pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries
NCT Number: NCT06478654
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain
Interventions: PROCEDURE: Bilateral Modified Pectoral Nerve Block (PECS II).|PROCEDURE: Bilateral Thoracic Erector spinae plane block (ESPB).
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-03-01
Completion Date: 2024-10
Locations: Yasmeen mohamed, Cairo, Egypt

Summary:
The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries.

Primary Outcome Measures: the time interval from end of the block technique to first supplemental dose of analgesia in hours., Postoperative pain will be evaluated by Numeric Rating Scale for pain (NRS Pain) which is a 11 point scale divided as 0=no pain,1-3(mild pain), 4-7(moderate pain) and 7-10(severe pain), 0-10 scale will be recorded by the main investigator at PACU, 2, 4, 8, 12,18 and 24 hours postoperatively.

First rescue analgesia will be given with Injection Morphine sulfate (0.1mg/kg) IV when numerical rating scale score is equal to or more than 4. If the patient requires second dose of rescue analgesia only half of the original dose of morphine is given taking into consideration the adverse effect of morphine, 24 hours
Secondary Outcome Measures: Total morphine doses in mg., Total morphine consumption in 24 hours postoperative will be calculated, 24 hours
Expanded Use in Persistent (B. Microti) Babesiosis
NCT Number: NCT06478641
Status: AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Persistent Babesiosis
Interventions: DRUG: Tafenoquine
Sponsor: 60 Degrees Pharmaceuticals LLC
Sex: ALL
Age: ADULT, OLDER_ADULT

Summary:
The purpose of this expanded access protocol is to offer a potentially effective treatment (tafenoquine) to patients with persistent babesiosis, who have not responded to standard of care treatments, and who are immunocompromised and thus at risk for more serious complications. Tafenoquine will be self-administered orally as 2 x 100 mg dark pink coated tablets once daily (total daily dose 200 mg) with food on Days 1, 2, 3 \& 4 then weekly thereafter (starting on day 11) until the patient has two consecutive negative PCR tests for Babesia parasites and symptoms of babesiosis have resolved. Other standard of care treatments recommended in the 2020 IDSA Guideline on Diagnosis and Management of Babesiosis should also be included in the treatment regimen.
Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation
NCT Number: NCT06478628
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Musculoskeletal Pain|Insomnia
Interventions: BEHAVIORAL: Inpatient rehabilitation|BEHAVIORAL: Outpatient day rehabilitation
Sponsor: Norwegian University of Science and Technology
Collaborators: Unicare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2026-06-30
Locations: Unicare Helsefort, Rissa, 7112 Hasselvika, Norway

Summary:
The main purpose of this project is to conduct a prospective cohort study in order to better understand the importance of insomnia symptoms in patients referred to interdisciplinary rehabilitation due to chronic pain. Moreover, this project will also raise awareness on how insomnia symptoms, alone, and in interplay with factors such as function, psychological distress, physical activity, and fatigue impact on patient's prognosis and work ability. Our aim is that this knowledge can be used to design new interventions and improve rehabilitation programs for this patient group.

Primary Outcome Measures: Insomnia, Measured by Insomnia severity index (ISI), Baseline|Pain intensity, Measured by visual analogue scale (0 to 100 scale), Baseline
Secondary Outcome Measures: Health-related quality of life, Measured by the the 5-level EQ-5D version (EQ-5D-5L) questionnaire. The index value range ranges from -0.285 to 1, where lower values indicate poorer health-related quality of life., Baseline|Fatigue, Measured using a visual analogue scale from 0 to 100, Baseline|Function, Measured by the patient-specific functional scale (PSFS), Baseline|Physical activity, Measured by questions from the HUNT study, Baseline|Workability, Measured by the workability index single item (self- assessed work ability on a 0-10 scale), Baseline|Symptoms of anxiety and depression, Measured by the Hopkins Symptom Checklist-25 (HSCL-25), mean score calculated (1-4), Baseline|Prescriptions, Use of sleep psychotropic medications, and pain medications based on registry data, Up to five years before rehabilitation and one year after rehabilitation|Sickness absence, Use of medical benefits based on registry data, Up to five years before rehabilitation and one year after rehabilitation|Health care use, Health care use in primary care based on registry data, Up to five years before rehabilitation and one year after rehabilitation
Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula
NCT Number: NCT06478615
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coring Out|Fistulectomy|Internal Sphincter|Lay Open Fistulotomy|Sphincter Repair|Transsphincteric Perianal Fistula
Interventions: PROCEDURE: Coring out Fistulectomy with Closure of Internal Sphincter Opening|PROCEDURE: Lay Open Fistulotomy and Primary Sphincter Repair
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-30
Completion Date: 2024-03-01
Locations: Ain Shams University, Cairo, 11591, Egypt

Summary:
This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula

Primary Outcome Measures: Incidence of recurrence of perianal fistula, Incidence of recurrence of perianal fistula was recorded and confirmed when an anal fistula or abscess is observed on any previously healed wound for 3 months., 3 months postoperatively
Secondary Outcome Measures: Incidence of stool incontinence, Incidence of stool incontinence was recorded for 3 months., 3 months postoperatively|Healing time, Healing was defined as cicatrization of all wounds without discharge at 3 months, 3 months postoperatively|Length of hospital stay, Length of hospital stay was recorded from admission till discharge from hospital., 1 week postoperatively|Complications, Complications such as (blood loss, pain, bleeding, discharge, urinary retention, urgency, wound infection) were recorded., 3 months postoperatively
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
NCT Number: NCT06478602
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Liver Cirrhosis
Interventions: BIOLOGICAL: Fecal microbiota transplantation
Sponsor: Cristian Ichim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-15
Completion Date: 2026-03-31
Locations: County Clinical Emergency Hospital of Sibiu, Sibiu, 550245, Romania

Summary:
The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).

Primary Outcome Measures: Implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis., The transfer of microbiota could potentially influence hepatic fibrosis via the gut-liver axis, as well as other complications caused by cirrhosis such as encephalopathy, ascites etc., Up to 3 months|Implications of fecal microbiota transplantation in modulating the condition of other organs., The transfer of microbiota could potentially modulate the function of other major organs in the body., Up to 3 months
A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity
NCT Number: NCT06478563
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity|Overweight
Interventions: DRUG: NNC0487-0111 (formulation D)|DRUG: NNC0487-0111 (formulation C)
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2025-01-27
Locations: Celerion, Lincoln, Lincoln, Nebraska, 68502, United States

Summary:
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).

Primary Outcome Measures: Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state, Measured as hours\*nanomoles per liter (h\*nmol/L), From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Secondary Outcome Measures: Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state, Measured as nanomoles per liter (nmol/L), From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126|Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state, Measured as hours, From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126|Phase B: The area under the NNC0487-0111 plasma concentration-time curve, Measured as h\*nmol/L, From pre-dose to after dosing on day 132|Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose, Measured as nmol/L, From pre-dose to after dosing on day 132|Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose, Measured as hours, From pre-dose to after dosing on day 132|Phase B:The terminal half-life of NNC0487-0111 after the last dose, Measured as hours, From pre-dose on day 132 until completion of the end of study visit (day 153)|Number of treatment emergent adverse events (TEAE), Measured as number of events, From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)
A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment
NCT Number: NCT06478550
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2025-06-26
Locations: University Hospital of Athens ATTIKON, Haidari-Athens, Attica, GR-12462, Greece|General Hospital Of Thessaloniki Papageorgiou, Thessaloniki, Nea Efkarpia, 56429, Greece|"Laiko" General Hospital of Athens, Goudi/Athens, 11527, Greece|Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, Larissa, GR-41110, Greece|Tzaneio General Hospital of Piraeus, Piraeus, GR-18536, Greece|General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki, GR-54635, Greece

Summary:
This study looks at how participants with type 2 diabetes take Ozempic® and if the Ozempic® app helps participants to stay on this treatment. Participants will already be prescribed with Ozempic® by the study doctor. Participants may be asked to use a device called Mallya®, which participants must attach to their Ozempic® injection pen. Participants might also be asked to install an Ozempic® app on their mobile phone which supports the participants in the use of Ozempic®. At the beginning and at the end of this study, the participants will have to fill out some questionnaires about their diabetes treatment. Participants may also be chosen to participate in a voluntary non-mandatory interview after the study has ended. The total duration of study is approximately 10 months.

Primary Outcome Measures: Persistency of semaglutide s.c. treatment in PSS app with connectivity vs control arm (Yes/No) (HCP reported), Measured as number of participants (Yes/No)., At Visit 2 (week 16)
Secondary Outcome Measures: Time from first dose to discontinuation (HCP reported), Measured in days., From Visit 1 (week 0) to Visit 2 (week 16)|HCP prespecified maintenance dose achieved at V2 (week 16), Measured as number of participants (Yes/No)., At visit 2 (week 16)|Time to HCP prespecified maintenance dose (HCP reported), Measured in days., From Visit 1 (week 0) to Visit 2 (week 16)
TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
NCT Number: NCT06478537
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Immune Thrombocytopenia
Interventions: DRUG: Hetrombopag Olamine|DRUG: Aspirin
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2027-06-20
Locations: Peking Union Medical College Hospital, Beijing, Beijing, China

Summary:
The aim of this study was to observe whether maintaining a high level of platelet count after TPO-RA in patients with primary immune thrombocytopenia (ITP) can induce immune tolerance, develop immune balance in ITP patients, and enable patients to achieve a sustained response (SRoT) after TPO-RA discontinuation.

Primary Outcome Measures: Sustained response off treatment (SROT), The percentage of participants with successful discontinuation of TPO-RAs after tapering and discontinuation, 3 year
Secondary Outcome Measures: Quality of life (QoL), The degree to which an individual is healthy, comfortable, and able to participate in or enjoy life events according to the MOS 36-item short-form health survey (SF-36) at week1, week24 and week56 (±5 d)., 3 year|Duration of Complete response (DCR), The time from the first assessment of complete resonse (platelet count ≥ 100 × 10\^9/L, without bleeding) until the date of the first occurrence of progression, or until the date of death.t, 3 year|Duration of Response (DoR), The time from the first assessment of response (platelet count ≥ 50 × 10\^9/L) until the date of the first occurrence of progression, or until the date of death., 3 year|Adverse events, The incidence and severity of thromboembolism, as well as other commonly used indicators such as abnormal clinical symptoms and vital signs, abnormalities observed in laboratory tests, are recorded.Toxicity will be graded according to NCI-CTC AE 5.0., 3 years|Bleeding events, Bleeding events occurring in patients due to ITP, 3 years
Music Intervention for Dialysis Patients
NCT Number: NCT06478524
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Renal Failure
Interventions: BEHAVIORAL: Live music|BEHAVIORAL: Pre-recorded music
Sponsor: National University of Singapore
Collaborators: National Kidney Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-27
Completion Date: 2025-12-31
Locations: NKF Clementi Dialysis Centre, Singapore, 120326, Singapore|Integrated Renal Care Centre, Singapore, 649808, Singapore

Summary:
The goal of this clinical trial is to examine the efficacy of both live and pre-recorded music interventions on alleviating the negative effects of dialysis treatment.

The main questions it aims to answer are:

* Does music intervention have an effect on experienced pain, itch, anxiety, depression, and quality of life in dialysis patients?
* To what extent do pre-recorded and live music performances differ in their effect on experienced pain, itch, anxiety, depression, and quality of life in dialysis patients?

Participants will Attend their regularly scheduled dialysis appointments for one week, and baseline data will be gathered (pain/itch NRS, WHO-5, DASS21).

During the second week, participants will be exposed to live music, and research data will be gathered.

This process will then be repeated in weeks 3 and 4, but with pre-recorded music as the intervention method.

Researchers will compare baseline data to intervention data (within group comparison), as well as live music to pre-recorded (between group comparison).

