pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
NCT Number: NCT06559007
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Prostate Cancer
Interventions: DRUG: HRS-5041 dose level 1|DRUG: HRS-5041 dose level 2
Sponsor: Atridia Pty Ltd.
Sex: MALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2024-12-15
Locations: Nucleus Network Melbourne, Melbourne, Victoria, 3004, Australia

Summary:
This is a phase 1, open-label, randomized study. The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.

Primary Outcome Measures: PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:, Parameters: Cmax, Day 10|PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:, Parameter: AUC0-t, Day 10|PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:, Parameter:AUC0-inf, Day 10|PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:, Parameter: Tmax, Day 10|PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:, Parameter: t1/2, Day 10|PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:, Parameter: CL/F, Day 10|PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:, Parameter: Vz/F, Day 10
Secondary Outcome Measures: Safety and tolerability - number and severity of adverse events, Incidence and severity of AE, Day 10|Safety and tolerability - Blood pressure, Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure), Day 10|Safety and tolerability - Body temperature, Incidence of Adverse Events and Abnormalities as assessed by body temperature, Day 10|Safety and tolerability - Physical examination, Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination, Day 10|Safety and tolerability - Laboratory tests, Number of abnormalities assessed based on safety bloods and urine test, Day 10|Safety and tolerability - ECG, heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS, Day 10
Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
NCT Number: NCT06558994
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cryptorchidism
Interventions: PROCEDURE: Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis|PROCEDURE: Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis
Sponsor: Assiut University
Sex: MALE
Age: CHILD
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

Summary:
This is a comparative study to see the outcome of yransection versus ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis in assisting the descent of the testis to the base of scrotum during the second stage

Primary Outcome Measures: testis-to-ring distance in mm at the second stage, After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the location of the testis away from the internal inguinal ring (the testis-to-ring distance in mm) will be measured during the 2nd stage (degree of descent) 6 months after the first stage and compared among the two groups., At 6 months after the first stage (during the second stage)|Testicular volume in mL, After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the testicular volume in mL will be assessed intraoperatively during the second stage (6 months after the first stage) and compared among the two groups., At 6 months after the first stage (during the second stage)
Secondary Outcome Measures: Operative time in minutes, After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the operative time in minutes of the second stage will be measured and compared among the two groups., At 6 months after the first stage (during the second stage)
Adjuvant Radiotherapy in High Risk Locally Advanced DTC
NCT Number: NCT06558981
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Thyroid Cancer
Interventions: RADIATION: Radiotherapy|OTHER: radioiodine treatment
Sponsor: Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2031-06
Locations: Fudan Univeristy Shanghai Cancer Center, Shanghai, China

Summary:
This study is a phase III randomized controlled clinical trial on the role of adjuvant radiotherapy in high-risk locally advanced differentiated thyroid cancer. Patients who meet the inclusion criteria were randomly assigned 1:1 to either the experimental group (adjuvant radiotherapy+RAI) or the control group (RAI), with LRFS as the primary endpoint of the study.

Primary Outcome Measures: Local-regional Recurrence Free Survival （LRFS）, The time from surgery to the occurrence of local-regional tumor recurrence based on the RECIST 1.1. The definition of local areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes., 5 years after surgery
Secondary Outcome Measures: Local-regional Recurrence Rate，LRR, The percentage of patients with local-regional recurrence in the total number of patients., 5 years after surgery|Progression Free Survival，PFS, The time from surgery to tumor progression, including local recurrence and distant metastasis., 5 years after surgery|Overall Survival，OS, The time from surgery to patient death., 5 years after surgery|Adverse Events，AE, The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with radiotherapy;, 5 years after surgery|Quality of Life as assessed by QLQ-H&N35, Patients in the experimental group were evaluated for QoL within 1 week before the start of radiotherapy, 1 week after the end of radiotherapy, 3 months after the end of radiotherapy, and 1, 3, and 5 years after surgery. The control group patients were evaluated for QoL at 1 month, 3 months, 1 year, 3 years, and 5 years after surgery. The QoL evaluation scale adopts the EORTC Quality of Life Measurement Scale QLQ-H\&N35 (V1.0) ., 5 years after surgery|Quality of Life as assessed by QLQ-C30, Patients in the experimental group were evaluated for QoL within 1 week before the start of radiotherapy, 1 week after the end of radiotherapy, 3 months after the end of radiotherapy, and 1, 3, and 5 years after surgery. The control group patients were evaluated for QoL at 1 month, 3 months, 1 year, 3 years, and 5 years after surgery. The QoL evaluation scale adopts the EORTC Quality of Life Measurement Scale QLQ-C30 (V3.0) Chinese version., 5 years after surgery
Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
NCT Number: NCT06558968
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Dentistry
Interventions: OTHER: aesthetic functional space maintainers
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-01-03
Completion Date: 2025-01
Locations: Ain Shams University, Cairo, Egypt

Summary:
Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to:

* Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up.
* Wear of the opposing teeth.

Primary Outcome Measures: Clinical performance, regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure., 1 year|Gingival health, Gingival Index of Loe and Silness. where score 0 indicates normal gingiva, score 1 mild inflammation (slight change in color, slight edema but no bleeding on probing. score 2 indicates moderate inflammation (redness, edema, bleeding on probing and score 3 refers to severe inflammation (marked redness, edema, ulceration with sponatnoeus bleeding., 1 year
Secondary Outcome Measures: Wear of the opposing tooth, using CAD/CAM software Cerec software (Cerec 4.2, DentsplySirona, Bensheim, Germany)volumetric loss on the surfaces were calculated in the last follow up visit after 1 year, 1 year
Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries
NCT Number: NCT06558955
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries|Dental Caries in Children|Diet Habit
Interventions: BEHAVIORAL: Technology-enabled anticipatory guidance and peer support|BEHAVIORAL: Conventional health education
Sponsor: National University of Singapore
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-15
Completion Date: 2028-09-01
Locations: National University Hospital, Singapore, Singapore

Summary:
Early Childhood Caries (ECC) is a significant clinical and public health challenge that the world and the Singapore population are facing. This study seeks to test the effectiveness of technology-enabled anticipatory guidance and peer support in empowering parents to establish proper childcare practices and prevent ECC.

Primary Outcome Measures: Incidence of early childhood caries, Number of new surfaces with coronal caries, 24 and 36 months of age for children
Secondary Outcome Measures: Toothbrushing behaviours, Using a questionnaire, toothbrushing behaviours will be categorised as:

1. Favourable (frequency of brushing \>=2times/day)
2. Unfavourable (frequency of brushing \<2times/day), 12, 24 and 36 months of age for children|Dietary and feeding practices (favourable/unfavourable), Self-reported frequency of snack, sweet/dessert and sugary drink intake, 12, 24 and 36 months of age for children|Dental Utilisation, Self-reported frequency of dental visits, 12, 24 and 36 months of age for children|Dental Costs, Sum of direct costs from dental treatment and indirect costs due to time taken off work by parents to attend dental visits, and loss of productivity. Costs will be captured in Singapore dollars (SGD)., 12, 24 and 36 months of age for children|Parental efficacy in managing oral health of child, Measured using the self-efficacy scale for maternal oral care (SESMO). Response options ("Yes" and "No"). A score of 1 is given for an answer with higher self-efficacy and 0 for lower self-efficacy. Minimum score is 0 and maximum score is 16 for the 16 questions. Higher scores indicate better outcomes., 12, 24 and 36 months of age for children|Plaque score, Plaque score based on the index recommended by Ramjford and modified for primary dentition. The plaque score is coded as following: 2 = visible plaque without use of probe, 1 = no visible plaque but a probe skimmed over the tooth surface reveals plaque, 0 = no plaque. Scoring is done at three sites (interproximal, buccal and palatal/lingual) on the index teeth (#54, #61, #64, #74, #81, #84)., 24 and 36 months of age for children|Breastfeeding rate, Duration of breastfeeding (in months), 12 and 24 months of age for children
Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection
NCT Number: NCT06558942
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Injury Caused by Animal Bites|Wound Infection
Interventions: DEVICE: incisional negative pressure wound technology
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-04-30
Locations: Emergency Department of Peking University First Hospital, Beijing, Beijing, 100000, China

