cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Pharmacokinetics of BAP5191 in Healthy Adults Following Topical Application of Repeat Doses

All enrolled participants will be randomized to 3 cohorts with 8 participants each and will receive BAP5191 and placebo topically on a square of 121 cm2 each in the left and right scapula region daily for 28 days, with a 28-d safety follow-up.

The squares will be covered with a semi-occlusive patch. The doses will escalate from Cohort 1 to Cohort 2 to Cohort 3.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy adult participants,18 to 65 years of age.
* Women of childbearing potential (WOCBP) must agree to use a highly effective form of contraception, from at least 7 days prior to first administration to 28 days after last administration.
* Male participants with WOCBP partner must be willing to use condoms from first IMP application to 90 days after last application.
* Body Mass Index (BMI) between 18 and 29.9 kg/m2. Body weight must be greater than 50 kg.
* Clinical laboratory parameters, vital signs, pulse oximetry, and ECG within the reference range from population studies, or showing no clinically relevant deviations.

Key Exclusion Criteria:

* Chronic use of immunosuppressants within 3 years prior to the first administration of the study drug.
* History of prior leishmaniasis or extensive travel to endemic regions within 1 year prior to the first administration of the study drug.
* Presence or history of severe adverse reaction to any drug, or sensitivity to components of the study medication or to adhesive bandages or tape.
* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application and skin assessment at the site of application.
PRediction Of Glycemic RESponse Study

The purpose of PROGRESS is to engage and intensively monitor 1000 individuals' dietary intake, activity levels, and continuous glucose values over 10 days, link to clinical events out to 3-years, and use that data along with genomic, microbiome, electronic health record (EHR), and other biomarker data to develop a predictive model of individual glucose responses to nutrient intake in individuals with and without type 2 diabetes.

Interested individuals will be directed to download the MyDataHelps™ (CareEvolution) mobile app to register and provide informed consent as well as prompt completion of surveys, share their electronic health record data and link the digital health technologies to be used in the study. Participants may be asked to schedule an initial virtual meeting (telephone or videoconference) with the research coordinator who will welcome and walk them through the study.

Once a participant has completed on-boarding, they will be asked to fill out a baseline health, lifestyle, and medical history surveys and, upon completion, invited to request a biosamples study kit to be delivered to their home. This biosamples kit will include:

* Salivary kit for genomics analysis
* Gut microbiome kit
* Home micro-puncture single-use blood collection

Additional study materials and devices include:

* A wrist-worn activity, heart rate and sleep monitor.
* A Dexcom 6 continuous glucose monitor (CGM) and application kit
* A standardized snack bar meal (2 per fasting days)

Participants will be asked to track various digital health measures including their continuous glucose as well as record their meals for a 10-day period. The data connections approved by the participants will continue in the following years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.

Exclusion Criteria:

* Type 1 diabetes mellitus
* Unable to participate in or comply with any of the testing modules asked during the study
* Currently pregnant
* Prior bariatric surgery
* Chemotherapy or radiation treatment for cancer in the past year
* Inflammatory bowel disease
* Known skin allergy to adhesives and nickel (or other contraindications to continuous glucose monitoring)
* Currently taking any oral steroids(these medications may impact glucose levels)
* Antibiotic use in the last 3 months prior to the start of the study or planned use during the duration of the study
* Non-dietary, supplemental probiotic use either daily or weekly
* Hospice care
* End stage renal disease
Human Subcutaneous Inflammatory Response to Glucose Sensors

The aim of the study is to describe the inflammatory response to enzimatic glucose sensors after 10 days of use and to evaluate the relationship between the magnitude of the FBR (foreign body response) with the accuracy of the sensor (MARD)

Eighteen Type 1 DM patients are going to be included. Primary Objectives

1. To define the intra-individual and inter-individual variability of the macrophage count around the sensor
2. To assess whether there is a relationship between the number of macrophages, fibrosis and MARD of the MCG registry.

