pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparison of Combination of Proximal ACB and iPACK With Large-Volume Distal ACB for Early Mobilization After TKR
NCT Number: NCT06525493
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adductor Canal Block|Postoperative Pain|Regional Anesthesia
Interventions: PROCEDURE: Regional Anesthesia
Sponsor: Indonesia University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2024-01-01
Locations: Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia, Jakarta Pusat, DKI Jakarta, Indonesia

Summary:
Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Primary Outcome Measures: Timed Up and Go test on Postoperative Day 1 (POD 1), The Timed Up and Go (TUG) test is a functional mobility assessment used to evaluate a person's ability to stand up from a chair, walk a short distance, turn around, return to the chair, and sit down again. It assesses balance, gait, and functional mobility, which are crucial aspects of postoperative recovery., The test is conducted specifically on the first day after the surgery, known as Postoperative Day 1 (POD 1)|Numeric Rating Scale, The NRS is a commonly used tool to assess pain intensity. Patients are typically asked to rate their pain on a numerical scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain, The NRS assessments are conducted at 6 hours, 12 hours, and 24 hours after the surgery|Total 24 hours morphine consumption, This measures the total amount of morphine consumed by patients within the first 24 hours after surgery. It reflects the effectiveness of pain management strategies and the need for opioid analgesia, The measurement is taken over the entire 24-hour period following the surgery
Mechanical Respiratory/Circulatory Support in Patients With Pulmonary Thrombectomy
NCT Number: NCT06525480
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pulmonary Embolism and Thrombosis|Extracorporeal Membrane Oxygenation|Percutaneous Pulmonary Thrombectomy
Interventions: PROCEDURE: Percutaneous pulmonary thrombectomy
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-22
Completion Date: 2024-10-01
Locations: Vall d´Hebron Research Institute VHIR, Barcelona, 08035, Spain

Summary:
Pulmonary embolism (PE) results from embolization of venous thrombi in the branches of the pulmonary arteries.

Although anticoagulation is usually the preferred method of treatment, patients with high-risk and/or intermediate/high-risk pulmonary embolism may benefit from immediate reperfusion therapy, such as mechanical catheter thrombectomy. During this procedure, there may be an increase in pulmonary pressures caused by the introduction of pulmonary catheters, which may trigger hemodynamic instability. In addition, anesthesia performed during percutaneous mechanical thrombectomy may precipitate hemodynamic and respiratory compromise due to hypoxia, hypercapnia and increased airway pressure.

We will perform a retrospective, single-center study to determine the incidence and immediate causes of hemodynamic and/or respiratory deterioration, before, during and after (first 30 days) of percutaneous pulmonary thrombectomy, as well as the need for mechanical respiratory/circulatory support.

Primary Outcome Measures: Incidence and causes of hemodynamic and/or respiratory instability, Determine the incidence and immediate causes of hemodynamic and/or respiratory instability in patients with intermediate/high risk of pulmonary embolism.

* Hemodynamic instability: obstructive shock (signs of hypoperfusion associated with a systolic blood pressure (SBP) \<90mmHg, and/or SBP ≥ 90mmHg with the need for vasoactive drugs), persistent hypotension (SBP\<90mmHg for ≥ 15 min or SBP decrease ≥ 40mmHg compared to baseline) or cardiac arrest with the need for cardiopulmonary resuscitation
* Respiratory instability: SpO2 \<90%, dyspnea, From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy
Secondary Outcome Measures: Need for ECMO treatment, Determine the percentage of patients who require ECMO and its associated complications (hemorrhage, thrombosis, ischemia), From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy
Primary Renal Lymphoma on a 48 Year Old Woman
NCT Number: NCT06525467
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Renal Lymphoma
Interventions: PROCEDURE: radical nephrectomy
Sponsor: Instituto Mexicano del Seguro Social
Sex: FEMALE
Age: ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-22
Completion Date: 2024-06-22
Locations: Mexican Institute Of Social Health, Mérida, Yucatán, 92227, Mexico

Summary:
A 48-year-old female presented to our hospital with the following medical conditions: Systemic arterial hypertension in treatment. She denies any allergies or surgical history.

She reports a history of asthenia and adynamia for 3 months, accompanied by intermittent pain in the left flank. She denies hematuria, fever or weight loss. She underwent an enhanced CT examination at the local hospital, and a mass (10 x 9 cm in diameter) was noted in the left kidney.

