pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Improving the Application Skill of the Semmes-Weinstein Monofilament Test
NCT Number: NCT06584968
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Training|Students
Interventions: OTHER: training with visual feedback|OTHER: classical learning
Sponsor: Hacettepe University
Collaborators: Çankırı Karatekin University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2024-11-30
Locations: Hacettepe University, Ankara, Turkey

Summary:
The Semmes-Weinstein Monofilament Test is one of the most widely used and objective clinical tests for assessing the sense of touch. Some guides include standard instructions for the application of the Semmes-Weinstein Monofilament Test. With monofilaments applied correctly by the instructions, patients' threshold values can be determined accurately. However, there are disagreements about the accuracy of the pressure applied by the therapist who applies the monofilament to the patient. The investigators aimed to compare the application of the Semmes-Weinstein Monofilament Test to undergraduate students of the occupational therapy department by teaching it using classical methods and visual feedback.

Primary Outcome Measures: Application duration of the Semmes-Weinstein Monofilament Test, The application duration of the Semmes-Weinstein Monofilament Test will be recorded in seconds., just before the intervention and just after completion of the intervention|The applied force of the Semmes-Weinstein Monofilament Test, The applied force of the Semmes-Weinstein Monofilament Test will be recorded in grams., just before the intervention and just after completion of the intervention|Intervals between the Semmes-Weinstein Monofilament Test applications, Intervals between the Semmes-Weinstein Monofilament Test applications will be recorded in seconds., just before the intervention and just after completion of the intervention
Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients with Hematological Malignancies
NCT Number: NCT06584955
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematological Malignancies
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-12-31
Completion Date: 2027-07-31

Summary:
The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.

Primary Outcome Measures: Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients with Cannabis Use Disorder (Pilot Study)
NCT Number: NCT06584942
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cue-reactivity|Cannabis Use Disorder|Functional MRI|Orexin Antagonist
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-11-15
Completion Date: 2025-10-31

Summary:
The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis. Suvorexant is an FDA-approved medication to treat insomnia. We think that suvorexant may reduce activity in certain parts of the brain associated with cannabis use. We are studying if this medication does affect brain activity in these areas.

For this study, we will ask participants to complete four study visits over approximately 14 days. Each study visit will include interviews and questionnaires. All participants will be asked to take suvorexant, an FDA approved medication for treatment of insomnia, for 14 days. They will complete two one-hour functional Magnetic Resonance Imaging (fMRI) scans: one before starting the study medication and one after 14 days of taking the study medication. MRI is used in typical medical settings and is considered to be safe.

Primary Outcome Measures: Change in Insula Activation to Cannabis Cues During a Cue Reactivity Task Measured by fMRI (Time Frame: baseline, Day 14), This task will measure brain reactivity to cannabis vs. neutral images. A whole-brain fixed-effects general linear model (GLM) will be run using image regressors (cannabis, neutral images) and motion confound regressors. Beta maps comparing cannabis with neutral images will be created for each subject. Multiple comparisons will be FDR corrected. Beta weights for the cannabis image \&gt; neutral image contrasts will be extracted from the anterior insula across all voxels within each ROI., Baseline, Day 14
Rural Smoking Cessation
NCT Number: NCT06584929
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: DRUG: Nicoderm CQ nicotine patch|DRUG: Nicorette Nicotine Lozenges
Sponsor: Masonic Cancer Center, University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 272
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-12-01
Completion Date: 2029-08-31

Summary:
Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

Primary Outcome Measures: Number of participants abstinent from all combustible tobacco products, Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months., 3 months
Secondary Outcome Measures: Cigarettes per day (CPD), Number of cigarettes smoked per day., 1 and 3 months
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)
NCT Number: NCT06584916
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Obesity|Overweight
Interventions: DRUG: Orforglipron|DRUG: Placebo
Sponsor: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 480
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-01
Locations: General Surgery MIST Division Loc. 4, Bellaire, Texas, 77401, United States

Summary:
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.

