cyrilzakka/clinical-trials huggingface dataset:
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis

This study evaluates safety, tolerability, biodistribution and performance of the \[68Ga\]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and tolerability of the tracer in healthy volunteers.

Vascular adhesion protein 1 (VAP-1) is an inflammation inducible endothelial cell molecule mediating leukocyte trafficking from blood into the sites of inflammation. Although VAP-1 plays important role in early phases of inflammation, its luminal expression on the endothelium will remain constant if the inflammation continues, which suggest VAP-1 as a promising target for molecular imaging of inflammation. We have previously shown that sialic acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a VAP-1 ligand, and the gallium-68 labeled 1,4,7,10-tetraazacyclododecane-N,N´,N´´,N´´´-tetraacetic acid conjugated peptide (\[68Ga\]Ga-DOTA-Siglec-9) containing residues 283-297 from Siglec-9 can be used for PET imaging of inflammation in various experimental models. This first-in-human study evaluates safety, tolerability, biodistribution and performance of \[68Ga\]Ga-DOTA-Siglec-9 after single intravenous injection in six healthy volunteers, and in ten patients with active rheumatoid arthritis (RA), five patients with vasculitis and five patients with pulmonary sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy 18-70 year-old men
* Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis

Exclusion Criteria:

* In healthy: ongoing infection/inflammation proven by blood or other tests
* In patients with rheumatoid arthritis: no treatment with disease-modifying anti-rheumatic drugs or biologic agents, and no corticosteroids for 2 weeks prior the study
* In patients with vasculitis: no immunosuppressives, and glucocorticoid less than 60 mg for 2 weeks or NSAIDs for 1 day prior the study
* In patients with pulmonary sarcoidosis: no corticosteroids for 1 week or NSAIDs for day prior the study
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activity.
* Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.
* Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.
* In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.

Exclusion Criteria:

* More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.
* Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
* Bowel obstruction.
* Known radiation enteritis or significant villous atrophy.
* Cardiac disease defined as: decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening.
* Clinically significant abnormal ECG.
* Repeated systolic blood pressure measurements \> 180 mm Hg.
* Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.
* Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
* Estimated creatinine clearance \< 30 mL/min.
* Severe hepatic impairment.
* Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.
* Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
* Unstable systemic immunosuppressive therapy within 3 months prior to Screening.
* Unstable biological therapy within 6 months prior to Screening.
* Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods.
* Previous exposure to glepaglutide.
* Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
* Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.
Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients

The purpose of this current prospective study is to assess and compare the effects of a hydrotherapy exercise programme against a conventional land-based exercise programme in individuals with hemiplegia. Both exercise interventions aim at improving posture, balance and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional therapy groups according to balance function (Berg Balance Scale score) and age (age\<59 and \>60 years). The physical examination consisted of (1) a lower-limb motor function recovery of the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional status measured with the Functional Independence Measure. Postural sway was evaluated with a pressure platform by using the variables of center of pressure (COP) displacements in the mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and evaluated using statistical programme SPSS.


Eligibility Criteria:
Inclusion Criteria:

* hemiplegia or hemiparesis after stroke or traumatic brain injury
* at least 6 months post-stroke from a single cerebrovascular accident
* independent in walking (with or without assistive device)
* clinical stable

Exclusion Criteria:

* unstable cardiac conditions
* epilepsy
* urinary or faecal incontinence
* open wounds
* significant musculoskeletal problems in lower extremities from conditions other than stroke
* Alzheimer
* Parkinson's disease
* polyneuropathy
* vestibular disorders
* current participation in an exercise program
Plasma Concentration of Biological Markers in Placenta Accreta Spectrum

The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.

Maternal blood samples will be taken at various points during the intrapartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - to 45-years old, inclusive
* Suspected or confirmed PAS or phenotypically matched controls
* Delivery by cesarean section
* Gestational age greater than 28 weeks
* Singleton pregnancy

Exclusion Criteria:

* Intrauterine fetal demise,
* Severe fetal anomalies (infant not expected to survive)
* Emergent cesarean delivery
Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence

This observational study aims to assess the predictive value of postoperative circulating tumor DNA (ctDNA) monitoring in evaluating the risk of recurrence in stage I-IV colorectal cancer patients. The study involves the collection of blood samples from patients who have undergone surgery for colorectal cancer. Sensitivity-enhanced molecular biology techniques are utilized to detect ctDNA in these samples. The correlation between ctDNA detection and the risk of recurrence is evaluated by analyzing patient follow-up data and clinical information. The findings of this study may contribute to the development of improved postoperative management strategies, such as identifying high-risk individuals and implementing additional treatment measures to reduce the risk of recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of signing the informed consent form.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
3. Histologically confirmed colorectal cancer located from the ileocecal junction to the rectosigmoid junction, with a distance of \>15cm from the anal verge. Regardless of mismatch repair (MMR) status, Rat sarcoma (RAS) gene and proto-oncogene serine/threonine-protein kinase (RAF) gene status.
4. Pathologically or cytologically confirmed American Joint Committee on Cancer (AJCC) tumor node metastasis (TNM) stage I-IV colorectal cancer patients (8th edition).
5. No evidence of distant metastasis confirmed by comprehensive examination (no distant organ or lymph node metastasis).
6. Normal organ function, as indicated by the following criteria:

   * Hematology criteria: For patients who have not received blood transfusion, white blood cell (WBC) ≥ 3.5/4.0 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelet (PLT) ≥ 100 × 10\^9/L.
   * Biochemistry criteria: Crea and bilirubin (BIL) ≤ 1.0 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN, alkaline phosphatase (ALP) ≤ 2.5 × ULN, total bilirubin (Tbil) ≤ 1.5 × ULN.
7. Ability to provide clinical data required for the study.
8. Sufficient tumor tissue available for analysis.
9. Patients capable of achieving R0 radical resection.
10. Patients capable of adhering to the planned schedule, actively participating in regular clinical follow-up, and necessary treatments.