Secondary Objectives

To describe the histology of tissue response. This description will include:

1. HE stain: cell types, arrangement, vascular structures, signs of hemorrhage-clot. Giemsa stain: mast cells. Masson's trichrome stain: str. vascular.
2. Immunohistochemistry: Vascular assessment, characterization of macrophages

Each patient will have 1 glucose sensor inserted in the non-dominant arm. During the useful life of the sensor (10), a minimum of 4 capillary blood glucose determinations/day will be performed The sensor has a length of 8 mm and a diameter of 0.4 mm. All the necessary material will be provided, including a control diary to help the patient remember to carry out the self-control and set its time distribution.

On the last day of sensor use, it will be removed and a 4-mm punch skin biopsy will be performed 5 minutes later.

Tissue samples will be fixed in 4% formaldehyde solution, paraffin blocks made and sectioned. The resulting samples will be stained Semiquantitative determination of lymphocytes, neutrophils, mast cells, macrophages will be performed; fibrin, fibrosis, vascular proliferation and karyorrhexis

In all cases, a quantitative immunohistochemical study will be performed with x40 field counting with photographs and grid (Dako omnis with envision system) for:

Macrophages

The monitor-glucometer will be recovered for download and study of the record. The interstitial glucose - blood pairs will be made with those recorded but not used for callibration.

Glucose sensor values and insulin doses will be recover from tha medical application

Eligibility Criteria:
Inclusion Criteria:

* 1. Type 1 diabetes of more than 6 months duration, confirmed by positivity for Ab antiGAD 65 2. Be a regular user of a continuous glucose monitoring system 2. To Understand the proposed protocol and acceptance of participation.

Exclusion Criteria:

* Treatment with drugs that could potentially modify the inflammatory response during the 10 days prior to surgery (non-steroidal anti-inflammatory drugs or corticosteroids, antioxidants or platelet antiaggregants).
Characteristics and Outcomes of Patients With Hematological Malignancies

The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency.

The pattern of hematological malignancies (HMs) in developing countries and developed countries differs. Among the different types of cancers, leukemia, lymphoma, and multiple myeloma appear to have greatly increased in frequency. These malignancies are induced by genetic damage or mutation in somatic cells, which can result from environmental exposure to chemicals, ionizing radiation, and viral agents. Comparison of the incidence of HMs across geographic regions and time is complicated by the existence of different disease classification systems, and diagnostic criteria that vary by country, and even between hospitals and cancer registries (CRs) within a country.

Leukemia is a malignant neoplasm of hematopoietic stem cells characterized by diffuse replacement of bone marrow or peripheral blood by neoplastic cells; its etiology is obscure. Leukemia typing is based on how quickly the disease develops and progresses. Leukemia is either chronic or acute. Furthermore, leukemia typing is also based on the type of white blood cell that is affected. There are 4 common types of leukemia: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). Most acute leukemias are classified as lymphoid or myeloid lineages via standard microscopic morphology, cytochemistry, and immunophenotyping. Previous studies have shown that there are important differences in the incidence of the various leukemia subtypes according to geography, race/ethnicity, age, and trend pattern, indicating that the subtypes may have different etiological factors and that comprehensive global assessment of leukemia patterns is warranted.

Lymphomas are a heterogenous group of diseases with differences in epidemiology, histology, and prognosis. The incidence of Hodgkin's lymphoma (HL) and nonHodgkin's lymphoma (NHL) is higher among males than females.

Multiple myeloma (MM) is included in the spectrum of diseases ranging from monoclonal gammopathy of unknown significance (MGUS) to plasma cell leukemia. Plasma cell proliferation usually results in extensive skeletal destruction, with osteolytic lesions, hypercalcemia, anemia, and occasionally plasma cell infiltration in different organs. Excessive production of a monoclonal (M) protein can lead to renal failure, hyperviscosity syndrome, or recurrent bacterial infections.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of Hematological malignancies (≥18 years)

Exclusion Criteria:

* patients who have started diagnosis and treatment for malignancy outside Assiut university.
* Age less than 18 years
Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

Postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. Anesthetic care might play a role in the development of postoperative delirium.

The purpose of this study is to compare the incidence of postoperative delirium between different intraoperative sedation regimen. Delirium assessment using standardized screening tools will be done every 8 hours after surgery.

