hackint0sh/New-Dataset huggingface dataset:
Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset.
The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Result of the Horne and Ostberg questionnaire. sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Service de pédiatrie, CHRU de Nancy - Hôpitaux de Brabois city: Nancy zip: 54500 country: France name: Iulia IOAN, MD role: CONTACT phone: 03.83.15.47.94 phoneExt: +33 email: ic.ioan@chru-nancy.fr name: Iulia IOAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Service de pneumologie pédiatrique, Hôpital Armand Trousseau city: Paris zip: 75012 country: France name: Jessica TAYTARD, MD role: CONTACT phone: 01 44 73 63 46 phoneExt: +33 email: jessica.taytard@aphp.fr name: Jessica TAYTARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
nctId: NCT06370949 id: 2024-01/17 briefTitle: The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block acronym: TAP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-30 date: 2024-11-30 date: 2024-04-17 date: 2024-04-17 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients.
Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries. conditions: Colorectal Cancer conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 84 type: ESTIMATED name: Bupivacain name: bupivacain+dexmedetomidine measure: Analgesic effectiveness of bupivacain and bupivacain+dexmedetomidine combination in colorectal cancer surgery sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital city: Ankara state: Cankaya zip: 06110 country: Turkey name: Hazal E Guran Aytug, MD role: CONTACT phone: 05078448449 email: drekinguran@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False
nctId: NCT06370936 id: NL84824.091.23 id: NL84824.091.23 type: OTHER domain: CCMO / Toetsingonline briefTitle: The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health acronym: EXPLAIN overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-17 date: 2024-04-17 name: Wageningen University class: OTHER briefSummary: Plant-based diets with little to no meat are considered healthy and sustainable by the general public. The increasingly popular plant-based meat analogues (PBMAs) allow consumers to easily decrease meat intake while maintaining their dietary patterns. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited.
The primary objective of this clinical trial is to evaluate if and to what extent replacing all meat products in an average Dutch diet with currently commercially available PBMAs affects the systolic blood pressure of middle-aged men and women in a 2x8 week fully dietary controlled crossover intervention study. The secondary objectives are to assess the effect of this replacement of meat products with PBMAs on cardiometabolic health, gut microbiome, intestinal health, well-being, and underlying biological mechanisms.
nctId: NCT06370923 id: 1R01MH133488-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH133488-01 briefTitle: Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention acronym: IMPERATIVE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-07 date: 2028-12 date: 2024-04-17 date: 2024-04-17 name: University of Stellenbosch class: OTHER name: Biomedical Research and Training Institute, Zimbabwe name: Imperial College London name: University of Lincoln name: University College London Hospitals name: University of Copenhagen name: University of Washington name: Heidelberg University briefSummary: Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA.
The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe.
The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomised trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Analysts blinded to allocation whoMasked: OUTCOMES_ASSESSOR count: 3591 type: ESTIMATED name: Peer Distribution name: Community Health Worker Distribution measure: PrEP initiation measure: PrEP adherence measure: ART adherence measure: Confirmatory tests sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-07 uploadDate: 2024-04-11T04:41 filename: Prot_000.pdf size: 766804 hasResults: False
nctId: NCT06370910 id: CAAE 58569421.5.0000.5327 briefTitle: Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction acronym: CL overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-05 date: 2024-01-10 date: 2024-04-17 date: 2024-04-17 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.
Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery. conditions: Episiotomy; Complications conditions: Laceration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 56 type: ACTUAL name: Low-Level Laser Therapy measure: To compare two techniques: Low-level laser and cryotherapy measure: Pain reduction assessed by the Visual Analog Scale (VAS). measure: Pain reduction assessed by McGill Pain Scale measure: Evaluate reduction of swelling using the REEDA scale. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hospital de Clínicas de Porto Alegre city: Porto Alegre zip: RS country: Brazil lat: -30.03306 lon: -51.23 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-04 uploadDate: 2024-04-12T18:23 filename: Prot_SAP_000.pdf size: 47665 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-04 uploadDate: 2024-04-12T18:21 filename: ICF_001.pdf size: 66023 hasResults: False
nctId: NCT06370897 id: 337421 briefTitle: Prediction & Mechanisms of Recovery Following IEDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-09 date: 2024-04-17 date: 2024-04-17 name: University of Plymouth class: OTHER briefSummary: Inner Ear Decompression sickness (IEDS) accounts for 20% of all types of decompression sickness (the bends) in divers. The condition commonly affects the peripheral vestibular system (inner ear). IEDS results in acute symptoms of dizzyness (vertigo) and imbalance. Even with the recommended treatment of hyperbaric oxygen therapy some people do not recovery fully. However, even in the presence of a permanent vestibular deficit many people can show a behavioural recovery where symptoms improve over time. Recovery can be aided by vestibular rehabilitation (VR) which is now routine for acute IEDS but was not provided before 2021, and is not widespread across the UK (United Kingdom) or world, meaning people may have a suboptimal recovery.
