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Researchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects:
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* V'O2-adjusted lactate at rest and during exercise
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* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids conditions: Metabolic Syndrome conditions: Dialysis; Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross-sectional comparative study with repeated measures primaryPurpose: BASIC_SCIENCE masking: NONE count: 42 type: ESTIMATED name: Exercise test name: Blood sample name: Impedancemetry measure: Compare V'O2-adjusted plasma lactate profile at rest and during exercise (metabolic stress test), between chronic renal failure patients, patients with metabolic syndrome and healthy subjects. measure: Compare between the 3 groups their metabolic profile (Krebs cycle cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (ß-oxidation cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (amino acids) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (acyl-carnitine profiles) adjusted to V'O2 at rest and during exercise. measure: Anthropometry Comparison between the 3 groups sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie city: Montpellier zip: 34295 country: France name: Jean-Paul CRISTOL, Prof role: CONTACT phone: +33(0)4 67 33 83 15 email: [email protected] lat: 43.61092 lon: 3.87723 facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06360289 id: ALN-TTR-NT-003 briefTitle: Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-11 date: 2024-04-11 name: Alnylam Pharmaceuticals class: INDUSTRY briefSummary: This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy. conditions: Hereditary Amyloidosis, Transthyretin-Related conditions: Asymptomatic Carrier State studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Standard of Care measure: NfL Levels in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline measure: Change in NfL Levels Over Time in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy measure: Correlation Between the NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy at Baseline measure: Correlation Between the Change in NfL Levels and Various Biological and Clinical Activity Parameters in Asymptomatic Carriers of a TTR Variant and Symptomatic hATTR Patients With Polyneuropathy measure: Comparison of the Measured NfL Levels to the Normal Levels Expected to be Seen in the General Population by Using the Existing Reference Ranges and Databases measure: Time to Onset of Active Disease in Asymptomatic Carriers of TTR Variants measure: Disease Progression in Symptomatic hATTR Amyloidosis Patients with Polyneuropathy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Universitaire (CHU) Le Kremlin-Bicêtre Assistance Publique-Hôpitaux de Paris (APHP) city: Paris state: Île-de-France zip: 94270 country: France lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06360276 id: 14012021 briefTitle: Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy overallStatus: COMPLETED date: 2022-03-14 date: 2022-08-02 date: 2022-08-12 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.
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Hypotheses for research:
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1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
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2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.
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A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping. conditions: Fatigue conditions: Coping Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Seated Exercises name: Psychoeducational Rehabilitation name: Routine Care measure: Piper Fatigue Scale measure: Mini-Mental Adjustment to Cancer Scale sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Nursing city: Alexandria zip: 56321 country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06360263 id: #1-6/2023 briefTitle: OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT overallStatus: RECRUITING date: 2023-07-11 date: 2024-08 date: 2024-08 date: 2024-04-11 date: 2024-04-11 name: Esraa Salem Kamal class: OTHER briefSummary: Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement. conditions: Bone Loss, Alveolar studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Densah bur in combination with activated plasma albumin gel measure: Postoperative pain measure: Implant stability measure: Vertical bone height gain measure: Bone density around implant sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University status: RECRUITING city: Alexandria country: Egypt name: Esraa S Kamal, BDS role: CONTACT phone: 106 054 3345 phoneExt: +20 email: [email protected] lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06360250 id: B2001-F20220601 briefTitle: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-10-30 date: 2024-10-30 date: 2024-04-11 date: 2024-04-11 name: Changchun BCHT Biotechnology Co. class: INDUSTRY name: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine name: Anning City First People's Hospital briefSummary: To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation conditions: Clostridium Tetanus studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 190 type: ESTIMATED name: Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation name: Tetanus human immunoglobulin (HTIG) name: Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo name: Adsorbed tetanus vaccine (TT) measure: Safety evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PK evaluation index measure: PD evaluation index measure: PD evaluation index measure: PD evaluation index measure: Immunogenicity evaluation index sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06360237 id: ISIS 678354 briefTitle: Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) overallStatus: AVAILABLE date: 2024-04-11 date: 2024-04-11 name: Ionis Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS). conditions: Familial Chylomicronemia Syndrome studyType: EXPANDED_ACCESS name: Olezarsen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360224 id: CASES briefTitle: Collect Flow and Ultrasound Images of Coronary Bypass Grafts acronym: CASES overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2029-05-15 date: 2029-05-15 date: 2024-04-11 date: 2024-04-11 name: Medistim ASA class: INDUSTRY briefSummary: This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG). conditions: Cardiac Bypass Surgery (CABG) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: MiraQ systems with Transit Time Flow Measurement (TTFM) and High Frequency Ultrasound (HFUS) probes measure: Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360211 id: 22251 briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-04-17 date: 2024-06-11 date: 2024-06-11 date: 2024-04-11 date: 2024-04-22 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations.
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Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer.
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In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations.
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BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
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Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.
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The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:
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* Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time
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* Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood
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The study will have 3 treatment periods:
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Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088
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Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.
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Participants will visit the study clinic:
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* More than/at least once, within 2 to 28 days before the treatment starts
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* Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment
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* Once, within 7 to 10 days after they finish treatment for a health checkup
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During the study, the doctors and their study team will:
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* do physical examinations
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* collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088
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* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
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* ask the participants questions about how they are feeling and what adverse events they are having
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An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: BAY2927088 name: Midazolam measure: Cmax of midazolam when given with and without BAY2927088 measure: AUC of midazolam when given with and without BAY2927088 measure: Number of participants with TEAEs measure: Severity of TEAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06360198 id: 2022-874/08 briefTitle: The Relationship Between Posture, Sense of Position, Musculoskeletal Discomfort and Anxiety overallStatus: COMPLETED date: 2022-06-30 date: 2022-11-30 date: 2022-12-30 date: 2024-04-11 date: 2024-04-11 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: It is known that posture is affected by various factors such as somatosensation, visual perception and cognition. In addition, it is also thought to affect conditions such as stress and anxiety through receptors. The aim of this study was to investigate the relationship between postural changes such as thoracic kyphosis, musculoskeletal problems, trunk position sense and anxiety in young individuals who were asymptomatic in terms of musculoskeletal problems. conditions: Kyphosis Postural Thoracic conditions: Proprioception conditions: Musculoskeletal System conditions: Anxiety studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 67 type: ACTUAL name: No intervention measure: Throcic Kyphosis measure: Trunk Position Sense measure: Musculoskeletal Discomfort measure: Anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06360185 id: Asthma V2 October 2023 briefTitle: Retrospective Study of Patients With Acute Presentation for Asthma to an Emergency Department in UK (RAPAE) acronym: RAPAE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-11 date: 2024-04-11 name: Norfolk and Norwich University Hospitals NHS Foundation Trust class: OTHER briefSummary: Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records. conditions: Asthma Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED measure: Change in body weight measure: Change in body height sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360172 id: 3-2024 briefTitle: The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2024-06-01 date: 2024-06-15 date: 2024-04-11 date: 2024-04-11 name: Alexandria University class: OTHER briefSummary: Motivational interviewing, or MI, is a collaborative, person-centered counseling technique to uncover and enhance a person\'s motivation for behavior change . MI was first created for the treatment of substance dependence, but it has since been successfully implemented in several fields, including healthcare and education (. Given the vital role that nursing students play in the healthcare system, Saudi Arabia, like many other nations, has realized how important it is to improve the motivation and well-being of its nursing students conditions: Nursing Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Motivational Interviewing measure: Kernis-Goldman Authenticity Inventory measure: The Life Orientation Test-Revised form for Adolescents measure: Academic Motivation Scale sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Alexandria university city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False
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<|newrecord|> nctId: NCT06360159 id: Massage on Newborns briefTitle: Massage for Newborns Receiving Nasal CPAP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-05-15 date: 2026-05-15 date: 2024-04-11 date: 2024-04-15 name: Sultan Besiktas class: OTHER briefSummary: One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.
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Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP. conditions: Massage conditions: Stress conditions: Newborn conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher.
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Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Intervention measure: Stress Level measure: Salivary Cortisol Level measure: Comfort Score measure: Bilirubin Level measure: Nutrient ıntake amount measure: Abdominal Circumference Measurement measure: Defecation Frequency sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06360146 id: 120685123 briefTitle: Early Mobilisation of Post Cardiac Surgery in Geriatrics. overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2023-06-01 date: 2024-06-01 date: 2024-04-11 date: 2024-04-11 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.
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Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.
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After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.
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A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).
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Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE maskingDescription: Single count: 100 type: ESTIMATED name: Early mobilisation measure: International Physical Activity Questionnaire measure: Two Minute Walking Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: İsmail Ceylan city: Kırşehir state: Merkez zip: 40100 country: Turkey lat: 39.14583 lon: 34.16389 hasResults: False
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<|newrecord|> nctId: NCT06360133 id: VVN001-CCS-301 briefTitle: Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-11 date: 2024-04-11 name: VivaVision Biotech, Inc class: INDUSTRY briefSummary: This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease. conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 700 type: ESTIMATED name: VVN001 Ophthalmic Solution, 5% name: VVN001 Ophthalmic Solution, Vehicle measure: Corneal Fluorescein Staining measure: Eye Dryness sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eye & Ent Hospital of Fudan University city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06360120 id: 00023098816 briefTitle: Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke overallStatus: RECRUITING date: 2024-04-10 date: 2025-04-10 date: 2025-05-10 date: 2024-04-11 date: 2024-04-11 name: Kafrelsheikh University class: OTHER briefSummary: Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Our study was single-blinded to the investigators; an independent statistician generated a computer-generated randomization chart with a block size of four in a one-to-one ratio, and participants were randomly assigned to receive either atorvastatin or rosuvastatin by a specially trained and qualified nurse. None of the investigators included in the study knew the patients' assignments. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included atorvastatin bills, and Drug B included rosuvastatin bills. The statistical analysis was performed by an independent statistician. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Atorvastatin 40 Mg Oral Tablet name: Rosuvastatin 20mg measure: the rate of new stroke at 90 days measure: Value of National Institute of Health Stroke Scale (NIHSS) after one week measure: value of Modified Rankin Scale (mRS) at one week measure: value of Modified Rankin Scale(mRS) at three months measure: rate of composite recurrent stroke, myocardial infarction, and death due to vascular events measure: rate of drug adverse effects measure: Drug adverse effects: all side effects related to the drugs of our study will be reported sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafr Elsheikh University Hospital status: RECRUITING city: Kafr Ash Shaykh zip: 33511 country: Egypt name: mohamed G. Zeinhom, MD role: CONTACT phone: 2001009606828 email: [email protected] lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06360107 id: 76729 briefTitle: RCT of a Brief Video Intervention Targeting Peer Inclusion to Reduce Depression-related Stigma in Adolescents overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-11 date: 2024-04-11 name: New York State Psychiatric Institute class: OTHER name: Columbia University briefSummary: The goal of this study is to test the efficacy of a brief video intervention emphasizing peer inclusion on depression-related stigma and stigma outcomes (e.g., help seeking attitudes, secrecy) among adolescents 14-18.
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Timely identification and treatment of depression in adolescents is a public health priority. However, most youth with depression do not seek treatment, and stigma has been identified as the primary barrier to help-seeking. Experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing depression-related stigma and increasing help-seeking among adolescents. However, given the extreme time constraints of these videos, optimizing the messaging is paramount. Prior research has indicated that concerns about peer social inclusion are fundamental in shaping stigma among adolescents.
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In this 3-arm RCT, we will recruit adolescents aged 14-18 using an online crowdsourcing platform, to test the efficacy of a) standard BVI that addresses mental health treatment but does not address concerns about peer inclusion/exclusion, b) novel BVI focused on mental health treatment and peer inclusion, and c) control condition that provides information without social contact. conditions: Depression conditions: Adolescent - Emotional Problem conditions: Stigma, Social conditions: Help-Seeking Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 650 type: ESTIMATED name: brief video measure: Depression Stigma Scale (modified) measure: Ultra-brief Self-stigma of Help-Seeking measure: Adolescent Stigma Scale (modified) sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: New York State Psychiatric Institute city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06360094 id: 1490-0004 id: 2023-510249-79-00 type: REGISTRY domain: CTIS id: U1111-1301-1311 type: REGISTRY domain: WHO Registry (ICTRP) briefTitle: A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-07-27 date: 2025-07-21 date: 2025-08-06 date: 2024-04-11 date: 2024-04-11 name: Boehringer Ingelheim class: INDUSTRY briefSummary: Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.
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Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.
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During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Idiopathic Pulmonary Fibrosis conditions: Progressive Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 230 type: ESTIMATED name: BI 1839100 name: Placebo measure: IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h) measure: IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h) measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score measure: IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm) measure: IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h) measure: IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL) measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score measure: IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm) measure: IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score measure: IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360081 id: 1479-0019 id: 2023-510495-31-00 type: OTHER domain: CTIS id: U1111-1303-4345 type: OTHER domain: WHO briefTitle: A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-06-24 date: 2024-06-24 date: 2024-04-11 date: 2024-04-11 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Zongertinib measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72h (AUC0-72h) measure: Maximum measured concentration of the analyte in plasma (Cmax) measure: Time from dosing to maximum measured concentration of the analyte in plasma (tmax) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06360068 id: SLE-SASP POC id: 82371767 type: OTHER_GRANT domain: National Natural Science Foundation of China briefTitle: A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-05-01 date: 2025-05-01 date: 2024-04-11 date: 2024-04-11 name: Qiong Fu class: OTHER briefSummary: The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:
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Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?
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Participants will:
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Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.
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Visit the clinic once every 4 weeks for checkups and tests. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Sulfasalazine Tablets measure: the change of disease activity (SLEDAI score) measure: the number of patients who can reach SRI-4 measure: the change of prednisone dosage measure: the change of interferon stimulating genes (ISG) expression sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360055 id: M2024130 briefTitle: Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2024-12-31 date: 2024-04-11 date: 2024-04-11 name: Peking University Third Hospital class: OTHER briefSummary: The aim of this study is to investigate the effects of oral D-mannose tablets for 2 consecutive weeks on the pharmacokinetics of dabigatrun etexilate, a P-glycoprotein probe substrate drug, in healthy adults conditions: Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Dabigatran Etexilate name: D-mannose measure: Plasma concentration of dabigatran measure: Serum concentrations of glycoomics such as D-mannose sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Cheng Cui role: CONTACT email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06360042 id: MA-HCC-II-021 briefTitle: Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC overallStatus: RECRUITING date: 2024-01-01 date: 2027-03-31 date: 2028-03-31 date: 2024-04-11 date: 2024-04-22 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC. conditions: Unresectable Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 111 type: ESTIMATED name: Adebrelimab plus Apatinib name: Adebrelimab plus Bevacizumab name: Camrelizumab plus Apatinib measure: 12-month overall survival rate measure: ORR measure: DCR measure: DoR measure: TTR measure: TTP measure: PFS measure: OS measure: safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Jun Zhou role: CONTACT phone: 13366152815 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06360029 id: LvL UP briefTitle: The LvL UP Pilot Trial overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2024-06 date: 2024-04-11 date: 2024-04-17 name: Singapore ETH Centre class: OTHER name: ETH Zurich name: National University of Singapore name: Nanyang Technological University briefSummary: Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.
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LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.
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The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:
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1. What are the intervention's preliminary, short-term effects? What is the intervention's level of engagement? What is the number of dropouts? What is the percentage of missing data? What is the intervention's responder / non-responder rate after week 4? How easy was to recruit the target sample size and which channels worked best?
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