* In this randomized controlled trial, the investigator will compare the incidence of postoperative delirium after total knee arthroplasty between 3 intraoperative sedation regimens including (1) propofol-fentanyl (2) dexmedetomidine -fentanyl (3) fentanyl alone
* Anesthesia techniques include spinal anesthesia and adductor canal block for postoperative analgesia. Sedation will be provide per group assignment.
* After performance of regional anesthesia, sedation protocols will be used as followed: (1) target-controlled infusion of Propofol to achieve MOAA/S of 3-4 (2) incremental titration of Dexmedetomidine to achieve MOAA/S of 3-4 (3) supplemental fentanyl for anxiolysis.
* Delirium will be screened by trained physicians, registered nurses every 8 hours postoperatively with validated Thai-version CAM-ICU (Confusion Assessment Method-Intensive Care Unit) until patient discharge.
* Serum Interleukins (IL-1, IL-6) Tumor necrosis factor-Alpha and S100B protein from preoperative period will be compared with serum from postoperative period between delirium and non-delirium group. The level of serum biomarkers will be acquired in a 6-hour interval for 5 measurement points during the first postoperative day in the first 12 participants. The subsequent participants will have 1 measurement of serum biomarker during the first postoperative day.
* Genetic profile for ApolipoproteinE genotype will be acquired and compared between delirium and non-delirium group.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 year or older
* Scheduled for elective primary total knee arthroplasty

Exclusion Criteria:

* Contraindication for spinal anesthesia
* Contraindication for adductor canal block
* Allergy to fentanyl or propofol or dexmedetomidine or bupivacaine
* Cognitive impairment
* NSQIP database risk calculator \> 10% overall complication
* Unable to communicate in Thai language
* Significant visual and hearing impairment
Hypoglycemia Biomarkers to Predict Timing of a Hypoglycemic Event

The study aims to obtain a panel of biomarkers from hypoglycemic diabetic patients with either type 1 or type 2 diabetics and from control patients with type 1 or type 2 diabetes who didn't have hypoglycemia in the last 72 hours.

Primary endpoint is establishing a panel of biomarkers from 100 hypoglycemic diabetic patients with type 1 or type 2 Diabetes during the incidence of hypoglycemia by taking a single blood sample to be analyzed for HbA1c, LDL, HDL, Triglycerides, CRP, CBC and biochemical analysis including liver and kidney function tests. In addition to 5 ml serum sample to be centrifuged and stored in RCSI lab.

Inpatient hypoglycemic patients may also be included in group of hypoglycemia and will be required to have a serial of blood samples taken to be analyzed on the 1st hour, 2nd hour, 3rd hour and 4th hour after the hypoglycemic event.

Secondary endpoint involves recruitment of 100 control Diabetic patients with type 1 or type 2 Diabetes to establish a panel of biomarkers by obtaining a blood sample for the HbA1c, LDL, HDL, Triglycerides, CRP, CBC and biochemical analysis including liver and kidney function tests to include 50 subjects fasting overnight and the other 50 subjects to be non-fasting but without having hypoglycemia at the time of recruitment or in the last 72 hours.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for diabetes subjects with hypoglycemia

* Diagnosed of type 2 diabetes or type 1 based on the WHO guidelines Patient's age from 21-75 years old
* Able to say when the hypo had occurred (free style libre in the outpatient setting, or documented blood glucose less than \< 4 mmol/l (\<70 mg/dl) as an inpatient

Inclusion criteria for diabetes subjects without hypoglycemia:

* Diagnosed of type 2 diabetes or type 1 based on the WHO guidelines
* Patient's age from 21-75 years old
* No hypoglycemia or hypoglycemia unawareness.