This project has two main parts. Part one is a prospective observational study where people with an acute onset of IEDS are serially monitored while they are receiving hyperbaric treatment and VR over 10-14 days. Part two is a retrospective observational study where who have had IEDS in the past 15 years are re-assessed in a one-off session. The tests in both parts involve clinical tests and specialist eye movement recordings that assess vestibular function. We will also determine the site of any vestibular pathology by using selective stimulation of the vestibular end organ or nerve and assess whether there are any changes in how the structure and function of central vestibular pathways in the brain. In people with chronic IEDS with vestibular symptoms we will offer participants a course of VR over 12 weeks and assess whether this is associated with any improvement in symptoms. conditions: Decompression Sickness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 41 type: ESTIMATED measure: Side of peripheral vestibular damage: Prospective cohort measure: Site of peripheral vestibular damage: Prospective cohort measure: Extent of peripheral vestibular damage: Prospective cohort measure: Side of peripheral vestibular damage: Retrospective cohort measure: Site of peripheral vestibular damage:Retrospective cohort measure: Extent of peripheral vestibular damage:Retrospective cohort measure: VOR gain v HIT: Prospective Study measure: VOR gain: Prospective Study measure: VOR Time constant:Prospective Study measure: Patient reported outcome measure: Prospective Study measure: Clinical measure of walking: Prospective Study measure: Clinical measure of balance: Prospective Study measure: Posturography: Prospective Study measure: Perception of verticality: Prospective Study measure: Functional MRI response to an optokinetic stimulus: Prospective Study measure: Vestibular Evoked myogenic Potentials latency: Prospective Study measure: Vestibular Evoked myogenic Potentials amplitude: Prospective Study measure: VOR gain: Retrospective Study measure: VOR Time constant: Retrospective Study measure: Patient reported outcome measure: Retrospective Study measure: Clinical measure of walking: Retrospective Study measure: Clinical measure of balance: Retrospective Study measure: Posturography: Retrospective Study measure: Perception of verticality: Retrospective Study measure: Functional MRI response to an optokinetic stimulus: Retrospective Study measure: Vestibular Evoked myogenic Potentials latency: Retrospective Study measure: Vestibular Evoked myogenic Potentials amplitude: Retrorospective Study sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06370871 id: 1403-0006 id: 2022-502985-26-00 type: REGISTRY domain: CTIS (EU) id: U1111-1292-9594 type: REGISTRY domain: WHO Registry briefTitle: Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-06-04 date: 2026-07-03 date: 2028-10-13 date: 2024-04-17 date: 2024-04-24 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing. conditions: Advanced Soft Tissue Sarcoma conditions: Undifferentiated Pleomorphic Sarcoma (UPS) conditions: Myxofibrosarcoma (MFS) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 263 type: ESTIMATED name: Brigimadlin name: Ezabenlimab name: Gemcitabine name: Docetaxel measure: Progression-free survival measure: Overall survival measure: Objective response measure: Duration of objective response measure: Disease control measure: Duration of disease control measure: Occurrence of treatment-emergent adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5 measure: Occurrence of treatment-emergent AEs leading to study drug discontinuation measure: Mean change from baseline to Week 12 in the domain fatigue (based on items from the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) and the EORTC item library) measure: Mean change from baseline to Week 12 in the domain fatigability (based on items from the EORTC QLQ-C30 and the EORTC item library) measure: Mean change from baseline to week 12 in the domain physical functioning (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain pain (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain dyspnea (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain global health status / quality of life (based on items from the EORTC QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06370845 id: 0000-00000; kt24timper briefTitle: Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure acronym: OLFO-Brain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-10-30 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Inhalation - Natural Odour name: Inhalation - Placebo measure: Detection of a natural odour in human CSF measure: Abundance of a natural odour in human CSF of obese versus lean participants measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF. measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Katharina Timper, Prof. Dr. med. role: CONTACT phone: 0041 61 328 57 42 email: katharina.timper@usb.ch name: Isabel M Hofer role: CONTACT phone: 0041 61 328 68 14 email: isabelmarie.hofer@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False
nctId: NCT06370819 id: NN9541-4923 id: U1111-1292-3441 type: OTHER domain: Universal Trial Number id: 2023-506381-32 type: OTHER domain: EU CT Number briefTitle: A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-19 date: 2025-04-19 date: 2024-04-17 date: 2024-04-17 name: Novo Nordisk A/S class: INDUSTRY briefSummary: NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: NNC0519-0130 measure: Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment measure: Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment measure: AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure measure: Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Research Organisation GmbH city: Berlin zip: 10117 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False