hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06347133 id: AROAPOC3-3009 id: 2023-509302-30 type: EUDRACT_NUMBER briefTitle: Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia acronym: MUIR-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety. conditions: Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1328 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06347120 id: PI2024_843_0011 briefTitle: Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction acronym: BOWNTI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03 date: 2027-04 date: 2024-04-04 date: 2024-04-18 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: Centre Hospitalier de Beauvais name: CHU de Rouen - Accueil name: Hospital Avicenne name: Centre Hospitalier Universitaire Dijon name: University Hospital, Limoges name: Saint Antoine University Hospital name: Centre Hospitalier Universitaire de Besancon name: Hôpital Cochin name: University Hospital, Toulouse name: CH Abbeville name: University Hospital, Angers briefSummary: Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.
Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.
To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO. conditions: Small Bowel Obstruction Adhesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 504 type: ESTIMATED name: nasogastric tube name: NOM without NGT insertion measure: Decrease of complication rate in patient without NGT group compared to control group measure: aspiration pneumonia rate in both patient groups sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens Universitary Hospital city: Amiens country: France name: jean marc Regimbeau, Pr role: CONTACT phone: +33 3 22 08 89 05 email: regimbeau.jean-marc@chu-amiens.fr name: charles sabbagh, Pr role: SUB_INVESTIGATOR name: Aiham Ghazali, Pr role: SUB_INVESTIGATOR name: Thierry Yzet, Pr role: SUB_INVESTIGATOR name: François Mauvais, MD role: PRINCIPAL_INVESTIGATOR name: Lilian Schwarz, MD role: PRINCIPAL_INVESTIGATOR name: Christophe Tresallet, MD role: PRINCIPAL_INVESTIGATOR name: Pablo Ortega deballon, MD role: PRINCIPAL_INVESTIGATOR name: Muriel Mathonnet, MD role: PRINCIPAL_INVESTIGATOR name: Jérémie Lefevre, MD role: PRINCIPAL_INVESTIGATOR name: Zaher Lakkis, MD role: PRINCIPAL_INVESTIGATOR name: David Fuks, MD role: PRINCIPAL_INVESTIGATOR name: Fabrice Muscari, MD role: PRINCIPAL_INVESTIGATOR name: Corina Iederan, MD role: PRINCIPAL_INVESTIGATOR name: Aurelien Venara, MD role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False
nctId: NCT06347107 id: S67215 briefTitle: Robotic Subretinal tPA Injection Study acronym: RoTIS overallStatus: RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: DORC Dutch Ophthalmic Research Center International BV briefSummary: In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:
As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review. conditions: Subretinal Hemorrhage conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Investigator-initiated, academic, mono-center, prospective, interventional case study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Robotic subretinal tPA injection measure: Percentage of patients with succesful subretinal insertion of the robot-held 41G needle measure: Percentage of patients with stable subretinal position of the needle for at least 3 minutes. measure: Device-related adverse events measure: Functional outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Peter Stalmans, MD PhD role: CONTACT email: peter.stalmans@uzleuven.be name: Ivo De Clerck, MD role: CONTACT email: ivo.declerck@uzleuven.be name: Ivo De Clerck, MD role: SUB_INVESTIGATOR name: Peter Stalmans, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
nctId: NCT06347081 id: P.T.REC/012/00449 briefTitle: Effect of Nd-YAG Laser on Hypertrophic Scar acronym: Nd-YAG overallStatus: COMPLETED date: 2022-05-01 date: 2024-02-28 date: 2024-02-28 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.
T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures. conditions: Hypertrophic Scar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one treatment one control group primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Nd- YAG laser at 532nm wavelength measure: hypertrophic scar maturation measure: hypertrophic scar volume sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Physical Therapy city: Cairo zip: 12613 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
nctId: NCT06347068 id: LCCC2128-ATL briefTitle: Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2028-05 date: 2024-04-04 date: 2024-04-23 name: UNC Lineberger Comprehensive Cancer Center class: OTHER name: Bellicum Pharmaceuticals briefSummary: This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC). conditions: Breast Cancer conditions: Relapse conditions: Resistant Cancer conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: iC9-CAR.B7-H3 T Cell Therapy name: cyclophosphamide name: fludarabine measure: Toxicity: NCI-CTCAE measure: Toxicity: Cytokine Release Syndrome (CRS) measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) measure: The recommended phase 2 dose (RP2D) NCI-CTCAE v5. measure: The recommended phase 2 dose (RP2D) CRS Grading measure: The recommended phase 2 dose (RP2D) measure: Objective response rate measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Duration of Response (DOR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Catherine Cheng role: CONTACT phone: 919-445-4208 email: catherine_cheng@med.unc.edu name: E. Claire Dees, MD, MSc role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
nctId: NCT06347055 id: 403690 briefTitle: NeuroControl of Nicotine Dependence overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2030-03-25 date: 2030-04-30 date: 2024-04-04 date: 2024-04-08 name: University of Missouri-Columbia class: OTHER briefSummary: The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours. conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: Acute effects of cTBS on cognitive control measure: Exploratory: Acute effects of cTBS on fMRI brain response measure: Safety and Tolerability sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
nctId: NCT06347042 id: 012/004897 briefTitle: Effect of Qigong on Sleep Quality in Fibromyalgia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: qigong exercise + routine medical treatment +Anti-inflammatory diet name: routine medical treatment +Anti-inflammatory diet only measure: Sleep quality measure: Heart Rate variability measure: Quality of Life o measure the quality of life of patients with problems found fibromyalgia. measure: pain self-administered questionnaire measure: Fatigue :prevalence and severity of fatigue measure: Depression and Anxiety assess Depression and Anxiety sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Physical therapy Cairo University city: Cairo state: Giza country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
nctId: NCT06347029 id: Endothelial dysfunction briefTitle: Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure Patients at Different Stages, and Evaluation of the Role of Antiphospholipid Antibodies overallStatus: RECRUITING date: 2023-10-17 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Brugmann University Hospital class: OTHER briefSummary: The vascular endothelium is an organ in its own right, playing, among other things, a primordial role in the control of vascular tone. This vascular tone is ensured by pro-dilator mediators (nitric oxide (NO), prostacyclins (PGI2)), or vasoconstrictors (endothelin, thromboxane A2 or PGH2).Uremic toxin accumulation in chronic kidney disease (CKD) is a well-known factor in endothelial dysfunction, often associated with higher cardiovascular risk. This association is also present for terminal chronic kidney disease characterized by the need to resort to an extra-renal purification technique (in-center hemodialysis (HD), daily home hemodialysis (HDQ), peritoneal dialysis) or to resort to renal transplantation.
