pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
NCT Number: NCT06585410
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)
Interventions: DRUG: Cemiplimab|PROCEDURE: Standard of care
Sponsor: Regeneron Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 369
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-28
Completion Date: 2029-06-03

Summary:
This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells.

The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.

The study is looking at:

* The side effects cemiplimab might cause
* How well cemiplimab works

Primary Outcome Measures: Event-Free Survival (EFS) as assessed by the investigator, Up to 1 year|EFS as assessed by the investigator, Up to 3 years
Secondary Outcome Measures: Composite Complete Response (CCR) for Target Lesion (TL), Experimental Arm, At week 13|Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL), Experimental Arm, Baseline and at week 13|Incidence of Treatment Emergent Adverse Events (TEAEs), Up to 3 years|Severity of TEAEs, Up to 3 years|Size of surgical defect, At week 13|Size of biopsy defect, At week 13
Evaluation of a 6-month Intragastric Balloon
NCT Number: NCT06585371
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity and Overweight
Sponsor: MEDICONE PROJETOS E SOLUCOES PARA A INDUSTRIA E A SAUDE LTDA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-10-31

Summary:
Post-market observational, adaptive, single-arm clinical study to evaluate the percentage of total weight loss after treatment with an intragastric balloon. Patients will be followed for 6 months after the device is installed.

Primary Outcome Measures: Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon, To analyze the percentage of total weight loss 6 months after installation of the intragastric balloon, the following formula will be used:

Percentage of total weight loss = kilos lost/initial weight x 100, From the installation of the balloon to the end of treatment at 6 months
Secondary Outcome Measures: Number of Adverse event occurrence assessed by clinical evaluation, Adverse event monitoring through medical clinical evaluation, From the installation of the balloon to the end of treatment at 6 months|Weight changes 6 months after installation of the balloon assessed by anthropometric balance in in-person consultations, Patients will be weighed on an anthropometric balance during in-person consultations, From the installation of the balloon to the end of treatment at 6 months|BMI changes 6 months after the installation of the intragastric balloon assessed by BMI calculation in in-person clinical consultations, To analyze the BMI changes, the BMI will be calculated in the follow-up medical consultations by dividing the weight (in kg) by the square of the height (in meters), according to the following formula: BMI = weight/(height x height), From the installation of the balloon to the end of treatment at 6 months|Abdominal circumference changes 6 months after the intragastric balloon installation assessed by measuring tape in in-person clinical consultations, To measure abdominal circumference, during in-person medical consultations, the patient will stand with arms extended at the side of the body, feet apart and parallel. The measuring tape will be positioned around the abdomen, midway between the lower costal margin and the iliac crest., From the installation of the balloon to the end of treatment at 6 months
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
NCT Number: NCT06585358
Acronym: DoseTB
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tuberculosis, Pulmonary
Sponsor: Karolinska Institutet
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2027-09

Summary:
The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug exposure of TB drugs during TB treatment.

Main research questions:

In adult patients with drug-susceptible pulmonary tuberculosis, can the use of current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase i.e. time from PK sampling to dose adjustment (keep or adjust dose)?

Specific aims

I. To perform a process evaluation of early MIPD for rifampicin, isoniazid, pyrazinamide and ethambutol during active TB treatment.

II. To study the target attainment of first-line TB drugs with MIPD.

III. To evaluate model precision of predicted versus detected drug concentrations.

Drug concentrations will be measured in study participants during TB treatment and drug exposure and optimal dose predicted by MIPD, using pharmacokinetic population models.