Primary Outcome Measures: Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5, Week 52
Secondary Outcome Measures: Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment, Week 52|Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5, Week 52|Change from Baseline in Body Weight, Baseline, Week 52|Change from Baseline in Waist Circumference, Baseline, Week 52|Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5, Week 24
Safe Indoor Temperature Limit for Fans
NCT Number: NCT06584903
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: To Determine At What Indoor Temperature a Fan Will Incur Greater Cardiovcascular and Thermal Strain Relative to Still
Sponsor: Lakehead University
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-01-20
Completion Date: 2024-04-30

Summary:
Extreme heat events are a significant global threat to health and wellbeing, and result in more morbidity and mortality than all other natural disasters combined. Thus, a key priority is identifying effective and accessible heat resilience solutions to protect individuals from the potentially fatal consequences of heat stress. Within a range of ambient conditions, a fan has been recognized a low-cost heat resilience solution. However, when ambient temperatures exceed skin temperatures (e.g., above 35°C), a fan will incur greater dry heat gain which may be counterbalanced with evaporation of sweat from the skin surface. However, at a critical indoor temperature, the rate of heat gain will exceed the rate of evaporation resulting in net heat gain. The critical indoor temperature has yet to be determined. The purpose of this present study is to identify the indoor temperature at which a fan results in greater cardiovascular and thermal strain relative to still air in young adults using a simulated heat wave scenario of a warming room.

Primary Outcome Measures: Rate Pressure Product, At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes|Core Temperature, Every minute for the 180 minute experimental trial|Whole-Body Sweat Rate, Net difference in body mass (pre versus post) using a balance scale placed below the chair of the participant, Assessed every 10 minutes of exposure up to 180 minutes.|Skin Temperature, Measured at 4 skin locations (chest, arm, thigh, and calf) using wireless iButtons affixed to the skin with surgical tape, Every minute for the 180 minute experimental trial|Blood Pressure, Measured with an electrocardiogram-gated automated cuff, At baseline (e.g. 0 minutes), and every 10 minutes of exposure up to 180 minutes|Heart Rate, Measured with a 3-lead electrocardiogram, Every minute for the 180 minute experimental trial
Capabilities ofArtificial Intelligence Models in Externation Decision of Patient Who Followed in Intensive Care Unit ()
NCT Number: NCT06584890
Acronym: ICU
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Artificial Intelegence
Interventions: OTHER: decision
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 398
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2025-09-30
Locations: Health Science University İstanbul Prof Dr Cemil Taşcıoğlu City Hospital, Istanbul, Küçükçekmece, 34303, Turkey

Summary:
This clinical study aims to evaluate the effectiveness of General Artificial Intelligence (AI) models, specifically ChatGPT and Gemini, in assisting with the decision-making process for discharging patients from the Intensive Care Unit (ICU) to a general ward or home. The timing of ICU discharge is a critical decision that significantly impacts patient outcomes and the efficient use of ICU resources. This study seeks to determine whether AI models can accurately and efficiently predict the optimal time for patient discharge, supporting clinicians in making informed decisions.

The primary hypothesis is that AI models can improve the accuracy and speed of discharge decisions compared to traditional methods. The study will assess the agreement between the AI model predictions and the decisions made by ICU specialists. Additionally, the study will compare the performance of ChatGPT and Gemini AI models to identify which model offers the most reliable and timely discharge decisions.

By exploring the potential of AI in clinical decision-making, this research could contribute to the development of innovative tools for ICU management, ultimately enhancing patient care and optimizing ICU operations. The findings could lead to the integration of AI models into clinical decision support systems, facilitating more accurate and efficient patient management in the ICU.

Primary Outcome Measures: accuracy, The primary outcome is the accuracy of the AI models (ChatGPT and Gemini) in predicting the optimal timing for ICU discharge. Accuracy will be measured by comparing the AI models\&#39; predictions with the actual decisions made by ICU specialists. This outcome will be quantified using statistical metrics such as sensitivity, specificity, and the area under the ROC curve (AUC)., 1 year
Secondary Outcome Measures: models comparison, The study will compare the performance of the two AI models, ChatGPT and Gemini, in predicting ICU discharge. This outcome will be assessed by evaluating the accuracy, agreement with clinical decisions, and time efficiency of each model., 1 year|utilzation, The effect of AI-assisted decision-making on ICU resource utilization, such as the length of stay and bed occupancy rates, will be evaluated. This outcome will assess whether AI-driven discharge decisions lead to more efficient use of ICU resources., 1 year
Investigating How Childhood Tumours and Congenital Disease Develop
NCT Number: NCT06584877
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Childhood Tumor|Congenital Disorders
Sponsor: The Wellcome Sanger Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2017-02-02
Completion Date: 2026-02-28

Summary:
Every cell and every organ in the human body derives from a fertilised egg. As the fertilised egg divides, a human being develops and grows. The process of how the fertilised egg divides and forms a human being is very sophisticated and is directed by the genetic information, the DNA, that is present in every cell.

When errors, mutations, in the DNA code arise, the orderly process of human development can be disrupted. This can lead to the development of tumours during childhood and congenital diseases (that is, abnormalities that children are born with).

The aim of this study is to define exactly which DNA errors underpin childhood tumours and congenital diseases.

Primary Outcome Measures: Description of the genetic mutations of each tumour and congenital anomaly., For each tumour a catalogue of mutations will be derived from sequencing reads. The catalogues will be compared across tumour types / anomalies to identify the mutations that drive individual tumour types / anomalies. The life history of each tumour / anomaly will be determined.

Methylation data will be analysed to derive a methylation profile for each tumour. The profiles of individual tumours will then be compared with each other to see whether tumour-type specific methylation profiles exist., 9.5 years
Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children.
NCT Number: NCT06584864
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Meningitis|Pediatric Disorder
Sponsor: Medical University of Warsaw
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-01
Completion Date: 2025-06-01

Summary:
The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture. An open-label, randomized interventional study.

Primary Outcome Measures: Obtaining cerebrospinal fluid after the first attempt at lumbar puncture, Obtaining cerebrospinal fluid after the first attempt at lumbar puncture (at least 0.5 ml in volume, with a red blood cell count of \<10,000/mm3)., 1 day
Secondary Outcome Measures: obtaining cerebrospinal fluid - < 10,000/mm3 - at any attempt, obtaining cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count \< 10,000/mm3) in subsequent puncture attempts, 1 day|obtaining cerebrospinal fluid - > 10,000/mm3 - at any attempt, obtaining bloody cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count \> 10,000/mm3), 1 day|total number of puncture attempts to obtain cerebrospinal fluid, total number of puncture attempts to obtain cerebrospinal fluid in each patient (next puncture will be understood as another puncture of the skin with a needle), 1 day|unsuccessful puncture - failure to obtain cerebrospinal fluid, total number of participants with unsuccessful puncture - failure to obtain cerebrospinal fluid, 1 day|duration of puncture, Mean duration of puncture for each patient Measured from the moment of puncturing the skin with the needle to the moment of obtaining cerebrospinal fluid or removal of the needle in the case of unsuccessful puncture.

Measured in seconds., 1 day|assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the experience of the physician performing the lumbar puncture, Difference in success rate depending on experience - measured by the number of punctures performed so far) puncture: 0-5 low experience, 6-15 medium experience, \>15 high experience., 1 day|assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the patient's BMI z-score, Difference in success rate depending onthe patient's BMI z-score, 1 day
Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft
NCT Number: NCT06584838
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: ACL|ACL Injury
Sponsor: Università Vita-Salute San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12
Completion Date: 2025-02

Summary:
The aim of this study is to investigate the differences in graft failure between patients that underwent ACL reconstruction using allograft tendons and patients that underwent ACL reconstruction using autograft tendons in patients older than 40 y.o. and after at least 2 years of follow-up. The hypothesis of the study is that there will be a difference in graft failure and patient reported functional outcomes between allograft and autograft ACL reconstruction.