Summary:
Animal injuries are a significant public health issue, with the most common being bites or scratches from cats and dogs. Every year, over 40 million people in China are bitten or scratched by cats and dogs, which can lead to wound infections and even systemic complications, with infection rates ranging from 10% to 80%. However, there is still no better way to reduce wound infection rates in current clinical studies and guidelines.

Incisional negative pressure wound therapy (iNPWT) is a new wound treatment technology developed in recent years. It creates a negative pressure environment on sutured or closed wounds, helps to fix the edges of the incision together, reduce lateral tension on the wound, stimulate blood perfusion at the edge of the wound, remove fluid from the wound, and act as an external pollution barrier. INPWT has been widely used for postoperative wound healing in surgery, but there is currently a lack of effective clinical trials on its ability to prevent wound infections caused by animal injuries and promote wound healing.

This study aims to apply iNPWT technology to the wounds of patients with rabies grade III exposure who underwent primary suturing, and compare it with wounds covered with ordinary gauze after previous primary suturing to determine whether it can help reduce postoperative incision infection rates and promote wound healing. This will provide high-quality clinical evidence for the widespread use of wound management in rabies grade III exposure patients in the future.

Primary Outcome Measures: Wound infection (WI), The local skin of the wound appears red, swollen, hot, and painful, with or without systemic hyperthermia, <4 weeks
Secondary Outcome Measures: Delayed healing of wounds (DHW), Wound healing time is longer than 14 days., 2-4 weeks|Wound reprocessing (WR), Including wound dehiscence, hematoma, seroma and other situation needed to switch treatments., ≤4 weeks|other wound complication, redness and rash of skin around the wound., ≤4 weeks
Evaluating the Effectiveness of Intervention Based on the Model of Occupational Harmony in Patients With CRSWD
NCT Number: NCT06558929
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Circadian Rhythm Sleep-Wake Disorder
Interventions: BEHAVIORAL: Occupational Therapy|OTHER: Conventional Treatment
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-06-30
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
The goal of this clinical trial is to learn the effectiveness of an intervention based on the Model of Occupational Harmony (MOHar) in treating patients with circadian rhythm sleep-wake disorders (CRSWD). The main questions it aims to answer are:

* Does intervention based on the MOHar can improve sleep quality in patients with CRSWD?
* Does intervention based on the MOHar can improve the quality of life in patients with CRSWD?

Researchers will compare intervention based on the MOHar to conventional treatment to see if the intervention works to treat CRSWD.

Participants will:

* Participate in an occupational therapy program for 6 weeks (including group therapy, individual treatment, and daily occupational tasks)
* Complete questionnaires at 1, 3, and 6 months after the program for follow-up

Primary Outcome Measures: Insomnia Severity Index, Using the ISI to measure sleep quality, 6 months|Pittsburgh Sleep Quality Index, Using the PSQI to measure sleep quality, 6 months|36-Item Short Form Survey (SF-36), Using the SF-36 to measure quality of life, 6 months
Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic
NCT Number: NCT06558916
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Analgesia|Renal Colic
Interventions: DRUG: Dexketoprofen Trometamol|DRUG: Meperidine Injectable Solution|DRUG: Paracetamol|DRUG: Fentanyl
Sponsor: Ismail Tekin
Collaborators: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2015-10
Completion Date: 2015-12

Summary:
This study aimed to compare the effectiveness of intravenous (IV) dexketoprofen trometamol, IV meperidine, and IV paracetamol as analgesics for renal colic in patients at the Emergency Department of Erciyes University Medical School. The double-blind, randomized trial included 90 patients aged 18-65 years. Patients were divided into three groups of 30, receiving 50 mg IV dexketoprofen trometamol, 50 mg IV meperidine, or 1000 mg IV paracetamol, administered in 250 mL of saline over 15 minutes. Pain intensity was measured at 15, 30, and 60 minutes post-administration using a 100-mm visual analog scale (VAS) and a 4-point verbal rating scale (VRS). Successful treatment was defined as a 50% or greater reduction in VAS score at 30 minutes. Patients with a VAS score of 40 mm or higher at the 30th minute were given fentanyl (1 mcg/kg, intravenously) as a rescue drug.

