr role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False