Primary Outcome Measures: Proportion of predicted dose, Proportion of participants with predicted doses of rifampicin, isoniazid and/or pyrazinamide within 5 days from sampling (%), Within the first 5 days from sampling
Secondary Outcome Measures: Proportion reaching predicted drug exposure, For participants with dose-predicted treatment, proportion who will reach the target levels for rifampicin, isoniazid and/or pyrazinamide after MIPD, Through study completion, an average of one month|Model precision, Precision of the model comparing predicted drug levels to the detected drug levels (%), Through study completion, an average of one month
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia
NCT Number: NCT06585345
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Acute-Leukemia
Interventions: BIOLOGICAL: CD7 CAR-T cell
Sponsor: The General Hospital of Western Theater Command
Collaborators: YakeBiotech Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-18
Completion Date: 2030-11-01
Locations: The General Hospital of Western Theater Command, Chengdu, Sichuan, China

Summary:
Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.

Primary Outcome Measures: Number of Adverse Events, Adverse events are evaluated with CTCAE V4.03, 12 months|Overall response rate (ORR), ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%., 24 months
Secondary Outcome Measures: Duration of overall response (DOR), Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up, 24 months|Progression-free survival(PFS), PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up., 24 months|Overall survival(OS), OS will be assessed from the CAR-T cell infusion to death or last follow-up, 24 months
Other Outcome Measures: the duration of CAR T-cells in vivo, the time of CAR-T cells' persistence in blood and the copies of CAR-T cells, 24 months|CAR-T related cytokine expression, CAR-T related cytokine expression, 24 months
Handgrip and Respiratory Dysfunction in HD Patients.
NCT Number: NCT06585332
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Huntington Disease
Sponsor: General University Hospital, Prague
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-10

Summary:
Hereditary neurodegenerative diagnosis of Huntington's disease (HD) is associated with a progressive deterioration of the respiratory system function . This fact contributes strongly to the increased risk of aspiration pneumonia as a primary cause of death in people with HD. But regularly objective monitoring of the airway system condition is in common clinical practice almost impossible for high time requirements and the need for specialized expensive devices . This drives the need for a simpler and more cost-effective screening tool. In recent years published studies, working with all ages and genders, show correlation between hand grip strength (HGS) and respiratory parameters. As a second simple screening tool, we chose a short questionnaire called the Index of pulmonary dysfunction.

Primary Outcome Measures: Maximal Hand grip strength, Unit of Measure: kg Assessment followed recommendation of The American Society of Hand Therapists. HSG is measured using DHD-1 digital hand dynamometer (SAEHAN®,Seahan Corporation)., Up to 35 weeks (once on a single screening visit)|Voluntary peak cough flow, Unit of measure: l/min Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines., Up to 35 weeks (once on a single screening visit)|Maximal expiratory pressure, Maximal inspiratory pressure, Unite of measure: cmH2O Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines., Up to 35 weeks (once on a single screening visit)
Secondary Outcome Measures: Index of Pulmonary dysfunction, Questionnaire of four questions. Scale range: 0-11 points A higher score indicates a worse pulmonary condition., Up to 35 weeks (once on a single screening visit)
Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19
NCT Number: NCT06585319
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: COVID 19
Interventions: DRUG: Collagen-polyvinylpyrrolidone|DRUG: Pirfenidone 1200 mg
Sponsor: Materno-Perinatal Hospital of the State of Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-02-01
Completion Date: 2024-08-31
Locations: Monica Pretelini Saenz Maternal Perinatal Hospital, Toluca, State Of Mexico, 50120, Mexico

Summary:
Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms. This work explores the therapeutic effects of both, on the early treatment of patients with severe COVID-19. The hospital stay, quick COVID-19 severity index (qCSI) and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone, compared to the controls treated with dexamethasone alone.

Primary Outcome Measures: Number of patients that survived the COVID-19 infection, After each of the treatments that were given for seven days, the evolution of the patients was recorded., From enrollment until one month of follow up
High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Sedative Gastroscopy
NCT Number: NCT06585306
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoxia|Obesity|Gastrostomy
Interventions: BEHAVIORAL: jaw lift, increasing oxygen flow, mask ventilation, intubation
Sponsor: XiaoLiang Wang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 882
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-10-10
Completion Date: 2025-10-20
Locations: Nanjing First Hospital, Nanjing, Jiangsu, 210006, China