Exclusion Criteria:

1. History of concurrent or prior malignancies (excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin).
2. Patients who have received neoadjuvant therapy.
3. Patients with other severe diseases that may affect follow-up and short-term survival, as determined by the investigator.
4. Any other medical, social, or psychological conditions that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
5. Inability to undergo clinical follow-up using contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).
Readiness Supportive Leadership Training

This study is a randomized controlled trial that assesses the effects of an evidence based, multi-component, leadership support intervention, Resilience-Supportive Leadership Training (RESULT), using accelerated learning strategies aimed at improving Service Member resilience and readiness in the military.

The intervention is expected to increase perceptions of resilience-supportive behaviors, resilience indicators, and related behavioral health outcomes such as emotion regulation, connectedness, team cohesion, and psychological health following the training from the perspective of the Service Member.

The goal of our proposed study is to adapt our existing, evidence-based supportive leadership training for an active duty population, focusing on training junior leaders in the Army on ways they can enhance readiness and resilience in their soldiers, as well as their own resilience. The investigators draw on best practices from existing military and civilian programs in a training that is engaging, interactive, and customizable. The investigators use micro-learnings - small, bite-sized pieces of information delivered in non-traditional ways, such as short podcasts or videos to enhance the training and enable it to be integrated easily into both military and civilian jobs.

The investigators evaluate the effectiveness of our Resilience-Supportive Leadership Training (RESULT) intervention with U.S. Army soldiers stationed at Joint Base Lewis-McChord (JBLM) in the State of Washington. The study includes a control group, so the investigators can better determine whether any observed changes in our participants are due to our training programs, and not some other factor. The investigators anticipate that the training programs will have a positive impact on service member readiness and resilience, psychological health, team cohesion, and reduced loneliness.

This research is designed to benefit not only U.S. Army soldiers but across all military branches, as well as first-responders and other civilian occupations that face highly stressful situations as part of their work. Our training has the potential to positively contribute to the military by enhancing service member readiness and unit autonomy, and improving mental and physical health.

Eligibility Criteria:
Inclusion Criteria:

Active Duty Service Members Serving in one of the two Striker Brigade Combat Teams (SBCT).

Exclusion Criteria:

-
Evaluation of the Ulthera® System for Treatment of the Brachia

This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.

This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 19 - 55 years.
* Subject in good health.
* Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
* Mild to moderate laxity of the upper arm.
* Mild to moderate subcutaneous fat of the upper arm.
* Mild crepiness of the skin of the upper arm.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the upper arm.
* Excessive skin laxity in the upper arm.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.
Differential Target Multiplexed Spinal Cord Stimulation

Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe chronic pain (\> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
* Age \> 18 years
* Patient has been informed of the study procedures and has given written informed consent
* Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

* Expected inability of the patient to receive or properly operate the spinal cord stimulation system
* History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
* Active malignancy
* Addiction to drugs, alcohol (\>5 units per day) and/or medication
* Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator
* Immune deficiency (e.g. HIV positive, immunosuppressive treatment)
* Life expectancy \< 1 year
* Local infection or any other skin disorder at site of incision
* Pregnancy
* Other implanted active medical device
Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations

For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.

A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).

Eligibility Criteria:
Inclusion Criteria:

* Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea

Exclusion Criteria:

* early onset and cases not to measure the sFlt/PlGF ratio and other markers
* twin pregnancy
* Chronic hypertension
* prior history of preeclampsia
* pregestational diabetes mellitus
* gestational diabetes mellitus
* patients delivered before 35 weeks of gestation
* preeclamptic patients with onset before 35 weeks of gestation
* patients with body mass index 25kg/m2 or greater
* maternal age 40 years older
A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or above
* Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
* Ability to provide written informed consent

Exclusion Criteria:

* nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
* The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
* Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* Patients with congestive heart failure(NYHA class III\~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
* History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
* Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c \> 8%
* History of severe or malignant retinopathy
* AST/ALT \> UNL \* 2, Serum Creatinine \> UNL \* 1.5, K \> 5.5mEq/L
* Patients with acute or chronic inflammatory status, autoimmune disease
* Patients who need to take antihypertensive drug besides Investigational products
* Patients must be treated with medications prohibited for concomitant use during study period
* Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
* Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
* History of malignant tumor within 5 years
* Patients who are dependent on drugs or alcohol
* History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
* Patients treated with other investigational product within 4 weeks at the time concents are obtained
* Women with pregnant, breast-feeding
* Not eligible to participate for study at the discretion of investigator
Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus

Exclusion Criteria:

* History of symptomatic coronary artery disease;
* Stroke or other known atherosclerotic disease;
* Cancer;
* HIV positive;
* Alcohol or drug abuse within the past 6 months previous the visit 1;
* use any antioxidant supplementation
Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism

To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.

The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.


Eligibility Criteria:
Inclusion Criteria:

* First or second Kidney Transplantation from deceased or living donor

Exclusion Criteria:

* Donor age \< 5 years.
* Patients who require plasma exchange because of high immunological risk
Monosodium Glutamate on Gastric Emptying

Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.

There is evidence that monosodium glutamate has effects on synapsis at the gastric and duodenum level that results in stimulation of contractility resulting on increase rate of gastric emptying. The purpose of the study is to demonstrate that the administration of a single dose of monosodium glutamate can shorten the gastric emptying time.

Patients with a prior study indicating a delay of gastric empting time, will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. Each patient will serve as her/his own control. Results will be analysed by pair-T test.

Eligibility Criteria:
Inclusion Criteria:

* children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours

Exclusion Criteria:

* Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.