hackint0sh/New-Dataset huggingface dataset:
For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required. conditions: Burns conditions: Self Efficacy conditions: Burn Second Degree conditions: Burns Third Degree conditions: Quality of Life conditions: Adherence, Treatment conditions: Burn Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pilot Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only subject will be single blinded to the intervention provided whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Self Management Education measure: Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12 measure: Change from Baseline in the Generic Quality of life at Week 4 & Week 12 measure: Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire measure: Change from Baseline in the Self efficacy at Week 4 & Week 12 measure: Change from Baseline in the Itchiness of life at Week 4 & Week 12 measure: Change from Baseline in the Pain level at Week 4 & Week 12 measure: Percentage in the Burn related out-patient clinic attendance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LIU Siu Kwong city: Hong Kong country: China name: Siu Kwong LIU, ANC role: CONTACT phone: 852 22557610 email: onceliu@yahoo.com.hk lat: 22.39407 lon: 114.13737 hasResults: False
nctId: NCT06263283 id: PROICM 2023-04 KYO briefTitle: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer acronym: KYOCOL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-16 date: 2024-02-16 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.
Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.
The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy. conditions: Cervical Cancer conditions: Brachytherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control Group: Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed) Experimental Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: session of Kine-Yoga measure: Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer. measure: assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention measure: Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy. measure: Evaluation of the evolution of fatigue during uterovaginal brachytherapy measure: assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy measure: Description of the use of anxiolytics by group (experimental vs control) measure: Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06263270 id: 12-2023-01 briefTitle: Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-16 name: Cytonics Corporation class: INDUSTRY name: Southern Star Research Pty Ltd. briefSummary: The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:
Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment. conditions: Osteoarthritis, Knee conditions: Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomisation to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183; Weeks 1, 4, 8, 12, 16, and 26 weeks post-first dose respectively). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: This study is double-blind, placebo-controlled. Neither the investigator, care providers, patients, nor study sponsor have knowledge of the interventions assigned to each participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: CYT-108, a recombinant protease inhibitor name: Phosphate Buffered Saline (PBS) measure: Adverse Events measure: Blood Pressure measure: Heart Rate measure: Respiratory Rate measure: Body Temperature measure: Titer of Human Anti-Drug Antibody measure: Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities) measure: Time of Onset measure: Concentration of Cartilage Degradation Fragments in Blood Plasma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emeritus Research city: Camberwell state: Victoria zip: 3124 country: Australia name: Stuart Game, MD role: CONTACT phone: +61 3 9509 6166 email: stuartgame@emeritusresearch.com lat: -37.84205 lon: 145.0694 hasResults: False
nctId: NCT06263257 id: 2023-631 briefTitle: The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-10 date: 2025-04 date: 2024-02-16 date: 2024-04-16 name: Busra Nur Temur class: OTHER briefSummary: The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.
H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients. conditions: Anxiety conditions: Transplant;Failure,Kidney conditions: Transplant Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For the intervention group, the first measurement (afternoon of the day before surgery) will include State-Trait Anxiety Inventory and General Comfort Questionaire, the second measurement (Postoperative Day 5 - discharge day) will include State Anxiety Inventory and General Comfort Questionaire. The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows: Session 1 on Postoperative Day 5 - discharge day (after the scales), Session 2 on 1st Control (1 week after surgery), Session 3 on 2nd Control (2 weeks after surgery), and the third measurement at 3rd Control (1 month after surgery). For the Control Group, the third measurement (1 month after surgery) will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire. This stage aims to conduct a randomized controlled study. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Blinding In this study, blinding of participants and the statistician is planned. Blinding of the researcher implementing the intervention will not be possible. Since participants will not know to which group they are assigned, participant blinding is considered feasible. Data related to the scales (post-test) will be coded as 'A' and 'B' without indicating whether they belong to the intervention or control group. The coded data will be analyzed by a statistician, without knowledge of group allocation. After the statistical analyses are completed, the coding for the intervention and control groups will be revealed. This blinding technique is intended to minimize statistical bias. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Mandala Art Therapy measure: Reduction in anxiety levels measure: Increasing comfort level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06263244 id: NL83403.018.22 briefTitle: Specifying the Anti-inflammatory Effects of Ziltivekimab acronym: SPIDER overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-16 date: 2024-03-25 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics. conditions: Atherosclerosis conditions: Inflammation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, double blind, placebo-controlled trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: After informed consent has been obtained, patients will be randomized via computer randomization to either 15 mg ziltivekimab (n=20) or placebo (n=20). On the eCRFs or other documents subjects will be identified by subject ID and randomization number only. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ziltivekimab name: Placebo measure: TBRmax coronary arteries measure: monocyte activation marker protein expression measure: delta PCAT measure: Correlation delta TBRmax and CCTA derived plaque characteristics measure: delta SUVmax bone marrow measure: delta TBRmax ascending aorta measure: changes monocyte phenotype measure: changes in hsCRP measure: changes plasma cytokine and chemokine levels (pg/mL) measure: changes plasma cytokine and chemokine levels (ng/mL) sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06263231 id: IT-03 briefTitle: A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) acronym: INVINCIBLE-3 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2028-12 date: 2024-02-16 date: 2024-02-16 name: Intensity Therapeutics, Inc. class: INDUSTRY name: Premier Research Group plc briefSummary: To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen. conditions: Sarcoma,Soft Tissue studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 333 type: ESTIMATED name: INT230-6 name: Eribulin name: Trabectedin name: Pazopanib measure: Overall Survival (OS) measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06263218 id: CCR-2023-200344 briefTitle: Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil overallStatus: ENROLLING_BY_INVITATION date: 2023-10-01 date: 2024-07-30 date: 2024-12-29 date: 2024-02-16 date: 2024-02-22 name: Hospital do Rim e Hipertensão class: OTHER briefSummary: This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable. conditions: CMV Infection conditions: CMV Viremia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED measure: Incidence of infection, CMV disease, and tissue invasive disease. measure: Incidence recurrent CMV infection/disease measure: Incidence of refractory CMV infection/disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital do Rim city: São Paulo zip: 04038-002 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False
nctId: NCT06263205 id: Dressing briefTitle: Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques acronym: Dressing overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-24 date: 2026-12-24 date: 2024-02-16 date: 2024-04-02 name: Fudan University class: OTHER name: Shanghai Changzheng Hospital name: Changhai Hospital name: Shanghai East Hospital briefSummary: The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:
2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.
This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses. conditions: Gastrointestinal Tumors conditions: Surgical Wound Infection conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 816 type: ESTIMATED name: Non-Dressing of Surgical Wound name: Regular Dressing Change of Surgical Wound measure: Rate of Postoperative Wound Healing Complications measure: Patient Pain Levels measure: Medical Costs Associated with Wound Care sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai zip: 2000000 country: China name: Dazhi Xu, MD,PHD role: CONTACT phone: 021-64175590 email: xudzh@shca.org.cn lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06263192 id: AMH-IUI briefTitle: Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles overallStatus: COMPLETED date: 2020-10-01 date: 2022-12-01 date: 2023-05-01 date: 2024-02-16 date: 2024-02-16 name: Jose Antonio Moreno class: OTHER name: Universitat Autonoma de Barcelona briefSummary: The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \> and \< 1.1 ng/mL. conditions: Infertility, Female conditions: Anti-Mullerian Hormone Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 342 type: ACTUAL name: Intrauterine insemination measure: Cummulative pregnancy rate sex: FEMALE minimumAge: 25 Years maximumAge: 39 Years stdAges: ADULT facility: Fertty International city: Barcelona zip: 08010 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False
nctId: NCT06263179 id: STUDY00007706 id: UL1TR001412 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR001412 briefTitle: Feasibility of Aerobic Exercise for Recovery From Work-related Concussion overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-14 date: 2024-12-30 date: 2024-02-16 date: 2024-04-08 name: State University of New York at Buffalo class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion. conditions: Concussion, Brain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Target Heartrate Aerobic Exercise primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Target Heartrate Aerobic Exercise measure: Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed. measure: Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale measure: Change in Patient Health Questionnaire-9 (PHQ-9) measure: Change in Generalized Anxiety Disorder-7 (GAD-7) measure: Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) measure: Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) measure: Work Climate Questionnaire - 6-Item Version measure: Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) measure: Time to return to work measured in days measure: Rate of adverse Events as assessed by questioning the participant sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-26 uploadDate: 2024-01-29T12:18 filename: ICF_000.pdf size: 252809 hasResults: False
nctId: NCT06263166 id: 5535 briefTitle: The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: A Randomized Controlled Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-12 date: 2024-02-16 date: 2024-02-16 name: Ondokuz Mayıs University class: OTHER briefSummary: Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.
* question 2: What is the effect of stress ball application on women's pain level during vaginal examination? conditions: Anxiety State conditions: Pain conditions: Exanimation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: Stress ball intervention measure: Anxiety change measure: Pain level sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False