Summary:
Obese patients often have fat accumulation in the head and neck, increased soft tissue in the oropharynx, decreased lung compliance, decreased lung volume and residual volume, and some obese patients also suffer from obstructive sleep apnea. Therefore, obese patients may experience hypoxemia during sedative gastroscopy. High-flow nasal cannula oxygen therapy (HFNC) can provide patients with high-flow (20-70 L/min) and adjustable oxygen concentration (21%-100%) through a special nasal prong catheter. It has the function of warming and humidifying the air, relieving pressure on the nasal mucosa, maintaining airway patency and moisture, reducing the risk of nasal bleeding. In addition, HFNC can generate positive airway pressure (3-7 cmH2O), increase end-expiratory volume, help with alveolar recruitment, prevent atelectasis, and reduce shunts. The flow rate of HFNC is positively correlated with the nasopharyngeal pressure. At a flow rate of 50 L/min, the nasopharyngeal pressure can exceed 3 cmH2O. Obese patients are prone to upper airway obstruction under sedation or anesthesia. The use of HFNC at 70 L/min perioperatively can reduce hypoxemia in patients, but discomfort in the nasopharynx may occur at this flow rate. The optimal flow rate for clinical use of HFNC has not been established. Meta-analysis shows that when the oxygen flow rate during painless esophagogastroduodenoscopy is greater than 30 L/min, it can significantly reduce the incidence of hypoxemia in patients. Therefore, for obese patients undergoing painless esophagogastroduodenoscopy, the investigators propose using HFNC at three different flow rates: 30 L/min, 50 L/min, and 70 L/min, to provide guidance on the optimal flow rate for clinical use of HFNC.

Primary Outcome Measures: incidence of hypoxia, 75% ≤ SpO2 \< 90% for \<60 s, through gastroscopy completion, an average of 6min
Secondary Outcome Measures: incidences of subclinical respiratory depression and severe hypoxia, (90% ≤ SpO2 \< 95%) and (SpO2 \< 75% for any duration or 75% ≤ SpO2 \< 90% for ≥60 s), through gastroscopy completion, an average of 6min|occurrence of adverse reactions other than hypoxia, body movements, vomiting, reflux, bronchospasm, through gastroscopy completion, an average of 6min|airway intervention measures, jaw lift, increasing oxygen flow, mask ventilation, intubation, through gastroscopy completion, an average of 6min
Assistive Device Satisfaction
NCT Number: NCT06585280
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Assistive Technology|Orthosis|Prosthesis|Device
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2024-10-15

Summary:
Assistive devices are of critical importance for the independence and participation of disabled individuals in society and there is an increasing interest in them today. When the literature is examined, it is seen that there are few studies evaluating the use of orthotic and prosthetic assistive devices in terms of patient satisfaction. The aim of this study is to investigate the satisfaction of individuals using assistive devices in a multifaceted way.

Primary Outcome Measures: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) is a survey used to assess the satisfaction of individuals using technological assistive devices. The first version of the survey, developed by Demers et al. in 1996 to assess the satisfaction of using assistive technological devices, consists of 24 items., 5 minute|Orthotics and Prosthetics Users Survey (OPUS), It is preferred to maintain activity development awareness in prosthesis and orthosis applications, to evaluate changes in quality of life, to make quality assessments and to evaluate patients; functional status and satisfaction with prosthesis and orthosis services., 5 minute
Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis
NCT Number: NCT06585267
Acronym: SYNC01- P4
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Complete Questionnaires Following TKR Surgery
Sponsor: Invibio Ltd
Collaborators: Oxford University Innovation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
Development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis.

Primary Outcome Measures: Validate final questionnaire, Validation of final questionnaire, From first post-op visit to 12month follow-up
A Study to Investigate the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in Adults to Prevent COVID-19
NCT Number: NCT06585241
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: SARS-CoV-2
Interventions: BIOLOGICAL: mRNA-1273 Variant-containing Formulation
Sponsor: ModernaTX, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-06
Completion Date: 2025-10-29

Summary:
The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously vaccinated adults.

