hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06332638 id: IN_APA_124 briefTitle: PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2024-07-31 date: 2024-07-31 date: 2024-03-27 date: 2024-03-27 name: HK inno.N Corporation class: INDUSTRY briefSummary: The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Tegoprazan 12.5mg name: Tegoprazan 25mg name: Famotidine 20mg measure: Cmax of tegoprazan and tegoprazan's metabolite M1 measure: AUC0-t of tegoprazan and tegoprazan's metabolite M1 measure: AUC0-∞ of tegoprazan and tegoprazan's metabolite M1 measure: Tmax of tegoprazan and tegoprazan's metabolite M1 measure: t1/2β of tegoprazan and tegoprazan's metabolite M1 measure: CL/F of tegoprazan measure: Vd/F of tegoprazan measure: Css,max of tegoprazan and tegoprazan's metabolite M1 measure: Css,min of tegoprazan and tegoprazan's metabolite M1 measure: Css,avg of tegoprazan and tegoprazan's metabolite M1 measure: AUCtau,ss of tegoprazan and tegoprazan's metabolite M1 measure: Tmax,ss of tegoprazan and tegoprazan's metabolite M1 measure: t1/2β,ss of tegoprazan and tegoprazan's metabolite M1 measure: CLss/F of tegoprazan measure: Vdss/F of tegoprazan measure: Accumulation index of tegoprazan measure: Fluctuation of tegoprazan measure: 24-hour, daytime and nighttime mean pH measure: 24-hour, daytime and nighttime median pH measure: 24-hour, daytime and nighttime TpH>3(%) measure: 24-hour, daytime and nighttime TpH>4(%) measure: 24-hour, daytime and nighttime Δ TpH>3(%) measure: 24-hour, daytime and nighttime Δ TpH>4(%) measure: 24-hour, daytime and nighttime Δ mean pH measure: 24-hour, daytime and nighttime Δ median pH sex: ALL minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: Inje University Busan Paik Hospital city: Busan zip: 47392 country: Korea, Republic of lat: 35.10278 lon: 129.04028 hasResults: False
3. A cross-sectional and longitudinal study at 7T: The added value of ultra-high-field Magnetic Resonance Imaging in leukoencephalopathies. conditions: Leukoencephalopathies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Brain quantitative magnetic resonance imaging measure: Quantitative Susceptibilty Mapping, QSM measure: Fractional Anisotropy, FA measure: Mean Diffusivity, MD measure: Relaxation times measure: Myelin water fraction, MWF measure: Neuromotor skills measure: Neuromotor skills measure: Epilepsy symptoms measure: Electroencephalography features measure: Neuro-psychological profile sex: ALL minimumAge: 0 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Associazione Oasi Maria SS Troina status: RECRUITING city: Troina state: Enna zip: 94018 country: Italy name: Maurizio Elia role: CONTACT lat: 37.78437 lon: 14.59605 facility: Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Cristina Baldoli role: CONTACT lat: 45.46427 lon: 9.18951 facility: Fondazione Istituto Neurologico Carlo Besta status: RECRUITING city: Milano zip: 20133 country: Italy name: Stefania Magri role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06332612 id: 8420224AROM briefTitle: Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial acronym: MROSF overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-12 date: 2024-03-27 date: 2024-03-27 name: Ziauddin University class: OTHER briefSummary: OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition conditions: Oral Submucous Fibrosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.
* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: It would be a single-blind, placebo-controlled design whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Metformin Hydrochloride name: betamethasone dipropionate name: Pentoxifylline measure: Cell Viability measure: Cytotoxicity measure: Morphological Changes Cell Shape measure: Morphological Change Cell Density measure: Morphological Change Extracellular Matrix (ECM) Structure measure: Cell Migration Assays measure: Cell Invasion Assays measure: Apoptosis Analysis measure: Assess Signaling pathway with optimal metformin concentration measure: Clinical Oral Mucosal Characteristics measure: Patient Burning sensation pain measure: Patient Mouth Opening sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ziauddin University city: Karachi state: Sindh zip: 74700 country: Pakistan name: Afifa Razi, FCPS OMFS role: CONTACT phone: +92 300 2247389 email: afifa.razi@zu.edu.pk name: Shumaila Usman, PhD role: CONTACT phone: +92 336 1882779 email: shumaila.usman@zu.edu.pk name: Afifa Razi, FCPS role: PRINCIPAL_INVESTIGATOR name: Shumaila Usman, PhD role: SUB_INVESTIGATOR name: Yamna Khurshid, PhD role: SUB_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False
nctId: NCT06332599 id: rjhy20240001 briefTitle: Minocycline for Helicobacter Pylori Rescue Treatment overallStatus: RECRUITING date: 2021-10-01 date: 2024-04-30 date: 2034-06-30 date: 2024-03-27 date: 2024-03-27 name: Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting. conditions: Helicobacter Pylori Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: BQT name: EBM4M4 name: EBM3M3 name: EBM2M4 name: EBM2M3 measure: Helicobacter pylori eradication rate measure: Rate of adverse effects measure: Compliance rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: None Selected zip: 200127 country: China name: Yu Huang role: CONTACT phone: 0198621791879 email: 15626211482@163.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06332586 id: 202311087RINA briefTitle: The Learning Effect of Applying Diversified Teaching in Emergency Injury Classification -Taking the Emergency Nurse of a Regional Hospital in Yunlin County as an Example overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2024-04-04 date: 2024-05-05 date: 2024-03-27 date: 2024-03-27 name: National Taiwan University Hospital class: OTHER briefSummary: "Triage" is the first process of emergency treatment. It is mainly based on the severity of the disease and the appropriate allocation of limited people, time, place, and medical resources. It is very important and related to the quality of medical care. In order to accurately judge the severity of patients, reduce the individual errors of artificial memory and increase the consistency of the judgment of triage levels, the new emergency five-level triage classification standard (Taiwan Triage and Acuity Scale) was implemented in 2010. , TTAS), the purpose is to allocate medical resources in the most appropriate manner at the appropriate time. It has been revised many times so far, so correct injury classification can maximize the safety of people's lives. This article reviews the relevant literature and finds that to have an efficient injury classification so that each patient receives appropriate medical allocation, an organized, effective and systematic injury inspection process structure is needed to enable the injury nurse to perform correct inspections. Injury skills and cognition should be actively promoted, and this policy must require traumatization nurses to continuously update their traumatization cognition and skills, and must also continue to conduct regular assessments and reviews to continuously improve the quality of traumatization grading by traumatization nurses. It can be seen that triage nurses must have skills, knowledge, attitudes and systems to improve the accuracy of triage levels and ensure the treatment of patients who need priority treatment . Therefore, this study can be used to understand the learning effectiveness of trauma care before and after diversified teaching, which can be used as a basis for teaching new trauma care nurses. conditions: Triage studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 22 type: ESTIMATED name: Diversified teaching measure: Improving the injury diagnosis ability of triage diagnosis nurses through diversified teaching sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Taiwan city: Taipei zip: Taiwan country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
nctId: NCT06332573 id: 24-06 briefTitle: Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer acronym: SEXOCARE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-12 date: 2024-03-27 date: 2024-03-27 name: Hôpital Européen Marseille class: OTHER briefSummary: Onco-sexology as a supportive care for patients treated for cancer is still rarely discussed or even non-existent in 2022. However, it's recommended to integrate the preservation of sexual health throughout the treatment and post-cancer process, given the impact of cancer, treatments and the importance of intimate life for a majority of patients.
Although sexuality is one of the fundamental needs of the human being, including in the case of a chronic disease or cancer diagnosis, the lack of training of health professionals to deal with intimate life, the difficulty to exchange on this subject between caregivers and patients, the lack of financial support for onco-sexology consultations, are all obstacles to the global management of oncology patients. However, it's a request from patients to be able to discuss the subject in an intimate way with a professional.
While onco-sexology is already recommended as supportive care, a study on the impact of the delay in the management of sexual difficulties on quality of life could provide a sufficient level of evidence to change the practices and the care pathway of the oncology patient. Our objective is to study whether early management in onco-sexology has an impact on quality of life compared to late management (ie onco-sexology consultation before vs. after introduction of systemic oncological treatment). conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 168 type: ESTIMATED name: Onco-sexology support name: Onco-sexology support measure: Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support measure: Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire measure: Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men) measure: Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men) measure: Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale ". measure: Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the "Body Image Scale". measure: Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care measure: Rate of patients expressing sexual difficulties during the consultation of announcement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Européen Marseille city: Marseille country: France name: Myriam BENNANI role: CONTACT phone: 0413428351 email: m.bennani@hopital-europeen.fr lat: 43.29551 lon: 5.38958 hasResults: False
nctId: NCT06332560 id: NL86247.091.24 briefTitle: Pain in Endometriosis And the Relation to Lifestyle acronym: PEARL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-05 date: 2024-03-27 date: 2024-03-27 name: Radboud University Medical Center class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development briefSummary: The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome.
Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Anti-inflammatory diet (DI) name: Cognitive behavioral therapy (CBT) measure: Change in Pain intensity assessed by the Numerical Rating Scale measure: Change in inflammatory characteristics in menstruum measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30 measure: Change in general Quality of Life assessed by the Short Form 36 measure: Change in the composition of vaginal and intestinal microbiome measure: Change in Objective stress assessed by measuring scalp hair cortisol levels measure: Adherence and anti-inflammatory status of the diet measure: Change in sleep quality assessed by the PSQI measure: Change in physical activity level assessed by the IPAQ-SF measure: Change in Subjective stress assessed by the Perceived Stress Scale measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale measure: Changes in pain cognitions assessed by the pain catastrophizing Scale measure: Changes in Fatigue assessed by the checklist individual strength measure: Anti-inflammatory diet rating sex: FEMALE minimumAge: 17 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud University Medical Center city: Nijmegen country: Netherlands name: E Huijs, B role: CONTACT name: A.W. Nap, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 hasResults: False
nctId: NCT06332547 id: TICVS briefTitle: Transfusion in Cardiac Valve Surgery acronym: TICVS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-30 date: 2027-12-30 date: 2024-03-27 date: 2024-03-27 name: Guangdong Provincial People's Hospital class: OTHER briefSummary: This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups. conditions: Cardiac Surgery With Cardiopulmonary Bypass conditions: Valve Heart Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1600 type: ESTIMATED name: Restrictive Transfusion Strategy name: Liberal Transfusion Strategy measure: A composite of postoperative morbidity and mortality measure: Rate of reoperation measure: Length of ICU Stays measure: Length of Postoperative Hospital Stay measure: Number of Blood Transfusion measure: Duration of mechanical ventilation measure: Postoperative thoracic fluid volume in the first 24 hours measure: Number of participants with postoperative atrial fibrillation measure: Number of participants with new-onset renal failure with dialysis measure: Number of participants with acute kidney injury measure: Number of participants with delirium measure: Hospitalization expense sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People's Hospital city: Guangzhou state: Guangdong zip: 510145 country: China name: Huang Huanlei, Phd role: CONTACT phone: 765 714 9765 email: hhuanlei@hotmail.com name: Huang huanlei, Phd role: PRINCIPAL_INVESTIGATOR name: Zhao Junfei, Phd role: PRINCIPAL_INVESTIGATOR name: He Biaochuan, Phd role: PRINCIPAL_INVESTIGATOR name: Zhang Zhaolong, BD role: PRINCIPAL_INVESTIGATOR name: Wang Zhenzhong, MD role: PRINCIPAL_INVESTIGATOR name: Wang Qiuji, MD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
nctId: NCT06332534 id: M14-671 briefTitle: Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-07-26 date: 2032-03-22 date: 2034-12-20 date: 2024-03-27 date: 2024-03-27 name: AbbVie class: INDUSTRY briefSummary: Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. conditions: Crohn's Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Upadacitinib measure: Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64 measure: Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12. measure: Number of Participants with Adverse Events measure: Achievement of clinical remission per PCDAI measure: Achievement of endoscopic response measure: Achievement of endoscopic remission measure: Achievement of clinical response per PCDAI measure: Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 measure: Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12 measure: Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
nctId: NCT06332521 id: 23CH296 id: ANSM type: OTHER domain: 2024-A00286-41 briefTitle: Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment acronym: BABYCRY_1000 overallStatus: RECRUITING date: 2024-03-20 date: 2029-04-01 date: 2029-04-01 date: 2024-03-27 date: 2024-04-26 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.