hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06372249 id: 22-249 id: 2U54MD012388-06 type: NIH link: https://reporter.nih.gov/quickSearch/2U54MD012388-06 briefTitle: A Clinical Trial of Soluble Fiber for Asthma overallStatus: RECRUITING date: 2024-04-02 date: 2027-04 date: 2027-04 date: 2024-04-17 date: 2024-04-17 name: Phoenix Children's Hospital class: OTHER name: Northern Arizona University name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet. conditions: Asthma in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: NOVELOSETM 3490 measure: Alpha diversity. measure: Asthma control. measure: Gut microbiome composition. measure: Nasal inflammatory response. measure: Quantification of circulating short chain fatty acids. sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Phoenix Children's status: RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States name: Destiny Ogbeama role: CONTACT lat: 33.44838 lon: -112.07404 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-04-02T16:19 filename: Prot_SAP_000.pdf size: 285020 hasResults: False
nctId: NCT06372223 id: SPH5030-102 briefTitle: A Food Effect Study of SPH5030 Tablets. overallStatus: COMPLETED date: 2024-03-04 date: 2024-03-25 date: 2024-03-25 date: 2024-04-17 date: 2024-04-17 name: Shanghai Pharmaceuticals Holding Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: SPH5030 name: SPH5030 measure: Peak Plasma Concentration (Cmax) measure: Peak time（Tmax） measure: Area under the plasma concentration versus time curve (AUC) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second Hospital ,Sichuan University city: Chengdu country: China lat: 30.66667 lon: 104.06667 hasResults: False
nctId: NCT06372210 id: 031-201-00521 briefTitle: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion overallStatus: COMPLETED date: 2023-06-26 date: 2023-07-19 date: 2023-07-19 date: 2024-04-17 date: 2024-04-17 name: Otsuka Pharmaceutical Development & Commercialization, Inc. class: INDUSTRY briefSummary: The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch. conditions: Mental Disorder conditions: Schizophrenia conditions: Major Depressive Disorder conditions: Bipolar I Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 54 type: ACTUAL name: Placebo IEM tablet name: Abilify MyCite® name: D-Tect Patch measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch measure: Cohort 1 and 2: Patch Detection Latency Period measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period measure: Cohort 1 and 2: Total Detection Latency Period measure: Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research site city: Garden Grove state: California zip: 92845 country: United States lat: 33.77391 lon: -117.94145 hasResults: False
nctId: NCT06372197 id: LIGPATD briefTitle: Low-Income Group Psilocybin Assisted Therapy for Depression acronym: LIGPATD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2024-08 date: 2024-10 date: 2024-04-17 date: 2024-04-17 name: Matthew Hicks class: OTHER briefSummary: Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population.
Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview.
Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment.
The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Psilocybin measure: Recruitment Feasibility measure: Retention Feasibility measure: Acceptability measure: Preliminary Safety and Tolerability: incidence and severity of adverse events measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) measure: Altered State of Consciousness rating scale (11-ASC) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06372184 id: WMT-AR-RCT briefTitle: Washed Microbiota Transplantation for Allergic Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2029-10-01 date: 2024-04-17 date: 2024-04-17 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR. conditions: Rhinitis, Allergic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Washed Microbiota Transplantation name: Placebo measure: Changes in the reflective total nasal symptom score (rTNSS) measure: Changes in the combined symptoms and medication score (CSMS) measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score measure: Changes in the single reflective nasal symptoms score measure: Specific IgE measure: Inflammatory factors measure: Flow cytometric analysis of lymphocyte clusters measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 measure: Changes in the Modified Lund-Kennedy endoscopic score measure: The changes in composition and metabolites of gut microbiota and nasal microbiota sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD,PhD role: CONTACT phone: 086-25-58509883 email: fzhang@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False
nctId: NCT06372171 id: NYCU112182AEF briefTitle: Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Satge 1 name: Stage 2 measure: General examination measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
nctId: NCT06372158 id: NYCU112181AE briefTitle: Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism overallStatus: RECRUITING date: 2024-04-08 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements. conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Stage 1 name: Stage 2 measure: General examination measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112 country: Taiwan name: ChienYu Huang, Bachelor role: CONTACT phone: +886-955-879163 email: chienyu.ns11@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
nctId: NCT06372145 id: LTS17043 id: 2023-503631-18 type: REGISTRY domain: CTIS id: U1111-1287-6797 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. overallStatus: RECRUITING date: 2024-04-25 date: 2029-04-30 date: 2029-04-30 date: 2024-04-17 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).
