pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparasion of Autogenic Inhibition and Reciprocal Inhibition Muscle Energy Techniques (METS) in Piriformis Syndrome
NCT Number: NCT06460675
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Piriformis Syndrome
Interventions: PROCEDURE: Autogenic Inhibition Muscle Energy Technique|PROCEDURE: Reciprocal Inhibition Muscle Energy Technique
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2024-11-10
Locations: IIMCT Railway General Hospital, Rawalpindi, Punjab, 46000, Pakistan

Summary:
To compare the effects of Autogenic Inhibition and Reciprocal Inhibition Muscle Energy Techniques (METS) in Piriformis Syndrome

Primary Outcome Measures: Pain : Numeric Pain Rating Scale (NPRS), Patients' overall assessment of pain will be provided using the numeric pain rating scale, 3 Weeks|Range of Motion : Universal Goniometer, It is frequently employed as a benchmark technique for the assessment of Range of Motion, 3 Weeks|Lower Extremity Functional Scale (LEFS), The LEFS is a self-report questionnaire intended to assess functional status in patients with disability of the lower extremity (e.g., hip, thigh, ankle) containing 20 questions about a person's ability to perform everyday tasks, 3 Weeks
Effect of Coccygeal Mobilization in Female With Coccydynia
NCT Number: NCT06460623
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coccyx Disorder
Interventions: OTHER: external mobilization|OTHER: rectal coccygeal mobilization
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09
Locations: Hafizabad Road, Gujranwala, Punjab, 50250, Pakistan

Summary:
Aim of the study to evaluate the impact of mobilization on symptom severity, disability \& quality of life in female with Coccydynia.

Primary Outcome Measures: Paris Scale Questionnaire, The Paris Questionnaire was specifically designed for coccydynia. It covers, specifically, the functional aspects of the pain, which are not assessed by the other two questionnaires. It explores the pain when sitting (and differs, in this respect, from the VAS, which only measures the intensity of the pain), when passing from sitting to standing (very specific of coccydynia with radiologic findings), when walking and at night (pain on these occasions is frequent in severe coccydynia), and when traveling (the most sensitive detector of coccygeal pain). This set of three questionnaires offers a correct representation of the pain impact in chronic coccydynia., 4th week|DALLAS Pain Questionnaire, The Dallas Pain Questionnaire (DPQ), which is a 16-item visual analog tool was developed by Lawlis, McCoy, and Selby (appendix) for the purpose of evaluating subject's cognitions about the percentage that chronic pain affects four aspects of the patients' lives: 1) daily activities including pain and intensity, personal care, lifting, walking, sitting, standing, and sleeping; 2) work and leisure activities including social life, travelling, and vocational; 3) anxiety-depression and 4) social interest that includes interpersonal relationship, social support, and punishing responses.

Each question asks the responder to rate their experience with different activities using a percentage scale from 0% to 100%. Retest reliability of DALLAS Pain Questionnaire is 0.970., 4th week|SF-36 Questionnaire in Urdu version, The SF-36-U is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health. SF-36-U presented good to excellent test-retest reliability for all eight domains (ICC2,1 = 0.75-0.92. Internal consistency for all domains (Cronbach's alpha = 0.73- 0.90), 4th week
Cardiac Rehabilitation With and Without Delorme Technique of Progressive Resisted Exercises in Patients of Post PCI.
NCT Number: NCT06460571
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Percutaneous CORONARY INTERVENTION
Interventions: OTHER: Standard Cardiac rehabilitation with Delorme technique|OTHER: standard cardiac rehabilitation
Sponsor: Riphah International University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-01-15
Completion Date: 2024-07-15
Locations: Bethania Hospital,, Sialkot, Punjab, 51040, Pakistan

Summary:
To find the effect of cardiac rehabilitation program with and without progressive resisted exercises on patients after acute stage of PCI with at least 8 weeks history. It is a randomized clinical trial using convenient sampling technique. Randomly assign participants into two groups: An intervention group receiving Delorme progressive resisted exercise along with cardiac rehab and a control group undergoing standard cardiac rehabilitation alone. In Group A, Delorme technique will involve a 10-repetition max of aerobic and resistance exercises along with cardiac rehab. Seven different exercises will be performed in 3 sets of 10-repetition max. The control group will not be performing any type of training but will undergo cardiac rehab alone. Data will be analyzed using t test and SPSS 21 will be used for data collection. Age group will be from ≥70 years with patient undergoing dyspnea along with recent history of primary diseases. Data will be collected from Bethania Hospital, Sialkot through tools like the 6-minute walk test, Rose Angina questionnaire or settle angina questionnaire, quality of life scale (QOLFS), and Modified Borg dyspnea scale.

Primary Outcome Measures: QUALITY OF LIFE SCALE:, "The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation, baseline and fourth week|MODIFIED BORG DYSPNEA SCALE, The Modified Borg Dyspnea Scale (MBS) is a numerical rating system (0-10) assessing dyspnea during submaximal exercise. Administered with the six-minute walk test (6MWT), a common measure for pulmonary arterial hypertension (PAH), the MBS is consistent within a single session, baseline and fourth week|SETTLE ANGINA QUESTIONNAIRE, Settle Angina Questionnaire (SAQ) scale is a disease specific scale is a diabetes specific scale for assessing QOL of CHD patients; have 5 items covering domains; Physical Limitation, Angina Stability, Angina Severity, Treatment Satisfaction and Disease Perception, baseline and fourth week
T1D Closed-loop and Physical Activity
NCT Number: NCT06460558
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes type1
Interventions: OTHER: Type 1 diabetes with insulin infusion system
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-06
Completion Date: 2026-05-06
Locations: CHU NiICE, Nice, Alpes Maritimes, 0600, France

Summary:
"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control \[1\] but also on reducing the incidence of diabetes-related complications \[2,3\]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity \[4\]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates \[5\]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) \[6\]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies \[7-9\]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ \[10\], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).

Primary Outcome Measures: IPAQ score, "Measurement of IPAQ in METs/min/week (reflects the amount of physical activity practised using a validated questionnaire). There are seven items whose the result corresponds to the sum of the given figures. ", At the inclusion
Secondary Outcome Measures: BAPAD-1 score ", The BAPAD-1 score, validated in French, will be used to assess the usual obstacles to physical activity in T1DM. It is a Likert scale (between 0-7) composed by twelve items. Then, a mean is calculated with all the answers., At the inclusion|BREQ-2, "To assess motivation to engage in physical activity, use the BREQ-2 score, validated by ONAPS. It is a Likert scale (between 0-7) composed by six items. Then, a mean is calculated with all the answers., At the inclusion|ONAPS PAQ, To assess sedentary behaviour, use the ONAPS PAQ score with only the sedentary behaviour section. 4 items. Then the sum of the results is calculated, At the inclusion
Effects of Diaphragm Manual Therapy Verses Sustained Natural Apophyseal Glide in Mechanical Neck Pain
NCT Number: NCT06460532
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: OTHER: Baseline treatment
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2024-09-30
Locations: Sehat Medical Complex, Lahore, Punjab, 54000, Pakistan

Summary:
Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.

Primary Outcome Measures: Numeric Pain Rating Scale (NPRS), The primary outcome was pain assessment by the Numeric Pain Rating Scale (NPRS). This is a reliable self-reported 11-point numeric scale, where each number reflects the intensity of the pain referred by the patient: "0" stands for "no pain" and "10" for "the worst possible pain". Patients verbally selected 3 values that were most in line with the intensity of pain that they had experienced in the previous 24 h, corresponding to current pain and to his/her best and worst pain. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 h. NPRS was assessed before and after each treatment session. The reliability is (r = 0.96 and 0.95, respectively) and validity correlations range from 0.86 to 0.95, upto 4 weeks|Neck disability Index (NDI), Disability was assessed using the Urdu version of the Neck Disability Index (NDI). This is a reliable scale and was self-assessed by the patients and filled in at the beginning and at the end of the whole treatment. The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage. The reliability is between 0.50 and 0.98., upto 4 weeks|Universal Goniometer, An instrument called a goniometer was used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer. The reliability is (r = .58). Neck ROM will be measured in this study using a Universal Goniometer., upto 4 weeks
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
NCT Number: NCT06460506
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Cystic Fibrosis
Interventions: DRUG: ELX/TEZ/IVA|DRUG: IVA
Sponsor: Vertex Pharmaceuticals Incorporated
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-09

Summary:
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).

Primary Outcome Measures: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Day 1 up to Week 100
Secondary Outcome Measures: Absolute Change in Sweat Chloride (SwCl), From Baseline through Week 96
Monitoring After Cardiac Arrest: Electroencephalogram and Cerebral Oximetry in Predicting Outcome
NCT Number: NCT06460480
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest|EEG With Periodic Abnormalities|Hypoxic-Ischemic Encephalopathy
Sponsor: Haseki Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-15
Completion Date: 2024-10-30
Locations: Haseki Training and Research Hospital, Istanbul, Sultangazi, 34000, Turkey

Summary:
Because of its high incidence, it is essential to determine the neurological prognosis after cardiac arrest. However, there is not much information to guide post-cardiac arrest care. Also, dynamic monitoring of the state of the brain can help provide information about the patient's prognosis other than previously described serum biomarkers. Therefore, the researchers will monitor postcardiac arrest patients in the intensive care unit for 48 hours by electroencephalogram and cerebral oximetry and collect blood samples for serum biomarkers: neuron-specific enolase (NSE), human neurogranin (NRGN) and human trigger receptor expressed on myeloid cells (TREM-2), which are associated with neuronal damage. And investigate the relation of these data to mortality.

Primary Outcome Measures: early mortality, the status of the patient as exitus or alive within seven days post cardiac arrest, from the first day of intensive care admission after cardiac resuscitation until seven days|late mortality, the status of the patient as exitus or alive within twenty eight days post cardiac arrest, from the first day of intensive care admission after cardiac resuscitation until twenty eight days
Secondary Outcome Measures: supression ratio, supression ratio is analyzed from the electroencephalogram monitorization as highest value during time frame, from the first hour of intensive care admission until 48 hour|oxyhemoglobin deoxyhemoglobin ratio, oxyhemoglobin deoxyhemoglobin ratio is a calculated value on the cerebral oximetry monitorization and recorded as the highest deoxyhemoglobine and lowest oxyhemoglobine values, from the first hour of intensive care admission until 48 hour|serum biomarkers, serum biomarkers as NSE, NRGN, TREM2 will be studied in the blood sample at 24 th hour of post cardiac arrest, post-cardiac arrest 24th hour
Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry
NCT Number: NCT06460467
Acronym: SSTR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Meningioma
Interventions: DEVICE: scintigraphy of 177Lu-DOTATATE
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-07-01

Summary:
The aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation.

Primary Outcome Measures: Dice index, Dice index between semi-automatic segmentation and reference segmentation, 1 day
PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing
NCT Number: NCT06460454
Acronym: PROFLu
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: DEVICE: PET scan of 18F-FDG
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-01-01

Summary:
The aim of this retrospective study was to assess the prognostic value of parameters extracted from 18FDG PET/CT and 68Ga-PSMA PET in the initial workup and follow-up of patients treated with 177Lu-PSMA in mCRPC.

Primary Outcome Measures: Diagnostic accuracy of 18FDG PET metabolic volume, Diagnostic accuracy of 18FDG PET metabolic volume in predicting 1-year overall survival., 1 year
Secondary Outcome Measures: Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax), Diagnostic accuracy of 18FDG PET tumor parameter (SUVmax) in predicting 1-year overall survival., 1 year|Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean), Diagnostic accuracy of 18FDG PET tumor parameters (SUVmean), in predicting 1-year overall survival., 1 year|Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch), Diagnostic accuracy of 18FDG PET tumor parameters (FDG/PSMA mismatch) in predicting 1-year overall survival., 1 year
Comparison of the SUNRISE© Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome: Collection of Preliminary Data
NCT Number: NCT06460441
Acronym: SUNPV
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome
Interventions: DIAGNOSTIC_TEST: SUNRISE© device
Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Collaborators: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-19
Completion Date: 2024-12-17
Locations: Hôpitaux Universitaires de Strasbourg, Strasbourg, Bas-Rhin, France

Summary:
Additional data on screening for obstructive sleep apnea/hypopnea syndrome (OSAHS) in patients with co-morbidities, such as diabetics and those with chronic respiratory diseases would enable current recommendations to evolve, with a view to promoting the widespread use of simplified techniques for OSAHS screening, particularly in patients with cardiorespiratory co-morbidities.

The primary objective of this observational multicentric pilot study is to compare the performance of the Sunrise® medical device with that of ventilatory polygraphy as part of routine screening for OSAHS in diabetic patients followed up in the diabetology department of the Strasbourg University Hospital, and in patients followed up in the pneumology consultation department of Mulhouse Hospital (GHRMSA).

Primary Outcome Measures: Apnea-hypopnea index (AHI), The apnea-hypopnea index (AHI) will be measured using the Sunrise® medical device and ventilatory polygraphy. It corresponds to the number of apnea-hypopnea episodes per hour of sleep., Day 1
Secondary Outcome Measures: Dorsal AHI, Day 1|Non- dorsal AHI, Day 1|Dorsal Obstructive respiratory disturbance index (ORDI), Day 1|Non dorsal ORDI, Day 1
Online Interactive Video Developed for Fertility Awareness
NCT Number: NCT06460428
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fertility Awareness
Interventions: BEHAVIORAL: Interactive video usage
Sponsor: Gazi University
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-24
Completion Date: 2025-06-30

Summary:
The main purpose of this research is to evaluate the effect of online interactive education provided to newly married couples via a web-based platform on fertility awareness.Since fertility awareness is a relatively new field of research, there are limited studies on this subject. These studies are generally given to women. But the concept of fertility in question concerns not only women but also men.The study conducted via web-based online interactive video developed to raise awareness about fertility; It is thought that raising the awareness of newly married couples, regulating fertility, and including men in this issue are important for public health and will set an example for future studies.The positive outcomes from Webb-based online videos will enable the application to be used on national and international platforms.

Primary Outcome Measures: Fertility Awareness Scale, Fertility Awareness Scale is a 19-item, five-point Likert type (1-Never, 2-Rarely, 3-Sometimes, 4-Often, 5-Always), two-dimensional scale: Body Awareness Sub-Dimension 7,9,10, 11,12,13,15,17,18,19 (10 items) and Cognitive Awareness Sub-Dimension 1,2,3,4,5,6,8,14,16 (9 items). There are no reverse items in the scale. The lowest score that can be obtained in the total of the Fertility Awareness Scale is 19 and the highest score is 95. As the total score from the Fertility Awareness Scale increases, the level of awareness increases. If the total score is between 19-43, awareness is classified as low, between 44-69, awareness is classified as medium, and between 70-95, awareness is classified as high level., 3 months|Fertility Health Information Scale, Fertility Health Information Scale includes biological information regarding gender-specific reproductive health (menstrual cycle, sperm survival and quality, ability to have an erection), non-modifiable (age) and modifiable (lifestyle choices such as weight, stress, marijuana and cigarette use). /exposure) related to healthy fertility, It includes statements about factors such as stress, caffeine, diet, exercise, sleep habits, etc.). The scale consists of 30 items and has a single-factor structure. Responses to the items related to the scale are on a five-point Likert type (5-definitely yes; 4-probably yes; 3-undecided; 2-probably no; 1-definitely no). Those who choose "definitely yes" or "probably yes" are considered correct. In the evaluation, item 20 is reverse coded. Scores between 0 and 30 points can be obtained from the scale, and as the score increases, knowledge increases., 3 months
Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care
NCT Number: NCT06460402
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Hemorrhoidectomy Pain|Post Operative Pain|Wound Heal
Interventions: OTHER: Ice packing|OTHER: Warm sitz bath
Sponsor: E-DA Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-07-01
Locations: E-Da hospital, Kaohsiung, 812, Taiwan

Summary:
This study aims to compare the effectiveness of cryotherapy and warm water sitz bath in post-hemorrhoidectomy wound care. It is a prospective, randomized controlled trial that will assess the impact of these two methods on postoperative pain, analgesic use, wound separation, and swelling.

Primary Outcome Measures: Postoperative Pain Scores, Pain scores assessed using the Visual Analog Scale (VAS) at 24, 48, and 72 hours after hemorrhoidectomy surgery., at 24, 48, and 72 hours post-surgery for pain.
Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
NCT Number: NCT06460389
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Presbyopia|Pseudophakia|Cataract|Refractive Errors
Interventions: DIAGNOSTIC_TEST: Visual Acuity Assessment
Sponsor: Democritus University of Thrace
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-12-31
Locations: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Evros, 68100, Greece

Summary:
The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

Primary Outcome Measures: Visual acuity assessment, Visual acuity assessment in 9 focal points using DDART chart, 4 months|Area of the curve (AOC) assessment, Calculation of the AOC as a visual outscome measure, 4 months|the degree of subjective satisfaction of the patient, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25), 4 months
Comparative Effects of Wurn Technique and Mercier Therapy in Women With Endometriosis
NCT Number: NCT06460376
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis
Interventions: OTHER: Wurn Technique|OTHER: Mercier Therapy
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09
Locations: DHQ Hospital Narowal, Narowal, Punjab, Pakistan|THQ Hospital Shakargarh, Shakargarh, Punjab, Pakistan

Summary:
This project was a Randomized controlled trial conducted to check the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. The duration was 6 months, convenient sampling was done, subjects following eligibility criteria from DHQ Hospital Narowal and THQ Hospital Shakargarh were randomly assigned, a baseline assessment was done, Group A participants were given baseline treatment along with wurn technique 2 sessions per week for 6 weeks, Group B participants were given baseline treatment along with mercier therapy 1 session per week for 6 weeks, the post-intervention assessment was done, via the Marinoff Scale, Mankoski Pain Scale and Endometriosis Health Profile Questionnaire (EHP 30). Data was analyzed by using SPSS version 26.

Detailed Description: Endometriosis

Primary Outcome Measures: Endometriosis Health Profile Questionnaire (EHP 30), Endometriosis health profile questionnaire (EHP 30) is to evaluate the suitably self- report health status. It involves 30 items to identify the health status of patients with endometriosis.A core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being support and self-image). Internal consistency reliability is high for all dimensions (alpha ranged from 0.84 to 0.91), 6 Weeks
Secondary Outcome Measures: Mankoski Pain Scale, The Mankoski Pain Scale is a numerical scale ranging from zero to 10: zero indicates no pain and 10 represents pain so severe that an individual loses consciousness. It will be used to indicate dysmenorrhea.The reliability of mankoski scale is 0.84, 6 weeks
Other Outcome Measures: Marinoff Scale, Marinoff scale is used to evaluate dyspareunia. It includes 4 choices with a score of 0-3. Reliability of the scale was obtained with a Cronbach's alpha of 0.94, 6 weeks
Transcranial Alternating Current Stimulation on Patients With Delirium and Critical Illness (DeliTACS)
NCT Number: NCT06460363
Acronym: DeliTACS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Delirium
Interventions: DEVICE: Transcranial alternating current stimulation (TACS)|DEVICE: Sham TACS
Sponsor: Kuopio University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-12-31
Locations: Kuopio University Hospital, Kuopio, Finland

Summary:
The goal of this clinical trial is to learn if transcranial alternating current stimulation can shorten the duration of delirium in intensive care setting. The main question it aims to answer:

* Is it possible to shorten the duration of delirium with transcranial alternating current stimulation?

Researchers will compare experimental treatment to sham.

Participants will receive experimental or sham treatment on maximum of two days depending on their delirium status. Duration of delirium is recorded and reported as "days alive and free of delirium".

Primary Outcome Measures: Days alive and free of delirium or coma, Days alive and free of delirium or coma, 28 days
Secondary Outcome Measures: Biomarker profile, Concentrations of neurofilament light (nfl), glial fibrillary acid (gfap) and plasma tau (ptau) on days 0, 2 and 4, 4 days|EEG changes, EEG Spectral power, 2 days|CERAD, CERAD test (Consortium to Establish a Registry for Alzheimer's Disease), 3 and 12 months|TMT test A, Trail Making Test A, 3 and 12 months|TMT test B, Trail Making Test B, 3 and 12 months|Short latency inhibition, Measurement of brain cholinergic function by short latency inhibition with transcranial magnetic stimulation, 3 and 12 months
Comparative Effects of Modified Otago and Frenkel's Exercises in Geriatric Population
NCT Number: NCT06460337
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Geriatrics
Interventions: OTHER: Modified Otago exercises|OTHER: Frenkel's exercises
Sponsor: Riphah International University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-20
Completion Date: 2024-11-01
Locations: Wahla Family Hospital, Pindi Bhattian, Punjab, 52180, Pakistan

Summary:
The goal of this randomized clinical trial is to compare the effects of modified Otago and Frenkel's exercises on balance, motor function, fear of fall and quality of life in the geriatric population. The main questions it aims to answer are:

* How modified Otago and Frenkel's exercises affect balance, motor function, fear of fall and quality of life in the geriatric population?
* Is there any difference between the effects of these two exercises? Researchers will compare the effects of modified Otago and Frenkel's exercises to see which kind of exercise has superior effects on the mentioned outcomes.

Participants will be randomly divided into two groups who will perform their respective exercises for 45 minutes 3 days a week for 8 weeks. Outcomes will be evaluated at the baseline, 4th week and 8th week.

Primary Outcome Measures: Mini-Best Test, Mini-BESTest (Balance Evaluation Systems Test) is a brief yet comprehensive clinical assessment designed to evaluate balance, mobility, and fall risk in older adults. Consisting of 14 items, it covers a range of balance-related functions such as anticipatory and reactive postural adjustments, sensory orientation, and dynamic gait movements. Each item is scored from 0 to 2, with higher scores indicating better performance, and the maximum achievable score is 28 points, 8th week|Falls Efficacy Scale- International, The Falls Efficacy Scale-International (FES-I) is a 16-item self-report questionnaire designed to assess an individual's fear of falling during daily activities. Scores range from 16 to 64, with higher scores indicating greater fear of falling. Healthcare professionals commonly use the FES-I to identify individuals at risk of falling and to tailor interventions that improve confidence and reduce the fear of falling., 8th week|Older People's Quality of Life Questionnaire (OPQOL), The Older People's Quality of Life Questionnaire (OPQOL) is a self-report tool designed to assess the multidimensional aspects of well-being in older adults. Covering domains such as physical health, psychological well-being, social relationships, and overall life satisfaction, the OPQOL provides a comprehensive understanding of the quality of life for older individuals. It consists of 35 questions with answers on 5-point Likert scale. The total score can range from 35 to 175, with higher scores indicating better quality of life., 8th week
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
NCT Number: NCT06460298
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Triple Negative Breast Cancer
Interventions: DRUG: ProAgio Dose Levels (DL) 1,2,3,4|DRUG: ProAgio Dose Expansion
Sponsor: ProDa BioTech, LLC
Collaborators: Emory University|Georgia State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 51
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2026-10-01
Locations: Emory University Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States

Summary:
This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer

Primary Outcome Measures: Part 1 (Dose Escalation), To identify the maximum tolerated dose (MTD) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy., 2 Years|Part 2 (Dose Expansion), To estimate the objective response rate (ORR) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy., 2 Years
Secondary Outcome Measures: Clinical Benefit Rate, To describe the clinical benefit rate (CBR) in patients with metastatic TNBC treated with ProAgio in combination with gemcitabine., 2 Years|Estimate the mean change from baseline in tumor stromal collagen, To estimate the mean change from baseline in tumor stromal collagen following treatment with ProAgio and gemcitabine., 2 Years|Progression free survival (PFS), To describe the progression free survival (PFS) in patients with metastatic TNBC treated with ProAgio in combination with gemcitabine., 2 Years
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
NCT Number: NCT06460246
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DEVICE: Pulse Oximeter
Sponsor: Acurable Ltd.
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-25
Completion Date: 2024-07-31
Locations: Vital Signs Research Group, L.L.C., San Francisco, California, 94107, United States

Summary:
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

Primary Outcome Measures: Performance of the pulse oximeters against corresponding arterial blood oxygen saturation., Performance of the pulse oximeters against corresponding arterial blood oxygen saturation., 1-4 hours
Impact of Astaxanthin on Cognition in Recreationally Active Females
NCT Number: NCT06460181
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Mental Fatigue
Interventions: DIETARY_SUPPLEMENT: Astaxanthin|DIETARY_SUPPLEMENT: Placebo
Sponsor: University of North Alabama
Sex: FEMALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2024-11-01
Locations: University of North Alabama, Florence, Alabama, 35632, United States

Summary:
The purpose of this study is to examine the protentional that the antioxidant Astaxanthin has on mitigating cognitive decline following mental fatigue.

Primary Outcome Measures: Reaction time, How quickly the participant reacts to a stimulus. Expressed in millaseconds., Pre supplementation and post 4-week supplementation period.|Speed, Speed at which responses are given., Pre supplementation and post 4-week supplementation period.|Responses Correct per Second, Accuracy of responses over time., Pre supplementation and post 4-week supplementation period.|Mental Fatigue, Assessed using a 180mm visual analog scale. 0mm = no mental fatigue, 180mm = highest possible mental fatigue., Pre supplementation and post 4-week supplementation period.
Secondary Outcome Measures: Lipid Panel, Cholesterol, lipid, and glucose levels. Tested using blood from the capillaries of the fingers, Pre and post
CompuFlo CathCheck
NCT Number: NCT06460155
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Epidural Placement
Interventions: DEVICE: 3 methods intervention
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-03
Completion Date: 2027-03-31

Summary:
The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.

Primary Outcome Measures: CompuFlo's Success, The measure is a binary outcome: the epidural catheter is in the epidural space or not.

Each modality assessed will either conclude positive (in the correct space) no negative (notnint he correct space) There is no "value". The tools used for the assessment is actually what is being studied, compuflo, meniscus test, physical exam and epidurogram., baseline
Effects of Bruegger's Versus Kendall Exercises in Cervical Postural Syndrome
NCT Number: NCT06460129
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain
Interventions: OTHER: Brugger's Exercises|OTHER: Kendal Exercise
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-09-26
Locations: Rasheed Hospital, Lahore, Punjab, 05450, Pakistan

Summary:
Cervical Postural Syndrome is an uncomfortable and painful condition characterized by a protruding chin and rounded shoulders, commonly resulting from poor posture in the neck, middle back, and shoulders. This syndrome often leads to an excessive forward curvature of the upper back, causing the chin to jut forward and the shoulders to hunch forward. A prevalent cervical abnormality associated with this condition is the forward head position, which increases the risk of neck pain. The entire clinical condition is referred to as "sterno-symphyseal syndrome" by Bruegger. He describes the muscles involved as "painfully tense and painfully weak." Bruegger's exercises are designed to align the spine correctly by strengthening the scapular and neck muscles. Similarly, Kendall's exercises focus on restoring cervical spine alignment, particularly for individuals with forward head posture, by targeting the shoulder extensors and deep neck flexors. While numerous studies have examined the direct effects of forward head posture on the cervical spine, there is limited research comparing the effectiveness of Bruegger's exercises and Kendall's exercises, particularly regarding exercises that do not directly target the neck.

Primary Outcome Measures: Pain level, A numerical pain rating scale is a quantitative tool for determining how much pain is experienced. This scale is trustworthy and valid for measuring pain. Its measurement ranges from 0 to 10. I mean that when the numbers go from 0 to 10, the pain is more intense. O denotes "no pain," 1-3 indicate "mild pain," 4-6 indicate "moderate pain," 7-9 indicate "severe pain," and 10 indicate the worst pain. Dependability, 6th week|Range of Motion, Range of movement refers to the area that a joint can cover while moving. We utilize a universal goniometer to measure the range of motion (ROM). A scale called a universal goniometer is used to measure the range of quantitative values. The universal goniometer is also a useful and trustworthy instrument for ROM measurement. For cervical range of motion and cranio-vertebral angle, therefore, we use it., 6th week|limited function, Disability is the inability of an individual to accomplish a goal or to carry out a daily activity. The Neck Disability Index (NDI) is the main tool used in neck assessments. The NDI is a scale used to assess a joint's limited range of motion or to measure the

useful action. This scale has ten items that are linked to carrying out an activity. The neck impairment can be measured using this accurate and trustworthy scale. Dependability, 6th week
Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging
NCT Number: NCT06460077
Acronym: SELPET
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Sponsor: Turku University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2028-12
Locations: Turku PET Centre, Turku, Finland Proper, 20520, Finland

Summary:
This is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in MS in vivo.

Primary Outcome Measures: Comparison of three different imaging, The number of lesions identified using each respective method and the potential co-localization of the RIM+ lesions identified using the various methods., 18 months, 36 months
Secondary Outcome Measures: Correlation of imaging and clinical variables, Imaging variables from PET and MR imaging correlated with clinical status of the patient evaluated with Expanded Disability Status scale, quality of life questionnaires and neuropsychological evaluation, 18 months, 36 months
First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP
NCT Number: NCT06460064
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Influenza
Interventions: BIOLOGICAL: fH1 2 ug|BIOLOGICAL: fH1 8 ug|BIOLOGICAL: DSP-0546LP 2.5 ug|BIOLOGICAL: DSP-0546LP 5 ug|BIOLOGICAL: DSP-0546LP 10 ug|BIOLOGICAL: Placebo
Sponsor: Sumitomo Pharma Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-26
Completion Date: 2026-03-27
Locations: Center for Vaccinology, Gent, Corneel Heymanslaan 10, 9000, Belgium

Summary:
This study is a single center, randomized, double-blind, placebo-controlled, dose-finding, FIH, Phase 1 study to assess the safety, tolerability, and immunogenicity of the adjuvanted Universal Influenza Vaccine (fH1/DSP-0546LP) after IM administrations in healthy adults.

Primary Outcome Measures: Incidence of solicited local adverse events (AEs) during a 7-day follow-up period after each administration., Solicited local AEs: pain, redness, swelling, induration, warmth, and pruritus at injection site, 7 days after each administration|Incidence of solicited systemic AEs during a 7-day follow-up period after each administration., Solicited systemic AEs: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise, and body temperature (measured axillary), 7 days after each administration|Incidence of unsolicited AEs from the first administration to 4 weeks after the second administration., Clinical observations, clinical laboratory values and vital signs, From the first administration to 4 weeks after the second administration.|Incidence of serious adverse events (SAEs), AEs leading to study discontinuation, and adverse events of special interest throughout the study period., From the first administration to 52-week follow-up after the second administration
Secondary Outcome Measures: Percentage of subjects with increased immunoglobulin (Ig) G response to long alpha helix (LAH) after administration of fH1/DSP-0546LP., From the day of the first administration to 52-week follow-up after the second administration|Percentage of subjects with increased neuraminidase inhibition antibody titer after administration of fH1/DSP-0546LP., From the day of the first administration to 1 week after the second administration.|Seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibody titers after administration of fH1/DSP-0546LP., SCR is defined as the percentage of subjects with either a baseline (Day 1) HAI titer \< 1:10 and post-administration titer ≥ 1:40, or baseline titer ≥ 1:10 and ≥ 4-fold increase in post-administration titer., From the day of the first administration to 1 week after the second administration.
Tenapanor in Synucleinopathy-Related Constipation
NCT Number: NCT06460038
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Synucleinopathy|Parkinson's Disease
Interventions: DRUG: Tenapanor|DRUG: Placebo
Sponsor: Cedar Valley Digestive Health Center
Collaborators: Ardelyx
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-03

Summary:
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Primary Outcome Measures: Complete spontaneous bowel movements (CSBM), Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation, 6 of 12 weeks
Secondary Outcome Measures: Abdominal pain and bloating response, Decrease in severity score of at least 20% or more from baseline in 6 of 12 weeks, 6 of 12 weeks|GIDS-PD, GIDS-PD improvement of 20%, where score ranges 1-108, or a 20% improvement in constipation, bowel irritability, or upper GI subscores, Week 12|Calprotectin, Decrease in fecal calprotectin by 20% or greater, Week 12|Lipopolysaccharide binding protein, Decrease in serum lipopolysaccharide binding protein by 20%, Week 12|Movement symptoms, MDS-UPDRS total improvement by 20% compared to baseline, Week 12|CSBM continuous, CSBM treated as a continuous variable. We expect an increase of CSBMs in the treatment group compared to the placebo group., Week 12