Primary Outcome Measures: DASS-21, Mental Health, Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.
Secondary Outcome Measures: WHO-5, Quality of Life, Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.
Other Outcome Measures: Pain and itch numerical ranking scale, Survey, Twice per week (first and third session of the week), for both baseline and intervention. Taken across all 4 weeks.
Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants
NCT Number: NCT06478511
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Immediate Implants
Interventions: PROCEDURE: Classic Immediate implant|PROCEDURE: Immediate implant combined with subepithelial connective tissue graft|PROCEDURE: Immediate dental implant placement using socket shield technique
Sponsor: Mansoura University
Sex: ALL
Age: ADULT
Enrollment: 33
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-12-05
Completion Date: 2024-04-20
Locations: Faculty of Dentistery, Mansoura, 35516, Egypt

Summary:
The purposes of study are:

1. To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically.
2. To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around implants clinically and radiographically.
3. To assess the efficacy of implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.
4. To compare immediate implant placement versus implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.

Primary Outcome Measures: Clinical success of socket shield technique in immediate implant placement, Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss., 6 months|Clinical success of socket shield technique in immediate implant placement, Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss., 12 months|Clinical success of SECT graft in immediate implant placement, Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss., 6 months|Clinical success of SECT graft in immediate implant placement, Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss., 12 months
Immune Responses in the Skin After Hookworm Infection
NCT Number: NCT06478498
Acronym: HiBiSki
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Necator Americanus Infection
Interventions: BIOLOGICAL: Necator americanus L3 larvae
Sponsor: Leiden University Medical Center
Sex: ALL
Age: ADULT
Enrollment: 5
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2026-10
Locations: Leiden University Medical Center, Leiden, 2333 ZA, Netherlands

Summary:
Five healthy volunteers will be repeatedly exposed to L3 Necator americanus larvae after which two skin biopsies will be taken. Three of the volunteers will be treated two weeks after each infection after which the study will end after 13 weeks. Two of the volunteers will retain the infection for up to two years and will be asked to donate stool samples.

Primary Outcome Measures: Identity of skin effector cells, Identification of effector cells in the skin by Hyperion Imaging Mass Cytometry after repeated controlled hookworm infections, 3 weeks + 1 day after initial infection (timepoint of taking the biopsies)|Correlation between macroscopic skin response and effector cells, Association between the macroscopic skin reaction and effector cells present identified by Hyperion Imaging Mass Cytometry, 3 weeks + 1 day after initial infection (timepoint of taking the biopsies)
Secondary Outcome Measures: Measurement of humoral (antibody responses and cytokines) and cellular immunological changes after controlled hookworm infections, 6 weeks from start of the study|Number of hookworm eggs in faeces after infection, Detection of hookworm eggs by faeces microscopy (Kato-Katz) at week 15-16 in volunteers who volunteered to be chronic donors, 15-16 weeks after start of the study
Other Outcome Measures: Number of adverse events following exposure(s) to hookworm larvae, Number of adverse events following exposure(s) to hookworm larvae, 12 weeks after last infection timepoint
Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI
NCT Number: NCT06478485
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Modified K-line and Modified SC-line in MRI
Interventions: DIAGNOSTIC_TEST: No Intervention: MCSM
Sponsor: Affiliated 2 Hospital of Nantong University
Collaborators: National Natural Science Foundation of China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2027-12-30
Locations: The Second Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226000, China

Summary:
This study intended to investigate the combined Impact of mK-line and mSC-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after LAMP.

Primary Outcome Measures: sex, male or female, From 2020 to 2026|age, years old, no month or date, From 2020 to 2026|Japanese Orthopedic Association (JOA) score, The Japanese Orthopaedic Association (JOA) score is widely used to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Scoring details refer to the Japanese orthopaedic association score (JOA-score modified by Keller 1993), From 2020 to 2026|Visual Analog Scale (VAS) score, A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson.The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS can be presented in a way a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). Patients points the scores and the investigators recorded., From 2020 to 2026|Neck Disability Index(NDI) score, The NDI can be scored as a raw score doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.