For HD to be effective, it is essential that the blood flow rate passing through the dialyzer is greater than 300ml/min. This imperative requires that any hemodialysis patient have specific vascular access (dialysis catheter or arteriovenous fistula (AVF)) to ensure these flow rates. The vascular access of choice is the arteriovenous fistula , because it is associated with a lower risk of infection and lower morbidity and mortality. Making an arteriovenous fistula consists of surgically creating an anastomosis between a vein and an artery.
Complications of arteriovenous fistula are common. Arteriovenous fistula maturation may be delayed (maturation delay) or even absent. Drainage veins and/or anastomoses can also be the site of stenosis or thrombosis. The pathophysiology of these complications is complex and multifactorial. Among the risk factors for these complications (delay or absence of maturation, stenosis thrombosis), the positivity of antiphospholipid antibodies (aPL) can be cited, as well as endothelial dysfunction.
Antiphospholipid syndrome (APS) is an autoimmune disease causing a thrombotic phenotype. This is an acquired thrombophilia. In the general population, the prevalence of antiphospholipid antibodies is around 0.5%; this prevalence is far from rare in hemodialysis, since it represents up to 37% in dialysis patients. In a retrospective study carried out at Brugmann University Hospital in 2023 , on 115 patients with AVF and in whom aPL dosages were available, the prevalence of persistent positivity (2 positive dosages spaced more than 12 weeks apart) was 21%.
Endothelial dysfunction is also implicated in the pathophysiology of APS. In clinical practice, the "flow mediated dilation" (FMD) test makes it possible to assess endothelial dysfunction in vivo. It involves the phenomenon of post-occlusive hyperemia which is mainly linked to NO and endothelium-dependent vasodilation. In the brachial artery, NO is the sole mediator of FMD. Endothelial dysfunction according to FMD has been described in populations with advanced chronic kidney disease, as well as patients with cardiovascular diseases. Hemodialysis patients with delayed/absence of arteriovenous fistula maturation have more pathological FMDs compared to dialysis patients without fistula problems. However, the additive role of aPL in this different population has not been studied in terms of endothelial dysfunction by FMD.
5. Evaluate the correlation between endothelial dysfunction according to FMD and other markers of endothelial dysfunction (urinary NO and metabolites of urinary NO, PGI2, endothelin, PGH2). conditions: Chronic Renal Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: Urine sampling name: Blood sampling name: Flow mediated dilatation test measure: Nitric oxide (NO) plasma level measure: Endothelin 1 (ET-1) plasma level measure: E-Selectine plasma level measure: P-Selectine plasma level measure: Intercellular Adhesion Molecule 1 (ICAM-1) plasma level measure: Interleukin 6 (IL-6) plasma level measure: Nitric oxide (NO) urine concentration measure: Endothelin 1 (ET-1) urine concentration measure: Tumour Necrosis Factor alpha (TNF alpha) urine concentration measure: Interleukin 6 (IL-6) urine concentration measure: Flow mediated dilatation test result (%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brugmann University Hospital status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Maxime Taghavi, MD PhD role: CONTACT email: Maxime.TAGHAVI@chu-brugmann.be lat: 50.85045 lon: 4.34878 hasResults: False
nctId: NCT06346990 id: Faculty 2023-2024-2-2 briefTitle: The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-14 date: 2025-05-15 date: 2024-04-04 date: 2024-04-05 name: Applied Science Private University class: OTHER briefSummary: This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome. conditions: Coronary Artery Disease conditions: Coronary Artery Bypass Graft Surgery conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Taking into consideration that this was a RCT, blinding the participants was not possible. However, data collectors and data analyzer were blinded. Directly after the intervention, each day at 3pm and 9 pm, the participants were evaluated for development of delirium by the Research assistant how do not know in which group was the participant allocated, and if the result was positive the intervention was discontinued. whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: Holy Quran Recital measure: Delirium measure: Length of stay-ICU measure: Length of stay-hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06346977 id: DTO-20231214 briefTitle: Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER briefSummary: Non-small cell lung cancer (NSCLC), occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide, afflicts an estimated 30% of its patients with intracranial metastatic spread. Among these, leptomeningeal metastasis (LM) is an exceptionally surreptitious and perilous manifestation, often evading timely and accurate diagnosis. The clinical landscape is further complicated by the presence of patients who, due to various reasons, are unable to undergo lumbar puncture, a procedure crucial for the investigation of LM. Moreover, even when cerebrospinal fluid (CSF) analysis via conventional cytological and immunohistochemical methods is attempted, a definitive diagnosis of LM may remain elusive in a subset of cases.
Intrathecal chemotherapy, particularly via the administration of pemetrexed, which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space, constitutes a cornerstone of treatment for NSCLC-LM. Despite its importance, the lack of robust, validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap. This deficit is compounded by the inherent challenges associated with CSF samples, including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques.