pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Exergame and Robotic Therapy Impact on Tenascin-C and Functional Outcome on Stroke Patients
NCT Number: NCT06563206
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Paralysis Arm
Interventions: PROCEDURE: Exergame|PROCEDURE: Robotic|PROCEDURE: Conventional
Sponsor: Hasanuddin University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2025-03-01
Locations: Hasanuddin University, Faculty of Medicine, Makassar, South Sulawesi, 90245, Indonesia|Wahidin Sudirohusodo General Hospital, Makassar, South Sulawesi, 90245, Indonesia

Summary:
This clinical trial aims to compare the effectiveness of Robotic versus Exergame versus Standard therapy to improve hand function among post-stroke patients. The main questions it aims to answer are:

1, Effectiveness of interventions in functional outcome recovery across time 2. Effectiveness of interventions in affecting Tenascin-C level 3. Clinical outcome difference between all interventions

Participants will be allocated into three groups, either a robotic group, exergame group as the main interventions, and standard rehabilitation group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome

Primary Outcome Measures: Fugl-Meyer Assessment Upper Extremity (FMA-EU) Score, a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement, changes of FMA-UE score from pre-intervention to six weeks after intervention|Nine Hole Peg Test Value, an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively., changes of NHPT values from pre-intervention to six weeks after intervention|Handgrip Dynamometer value, The handgrip dynamometer measures hand strength, with a typical range of 0 to 100 kg (0 to 220 lb). For men, normal handgrip strength usually falls between 30-60 kg (66-132 lb), while for women it ranges from 20-40 kg (44-88 lb)., changes of handgrip values from pre-intervention to six weeks after intervention|Tenascin-C value, The normal range of Tenascin-C levels in healthy individuals typically falls between 50 to 200 ng/mL., changes of Tenascin-C value from pre-intervention to six weeks after intervention
Urinary Neurotrophin Levels as Potential Biomarkers for Overactive Bladder: A Case-Control Study
NCT Number: NCT06563193
Acronym: urinary
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Overactive Bladder
Interventions: DIAGNOSTIC_TEST: NERVE GROWTH FACTOR
Sponsor: Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-06-01
Locations: Erzincan Binali Yıldırım University, Erzincan, Turkey

Summary:
Overactive bladder is a prevalent urological disorder marked by symptoms such as urinary urgency, increased frequency of urination, and nighttime urination (nocturia). Neurotrophins, including nerve growth factor and brain-derived neurotrophic factor, play crucial roles in the development and function of neurons. Recent research has suggested a possible connection between these neurotrophins and OAB.

This study sought to explore the relationship between urinary levels of NGF and BDNF and the presence of OAB.

Primary Outcome Measures: NGF anf BDNF levels in overactive bladder patients, NGF AND BDNF LEVELS ARE HIGH IN PATIENTS WITH OVERACTIVE BLADDER., 6 months
Impact of Climate Changes on Women's Health in Al Dakahlya Governorate, Egypt
NCT Number: NCT06563180
Acronym: Women
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Women's Health
Interventions: BEHAVIORAL: Health-Promoting Lifestyle Profile II
Sponsor: Delta University for Science and Technology
Sex: FEMALE
Age: ADULT
Enrollment: 700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-30

Summary:
the current study is to assess the impact of climate changes on Women's health.

Primary Outcome Measures: increasing awareness of global women climate vulnerability :, 1. Sociodemographic and occupational characteristics of women:

   It assesses sociodemographic and occupational characteristics .
2. women climate vulnerability index: identify 12 risk categories across physical, economic and political sectors that affect women.

these categories and attendant 51 risk indicators and will require a response on four -point likert rating scale as: one scale for assessing the likelihood of individual risk indicator (Frequent: 0.76-1; Probable: 0.51-0.75; Occasional: 0.26-0.5;Remote: 0-0.25) and one for the impact (Catastrophic: 0.76-1; Signiﬁcant: 0.51-0.75;Moderate: 0.26-0.5; Low: 0-0.25) were used when converting the data into numbers and equations for measuring risk scores.