Primary Outcome Measures: VAS score change at the 30th minute, The time at which treatment began was recorded as 0th minutes and pain levels were measured using the VAS scale, which ranges from "0 mm (no pain)" to "100 mm (unbearable pain)". The pain levels were measured before treatment and at the 15th, 30th and 60th minutes after the treatment. Pain severity was evaluated using VRS and classified as "none"-"mild"-"moderate"-"severe".

A treatment was considered successful if there was a 50% or greater reduction in the VAS score at the 30th minute., 0th minute and 30th minute
Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)
NCT Number: NCT06558903
Acronym: HYPE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Small Cell Lung Carcinoma
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-24
Completion Date: 2025-01-01
Locations: CHU de Brest, Brest, 29609, France

Summary:
The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples

Primary Outcome Measures: Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients, Features in the tumour microenvironment that can discriminate patients responding to anti-PD-L1 from non responders, 3 year
Secondary Outcome Measures: Progression-free survival, Time between treatment start and date of progression according to investigator, or death from any cause, 3 year|Overall survival, Time between treatment start and date of death from any cause, 3 year
High Selective Subiculum SEEG Guided RF-TC for mTLE-HS
NCT Number: NCT06558864
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis|Epilepsy
Interventions: PROCEDURE: Subiculum RF-TC
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2027-08-20

Summary:
The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).

Primary Outcome Measures: Seizure frequency (SF28), Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:

SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28., Up to 1 year after subculum-SEEG Guided RF-TC
Secondary Outcome Measures: Seizure Responder Rate, The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency., Up to 1 year after subculum-SEEG Guided RF-TC|Life quality evaluation, Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score., Up to 1 year after subculum-SEEG Guided RF-TC|Cognitive function evaluation (MMSE), Percentage change from baseline in Mini-Mental State Examination (MMSE) score., Up to 1 year after subculum-SEEG Guided RF-TC|Cognitive function evaluation (MoCA), Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score., Up to 1 year after subculum-SEEG Guided RF-TC|Adverse Events, Rate of adverse events which were judged to be study-related throughout the study., Up to 1 year after subculum-SEEG Guided RF-TC|Incidence of Sudden Unexpected Death in Epilepsy (SUDEP), The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up., Up to 1 year after subculum-SEEG Guided RF-TC
The Effect of Systematic Endurance Training in Treatment of Women With Lipedema
NCT Number: NCT06558851
Acronym: LipidEx
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lipedema
Interventions: BEHAVIORAL: High intensity endurance training
Sponsor: Norwegian University of Science and Technology
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2028-12-31
Locations: Institute for Circulation and Medical Imaging, NTNU, Trondheim, Norway

Summary:
Lipedema is a chronic adipose tissue disorder that primarily affects women. The etiology remains unclear and involves abnormal buildup of fat mainly in the lower limbs. It causes physical and psychological morbidity, often with significant impact of daily life. Effective treatment options are still limited, primary involving conservative measures such as compression therapy. Regular endurance training is known to have positive effects on pain management in other disorders, as well as beneficial effects on obesity management. Thus, LipidEx aims to explore the potential of high-intensity interval training (HIIT) as a novel therapeutic option for women with lipedema. We will now perform a cross-over randomized controlled trial (RCT) exploring the effects of 12 weeks of HIIT compared to a control period of usual care. Primary outcomes include changes in pain, and secondary outcomes include changes in adipose tissue mass and quality of life. Exploratory outcomes include changes in inflammatory markers, metabolites, and lipoprotein subfractions in blood and adipose tissue.

