hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06293378 id: Pengmingli briefTitle: Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis. overallStatus: RECRUITING date: 2024-02-28 date: 2028-10-10 date: 2028-11-10 date: 2024-03-05 date: 2024-04-02 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed. conditions: Cirrhosis, Liver conditions: Fibrosis, Liver studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 330 type: ESTIMATED name: Sulfasalazine enteric-coated tablets measure: Serum alkaline phosphatase (ALP) measure: Serum γ-glutamyl transpeptidase (GGT) measure: Serum bilirubin measure: Serum bile acids measure: Serum aspartate aminotransferase(AST) measure: Serum alanine aminotransferase (ALT) measure: Hepatic fibrosis and the improvement of microbial metabolites measure: Changes in immune cells sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Mingli Peng, Doctor role: CONTACT phone: +8613512362906 email: Peng_mingli@hospital.cqmu.edu.cn name: Yinghua Lan, Doctor role: CONTACT phone: +8613796050629 lat: 29.56278 lon: 106.55278 facility: Chongqing status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: Mingli Peng, Doctor role: CONTACT phone: 13512362906 email: peng_mingli@hospital.cqmu.edu.cn name: Yinghua Lan, Doctor role: CONTACT phone: +8613796050629 lat: 29.56278 lon: 106.55278 hasResults: False
nctId: NCT06293365 id: CVAY736A2202 id: 2023-508996-35 type: EUDRACT_NUMBER briefTitle: Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-26 date: 2025-07-29 date: 2029-02-08 date: 2024-03-05 date: 2024-04-09 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS. conditions: Sjögrens Disease conditions: Systemic Lupus Erythematosus conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 140 type: ESTIMATED name: VAY736 1ml PFS name: VAY736 2 ml PFS name: VAY736 2ml AI measure: Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab measure: Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab measure: Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab measure: Cohort 2 (optional): Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab measure: Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab measure: Cohort 2 (optional): Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab measure: Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab measure: Cohort 2 (optional): Concentration at the end of a dosing interval (Ctrough) for ianalumab measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Anti-ianalumab antibodies (ADA) measure: Incidence of ADA positive participants sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06293352 id: STU00220012 briefTitle: Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Northwestern University class: OTHER briefSummary: In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in.
There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.
We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction. conditions: Prosthetic-joint Infection conditions: Knee Infection conditions: Arthroplasty Complications conditions: Joint Infection conditions: Arthroplasty, Replacement, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 153 type: ESTIMATED name: All-cement articulating spacer name: Durable, real-component articulating spacer name: Rigid Spacer measure: 24 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 week Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 week 10-item PROMIS Global Health survey (PROMIS-10) measure: 6 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 6 month 10-item PROMIS Global Health survey (PROMIS-10) measure: 12 month Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: 12 month 10-item PROMIS Global Health survey (PROMIS-10) measure: 24 month 10-item PROMIS Global Health survey (PROMIS-10) measure: Revision/reoperation for infection (defined by positive culture by MSIS criteria) measure: revision for aseptic failure (defined by negative culture by MSIS criteria) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine city: Chicago state: Illinois zip: 60611 country: United States name: Orthopaedic Surgery Research role: CONTACT phone: 312-695-0332 email: orthosurveys@nm.org name: Adam I Edelstein, MD role: PRINCIPAL_INVESTIGATOR name: Kevin D Hardt, MD role: SUB_INVESTIGATOR name: Linda I Suleiman, MD role: SUB_INVESTIGATOR name: David W Manning, MD role: SUB_INVESTIGATOR name: William C Thomas, MD role: SUB_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
nctId: NCT06293339 id: CoGA-Re briefTitle: Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2025-05-31 date: 2024-03-05 date: 2024-03-05 name: Leiden University Medical Center class: OTHER briefSummary: This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606) conditions: Malaria,Falciparum studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 14 type: ESTIMATED name: CHMI with 3D7 malaria measure: Protective efficacy measure: Time to parasitaemia measure: Humoral immune responses after homologous CHMI rechallenge measure: Cellular immune responses after homologous CHMI rechallenge sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
nctId: NCT06293326 id: 22553 briefTitle: A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants overallStatus: RECRUITING date: 2024-03-06 date: 2024-06-06 date: 2024-06-06 date: 2024-03-05 date: 2024-04-19 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).