Primary Outcome Measures: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants, Day 29|Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants, Day 29
Secondary Outcome Measures: Number of Participants with Serious Adverse Events (AEs), AEs Leading to Study Withdrawal, and AEs of Special Interest, Day 1 through Day 29
Standardization of Physician-Modified Stent Grafts for Abdominal Aortic Aneurysms
NCT Number: NCT06585215
Acronym: RESTORE
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Abdominal Aortic Aneurysm|Endovascular Procedures|Stents|Vascular Surgical Procedures
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2014-06-14
Completion Date: 2025-06-30
Locations: Centro Vascolare Ticino, Servizio di Chirurgia Vascolare e Angiologia, Lugano, Ticino, 6900, Switzerland

Summary:
This study explores the use of physician-modified stent grafts (PMSGs) for treating abdominal aortic aneurysms that are unsuitable for open surgery or standard endovascular grafts. Custom-made fenestrated endografts are not viable in urgent or symptomatic cases due to lengthy manufacturing times. Although off-the-shelf branched devices are more readily available, they present challenges such as high costs, extensive thoracic coverage, limited long-term data, and anatomical restrictions. Parallel graft techniques are also associated with concerns regarding their durability. PMSG procedures, however, are not standardized and rely heavily on the physician's experience and expertise. The aim of this comprehensive study is to establish expert consensus on the indications, planning protocols, and procedural techniques for PMSGs.

Primary Outcome Measures: Expert Consensus on PMSG Indications and Techniques, To achieve expert consensus on aspects regarding indications, planning and performing PMSGs in the treatment of abdominal aortic aneurysms, as determined by the completion of a modified Delphi consensus., 30.06.2025
Secondary Outcome Measures: Survey-Based Review of PMSG Strategies and Techniques, To conduct a survey-based scoping review to identify the predominant strategies and techniques utilized in the execution of PMSGs for interventions on abdominal aortic aneurysms., 30.06.2025|Comparison of 3D-Printed Models and CT-Based Planning, To test the hypothesis that 3-D printed models offer an advantage in terms of fenestration precision compared to CT based planning methods., 30.06.2025
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT Number: NCT06585202
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Atopic Dermatitis
Interventions: DRUG: ATI-2138
Sponsor: Aclaris Therapeutics, Inc.
Sex: ALL
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-05
Locations: Aclaris Investigational Site, Encino, California, 91436, United States|Aclaris Investigational Site, San Diego, California, 92123, United States|Aclaris Investigational Site, Plainfield, Indiana, 46168, United States|Aclaris Investigational Site, Austin, Texas, 78759, United States|Aclaris Investigational Site, San Antonio, Texas, 78213, United States

Summary:
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.

Primary Outcome Measures: Incidence and severity of treatment emergent adverse events (TEAEs), From baseline up to two weeks after treatment (Day 98)
Secondary Outcome Measures: Change from baseline Eczema Area and Severity Index (EASI) Over Time, Up to Week 12|Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time, Up to Week 12|Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time, Up to Week 12|Change in IGA score over time, Up to Week 12|Change from baseline in AD Body Surface Area (BSA) over time, Up to week 12|Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time, Up to Week 12|ATI-2138 trough concentration ng/mL, Day 1 to Week 12|ATI-2138 peak concentration (Cmax) ng/mL, Day 1 to Week 12
CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS4]
NCT Number: NCT06585189
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Metastatic Non Small Cell Lung Cancer
Interventions: DRUG: Pembrolizumab|DRUG: Pemetrexed|DRUG: Cisplatin|DRUG: Carboplatin
Sponsor: Aetion, Inc.
Collaborators: AbbVie|Amgen|AstraZeneca|Bayer|Gilead Sciences|Janssen, LP|Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-02-01
Completion Date: 2023-04-13

Summary:
The goal of this non-interventional study is to emulate the KEYNOTE-189 randomized controlled trial of pembrolizumab for the treatment of metastatic non-small cell lung cancer using real-world, electronic health record data. The main questions this study aims to answer are:

1. Do patients with metastatic non-small cell lung cancer (NSCLC) treated with pemetrexed, cisplatin/carboplatin, and pembrolizumab have improved real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) compared with patients treated with pemetrexed and cisplatin/carboplatin alone?
2. How do the results of this non-interventional study compare to those of the KEYNOTE-189 randomized controlled trial?

Primary Outcome Measures: Real-world overall survival (rwOS), Time from study treatment initiation to death, Study treatment initiation to death or censoring|Real-world progression-free survival (rwPFS), Time from study treatment initiation to disease progression or death, Study treatment initiation to disease progression, death, or censoring
Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City
NCT Number: NCT06585176
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastroesophageal Reflux Disease|Epidemiology|Risk Factors
Sponsor: Zhongshan Hospital (Xiamen), Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-11-30

Summary:
Gastroesophageal Reflux Disease (GERD) is a condition characterized by the reflux of gastric and duodenal contents into the esophagus, primarily manifested by symptoms such as acid regurgitation and heartburn. GERD significantly affects patients' daily lives and health-related quality of life. Prolonged gastroesophageal reflux can lead to repeated irritation of the esophageal mucosa by gastric acid and acidic gastric contents, resulting in the replacement of normal squamous epithelium in the lower esophagus with metaplastic columnar epithelium. This pathological change, known as Barrett's Esophagus (BE), is considered a precancerous lesion for esophageal adenocarcinoma.

Primary Outcome Measures: The prevalence of GERD in Xiamen city, Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disorder in the world. In this study, we will study the incidence of GERD in Xiamen city., 3 months.|The percentage of reflux esophagitis, The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms., 3 months.|The percentage of Barrett esophagus, The percentage of paticipants diagnosed with pathological Barrett esophagus using endoscopy monitoring among patients with baseline symptom in gastroenterology department will be calculated., 3 months.
Secondary Outcome Measures: The life quality of GERD patients who were diagnosed by endoscopy, The life quality of GERD patients with different main symptoms before PPI test will be measured via the 50-item short form health survey , in which higher scores mean a better quality of life., 3 months.|The sensitivity of GERD-Q for diagnosis of GERD, The sensitivity of GERD-Q for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD., 3 months.|The specificity of GERD-Q for diagnosis of GERD, The specificity of GERD-Q for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD., 3 months.
Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
NCT Number: NCT06585163
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Hydrocodone Bitartrate|DRUG: Doxapram Hydrochloride
Sponsor: Quivive Pharma, Inc.
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2024-12
Locations: Cleveland Clinic Main Campus, Cleveland, Ohio, 44195, United States

Summary:
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.

Primary Outcome Measures: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Incidence, nature, and severity of TEAEs, Day 1 to Day 5|Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs, Changes from baseline in physical examination, vital signs, 12-lead ECG assessment and pulse oximetry, Day 1 to Day 5
Secondary Outcome Measures: Plasma PK Parameters (Cmax), Maximal plasma concentrations for hydrocodone and doxapram, Day 2 and Day 4|Plasma PK Parameters (AUC0-inf), Plasma area under the curve for hydrocodone and doxapram, Day 2 and Day 4|Plasma PK Parameters (Tmax), Time to maximal plasma concentrations for hydrocodone and doxapram, Day 2 and Day 4
Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment
NCT Number: NCT06585137
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility, Female
Sponsor: Hacettepe University
Sex: FEMALE
Age: ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-07-01
Completion Date: 2027-07-01

Summary:
The goal of this two-group parallel randomized controlled study is to determine the effect of a web-based mind-body-based awareness program based on Meleis Transition Theory on fertility awareness and readiness levels in women receiving infertility treatment.