0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation., From 2020 to 2026|Cobb angle, The Cobb angle is obtained by drawing parallel lines extending from the lower endplate of the most superior vertebral level (C2) and the lower endplate of the most inferior vertebral level (C7)., From 2020 to 2026|Ishihara's Cervical Curvature Index(CCI), Ishihara's Cervical Curvature Index(CCI) = (a1 + a2 + a3 + a4)/L\*100, where a1 - 4 are the distances between the posterior margins of the inferior endplates of vertebral bodies and a line between the posterior aspects of the inferior endplates of C2 and C7(distance defined as L)., From 2020 to 2026
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
NCT Number: NCT06478472
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Marginal Zone Lymphoma
Interventions: DRUG: Orelabrutinib in combination with rituximab
Sponsor: The First Affiliated Hospital of Xiamen University
Collaborators: The First Hospital of Jilin University|Fujian Cancer Hospital|Guangdong Provincial People's Hospital|Nanfang Hospital, Southern Medical University|The Second Affiliated Hospital of Dalian Medical University|Jiangxi Provincial Cancer Hospital|Wuhan Union Hospital, China|Shanxi Provincial Cancer Hospital|Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-23
Completion Date: 2027-06-23
Locations: Bing, Xu, Xiamen, Fujian, 361003, China

Summary:
Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma

Primary Outcome Measures: CR, Complete remission rate (according to Lugano 2014 criteria), Up to 36 months
Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer
NCT Number: NCT06478459
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Pancreatic Cancer Non-resectable
Interventions: BIOLOGICAL: CAR-NK
Sponsor: Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2026-06-30

Summary:
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.

Primary Outcome Measures: Maximum tolerated dose, Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose, within 28 days after NKG2D CAR-NK treatment|Dose limiting toxicity, Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK, From enrollment of the first subject to completion of follow-up of the last subject（up to 2 years））
Secondary Outcome Measures: Effectiveness evaluation, Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1, At weeks 4，8 and months 3，6，9，12，16，20 and 24 after treatment|Cell continued survival time in vivo, Detect the copy number of NKG2D CAR DNA in peripheral blood at each visit point after the end of the infusion, until any 2 consecutive test results were negative, At weeks 4，8 and months 3，6，9，12，16，20 and 24 after treatment
The Mediating Role of Death Anxiety in Hemodialysis Patients
NCT Number: NCT06478446
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hemodialysis Complication|Death Anxiety|Religious Stigmata
Interventions: OTHER: observation
Sponsor: Necmettin Erbakan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 203
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-02
Completion Date: 2024-03-15
Locations: Necmettin Erbakan University, Konya, Meram, 42090, Turkey

Summary:
This study aimed to determine the mediating role of death anxiety in the relationship between religious attitudes and spiritual care needs of hemodialysis (HD) patients in Turkey. The research was designed as a descriptive and cross-sectional study. A total of 203 patients were included in the study. Descriptive Characteristics Form, Religious Attitude Scale (RAS), Spiritual Care Needs Scale (SCNS), and Death Anxiety Scale (DAS) were used for data collection. In this study, it was found that the indirect effect of religious attitudes on spiritual care needs was significant, and death anxiety mediated the relationship between religious attitudes and spiritual care needs (b= -1.754, 95% CI \[-2.95, -0.65\]). It can be concluded that death anxiety in HD patients directs individuals towards religious attitudes, and in this case, the need for spiritual care increases. In other words, death anxiety mediates the relationship between religious attitudes and spiritual care needs. Therefore, nurses should include spiritual care when providing nursing care for HD patients.

Primary Outcome Measures: The mediating role of death anxiety on the impact of religious attitudes on spiritual care needs, It was evaluated whether there is a mediating role of death anxiety on the effect of religious attitudes on spiritual care needs, 2.10.2023/30.02.2024
COV-CHIM02: SARS-CoV-2 Omicron BA.5 Subvariant Dose Finding Infection Study
NCT Number: NCT06478420
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: SARS-CoV-2 Infection
Interventions: BIOLOGICAL: Omicron BA.5 SARS-CoV-2 challenge virus
Sponsor: University of Oxford
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2028-01
Locations: Centre for Clinical Vaccinology and Tropical Medicine, Oxford, Oxfordshire, OX3 7LE, United Kingdom

Summary:
A phase 1, dose-finding open label clinical infection, safety and viral detection optimization in healthy volunteers immunologically experienced against SARS-CoV-2.