As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned. conditions: Heartburn conditions: Indigestion conditions: Stomach Acid Related Symptoms conditions: Nocturnal Stomach Acid Related Symptoms conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: bi-layer calcium carbonate tablet (BAY1180654) name: Immediate release calcium carbonate tablet (BAY1180654) measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. measure: Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 8h post-dose during night-time comparing the bi-layer tablet and standard comparator measure: Percentage of total time gastric pH is above pH 3.5 from time of dosing until 6h post-dose during daytime comparing the bi-layer tablet and standard comparator. measure: Change in mean gastric pH measure: Gastrointestinal tract location using scintigraphic images. measure: Initial radiolabel release time, using scintigraphic images measure: Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images. measure: Complete radiolabel release time, using scintigraphic images measure: Gastric emptying kinetics of the dispersed radiolabeled material (t50% and t90%) of each formulation will be determined quantitatively via analysis of the scintigraphic images. measure: Participant questionnaire sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BDD Pharma Bio-imaging Unit status: RECRUITING city: Glasgow zip: G4 0SF country: United Kingdom lat: 55.86515 lon: -4.25763 hasResults: False
nctId: NCT06293313 id: Inonu-SBF-SO-03 briefTitle: The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level overallStatus: RECRUITING date: 2024-02-28 date: 2024-04-28 date: 2024-08-28 date: 2024-03-05 date: 2024-03-05 name: Inonu University class: OTHER briefSummary: The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test. conditions: Dysmenorrhea conditions: Anxiety conditions: Anxiety Disorders and Symptoms conditions: Pain, Menstrual studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of two groups, a control group and a experimental group wo mindfulness group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The determination of which university would be included in the control and experimental groups in the research was made through a randomization method. The selection was done blindly by an independent academician unrelated to the research. As a result of the randomization, the control group and the experimental groups. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Mindfulness training name: Will not be given any application measure: VAS Pain Scale measure: State and Trait Anxiety Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bartin University status: RECRUITING city: Bartın zip: 74001 country: Turkey name: Simge Öztürk, Ph.D role: CONTACT phone: 05398751788 email: sozturk@bartin.edu.tr lat: 41.63583 lon: 32.3375 hasResults: False
nctId: NCT06293300 id: 20231056 id: HT94252310608 type: OTHER_GRANT domain: Department of Defense Awarding Office: U.S. Army Medical Research Acquisition Activity (USAMRAA) briefTitle: Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A) overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-30 date: 2026-08-30 date: 2024-03-05 date: 2024-04-24 name: University of Miami class: OTHER name: United States Department of Defense briefSummary: The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: BoNT A measure: Change in photophobia measured by Numerical Rating Scale measure: Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) measure: Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8) measure: Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye). measure: Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25) measure: Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS) measure: Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6 measure: Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5) measure: Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI) measure: Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST) measure: Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Mariela Aguilar, PhD role: CONTACT phone: 305-326-6069 email: maguilar1@miami.edu name: Anat Galor, MD/MSPH role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False
nctId: NCT06293287 id: DJ-2023-02 briefTitle: Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy overallStatus: RECRUITING date: 2024-01-31 date: 2024-11-30 date: 2025-01-30 date: 2024-03-05 date: 2024-03-08 name: Zhongshan Hospital (Xiamen), Fudan University class: OTHER briefSummary: The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure conditions: Radial Artery Occlusion studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 156 type: ESTIMATED name: Subcutaneous enoxaparin sodium name: Placebo measure: RAO rate after 24 hours and 21days sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University (Xiamen Branch) status: RECRUITING city: Xiamen state: Fujian zip: 361015 country: China name: BoHeng Zhang, PHD role: CONTACT phone: 0592-3501990 email: zhang.boheng@zs-hospital.sh.cn lat: 24.47979 lon: 118.08187 hasResults: False
nctId: NCT06293274 id: sdilek5 briefTitle: The Importance of Discharge Education for Mommy Blues overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-30 date: 2024-05-30 date: 2024-03-05 date: 2024-03-22 name: Kocaeli University class: OTHER briefSummary: The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.
The sample size of the study was calculated using the G\*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G\*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up. conditions: Postpartum Sadness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Discharge training measure: Motherhood Sadness Scale measure: Edinburgh Postnatal Depression Scale - EPDS sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Sena Dilek Aksoy, Ph.D. role: CONTACT phone: +902623034739 email: sena.dilek@kocaeli.edu.tr name: Resmiye Ozdilek, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 39.62497 lon: 27.51145 hasResults: False
nctId: NCT06293248 id: 77979112 briefTitle: Music Application in Patients Undergoing Percutaneous Coronary Intervention overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-10 date: 2023-12-31 date: 2024-05-31 date: 2024-03-05 date: 2024-03-12 name: Kocaeli University class: OTHER briefSummary: This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used. conditions: Healthy conditions: Nurse's Role conditions: Patient Satisfaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single (Participant) whoMasked: PARTICIPANT count: 210 type: ESTIMATED name: musical application measure: Means of subjective pain scores measure: Means of body temperature (0C) measure: Means of systolic blood pressure (mmHg) measure: Means of diastolic blood pressure (mmHg) measure: Means of heart rate (/minutes) measure: Means of respiratory rate (/minutes) measure: Means of oxygen saturation (%) measure: Means of subjective anxiety scores measure: Means of Perianesthesia Comfort Scale Scores measure: Means of Patient Satisfaction Survey on Nursing Care Quality Scores sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli University Hospital city: Kocaeli state: Umuttepe Campus, İzmit zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False