Primary Outcome Measures: Fertility Awareness Scale, This scale was developed to measure fertility awareness in women. The scale is Likert-type and has 19 items and two sub-dimensions (Body Awareness, Cognitive Awareness). Items in the scale are scored from 1 to 5 (1-Never, 2-Rarely, 3-Occasionally, 4-Most of the time and 5-Always) and there are no reverse-scored items. Possible scores in total for the scale are 19-95, 10-50 for the "Body Awareness" sub-dimension, and 9-45 for the "Cognitive Awareness" sub-dimension. If the total score is between 19-43, the awareness level is interpreted as ''low'', if it is between 44-69, it is ''medium'', and if it is between 70-95, it is interpreted as ''high''., A pre-test will be administered before the study begins. Then, a post-test will be administered three times, 1 day after the OPU procedure, then at 3 months and 6 months.|Fertility Preparedness Scale for Women Receiving Fertility Treatment, The scale, consisting of 23 questions, was created to measure the readiness of women preparing to become pregnant. The scale consists of 3 sub-dimensions: "hope and awareness", "relaxed body and brain" and "positive feelings and thoughts". Since the scale items consist only of positive expressions, the scores obtained are calculated as they are. The scores of the items are 5, 4, 3, 2, and 1, respectively. The minimum score is 23, the maximum score is 115 on the scale, and a high score indicates that fertility preparedness is strong. The median score on the scale is 56. A score of 56 or higher on the scale indicates that the woman feels more prepared for pregnancy, while a lower score indicates that she feels less prepared., A pre-test will be administered before the study begins. Then, a post-test will be administered three times, 1 day after the OPU procedure, then at 3 months and 6 months.
Secondary Outcome Measures: Introductory Information Form, Follicle-stimulating hormone (FSH) and estradiol (E2) levels, number of oocytes collected, embryo transfer status, and blood pregnancy test results will be taken from the patient file and added to the form., FSH and E2 levels will be monitored on the 2nd-3rd day of the menstrual cycle, the number of oocytes collected on the 16th day of the cycle, embryo transfer status on the 18th day of the cycle, and pregnancy test on the 28th day of the cycle.
Flow Cytometry for the Study of T-Cell Populations in Hemophagocytic Lymphohistiocytosis Associated With Lymphomas
NCT Number: NCT06585124
Acronym: LA-HLH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lymphoma|Hemophagocytic Lymphohistiocytoses
Interventions: DIAGNOSTIC_TEST: Flow Cytometry
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-05-01
Locations: Stefan Hohaus, Rome, Lazio, 00168, Italy

Summary:
The goal of this study is to explore the associations between T cell activation and the occurrence of hemophagocytic lymphohistiocytosis (HLH) in patients with newly diagnosed lymphomas. The specific aims are:

Prediction of Lymphoma-Associated HLH (LA-HLH): Compare flow cytometric T cell activation markers with the H-score to predict LA-HLH.

Identification of new markers for predicting HLH in patients with aggressive lymphoma.

Description of the incidence rate of LA-HLH. Assessment of the outcomes of LA-HLH identified by flow cytometric analysis or the H-score.

This prospective, single-center observational study will include 150 patients newly diagnosed with aggressive lymphoma within one year. Peripheral blood samples will be taken at diagnosis alongside routine blood chemistry tests for flow cytometric analysis of the T-lymphocyte activation profile. Data on disease characteristics will be collected to calculate the H-score, HLH-2004 score, and OHI score for diagnosing HLH. The flow cytometry results will be compared with these scores to evaluate their effectiveness in diagnosing LA-HLH.

Primary Outcome Measures: Assocation of flow cytometry parameters on peripheral blood with the H-score, the standard for the diagnosis of lymphoma-associated HLH, Diagnostic rate of flow cytometry for lymphoma-associated HLH, 2 years
Secondary Outcome Measures: Determine the incidence of LA-HLH, incidence rate, 2 years|To evaluate the outcome of patients with LA-HLH, overall survival, 2 years|Define the rate of complete responses to lymphoma treatment, Complete remission rate, 2 years
Pancreatic Cancer and Diabetes Mellitus
NCT Number: NCT06585072
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreatic Cancer|Surgery|Diabetes Mellitus
Sponsor: Shanghai Changzheng Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-03
Completion Date: 2026-09-01

Summary:
The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:

1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
2. Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.

