pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes
NCT Number: NCT06499506
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Foot|Ischemic Leg
Interventions: PROCEDURE: Below knee amputation
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-01

Summary:
Below knee amputations (BKAs) are frequently performed among vascular patients with end stage chronic limb threatening ischemia and / or complications of diabetes and diabetic foot infections and gangrene, It may also be necessary for patients with aggressive diabetic foot infections or gangrene, or both; for those with extensive venous ulceration; or following major trauma. and in the case of extremity sepsis.

There is two main methods for constructing the myocutaneous flaps in below knee amputation; the long posterior flap (LPF) and skew flap (SF).

Primary Outcome Measures: Healing, Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility, 6 month|Re ampuation, Rate of reamputation at (a) same level; (b) higher level., 1 month|Mobilization, Number of participants mobilizing with a prosthetic limb., 6 month
Secondary Outcome Measures: Mortality, Thirty-day mortality rate., 1 month|Hospital stay, Length of hospital stay., 1 month|complaints, Symptoms relating to the stump, such as pain and swelling., 2 month
Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius
NCT Number: NCT06499493
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myofascial Trigger Point|Gastrocnemius Muscle|Manual Therapy|Pain Threshold
Interventions: OTHER: Myofascial induction in gastrocnemius muscle
Sponsor: Mayuben Private Clinic
Sex: ALL
Age: ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-07-28
Locations: Mayuben Clinic, San Sebastián De Los Reyes, Madrid, 28702, Spain

Summary:
In the present study we will test the effects of myofascial induction technique in the muscles close to the application in the gastrocnemius muscle.

Primary Outcome Measures: 1.Pressure pain threshold in flexor digitorum brevis, biceps femoris, extensor digitorum brevis muscles before intervention, The pressure at which the patient begins to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons., Immediately before intervention.|2.Pressure pain threshold in flexor digitorum brevis, biceps femoris, extensor digitorum brevis muscles after intervention, The joint range is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees.Measured in grades., Immediately after the intervention.
Italian Registry of Allergen ImmunoTherapy
NCT Number: NCT06499480
Acronym: RIAIT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Allergic Respiratory Disease
Sponsor: Società Italiana di Allergologia, Asma e Immunologia Clinica
Collaborators: Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2035-12-31
Locations: Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy, Rozzano, Milano, 20089, Italy

Summary:
RIAIT (Italian Registry of Allergy Immunotherapy) is a multicenter observational study that aims to prospectively collect the most extensive data available on Italian patients using AIT for respiratory allergies (rhinoconjunctivitis and/or asthma) in a real-life context, through a network of allergy centers with specific interest and expertise in the management of allergic respiratory patients.

Primary Outcome Measures: Life Quality as measured by Standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) (≥12years), Every year to ten year|Life Quality as measured by Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) For Children 6 - 12 years, Every year to ten year
Norepinephrine Equivalent Dose of Vasopressin, Phenylephrine and Epinephrine in Septic Shock
NCT Number: NCT06499467
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Septic Shock
Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-12
Completion Date: 2026-01
Locations: Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India

Summary:
Septic shock is the most common form of circulatory shock encountered in patients admitted in intensive care unit. The initial management involves fluid resuscitation but if hypotension does not get resolved solely by it, then vasopressors become the mainstay of the management of shock to maintain adequate mean arterial pressure (MAP).

Norepinephrine is recommended as the first line vasopressor in the management of septic shock as per Surviving Sepsis Campaign guidelines of 2021. It recommends addition of vasopressin to the regime if the target MAP is not achieved with just norepinephrine. However, in clinical practice various other vasopressors are being used in the management of septic shock, as per clinical condition. Different vasopressors have different modes of action and pharmacological effects on hemodynamics. Therefore, there evolved the need of development of a formula that would reflect the potency of each vasopressor in a standardized manner. Thus, the concept of Norepinephrine Equivalence (NEE) came into existence. In the recent years, different studies were conducted in various parts of the world with different primary objectives. These authors have proposed different formulas for calculation Norepinephrine Equivalence (NEE) dose of the used vasopressors as an inference from their studies. All these formulas are based on assumptions and there lacks standardization. There are presently no studies available in the existing literature, where a prospective study is done to primarily determine the Norepinephrine equivalence dose (NEE) of other vasopressors in patients of septic shock. Hence, the investigators aim to find out equivalent dose of these different drugs, which are being used commonly in the management of septic shock, in a prospective planned study.

Primary Outcome Measures: To evaluate the norepinephrine equivalent dose of vasopressin, phenylephrine and epinephrine used in patients of septic shock., Norepinephrine will be gradually tapered by 0.1 mcg/kg/min over 10-15 minutes and simultaneously a second vasopressor will be introduced to maintain the baseline MAP (± 1 mm Hg). After stabilization for at least 5 minutes and achieving the same baseline MAP, two readings of the dose of the second vasopressor will be recorded, at least 5 min apart, and averaged. The averaged value of the second vasopressor dose will be considered as a NEE dose for that particular vasopressor against NE dose of 0.1 mcg/kg/min, Within 30 minutes of initiation of second vasopressor
Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument
NCT Number: NCT06499454
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Lung Diseases
Interventions: DIAGNOSTIC_TEST: Ruby ROSE evaluation
Sponsor: Ruby Robotics Inc
Collaborators: Beth Israel Deaconess Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2024-11

Summary:
The goal of this study is to learn whether the Ruby Robotics system enables pathologists to determine whether a bronchoscopic biopsy sample is adequate for diagnosis. The main question it aims to answer is:

- Are pathologists' evaluations of Ruby digital images concordant with their evaluations of manually created rapid on-site evaluation slides?

Primary Outcome Measures: Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides, 2 months from time of sample collection
Secondary Outcome Measures: Pathologist ratings of quality metrics for Ruby images and manually-prepared slides, 2 months from time of sample collection
Ventricular Pacing Rate in Follow-up of Patients Treated With Definitive PM Implantation Post TAVI
NCT Number: NCT06499428
Acronym: P-P-P-TAVI
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Stenosis|Conduction Defect, Cardiac
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 67
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-10
Completion Date: 2026-06-10
Locations: IRCCS Ospedale GAleazzi-Sant'Ambrogio, Milan, 20132, Italy

Summary:
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI).

Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates.

Primary Outcome Measures: ventricular pacing rate, 1 year
The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction
NCT Number: NCT06499402
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Pain|Labor
Interventions: OTHER: massage
Sponsor: Osmaniye Korkut Ata University
Sex: FEMALE
Age: CHILD
Enrollment: 112
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-22
Completion Date: 2024-09-22

Summary:
Our study aims to determine the effect of pregnant-controlled automatic sacral massage on mothers' labor pain, perception, process and midwives' satisfaction. The research was planned as a randomized controlled experimental study. A total of 112 women, 56 pregnant women in the experimental and control groups, will be included in the study. In this project, an automatic massage device will be used during the active phase (when the cervical opening is between 5-6 cm and 10 cm) and a massage device in line with the pregnancy-controlled sacral massage application protocol. Pregnant women are followed throughout the active phase of labor and indicators reflecting labor pain, progress of labor, and the health status of the mother and the baby are used with the "Individual Identification Form", "Visual Comparison Scale", "Labor Monitoring Form", "Mother's Birth Perception Scale (ADAS)". The satisfaction of midwives will be evaluated with the "Evaluation of Satisfaction Status of Midwives Form".

Primary Outcome Measures: stress, questionnaire, stress scale, 1 day
Secondary Outcome Measures: labor pain, pain scale, VAS, 1 day
Clinical Deterioration Early Warning System Score
NCT Number: NCT06499376
Acronym: CDEWS
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Clinical Deterioration
Sponsor: Hospital Galdakao-Usansolo
Collaborators: Kronikgune|Biobizkaia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-08-01
Completion Date: 2022-01-15
Locations: Hospital Galdakao Usansolo, Galdakao, Bizkaia, 48960, Spain

Summary:
At present, there is no universal early warning system implemented in all Basque hospitals, but there are previous experiences, sometimes based on models generated in other health systems. In this project we intend to provide a robust model, based on the analysis of patient data from three Basque hospitals, i.e. generated in our population.

A three-phase study has been designed:

1. st phase: Derivation of the predictive model by means of a reprospective cohort study in which patients hospitalised at the Galdakao-Usansolo Hospital, Donostia University Hospital and Araba University Hospital will be recruited.
2. nd phase: Creation of an alarm system based on the probability of risk of clinical deterioration and implementation of the system in the electronic medical record (EHR) of the HGU, in the form of an "Action Guide".
3. rd phase: The model will be validated by comparing the percentages of clinical deterioration by means of a quasi-experimental intervention study, comparing the results of the HGU hospital where the system will be implemented, before and after the intervention and, on the other hand, with those of Hospital Universitario Donostia (HUD) and Hospital Universitario de Araba (HUA), where normal clinical practice will be followed, with an early warning system based on vital signs in HUD and clinical criteria in HUA.

Sociodemographic and clinical variables will be collected (patient's condition on arrival on the ward, main diagnosis, comorbidities, prescribed treatments and procedures performed during hospitalisation and prior to the onset of deterioration) and laboratory parameters.

This information will be extracted from the osabide global data exploitation system, Oracle Business Intelligence, and the laboratory data will be extracted from the information systems of the clinical laboratories of the participating centres.

Logistic regression models will be created with the dependent variable being clinical deterioration (cardiorespiratory arrest, death, admission to intensive care units) on a database of 10000 hospitalised patients. For external validation, at least 8000 admissions will be prospectively evaluated and multilevel modelling will be performed to see the influence of centre membership on the outcome variable. Confounding will be controlled for using propensity-score techniques.

Primary Outcome Measures: Clinical deterioration, death in admission or length of stay more than 12 hours in intensive or intermediary care unit (ICU)., at least 24 hours after admission
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
NCT Number: NCT06499363
Acronym: NEPHY
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Persistent Pulmonary Hypertension of Newborn
Sponsor: Ferrer Internacional S.A.
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-21
Completion Date: 2027-12-31

Summary:
This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).

Primary Outcome Measures: Characteristics of neonates receiving treprostinil in the clinical practice., Sex (male/female) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h), From baseline to Day 30 after last dose of treprostinil|Treprostinil-specific treatment patterns., Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg/ml) and treprostinil treatment duration (days)., From baseline to Day 30 after last dose of treprostinil|Number of participants with treatment-related adverse events to evaluate safety., From baseline to Day 30 after last dose of treprostinil
Secondary Outcome Measures: Composite endpoint of absence of complications through Day 14 after the index date., From baseline to Day 30 after last dose of treprostinil|Description of the clinical outcomes from treprostinil start day (i.e., Day 0) to Day 14 and at Day 30 after last dose of treprostinil., Evolution of pre- and post-ductal oxygen saturation (SpO2); oxygen partial pressure (PO2); clinical laboratory parameters and fraction of inspired oxygen (FiO2) at times 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil., 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable).|Description of neurodevelopmental progress over 2 years after treprostinil initiation through a Global Clinical Impression Scale., From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
NCT Number: NCT06499350
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Malignant Solid Tumors
Interventions: DRUG: FC084CSA+Tislelizumab combination (dose escalation)|DRUG: RP2D of FC084CSA+Tislelizumab combination (dose expansion)
Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2026-09-01
Locations: Shanghai East Hospital, Shanghai, Shanghai, 200120, China

Summary:
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.