Primary Outcome Measures: Cure of the disease, Complete cancer resection, 5 days
Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom
NCT Number: NCT06525454
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 1
Interventions: BEHAVIORAL: Personalized coaching messages for blood glucose and emotions
Sponsor: Samsung Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-29
Completion Date: 2025-07-29
Locations: Samsung Medical Center, Seoul, Korea, Republic of

Summary:
This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.

Primary Outcome Measures: Time In Range, Derived from CGM, Week 6
Secondary Outcome Measures: Diabetes treatment satisfaction, DSTQ, Week 6|Depressive symptoms, PHQ-9, Week 6|Time In Tight Range, Derived from CGM, Week 6|Time Above Range, Derived from CGM, Week 6|Time Below Range, Derived from CGM, Week 6|Coefficient of Variation, Derived from CGM, Week 6|Glycemic Management Indicator, Derived from CGM, Week 6
Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
NCT Number: NCT06525428
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Microsatellite Stable Metastatic Colorectal Cancer
Interventions: DRUG: standard systemic therapy combined with high/low-dose radiotherapy plus toripalimab
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2027-12
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200030, China

Summary:
TORCH-M is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of standard systemic therapy in combination with high/low-dose radiotherapy plus toripalimab in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will first receive one cycle of standard systemic therapy and toripalimab, followed by high/low-dose radiotherapy, and then continue with standard systemic therapy and toripalimab.The survival benefits, response rates, and adverse effects will be analyzed.

Primary Outcome Measures: PFS, Defined as the time from initiation of treatment to PD or death from any cause., Up to 2 years
Secondary Outcome Measures: OS, Defined as the time from initiation of treatment to death from any cause., Up to 3 years|ORR, The percentage of patients with objective response in all metastatic lesions., Up to 1 year|DCR, The percentage of patients with disease control in all metastatic lesions. Disease control is defined as CR, PR, or stable disease (SD) per RECIST v1.1 and iRECIST after treatment., Up to 1 year|Adverse events, The percentage of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy., Up to 3 years
Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease
NCT Number: NCT06525415
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Peripheral Arterial Disease|Perfusion
Interventions: DIAGNOSTIC_TEST: DCE MRI
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-11-30

Summary:
We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease

Primary Outcome Measures: preoperative perfusion parameters, preoperative perfusion parameters by dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), Between Aug.1 2024 and OCT.31 2024
Secondary Outcome Measures: ankle brachial index, Between Aug.1 2024 and OCT.31 2024|clinical success, Between Aug.1 2024 and NOV.30 2024|survival, Between Aug.1 2024 and NOV.30 2024
Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy
NCT Number: NCT06525402
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Mucositis|Chemotherapy Effect
Interventions: OTHER: Sodium Bicarbonate Group (Usual care)|OTHER: Saline Group|OTHER: Black Mulberry Syrup Group
Sponsor: Burdur Mehmet Akif Ersoy University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-02
Completion Date: 2025-03-31

Summary:
This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.

Primary Outcome Measures: Children's International Mucositis Evaluation Scale, Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions., up to 16 days|Oral Mucositis Evaluation Index of the World Health Organization, It is scored between zero and four points. Although there is no change in the grade-0 mucosa, grade-1 painless ulcers, erythema or mild sensitivity, grade-2 painful erythema and ulcers, solid foods can be consumed. Grade-3 painful erythema, edema or ulcer can be consumed only, grade-4 ulceration, necrosis and hemorrhage are present, the patient cannot be fed, enteral or parenteral support is required., up to 16 days
Secondary Outcome Measures: Neutrophil count, The neutrophil count will be evaluated. Numbers will be recorded., up to 16 days
Validity and Reliability of Smartphone Inclinometer Application for Measurement of Cervical Range of Motion
NCT Number: NCT06525376
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Joint Function Disorder
Interventions: DIAGNOSTIC_TEST: smartphone inclinometer application
Sponsor: Deraya University
Sex: ALL
Age: ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-12-01
Locations: Deraya university, Minya, 05673, Egypt

Summary:
Nowadays, smartphone technology provides opportunities for assessing and treating patients in clinical facilities and during the follow-up of the patient's progress. To date, many studies have assessed the validity and reliability of the smartphone application against universal goniometer for various joint motions, for instance, the spinal column, knee, and ankle. This study aims to determine the validity and reliability of smartphone inclinometer application for measurement of cervical region range of motion.