The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.

Primary Outcome Measures: Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus), The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association., From enrollment to five years after the end of the surgery
Secondary Outcome Measures: Overall Survival, From enrollment to five years after the end of the surgery|Disease-Free Survival, From enrollment to five years after the end of the surgery
The Risk Factors and Its Prognosis of Hyperglycemia Secondary to Pancreatic Surgery
NCT Number: NCT06585046
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pancreatic Surgey|Diabetes Mellitus
Sponsor: Shanghai Changzheng Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 382
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-01-01
Completion Date: 2024-08-01

Summary:
The goal of this observational study is to learn about post-pancreatic surgery diabetes mellitus(PCRD).The main questions it aims to answer are:

1. What are the clinical characteristics of PCRD?
2. What are the related factors for PCRD? All patients with pancreatic surgery have been given standardized treatment fot the condition.

The researchers will summarize the risk factors for PCRD from the PCRD group.

Primary Outcome Measures: Incidence of glycaemic disorders（prevalence of diabetes） (postoperative fasting blood glucose/HbA1C), The main objective of this study was the incidence of glucose metabolism disorders in patients treated with pancreatic surgery in our centre., (within 5 years after surgery)
Secondary Outcome Measures: overall survival, within 5 years after surgery|Disease-Free Survival, within 5 years after surgery
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
NCT Number: NCT06585020
Acronym: AKAPI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mycobacterium; Xenopi|Lung Diseases
Sponsor: Centre Hospitalier Universitaire, Amiens
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-08

Summary:
Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression. The outcome of these patients is poor, and treatment is very long. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast majority patients have converted after 6 months of treatment, so a 18 months duration in total. Unfortunately, few data are available for MX, as it is rare in USA, but it is the second NTM isolated in France and concerns an increasing number of patients. As it is uncommon in USA, no clinical studies conducted by the pharmaceutical laboratory will be planned. In a murine model of MX infection, the only drug which decreased the number colony formant units in mice lungs, was amikacin. Until now, amikacin was only available intravenously and used only for patients with very severe disease, because of renal and auditory toxicity. Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery. ARIKAYCE® increases amikacin uptake into alveolar macrophages, a refuge for NTM organisms; allows biofilm penetration; and limits systemic amikacin exposure ARIKAYCE® has already be tested in a randomized study on M. avium complex (MAC) refractory pulmonary infections. In this study, the culture conversion rate in the ARIKAYCE® group was higher than standard regimen group.

Primary Outcome Measures: variation of sputum conversion rate in ARIKAYCE® addition group compared to standard treatment, 3 months
Secondary Outcome Measures: variation of time to culture conversion between both groups, at 3 month|variation of mortality between both groups, at 12 months|variation of mortality between both groups, at 24 months
Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer
NCT Number: NCT06585007
Acronym: MEDCARE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Castration-resistant Prostate Cancer|Oligoprogressive
Interventions: RADIATION: Radiotherapy|PROCEDURE: metastasectomy
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 246
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-19
Completion Date: 2029-01-20
Locations: University Hospitals Leuven, Leuven, Belgium

Summary:
Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

Primary Outcome Measures: Overall Survival, Overall Survival, will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.
Secondary Outcome Measures: Quality of life scoring EORTC QLQ-C30, Quality of life scoring using the EORTC QLQ-C30, Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24|Quality of life scoring EORTC QLQ-PR25, Quality of life scoring using the EORTC QLQ-PR25, Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24|Quality of life scoring EQ-5D-5L, Quality of life scoring using the EQ-5D-5L., Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24|Cancer Specific Survival, Cancer Specific Survival, will be calculated from the day of randomisation until prostate cancer death, assessed up to 5 years.|Radiographic progression free survival, Radiographic progression free survival, will be calculated from the day of randomisation until the first day of progression (local, nodal or metastatic). Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms, assessed up to 5 years.|Progression-directed therapy induced acute or late toxicity scoring, Acute and late toxicity as a result of radiotherapy will be scored using the Common Toxicity Criteria Version 5.0 and metastasectomy related toxicity will be scored using Clavien Dindo scoring system., Toxicity will be scored every follow-up visit, assessed up to 5 years after progression-directed therapy.
Investigating the Role of Genetics in Disease Predisposition
NCT Number: NCT06584994
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Predisposition, Genetic|Cancer|Mutation|Fertility Disorders
Sponsor: The Wellcome Sanger Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-20
Completion Date: 2027-03-01