Level of risk scores:

* very high: 7.51-10
* high :5.01-7.5
* medium :2.51-5.0
* low: 0-2.5, 3 months
Secondary Outcome Measures: increasing Women's health health promoting lifestyle behaviors, health promoting lifestyle behaviors: to measure health promoting lifestyle behaviors (HPLBs). It included fifty-two elements within six dimensions: "Physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and health responsibility". Higher scores refer to higher adherence levels to healthier lifestyle behaviors. The total score ranged from (52 to 208). It used "a four-point likert scale", ranged from one (never) to four (routinely). The total score will be classified into four levels:

* Poor for the range 52-90
* Moderate for the range 91-129.
* Good for the range 130-168.
* Excellent for the range 169-208., 3 months
Are Exercise Capacity and Physical Fitness Related With Quality of Life, Physical Activity, Cognitive Health and Health Literacy in Dyslipidemia
NCT Number: NCT06563154
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dyslipidemias
Interventions: DIAGNOSTIC_TEST: Exercise Capacity Assessment|DIAGNOSTIC_TEST: Physical Fitness Assessment|OTHER: Quality of Life Assessment|OTHER: Physical Activity Assessment|OTHER: Cognitive Health Assessment|OTHER: Health Literacy Assessment
Sponsor: Çankırı Karatekin University
Collaborators: Hacettepe University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2024-11-30
Locations: Hacettepe University, Ankara, Turkey

Summary:
There is insufficient literature explaining the relationship between exercise capacity and physical fitness of dyslipidemia patients and quality of life, cognitive status and health literacy. Our aim with this study is to provide more information to the scientific literature about the relationship between exercise capacity and physical fitness and quality of life and health literacy in dyslipidemia patients.

Primary Outcome Measures: Exercise Capacity, First Day|Physical Fitness, Second Day
Secondary Outcome Measures: Physical Activity, Second Day|Quality of Life Assessment, Second Day|Cognitive Health, Second Day|Health Literacy, Second Day
Hypoalbuminemia in Critically Sick Children
NCT Number: NCT06563089
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypoalbuminemia
Interventions: OTHER: blood sampling
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-03-31

Summary:
The primary outcome in this Hospital-based study is to correlate the significance of hypoalbuminemia with different prognosis and outcome of different pediatric diseases.

The secondary outcomes of this study are i) to investigate the frequency of occurrence of hypoalbuminemia ii) to evaluate whether hypoalbuminemia on admission is a marker of adverse outcome in this population iii) whether correction of albumin by Human Albumin infusion or FFP helps in decreasing the length of stay in pediatric care unit, morbidity (e.g., duration of ventilator use) or mortality of the sick child.

Primary Outcome Measures: to correlate the significance of hypoalbuminemia with different prognosis and outcome of different pediatric diseases. 5, To evaluate whether hypoalbuminemia is a predictor of adverse outcome in different disease, Baseline
Finding ED90 of Flumazenil for Selective Improvement of Respiratory Distress by Remimazolam
NCT Number: NCT06563063
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stomach Neoplasm
Interventions: DRUG: Flumazenil
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-08-23
Completion Date: 2023-12-01
Locations: Severance hospital, Seoul, Korea, Republic of

Summary:
Patients undergoing endoscopic submucosal dissection with monitored anesthesia care (MAC) using remimazolam may develop respiratory distress during the procedure. In these cases, substandard doses of flumazenil have been found to improve respiratory distress without completely reversing sedation, a novel and previously unknown phenomenon. This study aimed to explore the ED90 of flumazenil to selectively improve only respiratory distress during MAC with remimazolam.

The dose determination for flumazenil will follow a biased-coin up-and-down design. Starting with an initial dose of 5 mcg, if there is an improvement in respiratory distress, the biased-coin method will be used to administer the same dose to the next patient with a probability of 8/9, and a decreased dose of 5 mcg to the next patient with a probability of 1/9. Any improvement in respiratory distress within 30 seconds of flumazenil administration will be recorded. After the procedure, the patient will be asked if they had any memory recall of the procedure. Centered isotonic regression will be used to obtain the ED90 of flumazenil.

Primary Outcome Measures: Whether it was successful or unsuccessful to improve the patient's respiratory distress, Respiratory distress occurring during the procedure were defined as follows: 1) sustained hypoxia (SpO2 \< 94%); or 2) excessive irregular breathing with heavy chest and abdominal movement, making it impossible for the endoscopist to perform the procedure. Improvement in respiratory distress was defined as recovery of hypoxia (SpO2 ≥ 95%) and improvement in respiratory pattern-loss of excessively irregular breathing and subdued chest and abdominal movement-within 30 seconds after flumazenil administration to the extent that the procedure could be resumed., 30 seconds after the intervention
Comparison Between Different Ways for Using Lidocaine During FB
NCT Number: NCT06563050
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lidocaine Spray|Nebulized Lidocaine|Lung Diseases|Lung Cancer
Interventions: PROCEDURE: Nebulized lidocaine|PROCEDURE: Lidocaine spray|PROCEDURE: Combination of nebulized lidocaine and lidocaine spray
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-11

Summary:
compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .

Primary Outcome Measures: The severity of cough using cough severity index, Assess the severity of cough during and within 4 hours after the procedure as (0 : absent cough is better ) , ( 5 : disturbing cough is the worst ), During and within 3 hours after procedure|pain during the procedure rated by the subjects on the Faces Pain Rating Scale., As (0 : no pain , the best) , ( 10 : worst pain ), During and within 3 hours after procedure|time taken to cross the vocal cords., the median time in seconds will be calculated during the procedure from the introduction the tip of bronchoscope from the nostril to second at which the tip of bronchoscopy cross the the vocal cords., at the beginning of the procedure(time zero) till seconds after crossing the vocal cords|changes in heart rate, changes in the heart rate from the baseline before procedure, During and within 3 hours after procedure|Changes in oxygen saturation, changes in the oxygen saturation from the baseline before procedure, During and within 3 hours after procedure
Secondary Outcome Measures: cumulative dose of lidocaine administered during the procedure., Less cumulative dose of lidocaine needed during the procedure is better, During the procedure|adverse reactions to lidocaine, assess for any adverse effects related to lidocaine use especially arrhythmia or other adverse effects as convulsions, involuntary movements, bronchospasm, and anaphylaxis., During and within 3 hours after procedure|overall satisfaction with the procedure using likert scale ., As (1 : strongly disagree , is the worst) and (5 : strongly agree , is better), During and within 3 hours after procedure
The Effect of Hallux Valgus Angle on Dynamic Knee Movement Pattern
NCT Number: NCT06563037
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hallux Valgus
Interventions: OTHER: No intervention
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sex: ALL
Age: CHILD, ADULT
Enrollment: 92
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-05
Completion Date: 2022-10-10
Locations: University of Health Sciences Turkey, Ankara, Turkey

Summary:
Abstract Background/aim: Little is known about the relationship between hallux valgus and the alignment of proximal joints. Dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. It is more prevalent in females and exacerbates during landing in jumping, predisposing athletes to injuries. The aim of this study is to investigate the effect of hallux valgus deformity on dynamic knee movement pattern and lower extremity injuries in athletes.

Materials and methods: This is a cross-sectional observational study. The study included 92 athletes with at least 3 years of experience in their respective sports.

Primary Outcome Measures: Drop Jump Test, The drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras. Two cameras were used, one placed in the coronal plane to view the participant from the front, and the other placed in the sagittal plane to view from the left side. Reflective markers were attached to the reference points for measurements, 30 minutes
Secondary Outcome Measures: Hallux Valgus Angle Measurement, Hallux valgus angle involves measuring the angle between the long axis of the first metatarsal bone and the longitudinal axis of the first phalanx \[15\]. The normal value ranges from 8˚ to 10˚. However, some authors suggest lateral deviation up to 15˚ may be considered normal, 10 minutes
18F-FET PET/CT in the Management of Glioma
NCT Number: NCT06563024
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glioma
Interventions: DEVICE: 18F-FET PET/CT
Sponsor: Buddhist Tzu Chi General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-08-01
Completion Date: 2023-12-30
Locations: Hualien Tzu Chi Hospital, Hualien City, Taiwan

Summary:
O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan, with the emphasis in radiomics analysis.

Primary Outcome Measures: Overall survival, Overall survival is measured from the date of diagnosis to the date of death, or censored at last follow-up date., 3 years
The Assessment of Nutritional Status of Patients With IPF
NCT Number: NCT06563011
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: OTHER: Counselling
Sponsor: İrem Çağla Özel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-09-05
Completion Date: 2024-06-05
Locations: Atatürk Sanatorium Training and Research Hospital, Ankara, Turkey

Summary:
The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.

A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. Also quality of life were assessed by SGRQ. Tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

Primary Outcome Measures: The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function, The effect of dietary counselling on change from baseline in FVC values at 12 weeks were assessed., 12 weeks|The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2, The effect of dietary counselling on change from baseline in DLCO values at 12 weeks were assessed., 12 weeks|The Effectiveness of Tailored Dietary Counselling in Patients with IPF on BMI, The effect of dietary counselling on change from baseline in BMI (kg/m2) at 12 weeks were assessed., 12 weeks|The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Body Composition, The effect of dietary counselling on change from baseline in body composition measured by BIA at 12 weeks were assessed., 12 weeks|The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Energy Intake, The effect of dietary counselling on change from baseline in energy intake (kcal/day) at 12 weeks were assessed., 12 weeks|The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Dietary Intake, The effect of dietary counselling on change from baseline in carbohydrate, protein and fat intake (kcal/day) at 12 weeks were assessed., 12 weeks|The Effectiveness of Tailored Dietary Counselling in Patients with IPF on HRQL, The effect of dietary counselling on change from baseline in St. George Respiratory Questionnaire (SGRQ) score at 12 weeks were assessed. Scores range from 0-100. While score of zero indicates normal, and a score of 100 indicates impaired quality of life., 12 weeks
Pentoxifylline Role Against Chemotherapy-induced Neuropathy
NCT Number: NCT06562998
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Interventions: DRUG: Pentoxifylline
Sponsor: Beni-Suef University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-07-01
Completion Date: 2024-08-01
Locations: University Hospital, Banī Suwayf, Beni-Suef, 13556, Egypt

Summary:
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.

Primary Outcome Measures: The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale, 12 weeks
Secondary Outcome Measures: Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5), 12 weeks
STL Registration Measures Mandibular Bone Loss After Denture Adjustment. 3D Analysis Quantifies Resorption Post-equilibration.
NCT Number: NCT06562972
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Resorption of Mandible
Interventions: OTHER: Occlusal equilibration of complete denture using articulating paper|OTHER: Occlusal equilibration of complete denture using occulosense
Sponsor: Badr University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-18
Completion Date: 2025-02-18
Locations: Badr university in Cairo, Cairo, Egypt

Summary:
STL registration-based superimposition is an advanced technique for assessing mandibular bone resorption in removable complete denture (RCD) patients. This 3D method involves aligning and comparing digital models of the mandible before and after RCD use, offering high accuracy and comprehensive analysis. The process includes 3D scanning, STL conversion, registration, superimposition, and quantification. Occlusal equilibration of RCDs plays a crucial role in distributing masticatory forces and influencing bone resorption patterns. Studies using this technique have revealed non-uniform resorption, with variations in different regions of the mandible. While offering numerous advantages over traditional methods, challenges include potential registration errors and the need for specialized equipment and expertise. Future developments may incorporate machine learning, biomechanical modeling, and long-term studies to enhance understanding and clinical application of this technology in prosthodontics and oral surgery.

Primary Outcome Measures: 3D Quantification Assessment of Mandibular Bone Resorption, 3D quantification assessment of mandibular bone resorption uses advanced imaging techniques like Cone Beam Computed Tomography (CBCT) and digital 3D software to measure and analyze bone loss in the lower jaw. This process is essential for accurate diagnosis, treatment planning (e.g., implants), and monitoring bone changes over time. It provides precise measurements, visual representations, and comprehensive analysis of bone density and volume, aiding in better clinical outcomes. Despite its advantages, it can be costly and involves radiation exposure, making it less accessible in some practices., six months
Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis
NCT Number: NCT06562959
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis Complication
Interventions: BEHAVIORAL: Fluid Restriction Program|OTHER: Intervention Bundle (Fluid Restriction Program and Auricular Acupressure
Sponsor: Alexandria University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-04-23
Completion Date: 2024-02-03
Locations: Faculty of Nursing, Alexandria, 56321, Egypt

Summary:
This study aims to evaluate the effects of auricular acupressure on salivary flow rate and fluid restriction adherence among children undergoing Hemodialysis .

Hypothesis Children undergoing Hemodialysis who receive both auricular acupressure and fluid restriction program exhibit better salivary flow rate and fluid control adherence than those who receive fluid restriction program only.

Primary Outcome Measures: Salivary Flow Visual Analogue Scale, This tool used to evaluate the salivary flow assessment. It consisted of 8 validated items measuring two main dimensions of salivary flow. The first dimension assessing the impaired oral functions due to the sensation of dry mouth as indicated by having difficulty in swallowing or speaking. While the second dimension evaluating the dryness of oral mucosa (lips, mouth, tongue, or throat). Additionally, children were asked two global questions regarding salivary quantity and thirsty level. In each item, children's responses were rated on a 100-mm horizontal numeric scale ranged from No (0) to very dry (100)., After one month
Secondary Outcome Measures: Fluid Control in Hemodialysis Patients Scale, This scale consisted of 24 items to evaluate the knowledge, behavior and attitude toward fluid restriction among patients undergoing hemodialysis. These items measure patients' compliance with fluid control., After one month
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function
NCT Number: NCT06562946
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacokinetics
Interventions: DRUG: Pimicotinib
Sponsor: Abbisko Therapeutics Co, Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-30
Completion Date: 2025-06-30
Locations: The first hospital of Jilin University, Changchun, Jilin, China

Summary:
This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function.

Primary Outcome Measures: Cmax, To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects., Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol|AUClast, To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects., Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol|AUC 0-∞, To evaluate the pharmacokinetics (PK) of pimicotinib and its two identified metabolites, M281 and M436-2, following a single oral dose of pimicotinib capsules in adult subjects with mild and moderate hepatic impairment compared to healthy control subjects., Conduct testing within 2 month after all subjects collect all samples at all time points required by the protocol
Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer
NCT Number: NCT06562920
Acronym: Neoadjuvant
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung Cancer
Interventions: DRUG: adebrelimab and chemotherapy
Sponsor: Zhejiang Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2028-07-31
Locations: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310000, China

Summary:
To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC

Primary Outcome Measures: pCR, Pathological Complete Response, Assessed average of 1 month after surgery|Safety and Tolerability, Adverse reactions (according to CTCAE v5 classification), Assessed average of 1 month after surgery
Secondary Outcome Measures: MPR, Major Pathological response, Assessed average of 1 month after surgery|Event-Free Survival(EFS), Refers to the time from randomization to the first occurrence of any of the following events: disease progression that is inoperable, local or distant recurrence, death due to any cause, etc., From the time of enrollment, until the disease relapses or metastasizes，assessed up to 5 years follow-up.|Objective Response Rate(ORR), The proportion of patients whose tumors shrink to a certain amount and remain shrinking for a certain period of time includes complete remission (CR) and partial remission (PR)., From the time of enrollment, assessed before surgery|Overall survival(OS), The time from the start of treatment to the death of the subject due to various causes was calculated based on the intention-to-treat population (ITT)., From the time of enrollment, assessed up to 5 years follow-up.|Exploration of tumor efficacy markers, Correlation between MRD biomarkers in tumor tissue and peripheral blood and patients' clinical outcomes, progression, and efficacy., From the time of enrollment, assessed up to 5 years follow-up.
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
NCT Number: NCT06562907
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Weight Management
Interventions: DRUG: GS-4571|DRUG: Placebo|DRUG: Omeprazole
Sponsor: Gilead Sciences
Sex: ALL
Age: ADULT
Enrollment: 134
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-07

Summary:
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM).

The primary objectives of this study are:

* To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571.
* To evaluate the effectiveness of a representative gastric acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571.
* To evaluate the effectiveness of concomitant food intake on the PK of GS-4571.
* To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.

Primary Outcome Measures: Single-Dose PK Parameter AUCinf of GS-4571, AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time., Up to 96 hours postdose|Single-Dose PK Parameter Cmax of GS-4571, Cmax is defined as the maximum observed concentration of drug in plasma., Up to 96 hours postdose|Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571, AUCtau is defined as area under the concentration versus time curve over the dosing interval., Up to 96 hours postdose|Multiple-Dose Plasma PK Parameter: Cmax of GS-4571, Cmax is defined as the maximum observed concentration of drug in plasma., Up to 96 hours postdose|Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths, Day 1 up to 95 days|Percentage of Participants of Treatment-Emergent Laboratory Abnormalities, Day 1 up to 95 days
Secondary Outcome Measures: Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants, Day 1 up to 95 days
Study to Evaluate Safety and Efficacy of SYHX1901 Tablets in Severe Alopecia Areata Patients
NCT Number: NCT06562894
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Severe Alopecia Areata
Interventions: DRUG: SYHX1901|DRUG: Placebo
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-16
Completion Date: 2026-12-17

Summary:
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of severe alopecia areata.

Primary Outcome Measures: Percentage of subjects with Alopecia Severity Score Tool (SALT) score < or = 20%, Percentage of subjects achieving a SALT score \< or = 20% at week 24, Week 24
Patient Navigation to Improve Surgical Access in Primary Hyperparathyroidism
NCT Number: NCT06562881
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperparathyroidism, Primary
Interventions: OTHER: Scheduling Navigation|OTHER: Without Scheduling Navigation
Sponsor: University of Pennsylvania
Collaborators: American College of Surgeons
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-15
Completion Date: 2024-12-01
Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
The goal of this study is to address surgical health equity in historically marginalized participants with primary hyperparathyroidism (PHPT). The main questions that this study aims to answer are, how does patient navigation impact:

* The proportion of PHPT participants undergo parathyroidectomy?
* The proportion of PHPT participants who complete surgical consultation?
* Time to surgical consultation?
* Time to surgery?

Primary Outcome Measures: Parathyroidectomy Surgical Outcome, The primary outcome will be the proportion of patients who undergo parathyroidectomy, Within 12 months
Secondary Outcome Measures: Completion of Consultation, Proportion of participants who complete surgical consultation, Through study completion, an average of 1 year after time of recruitment or surgery|Time to Consultation, Time from participant referral to scheduling and completion of surgical consultation consultation, Through study completion, an average of 1 year after time of recruitment or surgery|Time to Surgery, Time from participant referral to surgery, Through study completion, an average of 1 year after time of recruitment or surgery|Complications related to hyperparathyroidism, New, worsening, or recurrent end organ disease (osteoporosis, kidney stone, renal impairment, mental health disorders or cognitive function (requiring hospitalization or loss of independence), pancreatitis), Assessed at 6 and 12 months after recruitment or surgery in all groups|Parathyroidectomy complications, Complications rates of the following:

Bleeding/hematoma Hypocalcemia Surgical site infection Voice dysfunction Tracheostomy, Assessed at 6 and 12 months after recruitment or surgery in all groups|Persistent hyperparathyroidism, Rate of persistent disease, based on pattern of calcium and parathyroid hormone levels postoperatively, Assessed at 6 and 12 months after recruitment or surgery in all groups|Recurrent hyperparathyroidism, Rate of recurrent disease, based on pattern of calcium and parathyroid hormone levels postoperatively), Assessed at 6 and 12 months after recruitment or surgery in all groups|Surgical parathyroid re-exploration, Rate of re-exploration for hyperparathyroidism, Assessed at 6 and 12 months after recruitment or surgery in all groups
Comparison of the 2-year Clinical Performances of Class II Restorations Using Different Restorative Materials
NCT Number: NCT06562868
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries Class II
Interventions: OTHER: Bulk-fill Composite Resin|OTHER: Traditional Posterior Composite Resin|OTHER: High-filler Flowable Composite
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-10-18
Completion Date: 2024-06-09
Locations: Erciyes University Faculty of Dentistry Department of Restorative Dentistry, Kayseri, Melikgazi, 38039, Turkey

Summary:
The aim of this study is to compare the clinical success of different filling materials used in the treatment of dental caries. Systemically healthy individuals with good oral hygiene and interproximal caries in their posterior teeth participated in the study. Participants underwent initial radiographic and intraoral examinations. Three different filling materials were applied to the participants' teeth. The restorations were evaluated at baseline, 1 year, and 2 years.