Exclusion Criteria:

* eGFR less than 45 ml/min
* Liver enzymes 3 folds greater than upper limit
* Pregnancy
* Patients on steroids or Atypical Antipsychotics or Cyclosporine/Tacrolimus or other medications that may mask hypoglycemia

Exclusion Criteria for diabetes subjects with hypoglycemia

* Unable to determine when hypoglycemic event had taken place
* Hypoglycemic unawareness
* Severe hypoglycemic event in the last 3 months

Exclusion criteria for diabetes subjects without hypoglycemia

* Hypoglycemic event in the preceding week
* Hypoglycemic unawareness
Preventive Treatment of Groin Pain in Football

Groin pain represents a common issue in football. Currently, there are no prevention protocols demonstrating real effectiveness. We aimed to investigate the possible positive effect of a prevention program for groin pain.Forty-two élite male athletes belonging to a youth academy of a professional football club were recruited in this prospective, randomized, controlled, single-blind, study.


Eligibility Criteria:
Inclusion Criteria:

* subjects between the ages of sixteen and eighteen, belonging to the youth sector of a professional club.

Exclusion Criteria:

* Presence of pain or injuries at the level of the hip-hip region at the initial assessment.
Dalteparin in Preventing DVT in Participants With Cancer

This trial studies how well dalteparin works in preventing deep vein thrombosis (DVT) (blood clots) in participants with cancer. Dalteparin is a blood thinner that can treat blood clots and may prevent them from forming.

PRIMARY OBJECTIVES:

I. To determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopedic oncology patients.

II. To determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity.

OUTLINE:

Participants receive dalteparin subcutaneously (SC) once daily (QD) starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.

Eligibility Criteria:
Inclusion Criteria:

* GROUP A
* Metastatic disease, myeloma, lymphoma.
* Pathologic fracture or impending pathologic fracture of the femur.
* Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.
* GROUP B
* Primary sarcoma of bone or soft tissue of the lower extremity.
* T2 tumor (\> 5 cm by \< 20 cm).
* Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.

Exclusion Criteria:

* Presence of DVT on pre-operative screening ultrasound study.
* Massive tumor (\> 20 cm in greatest dimension).
* Amputation of the affected leg as treatment of tumor.
* Estimated blood loss \> 2 liters during surgery.
* Surgical drain output \> 500 cc of bloody fluid during first 8 hours.
* International normalized ratio (I.N.R.) \> 1.3 pre-operatively or \> 1.5 post-operatively.
* Platelet count \< 100,000 either pre-operatively or post-operatively.
* Indwelling post-operative epidural catheter for pain control.
* History of underlying bleeding disorder, such as hemophilia.
* History of adverse reaction to heparin such as heparin-induced thrombocytopenia.
* Severe liver or renal insufficiency.
* History of hypertensive or diabetic retinopathy.
* History of gastro-intestinal bleeding within 12 months.
* Treatment with warfarin, clopidogrel, aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), low molecular weight heparin (LMWH) or other anti-coagulants for conditions.
* History of stroke.
* Women of child bearing potential having a positive urine or serum pregnancy test (human chorionic gonadotropin \[hCG\]) at the time of pre-operative evaluation (within 7 days of surgery).
* Women who are breastfeeding.
* Hemoglobin \< 8.0 g/dL.
* Platelet count \< 100,000/L.
* Alanine aminotransferase \> 100 IU/L.
* Aspartate aminotransferase \> 100 IU/L.
* Direct bilirubin \> 0.5mg/dL.
* Serum creatinine \> 2.0 mg/dL.
* Patients taking COX-2 inhibitors.
* Patients who have fragmented mechanical heart valves.
Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer

There is a relation between inflammatory cells and the prognosis of tumors (cancer colon, renal, liver, and urinary bladder).

In this study, the investigators will link the Neutrophils to Lymphocytes ratio to the response to intravesical BCG therapy post trans-urethral resection of urinary bladder tumors for the non-invasive urinary bladder tumors.

The gold standard treatment for non-invasive urinary bladder tumors is by transurethral resection of bladder tumor (TURBT) and a re-TURBT when indicated, followed by adjuvant intravesical immunotherapy (BCG). However, the recurrence and progression rates of non-muscle invasive bladder cancer (NMIBC) for 5 years range from 31% to 78% and from 1% to 45%, respectively.

