pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Spatially Resolved IBD: Spatial Transcriptomics of Inflammatory Bowel Disease (IBD)
NCT Number: NCT06484738
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease|Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease
Interventions: OTHER: transcriptomic analysis
Sponsor: IRCCS San Raffaele
Collaborators: BGI, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08
Locations: Irccs Ospedale San Raffaele, Milano, 20132, Italy|IRCCS Ospedale San Raffaele, Milan, Italy

Summary:
The goal of this retrospective observational study is to obtain the spatial resolution of the entire intestinal fibrotic process through the technology STOmics Stereoseq. For this study we will use surgical specimens from 8 UC e 8 CD previously collected for the already approved project, IBD Biobank, and stored at -80° C.

Primary Outcome Measures: Profile of Spatial transcriptomics of all areas of the surgical specimen from UC and CD patients, to perform a transcriptomic analysis of the entire surgical specimen will be embedded in OCT block. To overcome any failures in the OCT embedding, we will cut serial sections and stain them to evaluate the presence of all intestinal regions of interest, and then choose the adjacent one for the spatial analysis. Moreover, we will evaluate by histological assessment whether one single piece of surgical specimen will encompass not inflamed, inflamed (in case of UC) and also fibrotic areas (in case of CD), 1 year
Oncotype DX in BRCA-mutated Breast Cancer Patients: Our Experience. A Retrospective Observational Monocentric Study
NCT Number: NCT06484725
Acronym: OnBRA
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Genetic Predisposition
Interventions: GENETIC: Oncotype DX assay
Sponsor: IRCCS San Raffaele
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-01-01
Completion Date: 2022-06-30
Locations: IRCCS Ospedale San Raffaele, Milan, MI, 20132, Italy

Summary:
The study aims to evaluate the distribution of the Oncotype DX RS® genomic test in patients with ER-positive and HER2-negative breast cancer treated from January 2012 to December 2021, focusing on patients presenting germline mutations.

Primary Outcome Measures: Oncotype DX assay and RS® in participants., To evaluate the Oncotype DX RS® distribution in ER-positive early BC patients comparing patients with a deleterious germline mutation, patients with a VUS in BC-related genes and patients with no mutation., 30 days after surgery.
Secondary Outcome Measures: Oncotype DX assay and RS® in participants by menopausal or nodal status., To evaluate Oncotype DX RS® distribution stratifying patients by menopausal or nodal status., 30 days after surgery|Distant or local recurrence., Evaluation of distant or local recurrence from follow-up data, Up to 10 years after surgery
Electrical Stimulation Effect on Ankle Instability During Walking in Virtual Reality Setup
NCT Number: NCT06484712
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Sprains|Ankle Instability
Interventions: DEVICE: Stochastic Resonance (SR)
Sponsor: University of Delaware
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-29
Completion Date: 2025-04
Locations: University of Delaware, Newark, Delaware, 19713, United States

Summary:
The purpose of the study is to investigate whether electrical stimulation to leg muscles and joints can help with balance in people with ankle instability. Participants will be asked to walk on a treadmill in a virtual reality cave. They will receive light electrical stimulation at the legs to improve your balance. The virtual reality image will sometimes shift in unexpected ways to challenge your balance. During the session, we will conduct a series of clinical assessments, including tests of functional performance and balance. Additionally, participants will be asked to fill out some questionnaires.

Primary Outcome Measures: Change in the Center of Mass (CoM) excursion, For the visual perturbation trials, we will use CoM excursion as the primary outcome measure since it has been used in prior studies in children and adults using visual perturbation protocols. This is determined by comparing the average CoM during perturbed steps to non-perturbed steps for each participant, integrated across the first eight steps initiated by the heel strike that triggered the stimulus. We will measure CoM using kinetics and kinematic computed through a motion capture system(Qualysis).

For the unperturbed trials, we will use margin of stability (MoS) as the primary outcome measure. MOS refers to the distance between extrapolated center of mass, which includes center of mass position and velocity, and the base of support. It has been previously used to measure balance in children with cerebral palsy and Parkinson Disease., At the end of the session after 12 walking trials of randomized stimulation.
Open Versus Laparoscopic Repair of Perforated Peptic Ulcer
NCT Number: NCT06484699
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Perforated Peptic Ulcer
Interventions: PROCEDURE: open repair of perforated peptic ulcer|PROCEDURE: laparoscopic repair of perforated peptic ulcer
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-13
Completion Date: 2025-02-01
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.

Primary Outcome Measures: Early postoperative follow up for repair of perforated peptic ulcer, resumption of oral intake, 3 days after the operation
An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
NCT Number: NCT06484686
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Varicella
Interventions: BIOLOGICAL: Live Attenuated Varicella Vaccine
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sex: ALL
Age: CHILD
Enrollment: 414
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-09

Summary:
This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.

Primary Outcome Measures: Seropositive rate, The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination, at 6 years after booster vaccination|Seropositive rate, The seropositive rate of VZV antibodies at 10 years after booster vaccination, at 10 years after booster vaccination|GMT of VZV antibody, The GMT of VZV antibodies at 6 years after booster vaccination, at 6 years after booster vaccination|GMT of VZV antibody, The GMT of VZV antibodies at 10 years after booster vaccination, at 10 years after booster vaccination
Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets
NCT Number: NCT06484673
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pulmonary Arterial Hypertension
Interventions: DRUG: Bosentan Dispersible Tablets|DRUG: Tracleer Tablet for Oral Suspension
Sponsor: Humanis Saglık Anonim Sirketi
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-21
Completion Date: 2024-05-27
Locations: ACDIMA Biocenter, Amman, Jordan

Summary:
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Bosentan 32 mg Dispersible Tablets versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in healthy subjects under fasting condition.

Primary Outcome Measures: Maximum concentration obtained (Cmax), two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax, 23 hours|AUC from time 0 to last collection time t (AUC0-t), two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-t, 23 hours
Secondary Outcome Measures: AUC from time 0 to infinity (AUC0-inf), Description Statistics, 23 hours|Time of the maximum measured plasma concentration (Tmax), Description Statistics, 23 hours
Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula
NCT Number: NCT06484660
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fistula Perianal
Interventions: PROCEDURE: Minimally Invasive Approach In The Mucosal Advancement Flap Technique
Sponsor: Hospital Son Llatzer
Collaborators: Fundació d'investigació Sanitària de les Illes Balears
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-08-01
Completion Date: 2025-12-31
Locations: Hospital Son Llatzer, Palma De Mallorca, Illes Balears, 07198, Spain

Summary:
The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery.

The main question it aims to answer is:

- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery?

Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time.

Quality of life and global morbidity will also be analyzed.

Participants will:

* Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.
* Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.

Primary Outcome Measures: Healing rate, Healing will be measured if 4 criteria are present: no supuration or pain for more than a week, no open external fistulous orifice, no palpable trajectory, no internal fistulous orifice and no tract or collections in 3D endoanal ultrasound., six months
Secondary Outcome Measures: Postoperative pain, Pain measured in visual analogic scale (VAS). Scale: 0 to 10. Higher scores mean a worse outcome., one week|Global morbidity, Clavien Dindo Scale. Scale: 1 to 5. Higher scores mean worse complications., one month|Quality of life score, SF 36 questionnaire. 36 items. Higher scores mean a better quality of life., six months|Fecal incontinence, Measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome., six months
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
NCT Number: NCT06484647
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease|Ischemic Heart Disease|Chronic Coronary Syndrome|Acute Coronary Syndrome
Interventions: PROCEDURE: Percutaneous Coronary Intervention
Sponsor: San Luigi Gonzaga Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 382
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-10-01
Locations: Rivoli Hospital, Rivoli, Turin, 10098, Italy

Summary:
Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Primary Outcome Measures: Target Lesion Failure (TLF), a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR), 5-years
Secondary Outcome Measures: Stent thrombosis (ST), Thrombosis of the stent after PCI, 5-years|Intrastent-restenosis (ISR), Intrastent restenosis with \>50% of the stent diameter, 5-years|Target Vessel MI (TVMI), Target vessel myocardial infarction at follow-up, 5-years
Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss
NCT Number: NCT06484634
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy Loss
Interventions: DRUG: Low molecular weight heparin
Sponsor: RESnTEC, Institute of Research
Sex: FEMALE
Age: ADULT
Enrollment: 175
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2024-05-31
Locations: DG Khan Hospital, Dera Ghazi Khan, Punjab, 32200, Pakistan

Summary:
Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.

Primary Outcome Measures: Efficacy of Low-Molecular-Weight Heparin, Efficacy was labeled as yes in terms of live births after the age of viability, i.e., 24 weeks of gestation., 32 weeks
Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery
NCT Number: NCT06484621
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: BEHAVIORAL: Acceptance and Commitment Therapy-Based Physical Activity Intervention|BEHAVIORAL: Physical Activity Education Control
Sponsor: Hartford Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-12-31
Locations: Hartford Hospital, Hartford, Connecticut, 06102, United States

Summary:
The goal of this clinical trial is to learn if a psychological intervention can increase regular physical activity to help prevent weight regain after metabolic bariatric surgery in adults. The main questions it aims to answer are:

1. Does the psychological intervention increase physical activity?
2. Does the psychological intervention prevent weight regain?
3. Does the psychological intervention increase internal motivation for physical activity and acceptance of the discomfort that can come with physical activity?

Researchers will compare the psychological intervention to an educational intervention to see if the psychological intervention works to increase physical activity and prevent weight regain after metabolic bariatric surgery.

Participants will:

* Complete 12 months of either the psychological or control intervention. This includes attending education and counseling workshops with a small group of participants and completing brief homework assignments and individual telephone calls with a counselor.
* Wear a device to measure physical activity, use an electronic scale to measure body weight, and complete questionnaires at home on five separate occasions over an 18-month period

Primary Outcome Measures: Moderate-to-Vigorous Physical Activity, Change in daily minutes of MVPA: total (in \>=1-minute bouts) and bouted (in \>=10-min bouts), From baseline to the end of treatment (at 12-months) and follow-up (at 18-months)|Amount (%) of weight regain, The percentage of weight that is regained from baseline, From baseline to end of treatment (at 12-months) and follow-up (at 18-months)
Secondary Outcome Measures: Autonomous motivation, Relative Autonomy Index Score measured via the Exercise Self-Regulation Questionnaire, From baseline to end of treatment (at 12 months) and follow-up (at 18 months)|Physical Activity Acceptance, Total Physical Activity Acceptance Questionnaire Score, From baseline to end of treatment (at 12-months) and follow-up (at 18-months)
Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery
NCT Number: NCT06484608
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyponatremia|Hypernatremia|Postoperative Care in Neonates|Edema
Interventions: DRUG: Isotonic Saline with Dextrose
Sponsor: Rawalpindi Medical College
Sex: ALL
Age: CHILD
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2023-01-01
Completion Date: 2023-12-29
Locations: Mehak Fatima, Rawalpindi, Punjab, 00042, Pakistan

Summary:
The goal of this clinical trial is to determine if isotonic or hypotonic fluids are more effective in maintaining serum sodium levels in neonates undergoing maintenance fluid therapy post-surgery. The main questions it aims to answer are:

Does isotonic fluid therapy reduce the risk of hyponatremia compared to hypotonic fluid therapy? Does hypotonic fluid therapy lead to fewer cases of hypernatremia compared to isotonic fluid therapy? Researchers will compare neonates receiving isotonic fluids (Group I: isotonic/normal saline with 5% dextrose in 0.9% saline) to those receiving hypotonic fluids (Group H: hypotonic saline with 5% dextrose in 0.45% saline) to see if there are significant differences in serum sodium levels and associated complications.

Participants will:

Be randomly assigned to receive either isotonic or hypotonic fluids. Have blood samples taken before and after surgery to assess serum sodium levels.

Be monitored for 24 hours post-surgery to observe any complications such as hyponatremia, hypernatremia, or edema.

This study enrolled 84 neonates admitted to the neonatal intensive care unit following surgery, and data analysis was conducted using SPSS software version 25.0.

Primary Outcome Measures: Incidence of Hyponatremia and Hypernatremia, This outcome measures the incidence of hyponatremia (serum sodium level \<135 mEq/L) and hypernatremia (serum sodium level \>145 mEq/L) in neonates receiving either isotonic or hypotonic saline with dextrose as maintenance fluid therapy post-surgery, Before surgery (baseline measurement) 24 hours post-surgery
Secondary Outcome Measures: Incidence of Edema, This outcome measures the incidence of edema in neonates receiving either isotonic or hypotonic saline with dextrose as maintenance fluid therapy post-surgery, Before surgery (baseline measurement) 24 hours post-surgery
Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers
NCT Number: NCT06484569
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Work Injury|Work-related Illness
Interventions: OTHER: Control|OTHER: exercise and cranio sacral therapy
Sponsor: Uskudar University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2024-12-01
Locations: Ölmezler Textile LTD.CO., Van, Turkey

Summary:
The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory.

Primary Outcome Measures: Bournemouth Neck Pain Survey, The survey consists of 7 questions. In addition to questions about pain and disability, it also includes questions about psychosocial issues. Each question is scored between 0 and 10. The highest score is 70, with a higher score indicating a higher level of disability. The content of the survey consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on daily life activities and social life, anxiety-depression level, kinesiophobia and coping with pain., 14 weeks|The Fremantle Neck Awareness Questionnaire, The questionnaire is a Likert-type questionnaire (0 = Never/Never feel like this, 1 = Rarely feel like this, 2 = Sometimes or sometimes feel like this, 3 = Often feel like this, 4 = Always or most of the time feel like this) that evaluates individual-specific altered perception. The questionnaire asks individuals 9 questions such as how they perceive their neck in relation to their body, how they perceive their body position. The total score varies between 0-36. A high score indicates a poor prognosis., 14 weeks|Fatigue Severity Scale, The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue., 14 weeks|Pittsburgh Sleep Quality Survey, The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality., 14 weeks
NW-301 TCR-T in Patients With Advanced Solid Tumor
NCT Number: NCT06484556
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Tumor, Solid
Interventions: DRUG: NW-301V|DRUG: NW-301D
Sponsor: Tao Zhang
Collaborators: Neowise Biotechnology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2027-06-30
Locations: Wuhan Union Hospital, Wuhan, Hubei, 430022, China|Wuhan Union Hospital, Wuhan, Hubei, China

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

Primary Outcome Measures: Dose-limiting toxicity (DLT), Safety, 28 days of single infusion
Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via Functional Food/Nutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes (BRACE)
NCT Number: NCT06484543
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes|Brown Adipose Tissue
Interventions: OTHER: Maslinic Acid|OTHER: Placebo
Sponsor: Institute for Human Development and Potential (IHDP), Singapore
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2027-08-31
Locations: Singapore Institute of Clinical Sciences, Singapore, Singapore

Summary:
To examine MA (Maslinic Acid) safety and efficacy in ameliorating insulin resistance and the cardinal features of metabolic syndrome. Chronic exposure to MA as a potent PPARgamma binder nutraceutical over 12 weeks will result in improvement in the features of metabolic syndrome including waist circumference, blood pressure, serum HDL-C level, fasting serum triglycerides and fasting plasma glucose. Expected secondary endpoints include favorable changes in metabolic rate, respiratory quotient, fat oxidation, body composition, weight, BAT/WAT compartments, batokines/adipokines, proinflammatory biomarkers, insulin sensitivity and beta cell function.

Primary Outcome Measures: Concentration of blood glucose, Week 0, 12|Rate of brown adipose tissue activation detection using Infrared camera, Week 0, 12|Change in Energy Expenditure using Whole Body Calorimeter, Week 0, 12|Change in Body Mass Index (BMI), Measurement of weight and height, Week 0, 12|Change in Fat percentage, Week 0, 12|Concentration of Insulin level, Week 0, 12
Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients
NCT Number: NCT06484517
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Difficult Intubation
Interventions: DEVICE: Hugemed Videolaryngoscope
Sponsor: Marmara University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-01
Completion Date: 2023-01-31
Locations: Marmara University Pendik Research and Training Hospital, Istanbul, Turkey

Summary:
Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.

Primary Outcome Measures: Percentage of glottis opening (POGO), The primary aim of this study was to compare the percentage of glottis opening (POGO, 0-100%) scores in direct and indirect laryngoscopy performed with HugeMed and McGrath video laryngoscopes in pediatric patients., Procedure (At the time of the intubation of the patient.)
Secondary Outcome Measures: Success of intubation, Number of attempts of the intubation., Procedure (At the time of the intubation of the patient.)|Need for optimization maneuvers, Whether there are any optimization maneuvers by an assistant., Procedure (At the time of the intubation of the patient.)|Degree of hemodynamic changes, Whether there are any acute changes in the patient heart rate during the intubation., Procedure (At the time of the intubation of the patient.)|blood pressure, Whether there are any acute changes in the patient blood pressure during the intubation., Procedure (At the time of the intubation of the patient.)
Urdu Translation of Bimanaual Fine Motor Functional Classification System 2
NCT Number: NCT06484465
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2024-07-20
Locations: Riphah International University, Lahore, Punjab, 54000, Pakistan

Summary:
In 2002, Beckung and Hagberg introduced the Bimanual Fine Motor Function (BFMF) classification system. However, the initial version struggled to clearly distinguish between its five defined levels. Despite this, the BFMF system aimed to align with the Gross Motor Function Classification System (GMFCS) levels. Since its introduction, the BFMF system has been widely utilized in the Surveillance of Cerebral Palsy in Europe (SCPE) registry and various epidemiological studies

Primary Outcome Measures: Bimanual fine motor classification system 2, Urdu version of Bimanual fine motor classification system 2 The Bimanual Fine Motor Function (BFMF) classifies fine motor function in children with cerebral palsy. The five levels in BFMF form an ordinal scale, which means that the levels are 'ordered' but differences between levels are not necessarily equal, and each level includes children with relatively varied function. It is therefore unlikely that BFMF is sensitive to changes after an intervention., 6 months
SpO2 Validation Study - Philips FAST 2024
NCT Number: NCT06484452
Acronym: FAST 2024
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Pulse Oximetry
Interventions: DEVICE: No Intervention
Sponsor: Philips Clinical & Medical Affairs Global
Sex: ALL
Age: ADULT
Enrollment: 96
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-06
Completion Date: 2024-09-30
Locations: Element Materials Technology, Louisville, Colorado, 80027, United States

Summary:
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.

Primary Outcome Measures: SpO2 Accuracy, Accuracy expressed in ARMS of SpO2 measurements obtained from the SpO2 sensors under test with the Philips Pulse Oximetry technology over the range of 70-100% SaO2, in comparision to SaO2 as ground truth., May-August 2024
Secondary Outcome Measures: Non-Disparate Bias, Non-disparate bias and differential mean bias of the SpO2 sensors under test in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% \< SaO2 ≤ 100%., May-August 2024
Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction
NCT Number: NCT06484439
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Pain, Post-operative|Third Molar|Oral Surgery|Pain, Acute
Interventions: DRUG: Ketorolac|DRUG: Oxycodone|DRUG: Acetaminophen|DRUG: Ibuprofen|DRUG: Hydrocodone
Sponsor: United States Naval Medical Center, San Diego
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-02-14
Completion Date: 2021-12-01
Locations: Naval Medical Center San Diego, San Diego, California, 92134, United States

Summary:
This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption.

Primary Outcome Measures: Post operative pain control after third molar extraction, All participants will complete a daily survey on the medications taken to relieve pain., Up to five days post operative procedure.|Post operative opioid use after third molar extraction, Daily survey will be used to assess the amount of post operative opioid us including dosage and frequency of use., Up to five days post operative procedure.|Post operative pain assessment after third molar extraction, Participants fill out daily for five days post operative procedure the Numeric Pain Rating Scale (NPRS). This is a ten point scale with 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain. The higher the number is a worse outcome., Up to five days post operative procedure.|Post operative quality of life assessment after third molar extraction, Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort.

The higher the score means a better outcome. This question is part of the daily survey that participants filled out for five days post operative procedure., Up to five days after third molar extraction.
Goal Attainment Scaling (GAS) Sub-Study
NCT Number: NCT06484426
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Alzheimer's Disease in Down Syndrome
Sponsor: LuMind IDSC Foundation
Collaborators: Ardea Outcomes Inc.|Pentara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-06-30
Completion Date: 2024-02-29
Locations: University of California, San Diego, San Diego, California, 920347, United States|Advocate Health, Park Ridge, Illinois, 60068, United States|Kennedy Krieger Institute, Baltimore, Maryland, 21205, United States|Massachusetts General Hospital, Boston, Massachusetts, 02129, United States|Case Western Reserve University School of Medicine, Cleveland, Ohio, 44106-6090, United States

Summary:
This is an optional sub-study that will enroll participants from LIFE-DSR parent protocol. The aim is to assess change over 16 months in individuals with Down syndrome through individualized goals set by their caregivers. This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population.

Primary Outcome Measures: Goal Attainment Scaling (GAS), Patient centered outcome measure aiming to assess change in individuals with Down syndrome through individualized goals set by their caregivers. This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population.

GoalNav® DS-AD Instrument

This is a web-based platform developed by Ardea Outcomes with a DS-AD menu of 58 symptoms/challenges developed in collaboration with LuMind IDSC Foundation. This instrument is intended to track pre-dementia and dementia symptoms over time, including behaviors and other challenges common in adults with DS-AD.

The goal scale is a 5-point scale. Minimum value is 1 maximum value is 5

No indicators of what higher or lower scores mean., 16 months
rTMS for Depression
NCT Number: NCT06484413
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Depression
Sponsor: Northwell Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-08-23
Completion Date: 2022-04-19

Summary:
This is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of FDA approved right DLPFC rTMS treatment.

Primary Outcome Measures: MADRS, Montgomery-Asberg Depression Rating Scale, 5 weeks
Study of Intra- and Interpersonal Multimodal Synchronizations in a Social Interaction in Individuals With a Diagnosis of Schizophrenia.
NCT Number: NCT06484387
Acronym: ENHANCER1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia
Interventions: BEHAVIORAL: Social interaction
Sponsor: University Hospital, Montpellier
Collaborators: Euromov Digital Health in Motion
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-15
Completion Date: 2025-07-15

Summary:
The aim of this study is to precisely identify deficits in intra- and interpersonal multimodal synchronizations during social interaction in individuals with schizophrenia (ISZ). During a social interaction, individuals use both visual and auditory channels to construct their discourse. The auditory channel encompasses the semantics and prosody of the speech, while the visual channel describes the entirety of non-verbal gestures (e.g., facial expressions, body movements). Prosody and non-verbal gestures are essential elements for the speaker. By accompanying speech, they contribute to the planning and conceptualization of the utterance and enhance its communicative power. For the listener, prosody and non-verbal gestures are also used to provide sensory feedback to the speaker.

Several studies have shown the existence of intrapersonal and interpersonal synchronizations of prosody and non-verbal gestures during interaction. These synchronizations are associated with numerous social benefits (e.g., increased mutual appreciation and quality of interaction). However, certain mental disorders, such as schizophrenia, exhibit deficits in non-verbal behaviors that can impair these synchronizations and the associated social benefits. We hypothetized that interaction with individuals with a daignosis of schizophrenia will be associated with deficits in intra and interpersonal synchronization.

Primary Outcome Measures: interpersonal synchronization, synchronization between body movements of two interacting partners, 4x6 minutes|intrapersonal synchronization, synchronization between voice and body movements of one individual, 4x6 minutes
Secondary Outcome Measures: correlation between primary outcomes and individuals with schizophrenia medications, 4x6 minutes|correlation between synchronization and willingness to continue the interaction, 4x6 minutes
A Study of Minimally Invasive Surgical Strategies for Robot-assisted Supratentorial Large Hematoma
NCT Number: NCT06484374
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hematoma Brain
Interventions: PROCEDURE: Robot-assisted minimally invasive treatment
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University|Affiliated Hospital of Nantong University|The First People's Hospital of Lianyungang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-12-31

Summary:
The AI robot is used to design precise coordinates and access routes for hypertensive cerebral hemorrhage patients with large supratentorial hematomas in conjunction with imaging data, to clarify the therapeutic efficacy of robotic-assisted endoscopic debridement of precise minimally invasive surgical system for perioperative and long-term functional recovery of supratentorial hematomas, and to ultimately achieve the improvement of prognosis for this group of patients, and to alleviate the economic burdens on the society and the families

Primary Outcome Measures: Good prognosis rate after 6 months of follow-up, Good prognosis rate after 6 months of follow-up, 6 months
Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users
NCT Number: NCT06484257
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myopia|Hypermetropia
Interventions: BEHAVIORAL: Myopia|OTHER: Hypermetropia
Sponsor: Superior University
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-11-01
Completion Date: 2024-10-30
Locations: The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society, Lahore, Punjab, Pakistan

Summary:
This study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). We'll compare visual comfort, eye strain, and user preference for PALs between myopic and hyperopic individuals while focusing on computer screens.

Primary Outcome Measures: Visual Acuity, Assessing visual acuity at different distances, including distance vision (for activities such as viewing the computer screen) and near vision (for reading text on the screen), while wearing progressive addition lenses., 12 Months|Subjective Visual Comfort, Using standardized questionnaires or subjective ratings from participants to assess their comfort level while using computers with progressive addition lenses., 12 months|Visual Fatigue, Assessing the level of visual fatigue experienced by participants during or after prolonged computer use with the progressive addition lenses. This could involve subjective ratings of eye strain, tiredness, or discomfort., 12 months
Evaluation of the Effectiveness of Prophylactic LMWH by Thromboelastography
NCT Number: NCT06484231
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malignancy
Sponsor: Ege University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-24
Completion Date: 2025-07-24
Locations: Ege University Faculty of Medicine, İzmir, Bornova, 35100, Turkey

Summary:
This study aims to evaluate the necessity and effectiveness of using low molecular weight heparin (LMWH) for prophylaxis in the postoperative period in patients who underwent lobectomy due to malignancy, using thromboelastography.Blood samples taken from the patients before low molecular weight heparin prophylaxis (preoperative), before prophylaxis in the postoperative period (postoperative day 1) and after the start of postoperative prophylaxis (postoperative day 3) will be examined by thromboelastography.

