pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL
NCT Number: NCT06489808
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapsed/Refractory Large B-Cell Lymphoma
Interventions: DRUG: Linperlisib|DRUG: Rituximab|DRUG: Gemcitabine|DRUG: Oxaliplatin|DRUG: Ifosfamide|DRUG: Carboplatin|DRUG: Etoposide|DRUG: Dexamethasone|DRUG: Cisplatin|DRUG: Ara-C|DRUG: Vinorelbine|DRUG: Mitoxantrone hydrochloride liposome
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 89
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2027-05-31
Locations: Institute of Hematology & Blood Disease Hospital, Tianjin, Tianjin, 300020, China

Summary:
To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.

Primary Outcome Measures: Dose-Limiting Toxicities, Dose-Limiting Toxicities per study protocol defination, Safety Run-in Period, up to the end of cycle 1 (each cycle is 21 days)|ORR, Response is assessed according to the Lugano criteria, up to 2 years
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, The adverse events were evaluated by NCI-CTCAE 5.0 standard Hematologic and non-hematologic toxicity, up to 2 years|Complete Response Rate (CRR), Response is assessed according to the Lugano criteria, up to 2 years|Duration of Response (DOR), From the date of achieving complete or partial response until disease progression, death or last follow-up, up to 2 years|Duration of Complete Response (DOCR), From the date of achieving complete response until disease progression, death or last follow-up, up to 2 years|Progression-free Survival (PFS), From the date of the first dose of therapy is given until disease progression, death or last follow-up, up to 2 years|Overall Survival (OS), From the date of the first dose of therapy is given until death, irrespective of cause, up to 2 years
Developing a Novel Human Laboratory Paradigm for AUD Medication Screening
NCT Number: NCT06489782
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Use Disorder
Interventions: OTHER: Model 1|OTHER: Model 2
Sponsor: Yale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-15
Completion Date: 2026-06-30
Locations: Yale University, New Haven, Connecticut, 06510, United States

Summary:
The intent of the study is to develop two versions of the 'ability to resist' drinking model designed to screen Alcohol Use Disorder (AUD) medications.

Primary Outcome Measures: Alcohol consumption, Means mls of alcohol consumed during 120 minute alcohol self-administration sessions, 120 minutes
Highlanders With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Arterial Pressure (PAP) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)
NCT Number: NCT06489756
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Altitude Pulmonary Hypertension
Interventions: OTHER: Echocardiography
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Aksay Medical Center, Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

Summary:
The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live \>2500m on pulmonary arterial pressure (PAP) assessed at 3200 m.

Primary Outcome Measures: Change in Pulmonary Artery Pressure with SOT vs.ambient air at 3200m, Change in RV/RA in mmHg assessed by echocardiography with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen
Secondary Outcome Measures: Change in Cardiac Output with SOT vs. ambient air at 3200m, Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in right to left heart diameter ratio with SOT vs.ambient air at 3200m, Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs.ambient air at 3200m, Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in right atrial area with SOT vs. ambient air at 3200m, Change in right atrial area by echocardiography with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in right heart strain with SOT vs. ambient air at 3200m, Change in right heart strain by echocardiography with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in pH by arterial blood gases with SOT vs. ambient air at 3200m, Changes in pH by arterial blood gases with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in PaO2 by arterial blood gases with SOT vs. ambient air at 3200m, Changes in PaO2 by arterial blood gases with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen|Change in PaCO2 by arterial blood gases with SOT vs. ambient air at 3200m, Changes in PaCO2 by arterial blood gases with SOT compared to ambient air at 3200m, at 15 min of breathing ambient air or supplemental oxygen
Highlanders With High Altitude Pulmonary Hypertension (HAPH), 6 Minute Walk Distance (6MWD) Assessed at 3200m With and Without Supplemental Oxygen Therapy (SOT)
NCT Number: NCT06489743
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Altitude Pulmonary Hypertension
Interventions: OTHER: 6-minute walk test (6MWT)
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Aksay Medical Center, Aksay Plateau, Naryn, Kyrgyzstan

Summary:
The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live \>2500m on 6-minute walk distance (6MWD) assessed at 3200m.

Primary Outcome Measures: 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m, Change in 6MWD in meters between SOT vs. ambient air at 3200 m, after 6 minute
Secondary Outcome Measures: SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m, Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m, after 6 minute|Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m, Change of the heart rate at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m, after 6 minute|Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m, Change of the blood pressure at rest and at end of the 6MWT with SOT vs. ambient air at 3200 m, after 6 minute|Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m, Change of the Borg CR10 dyspnea scale at end of the 6MWT with SOT vs. ambient air at 3200 m, after 6 minute|Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m, Change of the Borg CR10 leg fatigue scale at end of the 6MWT with SOT vs. ambient air at 3200 m, after 6 minute
HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
NCT Number: NCT06489730
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: High Altitude Pulmonary Hypertension|Sleep Apnea
Sponsor: University of Zurich
Collaborators: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-31

Summary:
The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.

Primary Outcome Measures: Change in pulmonary artery pressure in highlanders, Change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 in highlanders living above 2500 m., Year 2017 to 2024
Secondary Outcome Measures: Change in pulmonary artery pressure between highlanders and lowlanders, Difference in the change in pulmonary artery pressure (RV/RA measured by echocardiography) from 2017 to 2024 between highlanders and lowland controls., Year 2017 to 2024|Change in TRP/CO in highlanders, Change in TRP/CO slope from 2017 to 2024 in highlanders living above 2500 m., Year 2017 to 2024|Progression of oxygen desaturation index, Change in the oxygen desaturation index from 2017 to 2024 in highlanders., Year 2017 to 2024|Progression of quality of life, Change in the mental and physical component score of the SF-36 questionnaire from 2017 to 2024 in highlanders., Year 2017 to 2024|Progression of arterial blood gases, Change in the arterial blood gases from 2017 to 2024 in highlanders., Year 2017 to 2024|Progression of right heart strain, Change in the right heart strain from 2017 to 2024 in highlanders., Year 2017 to 2024
High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), SDB Assessed at HA (3200 m) vs LA (760 m)
NCT Number: NCT06489717
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Altitude Pulmonary Hypertension
Interventions: OTHER: SDB assessment
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Aksay Medical Center, Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

Summary:
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live \>2500m on sleep disordered breathing

Primary Outcome Measures: Mean nocturnal SpO2 during the first night at LA vs HA, Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m), night 1 at 760 m compared to 3200 m.
Secondary Outcome Measures: Mean nocturnal SpO2 during the sixth night at LA vs HA, Change in mean nocturnal SpO2 (%) between LA (760 m) vs HA (3200 m), night 6 at 760 m compared to 3200 m.|Time spent with SpO2<90% at LA vs HA, Change in time spent with SpO2\<90% between LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.|AHI at LA vs HA, Change in apnea-hypopnea index (AHI) between LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.|ODI at LA vs. HA, Change in oxygen desaturation index (ODI) between LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.|Time spent with periodic breathing at LA vs. HA, Change in time spent with periodic breathingbetween LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.|Heart rate variability at LA vs. HA, Change in heart rate variability between LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.|ECG markers of repolarization at LA vs. HA, Change in electrocardiogram (ECG) markers of repolarization (QT time) between LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.|pulse transit time drops at LA vs. HA, Change in pulse transit time drops between LA (760 m) vs HA (3200 m), night 1 and night 6 at 760 m compared to 3200 m.
High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), 6MWT Assessed at High Altitude (3200m) vs Low Altitude (760m)
NCT Number: NCT06489691
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: High Altitude Pulmonary Hypertension
Interventions: OTHER: 6-minute walk test (6MWT)
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Aksay Medical Center, Aksay Plateau, Naryn, Kyrgyzstan, Kyrgyzstan

Summary:
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live \>2500m on 6-minute walk distance (6MWD)

Primary Outcome Measures: 6-minute walk distance (6MWD) on day 2 of relocation to 760 m, Change in 6MWD in meter between LA (760 m) vs HA (3200 m), day 2 at 760 m compared to 3200 m
Secondary Outcome Measures: 6-minute walk distance (6MWD) on day 7 of relocation to 760 m, 6-minute walk distance (6MWD) in meter between LA (760 m) and HA (3200 m), day 7 at 760 m compared to 3200 m|Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 2 of relocation to 760 m, Change in SpO2 in % between LA (760 m) vs HA (3200 m), day 2 at 760 m compared to 3200 m|Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 7 of relocation to 760 m, Change in SpO2 in % between LA (760 m) vs HA (3200 m), day 7 at 760 m compared to 3200 m|Heart rate at rest and at peak 6MWD on day 2 of relocation to 760 m, Change in hear rate in bpm between LA (760 m) vs HA (3200 m), after the first night at LA (760 m)|Heart rate at rest and at peak 6MWD on day 7 of relocation to 760 m, Change in hear rate in bpm between LA (760 m) vs HA (3200 m), day 7 at 760 m compared to 3200 m|Blood pressure at rest and at 6MWD on day 2 of relocation to 760 m, Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m), day 2 at 760 m compared to 3200 m|Blood pressure at rest and at 6MWD on day 7 of relocation to 760 m, Change in blood pressure in mmHg between LA (760 m) vs HA (3200 m), day 7 at 760 m compared to 3200 m|Borg Dyspnea scale at end 6MWT on day 2 of relocation to 760 m, Change of the Borg CR10 dyspnea scale at end of the 6MWT after the first night at LA (760 m) vs HA (3200 m), day 2 at 760 m compared to 3200 m|Borg Dyspnea scale at end 6MWT on day 7 of relocation to 760 m, Change of the Borg CR10 dyspnea scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m), day 7 at 760 m compared to 3200 m|Borg leg fatigue scale at end 6MWT on day 2 of relocation to 760 m, Change of the Borg CR10 leg fatigue scale at end of the 6MWT after the first night at LA (760 m) vs HA (3200 m), day 2 at 760 m compared to 3200 m|Borg leg fatigue scale at end 6MWT on day 7 of relocation to 760 m, Change of the Borg CR10 leg fatigue scale at end of the 6MWT after seven nights at LA (760 m) vs HA (3200 m), day 7 at 760 m compared to 3200 m
Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
NCT Number: NCT06489678
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Neoplasms|Diagnosis|Lung Cancer
Interventions: DIAGNOSTIC_TEST: Cone-Beam CT|DIAGNOSTIC_TEST: Robotic Assisted Bronchoscopy
Sponsor: University of Zurich
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-25
Completion Date: 2027-07-30
Locations: University Hospital Zurich, Zürich, 8091, Switzerland

Summary:
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 3 study army (3x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.

Primary Outcome Measures: Diagnostic Yield, ATS 2024 consensus criteria, Including a 12-month follow-up (clinical data)
Secondary Outcome Measures: Radiation exposure, Dose area product, During Intervention|Safety profile, Rates of complications (bleeding, pneumothorax, pneumonia), During Intervention|Diagnostic accuracy for milignancy, True positives + true negatives / true positives + true negatives + false positives + false negatives, Including a 12-month follow-up (clinical data)|Quality of biopsies, Number of malignant cells, suitability rates for further molecular pathological testing, During Intervention|Navigation success, Anatomical confirmation of the position of the catheter in front or within the lesion as confirmed by r-EBUS or CBCT \[not fluoroscopy\], During Intervention
Other Outcome Measures: Procedure Duration, Time of the whole procedure, During Intervention
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
NCT Number: NCT06489665
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sensitivity and Specificity of Phase Contrast Mammography vs. Conventional Digital Mammography
Interventions: DIAGNOSTIC_TEST: Experimental Intervention
Sponsor: University of Zurich
Collaborators: Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland|GratXray AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2030-09-01

Summary:
Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.

Primary Outcome Measures: Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM., The standard reference will be the histologic specimen after biopsy, 30 month
Secondary Outcome Measures: Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference., The aim is to evaluate if PCM, due to the expected improved visibility of the lesions, can allow for a better estimation of lesion extent with subsequent benefit on the preoperative planning., 30 month
89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis
NCT Number: NCT06489652
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Systemic Sclerosis
Interventions: DRUG: 89Zr-Oxine-RY_SW01 Cell Injection
Sponsor: Jiangsu Renocell Biotech Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2027-05-31

Summary:
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.

Primary Outcome Measures: Urine SUV value, 14day|Fecal SUV value, 14day
Secondary Outcome Measures: Modified Rodnan Skin Score (mRSS), 4、12、24 week|Percentage of FVC projections, 4、12、24 week|Health Assessment Questionnaire Disability Index (HAQ-DI), 4、12、24 week
The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty
NCT Number: NCT06489626
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Arthritis Knee|Knee Osteoarthritis|Pain, Postoperative
Interventions: DRUG: Methylprednisolone 4 milligram Tab|DRUG: Dexamethasone injection
Sponsor: F. Johannes Plate
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-01
Locations: UPMC East, Monroeville, Pennsylvania, 15146, United States|UPMC Shadyside Hospital, Pittsburgh, Pennsylvania, 15232, United States

Summary:
Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.

Primary Outcome Measures: Daily Pain at rest and with movement, numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain, daily for two weeks|Prescription narcotic usage, Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication, daily for two weeks|Sleep disturbance, Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time, daily for two weeks|Knee Range of motion, goniometric measurement of knee extension and flexion, 2-week, 6-week and 3-month postoperative visits
Secondary Outcome Measures: Wound healing, Surgical site will be evaluated for normal wound healing, 2-week, 6-week and 3-month postoperative visits|Knee Injury and Osteoarthritis Outcome Scores, Questionnaire assessing for function will be administered (0= extreme problems present, 100= no problems present), 2-week, 6-week and 3-month postoperative visits
Other Outcome Measures: Postoperative complications, All complications related to the patients procedure including infection, need for revision, emergency room visits, readmissions, etc. will be collected, To occur at 30 and 90 days postoperatively
Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.
NCT Number: NCT06489613
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: M Protein|Monoclonal Gammopathy|Monoclonal Gammopathy of Undetermined Significance
Interventions: DIAGNOSTIC_TEST: M protein detection by iMS-LC Assay
Sponsor: Jian Li
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-06
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

Summary:
iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood.

The investigators propose to conduct a prospective, single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology. The goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.

Initially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE + FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of MGUS in this population based on mass spectrometry screening.

Primary Outcome Measures: Diagnostic efficacy of the iMS-LC Assay, Using any positive result from SPEP + SIFE + FLC as the gold standard, we will obtain the diagnostic performance parameters of the iMS-LC Assay for M-protein detection, including sensitivity, specificity, kappa value, likelihood ratio, and predictive values., 2024-07 to 2024-10|Prevalence of MGUS in the population undergoing routine physical examinations, The prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening., 2024-07 to 2024-12
Creatine Supplementation At Simulated Altitude
NCT Number: NCT06489587
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Exercise Performance
Interventions: DIETARY_SUPPLEMENT: Placebo|DIETARY_SUPPLEMENT: Creatine
Sponsor: California Polytechnic State University-San Luis Obispo
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2026-06
Locations: California Polytechnic State University, San Luis Obispo, California, 93407, United States

Summary:
Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude.

Primary Outcome Measures: Peak power, Peak power is measured in watts., Change from baseline to 3 days
Secondary Outcome Measures: Body Weight, Body weight is measured in kilograms., Change from baseline to 3 days|Relative peak power, Relative peak power is measured in watts per kilogram., Change from baseline to 3 days|Mean power, Mean power is measured in watts., Change from baseline to 3 days|Relative mean power, Relative mean power is measured in watts per kilogram., Change from baseline to 3 days|Fatigue index, Fatigue index is measured in watts per second., Change from baseline to 3 days
Neural Computations of Goal-directed Decision-making
NCT Number: NCT06489561
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Epilepsy Intractable
Interventions: BEHAVIORAL: Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system
Sponsor: Cedars-Sinai Medical Center
Collaborators: National Institute of Mental Health (NIMH)|California Institute of Technology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-08-01
Completion Date: 2028-07-01
Locations: Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States

Summary:
The purpose of this research is to better understand how the human brain accomplishes the cognitive task of making goal-directed decisions. These investigations are critical to better understand human cognition and to design treatments for disorders of decision making and performance monitoring.

Primary Outcome Measures: Decision Making (Firing Rates), Neuronal firing rates of cells (measured in spike rates per second) in the frontal lobes during a decision-making process., 5 years|Decision Making (Power), Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal lobes during a decision-making process., 5 years|Decision Making (Timing), Timing of neuronal discharges (measured in spike rates per second) across the frontal lobes during a decision-making process., 5 years
Assessment of Foralumab Safety and Modulation of Microglial Activation
NCT Number: NCT06489548
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dementia|Alzheimers Disease|Mild Cognitive Impairment Due to Alzheimer's Disease
Interventions: DRUG: Foralumab TZLS-401 50 µg|DRUG: Foralumab TZLS-401 100 µg
Sponsor: Brigham and Women's Hospital
Collaborators: Tiziana Life Sciences LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: Center for Alzheimer Research and Treatment, Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.

The trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.

Primary Outcome Measures: The number of adverse events in drug versus placebo groups., Establish the safety and tolerability of nasal foralumab dosing in subjects as a percentage of drug and placebo groups who experience adverse events., From baseline to the end of study, up to 20 weeks.|Assessment of microglial function via PET scan using the ligand [18F]PBR06, The ligand \[18F\]PBR06 provides a quantification of microglial activation during a PET scan. The investigatorshope to use this tracer at the start and end of the study to examine how the use of Foralumab may affect microglial function., From baseline to end of study, up to 20 weeks.|Measure the effect of foralumab on the ratio of CD4/CD8 memory/naïve T cells biomarkers in blood, From baseline to the end of treatment, up to 12 weeks.
Distribution of Pulmonary Ventilation in Lateral Decubitus of Healthy Adults Under Non-Invasive Mechanical Ventilation
NCT Number: NCT06489509
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Noninvasive Ventilation|Patient Positioning
Interventions: DEVICE: Positive End Expiratory Pressure 5 H2O|DEVICE: Positive End Expiratory Pressure 10 H2O
Sponsor: Attikon Hospital
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2017-12-06
Completion Date: 2018-07-08
Locations: Attikon University Hospital, Athens, Attica, 12462, Greece|Grigoriadis Konstantinos, Athens, Attica, 18452, Greece

Summary:
The aim was to investigate via impedance tomography apparatus the distribution of pulmonary ventilation at a lateral position at different Continuous Positive Airway Pressure levels (0, 5, 10 cm Η2Ο) in healthy subjects.

Primary Outcome Measures: The percentage change in pulmonary ventilation, The percentage change in pulmonary ventilation was measured at each position, without applying external positive end-expiratory pressure and under positive end-expiratory pressure of 5 and 10 cmH2O, Up to 3 minutes
Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial
NCT Number: NCT06489496
Acronym: PAX
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DIAGNOSTIC_TEST: 18F-1007 PSMA PSMA PET/CT
Sponsor: Alberta Health services
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2030-10-01

Summary:
Primary objective:

• To determine if 18F-PSMA-1007 PET/CT imaging is effective at diagnosing prostate cancers and/or metastases compared to conventional imaging \[including CT, MRI, 99mTc-MDP Bone Scans as available\].

Secondary Objective:

* To determine safety by evaluating for adverse events
* To determine which conventional imaging is being performed when 18F-PSMA-1007 PET/CT imaging is available

Primary Outcome Measures: Comparison of 18F-PSMA-1007 PET/CT imaging to CT/MRI/Bone scans in identifying prostate cancer and/or metastases, calculate sensitivity and specificity 18F-PSMA 1007 PET/CT compared to CT, MRI and bone scans using pathology and follow up as gold standard., 5 year study, approximately 200 patients/ year.
Secondary Outcome Measures: To determine safety by evaluating for adverse events, evaluate patient reported side effects during and after injection of 18F-PSMA 1007 while in the department, 5 year study, approximately 200 patients/ year.
Action Regulation Behavioral
NCT Number: NCT06489483
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease
Interventions: BEHAVIORAL: Action Regulation Movement Task
Sponsor: University of Texas Southwestern Medical Center
Collaborators: University of California, Riverside
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-24
Completion Date: 2024-12-13
Locations: University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
Parkinson's disease (PD) is a neurodegenerative disorder involving a part of the brain that is responsible for motor control, which not only results in changes or disruptions in movement, but also cognitive dysfunctions. Given that the decline of muscle control such as tremors, with difficulty walking or the ability to switch tasks once in movement, greatly affects the quality of daily life. Action regulation is a critical executive function (cognitive control over behavior), which includes actions such as suppressing activity when selecting between options, making decisions about stopping unwanted or inappropriate actions, and switching to new actions in response to environmental changes. Parkinson's disease (PD) has been shown to disrupt action inhibition which can be considered a measure to the progression of PD.

The purpose of this research study is to better understand the mechanism of action regulations in PD patients and how action regulations in PD can be improved using dopaminergic treatment, which is a drug that either releases or involves dopamine, which is a neurotransmitter involved in sending signals to nerve cells.

You are asked to participate in this research study because you are receiving a dopaminergic medication for treatment of your Parkinson's disease. There is currently no theory that integrates the mechanisms of action regulation into a unified framework, which this study aims to address. The researchers hope to learn more about the mechanisms of action regulation in PD patients and to help decrease action regulation disruptions in PD patients. This study will help characterize the motor behavior of PD patients.

Primary Outcome Measures: Stop-Signal Task, Each patient will complete a joystick-based stop-signal task which assesses reaction time, stop reaction time, accuracy, and joystick traces., Baseline|Switch Task, Each patient will complete a joystick-based switch task which assess reaction time, switch reaction time, accuracy, and joystick traces., Baseline
Strokectomy in Malignant Cerebral Media Infarction
NCT Number: NCT06489470
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: PROCEDURE: Strokectomy/Necrosectomy
Sponsor: University of Rostock
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2025-06-30
Locations: University Medical Center Rostock, Rostock, Mecklenburg-Vorpommern, 18057, Germany

Summary:
Decompressive hemicraniectomy (DC) is the standard procedure and life saving measure in case of malignant middle cerebral artery (MCA) infarction. However, there have been several studies reporting the neuroinflammatory cascade based on the necrotic tissue as one of the leading cause for the secondary brain damage, wherefore, strokectomy with resection of necrotic tissue has been proposed in some case series as an alternative surgical option. Thus, the aim of this study is to perform a pilot study by including patients with malignant MCA infarction and to check the feasibility of this specific surgical treatment.

Primary Outcome Measures: Rate of resurgery after necrosectomy of malignant MCA-infarction, After the surgical treatment, the patients will be treated in the neurointensive care unit. During the clinical course, the necessity to perform a secondary surgery (e.g. hemicraniectomy) will be observed. For the safety of the patients, intracranial pressure monitoring will be continously performed as well., up to 2 weeks
Secondary Outcome Measures: Surgical complications, The rate of wound infection, other infections, postoperative hemorrhage and postoperative seizure will be documented during the clinical course and follow-up., up to 3 months|Functional outcome via modified Rankin Scale (mRS; range 0-6; 0-3: favorable outcome, 4-6: unfavorable outcome) at 3 months, After 3 months, the functional outcome will be evaluated by modified Rankin Scale., up to 3 months
Fecal Amino Acids，Gut Taste Receptors and Irritable Bowel Syndromes
NCT Number: NCT06489444
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Irritable Bowel Syndrome
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-16
Completion Date: 2024-08
Locations: The second affiliated hospital of xi'an jiaotong university, Xi'an, Shaanxi, 710004, China

Summary:
Clinical data, fresh feces and intestinal mucosal tissues of patients with diarrheal IBS were collected. High performance liquid chromatography, immunohistochemistry and immunofluorescence were used to study the amino acid levels in feces of patients with IBS, the expression of taste receptors in intestinal mucosa, and the correlation between symptoms of abdominal pain and diarrhea and the expression of taste receptors, so as to obtain the conclusion that "intestinal amino acid perception abnormalities exist in patients with IBS. And correlated with clinical symptoms."

Primary Outcome Measures: Taste receptor expression was associated with symptom severity, The severity of symptoms was correlated with the expression of taste receptors, 1 year|Association between fecal amino acid levels and symptom severity in patients, The severity of symptoms was correlated with fecal amino acid, 1year
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
NCT Number: NCT06489431
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Erectile Dysfunction|Penile Prosthesis; Complications, Infection or Inflammation
Interventions: DRUG: Chlorhexidine|DRUG: Gentamicin|DRUG: Rifampin
Sponsor: Rush University Medical Center
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2023-12-04
Completion Date: 2025-12-31
Locations: Rush University Medical Center, Chicago, Illinois, 60612, United States|Uropartners Surgery Center, Des Plaines, Illinois, 60018, United States

Summary:
The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

Primary Outcome Measures: Infection Rate of Patients Receiving Traditional Antibiotic Irrigation vs Irrisept Only, All patients will be closely followed with appointments at regular intervals for the first year after surgery to monitor for infections as per usual care, 1-2 years
Horticultural Practices for Children
NCT Number: NCT06489405
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Internet Addiction Level|Perceived Stres Level|Social Skill Level
Interventions: OTHER: Horticultural practices
Sponsor: Gazi University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-10-13
Completion Date: 2024-06-26
Locations: Gazi University, Ankara, Emek/Çankaya, 06490, Turkey

Summary:
The study was conducted with a parallel group randomized controlled experimental design to determine the effect of horticultural practices on internet addiction, social skills and stress levels in children. The children underwent horticultural practices for 6 weeks. Children were given a post-test at the end of the intervention program (week 6), a first follow-up three months after the intervention and a second follow-up six months later.

Primary Outcome Measures: Internet Addiction Scale (Internet Addiction Scale for Adolescents), The scale consists of nine items. The unidimensional scale has a 5-point Likert-type rating. The responses to the items are graded as 'never', 'rarely', 'sometimes', 'often' and 'always'. The lowest score is 9 points and the highest score is 45 points. The higher the score obtained from the scale, the higher the level of internet addiction., Baseline (before the intervention)|Internet Addiction Scale (Internet Addiction Scale for Adolescents), The scale consists of nine items. The unidimensional scale has a 5-point Likert-type rating. The responses to the items are graded as 'never', 'rarely', 'sometimes', 'often' and 'always'. The lowest score is 9 points and the highest score is 45 points. The higher the score obtained from the scale, the higher the level of internet addiction., 6th week after the intervention|Internet Addiction Scale (Internet Addiction Scale for Adolescents), The scale consists of nine items. The unidimensional scale has a 5-point Likert-type rating. The responses to the items are graded as 'never', 'rarely', 'sometimes', 'often' and 'always'. The lowest score is 9 points and the highest score is 45 points. The higher the score obtained from the scale, the higher the level of internet addiction., three months after completion of the intervention|Internet Addiction Scale (Internet Addiction Scale for Adolescents), The scale consists of nine items. The unidimensional scale has a 5-point Likert-type rating. The responses to the items are graded as 'never', 'rarely', 'sometimes', 'often' and 'always'. The lowest score is 9 points and the highest score is 45 points. The higher the score obtained from the scale, the higher the level of internet addiction., six months after completion of the intervention
Mehri Turki Webbed Neck Classification
NCT Number: NCT06489392
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Turner Syndrome|Pterygium Colli|Web Neck|Klippel-Feil Syndrome
Sponsor: Mohamed Tahar Maamouri University Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 78
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-27
Completion Date: 2023-03-30
Locations: Mohamed Tahar Maamouri University hospital, Nabeul, 8000, Tunisia

Summary:
This study aims to identify all types of congenital neck deformities called " webbed neck ". Through a literature survey, the researcher selected 27 articles describing the surgical treatment of the webbed neck, but without considering the varieties of this deformity. For this reason, the researcher studied all the reported cases from which she developed a classification containing 4 types of webbed necks allowing the use of the most suitable technique to enhance the surgical outcomes.

Primary Outcome Measures: Mehri Turki Webbed neck classification, Baseline, pre-sugical procedure
High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room
NCT Number: NCT06489379
Acronym: GLAMOUR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Distress Syndrome, Adult
Interventions: DEVICE: high flow nasal cannula|OTHER: standard oxygen
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 234
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-07

Summary:
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.

Primary Outcome Measures: Early deterioration, occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death., 24 hours
Secondary Outcome Measures: Development of respiratory acidosis, arterial pH, 2, 12 and 24 hours|Development of hypercapnia, arterial pCO2, 2, 12 and 24 hours|Worsening hypoxemia, P/F ratio, 2, 12 and 24 hours|Worsening respiratory distress, respiratory frequency, 2, 12 and 24 hours|duration of any type of ventilatory support, hours of ventilatory support, 90 days|rate of ICU admission, number of patients admitted to ICU, 90 days|hospital length-of-stay, duration of hospitalization, 30 days|in-hospital mortality, death during hospitalization, 90 days|ICU length-of-stay, duration of ICU stay, 90 days|ICU mortality, death in ICU, 90 days|development of complications, composite outcome of septic shock, nosocomial pneumonia, cardiac arrhythmia, cardiac arrest, delirium, 90 days|level of dyspnea, utilizing Borg scale, 24 hours|patient comfort, utilizing visual analogue scale, 24 hours|clinical setting after ED stabilization, type of ward admission, 24 hours|standard vs asymmetrical high-flow nasal cannula, rate of early deterioration in the treatment group will be compared between patients treated with standard or asymmetrical high-flow nasal cannula, 24 hours