Primary Outcome Measures: Determine the Maximum Tolerated Dose (MTD), The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee., Approximately 8 months|Determine the Recommended Phase 2 Dose (RP2D), The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD., Approximately 8 months|Determine dose-limiting toxicity (DLT), Determine the DLT of FC084CSA, 21 days after first dose|Objective response rate (ORR), To explore the clinical effectiveness. Tumor response based on RECIST 1.1, Approximately 12 months
Secondary Outcome Measures: Disease control rate (DCR), DCR as assessed using RECIST 1.1, Approximately 12 months|Progression free survival (PFS), PFS as assessed using RECIST 1.1, Approximately 12 months|Overal suvival (OS), It is defined as the time from date of first dose to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates., Approximately 18 months|Pharmacokinetic (PK) Cmax, To investigate the pharmacokinetic (PK) profile of FC084CSA, Approximately 12 months|Pharmacokinetic (PK) Tmax, To investigate the pharmacokinetic (PK) profile of FC084CSA, Approximately 12 months|Pharmacokinetic (PK) AUC 0-t, To investigate the pharmacokinetic (PK) profile of FC084CSA, Approximately 12 months|Pharmacokinetic (PK) AUC 0-∞, To investigate the pharmacokinetic (PK) profile of FC084CSA, Approximately 12 months
Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes
NCT Number: NCT06499311
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postmenopausal Flushing|Hot Flashes
Interventions: OTHER: Foot Reflexology|OTHER: Acupressure
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-08-20
Locations: Faculty of Physical Therapy, Giza, 02, Egypt

Summary:
World health Organization (WHO) estimates that by 2030, 1.2 billion women will be over 50 years old. With a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. Postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. Therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reﬂexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.

Primary Outcome Measures: Pittsburgh Sleep Quality Index, A reliable, validated, self-reported questionnaire for assessing sleep quality. It is available of validated Arabic form that consists of seven components, namely, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over a 1-month time interval. It held a good internal consistency, and convergent, also divergent validity.

Each component scores are derived, each scored 'zero' means no difficulty, to 'three' means sever difficulty. component scores are summed to gain the whole score range 'zero to twenty-one' Higher scores indicates worse sleep quality., Pretreatment and immediately Posttreatment.
Secondary Outcome Measures: Hot Flashes Questionnaire, A valid and reliable measure for severity of hot flashes. It is an appropriately sensitive tool to negative changes over time, with its cut-points and minimally important differences could prove a useful tool in targeting important issues regarding therapeutic interventions, and monitoring management progress and response using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life., Pretreatment and immediately Posttreatment.
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer
NCT Number: NCT06499298
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Cancer|Gastroesophageal Junction Cancer
Interventions: DRUG: Nivolumab
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 115
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2025-06-16
Locations: Shanghai Chest Hospital, Shanghai, China

Summary:
The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China.

Primary Outcome Measures: Participant disease-free survival (DFS), Up to 1 year
Secondary Outcome Measures: Participant socio-demographics, Baseline and up to 1 year|Date of tumor initial diagnosis, Baseline|Tumor location at initial diagnosis, Baseline|Tumor histology at initial diagnosis, Baseline|Resected tumor margins status, Negative (clear), positive (involved), close margins, Baseline|Eastern Cooperative Oncology Group (ECOG) performance status, Baseline and up to 1 year|Pathological lymph-node status, Baseline and up to 1 year|Pathological tumor status, Baseline and up to 1 year|Participant biomarkers (if available), Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis, Baseline and up to 1 year|Participant outcomes after nivolumab treatment, Including disease stage, recurrence, disease progression, medical imaging test result, and death information, Baseline and up to 1 year|Participant medical history, Baseline and up to 1 year|Participant cancer treatment history, Baseline|Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation, Day 1|Indication for nivolumab treatment, Day 1|Nivolumab treatment duration, Up to 1 year|Time from surgery to nivolumab initiation, Day 1|Nivolumab treatment regimen, Up to 1 year|Participant concomitant treatment(s), Baseline and up to 1 year|Participant systemic treatment(s), Up to 1 year|Date of nivolumab treatment completion/discontinuation, Up to 1 year|Reasons for treatment discontinuation/cessation, Up to 1 year|Subsequent treatment after nivolumab discontinuation, Up to 1 year|Time to next treatment (TTNT), Up to 1 year|Nivolumab treatment modifications in relation to the management of adverse events (AE), Up to 1 year|Participant distant metastasis-free survival (DMFS), Up to 1 year|Participant distant metastasis-free survival (DMFS) rates, Up to 1 year
The Efficacy and Safety of Elritercept in Adult Participants With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) With Anemia (RENEW)
NCT Number: NCT06499285
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Myelodysplastic Syndromes
Interventions: BIOLOGICAL: KER-050|DRUG: Placebo
Sponsor: Keros Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 225
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2032-03-14

Summary:
KER-050-D301 is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of KER-050 versus placebo in adult participants with transfusion-dependent anemia with very low, low, or intermediate risk MDS, or more recently defined as myelodysplastic neoplasms, with or without ring sideroblasts. The study is divided into the Screening Period, Treatment Period, Safety Follow-Up Period and Long-term Follow-up Period.

Primary Outcome Measures: Efficacy evaluation of KER-050: Proportion of participants achieving TI for ≥ 8 weeks, To evaluate the efficacy of KER-050 in reducing RBC transfusions, from baseline through week 24
The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in NICU
NCT Number: NCT06499259
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Parents|Psychological Stress
Interventions: OTHER: Mandala coloring
Sponsor: Istanbul Medeniyet University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-22
Completion Date: 2024-12-31
Locations: Istanbul Medeniyet University, Istanbul, Kadıköy, 34720, Turkey

Summary:
The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).

Primary Outcome Measures: Visual Analog Scale (VAS), Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10., Before the first mandala painting session (pre-test)|Visual Analog Scale (VAS), Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10., After the 7th mandala painting session (7 days after the first session) (post-test)
Secondary Outcome Measures: State Trait Anxiety Inventory (STAI), The STAI (STAI-State Trait Anxiety Inventory) Scale consist of 20 items each and State Anxiety Scale was used in this study. The State Anxiety Scale has a rating scale consisting of (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the person feels the current situation. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) are reverse scored. The cronbach's alpha coefficient of the scale was 0.94 0.96., Before the first mandala painting session (pre-test)|State Trait Anxiety Inventory (STAI), The STAI (STAI-State Trait Anxiety Inventory) Scale consist of 20 items each and State Anxiety Scale was used in this study. The State Anxiety Scale has a rating scale consisting of (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the person feels the current situation. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) are reverse scored. The cronbach's alpha coefficient of the scale was 0.94 0.96., After the 7th mandala painting session (7 days after the first session) (post-test)
Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
NCT Number: NCT06499246
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoparathyroidism Postprocedural
Interventions: PROCEDURE: Donor Parathyroid
Sponsor: Karen Devon
Collaborators: University Health Network, Toronto|University of Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-07
Locations: University Health Network, Toronto, Ontario, M5S1B2, Canada

Summary:
Hypoparathyroidism following thyroid surgery presents significant challenges, often leading to debilitating symptoms and reduced quality of life despite conventional treatment. Having now reported the first successful case of a deceased donor fresh tissue parathyroid allotransplant with immunosuppression in a transplant-naive recipient, the purpose of this study is to further assess the safety and efficacy of this procedure in patients with severe intractable post-surgical hypoparathyroidism.

Primary Outcome Measures: Maintain calcium levels without standard calcium replacement treatment., Patients will demonstrate improvement in hypocalcemia symptoms, biochemical calcium profile, and parathyroid hormone levels as well as decrease frequency of emergency visits for intravenous calcium. Specifically at each assessment patients will be questioned regarding numbness and tingling and will be examined for presence of Chvostek's and Trousseau's sign. Additionally, to assess overall impact of symptoms in relation to quality of life. A hypoparathyroidism quality-of-life questionnaire will be filled out by the patient pre-operatively and at 12 months post-operatively. This questionnaire was formulated and has been used for research purposes by the HypoParaUK group. Biochemical calcium profile (serum total calcium, albumin, ionized calcium, parathyroid hormone level, vitamin D level, phosphate) using blood tests done on post-operative day 1, 3, 5, 7, and subsequently 2 weeks, 3 weeks, 4 weeks post-operatively, and afterwards monthly for a total of 12 months post-operatively., Pre-operatively and then at 4 weeks, 3 months and 12 months post-operatively
Secondary Outcome Measures: Rate of surgical complications, Whether parathyroid allotransplant from neurologically deceased donors amongst patients with permanent refractory hypoparathyroidism has minimal surgical and medical complications and the need for medications., 4 weeks, 3 months and 12 months post-operatively
Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
NCT Number: NCT06499233
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pneumonia, Pneumocystis|Autoimmune Inflammatory Rheumatic Disease|Autoimmune Diseases|Connective Tissue Disease|Prevention
Interventions: DRUG: Trimethoprim/Sulfamethoxazole
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-20
Completion Date: 2026-12-31
Locations: Tongji Hospital, Wuhan, Hubei, 43003, China

Summary:
This is an open-labeled, prospective clinical study aims at collecting and analyzing baseline characteristics of autoimmune inflammatory rheumatic disease (AIIRD) patients receiving sulfanilamide for preventive purposes, as well as subsequent follow-up data, in order to assess the efficacy and safety of the medication. Additionally, through a stratified analysis of risk factors, the investigators aim to identify the AIIRD population that would benefit most from preventive medication based on a favorable benefit-risk ratio.

Primary Outcome Measures: Number of participants with PJP infection, Defined as documentation/diagnosis of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PJP., 6 months, 12 months
Secondary Outcome Measures: TMP/SMZ related adverse drug reactions, Symptoms and signs that may be related to adverse drug reactions during treatment (such as nausea, vomiting, anorexia, jaundice, rashes and hives, and shock); incidence, duration and severity of adverse events, 6 months, 12 months|PJP-related mortality, PJP-related mortality at the end of month 6., 6 months, 12 months|All cause mortality, All cause mortality, 6 months, 12 months
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
NCT Number: NCT06499220
Acronym: ECHO-MDT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: DEVICE: Spinal Cord Stimulator
Sponsor: MedtronicNeuro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 201
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2019-10-30
Completion Date: 2023-10-16
Locations: Coastal Pain and Spinal Diagnostics, Carlsbad, California, 92009, United States|MercyOne Des Moines Medical Center, Des Moines, Iowa, 50314, United States|Nura Research Institute, Edina, Minnesota, 55435, United States|Twin Cities Pain Clinic, Edina, Minnesota, 55439, United States|iSpine Pain Physicians, Maple Grove, Minnesota, 55369, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States|Kettering Health, Kettering, Ohio, 45429, United States|Premier Pain Treatment Institute, Mount Orab, Ohio, 45154, United States|Center for Interventional Pain and Spine, Lancaster, Pennsylvania, 17601, United States|Rockefeller Neuroscience Institute West Virginia University, Morgantown, West Virginia, 26505, United States

Summary:
This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.

Primary Outcome Measures: Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system., The ECAP data collected is prototype system/device information for development of a closed loop system., 1 hour to 72 hours
Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
NCT Number: NCT06499207
Acronym: ACDC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Disease|Coronary Disease|PCI|Stent Restenosis
Interventions: DIAGNOSTIC_TEST: Photon-counting detector computed tomography (PCD-CT)
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-15
Completion Date: 2026-07-15

Summary:
This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).

Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.

Primary Outcome Measures: Quantitative comparison of PCD-CT and IVI in stent evaluation, Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization, Within 1 year|Qualitative comparison of PCD-CT and IVI in stent evaluation, Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent), Within 1 year
Secondary Outcome Measures: Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis, Severity of stenosis: Calculation of the percentage (%) of lumen diameter and lumen are stenosis with the appropriate CCTA and IVI analysis software, Within 1 year|Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology, Plaque morphology: Characterization of plaque components using Hounsfield units (HU) with the appropriate CCTA and IVI analysis software, Within 1 year|Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology, Two experienced radiologists/cardiologists will independently rate the visualization of in-stent restenosis and plaque morphology using a five-point scale (1 = inadequate; 5 = excellent), Within 1 year
Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension
NCT Number: NCT06499194
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension,Essential
Interventions: OTHER: DASH diet
Sponsor: Beni-Suef University
Sex: ALL
Age: ADULT
Enrollment: 364
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2024-06-29
Locations: Faculty of Medicine, Banī Suwayf, 621125, Egypt