Summary:
Gametogenesis is the production of sperm and eggs; it takes place through the process of meiosis. Gametogenesis is subject to the acquisition of mutations as with other processes in the body. Many of these mutations are somatic, meaning that they occur during life as part of the process of cell division rather than being passed down from parents. When somatic mutations take place during gametogenesis, there is the potential for hereditary genetic consequences. However, the processes that cause the mutations during gametogenesis and the implications they have for heritability and disease predisposition are poorly understood.

The goal of this research is to provide a detailed description of the genetic changes in gonadal tissues, and to understand how mutations acquired during the production of germ cells (sperm and eggs) contribute to the predisposition to a wide range of rare diseases and cancer predisposition in future offspring.

Primary Outcome Measures: How often mutations accumulate in healthy reproductive tissues, Establish how often mutations (changes in DNA) accumulate in healthy reproductive tissues (testes and ovaries)., 7 years
Secondary Outcome Measures: Identification and Characterisation of Mutations, Determine the genetic changes in gonadal tissues, including the frequency, type, and nature of mutations acquired during germ cell production, and identify the genes and cellular processes that these mutations may alter., 7 years|Comparative Analysis of Mutation Rates, Compare mutation rates in gonadal tissues across different age groups, sexes, and individuals with or without cancer predisposition syndromes., 7 years|Inheritance and Transmission Risk, Assess the inheritance risk and rate of transmission of pathogenic mutations by analysing the proportion of germ cells carrying these mutations in affected individuals and comparing them to unaffected donors., 7 years
Effect of PECS II, Parasternal and Serratus Plane Blocks on Postoperative Pain in MIDCAB Surgery
NCT Number: NCT06584981
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Postoperative|Coronary Artery Disease
Interventions: PROCEDURE: pectoral nerve block (PECS II), parasternal and serratus plane blocks|OTHER: analgesic
Sponsor: Hisar Intercontinental Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09
Completion Date: 2024-10

Summary:
AIM: It was aimed to evaluate the effectiveness of pectoral nerve block (PECS II), parasternal and serratus plane blocks in postoperative analgesia in minimally invasive cardiac surgery (MIDCAB).

INTRODUCTION: The frequency of minimally invasive cardiac surgery has increased in recent years. With this method, Coronary artery bypass graft (CABG) operations can be performed without sternotomy. It is a beneficial method for early postoperative mobilization, early recovery and better aesthetic appearance. Since there is a surgical intervention between the ribs, pain control is important in these patients.

METHOD: In the preoperative evaluation of patients planned for CABG, PECS II, parasternal and serratus plane blocks are routinely recommended for postoperative pain control. Consent for the procedure is obtained from patients who accept this procedure. After induction and before the surgical incision, these block applications are performed under sterile conditions under the guidance of ultrasonography. Standard intravenous analgesic agents are applied to our patients who do not accept block applications. The hospital core system files of our patients who underwent cardiac surgery with minimally invasive intervention in our hospital between January 1, 2021 and December 31, 2021 will be scanned retrospectively. Patients with and without block application will be divided into two groups. From our patients' files; Demographic data, extubation time, drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted. In addition, it will be noted whether there is a need for additional rescue analgesia in cases where block is performed. The data obtained will be evaluated statistically and the results will be published in national or international scientific journals.

Primary Outcome Measures: Analgesic efficiency, drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted