pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia
NCT Number: NCT06468475
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Birth Asphyxia
Interventions: DRUG: Magnesium Sulphate infusion
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2024-03-31
Locations: The Children's Hospital and the Institute of Child Health, Multan, Punjab, 60000, Pakistan

Summary:
Children's Hospital Multan is a tertiary care teaching hospital in South Punjab, the poorest and most backward area of Punjab, Pakistan, where a significant number of newborns suffer from birth asphyxia. Therefore, this study was planned with the objective of investigating the effectiveness of magnesium sulphate in severe birth asphyxia, hypothesizing that in cases of birth asphyxia, neonates who are treated with magnesium sulphate have a higher sucking reflex than those who are not treated with magnesium sulphate.

Primary Outcome Measures: Efficacy, Efficacy was labeled as yes if the infant was placed in the supine position, the index finger was placed in the infant's mouth, and the power of sucking movements was judged after 5 seconds, and If the sucking reflex appeared. Efficacy was termed no otherwise., 72 hours
Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload
NCT Number: NCT06468423
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pateints of β-thalassemia Major With Iron Overload
Interventions: DRUG: Deferasirox (DFX)|DRUG: Deferoxamine (DFO)
Sponsor: RESnTEC, Institute of Research
Sex: ALL
Age: CHILD
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-09-30
Locations: Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health, Multan, Punjab, 59210, Pakistan

Summary:
This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.

Primary Outcome Measures: Mean Serum Ferritin Levels, Change in mean serum ferritin level from baseline for each group., 6 months
Effect of Hatha Yoga on Pulmonary Function
NCT Number: NCT06468410
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: long duration Hatha Yoga|OTHER: short duration Hatha Yoga|OTHER: Control group
Sponsor: Monira Aldhahi
Collaborators: Çankırı Karatekin University|Bandırma Onyedi Eylül University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-12-01
Locations: Bandirma Onyedi Eylul University, Balıkesir, Turkey

Summary:
The goal of this clinical trial is to to investigate the acute and chronic effects of a four-week hatha yoga (HY) exercise program with different durations (60 min and 30 min) on pulmonary function in sedentary young individuals.. The main questions it aims to answer are:

• Does a four-week hatha yoga (HY) more effective than 30 min of a four-week hatha yoga (HY) and the control group in improving the pulmonary function? Researchers will compare a four-week OF 60 min duration hatha yoga (HY) , 30 min duration of HY and control to see the differences in the pulmonary function among high school sedentary students

Participants will:

Participants will be randomly assigned to one of three groups:

1. 60-minute Hatha Yoga group (60mHY, n=21)
2. 30-minute Hatha Yoga group (30mHY, n=21)
3. Control group (CG, n=21)

Primary Outcome Measures: Forced Vital Capacity (FVC), the maximum amount of air a person can exhale after taking a deep breath measured using spirometry, at baseline and end of 4 week|Forced Expiratory Volume in 1 second (FEV1), spirometry will be used to measure Forced Expiratory Volume in 1 second (FEV1). It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration., at baseline and end of 4 week
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
NCT Number: NCT06468397
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rhegmatogenous Retinal Detachment - Macula Off
Interventions: DEVICE: iSeelr™
Sponsor: Photofuse Pty Ltd
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-06-01
Locations: The Royal Victorian Eye and Ear Hospital (RVEEH), East Melbourne, Victoria, 3002, Australia

Summary:
This study is a first-in-human clinical trial testing a new treatment for rhegmatogenous retinal detachments. The new treatment called retinal thermofusion uses a special laser device called iSeelr™ during surgery. The benefit of the device is that it repairs retinal tears without needing a gas bubble making it quicker to recover from surgery. The study will help us determine how safe and well the device performs in repairing a retinal detachment in people.

Primary Outcome Measures: Number of participants with successful retinal reattachment without the need for gas tamponade, To assess the performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments., Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment|Assessment of intra-operative and post-operative adverse events, To assess the safety of the treatment and the significance of any adverse events, Up to 90 days post treatment
Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: Changes in Optic Nerve Sheath Diameter
NCT Number: NCT06468384
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Complex Regional Pain Syndromes
Interventions: PROCEDURE: thoracic erector spinae plane (ESP) block
Sponsor: Pamukkale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2024-09-20

Summary:
The thoracic erector spinae plane (ESP) block is suggested to potentially affect the stellate ganglion, a key component of the sympathetic nervous system, thereby influencing autonomic functions. Changes in optic nerve sheath diameter (ONSD) are used as indicators of intracranial pressure changes. This study aims to investigate the effects of the ESP block on ONSD, providing insights into its impact on the stellate ganglion and enhancing the understanding of the ESP block's safety and efficacy.

Primary Outcome Measures: Optic nerve sheath diameter (ONSD), To investigate the change in optic nerve sheath diameter (ONSD) following the thoracic erector spinae plane (ESP) block., Before the block and 30 minutes after the block.
Secondary Outcome Measures: Pain relief Visual Analog Scale (VAS), The Visual Analog Scale (VAS) is a tool for measuring pain intensity, using a line marked with "no pain" (0) at one end and "worst pain imaginable" (10) at the other. Patients mark a point on the line that reflects their pain level, and the distance from the "no pain" end to the mark is recorded as the VAS score. This straightforward, subjective measure provides a quantitative assessment of pain, useful for tracking changes over time, evaluating treatment effectiveness, and enhancing communication between patients and healthcare providers., Pain levels will be assessed using the VAS before the block, 30 minutes after the block, and 24 hours later to evaluate the effectiveness of the intervention.|Monitoring of Perfusion Index (PI), The perfusion index (PI) is a numerical value that reflects the pulsatile blood flow in peripheral tissues, measured non-invasively using a pulse oximeter. It indicates the strength of the blood flow at the sensor site, providing valuable information about peripheral perfusion., All perfusion index (PI) values will be measured at 3-minute intervals using 2 pulse oximeter sensors on both the blocked and contralateral unblocked upper extremities up to 30 minutes after local anesthetic injection.
Exercise Training Versus Ropinirole in Treating Restless Legs Syndrome Among Hemodialysis Patients
NCT Number: NCT06468371
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis|Restless Legs Syndrome|ESRD (End Stage Renal Disease)|Diabetes Complications
Interventions: DRUG: Dopamine Agonist (Ropinirole)|OTHER: Excercise training
Sponsor: Lahore General Hospital
Sex: ALL
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-01-02
Completion Date: 2024-02-01
Locations: Lahore General Hospital, Lahore, Lahore, Punjab, 54000, Pakistan

Summary:
This research aims to compare the efficacy of these two interventions, thereby addressing a critical gap in current therapeutic approaches. The rationale for this study is rooted in the existing evidence supporting non-pharmacological and pharmacological interventions for RLS, yet the comparative efficacy remains underexplored.

Primary Outcome Measures: Change in the International Restless Legs Syndrome Study Group (IRLSSG) score, The IRLSS score is a validated instrument used to assess the severity of Restless Legs Syndrome (RLS). It comprises ten questions that evaluate the intensity of symptoms, their impact on sleep and daily life, and the frequency of symptom occurrence. Each question is rated on a scale from 0 (no symptoms) to 4 (severe symptoms). The overall score ranges from 0 to 40., From baseline to 3 months of interval.
Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer
NCT Number: NCT06468293
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: Psychological support
Sponsor: European Institute of Oncology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-10-08
Completion Date: 2024-12-31
Locations: European Institute of Oncology, Milan, Italy

Summary:
The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options.

Primary Outcome Measures: Evaluation of the compliance with therapy, The primary endpoint of this study is to observe a difference of 3 points in the average values of the "Interpersonal aspect of care" and "Subjective norm" subscales of the Adherence Determination Questionnaire (ADQ), in favor of the intervention group.

Response options for each item formed a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 = strongly agree). The ADQ questionnaire contains 38 questions, with items 15 and 17 through 24 specifically phrased for patients who have cancer, 6 months
An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer
NCT Number: NCT06468254
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ovarian Cancer
Interventions: DRUG: Statin|DRUG: Sugar pill
Sponsor: Anhui Provincial Cancer Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-30
Completion Date: 2026-03-30
Locations: Anhui Cancer Hospital, Hefei, Anhui, 230001, China

Summary:
This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life.

Primary Outcome Measures: Progression free survival, The time between the start of the trial and tumor progression (in any way) or death (from any cause), 12-month|Disease free survival, Time from surgical resection to local recurrence, 12-month
Secondary Outcome Measures: Changes of tumor marker CA125, Changes in Serum CA125 from Enrollment to End of Trial, 12-month|Changes of tumor marker HE4, Changes in Serum HE4 from Enrollment to End of Trial, 12-month|Lipid change, Changes in Serum Lipid from Enrollment to End of Trial, 12-month
Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
NCT Number: NCT06468215
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Carcinoma, Endometrioid|Fertility Preservation
Interventions: DRUG: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
Sponsor: Peking University People's Hospital
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-10

Summary:
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.

Primary Outcome Measures: The Time Required for Complete Remission for the First Time, The time from the diagnosis of G2 endometrioid carcinoma to the first complete remission after fertility-preserving treatment.（year）, 5 years
Secondary Outcome Measures: One-year complete remission rate, The percentage of patients who achieved complete remission after one year of fertility preservation treatment., 5 years|two-year disease recurrence rate, The probability of recurrence within 2 years for patients who underwent treatment for preserving fertility and achieved complete remission., 5 years|cumulative pregnancy rate, The percentage of pregnancies that occurred during the observation period., 5 years|pregnancy outcome, The pregnancy outcomes in women who successfully conceived after undergoing fertility-sparing treatment. They can be categorized as: full-term delivery; premature delivery; miscarriage; stillbirth., 5 years
Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis
NCT Number: NCT06468150
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Deep Vein Thrombosis
Sponsor: Pirogov Russian National Research Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2427
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-06-01
Locations: The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation, Moscow, 117997, Russian Federation

Summary:
The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are:

1. How many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital?
2. What is the actual number of patients undergoing endovascular interventions for deep vein thrombosis?

Participants received endovascular treatment according to the clinical protocol of the treatment.

Primary Outcome Measures: Number of patients with deep vein thrombosis who could be eligible for mechanical thrombectomy and catheter-directed thrombolysis, The number of participants with deep vein thrombosis who would fit the eligibility criteria for performing the intervention, from date of admission until the date of discharge, up to 1-2 weeks
Secondary Outcome Measures: The number of patients with deep vein thrombosis who underwent mechanical thrombectomy and catheter-directed thrombolysis, The number of participants with deep vein thrombosis who fitted the eligibility criteria and underwent the intervention., from date of admission until the date of discharge, up to 1-2 weeks
Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases
NCT Number: NCT06468124
Acronym: PDO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Neoplasms
Sponsor: King's College London
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-07

Summary:
The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.

Primary Outcome Measures: Patient derived organoids, To generate PDOs from brain or extra-cranial metastases of breast cancer patients., 10 months
Secondary Outcome Measures: Response to radiotherapy, To determine the dose response curves of radiotherapy, 6 months|Response to therapy, To determine the IC50 doses of the previous and same systemic treatments that patients had or will have in PDOs, 5 months|recurrence and survival rates, To correlate the IC50 doses and dose response curves above with the recurrence rates and progression-free survival of patients, 4 months|Response rate of patients undergoing systemic treatment, To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment, 3 months
A Study of IBI363 in Subjects With Advanced Malignancies
NCT Number: NCT06468098
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Malignancies
Interventions: DRUG: IBI363 + chemotherapy|DRUG: IBI363 + Investigator's Choice SOC
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 556
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2026-12-31
Locations: Shanghai Chest Hospita, Shanghai, Shanghai, 20030, China

Summary:
This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients

Primary Outcome Measures: Adverse Enent (AE), Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0, Up to 90 days after the last administration|Treatment-Emergent AE (TEAE), Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0, Up to 90 days after the last administration|Adverse Event of Special Interest (AESI), Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0, Up to 90 days after the last administration|Serious Adverse Event (SAE), Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0, Up to 90 days after the last administration|Objective response rate (ORR), ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR)., Through out the study (up to 2 years)|disease control rate (DCR), DCR is defined as the proportion of participants with a complete response (CR) or partial response (PR) or stable disease(SD), Through out the study (up to 2 years)|time to response (TTR), TTR is defined as the time from the date of first dose of study drug to the date of first documented tumor response (CR/PR), Through out the study (up to 2 years)|duration of response (DoR), DoR is defined as the time from the date of first documented tumor response (CR/PR) until PD/death, Through out the study (up to 2 years)|progression-free survival (PFS), PFS is defined as the time from the date of first dose of study drug to the date of the first documented progression or death due to any cause, whichever occurs first, Through out the study (up to 2 years)|Overall survival (OS), OS is defined as the time from the date of first dose of study drug until the date of death from any cause., Through out the study (an average of 2 years)
Secondary Outcome Measures: Plasma concentration (Cmax) of IBI363, PK parameters maximum concentration (Cmax) of IBI363, Up to 2 years|Area under the curve (AUC) of IBI363, PK parameters area under the curve (AUC)?of IBI363, Up to 2 years|Half-life (T1/2) of IBI363, PK parameters half-life (t1/2)?of IBI363, Up to 2 years|Clearance (CL) of IBI363, PK parameters clearance rate of IBI363, Up to 2 years|Volume of distribution (V) of IBI363, PK parameters apparent volume of distribution(V)?of IBI363, Up to 2 years|Immunogenicity of IBI363, Incidence of anti-drug (IBI363) antibody, Up to 2 years
Evaluation of Pulpotomy Using Two Different Agents in Mature Anterior Teeth With Pulpitis
NCT Number: NCT06468085
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulpitis
Interventions: PROCEDURE: premixed Bioceramic NeoPUTTY®|PROCEDURE: Biodentine™|PROCEDURE: Root canal treatment
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-07-01

Summary:
the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.

Primary Outcome Measures: Clinical success, Absence of pain related to the treated teeth, including patient reported pain or sensitivity to percussion/palpation.

No evidence of swelling of supporting soft tissue or presence of sinus tract. Absence of excessive mobility affecting treated teeth., 3, 6, 9 and 12 months follow up|Radiographic success, No Internal or external root resorption. No Periapical radiolucency., 3, 6, 9 and 12 months follow up
Secondary Outcome Measures: Evaluation of tooth discoloration., Evaluation of tooth discoloration using the VITA Easyshade V digital spectrophotometer., 3, 6, 9 and 12 months follow up
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
NCT Number: NCT06468059
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation
Interventions: DEVICE: Layered Low Profile Foot|DEVICE: Prescribed Ankle
Sponsor: Little Room Innovations, LLC
Collaborators: Kennesaw State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-03-21
Completion Date: 2024-07-16
Locations: Kennesaw State University, Kennesaw, Georgia, 30144, United States

Summary:
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.

Primary Outcome Measures: Total Energy Stored (TES), TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics., through study completion, an average of 1 day|Ankle Range of Motion (ROM), ROM is the difference between the maximum and minimum ankle angles measured in a gait cycle., through study completion, an average of 1 day
Secondary Outcome Measures: Ankle Quasi-Stiffness (AQS), AQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics., through study completion, an average of 1 day|Walking Speed, This is the linear rate of change of position when a person walks, typically given in m/s., through study completion, an average of 1 day|Rollover Shape from Motion Capture, Rollover shape is a physical shape that is kinematically equivalent to the contact points of a deformable shape moving through a given loading pattern. Rollover shape is measured by combining the readings of a force plate with the kinematic data obtain from motion capture., through study completion, an average of 1 day|Device Satisfaction survey of the Orthotics and Prosthetics Users Survey (OPUS), The OPUS is a self-report questionnaire for determining quality, maintaining awareness of improvement in activities, evaluating changes in functional status, and assessing satisfaction with devices and services. Scores on the questionnaire range from Strongly Agree to Strongly Disagree. Strongly Agree is associated with the best outcomes in the survey., through study completion, an average of 1 day
Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children
NCT Number: NCT06468046
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Interventional
Interventions: BEHAVIORAL: Mama Empoderada [Mom Power]
Sponsor: San Diego State University
Collaborators: El Colegio de la Frontera Norte
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2026-08

Summary:
This pilot randomized controlled trial will test a theory-based, trauma-informed, and culturally-tailored intervention \[Mama Empoderada' (Mom Power)\] to promote mental health and positive parenting among migrant mothers with young children.

Primary Outcome Measures: Depression symptoms (Patient Health Questionnaire [PHQ]-9), Survey of Depression symptoms (PHQ-9), scores range from 1-27 with higher scores indicating more severe depression, Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)|Anxiety symptoms (General Anxiety Disorder [GAD]-7), Survey of Anxiety symptoms (GAD-7), scores range from 0-21, with higher scores indicating higher levels of anxiety., baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)|Parental Stress Scale, Survey of Parental Stress, Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress., baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
NCT Number: NCT06468033
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Primary Myelofibrosis|Myeloproliferative Neoplasm
Interventions: BIOLOGICAL: Ropeginterferon alfa-2b|OTHER: Placebo
Sponsor: PharmaEssentia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-08

Summary:
This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.

Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

Primary Outcome Measures: Clinically relevant Complete Hematologic Response (CrCHR): Platelet count, and, ≤400 × 10\^9/L, 56 weeks|CrCHR: White Blood Cells (WBC) count, and, \<10 × 10\^9/L, 56 weeks|CrCHR: Peripheral blood: Hemoglobin (Hgb), and, \>10.0 g/dL, 56 weeks|CrCHR: Absence of thrombotic events, and, Absence of major thrombotic events during the observation time frame, 56 weeks|CrCHR: No progression to AML, or, No progression to secondary acute myeloid leukemia (AML), 56 weeks|Symptom endpoint, No progression on clinical symptoms based on the MFSAF Total Symptom Score (TSS) v4.0, 56 weeks
Study of the Indications for Amyloid Positon Emission Tomography (PET) Scans and Their Usefulness for Patients With Suspected Alzheimer's Disease (AD)
NCT Number: NCT06467981
Acronym: TEPAmy
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease
Interventions: OTHER: Retrospective study
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-30

Summary:
The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD).

Primary Outcome Measures: Evaluate the indications for Amyloid PET in 7 centers in France to assess the relevance of the examination, Correlation between the request and the recommendations, 1 day
Secondary Outcome Measures: Evaluate the frequency of positive examinations for the diagnosis of AD, Number of positive PET exam, 1 day
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication
NCT Number: NCT06467968
Acronym: GATEDOTA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiac Inflammation
Interventions: OTHER: Cardiac ECG-gated PET imaging will added
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 99
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-02-02
Completion Date: 2025-08-26
Locations: Veronique Roch, Vandoeuvre les Nancy cedex, 54511, France

Summary:
Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.

The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.

Primary Outcome Measures: Relationship between the captation of radiotracer and the cardiovascular disease, Measurement of myocardial activity, 1 day
Secondary Outcome Measures: Relationship between the captation of radiotracer and the troponin value, Correlation between the myocardial activity and the troponin value, 1 day
MagDI Canada Study
NCT Number: NCT06467955
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Type 2 Diabetes
Interventions: DEVICE: Magnet System, DI Biofragmentable
Sponsor: GT Metabolic Solutions, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-10
Completion Date: 2025-08-31
Locations: University of Toronto, Toronto, Ontario, Canada|McGill University, Montreal, Quebec, H3A 0G4, Canada|Westmount Square Surgical Center, Westmount, Quebec, H3Z 2P9, Canada

Summary:
The objective of the MagDI Canada study is to evaluate the performance and safety of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion as one example of a small bowel clinical procedure requiring a side-to-side anastomosis. The secondary objective includes initial efficacy of the duodeno-ileal diversion using the MagDI System.

Primary Outcome Measures: Performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System., The duodeno-ileal diversion will be considered feasible if it results in successful:

* Placement of the Magnets (≥ 90% alignment of magnets) and
* Passage of Magnets without surgical re-intervention; and
* Creation of a patent anastomosis confirmed radiologically.

The primary endpoint will be met if the performance is confirmed in ≥ 80% of enrolled and treated participants., From date of study index procedure through 90 days|Safety of the MagDI System, Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including:

* All-cause mortality
* Intestinal perforation and/or peritonitis
* Intestinal obstruction
* Life-threatening bleeding
* Incidence of device malfunctions, From date of study index procedure through 360 days.
Prospective Collection of Endoscopic and Histopathologic Data From Endoscopic Procedures Performed in UZ Gent
NCT Number: NCT06467929
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endoscopy
Sponsor: University Hospital, Ghent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 510
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-22
Completion Date: 2025-10-30
Locations: University Hospital Ghent, Ghent, East Flanders, 9000, Belgium

Summary:
This is an observational study in which images (photos and/or videos of lesions found during endoscopy) will be collected and the associated data about these lesions (size, location in the body, outcome of histology, if resected and examined).

The images will be taken while performing a diagnostic or therapeutic endoscopy. This footage can be recorded in different light modalities, and various lesions can be removed during one procedure. It is of importance that the images are recorded in the best possible image quality.

The images can be either endoscopic images or endoscopic images combined with room view (this means that the endoscopic room can be filmed, for example, to visualize the endoscopist and thus show techniques of the procedure, without the patient being identified). The GDPR regulations will be respected at all times during the video recordings.

The purpose of this registry is to create a database with images in the form of photos and video clips, histopathological data, demographic data of patients and data about the endoscopic procedure. The recording of this data is standard with every endoscopic procedure that patients undergo at UZ Gent.

The data will be used for the following purposes: linking procedural outcomes with procedural data and patient data to improve endoscopic technique and to guarantee quality in our endoscopic unit. In this way the investigators will also be able to identify trends and link adverse events back to the patient data with the aim of informing the patient. In addition, as a university center, the investigators can train doctors in training with this educational material. The footage can be shared via online and/or live presentations that are only accessible to/by healthcare workers and without the patient being identifiable. Such material and its dissemination is essential to improve (the safety of) techniques (such as those of today), to share knowledge about techniques, and in this way to train the next generation of doctors and nurses.

Primary Outcome Measures: Digital Database of Prospectively collected images, videos and data of endoscopic procedures, Creation of a large digital database of prospectively collected images, videos and data of endoscopic procedures using any type of imaging technique (e.g., white light endoscopy, video chromoendoscopy, ...) and with consecutive resection of lesions providing a corresponding histology report., 01/11/2022 - 30/10/2025
The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
NCT Number: NCT06467916
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Perinatal Depression|Perinatal Anxiety|Post Traumatic Stress Disorder
Interventions: BEHAVIORAL: PATH
Sponsor: University of Colorado, Denver
Collaborators: Oregon Health and Science University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-15
Completion Date: 2026-04-30
Locations: University of Colorado Hospital, Aurora, Colorado, 80045, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States

Summary:
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as they transition from the NICU to home. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.

Primary Outcome Measures: Mental health self-efficacy scale, Mental health self-efficacy, ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Secondary Outcome Measures: City Mental Illness Stigma Scale, Mental illness stigma, ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge|Parenting Sense of Self Confidence Scale, Parenting self-efficacy, ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Other Outcome Measures: Edinburgh Postnatal Depression Scale (EDPS), Perinatal depression, ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge|GAD-7, Anxiety, ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge|Post-Traumatic Stress Disorder Questionnaire (PPQ), PTSD, ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device
NCT Number: NCT06467903
Acronym: Retina
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Interventions: DEVICE: SW as medical devices(comperator) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) .
Sponsor: Bonmedix Holding a.s.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-06-07
Completion Date: 2024-12-15
Locations: Jakub Sedivy, Příbram, Or, Czechia

Summary:
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device

Primary Outcome Measures: Sensitivity and specificity, The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard., 3 months
Knowledge of Vital Pulp Therapy in Permanent Teeth After Educational Programme: A Before and After Study
NCT Number: NCT06467890
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulp Disease, Dental|Knowledge
Interventions: BEHAVIORAL: Educational programme about vital pulp therapy
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 550
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-05-30

Summary:
evaluating the extent of knowledge of vital pulp therapy in permanent dentition among a group of dental interns in Egypt after educational programme.

Primary Outcome Measures: Knowledge of vital pulp therapy, Online Questionnaire, percentage will be the measuring unit, 6 months
Causes, Characteristics and Treatment of Hypercalcemia in the Emergency Room of a German Hospital
NCT Number: NCT06467877
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypercalcemia
Sponsor: University of Cologne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-01-01
Completion Date: 2025-12-31
Locations: Department II of Internal Medicine,University of Cologne, Cologne, 50937, Germany

Summary:
Patients with hypercalcemia were identified in the patient population of a German emergency department during a 11 year time period and studied regarding reproducibility of elevated calcium values, causes of hypercalcemia, symptoms. acute renal injury, mortality and treatment response.

Primary Outcome Measures: Course of total calcium values, Overview of total calcium values within 5 days, 5 days after enrollment
Secondary Outcome Measures: Reproducibility of elevated calcium values, Determination of cause of hypercalcemia, of symptoms, of treatment response. In dependence of hospital stay, kann be determined later than 5 days after enrollment, 5 days after enrollment|Correlation creatinine calcium, Determination of correlation between calcium and creatinine., 5 days after enrollment|Mortality, occurence of death within of 5 days after enrollment, 5 days after enrollment
Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response: A Multi-center Prospective Study
NCT Number: NCT06467864
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pneumonia, Ventilator-Associated|Respiratory Tract Infections|Prognosis
Interventions: PROCEDURE: bronchoscope
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-05-29
Locations: he First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 21000, China

Summary:
We are using a tool called QtNGS to measure the abundance of local pathogens in patients with ventilator-associated lower respiratory tract infections. We hypothesize that changes in pathogen abundance before and after treatment are related to patient outcomes. This study aims to evaluate the effectiveness of the tool by analyzing the changes in pathogen abundance and exploring the relationship between these changes and clinical outcomes.

Primary Outcome Measures: 28-day Mortality Rate, The 28-day mortality rate will be measured to determine the percentage of patients who die within 28 days of study enrollment. This outcome will help assess the effectiveness of QtNGS in evaluating early microbiological response., 28 day after enrollment
Effect of Suanzaoren Decoction and Huanglian Wendan Decoction on Biorhythm of Insomnia Patients
NCT Number: NCT06467851
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Insomnia|Melatonin|Circadian Rhythm|Suanzaoren Decoction and Huanglian Wendan
Interventions: DRUG: Suanzaoren Decoction and Huanglian Wenda Decoction
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT
Enrollment: 19
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-31
Completion Date: 2024-04-10
Locations: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, China|The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 224000, China

Summary:
The purpose of this study was to examine the impact of Chinese medicine on melatonin levels in patients with insomnia

Primary Outcome Measures: Changes from Baseline in melatonin concentration at Week 4, The level of melatonin in the body, Baseline and Week 4
Secondary Outcome Measures: Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks, The Pittsburgh sleep quality index (PSQI) is a validated,self-reported instrument assessing the sleep quality over the past 4 week period. Possible scores range from 0(the best sleep quality) to 21(the worst possible sleep) quality).The higher the score of PSQI, the worse the sleep quality. Change=(Month 1 Score-Baseline Score), Baseline and Week 4|Change from Baseline in the total score of Morning and Evening Questionnaire (MEQ) at 4 weeks, The Morning and Evening Questionnaire (MEQ) was used to evaluate the type of biological clock of subjects, Baseline and Week 4
Airway Approaches of Anesthesiology and Reanimation Physicians in Cervical Neck Trauma Patients in Turkey
NCT Number: NCT06467838
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Trauma Patients|Surgery|Trauma|Survey
Sponsor: Kocaeli Derince Education and Research Hospital
Collaborators: Kocaeli City Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 322
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-07-30
Locations: KocaeliDERH, Kocaeli, 41400, Turkey

Summary:
Title: Airway Approaches of Anesthesiology and Reanimation Physicians in Cervical Neck Trauma Patients in Turkey: A Survey Study This study aims to evaluate the knowledge, awareness levels, and equipment adequacy of anesthesiology and reanimation physicians in Turkey regarding airway management in cervical neck trauma patients through a 32-question online survey. The findings will inform targeted improvements in training and resource allocation to enhance clinical outcomes in this patient population.

Primary Outcome Measures: Survey, Knowledge and Awareness Level:Assessment of the baseline knowledge and awareness levels of anesthesiology and reanimation physicians in Turkey regarding the airway management of cervical neck trauma patients., 6 months|SURVEY, Evaluation of the availability and adequacy of the equipment used by physicians during airway management in cervical neck trauma cases. This measure will determine whether the existing equipment meets the standards required for safe and effective intubation and ventilation., 6 months