Summary:
DASH diet can reduce hypertension and decrease health expenses

Primary Outcome Measures: blood pressure, patient on DASH diet showing decrease on blood pressure, 9 month
Multimodal Orthognathic Study Comparing Use of Exparel With Standard of Care.
NCT Number: NCT06499181
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Pain, Postoperative
Interventions: DRUG: Liposomal bupivacaine|DRUG: Bupivacain|DRUG: Epinephrin
Sponsor: United States Naval Medical Center, San Diego
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2018-02-28
Completion Date: 2020-01-01
Locations: Naval Medical Center San Diego, San Diego, California, 92134, United States

Summary:
A prospective, randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life, versus traditional bupivicaine alone.

Primary Outcome Measures: Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures., The primary objective is to examine differences in post-operative opioid consumption between the two groups, Daily up to seven days post operative procedure.
Secondary Outcome Measures: Post-operative nausea and vomiting, Examine the number of times per day the participant experiences nausea and/or vomiting., Daily up to seven days post operative procedure.|Post-operative sleeping quality., The Epworth Sleepiness Scale will be used to ascertain the quality of sleep. Eight situations are presented with the participant choosing the following responses:

No chance of dozing = 0 Slight chance of dozing = 1 Moderate chance of dozing = 2 High chance of dozing = 3

The higher the combined score the poorer the quality of sleep., Daily up to seven days post operative procedure.|Post operative quality of life., 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., Daily up to seven days post operative procedure.|Post operative oral function., Clinician will assess occlusion and midline symmetry on day of surgery post operative procedure and at one week post operative procedure clinic visit per standard of care with the aid of photographs using a millimeter ruler., Day of surgery and at seventh day post operative procedure.|Post operative swelling., Photos comparing cheek and lower jaw swelling with a millimeter ruler taken on day of surgery post operative procedure and one week post operative procedure clinic visit will be made by clinician per standard of care., Day of surgery and on post operative procedure day seven.
Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
NCT Number: NCT06499168
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Locally Advanced Breast Cancer
Interventions: DRUG: neoadjuvant chemotherapy: anthracycline based chemotherapy and taxans before surgery
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2027-08

Summary:
Female breast cancer is the second leading cause of global cancer incidence in 2022 and the fourth leading cause of cancer mortality worldwide. Breast cancer (BC) remains the most prevalent cancer diagnosis among women; nevertheless, considerable advancements in diagnostics and treatment approaches have significantly enhanced patient outcomes. In locally advanced cases, primary systemic chemotherapy is often indicated, and the choice of treatment is influenced by the evaluation of routine prognostic and predictive factors.

Neoadjuvant chemotherapy (NCT) has emerged as a valuable approach to enhance the quality of life ,disease-free and overall survival for early and locally advanced BC patients Approximately 30% of BC cases achieve a pathological complete response (pCR) following NCT. Unfortunately, proper quantification of estrogen- and progesterone receptors (ER and PR), human epidermal growth factor receptor-2 (HER2/Neu) and proliferation markers are insufficient to predict chemosensitivity of some breast tumors , so the identification of these cases during routine pathological examination of biopsy specimens could be especially useful in planning the oncotherapeutic strategy for proper patient management.

CD10, has recently gained attention as an independent diagnostic and prognostic marker in various solid tumors with significant metastatic potential. This molecule has been shown to play a role in cell adhesion, migration, and extracellular matrix remodelling.

A strong CD10 expression has been linked to hormone receptor negativity and HER-2/neu overexpression in breast cancer. Moreover, the dynamics of stromal CD10 expression undergo changes during neoadjuvant anthracycline-based chemotherapy.

Recent research, has presented compelling data indicating that CD10 expression may serve as a predictive marker for the impact of neoadjuvant chemotherapy in breast cancer patients.