Primary Outcome Measures: r time, 'r time' value measured by thromboelastography, 24 months|k time, 'k time' value measured by thromboelastography, 24 months|maximum amplitude (MA), 'MA' value measured by thromboelastography, 24 months|angle a, 'angle a' value measured by thromboelastography, 24 months
Secondary Outcome Measures: complications, development of complications, 24 months
Pain Control After Lumbar Spine Fusion
NCT Number: NCT06484192
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Spine Fusion|NSAID (Non-Steroidal Anti-Inflammatory Drug)|Postoperative Pain
Interventions: DRUG: Naproxen 500 Mg|DRUG: Ketorolac|DRUG: OxyCODONE 5 mg Oral Tablet|DRUG: Metaxalone 800 MG
Sponsor: Rothman Institute Orthopaedics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 428
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-06-30
Locations: Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, 19107, United States

Summary:
The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.

Primary Outcome Measures: Fusion failure, Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays, 2 years
Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type
NCT Number: NCT06484179
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Smoking
Interventions: BEHAVIORAL: Targeted Self-Help|BEHAVIORAL: Usual Care
Sponsor: University of Utah
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2027-07
Locations: Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States

Summary:
The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.

Primary Outcome Measures: Recruitment, Number of participants who consent to participate in the study, Baseline|Retention- Completion of 2-week follow-up, Number of participants who complete the 2-week follow-up assessment, 2 weeks post-randomization|Retention- Completion of 1 month follow-up, Number of participants who complete the 1 month follow-up assessment, 1 month post-randomization|Adherence- 2 weeks post-randomization, Number of participants who read the booklet 2 weeks post-randomization, 2 weeks post-randomization|Adherence- 1 month post-randomization, Number of participants who read the booklet 1 month post-randomization, 1 month post-randomization|Acceptability, Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire. Values between 8 and 32 with higher scores indicating higher satisfaction., 2 weeks post-randomization, 1 month post-randomization
Secondary Outcome Measures: Motivation to quit smoking, Changes in motivation to quit smoking will be assessed using the Contemplation Ladder. This is a validated measure for the assessment of readiness to quit smoking on a scale from 0 to 10. Higher scores indicate greater motivation to quit smoking., Baseline, 2 weeks post-randomization, 1 month post-randomization|Treatment Engagement defined by the number of participants who enroll with the state tobacco quitline, Engagement in smoking cessation services defined by enrollment with state tobacco quitline, 2 weeks post-randomization, 1 month post-randomization|Smoking Status, 7-day point prevalence smoking abstinence (i.e., not smoking, not even a puff, in the past 7 days), 2 weeks post-randomization, 1 month post-randomization]|Smoking Status, 30-day point prevalence smoking abstinence (i.e., not smoking, not even a puff, in the past 30 days), 2 weeks post-randomization, 1 month post-randomization
Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
NCT Number: NCT06484153
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma|To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer|Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer
Interventions: DRUG: Pirfenidone|DRUG: Fruquintinib|DRUG: Pembrolizumab
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2026-12-30

Summary:
The purpose of this study is to evaluate the efficacy and safety of fruquintinib and pirfenidone in combination with anti-PD-1 antibody in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

Primary Outcome Measures: Progression Free Survival (PFS), The time from enrollment until tumor progression or death from any cause, whichever occurred first, 2 year|Occurrence of Grade 4 toxicity, CTCAE v5.0, Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)|Occurrence of Grade 3 toxicity, CTCAE v5.0, Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days
Secondary Outcome Measures: Objective response rate (ORR), The proportion of patients with a PR or CR, 2 year|Overall Survival (OS), The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date, 2 year|Disease control rate (DCR), The proportion of patients with a PR, CR, or SD, 2 year|Duration of response (DoR), For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first, 2 year