Primary Outcome Measures: Occurrence of solicited and unsolicited adverse events, including severe adverse events, Safety and human clinical response to SARS-CoV-2 Omicron BA.5 subvariant intranasal challenge in participants who are immunologically experienced against SARS-CoV-2 will be measured by solicited and unsolicited adverse events, including severe adverse events, post viral challenge and other objective parameters such as vital signs, physical examination, smell test, spirometry, ECG, and clinical laboratory results., Day 180|Selection of the optimal SARS-CoV-2 dose(s), The optimal dose is the dose required to induce laboratory confirmed upper respiratory tract infection in 50%-75% of immunologically experienced, healthy volunteers following intranasal challenge.

Laboratory confirmed infection is defined as two or more quantifiable SARS-CoV-2 qRT-PCR from mid-turbinate or throat swab samples, at two consecutive time points starting from D2 post challenge and up to discharge from quarantine., Day 14 or until discharge criteria is met
Secondary Outcome Measures: Determination of SARS-CoV-2 viral dynamics, Assessment of the SARS-CoV-2 viral dynamics in upper respiratory samples from immunologically experienced individuals including: determination of the incubation period, peak viral load and the mean duration of infectious viral shedding from quantitative RT-PCR or cell culture., Day 14 or until discharge criteria is met|Identification of host immune responses that are associated with SARS-CoV-2 infection status and/or viral load., Characterisation of humoral immunity markers via blood neutralising antibody titres, blood and mucosal binding antibody titres, and mucosal surrogate neutralising antibody titres., Day 180
Other Outcome Measures: Exploratory: Identification of alternate measures of viral shedding, Quantitation and detection of virus in exhaled breath using facemask insert technology; other methods of live virus detection; viral sequencing., Day 14 or until discharge criteria is met|Exploratory: Characterisation of immune responses to SARS-CoV-2, other coronaviruses and other commonly encountered vaccine or pathogen-derived antigens, Utilised assays will include but will not be limited to:

* Blood and mucosal antibody Fc-dependent functional assays
* Blood and mucosal T cell functional assays, Day 180
Community Screening Study of Diabetic Retinopathy in Tianjin in 2024
NCT Number: NCT06478407
Acronym: CSSODRIT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Retinopathy
Sponsor: Li Xiaorong
Collaborators: Tianjin Medical University Eye Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 18000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-28
Completion Date: 2025-03-28
Locations: Tianjin Medical University Eye Hospital, Tianjin, Tianjin, 300000, China

Summary:
Through this study, the investigators hope to understand the prevalence and influencing factors of diabetic retinopathy in Tianjin, improve the ability of complication detection and intervention in diabetic patients in primary medical and health institutions, and build a diabetes prevention and treatment network. The investigators should adhere to the policy of prevention first, combined with prevention and control, and explore a diabetes' prevention and control model suitable for our city. Extensive publicity and education should be carried out to improve the awareness of self-management ，improve the screening rate of diabetic retinopathy, and reduce the blindness rate.

Primary Outcome Measures: Classification of diabetic retinopathy, Fundus images were taken by fundus camera and graded, At screening
Secondary Outcome Measures: blood routine examination, Blood was collected and tested, At screening|OCTA imaging indicators, OCTA machine was used to photograph the fundus, At screening|blood biochemistry, Blood was collected and tested, At screening|glycosylated hemoglobin, Blood was collected and tested, At screening|glycated albumin, Blood was collected and tested, At screening|Urine ACR, Urine was collected and tested, At screening|Blood vessel color Doppler ultrasound of extremities, Blood vessels of extremities were photographed by color Doppler ultrasound, At screening
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
NCT Number: NCT06478381
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Relapsed/Refractory B-cell Lymphomas
Interventions: DRUG: L218CAR19
Sponsor: Henan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2026-06-30
Locations: Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, 450008, China

Summary:
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.

