hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06306521 id: 20235517 briefTitle: An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing acronym: BeginNGS overallStatus: RECRUITING date: 2024-02-29 date: 2029-02 date: 2029-02 date: 2024-03-12 date: 2024-03-12 name: Rady Pediatric Genomics & Systems Medicine Institute class: OTHER briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are:
Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test. conditions: Genetic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 10000 type: ESTIMATED name: BeginNGS Test measure: Comparison of the clinical utility of BeginNGS and standard of care (state NBS), defined by the proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention measure: Utility secondary outcome 1 measure: Utility secondary outcome 2 measure: Utility secondary outcome 3 measure: Utility secondary outcome 4 measure: Utility secondary outcome 5 measure: Utility secondary outcome 6 measure: Utility secondary outcome 7 measure: Utility secondary outcome 8 measure: Utility secondary outcome 9 measure: Utility secondary outcome 10 measure: Acceptability outcome 1 measure: Acceptability outcome 2 measure: Acceptability outcome 3 measure: Acceptability outcome 4 measure: Feasibility (ability of the study to be undertaken as designed) outcome 1 measure: Feasibility (ability of the study to be undertaken as designed) outcome 2 measure: Feasibility (ability of the study to be undertaken as designed) outcome 3 measure: Feasibility (ability of the study to be undertaken as designed) outcome 4 measure: Feasibility (ability of the study to be undertaken as designed) outcome 5 measure: Cost effectiveness outcome 1 measure: Cost effectiveness outcome 2 measure: Cost effectiveness outcome 3 measure: Cost effectiveness outcome 4 measure: Accuracy outcome 1 measure: Accuracy outcome 2 measure: Utility secondary outcome 11 measure: Feasibility outcome 6 measure: Feasibility outcome 7 measure: Utility secondary outcome 12 sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Rady Children's Hospital San Diego status: RECRUITING city: San Diego state: California zip: 92123 country: United States name: Lauren Olsen, MSN role: CONTACT phone: 858-576-1700 phoneExt: 228456 email: lolsen1@rchsd.org lat: 32.71533 lon: -117.15726 hasResults: False
nctId: NCT06306508 id: HUvbayraktaroglu briefTitle: Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis overallStatus: RECRUITING date: 2024-02-16 date: 2025-02-16 date: 2025-02-16 date: 2024-03-12 date: 2024-03-12 name: Halic University class: OTHER briefSummary: Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study. conditions: Cystic Fibrosis conditions: Cystic Fibrosis in Children studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED measure: Modified shuttle walk test (MST) measure: Forced expiratory volume at one second (FEV1) measure: Forced vital capacity (FVC) measure: Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC) measure: Peak expiratory flow (PEF) measure: Maximum inspiratory pressure (MIP) measure: Maximum expiratory pressure (MEP) measure: Physical Activity Questionnaire for Children (PAQ-C) measure: Munich physical fitness test (MFT) measure: Quadriceps strength measure: Handgrip strength measure: Cystic Fibrosis Questionnaire Revised (CFQ-R) measure: Parental Attitude Scale (PAS) measure: Parent Attitude Scale measure: Perceived Social Support Scale (PSS) measure: Breathlessness Beliefs Questionnaire (BBQ) sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: Haliç University status: RECRUITING city: Istanbul state: Eyup zip: 34060 country: Turkey name: Vildan Bayraktaroglu, PT, MSc role: CONTACT phone: (0212) 924 24 44 email: vildanbayraktaroglu@halic.edu.tr name: Seda Saka, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06306495 id: 26.01.2022/17 briefTitle: Insomnia, Physical Activity Level and Stress Level acronym: PA overallStatus: COMPLETED date: 2022-03-27 date: 2023-08-12 date: 2024-01-29 date: 2024-03-12 date: 2024-03-12 name: Halic University class: OTHER briefSummary: Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance. Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level. Research shows that college students face more sleep problems than the general public. Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes. The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group. Examining levels and other behavioral factors. The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022. It will be held online via Google Forms with students between the ages of 18-25. Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index. An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from people participating in the research. Statistical analysis of the data will be done with IBM SPSS 23.0 software. conditions: Sleep Initiation and Maintenance Disorders studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 473 type: ACTUAL name: International Physical Activity Survey measure: Prevalence of insomnia in university students measure: The effect of insomnia on physical activity level measure: The effect of insomnia on stress levels in university students measure: Effects of sleep hygiene on insomnia in university students sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Halic University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06306482 id: SBA 23/390 briefTitle: Determination of Posture in Patients With Restrictive and Obstructive Lung Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2025-03-07 date: 2026-03-07 date: 2024-03-12 date: 2024-03-12 name: Hacettepe University class: OTHER briefSummary: The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease. conditions: Lung Diseases, Obstructive conditions: Lung Diseases conditions: Postural; Defect studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Evaluation of horizontal alignment of the head anterior view measure: Evaluation of horizontal alignment of the trunk anterior view measure: Evaluation of horizontal alignment of the head lateral view measure: Evaluation of vertical alignment of the head lateral view measure: Evaluation of horizontal alignment of the trunk lateral view measure: Evaluation of vertical alignment of the trunk lateral view measure: Evaluation of horizontal asymmetry trunk in posterior view measure: Evaluation of scapulae measure: Posture measure: Functional exercise capacity measure: Respiratory Muscle Strength measure: Lung function measure: Dyspnea measure: Peripheral muscle strength measure: Lower extremity capacity measure: Energy expenditure measure: Balance and Fall risk measure: Tightness of muscle measure: Severity of disease for patients with COPD measure: Severity of disease for patients with bronchiectasis measure: Diffusion capacity for patients with diffuse parenchymal lung diseases measure: Symptoms for patients with COPD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aynur Demirel city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Aynur Demirel role: CONTACT phone: +905545295057 phoneExt: 178 email: aynur.demirel@hacettepe.edu.tr name: hidaye yamikan role: CONTACT phone: +905349898724 email: hidaye.yamikan@hacettepe.edu.tr name: hidaye yamikan role: SUB_INVESTIGATOR name: irem seleoglu role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
nctId: NCT06306469 id: PHRI-2022-1001 briefTitle: Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment overallStatus: COMPLETED date: 2022-07-02 date: 2022-07-09 date: 2024-01-11 date: 2024-03-12 date: 2024-03-12 name: Pranic Healing Research Institute class: OTHER briefSummary: The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.
This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 27 type: ACTUAL name: Meditation practice measure: Assessing the changes in gut and oral microbiome profile of the participants during retreat sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pranic Healing Research Institute city: Lyndhurst state: New Jersey zip: 07071 country: United States lat: 40.81204 lon: -74.12431 hasResults: False
nctId: NCT06306456 id: GH21C201 briefTitle: A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC overallStatus: RECRUITING date: 2024-02-06 date: 2025-12-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Suzhou Genhouse Bio Co., Ltd. class: OTHER briefSummary: This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations. conditions: Non-Small Cell Lung Cancer With EGFR Mutation studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: GH21+Osimertinib measure: Number of participants with dose limiting toxicities measure: Number of participants with adverse events measure: Progression-free survival (PFS) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Duration of response (DCR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Number of participants with adverse events measure: Plasma concentration (Cmax) measure: Time to achieve Cmax (Tmax) measure: Area under the plasma concentration-time curve (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Caicun Zhou, Doctorate role: CONTACT phone: 021-65115006 email: caicunzhoudr@163.com lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06306443 id: 20235453 briefTitle: Buprenorphine for Individuals in Jail overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-12 date: 2024-03-12 name: Friends Research Institute, Inc. class: OTHER briefSummary: This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: open label randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: extended-release buprenorphine (XR-B) measure: urine toxicology measure: days of opioid use measure: time to opioid relapse measure: retention in buprenorphine treatment measure: urine toxicology for other illicit substance use measure: days of illicit substance use measure: overdose events measure: PROMIS Patient-Reported Outcomes Measurement Information System - physical health measure: PROMIS Patient-Reported Outcomes Measurement Information System - mental health measure: HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score measure: HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score measure: criminal activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Friends Research Institute city: Baltimore state: Maryland zip: 21201 country: United States lat: 39.29038 lon: -76.61219 facility: Baltimore Central Booking & Intake Center city: Baltimore state: Maryland zip: 21202 country: United States name: Michael Gordon, DPA role: CONTACT phone: 410-837-3977 phoneExt: 251 email: mgordon@friendsresearch.org name: Thomas R Blue, PhD role: CONTACT phone: 4108373977 email: tblue@friendsresearch.org lat: 39.29038 lon: -76.61219 hasResults: False
nctId: NCT06306430 id: uLAM TB FIA briefTitle: Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis acronym: uLAMTBFIA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-10 date: 2024-03-12 date: 2024-03-12 name: Ospedale San Raffaele class: OTHER briefSummary: Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU). conditions: Tuberculosis conditions: Diagnoses Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 550 type: ESTIMATED name: STANDARDTM F TB LAM FIA measure: Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay measure: Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emerging Bacterial Pathogens Unit city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06306417 id: PKUTH TCM briefTitle: A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome overallStatus: RECRUITING date: 2023-09-28 date: 2025-04-30 date: 2025-08-30 date: 2024-03-12 date: 2024-03-12 name: Peking University Third Hospital class: OTHER briefSummary: To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients. conditions: Polycystic Ovary Syndrome (PCOS) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 144 type: ESTIMATED name: lifestyle intervention name: acupuncture name: Sham acupuncture measure: HOMA-IR measure: Hirsutism(FG score >4）, acne and early alopecia measure: AUC insulin measure: Follicle stimulating hormone (FSH) measure: luteinizing hormone (LH) measure: Progestin (P) measure: Estrogen (E2) measure: Prolactin (PRL) measure: Androgen(T) measure: Anti-mullerian hormone (AMH) measure: Sex hormone-binding globulin (SHBG) measure: Free testosterone index (FAI) measure: total cholesterol measure: triglycerides measure: high density lipoprotein (HDL) measure: low density lipoprotein (LDL) measure: Bile acidomics measure: Metagenomics and 16S rDNA sequencing analysis measure: short form-36 (SF36) measure: Self-Rating Anxiety Scale (SAS) measure: Self-Rating Depress Scale (SDS) measure: polycystic ovary syndrome questionnaire, PCOSQ measure: BMI measure: Fat% measure: waist to hip ratio(WHR) measure: glycosylated hemoglobin level measure: ovarian size measure: number of follicles measure: uterine size measure: endometrial thickness sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Peking University third hospital status: RECRUITING city: Beijing country: China name: Haolin Zhang, PHD role: CONTACT phone: +8615611963539 email: zoe@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06306404 id: NL86165.100.24 briefTitle: Improving Sleep and Mood in the Peri-menopause overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-06-01 date: 2028-06-01 date: 2024-03-12 date: 2024-03-12 name: VU University of Amsterdam class: OTHER name: ZonMw: The Netherlands Organisation for Health Research and Development name: Netherlands Brain Foundation name: Purplexus briefSummary: The perimenopause is known as a vulnerable period for some women, with noticeable somatic and psychological issues. Aside from climacteric symptoms, insomnia and depression are common. About half of women during the peri-menopausal period experience sleep problems like problems falling asleep, awakening during the night and being unable to return to sleep. This is often attributed to vasomotor symptoms, but this is not the only reason of poor sleep (Joffe et al., 2010). Also, the peri-menopausal period is a critical time for the occurrence of new onset and recurrent depressions (Cohen et al., 2006). It has been suggested that fluctuations in estradiol may increase the risk for depression by altering neuronal functions in the brain. But there are also indications that the risk for depression increases by indirect effects, such as the increase in insomnia. Poor sleep has increasingly been recognized as the key modifiable factor affecting mental issues like depression (Van Someren, 2021). While antidepressants and psychotherapies continue to be the treatments of choice for depression, and Cognitive Behavioral Therapy for sleep (CBTi) for insomnia, preclinical and clinical data support the benefits of estrogen-based therapies to improve mood, sleep and other menopause-related symptoms (Gordon et al. 2018). Transdermal estradiol patches, which provide a stable release of estradiol and lead to more stable blood levels, have been suggested to have a positive effect on sleep (Joffe et al., 2020) and depressive symptoms (Gordon et al., 2018) in randomized controlled trials. However, it is currently unclear if the relation between improvement in mood and estradiol patches is mediated by improvement in sleep problems, and if the effect of estradiol patches on sleep problems is more effective during peri-menopause than the current evidence-based sleep interventions of CBTi, preferably in combination with Circadian Rhythm Support (CRS). The aim of the study is to pinpoint the determinants of complaints about sleep and mood and how they respond to Menopausal Hormone Treatment (MHT) with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS.
Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch.
The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS. conditions: Menopause conditions: Insomnia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 222 type: ESTIMATED name: Estrogens and Progestogens name: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy measure: The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline). sex: FEMALE minimumAge: 40 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
nctId: NCT06306391 id: IMIMFCTL/NLX_1 briefTitle: Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. overallStatus: RECRUITING date: 2024-03-05 date: 2024-09 date: 2024-09 date: 2024-03-12 date: 2024-03-15 name: Parc de Salut Mar class: OTHER name: Food and Drug Administration (FDA) briefSummary: This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Intravenous naloxone name: Intranasal naloxone measure: Effects of naloxone on heart rate (HR). measure: Effects of naloxone on systolic and diastolic blood pressure (BP). measure: Effects of naloxone on plasma cortisol at visit 1 and visit 4. measure: Adverse effects. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: IMIM (Hospital del Mar Medical Research Institute) status: RECRUITING city: Barcelona zip: 08003 country: Spain name: Rafael De la Torre Fornell, PharmD, PhD role: CONTACT phone: 00343160780 phoneExt: 1780 email: rtorre@imim.es lat: 41.38879 lon: 2.15899 hasResults: False