SUBSTUDY: ToleDYNAMIC substudy conditions: Relapsing Multiple Sclerosis conditions: Secondary Progressive Multiple Sclerosis conditions: Progressive Relapsing Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 2500 type: ESTIMATED name: Tolebrutinib name: Placebo name: Teriflunomide measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs) measure: Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies measure: Annualized Relapse Rate (ARR) for RMS only measure: Number of new and/or enlarging T2-hyperintense lesions per year measure: Change from baseline in total volume of T2-hyperintense lesions measure: ToleDYNAMIC substudy Change from baseline in biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site Number : 0560005 status: RECRUITING city: Brugge zip: 8000 country: Belgium lat: 51.20892 lon: 3.22424 hasResults: False
nctId: NCT06372132 id: NL85305.068.23 briefTitle: G-POEM vs PEG-J in Gastroparesis Patients overallStatus: RECRUITING date: 2024-03-14 date: 2027-01 date: 2028-01-01 date: 2024-04-17 date: 2024-04-17 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.
Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point. conditions: Gastroparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: G-POEM measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months. measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months. measure: Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention. measure: Number and severity of (s)AEs in the treatment groups. measure: Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score. measure: Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Zuid-Limburg zip: 6229 HX country: Netherlands name: Kim Sweerts, MD role: CONTACT phone: 0883887298 email: kim.sweerts@maastrichtuniversity.nl lat: 50.84833 lon: 5.68889 hasResults: False
nctId: NCT06372119 id: 13/23/DD-BVMD briefTitle: Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-17 date: 2024-04-17 name: Mỹ Đức Hospital class: OTHER briefSummary: The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is:
Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe Femara® 2.5 milligrams (Novartis, Switzerland) at a dose of 5 milligrams/day for 5 days to stimulate follicular development and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day for luteal phase support. In contrast, the AC group will receive Valiera® 2 milligrams (Laboratories Recalcine, Chile) starting with a dose of 6 milligrams/day, up to a maximum dose of 12 milligrams/day) and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates. conditions: Embryo Transfer conditions: Irregular Menstruation conditions: Letrozole conditions: Hormone Replacement Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 480 type: ESTIMATED name: Letrozole-stimulated cycle strategy (LETS) name: Artificial cycle strategy (AC) measure: Live birth rate after one cycle of endometrial preparation measure: Positive pregnancy test after one cycle of endometrial preparation measure: Clinical pregnancy after one cycle of endometrial preparation measure: Ongoing pregnancy after one cycle of endometrial preparation measure: Multiple pregnancy after one cycle of endometrial preparation measure: Implantation rate after one cycle of endometrial preparation measure: Cycle cancellation rate measure: Ectopic pregnancy rate after one cycle of endometrial preparation measure: Threatened miscarriage rate before 12 weeks of gestation after one cycle of endometrial preparation measure: Early miscarriage rate after one cycle of endometrial preparation measure: Late miscarriage rate after one cycle of endometrial preparation measure: Gestational age at birth measure: Onset of labor measure: Mode of delivery measure: Very low birth weight measure: Low birth weight measure: High birth weight (macrosomia) measure: Very high birth weight (macrosomia) measure: Gestational diabetes (GDM) measure: Hypertensive disorders of pregnancy measure: Preterm birth measure: Stillbirth measure: Antepartum hemorrhage measure: Postpartum hemorrhage measure: Small for gestational age (singleton/twins) measure: Large for gestational age (singleton/twins) measure: Birth weight measure: Congenital anomalies measure: NICU admission measure: Reason for NICU admission measure: Neonatal mortality rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT hasResults: False