Primary Outcome Measures: Pain levels, BPI includes four questions that assess the severity of pain right now and at its worst, least, and average. Each question gives a possible answer of 0 to 10, were 0 means no pain and 10 is the worst pain you can imagine. The four BPI questions contribute with the same weight, and they are combined to a final pain severity score with a range from 0 to 40., Through study completion, an average of 8 weeks
Secondary Outcome Measures: Adipose tissue mass, Total adipose tissue mass and adipose tissue mass in the lower limbs measured by bioimpedance., Through study completion, an average of 8 weeks|Health-related quality of life, Measured by RAND-36, Through study completion, an average of 8 weeks
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
NCT Number: NCT06558838
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Herpes Simplex Oral
Interventions: DRUG: acyclovir-penciclovir cream|DRUG: Abreva
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2025-12-31

Summary:
This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 40 subjects with documented herpes labialis. Patients will be treated with the study drug, acyclovir-penciclovir cream, or the active comparator of Abreva.

Potential subjects will be assessed during a screening visit that must take place no greater than 2 weeks prior to the Day 1 (Baseline) visit. During the screening period, subjects that meet all other entry criteria will undergo Ultraviolet susceptibility testing to determine the subject's individual minimal erythema dose (MED). Ultraviolet susceptibility testing takes place over two days with exposure to Ultraviolet light on specified regions on the subject's back followed by an assessment of the exposed areas 24 hours later to identify the MED. Subjects who have a measurable MED will be allowed to enroll in the study. Each subject will be randomly assigned in a 1:1 ratio to receive either acyclovir-penciclovir cream or Comparator (Abreva).

Patients who express a cold sore will track the lesion with a diary card to rate their pain levels, and any unusual symptoms at Day 1, Day 3, Day 5, Day 7, and Day 10. Patients may also take photographs of the lesion throughout the study.

Primary Outcome Measures: Proportion of subjects using acyclovir-penciclovir cream versus those using the Comparator, who do not progress to Stage 3 (vesicle) of a herpes labialis outbreak following UV radiation exposure, We will measure the number of subjects who do not progress to Stage 3 of herpes labialis outbreak, up to 25 days per patient
Secondary Outcome Measures: Time of duration of the lesion until healed (loss of hard crust) of patients using acyclovir-penciclovir cream compared to those using the active comparator., We will measure the number of days lesions take to heal of patients using EDTA eye drops compared to those using the active comparator., up to 25 days per patient
Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
NCT Number: NCT06558812
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature Tooth Exfoliation
Interventions: DEVICE: prefabricated space maintainer|DEVICE: conventional space maintainer
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2025-10

Summary:
To assess the clinical efficacy of prefabricated space maintainers compared to conventional ones, focusing on preserving the integrity of each component of bands and loops, avoidance of soft tissue impingement as well as preservation of arch dimensions.

Primary Outcome Measures: appliance success, evaluation of clinical success criteria ( • Integrity of each component of band and loop - solder breakdown - decementation - abutment fracture - Soft tissue impingement ) Clinical examination by operator ( binary yes or no ), 0-3-9 month
Secondary Outcome Measures: Space loss between the abutment teeth., • Change in distance measured on digital cast between the mesial midpoint of the second deciduous molar and the distal midpoint of the primary canine in mm, 0-9 month|arch dimension, measured each of

1. Arch perimeter by measured on a digital cast as a sum of the incisor, canine and molar segment width in mm
2. Inter canine width = Measured on a digital cast from cusp tip of canine on one side to cusp tip of canine on the other side in mm
3. Intermolar width = Measured on a digital cast from central fossa of the second primary molar on one side to central fossa of the second primary molar on the other side in mm, 0-9 month|• Patient satisfaction, Patient-reported using 5-point Likert-type scale from 1-5 face scale, during insertion of appliance|• Cost effectiveness, Manually by incremental effectiveness cost ratio ,measuring unit is financial units per result, through study completion , an average of 9 month
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
NCT Number: NCT06558799
Acronym: LUNAR-4
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Interventions: DEVICE: NovoTTF-200T|DRUG: Pembrolizumab
Sponsor: NovoCure GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-10