Primary Outcome Measures: To compare the difference in graft failure between allograft vs autograft ACL reconstruction, Clinical evaluation measuring the percentage in graft failure between allograft and autograft ACL reconstruction, from 2 years after surgical procedure
Secondary Outcome Measures: To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction, Clinical evaluation collecting Tegner Lysholm Score (max, 100 - min. 0) (100 = no disability; 0= maximum siability), from 2 years after surgical procedure|To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction, Clinical evaluation collecting the Visual Analogue Scale for Pain (VAS) (min.0 - max. 10) (0= no pain; 100 maximum pain), from 2 years after surgical procedure|To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction, Clinical evaluation collecting the International Knee Document Comitee Score (IKDC) (min. 0 - max. 100) (0= lowest level of function; 100= highest level of fuction), from 2 years after surgical procedure
Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects
NCT Number: NCT06584812
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Coronary Syndrome|Ischemic Stroke
Interventions: DRUG: Tiprogrel|DRUG: Tiprogrel|DRUG: Clopidogrel|DRUG: Ticagrelor
Sponsor: Tianjin Institute of Pharmaceutical Research Co., Ltd
Sex: ALL
Age: ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2025-05-01
Locations: Beijing Tiantan Hosptial, Capital Medical University, Beijing, China

Summary:
This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.

Primary Outcome Measures: PK parameters： Cmax, Maximum Concentration of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： Cmax, Maximum Concentration of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： AUC, Area under the plasma concentration curve of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： AUC, Area under the plasma concentration curve of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： Tmax, Time to maximum concentration of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： Tmax, Time to maximum concentration of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： T1/2, Half life of Tiprogrel 's active metabolite, Day 1 to Day 9 in each period|PK parameters： T1/2, Half life of Clopidogrel 's active metabolite, Day 1 to Day 9 in each period|PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Tiprogrel, ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation, Day 1 to Day 14 in each period|PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Clopidogrel, ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation, Day 1 to Day 14 in each period|PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Ticagrelor, ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation, Day 1 to Day 14 in each period|Safety parameters: Number of Participants With Treatment-Related Adverse Events, Day 1 to Day 14 in each period
Therapeutic Effects of Jing Si Herbal Tea for COPD
NCT Number: NCT06584786
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Airway Disease
Interventions: COMBINATION_PRODUCT: Jing Si herbal tea (JSHT)|OTHER: Placebo
Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2024-12-31
Locations: Taipei Tzu Chi Hospital, New Taipei City, Xindan, 23142, Taiwan

Summary:
Chronic obstructive pulmonary disease (COPD), a leading cause of global mortality, significantly impairs health-related quality of life (HRQL). COPD is characterized by airway inflammation and lung tissue damage. Jing Si herbal tea (JSHT) is known to have anti-inflammatory effects but has not been explored for treating COPD. This study investigated the potential of JSHT as an adjuvant therapy for COPD. This randomized controlled study focused on patients with COPD in the exacerbation and stable phases. The control group received the standard treatment, and the JSHT group received the standard treatment plus JSHT. Both groups underwent HRQL assessments, blood tests, and cellular studies involving five different groups to assess the effect of JSHT on damage-associated molecular patterns (DAMPs) and inflammatory markers.

Primary Outcome Measures: COPD Assessment Test (CAT), The Taiwan Society of Pulmonary and Critical Care Medicine offers the Chinese version of the COPD Assessment Test (CAT) on the website (http://tspccm.org.tw). This test consists of eight items designed to evaluate COPD symptoms. These symptoms include cough, phlegm production, chest tightness, breathlessness, limitations in daily activities, confidence in leaving the house, sleep disturbances, and energy levels. Each symptom is rated on a scale from 0 to 5, culminating in a total CAT score ranging from 0 to 40. A higher score reflects more severe COPD symptoms. A score of 10 or higher is indicative of a significant symptom burden., Assess at baseline and three months of treatment|Modified Medical Research Council (mMRC), The Modified Medical Research Council (mMRC) scale was used to evaluate dyspnea. This scale, comprising a 5-point grading system ranging from 0 to 4, measures dyspnea severity. A score of 0 indicates dyspnea only during intense exercise, while a sore of 4 represents breathlessness at rest., Assess at baseline and three months of treatment|Brief Symptom Rating Scale (BSRS-5), The 5-item Brief Symptom Rating Scale (BSRS-5) was used to assess psychological distress. It consists of five items: feeling tense, being easily angered, feeling depressed, feeling inferior to others, difficulty with sleep, and suicidal thoughts. The scale is a 5-point scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptoms., Assess at baseline and three months of treatment
Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
NCT Number: NCT06584773
Acronym: QIS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Disorder Related to Renal Transplantation
Interventions: DRUG: Everolimus|DRUG: standard maintenance immunosuppression
Sponsor: University of Sao Paulo General Hospital
Collaborators: Carlucci G Ventura|Daniel R Salomon|Fabiana Agena|Flavio J de Paula|Francine B Lemos|Gislene Bezerra|Helcio Rodrigues|Maria da Luz Fernandes|Nelson Zocoler Galante|Noemia B de Lima|Paschoalina Romano|Patricia S Souza|Vivian Onuchic|Elias David Neto
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-06
Completion Date: 2025-07
Locations: Renal Transplantation Service, Sao Paulo, 05403-900, Brazil

