hackint0sh/New-Dataset huggingface dataset:
Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:
I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.
Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables. conditions: Feedback, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training name: Feedback and ROM (basic) measure: Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months) measure: Clinical Outcomes in Routine Evaluation-10 (Change in Session by session) measure: Working Alliance Inventory-Short Revised-Client (Change in session by session) measure: Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes measure: Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bergamo (DSUS) city: Bergamo state: Ita (bg) zip: 24125 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False
nctId: NCT06356948 id: H23-02918 briefTitle: Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study. acronym: RateTXA overallStatus: RECRUITING date: 2024-03-30 date: 2027-07-30 date: 2027-12-30 date: 2024-04-10 date: 2024-04-10 name: University of British Columbia class: OTHER briefSummary: Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, randomized, double-blind, non-inferiority trial.
Arm 1: Intravenous infusion of TXA 1g (10 mL) administered over 1 minute. Arm 2: Intravenous infusion of TXA 1g (10 mL) administered over 10 minutes primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Tranexamic Acid (TXA) measure: Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups. measure: Incidence of nausea measure: Incidence of vomiting measure: Incidence of hypotension measure: Incidence of hypertension measure: Incidence of central nervous system side effects sex: FEMALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BC Women's Hospital status: RECRUITING city: Vancouver state: British Columbia zip: V6H3N1 country: Canada name: Aislynn Sharrock, BA (Hons.) role: CONTACT phone: 604-875-2158 phoneExt: 6335 email: aislynn.sharrock@cw.bc.ca name: Anton Chau, MD MMSc role: PRINCIPAL_INVESTIGATOR name: Simon Wydall, MBBS MSc role: SUB_INVESTIGATOR name: Juliana Barrera, MD MSc role: SUB_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False
nctId: NCT06356935 id: HP2024 briefTitle: Effects of Heavy-load Resistance Training overallStatus: COMPLETED date: 2023-03-17 date: 2023-08-03 date: 2023-08-03 date: 2024-04-10 date: 2024-04-10 name: University of Southern Denmark class: OTHER name: Team Denmark briefSummary: The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON). conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: RT name: CON measure: Explosive muscle strength measure: Acceleration capacity measure: Agility performance measure: Jump ability sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Southern Denmark city: Odense zip: 5230 country: Denmark lat: 55.39594 lon: 10.38831 hasResults: False
nctId: NCT06356922 id: RC20_0123 briefTitle: Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia. acronym: PENTILULA overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2027-05-15 date: 2027-05-15 date: 2024-04-10 date: 2024-04-11 name: Nantes University Hospital class: OTHER briefSummary: CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\[177Lu\]Lu-PentixaTher/\[90Y\]Y-PentixaTher). \[177Lu\]Lu and \[90Y\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).
Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using \[177Lu\]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study. conditions: Acute Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Experimental drug [177Lu]Lu-PentixaTher measure: Safety of RLT using one injection of [177Lu]Lu-PentixaTher measure: Tolerance measure: Overall response rate measure: Complete response rate measure: Overall survival measure: Leukemia-free survival measure: Minimal residual disease measure: Whole-body biodistribution measure: Serum uptake measure: Radiation dosimetry measure: Renal safety measure: Renal safety measure: Renal safety measure: Renal safety measure: Correlation between different cytokines and toxicity measure: Factors associated response measure: Exploratory outcome measure = Identification of biological biomarkers sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux state: Gironde zip: 33604 country: France name: DUMAS Pierre-Yves role: CONTACT name: pierre-yves.dumas@chu-bordeaux.fr role: CONTACT lat: 44.84044 lon: -0.5805 facility: CHU de Nantes city: Nantes state: Loire-Atlantique zip: 44000 country: France name: Patrice CHEVALLIER role: CONTACT phone: 00332 40 08 39 94 email: patrice.chevallier@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU d'Angers city: Angers state: Maine Et Loire zip: 49100 country: France name: HUNAULT Mathilde role: CONTACT email: mahunault@chu-angers.fr lat: 47.46667 lon: -0.55 facility: CHU de Clermont-Ferrand city: Clermont-Ferrand state: Puy De Dôme zip: 63000 country: France name: MOLUCON Cécile role: CONTACT email: cecile.chabrot@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 hasResults: False
nctId: NCT06356909 id: SUPREMEneo briefTitle: Study of PREMEdication Before Laryngoscopy in Neonates in France acronym: SUPREMEneo overallStatus: RECRUITING date: 2024-03-11 date: 2024-04-07 date: 2024-04-07 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety) conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Survey of sedo-analgesia practices before laryngoscopy measure: Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement measure: Molecules used for sedo-analgesia measure: Cumulative doses of sedo-analgesia used measure: Questionnaire for the operator describing reasons for non-compliance with best practice guidelines measure: Numeric rating scale for pain (by operator and assistant) measure: TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment) measure: Side effects related to the premedication sex: ALL minimumAge: 20 Weeks maximumAge: 44 Weeks stdAges: CHILD facility: Centre Hospitalier Intercommunal de Creteil status: RECRUITING city: Creteil zip: 94000 country: France name: Manon TAUZIN, MD role: CONTACT phone: 0157023458 email: manon.tauzin@chicreteil.fr lat: 48.78333 lon: 2.46667 hasResults: False
nctId: NCT06356883 id: 2024-4938 briefTitle: Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-10 date: 2024-04-10 name: Université de Sherbrooke class: OTHER briefSummary: The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.
Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.
Putting together these data will allow to correlate clinical and radiological response to QOL and NC. conditions: Glioblastoma Multiforme conditions: Relapse studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: IA Carboplatin + IA Caelyx name: IA Carboplatin + IA Etoposide Phosphate measure: Tumor Response on MRI using the RANO Criteria measure: Progression-free Survival measure: Median overall survival measure: Treatment-related toxicity measure: Per treatment quality of life assessment measure: Incidence of treatment related Neurocognitive decline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUS status: RECRUITING city: Sherbrooke state: Quebec zip: J1H 5N4 country: Canada name: David Fortin, MD role: CONTACT phone: 819-346-1110 phoneExt: 13895 email: david.fortin@usherbrooke.ca name: Marie-Andrée Roy, Nurse role: CONTACT phone: 819-346-1110 phoneExt: 13895 email: marie-andree.roy.s-inf.ciussse-chus@ssss.gouv.qc.ca lat: 45.40008 lon: -71.89908 hasResults: False
nctId: NCT06356870 id: BUE briefTitle: Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone. acronym: BMAC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting conditions: Alveolar Cleft Grafting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: BMAC MIXED WITH ALLOGRAFT name: Cancellous bone from anterior iliac crest measure: bone density measure: Bone gain measure: Postoperative donor site morbidity sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
nctId: NCT06356857 id: H-23070312 briefTitle: Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging acronym: Heart-Wave overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-04-10 date: 2024-04-11 name: Peter Hovind class: OTHER briefSummary: This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI. conditions: Myocardial Blood Flow studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT measure: [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bispebjerg Hospital city: Copenhagen state: RegionH zip: 2400 country: Denmark name: Laila Seidelin, MD role: CONTACT phone: +4520353008 email: laila.seidelin.01@regionh.dk name: Martin Krakauer, MD, Phd. role: CONTACT email: martin.krakauer@regionh.dk name: Laila Seidelin, MD role: SUB_INVESTIGATOR name: Martin Krakauer, MD, P.hd role: SUB_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False
nctId: NCT06356844 id: 27.02.2023-E.142568 briefTitle: The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain overallStatus: RECRUITING date: 2024-02-27 date: 2024-04 date: 2024-12 date: 2024-04-10 date: 2024-04-10 name: Bezmialem Vakif University class: OTHER briefSummary: Brief Summary: Inflammatory back pain is a chronic condition localized in the axial spine and sacroiliac joints.1 It often accompanies mechanical issues like lumbar disc herniation. While non-surgical interventions such as medication, physiotherapy, and epidural steroid injections are typically the initial approach, surgical options may be considered if these prove ineffective.2 Resolvins, derived from omega-3 fatty acids, have shown promise in reducing inflammation and pain. They help to resolve inflammatory responses, promote tissue repair, and decrease disc size, potentially reducing the need for surgery.3,4 This clinical trial aims to evaluate the efficacy of adding oral resolvins to transforaminal epidural steroid injections for treating lumbar disc herniation (LDH) The control group (Group C: n=25) will receive epidural steroids, while the study group (Group R: n=25) will receive both oral omega-3 supplementation and epidural steroids on the same day. Additionally, the study group will continue taking oral omega-3 supplements for six months.
Discussion: This trial anticipates that combining the anti-inflammatory properties of resolvins with epidural steroid injection will provide a beneficial treatment for patients suffering from inflammatory low back pain. conditions: Low Back Pain conditions: Inflammatory Response conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Resolvin supplement measure: changes in protruded/extruded disc size measure: Pain intensity score measure: Cytokine markers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aylin Ceren Şanlı status: RECRUITING city: Istanbul country: Turkey name: Aylin C Sanli, Asist Dr role: CONTACT phone: +0905496522412 email: aylincerensanli@hotmail.com lat: 41.01384 lon: 28.94966 facility: Aylin Ceren status: COMPLETED city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06356818 id: E-74555795-050.04-941155 briefTitle: Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-10 date: 2024-04-10 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: In this study, the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment. Via comparing virtual reality, motor imagery, and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance, proprioception, range of motion, muscle strength, pain, function and patient satisfaction. conditions: Ankle Sprains studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three groups with a conventional therapy control group. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Conventional physiotherapy program name: Virtual reality (VR) name: Motor imagery (MI) measure: Visual Analog Scale (VAS) measure: Pressure Pain Threshold (PPT) measure: Star Excursion Balance Test (SEBT) measure: Single Leg Balance Test (SLBT) measure: Joint position sense (JPS) measure: Range of Motion (ROM) measure: Muscle strength measure: Cumberland ankle instability questionnaire (CAIT) measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa (IUC) city: Istanbul country: Turkey name: Doaa HAKAM, PT role: CONTACT phone: +905345456224 email: d.hakam@ogr.iuc.edu.tr name: YILDIZ AKBABA, Assoc. Prof. role: CONTACT email: yildizanalay@iuc.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False