Primary Outcome Measures: Dose limiting toxicity (DLT), Occurrence of DLTs, Up to 4 weeks|Treatment-emergent adverse event (AE), Incidence of treatment-emergent AEs, Up to 1 year
Secondary Outcome Measures: Quantification of L218CAR19 in peripheral blood, To quantify L218CAR19 in a patient's peripheral blood at different time points, Up to 1 year|Time to reach Cmax (Tmax) of L218CAR19, To identify the time point when the concentration of L218CAR19 reaches maximum in a patient's peripheral blood, Up to 3 months|Area under the curve (AUC) of L218CAR19, To quantify the cumulative amount of L218CAR19 in a patient's peripheral blood over time, Up to 3 months|Clearance (CL) of L218CAR19, To determine the clearance factor of L218CAR19 in a patient's peripheral blood, Up to 3 months|Immunogenic response to L218CAR19, To evaluate the anti-drug antibodies in response to L218CAR19 administration in a patient's peripheral blood, Up to 1 year|Serum cytokine concentrations, To measure the cytokine levels (e.g. TNFa, IL-6, IL-1, IL-2, etc.) in a patient's peripheral blood at different time points, Up to 3 months|ORR, To determine the overall (best) objective anti-cancer response by Lugano criteria, Up to 1 year|PFS, To evaluate the duration of patient's progression-free survival, Up to 1 year|OS, To evaluate the overall duration of patient's survival, Up to 1 year
Intracervical Block During Laminaria Insertion
NCT Number: NCT06478316
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Late Abortion|Dilation and Evacuation
Interventions: PROCEDURE: Intracervical block
Sponsor: Assaf-Harofeh Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12

Summary:
Whether intracervical block with lidocaine 1% is superior to sham procedure - intracervical injection of saline 0.9% - in terms of pain control.

Primary Outcome Measures: Pain level using 0-100 Visual Analog Scale (100=worst pain), Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale, During the procedure|Rate of patient reporting severe pain (VAS 75-100) during laminaria insertion, Patients will be asked to rate their maximal pain level during the procedure of laminaria insertion using 0-100 Visual Analog Scale, During the procedure
Secondary Outcome Measures: The rate of complications, Complications during laminaria insertion: rupture of the membranes, cervical bleeding, false route; complication during dilation and evacuation - failure to complete the dilation and evacuation procedure, During and immediately after the procedure|Acceptability of the procedure measured as the rate of patients who will state that they found the procedure acceptable, Patients will be asked to state whether they find the procedure they undergone acceptable, Immediately after the procedure
LAnguage-Motor Imagery Circuits to Improve Motor Learning and Language Comprehension
NCT Number: NCT06478303
Acronym: LAMI
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Corticospinal Excitability|Cortical Activation
Interventions: OTHER: Motor imagery|OTHER: Action reading|OTHER: Motor localizer
Sponsor: University Hospital, Grenoble
Collaborators: University of Burgundy
Sex: ALL
Age: ADULT
Enrollment: 105
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-27
Completion Date: 2028-07-26
Locations: CHU Grenoble Alpes, Grenoble, Grenob, 38043, France|Université de Bourgogne, Dijon, France

Summary:
Recent evidence suggests that cognitive systems do not operate in isolation but interact within broader networks, thus opening new avenues for fundamental and clinical research. An illustrative example is the interaction between language comprehension and motor representations. For instance, motor training (e.g., sports, origami training) can facilitate action verb recognition, whereas motor deficits (e.g., upper limb immobilization) can hinder the processing of action language. Similarly, action language has been shown to affect motor performance. These effects are attributed to an implicit form of motor imagery, an automatic simulation of motor experience (without actual movement) evoked by action words. Interestingly, literature supports the idea that the motor simulations used for imagining an action are also engaged during the reading of action language, leading to similar neurophysiological and behavioral changes in both processes. However, questions remain about the similarity of the simulations generated by motor imagery and action language. This project, encompassing three experimental sequences, aims to address these questions to achieve significant scientific advancements in both theoretical and applied domains.