Primary Outcome Measures: FDI World Dental Federation Evaluation Criteria, The FDI evaluation criteria, developed by the World Dental Federation, are used to assess the clinical performance of dental restorations. The restorations were evaluated separately for each criterion and scored on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement)., two years
Tension-Type Headache Gene Expression and Methylation
NCT Number: NCT06562855
Acronym: TTH
Status: AVAILABLE
Study Type: EXPANDED_ACCESS
Conditions: Tension-Type Headache, Unspecified, Intractable
Interventions: GENETIC: Peripheral blood sampling
Sponsor: University of Gaziantep
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Locations: Gaziantep University Şahinbey Research and Application Hospital, Gaziantep, Şehitkamil, 27310, Turkey|Medicine, Gaziantep, Şehitkamil, 27310, Turkey

Summary:
Tension-type headache (TTH) refers to pain radiating from the forehead to the back of the head as a bilateral band. It often occurs without warning and spreads to the neck muscles. Patients describe it as tension, pressure, or dull pain. It is usually triggered by stress. The complexity of the processes is the biggest difficulty in diagnosing and treating TTH. Although there are genetic connections, there are no single responsible genes.
The Main Content of This Study is to Use Virtual Reality Technology Combined With Local Anesthesia With Lidocaine Injection at Different Times to Reduce the Pain of PICC in School-age Children
NCT Number: NCT06562829
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Catheterization, Peripheral
Interventions: DEVICE: Virtual reality technology|OTHER: different timing of lidocaine injection
Sponsor: Qi Yu
Sex: ALL
Age: CHILD
Enrollment: 174
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2020-05-21
Completion Date: 2021-05-28
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Summary:
We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children. Using the convenience sampling method, the selection in May 2020, 2021 - may need to PICC placement of children as the research object, is divided into three groups A, B, c, group A in ultrasound guided by PICC placement; Group B and group C adopt VR intervention, and 5 min before the beginning of the next surgery using VR equipment. Group B was anesthetized after the needle was placed into the guide wire, and group C was anesthetized before the needle was placed into the guide wire.

Primary Outcome Measures: Success rate of one puncture, The blood vessel was entered by one puncture, and there was no other operation to explore the subcutaneous vessel, pull out the needle or change the puncture site, Immediately after the end of the catheterization
Secondary Outcome Measures: pain score, Assessed using the Visual Analogue Scale ranging from "no pain" (0) to "the most severe pain" (10). A higher score indicates a greater degree of pain., Immediately after the end of the catheterization
Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain: A Randomized Controlled Trial
NCT Number: NCT06562816
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Effect of Drug
Interventions: DRUG: Trypsin-Chymotrypsin|DRUG: Naproxen Sodium 550mg
Sponsor: Dow University of Health Sciences
Sex: ALL
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2025-01-31
Locations: Dow University of Health Sciences, Karachi, Sindh, 74200, Pakistan

Summary:
This study aims to compare the pain reduction efficacy of Trypsin-Chymotrypsin and Naproxen sodium after root canal treatment in patients with symptomatic irreversible pulpitis. A lot of patients suffer greatly from post endodontic treatment pain and have a fear of dental treatments due to the pain. Patients refuse to go to the dentists and neglect oral hygiene care. That's why it is very important to find an effective drug regimen to reduce this post treatment pain. The null hypothesis is that there will be no difference between the efficacy and mean pain scores of Trypsin-chymotrypsin and Naproxen Sodium for post-endodontic treatment pain. Conducted as a triple-blinded, parallel, randomized controlled trial, 100 patients will be randomly assigned to receive either Trypsin-Chymotrypsin or Naproxen sodium following standard root canal therapy. Pain levels will be assessed using a numerical rating scale at 1, 6, 12, and 24 hours post-treatment to evaluate the effectiveness of these two pain management modalities.

Primary Outcome Measures: Change in post-endodontic treatment pain score using Numeric Rating Scale, The Numeric Rating Scale (NRS-11) is an eleven-point scale that ranges from 0, indicating no pain, to 10, representing the most severe pain the patient has ever encountered., 24 hours
Study of Gamma PN3 in the Elderly
NCT Number: NCT06562790
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pneumonia, Pneumococcal
Interventions: BIOLOGICAL: Gamma PN3|BIOLOGICAL: Prevnar
Sponsor: GPN Vaccines
Sex: ALL
Age: OLDER_ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-06

Summary:
Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly

Primary Outcome Measures: Adverse events, Spontaneous and diary recorded events, 57 days|Geometric fold increase in IgG titre, Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in IgG titre, 56 days
Secondary Outcome Measures: Geometric fold increase in OPA titre to 36 serotypes of S. pneumoniae, Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in opsonophagocytic titre, 56 days|Geometric fold increase in IgA, Day 29 / Day 1 and Day 57/Day 1 geometric fold increase in serum and mucosal IgA, 56 days|Memory B cells, Memory B cell count, 56 days|Rate of community acquired pneumonia, Number of participants with community acquired pneumonia, 1 year
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
NCT Number: NCT06562777
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematopoietic and Lymphatic System Neoplasm|Malignant Solid Neoplasm
Interventions: OTHER: Non-Interventional Study
Sponsor: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-15
Completion Date: 2025-07-31
Locations: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States

Summary:
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.

Primary Outcome Measures: Patient-reported symptoms, Will compare the number, severity, and burden of symptoms by sex. Will be assessed using the Common Toxicity Criteria and Adverse Events v1.0 (PRO-CTCAE) reporting tool., Baseline, weekly thereafter up to 26 weeks|Patient-reported QOL - Part 1, Will use the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29), Baseline, month 3, month 6|Patient-reported QOL - Part 2, PROMIS Cognitive Function instruments, Baseline, month 3, month 6|Patient-reported QOL - Part 3, Selected questions from the EORTC-QLQ-C30 to evaluate the impact of immunotherapy on QOL., Baseline, month 3, month 6|Clinician-assessed patient symptoms, Clinicians will rate patient symptoms according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scoring system, which grades adverse events according to 5 categories of severity and requires evaluation of the extent to which the adverse event can be attributed to treatment ("unrelated" to "definite"). Will examine agreement using intraclass correlations by patient gender., Baseline, month 3, month 6
To Evaluate Newly Developed Pictogram Cards and Their Utility in Improving Inhaler Techniques in Asthmatic Patients
NCT Number: NCT06562764
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma
Interventions: OTHER: Counselling by the Trained Pharmacist|OTHER: Pictograms Cards and Counselling by the Trained Pharmacist
Sponsor: Islamia University of Bahawalpur
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-10
Completion Date: 2024-08-25
Locations: The Islamia University of Bahawalpur, Bahāwalpur, Bahawalpur, 63100, Pakistan

Summary:
To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.

Primary Outcome Measures: Proper/Improper use of inhaler, Determine the proper/improper use of inhaler via checklist. The dichotomous primary endpoint (Proper inhaler technique/ Improper Inhaler Technique). A participant is categorized as having proper inhaler technique if the score was 7/7 and improper technique if the score was \< 7., 12 weeks
Secondary Outcome Measures: Determine the adherence via a validated tool named the Medication Adherence Report Scale (MARS-5)., Adherence is the extent to which a person's behavior- taking medication, following a diet, and/or executing lifestyle changes- corresponds with the agreed recommendations from a healthcare provider. The adherence is measured via a validated tool named the Medication Adherence Report Scale (MARS-5). MARS-5 shows promise as a self-report tool for measuring patients' reports of their medication use across various illnesses. The score ranges from 5 to 25, where a higher MARS-5 score indicates higher self-reported adherence., 12 weeks|Determine the Asthma Control in the asthmatic patients via ACT questionnaire., Asthma control is determined via ACT questionnaire. ACT scores range from 5-25 for the adult test and 0-27 for the child test. The higher the score, the better the asthma control. In both tests, a score of 20 or higher suggests your asthma is probably under control., 12 weeks