Summary:
The purpose of the study is to test the effectiveness and safety of TTFields therapy, delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

Primary Outcome Measures: Overall Survival, To compare OS in subjects treated with TTFields concomitant with pembrolizumab compared to OS of subjects who were treated with docetaxel alone in the LUNAR/ EF-24 study (superiority analysis), 16
Registry for Esophageal and Gastroesophageal Junction Cancer
NCT Number: NCT06558786
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastroesophageal-junction Cancer|Esophageal Cancer
Interventions: OTHER: EORTC QLQ-C30 questionnaire|OTHER: QLQ-OGS25 questionnaire
Sponsor: Memorial Sloan Kettering Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2029-08-12
Locations: Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States

Summary:
The purpose of this registry study is to create a database-a collection of information-for better understanding standard treatments for esophageal and Gastroesophageal Junction Cancer/GEJ cancer. Researchers will use the information from this database to learn more about the effectiveness of different treatment options.

Primary Outcome Measures: Progression Free Survival, Estimate 12-month PFS among patients who undergo definitive local therapy after induction chemotherapy, 1 year
Changes in the Treatment of Acute Appendicitis
NCT Number: NCT06558760
Acronym: TreatApp
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Acute Appendicitis
Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Collaborators: CLINOTEL Hospital Association Germany
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31988
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-01-01
Completion Date: 2022-12-31

Summary:
The purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in Germany based on routine data between 2010 and 2022.

Primary Outcome Measures: Changes in surgical techniques over time, Development of the use of surgical techniques (open, laparoscopic or conversion from open to laparoscopic), 2010-2022
Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity
NCT Number: NCT06558721
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Conventional rehabilitation|OTHER: Mirror therapy|DEVICE: Bicycle ergometer with functional electric stimulation
Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2024-10-01
Locations: Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, Ankara, Çankaya, 06800, Turkey

Summary:
There are different methods in stroke rehabilitation. In addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. In this study, we will compare functional electric stimulation with bicycle ergometer therapy and mirror therapy in stroke patients.

Primary Outcome Measures: Fugl Meyer Lower Extremity Motor Subscale, Before treatment (0. week), finishing time of treatment (6.week)
Secondary Outcome Measures: Brunnstrom Staging, Before treatment (0. week), finishing time of treatment (6.week)|Berg Balance Scale, Before treatment (0. week), finishing time of treatment (6.week)|Functional Independence Measure - Motor Score, Before treatment (0. week), finishing time of treatment (6.week)|Stroke Specific Quality of Life Scale, Before treatment (0. week), finishing time of treatment (6.week)|Functional Ambulation Scale, Before treatment (0. week), finishing time of treatment (6.week)
A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD
NCT Number: NCT06558708
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Type 2 Diabetes
Interventions: DRUG: GZR101 Injection|DRUG: GZR33 Injection|DRUG: Insulin aspart
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2024-12
Locations: Study Site 01, Tianjin, China

Summary:
This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.

Primary Outcome Measures: Change in HbA1c, Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment, Week 0, week 16
Secondary Outcome Measures: Change in Fasting Plasma Glucose (FPG), Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment, Week 0, Week 16|Change in 7-point SMPG profile, Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV, Week 0, Week 16|Incidence and Rate of Treatment-emergent AE/SAEs, A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period., Week 0, Week 19|Incidence and Rate of hypoglycemia Events, Hypoglycaemia alert episodes (level 1) are defined as episodes that are sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (\>=) 3.0 and less than (\<) 3.9 mmol/L (\>= 54 and \< 70 mg/dL) confirmed by BG meter. Clinically significant hypoglycaemic episodes (level 2) are defined as episodes that are sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) are defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) are defined as episodes that are associated with severe cognitive impairment requiring external assistance for recovery., Week 0, Week 19
Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)
NCT Number: NCT06558695
Acronym: TIVA
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Stenosis, Lumbosacral Region
Interventions: DRUG: Sevoflurane|DRUG: TIVA
Sponsor: Saglik Bilimleri Universitesi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2023-05-01
Completion Date: 2024-06-30
Locations: Saglik Bilimleri Universitesi, Istanbul, Turkey

Summary:
Key Points:

1. Objective:

   o To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries.
2. Methodology:

   * A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups.
   * Respiratory and hemodynamic parameters were measured at various time points.
3. Results:

   * No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability.
   * Both anesthesia techniques maintained stable intraoperative conditions.
4. Clinical Implications:

   * Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements.
   * TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring.
5. Future Research:

   * Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies.
   * Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.