Primary Outcome Measures: The response to neoadjuvant chemotherapy in locally advanced breast cancer in relation to CD10 expression, 6 months
Secondary Outcome Measures: progression free survival (PFS), the average length of time after the start of treatment in which a person is alive and their cancer does not grow or spread, 2 years|Overall survival (OS), the average length of time patients are alive after diagnosis or the start of treatment, 2 years
Comparison of Cyanoacrylate Tissue Adhesive With Suture in the Treatment of Gingival Recession
NCT Number: NCT06499155
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingival Recession
Interventions: DEVICE: Use of periacryl in gingival recession closure procedures|PROCEDURE: Use of sutures in gingival recession closure procedures
Sponsor: Necmettin Erbakan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-12-30

Summary:
The aim of this randomized controlled clinical study was to determine the effects of gingival recession closure procedures performed with tissue adhesive and suture on gingival thickness, To evaluate the effect on the amount of gingival recession, keratinized tissue amount, clinical attachment level, probing pocket depth, papilla width and height, root coverage rate, wound healing, visual analogue scale, gingival index and plaque index.

The main questions it aims to answer are:

* Does the use of tissue adhesive in gingival recession closure procedures affect tissue healing in the recipient area?
* Does the use of tissue adhesive in gingival recession closure procedures affect tissue healing in the donor area? Participants will be informed about the study and the procedures to be performed, and the patients will continue their routine follow-up.

Primary Outcome Measures: Evaluation of the effect of periacryl on wound healing in the donor area with a visual analog scale, In clinical follow-ups of gingival recession closure procedures; Wound healing in the donor area will be monitored with the help of a visual analog scale filled in by the patient., 6 months|Determining the effect of periacryl on the root surface closure rate in the recipient area by proportioning the amount of root closure to the initial recession amount., In clinical follow-ups of gingival recession closure procedures; Root surface closure rate in the recipient area; After the procedure, the amount of closure obtained in millimeters is divided by the initial amount of gingival recession to obtain a percentage value. Using these data, the effect of periacryl on the root surface closure rate will be determined., 6 months|The effect of periacryl on the tissue thickness obtained after the procedure in the recipient area, In clinical follow-ups of gingival recession closure procedures; The increase in keratinized tissue thickness obtained in the recipient area will be measured in millimeters using the who probe. The data obtained will be compared to the initial keratinized tissue thickness amounts. In this way, the effect of periacryl on the increase in keratinized tissue in the recipient area will be observed., 6 months
STP.168 Clinical Study Protocol Parakeet
NCT Number: NCT06499142
Acronym: Parakeet
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parathyroid; Anomaly|Parathyroid Dysfunction|Hyperparathyroidism|Parathyroid Gland Adenoma
Interventions: DEVICE: Parakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample.
Sponsor: Neurovision Medical Products Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-12-18
Completion Date: 2025-01-31
Locations: Ventura County Medical center Santa Paula, Ventura, California, 93003, United States

Summary:
STUDY PURPOSE

The purpose of this study is to demonstrate the performance of the Parakeet Rapid Parathyroid Testing Kit by comparing Parakeet results with histopathologic Diagnosis.

STUDY OBJECTIVES

To demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Parakeet Rapid Parathyroid Testing kit test results in FNA from excised tissue during parathyroid surgery with Pathologic Diagnosis.

Primary Outcome Measures: The participant's IVD PTH concentration is < 57 pg/ml and the pathology report will be negative for parathyroid gland. The participant's IVD PTH concentration is > 57 pg/ml and the pathology report will be positive for parathyroid gland., PT ID (visual): Visual Reading for FNA only; Positive (indicates a PTG), Negative (non-PTG). Qualitative variable, if the sample demonstrates a Test Line visual development, it is "Positive." If the Test Line does not demonstrate visual development this indicates less than the threshold of 60 pg./ml of PTH and it is considered negative (non-PTG) (Figure 5). The visual reading is by the tester and the surgeon is not notified. A faint or equivocal Test Line reading should be evaluated by the tester and repeated or other measures taken, 5 minutes