Summary:
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.

Primary Outcome Measures: Occurrence of acute rejection and/or positive viremia for CMV, First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients., From enrollment to the end of treatment at 52 weeks
Research on the Impact of Chronic Pelvic Pain on Endometriosis
NCT Number: NCT06584760
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Pelvic Pain|Endometriosis
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-09
Locations: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, No. N1, Shopping Mall Avenue, Yiwu, Zhejiang, 322000, China

Summary:
Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.

Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.

Primary Outcome Measures: Chronic pelvic pain, Using Simplified McGill Pain Questionnaire (SF-MPQ) for scoring, Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)|In vitro detection results, The results of immunohistochemistry, ELISA, and transcriptome sequencing of preoperative venous blood and endometrial tissue excised during surgery in patients with endometriosis, Venous blood within 3 days before surgery; Endometriosis sample excised during surgery
Study of Cerebral Vascular Reserve Using Pharmacological Testing With Acetazolamide: A Non-Inferiority Study of PET Method Compared to Conventional Reference Scintigraphy
NCT Number: NCT06584747
Acronym: DIAMOX-TEP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebrovascular Circulation
Interventions: DIAGNOSTIC_TEST: PET scan
Sponsor: Centre Antoine Lacassagne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10
Completion Date: 2026-10
Locations: Centre Antoine Lacassagne, Nice, 06000, France

Summary:
This study compares two methods for assessing brain blood flow. PET scan will be use with a drug called Acetazolamide and compare its effectiveness to the standard scintigraphy method. The goal is to see if the PET scan is just as good as the traditional method in measuring how well the brain's blood vessels respond to the drug.

Primary Outcome Measures: diagnostic performance of the 18F-FDG PET, The primary endpoint is the sensitivity of the examination in detecting a decrease in cerebral vascular reserve (CVR). The presence or absence of a decrease in CVR for each patient will be determined by clinical consensus, based in particular on spontaneous follow-up (clinical progression, cerebral ischemic episodes, etc.) and/or on the progression after revascularization in cases where it is performed., 12 months
Secondary Outcome Measures: contribution of late 18F-FDG PET metabolic information, To study the contribution of late 18F-FDG PET metabolic information: Late 18F-FDG PET metabolic images will be analyzed using Scenium® software, which enables stereotaxic normalization and the expression of uptake in terms of standard deviations relative to a database of normal subjects. The corresponding values will be compared based on the clinical progression of patients after revascularization., 12 months
Short Foot Exercises and Anti-pronation Taping on Low Back Pain Associated With Hyper Pronation
NCT Number: NCT06584721
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Low Back Pain
Interventions: OTHER: Anti-pronation taping (Low dye taping) + Conventional therapy|OTHER: Short Foot Exercises + Conventional PT
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-27
Completion Date: 2025-08-27
Locations: Rawal Surgical Hospital, Nawababad, Wah Cantt, Wāh, Punjab, Pakistan

Summary:
The aim of this randomized clinical trial is to find the comparison of Short foot exercises and anti-pronation taping on low back pain associated with hyper pronation on reducing back pain improving range of motion of foot, back and foot posture.

Primary Outcome Measures: Range of motion (Goniometer), It is a tool used to measure the range of motion of joint (0-180). Record the starting measurement, remove the goniometer, and allow the patient to move the joint through the available range of motion. Replace and realign the goniometer. Read and record the measurement., 4 weeks|Numeric Pain Rating Scale NPRS, The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain., 4 weeks|Foot Posture Index, It is a tool which provides quantitative data about foot posture. It has total six items. Talar head palpation, observation of curves above and below the lateral malleolus, a bulge in the region of the talonavicular joint, eversion and inversion of the calcaneus, congruence of the medial longitudinal arch, adduction and abduction of the forefoot in relation to the rear foot. Total score between (- 12 and + 12). (0 and + 5 normal feet) ;( + 6 to + 9 pronated feet) ;( ≥ + 10 highly pronated feet) ;( - 1 to - 4 supinated feet); - 5 to - 12 indicate highly supinated., 4 weeks|Oswestry Disability Index, The ODQ scale was utilized to quantify the limitations in regular daily life activities. It depends on 10 segments with six levels each, evaluating the restriction of different activities of day to day living. The qualities range from 0 (the best wellbeing state) to 100 (the most worsening wellbeing state). For each segment of the poll, the absolute plausible score is 5., 4 weeks
Effect of Low-Volume HIT vs. MIC Exercise in Individuals With Increased BMI
NCT Number: NCT06584708
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overweight and Obesity
Interventions: OTHER: Low-volume high intensity interval training|OTHER: Moderate intensity continuous exercise
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-02-15
Completion Date: 2024-09
Locations: Cantonment General Hospital, Saddar, Rawalpindi, Punjab, 46060, Pakistan

Summary:
To compare the effect of low volume high intensity training and moderate intensity continuous exercise on Rate Pressure Product (RPP) and functional capacity. Limited literature available on effectiveness of Low-volume HIIT in comparison of other Aerobic interventions in obese individuals. In our community, people are sedentary and not involved in routine exercise because of increased weight, so Low volume HIIT would be safe and convenient for such individuals to perform. There is also limited studies available on female gender so both genders are included in this study.

Primary Outcome Measures: Rate Pressure Product, Changes from baseline to 2 weeks and 4 weeks after the intervention, measured through product of heart rate and systolic blood pressure, is a very reliable indicator of myocardial oxygen demand. An RPP above 20,000 mmHg per minute is considered healthy, whereas anything below 16,000 mmHg is considered insufficient., 2 weeks, 4 weeks|Functional Capacity, Changes from baseline to 2 weeks and 4 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional/exercise capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support., 2 Weeks, 4 Weeks
Effects of Sub Occipital Muscle Inhibition Technique on Hamstring Flexibility in Post-laminectomy Patients.
NCT Number: NCT06584682
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hamstring Tightness
Interventions: OTHER: Sub-occipital muscle inhibition technique|OTHER: conventional therapy
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-01
Locations: Health and wellness rehabilitation center, Swābi, KPK, Pakistan

Summary:
to find out the effects of sub-occipital muscle inhibition technique in combination with upper cervical spine exercises on hamstring muscle flexibility in post-laminectomy patients.

Primary Outcome Measures: Active knee extension test, Patient is supine, unaffected limb on support surface and the examined limb elevated so that hip in 90 degree of flexion and knee to extended position perpendicular to ground. A lag of 20 degrees is considered normal from full extension, less than 20 degrees is considered as hamstring muscle tightness, two weeks|Numeric pain rating scale, The NPRS is a self-reported, or clinician administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form., two weeks|Modified Oswestry disability index, The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. There are 10 questions, for each question there is a possible 5 points; 0 for the first answer, 1 for the second answer, etc., two weeks
Evaluation of Serum Gasdermin D Level As a Potential Biomarker of Disease Activity in Vitiligo Patients
NCT Number: NCT06584643
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Serum Gasdermin D in Vitiligo
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2025-12

Summary:
Assessment the serum level of Gasdermin D level in vitiligo patients. Correlate its level with disease activity scores using Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores and with different disease parameters.

Primary Outcome Measures: Assessment the serum level of Gasdermin D level in vitiligo patients, estimate the serum level of Gasdermin D level in vitiligo patients and correlate its level with disease activity and various disease parameters., basline
Molecular Classification of Endometrial Cancer: Impact on Adjuvant Treatment Planning.
NCT Number: NCT06584630
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endometrial Cancer
Sponsor: Aristotle University Of Thessaloniki
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-31

Summary:
Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients.