Primary Outcome Measures: PEEP, positive end-expiratory pressure, 5, 15, and 30 minutes after positioning in the prone position|ETCO2, end-tidal carbon dioxide, 5, 15, and 30 minutes after positioning in the prone position|VT, tidal volume, 5, 15, and 30 minutes after positioning in the prone position|Ppeak, peak airway pressure, 5, 15, and 30 minutes after positioning in the prone position|Pmean, mean airway pressure, 5, 15, and 30 minutes after positioning in the prone position|RR, Respiratory Rate, 5, 15, and 30 minutes after positioning in the prone position|MV, Minute volume, 5, 15, and 30 minutes after positioning in the prone position|Cdyn, Dynamic. compliance, in the supine position after intubation and in the prone position at the 30th minute|PaO2/FiO2, Partial Oxygen pressure/traction of inspired oxygen, in the prone position at the 30th minute|Vd/Vt, dead space/tidal volume, in the prone position at the 30th minute
Secondary Outcome Measures: HR, Heart Rate, 5, 15, and 30 minutes after positioning in the prone position|SBP, Systolic Blood Pressure, 5, 15, and 30 minutes after positioning in the prone position|DBP, Diastolic BloodPressure, 5, 15, and 30 minutes after positioning in the prone position
Neoadjuvant Therapy in Cervical Cancer
NCT Number: NCT06558682
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Cervical Neoplasms
Interventions: DRUG: Disitamab Vedotin and Cisplatin
Sponsor: Kun Song
Collaborators: RemeGen Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-10-01

Summary:
In the comprehensive dataset of clinical diagnoses and treatments for cervical cancer in China, 49.8% of patients with stage IB3 and IIA2 receive surgical intervention following neoadjuvant chemotherapy. This indicates a pressing need to optimize neoadjuvant chemotherapy regimens for locally advanced cervical cancer. While paclitaxel combined with cisplatin is the conventional approach, 9.8% to 30.6% of patients demonstrate suboptimal responses, with a pathological complete response rate of approximately 10%.

Currently, the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored. This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expression.The study will assess the impact of this regimen on pathological complete response rates, surgical complications, surgical resection rates, and overall survival.

Primary Outcome Measures: pathologic complete remission, The pathological examination of the cancer patient post-treatment revealed an absence of malignant cells., At the end of Cycle 3 (each cycle is 21 days)
Secondary Outcome Measures: Objective Response Rate, the proportion of patients whose tumor volume has shrunk to a predetermined value and maintains the minimum time frame required, At the end of Cycle 3 (each cycle is 21 days)
Effect of Sugarcane Juice on Liver Patients
NCT Number: NCT06558669
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver; Disease, Inflammatory
Interventions: OTHER: Fresh Sugarcane juice
Sponsor: Pir Mehr Ali Shah Arid Agriculture University
Sex: ALL
Age: ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-10
Completion Date: 2024-03-10
Locations: Asif Ahmad, Rawalpindi, Punjab, 43600, Pakistan

Summary:
This study aims to investigate the potential benefits of sugarcane juice on liver health in patients who are suffering from liver-related conditions. We hypothesize that regular consumption of sugarcane juice may improve liver function and alleviate symptoms in patients with liver disease. Patients participating in this study will consume a specified amount of sugarcane juice daily for 90 days, and their liver health will be monitored to assess any improvements. This study could help identify a natural, accessible treatment option to support liver health in patients with liver disease, potentially improving their quality of life.