Primary Outcome Measures: Cervical range of motion device (CROM), The cervical range of motion (ROM) serves as a functional measure of one's capacity for head and neck movement, 6 weeks
Clinical Assessment of Chitosan Nanoparticles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial
NCT Number: NCT06525363
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Periodontal Diseases
Interventions: DRUG: Chitosan
Sponsor: Deraya University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-03-01

Summary:
Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. The understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. Systemic antibiotics have been used in different forms of periodontal disease treatment. Systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. However, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at To evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.

Primary Outcome Measures: Levels of oral Streptococcus mutans, counting number of of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs), each 3 weeks for 12 weeks|Plaque Examination, Plaque is recorded using the plaque index (PI), each 3 weeks for 12 weeks|The inflammatory status of the gingiva, recorded using the gingival index (GI), each 3 weeks for 12 weeks
A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer
NCT Number: NCT06525350
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression
Interventions: DRUG: Glumetinib tablets|DRUG: HB1801 (docetaxel, albumin-bound）|DRUG: Docetaxel
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 256
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-06-25

Summary:
This study consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (randomized controlled study). The main purpose of Stage 1 is to preliminarily evaluate the safety and tolerability of the combination of glumetinib Tablets and Docetaxel for Injection（Albumin Bound）(HB1801) in the treatment of MET-overexpressed non-small cell lung cancer (NSCLC); The main purpose of Stage 2 is to evaluate the efficacy of the combination of glumetinib tablets and HB1801 compared to glumetinib tablets monotherapy or docetaxel in the treatment of MET-expressed NSCLC.

Primary Outcome Measures: Dose-limiting toxicity(DLT) occurrence and incidence, Up to approximately 48 months after the first participant is enrolled|Recommended phase 2 dose(RP2D) of the combination therapy, Up to approximately 48 months after the first participant is enrolled|Adverse events (AE) and serious adverse events (SAE) occurrence and incidence, Up to approximately 48 months after the first participant is enrolled|Objective response rate (ORR) per RECIST 1.1, Up to approximately 48 months after the first participant is enrolled
Secondary Outcome Measures: Disease control rate (DCR) per RECIST 1.1, Up to approximately 48 months after the first participant is enrolled|Duration of response (DoR) per RECIST 1.1, Up to approximately 48 months after the first participant is enrolled|Progression free survival (PFS) per RECIST 1.1, Up to approximately 48 months after the first participant is enrolled|Blood drug concentrations of glumetinib and HB1801, Up to approximately 48 months after the first participant is enrolled|MET expression level, Up to approximately 48 months after the first participant is enrolled|MET amplification level, Up to approximately 48 months after the first participant is enrolled|Tumor-associated gene variations, Up to approximately 48 months after the first participant is enrolled|Overall survival(OS), Up to approximately 48 months after the first participant is enrolled
Adherence to Health Coaching With Wearable Devices: Enhancing Patient Engagement and Outcomes
NCT Number: NCT06525337
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea
Interventions: BEHAVIORAL: STANDARDCARE (STAND) group|OTHER: CONTROL (CON) group
Sponsor: Coastal Carolina University
Collaborators: inHealth Medical Services, Inc.|Apnimed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-08-30

Summary:
The goal of this clinical trial is to learn how integrating health and wellness coaching (HWC) with Continuous Positive Airway Pressure (CPAP) therapy affects adherence to treatment and overall health outcomes in individuals with obstructive sleep apnea. The main questions it aims to answer are:

* Does HWC improve CPAP adherence compared to standard care, in terms of device usage metrics (hours per night and days per month)?
* How does combining HWC with weight management influence CPAP adherence and weight loss?
* What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC?

Researchers will compare two groups:

* Standard Care Group: Participants receiving standard CPAP therapy without additional health coaching.
* HWC Group: Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene.

Participants will:

* Attend 2 in-office visits with a study physician (2 hours maximum)
* Have 6 virtual visits via video with a study health coach (3 hours maximum) if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy.

Primary Outcome Measures: AHI Number (Apnea-Hypopnea Index), The Apnea-Hypopnea Index (AHI) measures the severity of sleep apnea based on breathing interruptions per hour., Daily for 90 days|Oxygen Saturation, Oxygen saturation measures the percentage of oxygen in the blood, indicating respiratory efficiency and function., Daily for 90 days|Quality-of-life survey responses, Quality-of-life survey responses assess an individual's overall well-being, encompassing physical, mental, and social health., Through Study Completion, an average of 3 months
Comparision of Clinical Efficacy of Immediate Implants With T-PRF and Bone-graft Versus PRF and Bone-graft
NCT Number: NCT06525324
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Implants
Interventions: PROCEDURE: Immediate implant surgery with T-PRF and xenograft|PROCEDURE: Immediate implant surgery with PRF and xenograft
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-10
Locations: Krishnadevaraya college of dental sciences, Bangalore, Karnataka, 562157, India

Summary:
The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.

In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.

So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.

Primary Outcome Measures: Marginal Bone Level Using RVG and Grid., Marginal bone level measured ., Baseline , 3 months , 9 months|Soft tissue healing, Soft tissue healing will be assessed using Wachtel-et-al 2009 classification, Baseline ,3 months , 9 months|Bone fill using RVG with grid, Measuring the Bone fill by formula Linear bone growth/depth of original bone defect, 3 months , 9 months|Bone dimensions using CBCT, Extent of bone dimensions is measured through CBCT, 9 months
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
NCT Number: NCT06525298
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumor|Homologous Recombination Deficiency|HRR Deficiency
Interventions: DRUG: EIS-12656|DRUG: Olaparib|DRUG: Trastuzumab deruxtecan
Sponsor: Eisbach Bio GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).

Primary Outcome Measures: Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), Number and percentage of participants with adverse events, serious adverse events, adverse events of special interest including changes in safety lab parameters, physical examinations, vital signs, and electrocardiogram (ECG), From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)|Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only), A DLT is defined as an EIS-12656 related adverse event during the first treatment cycle that meets the criteria outlined in the study protocol, Within 21 days of first dose
Secondary Outcome Measures: Maximum plasma concentration of EIS-12656 (Cmax), The concentration of EIS-12656 in plasma will be determined (Cmax will be derived), At pre-defined intervals from pre-dose Day 1 to Day 29|Area under the curve (AUC0-24), The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval, At pre-defined intervals from pre-dose Day 1 to Day 29|Time to maximum concentration (Tmax), The concentration of EIS-12656 in plasma will be determined (Tmax will be derived), At pre-defined intervals from pre-dose Day 1 to Day 29|Overall Response Rate, Overall response rate defined as percentage of participants with the best overall response of confirmed CR or confirmed PR according to RECIST v1.1, From screening to disease progression (approximately 1 year)|Duration of Response, Time from first response to progression or death, as defined by RECIST 1.1, From screening to disease progression or death (approximately 1 year)|Progression Free Survival, Time from first dose of EIS-12656 to progression or death, as defined by RECIST 1.1, From screening to disease progression or death (approximately 1 year)
MCAF and EMD With and Without CTG Wall Technique for the Treatment of Class III and IV Gingival recessions-a Randomized Control Trial
NCT Number: NCT06525285
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Recession
Interventions: PROCEDURE: Connective tissue graft wall technique
Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2025-04-30
Locations: Dr. Prabhuji MLV, Bengaluru, Karnataka, 562157, India

Summary:
Research is to compare and evaluate the clinical outcomes of the Connective tissue graft wall technique with modified coronally advanced flap to improve root coverage and clinical attachment levels in Miller's class III and IV gingival recession.

Primary Outcome Measures: Root coverage, Mean root coverage Cairo's RT3 gingival recession treated with MCAF + CTG wall + EMD technique is non-inferior to MCAF + CTG + EMD in terms of root coverage., 6 months
Secondary Outcome Measures: Gingival health and evaluation, clinical attachment level, 6 months
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With Pleurisy
NCT Number: NCT06525272
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pleurisy
Interventions: DRUG: Recombinant Human Chymotrypsin(OsrhCT)|DRUG: Placebo for Recombinant Human Chymotrypsin(OsrhCT)
Sponsor: Healthgen Biotechnology Corp.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-12
Locations: Anhui Chest Hospital, Hefei, Anhui, 230031, China|Shenzhen Third People's Hospital, Shenzhen, Guangdong, 518112, China|Wuhan Pulmonary Hospital, Wuhan, Hubei, 430000, China|Changsha Central Hospital, Changsha, Hunan, 410004, China

Summary:
Primary Objectives:

To evaluate the safety and tolerability of single and multiple ascending doses of OsrhCT administered intrathoracically in patients with pleurisy, and to explore the DLT, MTD, and recommended effective dose of OsrhCT.

Secondary Objectives:

To evaluate the preliminary efficacy of single and multiple intrathoracic doses of OsrhCT.

Population:

Patients diagnosed with pleurisy requiring chest tube drainage.

Investigational Products:

Investigational Drug: Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder, stored at 2-8°C.

Placebo:

Placebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.

Study Design:

The study comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), both employing a multicenter, randomized, double-blind, and placebo-controlled design.

Sample Size:

A total of 72 subjects (both male and female) are expected to be enrolled in this trial, including 48 subjects for single-dose administration and 24 subjects for multiple-dose administration.

Primary Outcome Measures: Safety Outcome Measures, Incidence of AE, Single Ascending Dose (SAD) Study:7days;Multiple Ascending Dose (MAD) Study:30days
Secondary Outcome Measures: Efficacy Outcome Measures:Changes in pleural opacity area on chest X-ray, Measured as the absolute change from baseline in the percentage of pleural opacity area in the ipsilateral half of the chest on chest X-ray from pre-administration to Day 7, 7 days|Efficacy Outcome Measures:Relative change in pleural opacity area on chest X-ray, Relative change in pleural opacity area on chest X-ray (measured as the percentage reduction of the baseline area from pre-administration to Day 7), 7 days|Efficacy Outcome Measures:Drainage of pleural effusion, Drainage of pleural effusion from the first administration to Day 7, 7 days|Efficacy Outcome Measures:Changes in inflammatory markers, White blood cell count and C-reactive protein before and after treatment, 7 days
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
NCT Number: NCT06525259
Acronym: DISCOVERY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus Type 2, Childhood-Onset
Sponsor: George Washington University
Sex: ALL
Age: CHILD
Enrollment: 3600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2028-01-31

Summary:
The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.

Primary Outcome Measures: Type 2 diabetes, Development of type 2 diabetes, as defined by a hemoglobin A1c (HbA1c) ≥6.5% at an annual or mid-year visit followed by a confirmatory HbA1c ≥6.5% collected within 2 weeks of the first value., Through study completion, an average of 2.5 years
Secondary Outcome Measures: Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux, Intermediary changes in glycemia, β-cell function, insulin sensitivity, and free fatty acid flux along the spectrum of normal glycemia to prediabetes to type 2 diabetes., Through study completion, an average of 2.5 years
ONO-7475-03: ONO-7475 Phase I Study An Open-label, Uncontrolled Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
NCT Number: NCT06525246
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: EGFR Mutated, Stage IIIB/IIIC/IV or Recurrent, NSCLC
Interventions: DRUG: ONO-7475|DRUG: Osimertinib Mesylate
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-08-06
Completion Date: 2025-04-30
Locations: National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan|Kobe City Medical Center General Hospital, Kobe-shi, Hyogo, Japan|Hyogo College Of Medicine College Hospital, Nishinomiya, Hyogo, Japan|Kitasato University Hospital, Sagamihara-shi, Kanagawa, Japan|Kanagawa Cancer Center, Yokohama shi, Kanagawa, Japan|Saitama Cancer Center, Ina, Kitaadati-gun, Saitama, Japan|University Hospital Kyoto Prefectural University of Medicine, Kyoto-shi, Kyoto, Japan|Osaka International Cancer Institute, Osaka-shi, Osaka, Japan|Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan|Shizuoka Cancer Center, Nagaizumi-chō, Sunto-gun, Shizuoka, Japan|The Cancer Institute Hospital Of JFCR, Koto-Ku, Tokyo, Japan|Tokyo Medical University Hospital, Shinjuku-Ku, Tokyo, Japan|Nigata Cancer Center Hospital, Niigata, Japan

Summary:
This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.

Primary Outcome Measures: Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）, 28 days|Adverse event (AE), Up to 28 days after the last dose
Secondary Outcome Measures: Pharmacokinetics (Cmax), Up to 57 Days|Pharmacokinetics (Tmax), Up to 57 Days|Pharmacokinetics (AUC), Up to 57 Days|Pharmacokinetics (Ctrough), Up to 57 Days|Objective Response Rate (ORR), Through study completion, an average of 2 year|Disease Control Rate (DCR), Through study completion, an average of 2 year|Overall Survival (OS), Through study completion, an average of 3 year|Progression-Free Survival (PFS), Through study completion, an average of 2 year|Duration of Response (DOR), Through study completion, an average of 2 year|Time to Response (TTR), Through study completion, an average of 2 year|Best Overall Response (BOR), Through study completion, an average of 2 year|Percent change in the sum diameters of the target lesions, Through study completion, an average of 2 year|Maximum percent change in the sum diameters of the target lesions, Through study completion, an average of 2 year
Interval Aerobic Training and Continious Training
NCT Number: NCT06525233
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease|Exercise Addiction
Interventions: OTHER: Physiotherapy and rehabilitation
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-05-05
Completion Date: 2019-05-20
Locations: Physiotherapy and Rehabilitation Center, Bursa, Turkey

Summary:
This research is comparing the effects of interval and continuous training which are the two types of aerobic training on persons' life quality and exercise capacity on coronary artery disease patients.

Primary Outcome Measures: the effect of intermittent and continuous aerobic exercise on exercise capacity, we used the symptom-limited exercise test and six minute walking test (6DYT). All evaluation tests are done before and after training. Participants were into randomised two groups: interval aerobic training (AAE) and continuous aerobic training (SAE). Training lasted three times a week during 6 weeks. In both groups, significant changes were found in evaluation tests scores after the rehabilitation program (p\<0,05). But only AAE group have important statistical difference comparing to SAE group on test time and 6DYT scores., 30 minutes 3 times a week during 6 weeks
Secondary Outcome Measures: the effect of intermittent and continuous aerobic exercise on life quality, The participants have no mental and physical disability to join in research. The participants' demographic infos and clinical story were recorded.We evaluate the life quality by using Short Form-36 (SF-36). All evaluation tests are done before and after training. Participants were into randomised two groups: interval aerobic training (AAE) and continuous aerobic training (SAE).After training SAE group showed significant statistical change in every SF-36 parameter, while AAE group showing significant values except energy/fatigue. AAE group have statistically significant changes comparing to SAE group on that parameters; physical function, role limitations due to physical function, role limitations due to emotional function and general health (p\<0,05). Consequently AAE is much more tolerable comparing to SAE and AAE is considered more effective in increasing some parameters. On the other hand, we observed that both training types can be used in cardiac rehabilitation safely., 30 minutes 3 times a week during 6 weeks
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer
NCT Number: NCT06525220
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: Petosemtamab|DRUG: Pembrolizumab
Sponsor: Merus N.V.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2030-07
Locations: Site 2, Louisville, Kentucky, 40202, United States|Site 1, Houston, Texas, 77030, United States

Summary:
This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.

Primary Outcome Measures: Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR, Up to approximately 2 years|Overall Survival (OS), Up to approximately 3 years
Secondary Outcome Measures: Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR, Up to approximately 2 years|Duration of Response (DOR) per RECIST v1.1 as assessed by BICR, Up to approximately 2 years|Incidence and Severity of AEs and SAEs, To evaluate safety and tolerability of petosemtamab in combination with pembrolizumab, Up to 30 days post-last dose
An Interprofessional Education Program
NCT Number: NCT06525194
Acronym: ARCS-V
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Education|Professional Role|Interprofessional Relations|Patient Safety|Acceptability of Health Care|Patient Acceptance of Health Care
Interventions: BEHAVIORAL: Education
Sponsor: Izmir Democracy University
Collaborators: Ege University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-07-02
Completion Date: 2022-07-03
Locations: İzmir Demokrasi Üniversitesi Tıp Fakültesi, İzmir, Konak, 35290, Turkey

Summary:
Aim: The aim of the study was to develop and implement an interprofessional education (IPE) program that will enhance healthcare students' learning through motivating them with a theme. Methods: Undergraduate healthcare students enrolled in faculties of dentistry, medicine, and health sciences at a higher education institution in Turkey participated in this program. The program was based on the ARCS-V motivational design model, included three sessions and was hybrid. Tactics and strategies from the motivational model were used throughout the online and face-to-face training process. The Readiness for Interprofessional Learning Scale (RIPLS) was used to assess students' readiness for interprofessional education, while the ARCS-V Motivation Scale was used to assess the program. Data were analyzed using Chi-Square test, Independent t test, Wilcoxon rank test, Mann Whitney U test, and one way analysis of variance.

Primary Outcome Measures: The Readiness for Interprofessional Learning Scale (RIPLS), The Readiness for Interprofessional Learning Scale (RIPLS) was developed by Parsell and Bligh (1999), revised by McFadyen et al. (2005,2009) and adapted to Turkish by Ergönül et al. This scale is a three-dimensional, five-point Likert type scale consisting of 19 items used to measure participants' attitudes towards teamwork and collaboration, professional identity, and roles and responsibilities. According to the literature, a score of 4 and above indicates increased readiness., 2 days|ARCS-V Motivation Scale, The study utilized the ARCS-V motivation model alongside the ADDIE instructional design model. ARCS-V Motivation Design Scales, 5-point Likert type scales where higher scores indicate higher motivation, assessed the effectiveness of motivational strategies in the IPE program.

Scales Used:

Instructional Materials Motivation Survey (IMMS): Developed by Keller in 1993 and revised in 2009, this scale has 16 items focusing on attention, relevance, confidence, and satisfaction.

Course Interest Survey (CIS): Created by Keller in 1993, it also consists of 16 items, targeting the same four factors as IMMS.

Volition For Learning Scale (VFLS): Developed by Keller et al. in 2020, this 13-item scale is two-dimensional, focusing on action planning and action control, reflecting the need for motivation, volition, and self-regulation., 2 days
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
NCT Number: NCT06525168
Acronym: DA414
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Ischemic Stroke
Interventions: DRUG: DA414 Granules|DRUG: DA414 placebo
Sponsor: Chendu DIAO Nine Hong Pharmaceutical Factory
Sex: ALL
Age: ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-06
Completion Date: 2026-09-30
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China, Wuhan, Hubei.China, 430000, China

Summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.

Primary Outcome Measures: safety and tolerability, Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0., Through study completion, an average of 28 days.
Secondary Outcome Measures: Cmax, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.|AUC0-t, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.|Tmax, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.|T1/2, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.|CL/F, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.|Vz/F, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.|AUC0-∞, Plasma samples were collected at different points for pharmacokinetic analysis., Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Effect GnRH Agonist Administration in Endometriosis Cyst Patients
NCT Number: NCT06525155
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Endometriosis
Interventions: DRUG: Triptorelin Embonate|DRUG: Triptorelin Embonate
Sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Collaborators: Dexa Medica Group
Sex: FEMALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-02
Completion Date: 2025-02
Locations: Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto, Jakarta, 10410, Indonesia

Summary:
Endometriosis is a chronic disease that affects 10-15% of women of childbearing age. The most common symptom is pelvic pain. One of the treatment options that has been proven effective in treating endometriosis symptoms, including endometriosis pain, is triptorelin. Triptorelin has also received a distribution permit in Indonesia for the treatment of endometriosis.

However, patient compliance in using this drug is very low due to high medical costs and side effects of the drug. Standard treatment with triptorelin is generally given every 4 weeks. A previous preliminary study showed that triptorelin could be given at 6-week interval and provided treatment results that were no different from those at 4-week interval. This is certainly better, because with longer interval doses it can reduce medical costs, reduce side effects due to hormone suppression and can increase patient compliance in undergoing treatment. Therefore, in this study triptorelin will be given to 2 groups and observed for 18 weeks. The first group will be given triptorelin twice before surgery, each with an interval of 6 weeks, at baseline and week-6. Then triptorelin will be given again once after surgery at week-12. In the second group, triptorelin will be given once after surgery at week-12. In this study, the effect of triptorelin on the treatment of endometriosis will be measured based on the improvement in the degree of pain felt by the subjects using a visual analogue scale (VAS) at baseline, week-6, week-12 (prior to surgery) and week-18; Anti Mullerian Hormone (AMH) levels, and estradiol levels before triptorelin administration (at baseline) and prior to surgery (week-12). The condition of the uterus and cysts will also be evaluated at the time of surgery.

Primary Outcome Measures: Anti Mullerian Hormones (AMH) levels, Hormone which is produced by ovarian follicles indirectly represent remaining ovarian reserves., Baseline, week-12 (prior to surgery)
Secondary Outcome Measures: Visual Analogue Scale (VAS), Pain intensity measurement tool and presented in the form of a horizontal line and given a number 0-10., Baseline, week-6, week-12, week-18|Estradiol levels, Estradiol is a sex hormone that has proinflammatory and anti-apoptotic effects on endometrial cells which can exacerbate endometriosis., Baseline, week-12 (prior to surgery)