To improve personalized care, prognostic models have been developed to help in prediction of the high-risk patients and recurrence helping in clinical and therapeutic decision-making. These models are based on standard clinic-pathological features such as T stage, grade, multifocality, sex, tumor diameter, recurrence rate, and concomitant carcinoma in situ.

According to the current theories, the systemic inflammatory response triggered by cancer leads to relative neutrophilia and lymphocytopenia, creating a pro-oncogenic inflammatory condition. An elevated NLR (Neutrophil to lymphocyte ratio) implies that cell-mediated immunity is impaired and systemic inflammation is increased in inflammatory processes. Among patients with non-invasive urinary bladder tumors, an elevated NLR (Neutrophil to lymphocyte ratio) was described in the literature to be associated with advanced pathologic stage, invasiveness, and bad prognosis.

The study aims to assess the role of preoperative Neutrophils to Lymphocytes ratio as a predictor for the response to BCG in patients with non-muscle invasive bladder cancer in patients following trans-urethral resection of bladder tumor (TURBT).

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-muscle invasive urothelial tumor of the urinary bladder

Exclusion Criteria:

1. Concomitant malignancy.
2. Hematological disorders.
3. History of radiation or chemotherapy.
4. Concomitant infection or chronic inflammatory diseases.
5. Missing preoperative differential blood cell count.
6. Patients with low grade non muscle invasive Urinary baldder tumors.
7. Patients missing BCG after biopsy revealing NMIBC.
8. patients with non-compliance to BCG doses or the scheduled follow up.
Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis

Type A acute aortic dissection (TA-AAD) patients are prone to life-threatening complications and death during the acute phase. Currently, little evidence is available with regards to the relationship between eosinophils (EOS) and TA-AAD.

A total of 274 patients with TA-AAD were eligible for inclusion and 54 patients deceased within 1 month following surgery. Multivariate regression analysis, the general linear model repeated-measures ANOVA analysis (corrected by Greenhouse-Geisser test), receiver-operating characteristics (ROC) curves and a Kaplan-Meier curve were applied for statistical analysis.

For this study, 274 patients with TA-AAD admitted into our hospital between February 2019 and July 2021 were enrolled retrospectively. A total of 54 patients deceased unfortunately within 1 month following surgery. We compared baseline sociodemographic, clinical, and functional status based on the main outcome using t tests or Mann-Whitney U test for continuous data and χ2 or Fisher's exact tests for categorical data. Continuous variables were expressed as mean SD median depending on the normality of distribution, and categorical variables were expressed as absolute number along with their percentages and compared using the chi-square test. Multivariate regression analysis was applied to assess the association between EOS and 1-month mortality in an unadjusted model, in an age-, sex-, Body mass index (BMI)-adjusted model (model 2), adjusted for age, sex, BMI, systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) (model 3), and further adjusting for age, sex, BMI, SBP, DBP, MAP, heart rate (HR), diabetes, stroke and hyperlipidemia (model 4). In addition, the general linear model repeated-measures ANOVA analysis (Corrected by Greenhouse-Geisser test in nonspherical cases) was used to compare preoperative EOS and postoperative eight-days EOS. For prognostic analysis, receiver-operating characteristics (ROC) curves were used to determine the optimal cutoff of EOS at different points and the time of postoperative EOS to return to normal levels for the prognostic events. A Kaplan-Meier curve was then applied to compare the prognosis between the 2 subgroups based on the predictive threshold. A P value\<0.05 was regarded as statistically significant for all statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* The patients with a diagnosis of Type A acute aortic dissection by the computer tomography

Exclusion Criteria:

* History of cardiogenic shock or cardiac tamponade;
* Iatrogenic aortic dissection;
* Traumatic aortic dissection;
* Severe valvular disease;
* Congenital heart disease;
* Severe organ dysfunction, such as liver and kidney failure;
* Metabolic diseases such as gout or hyperthyroidism;
* Malignant tumor;
* Severe gastrointestinal diseases;
* Recent drug usage that might affect EOS;
* Allergic diseases;
* Infectious diseases;
* Skin diseases;
* Hematological diseases, such as leukemia and myelodysplastic syndromes;
* Immune system diseases.