Primary Outcome Measures: Liver Health Status, Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 1., ["1 Month" at study commencement (Phase 1)]|LIver Health Status, Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 2 after completion of three month intervention, [Termination of Phase 2(intervention period), "3 Month"]|LIver Health Status, Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 3 which is wash-out time, [Termination of Phase 3 (Washout period), "1 Month"]
Secondary Outcome Measures: Dietary Pattern Analysis, Dietary patterns will be analyzed using a Food Frequency Questionnaire (FFQ) to evaluate the patients' intake of various food groups. This will include an assessment of the frequency, portion sizes, and overall dietary diversity. The aim is to correlate dietary habits with the study's primary outcomes., [Through studyy compeletion, an avaerage of 9 month]|Dietary Pattern Assessment, A Food Frequency Questionnaire (FFQ) will be administered to assess the dietary patterns of the patients. This questionnaire will capture the frequency, portion size, and types of food consumed over the study period. The collected data will be used to analyze the relationship between dietary patterns and the primary outcomes of the study., [Through studyy compeletion, an avaerage of 9 month]
Effect of Food of NTQ5082 in Healthy Subjects
NCT Number: NCT06558656
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Complement-mediated Hemolytic Diseases
Interventions: DRUG: NTQ5082 capsule
Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-02
Locations: The Third hospital of Changsha, Changsha, Hunan, 410035, China

Summary:
NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, open label, two sequence, two period, double crossover-design phase 1 clinical trial to evaluate the food effect on PK after a single oral administration of NTQ5082 capsules and the safety and tolerability of single oral administration of NTQ5082 capsules on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy subjects

Primary Outcome Measures: AUC0-last, up to 15 days|AUC0-∞, up to 15 days|Cmax, up to 15 days|Tmax, up to 15 days|t1/2, up to 15 days|CL/F, up to 15 days|Vz/F, up to 15 days
Secondary Outcome Measures: the safety and tolerability, Safety and tolerability as assessed through collection of Adverse Event, Serious Adverse Event, Clinical Chemistry/Haematology/Coagulation/Vital Signs and ECG, up to 15 days
ED Airway Management in the Netherlands.
NCT Number: NCT06558630
Acronym: DEAR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endotracheal Intubation
Interventions: PROCEDURE: Endotracheal intubation
Sponsor: Medical Centre Leeuwarden
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2027-01-01
Locations: Leeuwarden Medical Centre, Leeuwarden, 8934AD, Netherlands

Summary:
Airway management is one of the resuscitative procedures patients may undergo in the Emergency Department (ED). While this is a high risk procedure, to date there is no data available on airway management practices, success or safety in EDs in the Netherlands. The objective of this study is to describe airway management in the Netherlands.

Primary Outcome Measures: Adverse events during or after endotracheal intubation, The occurrence of adverse events peri-intubation, the following adverse events are defined:

* Desaturation, defined as a decrease of SpO2 of 10% or more
* Hypotension, defined as a systolic blood pressure of \<90mmHg AND a decrease of 20% or more. In case of suspected raised intracranial pressure hypotension is defined as a systolic blood pressure of \<120mmHg AND a decrease of 20% or more.
* Hypertension
* Bradycardia
* Tachycardia
* Cardiac arrest
* Aspiration
* Oesophageal intubation
* Mainstem intubation
* Dental trauma
* Airway bleeding due to intubation attempt
* Other adverse event, further specified by provider, Within 10 minutes after start of procedure. The data has to reported within 24 hours of endotracheal intubation.
Secondary Outcome Measures: First pass success, The percentage of patients that are successfully intubated during the first attempt of endotracheal intubation. An attempt is defined as an attempt to visualize the larynx and an attempt ends when the laryngoscope blade is removed from the mouth., Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.|Indications for intubation, The underlying pathology that led to the decision to intubate, these are defined as:

* Pulmonary
* Cardiac
* Neurologic
* Cardiac arrest
* Post-cardiac arrest
* Intoxication
* Metabolic derangement
* Trauma
* Shock
* Airway obstruction
* Other, Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.