Primary Outcome Measures: Multidisciplinary Team Board decision change, MDT decision for adjuvant treatment (Rate of adjuvant treatment change), 2 years (study completion)
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
NCT Number: NCT06584617
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot Ulcer
Sponsor: VULM s.r.o.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-17
Completion Date: 2025-12

Summary:
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®.

The main questions it aims to answer are:

* Does medical device Berovenal® lower the size of diabetic foot ulcer?
* What medical problems do participants have when using medical device Berovenal®?

Researchers will compare medical device Berovenal® to a reference device (device with similar purpose of use).

Participants will:

* Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device

Primary Outcome Measures: Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area., 8 weeks
Secondary Outcome Measures: Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers, 8 weeks|Evaluation of clinical efficacy based on median time until complete Index ulcer closure, 8 weeks|Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80%, 4, 6 and 8 weeks|Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area, 2, 4, 6 and 8 weeks|Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL, 2, 4, 6 and 8 weeks|Evaluation of safety based on proportion of target wounds with a documented wound infection, 8 weeks|Evaluation of safety occurrence of adverse events, device failures or complaints, 8 weeks|Evaluation of clinical efficacy based on wound healing process, The analysis will inolve evaluation wound depth, presence of granulation tissue, exsudate and infection at individual time points., 2, 4, 6 and 8 weeks
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation.
NCT Number: NCT06584604
Acronym: PESCA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intensive Care Unit|Mechanical Ventilation|Critical Illness
Sponsor: Leiden University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-01

Summary:
Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.

Primary Outcome Measures: Esophageal pressures measured by the balloon catheter at different filling volumes, To obtain a calibration method for the oesophageal balloon catheter in patients ventilated with a support mode and breathing spontaneously. Two, often used balloon catheters will be tested., 45 minutes
Secondary Outcome Measures: To compare the calibration method and the derived values while spontaneously breathing with the calibration method and the derived values while ventilated in a passive mode., After measurements were done during spontaneously breathing patients, measurements were done during mandatory ventilation, while patient is passive, 45 minutes
Proximal Metatarsal Osteotomy in Correction of Hallux Valgus
NCT Number: NCT06584487
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hallux Valgus and Bunion
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-10
Completion Date: 2025-10

Summary:
The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy

Primary Outcome Measures: The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale)., Pain-Function-Alignment, baseline
Secondary Outcome Measures: Post operative radiographic changes in standing AP view foot and standing lateral view foot., In standing AP view foot

* The hallux valgus angle HVA in degrees.It is the angle between long axis of 1st metatarsal and proximal phalanx of big toe
* The intermetatarsal angle IMA in degree
* The distal metatarsal articular angle DMAA in degree
* The 1st metatarsal length in centimeter In standing lateral view foot
* The inclination angle of the 1st metatarsal in degree In standing AP view foot
* The hallux valgus angle HVA in degree
* The intermetatarsal angle IMA in degree
* The distal metatarsal articular angle DMAA in degree
* The 1st metatarsal length in centimeter In standing lateral view foot
* The inclination angle of the 1st metatarsal, Baseline
The EFFECT of NEBULIZED AZITHROMYCIN AS THERAPY for BRONCHOPULMONARY DYSPLASIA
NCT Number: NCT06584474
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bronchopulmonary Dysplasia|Premature|Ventilation, Mechanical
Sponsor: Alexandria University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-02
Completion Date: 2025-11-02

Summary:
The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.

Primary Outcome Measures: Development of BPD (bronchopulmonary dysplasia), Developed BPD :Yes or No If patient fulfilled criteria of BPD ; patient is born at or less than 32 weeks gestational age and still need oxygen and or respiratory support at the 28 day or more postnatal age and/or 36 weeks postmenstrual age., 28 days of life and/or 36 weeks postmenstrual age|Lung Ultrasound assessment, Lung ultrasound score The score is calculated by the following points at different lung zones using lung ultrasound 0: A lines

1. 3 or more nonconfluent B lines
2. confluent B lines
3. C profile or consolidation, 14 days postnatal age.