Primary Outcome Measures: Level of corticospinal excitability, this is a physiological response obtained by transcranial magnetic pulses (TMS). This is an indicator of the excitability of the motor system, which can be used at rest or during various cognitive tasks (motor imagery or action reading)., 1 hour and 30 minutes|Cortical activation (BOLD signal), this is a cortical response obtained via a fMRI. This is an indicator of the brain activity, which can be used at rest or during motor and cognitive tasks (motor imagery or action reading)., 1 hour
NW-301 TCR-T in Patients With Advanced Solid Tumor
NCT Number: NCT06478251
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Tumor, Solid
Interventions: DRUG: NW-301V|DRUG: NW-301D
Sponsor: TingBo Liang
Collaborators: Neowise Biotechnology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-31
Completion Date: 2027-06
Locations: The First Affiliated Hospital of Zhejiang University school of Medicine, Hangzhou, Zhejiang, China

Summary:
An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor.

Primary Outcome Measures: Dose-limiting toxicity (DLT), Safety, 28 days of single infusion
Calcium Folinate Treatment of Spastic Paraplegia 56
NCT Number: NCT06478238
Acronym: CFT-SPG56
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Hereditary Spastic Paraplegia
Interventions: DRUG: calcium folinate
Sponsor: Shanghai 6th People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2030-05-31
Locations: Shanghai 6th People's Hospita, Shanghai, Shanghai, China

Summary:
SPG56 is one of the complicated and early-onset HSP subtypes caused by genetic mutations in CYP2U1. So far, there is no standardized and specific clinical therapy for SPG56. The goal of this clinical trial is to explore the efficacy and safety of calcium folinate in the treatment of SPG56 patients.

This study is prospective, open-label and single arm and this trial will last for 6 years. A total of 10 patients will participate and they will receive calcium folinate treatment and professional clinical evaluation regularly.

Primary Outcome Measures: GMFM-88, The change in the Gross Motor Function Measure-88 (GMFM-88) score from baseline (range: 0-264, higher scores mean a better outcome)., At the end of the 5-year follow-up period
Secondary Outcome Measures: SPRS score, The change in the Spastic Paraplegia Rating Scale (SPRS) score from baseline (range: 0-52, higher scores mean a worse outcome)., At the end of the 5-year follow-up period|MMSE score, The change in the Mini-Mental State Examination (MMSE) score from baseline (range: 0-30, higher scores mean a better outcome)., At the end of the 5-year follow-up period|Laboratory indicators, The change in the Laboratory indicators (blood biochemistry, lipid metabolism, folate, etc) and the number of participants with abnormal laboratory indicators., At the end of the 5-year follow-up period|Cranial CT/MRI, The change in the cranial CT/MRI from baseline., At the end of the 5-year follow-up period|Gait examination, The change in the gait examination from baseline., At the end of the 5-year follow-up period|MoCA score, The change in the Montreal Cognitive Assessment (MoCA) score from baseline (range: 0-30, higher scores mean a better outcome)., At the end of the 5-year follow-up period|High density electroencephalogram, The change in the high density electroencephalogram from baseline., At the end of the 5-year follow-up period
Evaluate the Safety and Efficacy of BGT007H Cell Therapy in Patients With Relapsed/Refractory Pancreatic Cancer
NCT Number: NCT06478225
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tumor Pancreas
Interventions: DRUG: BGT007H Cell Injection
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-07
Completion Date: 2027-08-31
Locations: Renji hospital, Shanghai, Shanghai, 200127, China

Summary:
The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer.

Primary Outcome Measures: Dose-Limiting Toxicity (DLT), Dose-Limiting Toxicity, through study completion, an average of 3 year|Maximum Tolerated Dose (MTD), Maximum Tolerated Dose, through study completion, an average of 3 year|Optimal Biological Dose (OBD), Optimal Biological Dose, through study completion, an average of 3 year|Adverse events (AE), Adverse events, through study completion, an average of 3 year
Secondary Outcome Measures: Evaluate the disease control rate (DCR), Evaluate the disease control rate ,according to the RECIST 1.1 criteria., through study completion, an average of 3 year|Evaluate the duration of response (DOR), Evaluate the duration of response ,according to the RECIST 1.1 criteria., through study completion, an average of 3 year|Evaluate the progression-free survival (PFS), Evaluate the progression-free survival, according to the RECIST 1.1 criteria., through study completion, an average of 3 year
Other Outcome Measures: Evaluate the overall survival (OS), Evaluate the overall survival ,according to the RECIST 1.1 criteria., through study completion, an average of 3 year